UNITED STATES OF AMERICA


                              )
ADVISORY COMMITTEE ON HUMAN   )
RADIATION EXPERIMENTS         )
PUBLIC MEETING                )
                              )

                         Blue Room
                         Omni Shoreham Hotel
                         2400 Calvert Street, NW
                         Washington, D.C.

                         Friday,
                         February 17, 1995

                         8:00 a.m.

          Advisory Committee Members:

          RUTH R. FADEN, PH.D., M.P.H. - CHAIR
          KENNETH R. FEINBERG, J.D.
          ELI GLATSTEIN, M.D.
          JAY KATZ, M.D.
          PATRICIA A. KING, J.D.
          SUSAN E. LEDERER, PH.D.
          RUTH MACKLIN, PH.D.
          LOIS L. NORRIS
          NANCY L. OLEINICK, PH.D.
          HENRY D. ROYAL, M.D.
          PHILIP K. RUSSELL, M.D.
          MARY ANN STEVENSON, M.D., PH.D.
          DUNCAN C. THOMAS, PH.D.
          REED V. TUCKSON, M.D.

          Staff Members:

          DAN GUTTMAN
          ANNA MASTRIOANNI
          SARA CHANDROS
          JEREMY SUGARMAN
          JOHN HARKNESS
          JONATHAN MORENO
          GARY STERN









                       A G E N D A

AGENDA ITEM:                                 PAGE:

Update on Research Proposal Review Project    439
     Sara Chandros

Update on Subject Interview Study             475
     Jeremy Sugarman and Nancy Kass

Committee Discussion:  Professional           486
     Standards and Practices

Committee Discussion:  Cold War Research      533
     Ethics Standards in Retrospect

Committee Discussion:  Remedies               589





































                  P R O C E E D I N G S

                                             8:05 a.m.

          DR. FADEN:  Would the committee please come to order?  

Somewhere buried in here is my copy of the agenda, but who knows.  

It's yellow, and that should help, right?

          Guys, if we could come to the table, that would be great, 

especially Phil, who was here really early, right?  

          All right.  We have a full Friday, and we're going to start 

-- too late, only about five minutes late -- with an update on the two 

contemporary empirical projects.  Sara is with us to update us on the 

status of the Research Proposal Review Project.  Okay.  Good.

          Jay is here, isn't he?  I know Jay wants to be part of this 

discussion.  So, let's see if we can find Jay.  I saw him.  Okay.  

Thank you.

          We have the Update on the Research Proposal Review Project, 

then the Update on the Subject Interview Study, and then we launch 

into two chapters, then we have lunch, and then we do Remedies 

essentially all afternoon.

          What a fun day, right?  Actually, I think it will be very 

interesting.  There's a certain risk in





having such an important topic on the last day of a very intense 

meeting, but, on the other hand, it's hard to nod off when that's the 

topic.  So, we figured that would be a good way to keep people engaged 

until the last minute.  We'll see if it works.

          All right.  Sara, are you ready?  We've got Jay now.  We do 

have Jay.  Okay.  Good.  Sara, can you just start us?

       Update on Research Proposal Review Project

          MS. CHANDROS:  Sure.  You can follow along on the hand-out 

that I passed out yesterday.  It's titled "Update on the Research 

Proposal Review Project, Preliminary Results".

          We are now well into the review phase of this project, 

although maybe not as far as would be ideal, but we've begun to do 

some preliminary analyses of the results based on a total of 47 

reviews that have been conducted.

          So, in this report, there's a number of bullet points, 

preliminary hypotheses, that we put forth for you to consider, 

consider if this is the sort of analysis you want done, or if you have 

any different observations that you've noted you'd like to see 

included or that you disagree with.

          One update from the last meeting, based on





the responses from the extramural institutions, we're now up to a 

hundred percent, all 40 institutions showed a willingness to comply.  

So, that's good news.

          Also, just so you know, I don't know if we'll get to it in 

this report, but the second half of this memo just talks about the 

state of the sample.  We had to do some recategorization, and there's 

some tables.  Those are updated for you to look at.

          DR. FADEN:  I don't think we have to go over it, Sara, but 

it's back there, and --

          MS. CHANDROS:  Okay.  Anyway, that's what we've got.

          DR. FADEN:  -- people can read it, and if they have 

questions, they can call you.

          MS. CHANDROS:  Great.  So, we have 47 reviews entered into 

the data base now.

          First, I want to emphasize that what's included in the 

report, the percentages and the numbers, are not meant to be a 

statistical analysis.  It's only -- they're only reported to give a 

sense of the distribution of various trends and various responses that 

reviewers have reported, but it's not a formal statistical analysis.  

The numbers don't mean much, especially based on 47 reviews at this 

point.  They're only preliminary distributions.





          To give an overview of the state of the research documents 

that we've been reviewing, in several cases, we've been finding that 

there is incomplete documentation, and this actually looks like it's 

about all we're going to be getting for some of the studies, and if we 

have at least a protocol, at least a description of the research, 

we're going to go ahead and review it, even if there are no consent 

forms.  We can get some sort of statement about the research.

          When this wasn't included, we're going to have to eliminate 

those studies from this sample.  So, we've been finding a mixture.  

Unfortunately, there have been a notable number that aren't going to 

have complete information, but we'll forge ahead with those reviews 

anyway.

          With -- generally speaking, those -- a problem that was 

noted with program project grant proposals, that's noted in the second 

bullet that you see, full protocols for the specific sub-projects are 

not included, and reviewers were concerned that there's not adequate 

descriptions of these projects, and they're difficult to review, and 

also sometimes sub-projects were considered to be completely out of 

the purview of the overall project grant, program project





grant.  These titles are alliterative, and they get confusing, but -- 

so, just to mention so people can note when they're looking at future 

proposals, that's what some of them are going to look like.

          And then one other general observation about these 

proposals, intramural materials seem to have less detail than the 

extramural materials in the actual proposals.  The descriptions are 

less detailed and comprehensive, and I just put these out as 

observations and not necessarily as judgments of the proposals, even 

as noted by the reviewers.

          We've noted that a lot of the issues that have been raised 

are not necessarily specific to radiation research.  They are 

observations that can be noted about all research.  So, the specific 

problems are not necessarily of issue to radiation research alone.

          We've been giving an overall assessment to each of the 

proposals.  Reviewers kind of give a gross analysis of one to five, 

which we want to now consider, like a grading system, a school grading 

system, A to F, where one is outstanding and five would be 

unacceptable, the equivalent of failing.

          We have -- approximately half of the studies received an 

overall assessment of one, the best rating





possible.  About a quarter of the studies were given a rating of two, 

13 percent received three, six percent received a four, and two 

percent received a -- I mean four percent, two total, received a 

rating of five, and then we have one non-response, and I just want to 

throw in there, there's not supposed to be any non-responses with 

these questionnaires.  Every question is supposed to be answered.  So, 

I want to alert reviewers that you have to be careful to put an answer 

for each question on the form.

          With respect to these ratings, at least half of them, 

especially primarily the ones that received a rating of one, were 

categorized as minimal risk studies.  A high proportion of the 

problems were concentrated into the studies that involved more than 

minimal risk, and when I'm done giving this overview, I know Jay wants 

to go further into that, some work he's done on that area.

          For reasons that we may want to discuss or speculate about, 

clinical trials on the whole fall into the category of highly 

acceptable research.  There have been relatively few problems reported 

with those kinds of studies as a category.

          We're looking -- some proposals we have multiple sites for 

the same proposal, and we're looking





at those together to see if there are any comparisons between the way 

that -- the requirements that IRBs have for the consent forms at each 

of their institutions, and with at least one study, we found that they 

were -- the consent forms were revised quite differently with respect 

to the discussion of risk.  So, we're finding differences between 

institutions for those same exact protocol.

          We have one-quarter of our studies are categorized as 

epidemiological or follow-up studies, and these, I want to point out, 

these, as we know, raise different issues than the tracer, diagnostic 

or therapeutic studies, and need to be looked at for specific areas, 

such as psycho-social risks in particular, confidentiality issues, and 

the degree of follow-up, just the medical, psychological and 

statistical follow-up.

          So, I want to alert reviewers that there's going to be 

different issues that we have to look at.  This hasn't been pointed 

out in the past before.

          With respect to some individual items in the coding form, 

the process of subject selection.  For example, there have been a lot 

of indications that these are inadequately discussed in the research 

documents for these studies.





          Approximately -- almost half of the studies lack an adequate 

discussion of the recruitment process, how subjects are being brought 

into the study, and 41 percent of the ones reviewed so far don't 

adequately discuss the confidentiality issues, how that will be 

handled.

          In addition, 60 percent of the documents do not include any 

information about the alternatives to participation for subjects.  

This was one of the most noted things in the reviews by reviewers.

          The selection of subjects.  The inclusion criteria for 

certain subject populations is generally not discussed 

comprehensively.  A lot of inferences can be made about where the 

study is being held, but oftentimes it's not specifically mentioned 

whether pregnant women, whether the economically disadvantaged, 

institutionalized persons, such as prisoners, and adults of 

questionable competence.  Their participation is not discussed one way 

or the other, and in some cases, persons with questionable competence 

appear to be included in the study, but no specific mention was given.

          So, this was highlighted as a concern, and also in those 

cases, how consent would be secured, and whether another party was 

going to be used to authorize





the research was not discussed.

          The level of compensation is another area that was -- that 

stood out as a problem in a lot of these reviews.  Some reviewers 

indicated that subjects may have been paid too much or compensated 

unnecessarily at all, and, additionally, people were -- reviewers were 

concerned that the payment would prejudice -- would bring in a 

specific population, mainly the economically disadvantaged, in many of 

the situations, and a third note, patients oftentimes were expected to 

pay for the experimental procedures themselves on the other side.  

Rather than being compensated, they were being asked to pay from their 

medical insurance or their own pocket.

          The next issue, the next category I have in this memo is the 

discussion of risk versus potential benefit in the consent forms.  The 

consent forms in general varied, varied greatly from between 

institutions and used very different descriptions of risk to patients, 

primarily -- I mean particularly of radiation risk.

          I'm skipping around actually.  That's a point that shows up 

later, but there's three ways generally that it's discussed.  Highly 

technical explanations of the doses that are being used, a comparison 

with a





known risk that is relevant to radiation research, such as x-rays, 

even if that's not the procedure included in the study, and then 

comparison to something like crossing the street, something that the 

patient is familiar with but isn't necessarily germane to radiation 

research.

          So, there's great variability.  These observations may not 

be surprising, but they were widely noted between all of the forms.

          Another variability in the forms is the use of standard or 

what we call boilerplate language.  Many forms include a standardized 

section that's very much set apart from the rest of the form, where 

the font is even smaller.  So, it literally forms the fine print, and 

the reviewers were concerned that subjects would gloss over these 

sections, and particularly if that's a concern, the fact that the 

benefits, potential benefits is discussed in this section as a 

standard section, rather than specified -- rather than specifically 

discussing it as relates to the study.

          It shouldn't be part of a standardized section.  It should 

be discussed very specific to the research that the consent form is 

relating to.  So, this was another area that was highlighted.  That 

was a specific example.





          The language.  34 percent, about a third of the studies, 

were highlighted as using inappropriate language for the subject 

population, too complex or too technical and therefore unsuitable.

          Another aspect of risk that was -- that concerned reviewers 

is that many -- not many, but in some cases, patients were taken off 

medications that they were on for psychiatric or cardiac conditions to 

participate in the experiment's procedures, and the discussion of the 

risks associated with coming off medication was inadequately described 

to subjects.

          So, overall, a total of five or about 10 percent of the 

sample that we have so far raised serious ethical concerns among 

reviewers.  In general, the problems highlighted with respect to these 

proposals that raised high concerns were the disclosure of risks and 

potential benefits to subjects, and excessive levels of risks and 

burdens in the design of the experiments.

          But the studies that were found to be troubling will be 

evaluated further by the proposal review subcommittee and staff before 

any final determinations are made about how to regard these studies.  

That's the preliminary view of those results.

          Now, I want to defer to Jay to talk a little





about what you wanted to.

          DR. KATZ:  Thanks, Sara, and I wanted to bring some matters 

to your attention, and Ruth Faden and I talked about that last week, 

and what I'm going to say is going to be quite brief because I haven't 

completed my review yet, and I hope to be able to give you a fuller 

report next time.

          But at least to me, some of my findings are somewhat 

disturbing, and I thought you ought to know about it so we can all in 

the ensuing weeks think about it.

          First of all, I've worked fairly closely with Sara, and I 

just wanted to tell you that she's done a marvelous job as have so 

many other staff members, but she's had a very, very difficult time in 

getting on top of all these massive pieces of paper, to organize them, 

and we all should be grateful to her.

          Now, I on my own volunteered for reviewing protocols.  I 

eventually reviewed at least a 120 protocols, and I've already 

reviewed 90, and that's what I wanted to give you the briefest kind of 

report on, but I want to go first -- I want to go back -- don't shake 

your head, John.  I thought in the Army, everybody volunteers.

          So, I mentioned the review first because I





first want to make it very -- a few brief comments on the official 

review.  John Herbert and I have reviewed 20 of the 47 protocols so 

far, mainly because both of us for whatever reasons do these things 

almost immediately, then we talk on the telephone for awhile, and, but 

when I looked at the -- at my notes of the first 25 protocols that I 

reviewed, and just stared at them for half an hour, to see what I was 

learning, I noted that many of the studies that I reviewed had next to 

it trivial, most minimal kind of risks, etc., etc., and I began to 

wonder about it, and particularly paid attention and alerted John to 

this, and we paid attention to it in the 20 protocols that we 

reviewed.

          We have, I think, a somewhat skewed number.  It doesn't 

quite -- it isn't quite in line with my unofficial review.  Of the 20 

that we reviewed, 15 were trivial, non-complex, most minimal kind of 

risks.

          One we couldn't evaluate.  So, that leaves 16.  Of the four 

that were both problematic and raised questions about risk benefits, 

one was quite acceptable.  One of them we disagreed on.  John gave it 

a three, and I gave it a four.  The other two, we were in agreement of 

giving it four and five.

          The implication is if you only then look at the four 

documents that are really pertinent to our





inquiry, 75 percent raised questions of ethical concern.  If you 

evaluate it against 20, then, of course, it gets very much reduced, 

only 10 or 15 percent raise questions, and that is our finding with 

respect to the official reviews we've done so far.

          Very briefly, and I'll give you a fuller report next time, 

and I've -- of course, by getting -- immersing myself in this work, 

all kinds of new categories come to mind that deserve possibly a 

separate attention, but what I'm giving you now is my most inclusive 

kind of evaluation in terms of problematic/non-problematic and very 

problematic kind of protocols and consent forms.

          If I were to subdivide them a little bit more, the issues 

that emerge are even at least more troublesome to me.  But, anyway, of 

the 91 protocols, 55 or 60 percent, it's lower than in the official 

review, deal with trivial kind of issues, tracer studies, 

epidemiological studies, follow-up studies, etc.

          So, there are 40 percent left and/or 36 protocols.  Of these 

36 protocols, 10 were good ones, 12 were problematics, and 14 were 

very problematic, which means that in my evaluation, 39 percent of the 

protocols, sticking only not with the 91, but with the





34, to me, they raise serious concern.  About 33 percent, one can 

differ, though they raise concerns for me, and 28 percent are very 

adequate.

          But that number -- take, for instance, the very problematic 

one, which in my evaluation amounts to 39 percent, would be reduced to 

15 percent, the more acceptable kind of figure, if you included the 

other 55 experimental studies.

          I will be able to give you much more detailed breakdown 

hopefully next time, but Ruth and I thought that we should bring this 

matter briefly to your attention.

          DR. FADEN:  I see some people wanting to ask some questions.  

Ruth, Duncan, Henry, and Nancy, I have so far.  Ruth?

          DR. MACKLIN:  Yes.  If I'm going to frame my remark as a 

question --

          DR. FADEN:  Or it can be a comment.

          DR. MACKLIN:  Yeah.  Well, I'll frame it as a question, 

which is, what should we take to be the implications of this?

          Now, I don't remember, Jay, the specific phrase that you 

used, but you said something, I think you used the phrase, "the ones 

that really concern us or the things that concern the committee", and 

it's my





understanding that all research, I mean specifically radiation 

research, but all research concerns us since, in our retrospective 

look and the look at a lot of these historical studies, the conclusion 

has already been tentatively drawn that they were low-risk or 

minimal-risk, but the problem with the research lay elsewhere.

          Minimal-risk studies on mentally retarded children in the 

Fernald School or low-risk studies where children were involved but 

their parents were not asked for consent raised ethical problems.

          So, and I'm sure you would agree that any research done 

today, no matter how minimal, if people don't know they're part of a 

study or if there's inadequate consent or if they're coerced in some 

way, is also not acceptable.

          So, I appreciate the evaluation of the serious concerns in 

the more than minimal risk, but I don't think we should take that as a 

reason not to look at or be concerned about all the ethical features 

of those that do pose only minimal risk.

          Since our sample is presumably -- I mean we can only presume 

a sample of research carried out today in the United States, the 

percentages of the total are relevant, at least for looking at what 

percentage posed





higher risks.

          We might find, though, that among the low-risk studies, 

there is inadequate consent.  I mean I can only think of one consent 

form in the 17 or 18 that I looked at that I said was adequate.

          So, there are still problems with research that's carried 

out today, even if it's in the more than minimal category.  So, I mean 

--

          DR. KATZ:  Well, a brief answer, and, of course, your 

question, Ruth, is well taken, and, of course, I paid attention to 

this but didn't include it in my brief report.

          When I talk about minimal risk, I concluded from the minimal 

risk because my categorization at the moment is minimal, non-complex 

kind of issues.  When -- like the Fernald problem came up, I put it -- 

I put it in the category for separate evaluation, and we are not 

included.  There were few, only a few of those kinds of protocols 

because this kind of research is not done.

          So, at least that point, and maybe other points, you're 

quite rightly concerned about, I've taken into account.

          But let me, in the light of what you've said, put it most 

starkly, and I will try to document it more for you by next time, my 

preliminary conclusion is,





which, of course, could be changed, as I go along, but 90 out of a 120 

that I plan to review and 90 out of a 160-70 that were -- that we are 

going to review as a committee is a large number.

          My impression is from this review, and that's what I focused 

on, that the information disclosed to subjects of research is 

inadequate in at least the informed consent form to a disturbing 

extent, and, secondly, that the IRB process, the review process, in 

many crucial respects, isn't working very well, and we are now in 

1994, we are now in a post-federal regulation, and we're now in the 

period of having made a great deal of more progress, but more progress 

in my view has not been as great as I would have hoped for, though 

these findings, as you know from our writing, are not unexpected.

          DR. FADEN:  Duncan?

          DR. THOMAS:  I'll wait.

          DR. FADEN:  Okay.   Henry?

          DR. ROYAL:  I think it's -- that the data that Jay presented 

is important because if it were true that there were more problematic 

studies with minimum risk, it would mean to me that you would want to 

review those kind of protocols more extensively.

          The thing I'm confused about is the mixed





messages that I'm getting.  In the hand-out, it says, on Page 2, "a 

high proportion" -- the very last sentence, "a high proportion of the 

problems that the reviewers identified are concerned among studies 

with more than minimum risk", which is what Jay has said, but then the 

next bullet says, "clinical trials/studies with therapeutic categories 

have on the whole raised few major ethical concerns", and I guess the 

reason that I'm confused is therapeutic trials, I would have thought, 

would be more likely to have more than minimum risk than 

non-therapeutic trials.

          DR. FADEN:  I think, Sara, you might respond, but my sense 

is that within the category of the ones that are more than minimal 

risk, the clinical trials seem to be more better thought through.  So, 

it's not like all the ones that are more than minimal risk are 

ethically problematic.  Is that a fair characterization?

          MS. CHANDROS:  That's a fair characterization.

          DR. FADEN:  But the ones that are particularly multi-center 

clinical trials, it appears as if more thought has been given to the 

ethics questions.  That's a hypothesis, but I mean it looks like 

they're more detailed discussions, and that may be





because clinical trials now have multiple levels of monitoring and 

review.

          So, the inference is -- this is all preliminary.  This is 

not -- Jay's done 90, this is based on 47.  So, it may turn out that 

that doesn't hold.  I mean it may turn out as we do a couple more 

clinical trials --

          DR. ROYAL:  Maybe I should ask Jay directly then.

          DR. FADEN:  Sure.

          DR. ROYAL:  About whether or not the protocols which you 

found ethical problems in were more likely to be in the 

non-therapeutic category or the therapeutic category.  Though I must 

admit I hate those words.

          DR. KATZ:  I can't tell, Henry.  I think they are more in 

the therapeutic categories or in that mixed group, you know, where 

therapeutic and non-therapeutic -- what's the word -- objectives are 

intertwined.

          For example, a number of them are Phase 1 clinical trials, 

and two or three of them raise some very serious issues with respect 

to the informed consent process.  Is this what you have in mind?

          DR. ROYAL:  Let me ask you in a different





way.  The radiation aspect of the study could be used in one of two 

ways.  One way would be to do some diagnostic technique to tell what's 

happening in some intervention, and another way would be to use 

radiation to treat something.

          The ethical problems that you're seeing, is it with the 

radiation part that's being used to monitor some intervention, or is 

it the intervention itself that you're seeing the problem with?

          DR. KATZ:  I'm not sure yet.  Unfortunately, I have the data 

on that, but I have not tabulated yet for myself.  It's an important 

question.  I hope to be able to tell you more about that next time.

          DR. FADEN:  We've got Nancy, Lois and Ruth is back.  Did you 

want to come right on this -- right on Henry's point?  Okay.

          DR. MACKLIN:  I just wanted to ask Henry, why you would be 

surprised.  I mean the clinical research and clinical trials that 

provide some direct benefit to patients may pose higher risks, but 

they may be judged acceptable because there is some benefit.

          So, it's entirely possible for there to be a lower risk in a 

study that provides no direct benefit to the subjects, and therefore 

that's more problematic.  So, because the risk benefit ratio is the 

critical





thing we have to look at when there's no direct benefit to subjects, 

there's a higher index of concern for the -- so, I mean to me, what 

you find surprising is less surprising.

          DR. ROYAL:  Well, that does seem to be a theme.  I noticed 

in the chapter on children, there was that exact statement, that 

non-therapeutic research tended to be more problematic than 

therapeutic research.

          I must say I don't -- I'm not convinced of that position, 

and the reason that I'm not convinced of that position is what you 

really want to know is the net benefit or harm, and the potential for 

a much more negative -- much more harm is often much greater with a 

therapeutic study because you're willing to take much greater risk.

          I'm wondering if the committee, and maybe I'm the outlier, 

but many people I don't think have a very realistic view of medical 

research.  That is, they believe that people are more likely to 

benefit from the research than to be harmed from the research, and I 

think if that were true -- in other words, if before you did the 

study, you were reasonably convinced that there was more benefit than 

harm from whatever it was that you were proposing, then I think that 

you would be





using that, whatever it was that you were proposing, routinely, 

because you would be -- you already had convinced yourself that it's 

more likely to be beneficial than harmful.

          In reality, if you look at chemotherapeutic agents as an 

example, and you look at how many of them are clinically tested, and 

how many of them ultimately turn out to be clinically useful, I think 

that you would find that the odds are greater that it's not ultimately 

going to be turned out to be clinically useful.

          So, again, I'm just not convinced that testing therapeutic 

agents doesn't ultimately result in more net harm than non-therapeutic 

trials.

          DR. FADEN:  This is an important discussion, obviously, not 

just for this but for our general implications.  I've got Eli and 

Phil.  The only problem is we have an extended agenda.  So, I've got 

Nancy, Lois, Eli, Phil.  Are there -- unless someone is really moved 

by some comment that one of the four makes, I'm going to -- we'll have 

those four, and hopefully the discussion that Henry and Ruth are 

having, we will keep in mind as we work -- as we all work on the 

proposals themselves.  Nancy?

          DR. OLEINICK:  Okay.  First, I just have a





small comment on one of the findings that you found less detail in the 

proposals on the intramural research than the extramural.

          I think that's probably to be expected, at least with NIH, 

and I don't know about the other agencies.  The intramural research is 

judged primarily on the track record of the investigators, whereas 

extramural is judged primarily on the proposed research.  That's just 

inherent in the way that it's done.  So, I'm not surprised to hear 

that.

          But my question has to do with what we're finding and 

however the percentages come out, there's still -- what we're finding 

is that there is some significant fraction of these proposals that 

have serious problems about how human research is being conducted, and 

what I wonder is if we as a medical- scientific-ethical community 

today are carrying out our research in a less-than-perfect way.

          Does this in any way compromise our ability to make 

judgments about the past where the guidelines and standards were less 

clearly defined?  And I don't have an answer to that at the moment, 

but I think that's something we might want to think about.

          DR. FADEN:  Right.  I think that's a very important 

observation, worth thinking about.





          MR. GUTTMAN:  It just means that doctors shouldn't make the 

judgments.

          DR. FADEN:  Spoken like a lawyer.  Eli?

          DR. GLATSTEIN:  Well, as far as those therapeutic studies 

are concerned, I'm not surprised that the major problem Jay see is in 

the Phase 1 trials because by definition, a Phase 1 study is a study 

in which one doesn't know what dose of an agent to give.

          So, you start off with a very low dose and escalate doses on 

a gradual pre-planned way, until you finally reach a point where the 

patient has side effects of the drug, and a patient has toxicity.

          The expectation is not to see objective improvement.  It's 

one of the things you'd like to see, but that's not the point of the 

study.  The point of the study is to define the dose.

          What I find interesting in some of the studies I've seen, at 

least the last one I looked at, which stunned me, was no description 

at all of the potential lethality of aggressive treatment for lymphoma 

in this particular case, and I mean these treatments do have a finite 

lethality associated with them.  Anyone who thinks they don't is 

naive, and that has to be addressed.

          The other thing that stunned me in the one





that I was looking at is it happens to deal with an invalant kind of 

lymphoma where the Number 1 controversy among specialists is, is 

treatment at all indicated when the diagnosis is made, because it 

happens to be very invalant process.

          That isn't even described in this particular protocol.  The 

natural history of the lymphoma is not described, and, so, there are 

more problems than I would have guessed.

          DR. FADEN:  Phil?

          DR. RUSSELL:  I agree with Nancy's comment about the meaning 

of the lack of detail in the intramural versus extramural.  The 

extramural ones are written to be competitive in a funding process, 

and the intramural ones are not, and the lack of extensive detail is 

not at all related to quality in a necessary sense.

          I'm hearing the discussion here, and I'm trying to sort it 

out, whether we've got the parameters that we're talking about clear 

in our minds.  On the one hand, we've discussed judgment issues, the 

harm versus benefit issues, and are there -- have we found any 

protocols that are -- where there's evidence of very bad judgment, but 

that the process didn't sort out a risk benefit issue that clearly 

everybody agrees they





shouldn't have done that study, and I haven't heard that yet, and I 

wonder.

          DR. FADEN:  That's what we're working towards, to see if 

there are any.

          DR. RUSSELL:  One fundamental issue.  There's a lot of 

discussion about process and documentation of the process, and I think 

we have to differentiate whether there was evidence that a bad process 

occurred or whether the paper work wasn't fully complete.

          And then at the end of the day, I think most of the 

inadequacies are discussing the issue of the adequacy of the informed 

consent, and not only the quality or the extent of the content of the 

perceived risk, but whether it was put in the language that was both 

precise and comprehensive and understandable, and in most instances, 

that's mutually exclusive.

          To obtain -- having attempted to write consent forms for 

vaccines which are -- have immensely complicated potential dangers 

involved, and to be reasonably precise and accurate makes it 

impossible to write at a level that's understandable, for example, to 

a below high school education.

          So that I wonder whether we're able in our minds to sort out 

the judgment, the process, and the linguistic problems that seem to 

hang us up, and I





hope, Jay, that when you analyze these, you'll be clear, make it clear 

to us where your -- which of those parameters you're most concerned 

about because I'm much more concerned about judgment issues and the 

probability of something bad happening.

          Do we have that barrier firmly in place and rather than the 

details of the process?

          DR. FADEN:  If I can just interject, I think it will be 

obviously incumbent on us when we conclude our finding -- we conclude 

our deliberations and report our findings to be very specific about 

what it is that is ethically troubling in whatever categories of 

research we identify. 

          So, we do want to distinguish those studies where we think, 

as best as we can tell, there is an unacceptable balance of risks to 

potential benefits, if there are any, from those where the study might 

be ethically permissible if there were proper safeguards with respect 

to questions of consent and authorization.

          So, that is, I think, an important distinction or if a 

different study population were selected or whatever the issue happens 

to be.  So, however we conclude it, I'm sure that we all agree that we 

have to be quite specific in providing our reasons why we are 

concerned about the studies that we are





concerned about.

          We've got -- and those are important distinctions to keep in 

place.  I saw Henry wanting to respond and Jay wanting to respond.  I 

keep saying we're calling it, it's like my new role in life, but how 

about if we just do that, and then we will have a very full discussion 

of this.  This was to be just a preliminary report, both from Sara on 

the part of our collective review, and Jay on his review personally.

          So, it's not as if we won't have a lot of space in March to 

really, really take this apart.  Let me just emphasize one thing that 

Sara didn't, and then we'll go to Henry and Jay, and that is, some of 

us have not kept pace with Jay and Ruth Macklin in terms of -- and me 

included here, in terms of the numbers of protocols that we have been 

reviewing.

          Jeff showed me some numbers, Sara.  I don't know.  I don't 

have them in my head, about the number we have to do.  Is it 30 a 

week, if we want to get done by the end of March?

          MS. CHANDROS:  That's what it would take.

          DR. FADEN:  All right.  We have to really -- I know that so 

much is being asked of all of us in the context of this committee, but 

we really need for each of us to do our reviews, and I'm hoping that 

given the





significance of what we're finding, and I want to be clear about the 

message, it does look that we are identifying, as Nancy put it, some 

number of research projects that raise very serious concerns.

          We're also identifying, as Jay has characterized it, keeping 

in mind Ruth's very careful qualifier, that at least from the 

perspective of the risks to which the public are being put, quite 

apart from questions of subject selection and adequacy of consent, 

that we -- the message tentatively is that a substantial number of 

research projects currently being conducted do not appear to put 

subjects involved at substantial risk.

          So, there's, you know, there's a way to phrase -- there's a 

-- we have to be careful about the complicated take-home message at 

the end of the day.  But we really -- I'm hoping that people, seeing 

we have some serious issues that we are going to have to report in our 

findings, that that will spur people even more to do their reviews and 

get them back because unless we do them, obviously we can't report 

them, and I know it's a tremendous burden, but -- and I'm guilty, too.  

So, we all need to do it.

          Okay.  We've got Henry and Jay, and then we end this 

discussion.





          DR. ROYAL:  My first comment is similar to Phil's comment, 

and that is that we should distinguish concerns that are what I might 

call errors of omission from errors of commission.  I mean there are 

some protocols that you downgrade because you just can't figure out 

what they did, and there are others that you find unacceptable because 

you know what they did, and it's unacceptable, and if there's a way to 

distinguish those two in the reporting forms, I think that we should 

do it.

          The second thing is I would like it if we recorded that 

final score that the individual reviewers come up with, and then also 

record whatever the consensus is.  I think it would be useful to know 

how much variability there was among the individual reviewers.  You 

would just basically report two sets of scores, what each person had 

originally did and then what consensus that they reached.

          DR. FADEN:  The problem I have with that, Henry, at least in 

the few that I've done with John, is that I sometimes reserve my final 

judgment until I get information from -- I mean we've only done a few, 

but as a team, we sit down together, and we really discuss what's 

going on and then can jointly -- I mean I don't -- I don't think it's 

a process.  It's never been





for me a test of how much agreement there is individually as to the 

overall ethics of this.

          Of course, the issues of what's the difference between a 

four and a five and a three and a four, I don't think -- I don't want 

to invest this with unwarranted precision.  These are judgment issues.  

This is not, you know, like a standardized IQ test with all of its 

problems, where we've got norms and standard deviations to deal with.

          This is -- these are judgment --

          DR. ROYAL:  The place that it might help is you -- if you 

knew individual reviewer scores, you could then adjust them.  If one 

reviewer on average was always a point higher than another reviewer, 

you could do those sorts of adjustments.  You can't do them if you 

just sort of combine them and you don't know anything.

          So, I think that you would -- you could correct for 

individual -- the fact that everyone has a different threshold, if you 

recorded individual reviewer scores --

          DR. FADEN:  Here's -- I mean I understand what you're 

saying, but I think the correction we have is this.  We have two 

people who look at every -- I'm not now talking about Jay's personal 

reviews, but in





every instance, we have two people, and the two people agree, and if 

there's a disagreement as, for example, one that Jay and John 

mentioned, and that was only by one point overall, but certainly if 

someone thought it was a two and someone else thought it was a five, 

the role that Sara's operating is that then would go to other 

reviewers, and we would keep note of any discrepancies of that sort.

          Of course, any proposal that's given a four or a five will 

then be shown to other reviewers, so that even that joint review, like 

the two people with 

-- with two people agreeing that a review gets a four or a five will 

now be shopped around and shown to other people to see if there's 

broad agreement that this isn't an ethically problematic proposal.

          So, I think we have corrections at multiple levels for at 

least people who would be against the norm, if there were one, 

hyper-critical.  People who were hyper-uncritical at the other end, we 

don't have quite the same protections.  I mean we don't sit there and 

say all the proposals, where the two reviewers agree, it should get a 

one are now being shopped around just because reviewers were clearly 

more worried in this case about one kind of judgment than the other, 

and maybe that's a mistake, but we can try and keep





track, if you want, Henry.

          DR. ROYAL:  It just seemed like a simple thing to do, but 

that's fine. 

          The last thing is readability index.  It is possible to 

generate readability indexes, and that's certainly a more objective 

measure of how readable the consent form is and whether or not we'd 

want to do anything like that.  It's something we should think about.

          DR. FADEN:  That's a task --

          DR. ROYAL:  Yes.

          DR. FADEN:  -- kind of thing.  Right.  Jay?

          DR. KATZ:  I'll be most brief, and a number of comments I 

want to make, but I'll leave them, but important for our purposes at 

the moment is Phil's comment very much on target and of concern.  If 

Ruth Faden agrees, and if I can do it, I would like to send all of you 

maybe a week prior to the meeting, I'm not sure whether I can deliver, 

my findings with some brief commentary, but I will only want to -- 

only am comfortable of doing it if I then can get the kind of input 

from all of you and questions and words of caution that Phil mentioned 

in -- that Phil mentioned earlier.

          Let me just say one thing, is the -- I have





so many sub-categories, I do not know whether I -- the findings are so 

rich and whether one can -- I'm still struggling how to categorize 

them.  The complete informed consent forms, they have everything in 

there, are the most incomprehensible of the ones that I've seen.  They 

include chemical formulae because you can interpret, you know, the 

regulation to require that.

          It really is in part a mess, but in terms of the informed 

consent form, I've been primarily interested and based my evaluation 

for better or for worse on a number of criteria in mind, but one I 

want to bring to your attention.

          Is there anything that is so basic to the disclosure process 

that should be in the informed consent form?  And if it's not there, 

it raises serious questions.  Like if in the Phase 1 study, for 

example, the informed consent forms begins and then repeats the theme 

throughout, you are being invited to participate in the frontier study 

for the treatment of breast cancer.

          Now, and this just is the headline, and then it goes on, and 

to me, putting it that way, and talking about treatment, treatment, 

treatment and not research throughout the informed consent form, in my 

thinking, there's something problematic about that.





          But I'll tell you more about it as I go along.

          DR. FADEN:  Phil?  This is pushing it guys.  Come on, group.

          DR. RUSSELL:  There's a potential for endless discussion of 

gradation of judgment here that could go on forever, and I think 

nobody loves just arguing and discussing more than I do, but I think 

what we also need to concern ourselves with all of these discussions 

is issues of recommendations of what on earth we could do about 

improving the system, and I think we need to be very, very careful 

about not getting -- not to get to wound up in the judgmental -- wrong 

word -- in discussing the nuances of verbiage and gradation of 

language and so forth, when what we're really trying to do is look at 

the current system to be sure that it's got as many barriers in it as 

possible to prevent, you know, bad things from occurring, while still 

allowing a reasonable level of investigative endeavor to occur.

          And I just want to be sure that we're looking at our end 

objective here rather than trying to decide exactly what the ideal 

consent form looks like.

          DR. FADEN:  Well taken, and obviously the take-home message 

is this, we're doing these as we have ideas, some of us already had 

some and that may be





shifting based on this experience, but as we have ideas about how we 

might improve things, we should be making note of those and that 

clearly should be a big part of what we're reporting, and again the 

March meeting is devoted both to this project, findings from the other 

contemporary project, and after that recommendations for the future, 

whether it's with respect to this or coming out of some of the other 

areas.  So, that's very important.

          This just shows me how much time we're going to need for 

discussion of this project at the March meeting, among other things, 

and again I want to underscore Jay's comments about the hard work, and 

Sara and Jay and Ruth as chairs of this subcommittee have done an 

extraordinary job.  This is a huge project, and it may turn out to be 

among the more interesting of the projects that we will have done as a 

group.

          Sara, thank you very much.

          We're now going to move on to another very interesting 

project, probably with a somewhat shorter discussion because we're not 

at the stage of reporting any findings.  This is more a process 

report, Jeremy, is that correct?

          MR. SUGARMAN:  Correct.

          DR. FADEN:  On the subject -- so, again, you





have a hand-out that was somewhere or other and hopefully made it to 

your blue folders on this project.

            Update on Subject Interview Study

          MR. SUGARMAN:  I just wanted to provide first an update on 

the memo that you've received with respect to several items with 

subject interview study.

          Right next to Nancy is a book here which shows what the 

actual interview forms look like because they are on NCR paper, and 

the photocopies that you have don't reflect the actual forms.  So, 

we're just handing those around so you can know what the interviewers 

were using in the field.  That's the only show and tell portion of my 

brief presentation.

          In terms of institutional participation, on your memo, I'm 

just going to march through the 19 institutions and tell you where we 

stand with respect to where they are in their institutional review and 

their willingness to participate.

          The Ann Arbor VA is -- its IRB met yesterday.  So, we don't 

have feedback.  The Baltimore VA and Baylor University Medical Center, 

their IRBs have met, and we're uncertain about what sorts of 

deliberations went on, and we're trying to find out.  I'll explain 

what these sort of categories mean at the end.

          The Dallas VA has been approved.  Duke, we're





-- the IRB has met, and we're uncertain of the outcome.  The Durham VA 

and Greater Baltimore Medical Center are both approved.  Johns Hopkins 

Hospital IRB met, and we're uncertain of the outcome.

          Madigan Army Medical Center is approved.  The NIH, the NHLBI 

IRB has met, and we have responded to some concerns that their IRB 

had, which were easy to answer.  It was just a sort of 

miscommunication problem, and the NCI meets next Tuesday.

          Rex Hospital in Raleigh is approved.  St. Joseph's Hospital 

in Michigan is approved.  The Seattle VA and also in conjunction with 

the University of Washington, we're uncertain because the PI for that 

study's mother has been extraordinarily ill, and he had been out of 

town when the IRB materials needed to be submitted and didn't 

designate someone on his way out of town because things were more 

urgent.  So, we're uncertain whether we're going to be able to make 

those two institutions work because of human frailty.

          Swedish Hospital's approved.  University of Michigan's IRB 

met yesterday.  University of Texas-Southwestern is approved.  Walter 

Reed is approved, and Wilford Hall is approved.

          So, what we're left with is we have 10 approvals of the 19 

institutions.  We're waiting for





IRB information without any idea about what direction that went at 

three institutions, and we're uncertain about six institutions.

          The reasons for the uncertainty are -- will be sorted out 

over the next couple of weeks.  As one investigator at one of the 

institutions mentioned the other day, he said, "You know, when you put 

through a proposal like this to an IRB, everyone thinks they're an 

expert and they have a lot to say about it", and we have to deal with 

a lot of experts. 

          So, for anyone who's been through the IRB process knows that 

the fact that we have 10 institutions through is encouraging.  We're 

just going to try to sort through and see if we can have these experts 

reach consensus within the time constraints of the committee.

          We do need because of the committee's deadlines to finish 

data collection really by the end of the month, and if we can't get 

into the institutions to sample, we're not going to be able to provide 

data that can be analyzed.

          Next in terms of instrument development, your comments as 

well as comments of consultants and focus group data helped to refine 

the brief survey instrument and the in-depth interview guide, which 

you have copies





of.  We believe that instrument now is quite nice and should provide 

us with some useful data.

          Based on the committee's discussion last time about the 

concerns that we hadn't elaborated our mechanisms for determining 

research participation, we have had Pat Parentesis join the staff of 

the subcommittee to focus her efforts on this task, and basically 

we're going to develop an institutionally-specific way of determining 

research participation.

          But in every case, we're going to use at least three prongs.  

The first prong is the shadow chart or the clinic chart that's in the 

clinics that we're sampling in.  The second is the institutional 

medical record.  The third is to go to investigators and look at 

investigators' files, and those investigators will be identified in a 

variety of ways, through research nurses or protocol offices and the 

like.

          In some institutions, and there are only a handful, and we 

will use this fourth prong when it's available, is to verify research 

participation using a centralized computer system.  Wilford Hall, for 

instance, has such a system and should make this task a lot easier to 

accomplish.

          That's the best we're going to be able to do,





but I think by taking multiple approaches, it would be hard to do this 

any better than that, and Pat is watching over the subcontractors by 

developing this institutionally-specific mechanism, so they know 

clearly where to go and in what order.       

          In terms of interviewer training, members of the staff 

attended the interviewer training for both the brief interviewers, 

there's something like 30 or 35 of them, and for the dozen or so 

people that will be conducting the in-depth interviews.

          We will be monitoring the quality of the work of Research 

Triangle Institute in two ways.  Next week, we will be having some 

staff, unknown to the subcontractor, in the waiting rooms of where 

patients are being interviewed, and they will just observe the process 

to make sure the process is going well.  

          That should answer any questions about people being coerced 

or anything like that, not that we've had any complaints.  The folks 

have been at University of Texas, and Eli have said that things had 

been going well there.  We have no reason to suspect it, but we want 

to make sure that we have a view of what happens since we're not there 

doing the interviews.

          The second way we'll check is that we will develop a phone 

system for following up with some of





the people who are willing to be contacted back and just asking them 

what they thought of the process.  So, we'll have some systematic way 

of looking at the quality of the interview from two perspectives.

          That's all I have to report at this point, but in the next 

meeting, we should have preliminary data from the brief interview and 

some small pieces of the in-depth data to let you chew on.

          DR. FADEN:  Are there questions for Jeremy?  Ruth?

          DR. MACKLIN:  What do you do if you find out these RTI 

people are behaving badly after they're being covertly observed?

          MR. SUGARMAN:  They know they're going to be observed.

          DR. MACKLIN:  They know?  They've been told?

          MR. SUGARMAN:  They've been told that they've been observed 

randomly.  We've told the head of RTI at the beginning, and we've also 

told the site coordinators that they would be observed in this way.

          It's merely to get a picture on it.  We couldn't figure out 

a better way to check.  If the staff would go out and see something 

that they don't think is right, they'll call, and we'll call, and we 

will stop it.





          DR. MACKLIN:  This is an institution that does a lot of this 

stuff, isn't it?

          MR. SUGARMAN:  Correct.

          DR. FADEN:  That's right.

          DR. MACKLIN:  And these are people who are presumably 

trained in doing these --

          MR. SUGARMAN:  Correct.

          DR. MACKLIN:  -- things?  I mean we may -- I mean I hope we 

don't, but if we actually find something here, it's another piece of 

data about contractors who are --

          DR. FADEN:  That's right.  We've had an interesting 

experience.  I really have to commend Nancy and Jeremy, now Pat.  This 

has basically taken over Jeremy's life.  It's taken over a bigger 

chunk of some of the rest of our lives than we had anticipated.

          The quality assurance looms large.  I mean if we're going to 

stand behind these findings, we have to be fairly confident about the 

quality of the data and the limitations of the data, and, so, we're 

now investing at our end a substantial level of energy in assuring 

ourselves that the information -- assuring ourselves about what we can 

say about the information we obtain, and the view of this committee 

from the beginning was that if it couldn't be done well, we





weren't going to do it at all.

          We'll call it if, you know, God forbid, it is not done well 

enough, we're prepared to say that.  This is not -- you know, the 

standing of the committee doesn't rise and fall on whether the study 

gets done.  It rises or falls on the study being done well, and we're 

all committed, we're all committed to that.

          So, we have every expectation it will be fine, if Jeremy and 

Nancy and Pat have anything to do with it, it will perfect, because 

they're very anal about it, but, you know, there are lots of steps.  

We all are, and that's probably a little too graphic description, but 

the point is that this has become a very obsessive experience.

          I mean we're into dotting I's and crossing T's, but we have 

to be because if we stand -- if we stand behind the findings that come 

from this, we have to be fairly confident that the data are -- were 

obtained in the way in which we thought they were obtained from the 

people from whom we thought they were being obtained.

          So, Jeremy, can you tell us how many places -- you mentioned 

Southwestern.  How many places are interviewers already working?

          MR. SUGARMAN:  Interviewers, I think, have





been in three institutions or are in three institutions.  Next week is 

a big week for interviewers because we've now obtained IRB approvals.

           With the 10 that we have approvals, data collection at 

those places should be completed by the end of next week.  So, it's a 

matter of the other institutions coming on board and then moving the 

interviewers around to be able to conduct the brief interviews.

          DR. FADEN:  I think we should emphasize, too, that the 

institutions that are letting us in are doing us a huge favor.  We 

have tried to emphasize this to RTI, so that they can communicate, and 

we've tried to communicate directly to the interviewers that, look, 

this is really a tremendous extension on the part of these 

institutions to let us in.  Unlike other kinds of studies, there are 

absolutely no benefits to the institutions.  They're getting no money.  

The faculty or the professional staff of these institutions are not 

getting co-authorship.  Nobody's getting authorships.  Nobody's 

getting money.  Nobody's getting authorship.  Nobody's getting 

clinical services paid for.  There's none of the normal benefits that 

generally are offered to offset the intrusiveness of having somebody 

do a study in your clinical setting or being offered, plus





these institutions who agree are putting themselves up for public 

scrutiny, and we are very appreciative of that.

          We think that all these institutions, regardless of how the 

data break, ought to be commended for having the courage to allow a 

federal advisory committee to come in and talk to their patients in 

ways that they know will now become public, even though we are 

committed to not reporting our findings by institution, what is 

collectively these institutions, now are willing to come forward, and 

it's in the spirit of if there are problems, they want to fix it.  If 

there's good news, they want to tell it.  That's wonderful, and 

obviously by inference, the institutions that don't let us in, we're 

not entirely -- we can appreciate their reservations, but we can't 

praise them, let's put it that way, in the same way, for having the 

courage to allow -- to open themselves up to public scrutiny.

          So, we really on the record ought to say thank you to the 10 

institutions that have had the commitment to high-quality bio-medical 

research and clinical care to let us in and let us talk to their 

patients.  We think that's really, you know, worth noting, and we're 

hoping that all the other





institutions will come on line.

          For those of you that are in administrative positions, you 

know, medical colleges, I'm looking at Reed, this is not a trivial 

thing to let -- to let --

          DR. TUCKSON:  I assume, by the way, in the final report, 

there will be a little blurb on this section.

          DR. FADEN:  Absolutely.  I think it should be very much up 

front, that rather than hold these institutions up for sort of 

negative scrutiny, the major point is that I'd like to get my medical 

care at these institutions, becuase if they're willing to let people 

in and allow themselves to be open about how they're treating their 

patients, that means these are institutions that are really committed 

to providing care to their patients in a high-quality way and to 

respecting the rights of their patients.

          So, I mean I think we ought to start out and leave with 

that, and say, you know, in that respect, we obviously also have -- 

especially if we have institutions that turn us down, by a sample of 

institutions who feel comfortable about this level of scrutiny, places 

that don't let us in, I don't want to suggest they have something to 

hide, but they're at least not as comfortable about opening themselves 

up to





the public for this kind of inquiry.

          So, that said, thank you all very much, and we'll move on, 

and again this will be a bigger chunk of agenda time in March as we 

get findings.

          What I'd like to do, we are behind schedule but not 

impossibly so, is just march on to the next agenda item.  We're going 

to move into chapters again, and here John's coming to the table.  

That's John Harkness, who's the chief drafter of the Chapter on 

Professional Standards and Practices, which, John, we should just all 

acknowledge, is in process.

      Committee Discussion:  Professional Standards

                       and Ethics

          DR. FADEN:  What percentage have we done, would you say, in 

terms of content, not in terms of style, but about how much of the 

content that you want to cover do you think is covered here?  Half?  

25 percent?  70 percent?

          DR. HARKNESS:  I would say roughly half.  I mean as I am 

conceding this thing, as I hope it's relatively clear, it consists of 

sort of two halves.  One, the first half, dealing with professional 

standards, and that's -- there is a draft of that largely completed, 

and the second half dealing with what I loosely call the real world of 

professional





practices, that half roughly is not finished.

          Now, I mean in terms of number of pages, the second half 

will probably be a bit longer than the first because, as I view it at 

this point at least, it's a more complicated story and therefore takes 

more words to tell.

          DR. FADEN:  All right.  So, that gives everybody some 

orientation.  We're talking about Part 1, Chapter 4.  Reed?

          DR. TUCKSON:  Let me just say I just found that -- I just 

find this fascinating reading.  I mean just -- it's -- for somebody 

that doesn't know this field, I -- it's better than a Clancy novel.

          DR. FADEN:  That's high praise.

          DR. TUCKSON:  And I -- let me just -- a couple of just quick 

thoughts to see how you can just help me to get started thinking about 

this.

          The coverage of the Nuremberg Trials, I kept -- that was one 

of the questions I wanted to get from your document, was just how 

widespread was this conversation.

          DR. HARKNESS:  By coverage, you mean press coverage or --

          DR. TUCKSON:  Yeah, in the American literature, and it was 

interesting when I finally got





to a part that said that it really was not a big deal in American 

literature, which I found fascinating, that it was not a big deal, 

which I don't understand.

          But -- and, so, it's possible that this stuff was really not 

in the minds of a lot of ordinary Americans, but that the AMA 

discussions about this would have captured at least 70 percent of all 

American physicians, given that they were in the AMA, and this was 

clearly a part of the deliberations of the AMA at that time.

          These physician scientists category that is coming up in the 

world, this new thing, I would imagine is a lower penetration of 70 

percent, but maybe not since they're mostly all M.D.s, but -- so, I 

don't know how to deal with that group of folk.

          So, I guess the first is just a notion of the widespreadness 

of it and the penetration in particular markets are important.

          What I'm coming to is that what is not discussed is any 

estimate of the penetration in the market of military leaders.  It 

would seem to me that in the military, and given that so much of our 

work is about government-sponsored research and folks that were in 

that military-industrial complex, that it would seem that they 

certainly were reading this stuff.  Well,





again, but it's a real question, I guess.

          Let me stop there with that question.

          DR. HARKNESS:  Okay.  First, I'll take them in sort of the 

order that you raised them.

          The press coverage question in my opinion at least has not 

been fully answered.  The person, as I think I said in the piece, 

that's given most attention to this is Historian David Rothman, and 

from what I can tell, my reading of his work, he has based his 

assessment of the American -- the coverage given to the Nuremberg 

Medical Trials -- he based his judgment on a review of the New York 

Times, which, as any historian would know, is -- I mean it's 

important, as obviously the New York Times is influential, but that's 

the easy step, because the New York Times is indexed.  That's not true 

of any other newspaper, any other significant newspapers.

          So, to do a -- to do the rest of the work means sitting at 

microfilm readers and going like this for long periods of time.

          Now, we have somewhat, I understand, we have brought someone 

on --

          DR. FADEN:  That's right.

          DR. HARKNESS:  Can I give the --

          DR. FADEN:  Sure.





          DR. HARKNESS:  We have brought a staff person or a 

consultant to the staff, Rebecca Lowan, I understand, to do just this, 

and we're -- and look through the Readers Guide and the periodical 

literature and just do some --

          DR. FADEN:  Sue just wanted to chime in.

          DR. HARKNESS:  Yeah.  Go ahead, Sir.

          DR. FADEN:  She can describe that a little bit more.

          DR. LEDERER:  I just want to make the point that this public 

-- the public discussion of human experimentation is a piece that I 

think that we need to take greater cognizance of in evaluating sort of 

the fears of the AEC, for example, about the liability questions, and, 

so, we are having this person -- she's going to be using the New York 

Times again because there is a useful index, and you have access to 

it, but also the discussion of Nuremberg in popular magazines as well, 

so that we have a greater sense of this.

          But I would say we might want to sort of enlarge the net a 

little bit.  It's not just, I think, the coverage of the Nuremberg 

Medical Trial, but the treatment of the Nazi guinea pigs, because 

there is a lot of press coverage of when some of the Nazi guinea pig 

patients come to the U.S. for treatment in the same





way that the Hiroshima maidens come to the U.S.

          So, I think we can enlarge the discussion a little bit 

beyond coverage of the trial itself.

          DR. HARKNESS:  Yes, I fully agree.  I mean for me personally 

as a historian, I mean frankly in some ways I wish that I wasn't doing 

this, and I was doing what Rebecca Lowan is doing.  I mean it's a 

fascinating historical --

          DR. FADEN:  People are fighting over this political -- I 

should point out that Rebecca, if I understand this, is a historian in 

science.  She's doing a fellowship with Greg Herken, who is one of our 

obviously key historian staff members, in addition to Jon and a few 

others.  So, we are just delighted that we could get her to do this.

          One thing that you pointed out is that this is obviously -- 

this is plowing new territory, and these will be original 

contributions on the part of the committee to the literature in this 

area.  So, it's critical for us, and we will be in a much better 

position in the next draft hopefully --

          DR. HARKNESS:  Right.

          DR. FADEN:  -- to address that issue.  

          I just want to make sure -- I lost some hands, and I know 

you have another question, but I see





Eli, Henry, Nancy, Ruth.  All right.  You can have the floor.

          DR. HARKNESS:  I'll try to proceed a bit more quickly.

          The professional coverage, medical profession coverage 

question that you raised, I think I should caution that the 70 percent 

-- the impact of the AMA decision on the 70 percent roughly members of 

the American -- of physicians who are members of the AMA.

          It would be inaccurate to say that the presentations of this 

-- these rules were, you know, headlined in the Journal of the 

American Medical Association.  These were buried, as may be a little 

bit too strong, but these were part of the proceedings listed in the 

-- in JAMA of a meeting, even though they took up this much -- they 

took up a few inches of space on, you know, pages of text.

          So, I mean -- and yet, and yet, this was an official 

pronouncement of the AMA House of Delegates.  So, it seems to me that 

-- I mean -- and David Honicker, who's the AMA counsel, ethics counsel 

now, told me that this -- this was an official ruling of the House of 

Delegates of the AMA.  That means that it is the standard of the 

American medical profession.

          As he put it to me, if I were trying -- if he





were trying a case in 19 -- in the mid-1950s, he's pretty confident 

that he could turn to these rules, and they would have very probative 

value in court, and --

          DR. TUCKSON:  I see that Phil is going nuts here.

          DR. FADEN:  You want to jump right in on this point?

          DR. RUSSELL:  The fact that the membership of the AMA was 

heavily on those who were engaged in the practice of medicine, and 

that there was a -- the research community probably comprised most of 

that 20 or 30 percent that didn't belong.

          DR. FADEN:  Is there any way we can find that out?

          DR. RUSSELL:  The AMA had much less impact on the research 

community than it did on the general practitioner community.

          DR. MACKLIN:  Furthermore, just one other fact on that 

membership, many people in earlier times, may be very different now, 

were members of the AMA because they had to be members of their county 

medical association for reasons of admission to hospitals and 

certification, and in order to be a member of your county medical 

association, you had to be a member of the AMA.





          So, it's not as if this 70 percent were members voluntarily 

and interestedly in an organization.

          DR. RUSSELL:  And military members were members because it 

was free to military.

          DR. FADEN:  I mean those all raise other issues, but I think 

we're still trying to get to the fact that it was the official 

whatever.

          DR. HARKNESS:  Right.

          DR. FADEN:  Okay.

          DR. HARKNESS:  The military penetration, perhaps General 

Russell -- almost certainly General Russell could speak to this better 

than I, but I -- the Nuremberg prosecutors, it's perhaps important to 

point out, were in Army uniform.  I mean these were -- this was a 

military enterprise, these -- Sue, did you want -- I see --

          DR. LEDERER:  No.  I just wanted to ask.  Who was the 

surgeon general of the Army who was responsible for the appointment of 

Ivy to the --

          DR. HARKNESS:  You know, I just --

          DR. LEDERER:  -- or the request to the AMA for Ivy to be 

appointed to serve?

          DR. HARKNESS:  I have not run that down.

          DR. LEDERER:  Is it Norman Kirk?  Is that who





it -- well, I think we should find that out.

          DR. HARKNESS:  Definitely.  I just haven't had the time.  I 

just got that -- I just figured out that, you know, the actual 

transaction by getting this stuff very recently from the AMA archives, 

but I do want to get that nailed down.

          The other thing about military penetration is that a few 

years later, the Wilson memo, which is a military document, is, of 

course, based on the Nuremberg Code, and as I will reiterate from the 

stuff that Jonathan's been working on, there is the -- Robert Jackson, 

this military attorney, who makes this very strong statement about the 

Nuremberg Code as being sort of legitimate, legal precedent in 1952.

          DR. TUCKSON:  The only other thing I wanted to ask, and I'll 

truncate it, just one comment on this notion that comes through in the 

report that Americans didn't have to much worry about all that other 

stuff because what that other stuff was was a bunch of Nazis who were 

barbarians and bad people, and we're good guys, and, so, we don't have 

to monitor ourselves or we don't -- those things don't apply to us 

because we're inherently good guys.

          There's a lot of important stuff in that, and if this 

business of the AMA, which worries me in terms





of the answer you gave me, if the AMA folk didn't put that prominently 

-- if you didn't -- it's an interesting attitude that says, boy, these 

are -- you know, we're going to hang these folks in Germany.  This is 

really important stuff, but it ain't important to me, and it's not 

important to my life, and I don't have to be questioned about it or I 

shouldn't even be introspective about it, because somehow I am 

inherently better, which is obviously a very frightening notion, and I 

don't think it's going to be that our report -- I mean I just don't 

think it can be that clear-cut.

          DR. HARKNESS:  Right.

          DR. TUCKSON:  But how we speak and understand that better, I 

think, is going to be very important.

          The only thing I want to -- and I'm sure other people will 

comment on that, and I'll be interested to hear what they say.  This 

issue of other fields of endeavor at the time, other research, we're 

still not speaking much in the chapter to other activities, other 

research areas of investigation, and I don't know if we can begin to 

understand that better.

          We take away this -- something -- if we could -- I think we 

should be figuring out the most concrete, i.e. non-mysterious 

radiation invisible stuff, but something that is very concrete and so 

tangible





research at that time, and see if we can't understand again those 

practices, --

          DR. HARKNESS:  Right.

          DR. TUCKSON:  -- which I think is just an important 

counter-balance as we begin to understand the day.

          DR. FADEN:  Reed, can I interrupt you for a minute?  Do you 

mean by researchers who are not physicians, are you trying to get at 

the practices and standards for people who did research involving 

human subjects who were not physicians or are you thinking by 

physicians but in areas other than radiation?

          DR. TUCKSON:  I was thinking of the latter, but what I'm 

quickly trying to think of is what -- because it would be wonderful if 

I could give you an example of the former.

          DR. FADEN:  Psychologists would be an example of the former, 

although --

          DR. TUCKSON:  Probably -- yeah, but --

          DR. FADEN:  Physiologists, Ph.D.s, and --

          DR. TUCKSON:  Oh, I see what you're saying now.  Yes, yes.  

The -- it's funny.  I go right to the day, and I make no distinction 

between -- yes, absolutely.

          DR. FADEN:  There's always people who don't





belong to the --

          DR. TUCKSON:  And again --

          DR. FADEN:  -- medical association because they're not 

physicians, let alone for all these other reasons, but also engaged in 

research involving human subjects.

          DR. TUCKSON:  And not taking the time to try to figure it 

out now, but, again, if we could think of those -- of categories again 

that were, you know, very concrete, that didn't involve invisible 

matters that are hard for people to conceptualize.

          DR. HARKNESS:  I'd like to just make one response to 

something you said a little bit earlier, and that is this business of 

the Nuremberg Code not being perceived as applying to American 

researchers because these American researchers perceived the Code as 

something intended for barbarians, as Dr. Katz has put it.

          I think another -- and I think there is some truth to that, 

and indeed our oral history project has borne that out.  But another 

take on that, and I don't think they're mutually exclusive, is that 

some researchers didn't see the Nuremberg Code as being especially 

pertinent or pressing to what they were doing because they perceived 

it as a summation of what





they were already doing, that this wasn't news to them, that -- and I 

-- my working hypothesis is that that is to some extent true in 

non-therapeutic research with healthy subjects, that -- and that is -- 

that's really Ivy's claim on the stand at Nuremberg, that -- and it's, 

as I argue here, this is what the judges are presenting.

          You know, we aren't presenting new stuff, we're summarizing 

longstanding, widely-agreed-upon stuff.

          DR. TUCKSON:  Yeah.  By the way, I really appreciate the 

note on the footnote to Ivy's statement about -- that's not in the 

abridged version.  You know, one of the things I kind of got left with 

-- and I don't know if you meant to leave me with the impression, that 

Ivy is -- was -- is basically, you know, an egomaniac who decides -- 

who has to be very forthright and who got caught for a minute on the 

stand by saying -- I mean -- and who basically wasn't going to admit 

that he overstated his argument and basically blustered his way 

through it, and I mean that's the kind of nagging thing that kind of 

got left in the back of my head, which is this one guy with a lot of 

ego that wasn't about to be embarrassed and wasn't going to back down.  

He was going to say whatever he had to say.





          DR. RUSSELL:  People with no self-doubt are very convincing.

          MS. MILLER:  But on the other hand, what you're saying, and 

the reason why I just -- I'm underscoring this is this is a profound 

point in my mind that you're leaving me with, and that is that in 

fact, it is not unrealistic to think that Ivy was within reason 

correct, and that these really were the prevailing attitudes and 

standards of the day, and buttressed by this other statement you just 

made, where this sense that these Nuremberg stuff didn't apply to us 

because we were already literally -- that was our concept and belief, 

and if that's the case, then that really does start to lay a very firm 

groundwork for expectations.

          DR. FADEN:  The awkwardness, and John and I are looking at 

each other, is that this has to be so carefully nuanced.  If this is 

correct, it seems to be correct not -- if this thesis that several of 

us have sort of been plowing the way, if there indeed was this view 

that this was no big deal, this was the way we were doing business, 

the evidence seems to come for that view disproportionately, if not 

exclusively, from people whose subjects were healthy persons on whom 

the research was outside of the context of providing





medical care, which is directly analogous obviously in some horrific 

ultimate sense to the Nazi experience.

          The people who were doing research as physician clinicians 

with patients, you don't hear this as much from.  I mean the evidence 

for that view that this is what we've always been doing is not new, 

doesn't seem to come from clinical research done by physicians on 

patient subjects.

          DR. KATZ:  Good point.  But you have to take into account 

here that doctors, you know, have a penchant for considering everybody 

a patient.  There's no such thing as a non-patient.  So, the whole 

community is included under the rubric of --

          DR. FADEN:  I don't think that's right, Jay.

          DR. KATZ:  But, no, we have enough to talk about.

          DR. FADEN:  That's --

          DR. KATZ:  Let's leave that aside for the moment, but the 

point I want to make is I mean at best, if it wasn't deliberate, Ivy 

didn't know what he was talking about because he invoked the 

Hippocratic oath as an important justification for the ethical 

behavior of physicians, and that this attested his belief that this is 

so deeply embedded in the psyche of physicians, that therefore they 

behave ethically, but if he was





only talking about normal non-patient volunteers, the 

-- if that is the message of the Nuremberg Trial, which I think it's 

much more confused than that, then the Hippocratic oath has no 

relevance to what's going on.

          DR. TUCKSON:  But, Ruth, let me just close out on this.

          DR. FADEN:  Okay.  Susan wanted to get in, too.

          DR. TUCKSON:  I promise to get off this line of questioning.  

But it's just -- let's say you just fast-forward this thing to the 

intentional releases, I mean, you know, any of the environmental 

stuff, any of this.  Just go out of the hospital.

          I mean is it possible --

          DR. FADEN:  Prisoners.

          DR. TUCKSON:  Prisoners.  Is it possible that any military 

or anyone connected with the military-industrial complex could not 

have known or been guided by this experience only so relevant, so 

recently, in the making of their decisions about environmental 

releases?

          I mean it's just -- it's just -- it's just hard to imagine.

          DR. RUSSELL:  I would ask the question.  Do you think 

anybody drew the connection between





environmental release and the medical experimentation?

          DR. FADEN:  Susan, did you want --

          DR. RUSSELL:  I don't believe -- I think that was totally 

unrelated subject in anybody's mind, and I don't think anybody dealing 

with environmental release ever even thought about those issues in 

that context.

          DR. LEDERER:  I just want to go back for a minute to 

something that Jay said.  I think it's a mistake to dismiss Ivy's 

invocation of the Hippocratic oath as being wholly unrelated to a 

point he was trying to make, and this has to go -- and this goes to 

John's analysis of the importance of harm and the physician's 

responsibility to avoid needless harm to a patient.

          DR. KATZ:  If it's a patient, it's different.  These are 

volunteers.  That's what I was referring to.  If it's patient, it's 

different, but if they're considered the normal volunteer, are they 

encompassed by patient truth?  That's the -- I don't have the answer 

to that, but that's the question.

          DR. LEDERER:  Well, I think he would -- I think he would 

have differentiated that, and that's why there are special rules when 

you use normal patients and you're giving them disease, and that's why 

the profession as a whole, I would argue, was sensitized to using that 

particular group and doing those particular





things.

          DR. KATZ:  Normal patients or normal persons?

          DR. LEDERER:  Normal persons.

          DR. KATZ:  That's the problem.  That's the problem.

          DR. FADEN:  We'll have to hash this out, but the argument 

is, the take-home message that sort of encapsulated misleading maxim 

of do no harm, okay, is, I think, where Susan is going.  So, okay, 

whether it's patients or persons, doctors aren't supposed to harm 

people, and if they harm people, they're only supposed to do it 

because there's an offsetting benefit.

          So, that's the sort of -- you know, if you wanted to be 

generous to Ivy, that's the -- this pervasive view that doctors are 

not supposed to be running around harming people, patients, anybody.

          I'm not sure this is right, Jay, but I think that that would 

be the way to see it as not entirely --

          DR. HARKNESS:  It seems to me that it's important to 

separate out the questions that we might raise about Ivy's 

philosophical --

          DR. FADEN:  Good point.

          DR. HARKNESS:  -- abilities as opposed to the official 

conclusions that he presented on the stand at Nuremberg.





          DR. FADEN:  Good point.  Good point.  Whether Ivy would have 

done well in a violative discourse is sort of beside the point, right?  

We've got Eli, Henry, and Nancy, Ruth Macklin, Phil.  Susan, are you 

-- can you wait or is it right on this point?

          DR. LEDERER:  No.  I can wait.

          DR. FADEN:  Okay.  Eli's got the floor.

          DR. GLATSTEIN:  I just wanted to say that with respect to 

the publicity and notoriety that the Nuremberg trials had, wasn't 

confined just to the New York Times.  I mean I can remember growing up 

in a small town in Iowa and reading in the Chicago Tribune, and when 

Des Moines --

          DR. HARKNESS:  You know the date, the page?

          DR. GLATSTEIN:  Beg pardon?

          DR. FADEN:  Do you remember the page?

          DR. GLATSTEIN:  You'll find it in the Des Moines Register 

and the Chicago Tribune, both of them.  You'll find it in Life 

Magazine.  You'll find it in Time.  If you go to film archives, you'll 

find it in newsreels, which we don't see today.

          DR. FADEN:  Good point.

          DR. GLATSTEIN:  But in an era when you didn't have -- when 

people didn't get their news from the tv --





          DR. HARKNESS:  I often wonder what CNN would have done with 

this.

          DR. GLATSTEIN:  CNN would have had a field day.  But there 

were newsreels at the time, and roughly 10 years later, a movie was 

made on the subject with Spencer Tracy.  So, you find a lot of it.

          DR. FADEN:  Judgment at Nuremberg, of course.  Yes, Marlene 

Dietrich.  So, the doctors trials aren't a big part of Judgement at 

Nuremberg.  It's a great movie.  Extraordinary.  Newsreels.  Are we 

looking at newsreels?  No?  We're not looking at newsreels?

          DR. LEDERER:  There are indexes to newsreels.

          DR. HARKNESS:  If I were doing this, that would be one of 

the places I would go.  At the National Archives, they're pretty well 

indexed.

          DR. GLATSTEIN:  It was not hip by any stretch of the 

imagination.

          DR. FADEN:  Well, look at newsreels.  Henry?

          DR. ROYAL:  Does this go back to this era?

          DR. HARKNESS:  Yes, it does.

          DR. ROYAL:  And does it -- is it a useful source of --

          DR. HARKNESS:  Oh, sure.  Yeah.  The -- I think I have -- I 

think I have mined that pretty well.  There's not a terrific amount of 

coverage in the





medical -- there's a fair amount in JAMA.  Yeah.  I mean there is an 

editorial, the brutalities, the Nazi physicians

          DR. GLATSTEIN:  Probably screen the index for JAMA and the 

index probably for the New England Journal of Medicine.  Those would 

be the two journals where I'd expect to see editorial commentary on 

that subject.

          DR. ROYAL:  I'd like to see a summary of what was published 

in the medical journals at that time.

          DR. FADEN:  Nancy?

          DR. OLEINICK:  No.  I'll pass.

          DR. FADEN:  Ruth Macklin?

          DR. MACKLIN:  There were two things, not directly related to 

Nuremberg, that I noted in the chapter.  The first is the reference to 

the text by Lewis J. Reagan, and my question here -- I mean you noted 

that in his next edition, he expanded it and talked about Nuremberg, 

etc.

          But I'm interested in the one -- the interpretation of the 

point here, this is on Page 13, a physician must keep abreast of 

medical progress, but he's responsible if he goes beyond usual and 

standard procedures to the point of experimentation, and then he goes 

on, if such treatment is considered.

          This seems to me to be the use of





experimentation very common among physicians where they say something 

like every patient's an experiment.  I mean those who are not talking 

about, say, you know, you never know what you're going to get, each 

case is different, and this sounds like, well, the kind of thing not 

systematic to gather data, but experiment, well, I'm going to try 

this.  The trial and error approach to medicine.

          And then his next line, if such treatment is considered or 

indicated, and, of course, he calls it treatment, you know.  So, 

experimental treatment.  It should not be undertaken till 

consultation, etc., and the patient has signed a paper acknowledging 

and assuming the risk.  Okay.  So, clearly, it's the medical-legal 

defense.

          Does that require some interpretation?

          DR. HARKNESS:  Yeah, and I think it does, and I can do that 

briefly right now, if you'd like.

          DR. MACKLIN:  Well, I'm not -- no.  I'm just making the 

observation.  I just think there ought to be a little explanation of 

it in the text.

          DR. HARKNESS:  It's actually a bit different, I think.  It's 

close, but a bit different than what you've offered.

          DR. MACKLIN:  Okay.





          DR. HARKNESS:  The -- in case law before Nuremberg at least, 

the term "experimentation" was -- when it came up in court cases, was 

generally used as a term somewhat synonymous with malpractice, that a 

doctor is just experimenting on a patient, that he is doing something 

wrong.

          And Irving Ladimer's point in his article and in his 

dissertation was that doctors needed -- that the medical community, 

the research community, needs to make clear that experimentation is 

not just malpractice, that there is a legitimate organized manner in 

which medical experimentation can be and indeed is conducted, and what 

the research community needs to do is to clarify or indeed in a sense 

correct the mistakes of these cases in which experimentation is made 

synonymous with malpractice.

          And what -- basically, what Reagan does is buys, in my 

opinion, buys Ladimer's argument whole cloth.  In fact, I mean Reagan 

was clearly not an expert in copyright.  He -- if you compare Reagan's 

-- I mention in here that he quotes the judge's preamble without 

quotation marks, and then he also characterizes the standards 

enunciated by the judges as the most carefully developed set of 

precepts specifically drawn to meet the problems of human 

experimentation.





          Well, if you go down to the very bottom of that page, where 

I discuss what Ladimer's saying about Nuremberg and flip to the next 

page, without a doubt the most highly publicized and carefully 

developed set of precepts specifically drawn to meet the problems of 

human experimentation.  Exact same words, and Reagan doesn't even cite 

Ladimer.  But, anyhow.

          DR. MACKLIN:  Okay.  I have just one other little point.  

Things leap out at you when you're familiar with the setting or 

something, and on Page 16, the prominent radiologist who was in his 

residency at Montefiore Hospital in the Bronx.  It's not surprising.  

I mean this was the strongest statement.

          You quote here this strongest statement as part of the 

history of the day, surely something at least in the environment I was 

in, we were aware of, etc.

          Now, I mean I would underline here at least in the 

environment I was in.  I mean this is such an unusual institution.  A 

very large number of Jewish physicians.  Many, many people who escaped 

the Nazis during the 1930s, that is actually prior to the War, and 

then survivors of concentration camps eventually came to the Bronx and 

to Montefiore Hospital and were working there.





          So, this is so atypical that --

          DR. HARKNESS:  That's fascinating.  I just didn't know that.

          DR. MACKLIN:  Well, I mean I only mention it because -- 

again, not to mislead in some way, because this is the -- I mean I've 

worked there.  So, the -- I think it might help just to -- for 

balance, to put in under the -- what the other things from the oral 

history project, possibly some other quotations and statements for the 

sake of balance, to indicate that because that was probably more 

mainstream, and even though you do acknowledge that this is the 

strongest statement, it's so unusual because the large number of 

Jewish doctors and escapees.

          DR. HARKNESS:  Yeah.  Thank you for pointing that out.  

That's very important.

          DR. MACKLIN:  On Page 16.  It says, "the strongest statement 

came from a prominent radiologist who was in his residency at 

Montefiore Hospital in the Bronx throughout most of the trial."  I can 

probably even guess who it was, even though I didn't ask, but I mean 

that's just a factor, and that's why, when he says at least in the 

environment I was in, I think that probably may be a reference to 

that.

          DR. ROYAL:  I had thought that that statement





was because he was a radiologist.

          DR. MACKLIN:  He might make that statement today about the 

experiments that were sponsored by the United States Government, okay, 

but I don't know about the radiologist and radiology.

          DR. FADEN:  Phil?  Okay.  Jay?

          DR. KATZ:  Just a few points.   First of all, to what you 

brought to our attention, I don't think we should take the 

deliberations of the American Medical Association too seriously.  One 

is, I hope that you will reproduce that page for all of us, where the 

Nuremberg Code has been adopted by the AMA.  It's such fine print, I 

have to take my glasses off to read it, and it's an obscure part of 

the journal.

          You might even look in the index and see whether it's 

indexed in the table of contents.  It would be nice to see.  I don't 

remember that.  But keep also in mind that, okay, they adopted this 

puny kind of dissertation of the Nuremberg Code, the voluntary consent 

of the person, whatever that means, is required.  They didn't say 

essential.  It's required.  Change that.

          DR. HARKNESS:  I think it says must be obtained.

          DR. KATZ:  Huh?





          DR. HARKNESS:  I think it says must be obtained.

          DR. KATZ:  Must be obtained?  Well, whatever it says, 

anyway.  Secondly, then we talk about animal experimentation, which is 

a problematic anyway, and then they say, of course, that should be 

done by physicians.  That was Principle Number 3.  But I would expect 

that from the AMA.

          But they never construed -- they never construed the code in 

any kind of way.  They never came back to it in the post-1970 -- let 

me see.  The post-1960 world, when informed consent became an issue 

for therapy.  The Judicial Council finally made a statement about it, 

but a fascinating statement, saying not that informed consent is 

medical policy, but it's social policy to which, you know, -- which 

the medical community has to comply.

          There's always this foot-dragging going on, etc., etc.  The 

point is -- and by the way, I mentioned this, and you had copies of it 

in my Harvard lecture, and I checked now three or four of my 

classmates.  I was in medical school from '45 to '49, and during and 

after the Nuremberg proceedings during the -- against Nazi physicians.

          We heard nothing about it.  No -- it was





never discussed or brought to our attention, in our medical school 

education, even though we were there at the time, and we all agreed 

that they scratched their head and thought about it and thought it was 

important.

          But be all that as it may, and I talked very briefly with 

John about it, and I have to talk to him about it at greater length, 

and I don't want to take up our time here too much to do, but this is 

a very interesting kind of piece, let me put it, so far.

          Of course, I can't evaluate it because you haven't yet 

started on the realities and the realities section, and that -- and 

I'm looking forward to reading this because if that is going to be the 

reality section, I would call this one the fantasy section, and it 

goes -- you know, as you all know, I have to take two or three 

minutes, and I'll try to shut up as quickly as I can.

          I've written a great deal of the Nuremberg Code, and I have 

even probably a greater respect for the code than many other 

colleagues of mine do, but I have respect for it as an explanational 

document, as something that we might really go back to look at and see 

to what extent we can protect the viability of subject research to the 

extent to which the Nuremberg Code commands us to do.





          But as a document that has had much of an effect, serious 

impact on research practices, no, and I know that John will discuss 

the Helsinki Code, the first code on medical research promulgated by 

the World Medical Association.  They did not adopt the Nuremberg Code.  

They wrote a new code, and in its first promulgation, informed consent 

wasn't even mentioned among the basic principles for the conduct of 

research.

          So, a small progress, and, finally, I think it's beautifully 

written 15-16 pages, but I can't -- personally, I can't find the 

thesis that you have to talk about it on Page 1, and I felt I needed 

to bring it to the attention of the committee, but these kinds of 

things, one can fiddle with because it's interpretation.

          We offer -- I guess we as the committee, right, at this 

point?

          DR. HARKNESS:  Yeah.

          DR. KATZ:  We offer historical arguments that the Nuremberg 

Code and the related 1946 rules of the American Medical Association 

should be given serious attention as legitimate standards for the 

conduct of human experimentation, and then, of course, there's the 

interesting parenthetical remark, and especially non-therapeutic, and 

in this country, during the post-War





period.

          Then you go on in the second sentence, you know, you use the 

word "complicated", and I'm not sure that's the right word, but you 

are exactly on target.  This has to be at least expanded to a page 

rather than a sentence.

          DR. FADEN:  Jay, we can't hear.

          DR. KATZ:  Oh, rather than two sentences, and I think you 

tried in this piece to give greater importance to the -- not to the 

aspirational nature of the Nuremberg Code.  With that, I would agree.  

But to the practical -- to the standards it provided to the medical 

profession in the conduct of research, and I don't believe that is so.

          You made a little bit too much of the same of Ivy.  I think 

he's a very problematic figure, and after all, he was a prosecution 

witness, and prosecution witnesses or defense witnesses, if one wants 

to give him his due, try to put their best foot forward and say what 

will support the prosecution's cause, but I think he was very 

inaccurate about many of the things.

          DR. HARKNESS:  But maybe a quick way to summarize what I am 

trying to say in this is that the judges at Nuremberg disagreed with 

you.

          DR. KATZ:  Well, --





          DR. HARKNESS:  The judges at Nuremberg --

          DR. KATZ:  -- that's another thing we have to talk about.  

The judges in Nuremberg, and I disagreed then with the judges in 

Nuremberg, when they are saying, unless -- you know, because it's 

complicated by the fact that who are we talking about?  Are we talking 

about patients?  Are we talking about normal volunteers?  Are we 

talking about people that were conscripted without being asked 

anything, except they were actually given many of these research 

subjects in the concentration camp, gave their informed consent 

because they were asked, do you want to participate in research or do 

you want to go to the crematoria?  And many of them said no, we'll 

participate in the research, and, of course, that's a version of 

informed consent.  They knew what was going to happen to them, etc.

          But I think it will take time.  These were the standards of 

the medical profession, and everybody subscribes to it.  You know, you 

quote that paragraph.  Where the hell did we get that from?

          DR. HARKNESS:  But I mean -- I'm not a lawyer, but where the 

hell did the judges get their opinions from in general?  I mean where 

does Beckwith get her opinion from that she rendered just a few weeks





ago that the Nuremberg Code stood as a legitimate legal precedent?  

          I mean at some point in making case law, as I understand it, 

judges make decisions, and those have some meaning in the real world.

          DR. KATZ:  Is Dan Guttman here?  You must -- you must -- you 

must -- it's very, very important that you send John for two weeks of 

the year to law school, so he'll learn something about how judges make 

their opinions.

          MR. GUTTMAN:  I guess to me, this is the most important 

discussion that we can have, this particular session, about the 

historical part, because you're really talking about something that is 

so profound, you're really -- Nancy remarked that it may be that the 

present is out of sync with the regs, and maybe on the notion of moral 

progress, there is a constant in history that we have these Nuremberg 

Codes that are out of sync, and the question is how do they come to be 

Nuremberg Codes?

          And, so, the real remarkable question is whether there is 

something that -- I've used the word maybe inadvisedly, a bad seed in 

the way you have, as General Russell says, a combination of events for 

whatever convenience leading up to an international





statement by a tribunal in the most important part of our century, and 

what goes into that, and this is profound stuff, you know, and this is 

really important stuff.  That's all I can say about it.

          DR. FADEN:  Phil wants to chime in.

          DR. RUSSELL:  I think we have to be very careful about the 

communities we're discussing.  Prior to the second World War, the 

bio-medical research community was very, very small compared to the 

total medical community.  There were very, very few drugs.  There was 

this huge industry of Phase 1 trials and therapeutic research that 

just came into existence at that time.

          So, talking about the medical community and the research 

community, you have to make a very clear distinction.  The medical 

community, only a small part of it is conducting research.  The 

research community includes lots of folks other than physicians.

          So, I think we need to be very clear on that distinction, 

and it's quite possible that the -- a large part of the research 

community had an ethical standard for their conduct of their work, 

most of which was on normal individuals that was quite different from 

the perception of the general medical community, and I think that's an 

important concept.





          The AMA was not an organization of research scientists.  It 

was a --

          DR. HARKNESS:  But Ivy was certainly a research scientist.

          DR. RUSSELL:  He was a research scientist.

          DR. FADEN:  That's important to emphasize.

          DR. RUSSELL:  His experience was drawn from the research 

community.

          DR. FADEN:  What kind of research did Ivy do at that time, 

before he got into the chromosome stuff? 

          DR. HARKNESS:  He did aviation physiology a lot during the 

War.  He did lots of nutritional work, work in the digestive system, 

that sort of thing.

          DR. RUSSELL:  The physiology community did an immense amount 

of research during World War II on normal subjects.

          DR. HARKNESS:  He was head of the Navy Research Lab.  That 

isn't quite the right title.  During the War.

          DR. RUSSELL:  Navy Medical Research Institute.

          DR. HARKNESS:  Yeah.

          DR. FADEN:  Susan?

          DR. LEDERER:  I just want to make -- I think that Phil's 

right to point out the distinction between





the medical research community, which was very small and quite 

distinct from the medical community, but I think there is a way to 

integrate John's point about what importance we may attribute to the 

AMA's adoption of this puny or impoverished version of the Nuremberg 

Code, and that's because the AMA -- what did have a very active 

defense of research component in which people like Ivy was a very 

active participant, and that goes to the whole point about why Ivy was 

selected to be the medical witness at Nuremberg, because he was very 

active in the defense of medical research, both animal and human, and 

the AMA was fully supportive of that.

          So, I think that actually you would find in this period that 

the bio-medical research community did belong to the AMA, because of 

the AMA's advocacy of medical research.

          DR. FADEN:  We need to track -- I mean this is obviously 

very important, but we need to flesh more of this out.  I don't -- and 

see if we can add some substance to all this -- all of this.  I think 

a lot hangs in your objection, Jay, to the language that John gives us 

in that middle paragraph on Page 1 to what we mean by a standard.

          That's very critical, and that turns into





Jonathan's discussion.  It's a wonderful seque to the next chapter, 

but what do we mean by a standard?  It clearly was adopted as a 

standard.

          Now, what is the meaning of that?  And in what sense was it 

a standard?  The AMA did something with it.  That's -- it seems that 

the language itself is not going to help us to get to the core of 

whether there is a disagreement about what are we all trying to say or 

not in using words like that, which in and of itself is historically 

correct.  They adopted it.  It was the standard, but what does that 

mean?

          I think that's -- Phil wants to get back into it.

          DR. RUSSELL:  I think we need to also look at the 

relationships between the Armed Service Medical Departments and the 

AMA.  It's a very close relationship, had been historically, and the 

-- I think the AMA has on its delegation -- on its House of Delegates 

or their governing body some official representation from the Armed 

Services.

          The -- at that time, I'm sure that all members of the 

service medical departments were members of the AMA, kind of 

officially.  That came with the territory.  So, there would have been 

--

          DR. HARKNESS:  The military people in the





House of Delegates, as they were voting on this thing.

          DR. RUSSELL:  Yes.  As I recollect, the -- each of the 

services has an official delegate to the House of Delegates, and the 

services use the AMA as a principal professional association.  So, I 

think that that's an important aspect.

          DR. FADEN:  Probably is.  Dan?

          MR. GUTTMAN:  Yeah.  I just want to reflect on Jay's basic 

law school point of view.  That's what Jay is soliciting from anybody 

who can -- is that -- it is no surprise that a judge can reach any 

decision, and for any number of reasons, and we in this committee are 

experiencing that very phenomenon.  You've got to reach a decision.

          DR. FADEN:  For anything that we want.

          MR. GUTTMAN:  You look for information.  You pull it, and 

you -- we're all seeing the psychological urge to find some justice 

and some easy compelling reason, and it's clear, it's obvious, it's 

not a difficulty for any other law school student, you just say, 

judge, this is convenient, it sounds right, that's easy.

          The difficult question, and Ruth and I have had this 

discussion over coffee at numerous occasions, --





          DR. FADEN:  Always coffee, though.

          MR. GUTTMAN:  Right, right.  The question, I guess I have -- 

it's a two-step question.  One is how do judges reach decisions, and 

the answer is they pull from whatever they can get, and the easy 

psychological explanation is the Nazi experience was so bad, that the 

principle that -- any principle would have covered that one.  But you 

needed something that -- you know, you didn't have to -- it wasn't a 

hard case.  So, they didn't have to struggle.  That's part of what Jay 

is saying.  They didn't have to worry about exactly how much animal 

experimentation, exactly what do we mean by consent, exactly how we -- 

all those things didn't have to get into the judge's decision.

          To me, the difficult question from the juris-prudential and 

real world is, well, how come, if to an average citizen, to all these 

witnesses out there, they look at this, and they say, well, that's 

about experimentation, and it certainly seems to be pretty broad, and 

we're struggling here to say, well, no, it's really healthy subjects, 

I mean how come there wasn't a very quick reality check when that went 

out in the world?  How come it's dangling there in the AMA?  How could 

they have --

          DR. FADEN:  I think there's another way to





turn it around.  Would the AMA ever have passed on those three 

principles, puny as they are, okay, if they really thought it applied 

to patient care?  Given exactly the argument Jay made, given how long 

and how hard the AMA struggled and fought against the movement towards 

informed consent in the evolving legal doctrine, would they have said 

no problem, we'll just pass on these three rules, if they thought it 

applied to how doctors care for their patients?

          MR. GUTTMAN:  Why would they have done something so trivial 

with that?

          DR. FADEN:  It wasn't trivial.

          MR. GUTTMAN:  What --

          DR. FADEN:  It wasn't trivial.  That's why they didn't use 

the word patient.  They did not use the word patient in that 

formulation nor did --

          DR. KATZ:  It's like the Nuremberg Code.

          DR. FADEN:  They were thinking -- they were thinking -- they 

couldn't have been thinking patients.  If they were thinking patients, 

it would never have passed through the House of Delegates.  That's the 

only thing I can think of.  They wouldn't have possibly said we need 

to get the consent of our patients before we can do, because they 

fought consent for years afterwards, decades afterwards.





          DR. MACKLIN:  But how does that fit with the other 

observation that Phil's been making, that very few of these were 

doctors who did research?

          DR. FADEN:  Because they just said it doesn't apply to us.  

We need something that covers human experimentation.  The AMA -- it 

comes from the top.  There's this tribunal going on.  We need to have 

this so that our expert witness can say the AMA endorses these 

principles.  Okay.  So, we need to do something.  So, don't worry, 

it's not a big deal.  It's not controversial.  It's how you -- it's 

how you do human experimentation with normal people off the street.  

It doesn't have -- affect what most of us do.

          So, yes, there's a small community of people like Ivy, and I 

think Susan's point is very telling.  I would like to know more about 

that.  If the AMA is actually in the business of promoting bio-medical 

research and assisting people who are doing physiology and vaccine 

development and stuff like that with healthy subjects to get 

credibility and political acceptance and whatever else the AMA is 

doing, this is fine, and especially if people like Ivy are saying this 

is okay, we live with this, this is basically how we do business.  We 

ask people's permission before we inject them with a live vaccine.  We 

try not to harm them, and





we usually do work on animals first.  This is basically how we do 

business.

          I mean I don't see it as that revolutionary when it's 

understood and cast that way.  Otherwise, I can't make sense of it.

          DR. LEDERER:  I'd just point out that in fact, the AMA did 

debate whether or not they should amend the Code of Ethics regarding 

human experimentation 30 years earlier in 1916, and they did not do so 

precisely because they thought it was going to interfere with 

innovation and patient care.

          So, we have sort of an earlier test case, and just to go 

back to this other point that Ruth alluded to, I think it should be 

pointed out in this document who funds Ladimer's first conference on 

the law-medicine group looking in human experimentation.

          The money for that comes from the animal research advocacy 

group.

          DR. HARKNESS:  National Society for Medical Research.

          DR. LEDERER:  Yes.

          DR. FADEN:  I didn't know that.

          DR. LEDERER:  Yes.

          DR. HARKNESS:  This is the 1958 conference that led to the 

formation or the application for the





funds from NIH that resulted in the law-medicine research --

          DR. FADEN:  Pilot?

          DR. LEDERER:  Yeah.  The pilot work.

          DR. FADEN:  Okay.  

          DR. LEDERER:  But I think, you know, why is that group, you 

know, funding that?  I think that it should at least be sort of 

footnoted in here.

          DR. FADEN:  They're a notorious group.

          DR. HARKNESS:  Notable.

          DR. FADEN:  Notable group.  Excuse me.  They're a notable 

group.  Excuse me.  I'm sorry.  Phil, and then Reed, and then maybe we 

should stop for purposes of --

          DR. RUSSELL:  Some documentation that John showed me just a 

minute -- a few minutes ago regarding the response of the physicians 

at Harvard when they were told that the Army Surgeon General was going 

to apply those restrictions on extramural research and research on 

patients at Harvard, they resisted it tremendously, and it speaks to 

the same issue, and they thought that they were either unworkable 

regulations or they would be inordinately constraining, and they 

didn't need that kind of meddling by the government, in spite of the 

fact they were taking --





          DR. FADEN:  Government money.

          DR. RUSSELL:  And the -- one of the members of the Harvard 

faculty that was prominent in that discussion was the president of the 

AFEB, Gus Dammin.

          DR. FADEN:  Really?

          DR. RUSSELL:  Yeah, and it very strongly supports your point 

there, that the AMA had no intention of applying this to therapeutic 

research on patients.

          DR. FADEN:  Or any kind --

          DR. RUSSELL:  Doctors were going to continue to practice 

medicine in their traditional way unconstrained.

          DR. FADEN:  We've got Reed, and then Susan wanted to make a 

last comment, and then we'll just end it and have a break and go to 

our next discussion, which very much continues many of these issues.

          DR. TUCKSON:  Let me -- my comment is really not about the 

specific discussion, but I want to fast-forward to the report itself.  

I think that our reasoning needs to be very transparent, that any 

reader of the document, I think, has to understand very clearly how we 

got where we got, and I don't know how we do that.

          I think we have to be able to -- and I'm





being very concrete here, and I don't mean -- I mean just for 

consideration.  I'm not expecting to open this up into an 

eight-million hour discussion, but, you know, we started with the 

Nuremberg Code.  We -- our understanding of it was the following.  We 

were concerned about thus and so.  We then went to the AMA document, 

and then we were concerned about such and so, and we fleshed it out by 

going to talk to the physiology community to see what they were doing 

at that time.

          We were aware of.  We determined finally that.  Therefore, 

we concluded.  But I think that the 

-- you know, what is going to be very important is that the trail of 

our thinking is so transparent, because -- I just have a feeling that 

this work, if we -- and I don't want to over-estimate --

          DR. FADEN:  I know where you're going.

          DR. TUCKSON:  That people are going to come back and really 

want to understand, but didn't they read the Nuremberg -- it says it 

right there, and it's so clear, and the subtleties that we're getting 

caught up in need to be so clearly highlighted, and then what we did 

about those subtleties.  So, we worked so hard.

          But I think that our -- we got to be able to check our math 

when we go back on this thing, and any





casual reader is -- well, not the casual -- but I think this is very 

important.

          DR. FADEN:  I think that's critically important.  Also, I 

think we will want later, and this is another seque to Jonathan's 

chapter, whatever sort of descriptive account of the Nuremberg Code 

and its implications for practice and what -- the reality part of this 

chapter we end up saying, it still doesn't follow that that is what we 

conclude about what should have happened.

          For example, I mean it would be very nice in this chapter to 

follow up on what Jay said, John, about how the AMA never returned to 

this again.  I mean somebody ought to hold the AMA accountable for 

putting out these three principles and leaving them there.

          DR. HARKNESS:  Actually, that's -- I was going to comment 

that that's not entirely true because --

          DR. FADEN:  Or whatever they did --

          DR. HARKNESS:  -- the AMA did periodically produce catalogs 

of their standards, and the experimentation standards are repeated.

          DR. FADEN:  But other than that, we have no evidence that 

the AMA did anything more than that.  They didn't ask for medical 

schools to include this in





their curriculum.  I mean there was a whole bunch of things that if 

you were serious about saying that these are the principles by which 

we want our members who conduct bio-medical research to conduct 

themselves, you could have done something as a professional 

organization, and that has to be -- that part of the story has to be 

out there, too, if it's correct, I mean if it's correct that very 

little was done.

          DR. TUCKSON:  With regards -- just again in terms of how the 

staff functions, in terms of -- first of all, just giving some thought 

to how you lay out the --

          DR. FADEN:  Absolutely.

          DR. TUCKSON:  But also as a matter of -- as things start now 

to come down to the wire, and they're moving so fast and so many 

directions, it's almost the role of a historian of the intellectual 

process that we're going through, because I mean it's -- again, we're 

going to be challenged at every level of how we got to where we got, 

and we're -- you know, right now, we're going like this and like this 

and back around, but if we can make sense of it starting particularly 

at this moment, it would be much easier for Ruth, when she's in front 

of the eight million microphones, on that fateful day and days, for a 

psychotic you get





there, and it's just going to be very -- I mean the amount of pressure 

that she's going to be under as well as all of us is going to be 

enormous, and inevitably, no matter which way this thing goes, I mean 

I hope everybody keeps in mind what the future is going to look like 

for us.

          It's not going to be a lot of fun, and, so, the 

meticulousness with which this stuff is laid out is very important.

          DR. FADEN:  Susan wants to pass.  Okay.  I think that's -- 

those are very important comments, Reed.  Thank you.  As are all the 

comments.

          We're going to take a break and reconvene at 10:30, and we 

should still get it in.  We should still get in everything we need to 

get in this morning.  You're right, Reed.  You're absolutely right.

          (Whereupon, a recess was taken.)

          DR. FADEN:  Well, Jonathan, are you ready?

          MR. MORENO:  No.

        Committee Discussion:  Cold War Research

             Ethics Standards in Retrospect

          DR. FADEN:  We're now going to turn to a really defining 

chapter for the report, which in part must relate to the chapter that 

we've just discussed, and that's Part 1, Chapter 5, which is titled 

"Cold War





Research Ethics Standards in Retrospect".  It's an attempt to distil 

the committee's position on the question of the standards by which we 

will be judging or evaluating, if judging is perhaps too stark a word, 

assessing, evaluating the experiments and experiences under our 

charter.

          So, the floor is open.  I know we lost a few people because 

they were checking out.  I just remembered that.  So, we can't help 

that.  For discussion of this chapter.

          (No response)

          DR. FADEN:  Silences are painful.  Jay?  Thank you.

          DR. KATZ:  I just have one question, Jonathan.  You know, I 

have some ideas, not precise ideas, vague ideas, what we mean by 

voluntary consent, consent, informed consent, etc., etc., etc., but 

you are introducing a new concept, which I do think you define, but I 

may have missed it, the simple consent. 

          That's a new notion.  What is simple consent?

          MR. MORENO:  Ruth, what's simple consent?

          DR. FADEN:  I knew you were going to do that, Jonathan.  We 

were struggling for leverage to acknowledge -- like the distinction in 

the law.  The notion that without a requirement of disclosure or of





understanding of the implications of participation, the merely asking 

of someone's permission.  May I do this to you?

          DR. KATZ:  Just acquiescence in a sense.  You say something 

to them.  Like the old notion in late 19th Century in law, that 

passive acquiescence if the doctor --

          DR. FADEN:  No, no.  I think it's more.  It's -- there would 

be a can I -- can I touch you, yes, you may.  Well, I think --

          MR. MORENO:  I hate to use the term "assent".

          DR. FADEN:  I don't want to use -- I think -- I don't want 

to complicate the language more than it's already complicated, but to 

distinguish asking permission from us, the obligation to ask 

permission, and to get it with the presumption that if somebody says 

no, you can't do it, to the obligation to ask for permission after 

having provided some description of the risks and benefits, burdens, 

advantages, alternatives, and so on.

          So, if the primitive notion is, first, I cannot touch you 

without your permission, without necessarily having to elaborate on 

all the implications of what it means for me to touch you, but enough 

of a notion that I would like to inject you, may I do that,





yes, no.

          DR. KATZ:  Well, it deserves --

          DR. FADEN:  That's what I had in mind.

          DR. KATZ:  It deserves the paragraph if it is because it 

comes --

          DR. FADEN:  Fine.

          DR. KATZ:  -- through again and again.

          DR. FADEN:  We just struggled for some --

          DR. KATZ:  Yeah, I know.

          DR. FADEN:  That's basically the idea, to distinguish it 

from the additional duty of having to provide a disclosure.

          DR. LEDERER:  I was just going to say, I think it's a very 

useful one, though, because I mean if you -- that qualifier sort of 

distinguishes it from consent, which raises all these other questions.  

Does it mean informed consent or what kind of consent?  So, it's good.

          MR. MORENO:  Am I excused?

          DR. FADEN:  No.

          DR. KATZ:  This silence is -- I think it's a very 

interesting and good chapter.  Are you going to do more with it or -- 

because what flows from all this.  Are you going to go into this or is 

that going to be in another chapter?  Is this --





          MR. MORENO:  I was planning on drafting a paragraph on 

simple consent a little later today.

          DR. KATZ:  Pardon me?

          MR. MORENO:  I'm planning to draft a paragraph on simple 

consent, to begin with.

          DR. KATZ:  Yeah, that's all right.

          MR. MORENO:  And I'm hoping that we get the reaction of 

committee members and other staff members to the text as it stands, so 

that we can move forward.

          There is a -- there are some promissory notes about the way 

in which this is going to apply and the rest of the report that I 

guess those of us who have been working specifically in the ethics are 

going to have to stay on top of.

          DR. KATZ:  You'll address that, too?

          MR. MORENO:  I think what we're going to try to do, and as I 

understand we're going to try to do, is have us have all of the 

subsequent chapters that bear on that ethical judgments entertained by 

people who have been doing the ethics and to make sure that the 

strands that we've introduced in this chapter especially get carried 

through the whole report.

          Otherwise, it's isolated and has no significance.

          DR. FADEN:  I think we should be clear about





what function.  We've all been talking about the purpose of each of 

these chapters.  The purpose of this chapter is to present the 

committee's position on the standards, criteria, by which it will be 

judging the government and then government agents and then individual 

investigators and physicians.

          We may not have made that clear enough.  This is Jonathan's 

attempt, I'm speaking for you, Jonathan here, and some others of us 

have been working with him on it, to capture that torturous discussion 

we had over two meetings about, well, does the AEC standard apply, and 

we have votes and these quasi-votes and then another vote.  

          This is supposed to be the written representation of the 

deliberations and decisions of the committee, and, so, it's really 

critical, you know.  We don't all have to sign off necessarily this 

minute, but this is the chapter that is supposed to stand for that 

part of the charter that says the committee shall identify the 

relevant ethics standards by which to whatever the experiments.  

That's this chapter.

          We're on to Chapter whatever this is.  Part 2, Chapter 5 -- 

Part 1, excuse me, Chapter 5.  Susan?

          DR. LEDERER:  I guess these are two small comments, but on 

Page 7, we talk about the infamous





Tuskegee syphilis study, and --

          MR. MORENO:  I'll take it as infamous, if you like.

          DR. LEDERER:  Infamous is a quotation from your text.

          MR. MORENO:  Yes, I'll take it out, if you like.

          DR. LEDERER:  Oh, no, no.  It's not a problem with that 

word.  It's just they appeared not to be self-conscious about their 

discriminatory -- it strikes me as a very strange description of the 

infamous Tuskegee syphilis study.

          MR. MORENO:  All right.  I'll come up with a better one.

          DR. LEDERER:  And on Page 13, Walter Reed did yellow fever 

research, not malaria research.

          MR. MORENO:  Oh, well.  Should have done the other one.

          DR. FADEN:  That would have been two hospitals named after 

it.  Nancy?  Nancy, and then Jay.

          DR. OLEINICK:  Forgive me for walking in a few minutes late.  

So, if somebody has said this already, you can say something.

          I found this a very well-written chapter, and I found myself 

being very beautifully led in one step





to the next to the next to the next, and when I got to the end, I 

wasn't quite sure if that's where I wanted to be or not, and I guess 

what it was, is that everything was there and all in a neat little 

package, but I felt that there was an emphasis that maybe was a little 

stronger than the way I felt by the time I got there.

          And I guess the issue that is uppermost in my mind is the 

problem of making a judgment in the absence of a complete evidentiary 

base, and we've talked about this before, but -- and you've said 

something here, which I can't quite find, but, you know, if you have 

the right -- let's see.  We have to make the moral judgments or 

something, providing, of course, that the relevant facts are there.

          I guess I would feel better if the statement were turned 

around on its head to say that it is our obligation not to make moral 

judgments, and when the facts are not there.

          I mean what is our obligation here, and I think our 

obligation is to first decide what the facts are, and then, if the 

facts are there to make the judgment, but if they're not, not to.  You 

have that there, but you seem to have the emphasis on the wrong 

syllable for my good.





          And then we come back to the other factor, which struck me 

in reading these various chapters that we're talking about today.  

Should we be judging, and can we judge, when we're sort of less than 

perfect ourselves?  I'm not sure to what extent you want to deal with 

that in here, but since we're being led to the point of making the 

judgments, this is setting up the way in which we're going to arrive 

at these judgments, I'd like to have that dealt with.

          DR. FADEN:  I'm sorry.  We had a little side bar 

conversation we shouldn't be having.  Do you want to respond, 

Jonathan, or do you just want to wait?  Let us know at any point you 

want to --

          MR. MORENO:  No.  They sound like perfectly sensible 

remarks, though I guess I'd only say I don't know how we can in this 

world avoid making judgments, short of divinity though we fall.

          DR. ROYAL:  I don't think that we want to avoid making 

judgments.  We want to have good reasons for making the judgments that 

we make.

          MR. MORENO:  Absolutely.

          DR. FADEN:  Jay?

          DR. KATZ:  Just it comes up a number of other places, not 

just here, but elsewhere, too.  On Page 14, in the last paragraph, you 

make the important point,





differing conceptions of who's a volunteer and what is a volunteer.  

Either you or somebody should really expand on that because, you know, 

that was -- it's been so confusing in -- for example, in the published 

reports on the Tuskegee syphilis study, many people were confused, 

myself included.  We didn't pay much attention to it, to the papers, 

and the implication prior to -- when the whole story came to public 

attention because in the literature, they were talking about 

volunteers.

          These were volunteers, the African-Americans of Macon County 

had volunteered, and, so, you know, you read it how it reads, but 

since they're volunteers, you know, why be concerned?  So, that 

deserves some attention.

          And then it comes up in the prior paragraph, the second 

point, scholars continue to debate the precise origins of the modern 

idea of informed consent, and do you mean informed consent as it's 

used even in documents already in the '40s and '50s or are you talking 

about the legal concept of informed consent, and there, of course, we 

have a pretty precise -- we do know what the date was in 1957, and if 

you then talk about informed consent as best as I -- in a general way, 

I think, though, we don't have precise information





that when we talk about informed consent, we didn't mean it in light 

of the legal definition, where informed means disclosure obligations, 

but they used it in the sense that people even used it subsequently, 

that the person be -- that the person give a knowledgeable, educated 

consent as defining, as modifying consent, rather than speaking to a 

different obligation, namely the doctor's obligation to disclose.

          And people like Englefinger, the late doctor, in the New 

England Journal of Medicine, wrote an editorial where he talked about 

informed but uneducated consent, and he railed here against patient's 

incapacity to really give a consent that takes efficient account of 

what they need to know in order to consent.

          But these are entirely different --

          MR. MORENO:  You're distinguishing between disclosure and 

understanding.

          DR. KATZ:  Yeah, yeah.

          MR. MORENO:  Yeah.  There may be disclosure without 

understanding.

          DR. FADEN:  Susan, and then Nancy again.

          DR. LEDERER:  Just to respond to something that Jay said 

about the way that the subjects of the Tuskegee syphilis study were 

referred to, and the





importance of sort of designating volunteer as a patient, is that I 

actually went back and I read all the published papers that came from 

the Tuskegee syphilis study, and they're not identified as volunteers 

until 1955, which also suggests greater sensitivity to sort of what a 

volunteer is in this decade that we've been so interested in.

          DR. FADEN:  That's interesting.  We are blessed with all of 

these people who have relevant expertise on this committee in every 

conceivable direction.

          Nancy has the floor again.

          DR. OLEINICK:  Just a couple other points that came to mind 

in reading this.  In the questions that you've drafted at the 

beginning, there's a statement here of the need for written patient 

consent and chart documentation developed through the decade of the 

'50s.

          I haven't heard anything or seen anything in any of the 

mountains of paper that I think have arrived from Washington to 

Cleveland on that particular issue, and this is something that you may 

all know, but maybe in some of this somewhere it ought to be buried 

in.  It's part of the history of the development of the process.  Have 

I just missed it?





          MR. MORENO:  There is a section on -- a sub-section on 

documentation of --

          DR. OLEINICK:  I haven't -- maybe I just missed it.

          MR. MORENO:  -- consent here.  It starts around Page 17.

          DR. OLEINICK:  Then I missed it.

          MR. MORENO:  It gives some of the examples.

          DR. OLEINICK:  It's possible that in reading this at about 2 

a.m., I did miss it.

          MR. MORENO:  Sure, sure.  It is itself a very vast issue 

because, of course, of the different terms that were used for these 

forms that people would sign, and the different purposes that were 

served by the forms at different times for different institutions.

          Legal purposes in a very sort of simplistic way and --

          DR. OLEINICK:  Okay.  I guess I didn't read that as meaning 

this as ordinary consent and chart documentation.

          MR. MORENO:  Oh, okay.

          DR. OLEINICK:  And maybe it's just me.

          MR. MORENO:  Right.  Well, I'll try to make that a more 

explicit reference.

          DR. OLEINICK:  Yeah.  That may have just been





me.  And then, just a small point.  This may also be reading these 

things at 2 a.m., it doesn't come clear.

          On Page 5, you -- at the bottom of the page there under 

Mitigating Circumstances, you talk about "so far in this chapter, we 

have mainly addressed the questions of what standards of research 

ethics were included".  Where had that been addressed or is that just 

the paragraphs got moved around?

          MR. MORENO:  The blessings of blocking in Word Perfect.

          DR. OLEINICK:  Yeah.  Okay.

          MR. MORENO:  Sorry.  Thank you.

          DR. OLEINICK:  Fine.  Okay.  Small problem.

          MR. MORENO:  Thank you.

          (Pause)

          DR. FADEN:  Duncan?

          DR. THOMAS:  We have here at the end here sections on 

judging government culpability, then a section on judging medical 

professions culpability, and finally a section on judging individual 

medical practitioners culpability, and my question relates to the 

question of where does Alan Buchanan's most recent memorandum in this 

briefing book on the moral obligations of members of bureaucracies fit 

in.

          The section on government culpability would





seem to be the most obvious place.  It's very brief and only has one 

sentence here that I can find that identifies who we mean by the 

government, where it refers to officials who occupy the highest 

positions of authority in federal agencies, and it seems to me we need 

to expand on those thoughts and talk about some of the underlinks as 

well.

          And then in this context, I wanted to revisit a point which 

Nancy raised at the last meeting on in what context do we view the 

role of the advisory committees that we have been so interested in 

pursuing.

          Do they represent just part of government or are they viewed 

as independent and perhaps ought to be put under the heading of the 

medical professions culpability or do they need another whole section 

by themselves?

          I circulated to a few individuals, and I don't know whether 

you saw it or not, but Alan Buchanan has now some excerpts from a book 

called "Advice and Dissent", which unfortunately is now out of print 

but at least I've left a copy for the advisory committee to look at, 

which I think has a lot to say on that last point.

          MR. MORENO:  I'll only say that the -- my esteemed 

colleague's paper has not yet been digested by





the rest of the staff working on the ethics, and when it is, it will 

be represented.

          DR. FADEN:  Can I make one comment?  I want to be careful 

about our language.  These headings are called Standards for Judging 

the Actions of and Policies.  The word "culpability" isn't in the 

heading for a reason, because it's -- I think we should remember 

there's a sort of two-step process.

          One if the standard for judging whether something wrong 

happened, and then how culpable institutions, agents, actors, would be 

for that wrong thing.

          So, we want to be able to preserve making different kinds of 

judgments, and that's why the headings don't lead with culpability.  

That's an additional judgment we would to want to make once there was 

a finding that something wrong in fact occurred.

          MR. MORENO:  And mitigating circumstances are then factored 

in at that level.

          DR. FADEN:  A wrong thing, but not hold people too culpable 

for it or you could hold them very culpable.  That's the whole 

Chestnut thing we were -- you know, we were talking about that the 

past two sessions, but I just want to be careful that we remember 

that, particularly with respect to the





Remedies discussion that we have this afternoon.

          Ruth is next on the --

          DR. MACKLIN:  First, I want to say that this was extremely 

well-written and well-done, and, secondly, apologize for not reading 

it more carefully because it was the last thing one had to read in 

this huge amount.

          Let me just -- a couple of small points and then a quick 

observation on Nancy's.  On the very top of Page 7, it's a little 

cryptic.  I'm just -- I'd like you to spell it out a little more 

because I didn't understand what you mean.  

          The last sentence on 6 and top of 7 says, "The advisory 

committee cannot fulfill its charge if it refrains from making 

retrospective moral judgments all together, but it cannot fulfill its 

charge responsibly if it issues certain judgments of culpability while 

excluding others without good reason."

          I mean did you have any more in mind, or is that just the 

general statement?  I mean I know because earlier you were talking 

about consistency, and that's very important, and it kind of leaves 

the reader questioning or left this reader questioning what others did 

you have in mind or is this just a general statement.





          MR. MORENO:  It's a general statement, nothing more.

          DR. MACKLIN:  All right.  Maybe it just needs to -- I don't 

know.  It just -- you see, if it leads me to question, well, what's 

underlying this.  I mean is there some thought about leaving some 

judgments out.  Did someone think some judgments ought to be left out 

and furthermore what constitutes a good reason.  I mean consistency is 

one reason.

          DR. FADEN:  My guess is, I'm trying to remember where this 

came from, my guess is, Jonathan, it may have sort of come in part 

from the condensation of something that was in Alan's, but I think the 

notion here was that we don't want to let ourselves off the hook just 

because certain sorts of judgments will be uncomfortable to make.

          The fact that it would give us distress or discomfort to 

make it isn't the issue.  It's got to be because there's insufficient 

evidence or because of something else that constitutes a good reason 

and not simply because it's easier to make a judgment about -- an 

example like that.

          DR. MACKLIN:  Then that kind of thing just needs to be 

spelled out a little more, too, to make it clearer.





          Another point on Page 12, I mean this is very briefly going 

back to the question of informed and consent, etc., is there any 

significance to the AEC general manager's inclusion of the term 

"informed", which seems to be the single instance?

          I mean you then go on to say mainly the terms "consent" and 

"voluntary" consent, but this kind of glosses over it, whereas since 

this was an early place where it appeared, it just seemed to me that 

it required some kind of comment.

          Was this an anomaly or was this once recognized that it was 

not merely consent something that somehow should -- more should be 

said about it?

          MR. MORENO:  I couldn't think of -- I just don't -- we 

haven't seen any other documentation that suggests that that was more 

than an anomalous construction on somebody's part at that time, though 

--

          DR. MACKLIN:  Well, you know, just for the sake of readers' 

understanding, I would put the later statements first, and then said, 

however, there's this anomaly.

          MR. MORENO:  I see.

          DR. MACKLIN:  Somehow, because somehow you read this, and it 

says informed consent, and then it backtracks almost.  So, maybe 

putting it in the other





order.

          MR. MORENO:  Right.  I think that is sensible.

          DR. MACKLIN:  And then your reference to the Salgo decision, 

I mean that was a treatment decision, purely a treatment decision.

          MR. MORENO:  Yes.

          DR. MACKLIN:  And therefore, I think that ought to be 

brought out, since it shouldn't -- I mean the screen and the history 

of informed consent to treatment and informed consent to research are 

very different.  They're entirely separate, and maybe that requires 

either a very slight elucidation or at least a reference to this, that 

these have.

          DR. FADEN:  I'm sorry.  I think I've been led out of the 

tunnel.  It was almost impossible for me to focus with that noise, and 

I don't know if it affected anybody else at this end of the table, but 

it was just as if we had been put in some sort of strange zone for 

awhile in a video game.  I think we're out till another strange video 

game, one round into another.  Thank you.

          DR. MACKLIN:  Anyway, I mean that's really the only point, 

and if it's necessary to make any further points about informed 

consent to treatment, to link with the discussion we were having 

earlier in the





previous chapter, you know, about the AMA, maybe there is something 

more to be said, but these were really two very separate streams.

          DR. FADEN:  I'm a little worried about the -- I don't know 

what we mean by anomalous.  I mean there is this -- we do have several 

statements, ones here, that do suggest there was a disclosure duty 

implied, not in the strict legal sense, but be clearly informed of the 

nature of the treatment, is the AEC, and that language appears, that 

the potential subject -- the subject is to be informed of or told 

about or whatever.

          But, you know, the happenstance of calling it an informed 

consent just makes good language.  I mean it's a perfectly ordinary, 

you know, modifier, and it makes sense to call it informed consent.  

Sort of in retrospect, odds are nobody else ever used it either, but 

--

          DR. MACKLIN:  Well, and I think that is -- I mean the 

historians and Jay would know more about this than I, but I think that 

does contrast with the treatment setting, since the arguments, why 

Salgo was important -- I mean the notion of having to obtain consent 

goes back to Cardozo decision and earlier, and then there was this 

huge gap from 1914 up to 1957 in which it was consent but not informed 

consent, and the





reason that Salgo -- I mean this patient gave her permission for 

something.  For radiation, didn't she?  Was that Salgo?  The radiation 

burn?

          Anyway, the point here was that there was no requirement of 

informing in the treatment context, and, yet, as we've been seeing all 

along, and as Ruth just pointed out, you know, tell the subject, 

inform the subject, give the subject adequate information in the 

experimental setting.  So, I mean it's an even further contrast.

          DR. KATZ:  Well, just elucidate a little bit.  If you go 

back to Schloendorff and you -- and the earlier case, 1905 Pratt v. 

Davis, the issue, even though the judges talked about consent, the 

real issue before them was in both cases that no consent -- no consent 

has been -- had been given at all, and therefore this was battery, and 

because they violated really fundamental legal -- it violated really 

very fundamental legal prescriptions that if you have no consent 

whatsoever, it's trespass and etc., etc.

          But then Salgo came around and began to invent the notion of 

informed consent, which was elaborated on, and this was the cobalt 

radiation experiment, therapeutic intervention, and I believe and have 

said before that all prior references to informed





consent, also in these Army documents, really -- except specifically 

as indicated that there was a requirement of disclosing something, 

really had nothing to do with disclosure, but it had more to do with 

knowledgeable -- the idea of knowledgeable consent, and what the 

nature of the duty was, you know, how much you had to disclose, the 

medical profession really had paid no attention to prior to the 1960s, 

when it had to begin to wrestle with it because of the new legal 

requirement, quote unquote, to obtain informed consent.

          So, there is the problem here, as I put it in my book, the 

notion of autonomy was not -- had -- has not really been part of the 

lexicon of medicine, until the 1960.  If you go -- except here and 

there, and, Sue, if she wants to contradict it, but the notion of 

patient autonomy was, except here and there, was really not discussed 

at all in the medical literature.  That's something that came upon us 

relatively recently.

          Would you go along with that?

          DR. LEDERER:  I guess I'd agree with it.  You might want to 

qualify it.  I think that there might be a class difference.  That is, 

there's much greater respect for the autonomy of wealthy patients in 

an effort to sort of enlist them in doing what's best for their 

medical care.  So, interest in that way.





          DR. KATZ:  But it was more in the Platonian sense.  You 

know, Plato wrote about that, of educating them.

          DR. LEDERER:  Yes, yes, it's precisely in that sense.

          DR. KATZ:  And it part, you know, that also meant 

indoctrinating them, that it's really important for their welfare that 

they better listen to --

          DR. FADEN:  That's exactly right.  I think, though, the 

point that, if I could interject, that Ruth's making may be worth 

drawing out more, and that is, we have a suggestion that in fact this 

sense that 

-- in the AEC stuff, and we were saying this is the standard, that in 

the research context, people -- the investigator should tell the 

patient, the subject, whoever that person is, something before getting 

their consent, comes out earlier, is what this is suggesting, because 

if you see the stuff here, it's not -- it's multiple times.

          The subject has to be fully informed.  The subject has to be 

informed of all the risks.  We have multiple documents that use 

language like that, and whether you want to reserve the term of art, 

informed consent, for the legal doctrine only and bless it with its 

birth in Salgo or not is to me less of an issue





than to point out that there was certainly evidence, and we're taking 

it as the standard using the AEC, that there was an expectation in 

this standard that subjects were supposed to be told something. 

          The subject is to be fully informed.  The subject is 

supposed to be informed of the risks or informed of the hazards, and 

then consent obtained.  So, again, it's strong -- a difference.  I 

don't disagree at all with the characterization for clinical 

practices.

          You know, Jay, that you've just -- that you've just -- that 

you've just given, but I think, Ruth, your point is well taken, that 

there's a way in which this requires underscoring because it is in 

stark relief to what was the apparent conduct and standard for 

clinical practice.

          So, we might want to do a little bit more with it.  Ruth, 

you still have the floor.

          DR. MACKLIN:  Yeah.  It's just now the concluding part and 

going back to Nancy's point.

          I think that the way the discussion -- I mean it's short, 

Section X, but it seems to be very persuasive, and it does not seem to 

me to be too strong.  So, we may have to battle this one out.

          However, Nancy, I think your point about if





we find that things aren't so red hot today, how can we be judging the 

past, the answer to that is we should judge the present, too.

          I mean the fact that even after all this time and much 

discussion and attention and a regulatory mechanism in place, etc., 

etc., there seem to be lapses or lapses or gaps in informed consent 

and perhaps some studies that -- or research that poses too great a 

risk doesn't mean, ah, so, they're doing it today.  How can we judge 

the past?

          I think we can then say something as we probably will about 

judging the present as well.  So, I don't think the fact that things 

may still be going on in all -- at all requires that we refrain or 

weaken judgments about the past.

          DR. FADEN:  Okay.  Reed?  Go ahead.

          DR. TUCKSON:  I'm afraid to ask this question.

          DR. FADEN:  Now is not the time to be timid.

          DR. TUCKSON:  In the last couple of days, as I've struggled 

over the issues with the surgeon general nominee, and the notion of 

criticism that he's been subjected to for potentially having performed 

hysterectomies in mentally retarded persons, and given that we don't 

believe in that any more -- back to the





Twilight Zone, --

          DR. FADEN:  I was afraid, but it looks like it's not kicking 

in yet.  You saw the panic on my face.  Go ahead.

          DR. TUCKSON:  Given this notion that now, when we look at 

it, that was -- that's not a practice that we believe in, at the time 

it was a practice that was legitimate in the profession.

          I'm -- I guess I'm --

          DR. FADEN:  Yeah.  I know.

          DR. TUCKSON:  -- looking for a little help.  How do I -- 

since that will be on the minds of people at the time this report 

comes out, it will be the one way that many people will find the door 

to --

          DR. FADEN:  Ruth, do you want to respond?

          DR. MACKLIN:  Sure.  The analysis in the -- and maybe it's a 

little briefer than it needs to be because when I made my brief 

presentation months ago and then Allen wrote his beautiful -- Allen 

Buchanan wrote his beautiful and carefully-thought-out paper, the 

distinctions made in that paper take account of this; namely, the 

difference between making judgments about the past in which there were 

no articulated standards, no -- nobody had ever articulated even if 

they didn't consist of policies; that is, the practice,





the practice may have been one thing, but when there were no 

standards, and no one raised questions that would put into people's 

minds that it may be wrong to sterilize mentally retarded persons, 

that's a very different category of making judgments about the past 

from situations in which either people did make comments or there were 

policies or there were articulated, even if they weren't standards, 

they were articulated judgments.

          Now, we can also say that just because nobody in Ancient 

Greece thought slavery was wrong, they ought to have thought that it 

was wrong, but as this article -- I mean this section says, and as 

Allen's paper said, there were degrees of moral culpability.

          So, we now think it was wrong or it is wrong in some but 

arguably not all circumstances to sterilize mentally retarded persons.  

We've come to respect classes of people who were not accorded as great 

respect.

          Certainly people would have argued that it would be -- it 

was wrong from today's standpoint, but we can make a retrospective 

judgment that it was wrong then to use mentally retarded persons as 

experimental subjects and human guinea pigs and wrong to kill them, no 

matter how people acted in the past.





          But when we're talking about a specific act, like 

sterilization, we could probably a give of justification that said 

nobody had articulated at the time and hadn't thought to articulate 

the kind of criticism that we give today.

          So, there are both degrees of judgments or culpability of 

the past and categories that make it meaningful from today's vantage 

point to judge the past.

          Now, maybe that's not sufficient --

          DR. FADEN:  You probably need to put more of that in there.  

We can put more in there.

          Let me point out on that -- I've got Henry and Jay.  This 

should not, of course, turn into a -- and Lois.  But one of the other 

issues that introduced -- that gets introduced, I think, in that 

particular case with the sterilization issue is that there are now -- 

insofar as the goal was to control menses, where there was problems 

with that, now there are different means to do that then short of 

sterilization.

          So, you start to look at the practice and the purpose and 

the justification, and whether we would still be as -- we would -- it 

also -- there is a -- the -- the methods for trying to achieve the 

good have





changed in ways that are less violable, less violating of other 

interests and rights that the person would have had, and that to me is 

very powerful in thinking through that issue and is in part why it 

wasn't as obviously condemned, particularly for people who were very 

profoundly retarded.

          But there were, of course, -- I think it's quite just as 

disturbing -- I mean they weren't that far in time and -- so, we don't 

want to get into the Foster thing.

          So, there was sort of brewing a view that there were abuses, 

but I think Ruth's point is there were also justified indications, 

and, so, it could -- but we have to be sensitive and make sure.  This 

is back to your point, Reed.

          We've got to make this understandable in five sentences.  

That's going to be the rough part, given how subtle in fact some of 

these levels of judgment actually are.

          I had Henry, and then Jay, and then Lois, is that right?  

Okay.  Henry?

          DR. ROYAL:  I would just agree with Reed that this is going 

to become an issue, and that it has to -- the clear distinction needs 

to be made if there is a clear distinction.  The Fernald and Wrentham 

School





stuff seem to me to be -- to raise many of the same ethical issues as 

the sterilization.  Even though the procedure is very different, it 

seems like the fundamental problem is the vulnerable population issue 

and the ability to get informed consent in that population.

          Ruth is shaking her head no, that she doesn't think that 

that's the fundamental problem.

          DR. MACKLIN:  Well, let me just say, I mean both situations 

involved mentally retarded populations, but it's the purpose or the 

objective of the action, and whether that can be justified, that is 

the key ethical question.

          Why did they use residents of Fernald or Willowbrook to do 

research?  It was a population of convenience.  The people in the 

institution were in control.  Scientifically, it makes a fairly good 

population because you control the variables a little more than people 

on the outside.

          Parents were -- even if there were a practice of getting 

consent, parents weren't even in the picture, and, besides, the 

parents put these kids in an institution, and they were at some 

removed and might not have even cared about them.

          So, here you have a population of convenience





to use as experimental subjects.

          In the case of sterilization of mentally retarded persons, 

and there were, of course, many reasons, many cases, many reasons and 

some of them not justifiable from today's standards, that is, from the 

convenience of others or the parents, knowing that there was sexual 

abuse, frequently requested -- saw that the -- women -- it was always 

women were sterilized, but, of course, that fits in with the control 

of the menses.

          But, there, it had something to do with the condition of the 

individual.  In the case of profoundly retarded people, who might even 

be frightened women, young women, might even be frightened and 

produced anxiety by menstrual -- monthly menstrual blood, one could 

even argue that sterilization, even though there are now less 

restrictive alternatives, was for the benefit of those people 

psychologically.

          If it was for the convenience of staff in the institutions, 

that doesn't count as a good reason today, but that's because we view 

mentally retarded people with greater respect, and we have a different 

view of it.

          But I think that the questions having to do with the 

objectives are what -- where you would make





the argument that there's a difference between the use of mentally 

retarded patients/persons as convenient samples for research in 

contrast to sterilization, which is presumably to -- either to prevent 

pregnancy and arguably, of course, from today's standpoint, we 

wouldn't do that, because there are less restrictive alternatives, or 

to control their menses.

          DR. MORENO:  By the way, orchiectomy was performed on 

violent offenders in the late 19th Century in many institutions in the 

Midwest, the notion being that they might be less violent if they 

didn't have all that testosterone flowing.

          DR. ROYAL:  You're more convinced that the purpose was for 

the benefit of the person than for the convenience of the institution 

than I am.

          DR. MACKLIN:  I'm not -- I'm not at all convinced of that.  

I'm saying it can be ethically justified, even today, if it's for the 

benefit -- if it was strictly for the benefit and could justifiably be 

shown to be for the benefit of mentally retarded people, that could be 

-- that could be justified today.

          I think the excuse rather than the reason that might be 

given is that it's for the benefit of the individual, whereas we know 

that very often and most of the times it was for the convenience of 

the staff.





          Now, I mean that -- there are people who may even argue 

today that in institutional settings, that are under-staffed, etc., it 

can still be justified, but I mean that's a much finer point, and 

entirely different, I think, from the use of very vulnerable subjects 

for a purpose that had nothing to do with their benefit.

          DR. ROYAL:  If it was done for the convenience of the staff, 

then to me it seems very analogous to Fernald and Wrentham.  If it was 

done to benefit the individual, then it's obviously very different.

          DR. MACKLIN:  I would agree.  I would agree.

          DR. FADEN:  But the point is that this is tough.  I mean 

these nuanced distinctions don't admit themselves to this was wrong, 

this was right, which is the challenge, I think, in how we express 

ourselves.

          Reed was referring to earlier, we don't have too many cases 

or maybe we do.  We'll find that out later.  Jay?

          DR. KATZ:  Briefly, a few points that go even beyond this 

chapter.  You know, one of the problems of ethical justifications is 

that almost anything can be ethically justified, depending on what 

point of view you are taking.





          If you look through your New York Times, and I gave some of 

these stories to my students when ethical issues are inquired into, 

and some of the most respected ethicists comment on it, and some say 

certain things are ethically justified, ethically problematic, 

ethically unjustified, the question is, will this stand up, you know, 

in terms of what is and what is not ethically justified.  It's a real 

problem.

          Second, I do not know where it takes us, the point that Ruth 

Macklin made earlier, that the Greeks should have known better as far 

as slavery is concerned.  I find it hard to comprehend.  Could they 

have known better?  My good wife is writing a book, which also 

includes why citizen women in Ancient Greece weren't given any kind of 

political right, and she's sort of fleshing out, you know, what the 

background tour is, and to say whether the Greeks should have known 

better or should not have known better almost becomes -- I don't know 

what the thrust of the question is.

          In a certain sense, couldn't have known better in the light 

of where they were coming from and what the thought was and the 

underlying philosophies at the time.  Maybe from the perspective of 

the 20th Century, we can say -- we may make an argument that





they should have known better.

          And, finally, you know, we have been talking a lot, and in 

earlier meetings, about the concept of moral progress, and what Reed 

is bringing to our attention, other -- and what Nancy brought to our 

attention, may be that idea of moral progress only carries us so far.

          This doesn't prevent us from making moral judgment.  We 

perhaps instead -- we are substituting for the concept of moral 

progress a concept that probably can be less cumbersomely expressed, 

namely moral progression and moral retrogression, that throughout 

history, there is always the ebb and flow of progression, 

retrogression, and depending on all kinds of considerations, but you 

talk about the notion of any kind of lineal progress, beyond a certain 

point, I don't want to throw out the baby with the bath water here, 

but beyond a certain point becomes also very problematic because we're 

going back and forth about these matters, you know.

          Actually an interesting example is the history of and the 

treatment of homosexuality in the Western world, which really went 

through periods of considerable enlightenment, even during the Middle 

Ages, and then we went back to the oppressive measures,





and now are entering a much more liberal kind of phase of thinking 

about the kind of respect that ought to be accorded to homosexuals, 

etc.

          So, these are great problems.  How are we going to resolve 

them?  We'll have to do the best we can, and I think to some extent, 

we may be able as clearly as possible as Reed tells us to describe the 

dilemmas and the problems and whatever judgments we make, make them 

and say why we want to make judgments, but also indicate briefly what 

our reservations are, and to state this as clearly as possible without 

-- so that we wouldn't be misunderstood.

          DR. FADEN:  Lois?

          MS. NORRIS:  I just want to say that generally I thought 

that the tone and the quality of this article were very fine, and 

they've come a long way in raising my comfort index with the 

desirability to or for and indeed the need to engage in this process, 

and that's saying a great deal because this has been very painful for 

me intellectually and emotionally.

          Beyond that, I had a couple of questions.  There's -- on 

Page 6, Lines 12, when we're talking about distinguishing between 

judgments with respect to the acts of individuals and the individual 

characters,





I don't understand the sentence starting with, "such patterns cannot 

reliably be inferred from information about a few isolated actions a 

person performs in one particular department of his/her life or those 

of a government agency throughout its period of service."

          Those last words, I don't understand.  Can you explain what 

you mean?

          MR. MORENO:  Well, the analogy that I'm attempting to draw 

between a human person and a corporate entity may not be licit, but we 

may on grounds that are similar to those in which we reserve judgment 

about a person until we know something about the entire course of his 

or her biography, reserve judgment about, and a corporate entity, 

until we know more, that's the -- that was the force of the 

association that I was reaching for.

          Therefore, we may feel that the Atomic Energy Commission, 

the Department of Defense, made some mistakes, but we're not willing 

to say that there's something venal at the core of those entities.

          MS. NORRIS:  And one more comment while I've got the floor, 

and that is, it seems to me that there is a distinct difference in the 

tone and the flow between Roman Numeral I, Types of Moral Judgment, 

and the rest of it.





          The style.  It's more a style, I think, than anything.

          DR. FADEN:  There's an easy explanation.

          MS. NORRIS:  I think I know the explanation.

          DR. FADEN:  Yeah.  We have to get the voice of the authors.

          MR. MORENO:  Well, fortunately, we have an editor now, I 

understand, who's going to --

          DR. FADEN:  Who's got a 100,000 problems.

          MR. MORENO:  -- produce things.

          DR. FADEN:  But, yeah, we've different voices.

          MR. MORENO:  Thank you.

          DR. FADEN:  Thank you.  Kind words.  Just to re-emphasize 

the significance of this chapter, when we go to Remedies, we use -- we 

-- the standards by which we're going to -- those categories all fall 

in are the standards in this chapter.

          The Remedies section on government culpability, the 

standards that are endorsed in this section, whatever number it is, 

are then the standards that -- Duncan, what was your acronym?  What 

was that standard?

          DR. THOMAS:  Failure to follow ethical standards.





          DR. FADEN:  Right.  The failure to follow ethical standards 

emerges as language throughout the Remedies section.  The ethical 

standards are the ethical parenthetically are defined in the Remedies 

chapter as the standards adopted by this committee in this chapter.

          So, these are the standards for government judging -- 

evaluating -- in Section 4 are the standards that presumably the 

committee has adopted and endorsed for purposes of making the 

evaluations and the Remedies section.  So, just to underscore as to 

what's at issue here.

          Hopefully there's nothing new because it's summarizing what 

the committee deliberated on the past -- during the past two meetings, 

but it is really just so we all know what we're talking about.  The 

sections for the professions and individuals are separate.  They're in 

here.  They're sort of in here.

          MR. MORENO:  What's that?

          DR. FADEN:  They're in here.  The standards for judging --

          MR. MORENO:  Individual physicians and the professions?

          DR. FADEN:  They're in separate sections.  The AMA would 

fall where, Jonathan?  If we wanted --





the medical professional?  Here we go.  Language of culpability gets 

introduced.  We probably should go back to the more general one.

          MR. MORENO:  I would tend to say that Section 8 would be.

          DR. FADEN:  Starting on Page 30, 31.

          MR. MORENO:  31.

          DR. FADEN:  Probably need a little bit more work there and 

in line with what John is developing to try to -- this gets to 

Duncan's question about where the duties of people in the 

bureaucracies go.  We probably need a clear articulation of what the 

duties are of a professional.

          MR. MORENO:  That's on my list.

          DR. FADEN:  That could get into here, just sort of 

generically professions are supposed to be the following sorts of 

entities with the following kinds of responsibilities.  I don't --

          DR. MACKLIN:  A profession is different from a bureaucracy.

          DR. FADEN:  Oh, absolutely.

          DR. MACKLIN:  And --

          DR. FADEN:  It's different duties.

          DR. MACKLIN:  I mean the question here of what are the 

duties of a member of a profession when





the member of the profession is not acting in accordance with 

standards that are set for another purpose, that is, theory becomes -- 

I mean therapy.  I'm sorry.  Therapy becomes tricky.

          I mean the standards for the medical profession, be they 

made by the AMA or not, which is a professional organization, I mean 

we don't have to be distinguished between the profession and a 

professional organization that presumes to speak for it, and the 

question -- I mean things are -- it's still being debated, what are 

the duties of a physician or a professional, and there are certainly 

not those that would be articulated in the AMA's Code of Ethics.

          I mean they must go beyond that, both in detail and in --

          DR. FADEN:  Actually, one of the things I was struggling 

with comes before that, which is understanding the obligations of a 

profession as opposed to a member of a profession, and can you take a 

professional organization as standing for the profession, which is, I 

think, something -- I think the second part of the chapter, which is 

the newest part, probably needs some more --

          MR. MORENO:  Yeah, it does.

          DR. FADEN:  -- thinking and development, but





if we're talking about can you make judgments about the medical 

profession, is that a code word for the AMA or is it something other 

than the AMA, and then how do you talk about judging the whole 

profession like, you know, all stockbrokers are X or the profession of 

stockbrokers should do Q versus members of the profession versus 

organizations that, as you say, purport to represent a profession.

          Henry, and then Phil.

          DR. ROYAL:  One of the problems I have is what the 

significance is of the judgment that we make.  For example, if we were 

to make a judgment that the AMA was culpable, and that's a word we 

like to use, I know, I'm not sure what that really means.

          It doesn't particularly trouble me one way or another 

whether or not we say the AMA was culpable or not because it doesn't 

seem to me that it has any major implications to make that judgment.

          We could make the same judgment about another organization 

or individual, and even though the -- we're doing the same process, 

the implications of having made that judgment might be profoundly 

different, and, so, even though, you know, the rules for making 

judgments might all be the same, we're using these standards.  We're 

holding everyone up to the same





rules.

          Having made the judgment made -- there are different 

implications, and I don't know how to factor that in or if I should be 

factoring that in.

          DR. FADEN:  Ruth?

          DR. MACKLIN:  Well, I mean I agree, Henry, that talking 

about the implications for the AMA are just silly in a way.  I mean I 

don't think that's relevant to our concerns.  That's a professional 

organization, and we may question some of its decisions or its house 

of delegates.

          I think the implications of making judgments about a 

profession are whether the profession adequately as a profession, 

which is an important thing to say, it's not just an occupation, it's 

a profession, and the implications of making judgments that a 

profession has failed in some way to adhere to proper ethical 

standards have to do with self-policing and the autonomy of 

professions.

          I mean physicians or the medical profession has long 

resisted outside oversight, government interference or whatever we 

want to call it, on the grounds that we police our own members or 

police isn't the right word, but, of course, it's the self-policing 

activities.





          So, the implications in finding, for example, -- I mean 

let's take an example outside our own area.  If the medical profession 

has failed to censure or take action against its members or engaged in 

egregiously bad behavior, like raping patients, for example, or 

sexually molesting patients, then one might argue the profession has 

failed to do what it should do, and there needs to be some kind of 

oversight or outside sanctions that might be placed.

          So, there are implications that are practical implications 

if a judgment is made that the profession itself fails in whatever its 

self-policing activities are.  It's going to differ, I agree with you 

entirely, it's going to differ.

          DR. ROYAL:  But the implication of judgments made against -- 

maybe a clearer way to say it, the implications of a judgment made 

against organizations are very different than the implications of a 

judgment made against individuals, and I guess when you're making a 

judgment, I think, personally think that you need to take into account 

the implications of having made that judgment.

          I guess I don't -- I don't -- I wouldn't personally feel 

comfortable about making a judgment unless I had thought about the 

down stream effects of





that judgment, because it doesn't seem to me that it would be justice 

if I hadn't considered what the implications of making that judgment 

were, and it's not clear to me where that comes in to this document or 

our discussions.

          DR. FADEN:  Oh, I'm sorry, I was just taking notes on just 

this discussion, and that was --

          DR. ROYAL:  That's okay.  We'll turn the fan back on.

          DR. FADEN:  No, no.  I was writing -- I was 

-- I think that in part, that goes to every time you make a judgment, 

if you want a response from me.  As we go through the chapters and 

also in Part 4, when we reach our global judgments about whatever 

large issues we make, we need to be thinking if we reach this 

conclusion, that X was wrong and Y wasn't culpable or X was wrong and 

Y was culpable for the wrong thing, whichever way we ended up, we have 

to be thinking what follows from that.  That's all.

          Making the judgment is towards an end or a purpose.

          DR. MACKLIN:  Well, Jonathan, the chapter does have that in 

here.  Maybe it needs to be highlighted and brought out more 

specifically, and some of maybe the down sides of making some of these





judgments as well as -- I mean there's a more systematic look at the 

implications.

          On Page 33, the -- this is the discussion of the medical 

profession being culpable in the past, and then the sentence goes on 

to say "there are fundamental moral implications for the medical 

profession today", and then it goes on to specify what some of those 

implications are.

          Now, I mean maybe systematically, if it had to take Henry's 

point, one would have to look at what might be some of the negative 

consequences of making past -- judgments about the past, culpability 

of the profession because this says what will happen today and how 

this bears on what should happen today with regard to regulation, 

reform and matters like that.

          DR. FADEN:  I'm sorry.  Was there anybody waiting on the 

list?  I got -- Phil?  I'm sorry.  Thank you.

          DR. RUSSELL:  My discomfort with this section is just about 

in the same area.  How to go from a generic expression of the 

responsibilities of the profession to something that makes sense in 

terms of the down stream implications.

          The profession is profoundly different now than -- both in 

concept and in organization than it was





in 1940.  There's a lot more organized activity on the part of the 

various academies and the sub-specialty organizations.

          The role of the AMA, I think, is much diminished in terms of 

its impact on the behavior of the many of the people in the 

profession, and going from a judgment of some culpability on the part 

of the profession as a whole to obligations in the current context is 

very difficult because at the top of Page 34, discharging this 

obligation requires cooperating, implementing new regulations.

          Well, who -- who's going to do that?  What organizations? 

          DR. FADEN:  That's a good point.

          DR. RUSSELL:  I mean does this put an obligation on 

individuals?  Does this put an obligation on the Academy of 

Pediatrics, the American Academy of Physicians, the Surgeons?  Who 

does it put an obligation on?  I think that's very much related to the 

concerns that Henry expressed.

          DR. FADEN:  So, it's on whom do these obligations fall, 

right?  If there are duties of the profession, who exercises -- who 

has these duties?

          DR. RUSSELL:  If there's implications of the judgment, what 

are they, and, you know, what's going to





follow from that judgment?

          DR. MACKLIN:  I just want to ask Phil.  I mean is the 

implication -- I agree with your observation, entirely agree.  But 

now, the question is, if someone were to put forth a suggestion for 

those upon whom the obligation falls, I mean is anything going to be 

acceptable?

          DR. RUSSELL:  May be.

          DR. MACKLIN:  I meant let me just give one kind of example.  

This is not -- I'm not putting this forward as the example, but for -- 

in most -- correct me, physicians, if I'm wrong, but in many or most 

or some medical specialties, there are specifically such 

organizations.  There's the -- what is it?  The Society for Clinical 

Research or is it a consortium of organizations? 

          There's certainly the pediatric.  I know the pediatric one.  

The pediatric was called an association or society for clinical -- for 

pediatric research, whatever it is.

          Now, these are -- that's not the whole profession, but there 

-- certainly if you take all specialties and sub-specialties who might 

be in some kinds of groups, those who are specifically concerned with 

research on patients, I mean would that be -- and





I don't mean that particular example, but if this document or if some 

examples like that were put forward, would those count as appropriate 

kinds of suggestions or is it likely that any suggestion is going to 

be flawed?

          DR. RUSSELL:  I'm not sure yet, but I think that it's quite 

possible that to specify the kinds of organizations that might take 

the lead, but in -- you're implying that these organizations don't 

have to rectify some culpability of the past.

          DR. MACKLIN:  No, no, no.  We're talking about prospective.

          DR. RUSSELL:  Prospectively, I think there's no problem in 

asking those organizations that are focused on research within those 

professional societies that are focused on research, asking them to 

take a more -- a greater cognizance and a leadership role in the 

dealing with human subjects.

          Oh, on the other hand, I don't think we've looked at the 

spectrum of activities that are already on-going in those --

          DR. FADEN:  Good point.

          DR. RUSSELL:  -- organizations.  For example, I suspect the 

pediatric research folks are looking at those issues very intensely on 

an on-going basis.





          The AIDS epidemic has focused a lot of attention on those 

issues, and both the process and the underlying ethical conflicts 

relating to AIDS.  I think we may be asking organizations to do 

something that they perceive they're already doing very vigorously, 

and I think maybe we ought to look at that before we make -- before we 

say a professional organization should do this, we better be sure that 

they aren't way ahead of us.

          DR. FADEN:  It would be interesting if we didn't do that.

          DR. MACKLIN:  I think what very many professional 

organizations, training programs partly at the behest of the NIH, are 

doing now is putting in place education and training programs and 

ethics components and requirements for education and training.

          What's not -- and that may be good, and that's a good first 

step.  I'm not quarreling with that.  What's -- what seems to be 

lacking is any mechanism for -- I don't know -- dealing with those who 

are found to be culpable of wrong-doing today.

          It's only the -- when the NIH takes action and takes away 

people's money.  The hospitals, the medical centers, the chairman of 

the department vigorously defend the palpable wrong-doers until they





violate criminal law.  Well, this is what's happening.  I mean if you 

take a look at the old story about the whistle-blowing and stuff, but 

I mean I think what is being called for here is really two things.  

Some pro-active steps --

          DR. RUSSELL:  Then maybe you're looking at the wrong folks 

because I don't think these -- many of these societies perceive 

themselves as oversight and policing organizations.  They perceive 

themselves as proponents of both research and ethical behavior and 

education and so forth, and they leave the regulatory aspects of this 

to things like the Joint Commission on Hospital Accreditation and on 

the licensure authorities of the states, and those that have been 

constituted either by law or by the professions themselves as a joint 

activity, the joint commission, and I think that they -- you may say 

that the societies that form the joint commission have kind of turned 

over their responsibilities, but they perhaps would come back and say 

they found a way to discharge the responsibility in an appropriate 

manner through a structured -- now whether it's working effectively or 

not is another -- totally another question.

          But asking the professional societies to undertake something 

that is beyond their scope is





something that is very questionable.

          DR. FADEN:  We will try to find out -- much of Wilhelmine's 

task has been to find out what the federal agencies are doing with 

respect to oversight.  We'll try to see what we can find out with 

respect to professional societies, hospital organizations, AAA and 

stuff like that.

          DR. RUSSELL:  HMOs now, that's beginning to do the same --

          DR. FADEN:  We'll see what -- we'll try to come up with some 

general description of what people are proclaiming anyway they're 

doing.  Henry?

          DR. ROYAL:  Ruth was -- Ruth Macklin was describing what I 

would refer to as the bad apple approach; that is, that there were 

these bad apples out there that we need to find, and there are two 

ways that you can try to improve things.

          One is to improve everyone on the average, and the other is 

to sort of truncate from the bottom, and I guess I would be in favor 

of improving everyone on the average rather than cutting off the tail 

of the curve, and the approach would be totally different to find the 

however many percent are at the bottom versus shifting the whole curve 

in a better direction.

          DR. MACKLIN:  I think one way of trying to





improve the average is to demonstrate that wrong-doing gets punished.  

I mean -- but there are other methods, and perhaps a slightly more 

noble methods, but that's one key --

          DR. FADEN:  I have this image that if you cut the tail of 

the dog, the dog jumps.  That's kind of the image.

          DR. ROYAL:  Anyone who runs a company has this problem of 

how are they going to improve performance, and as I said, I think the 

modern version of -- the old version used to be cut off the tail --

          DR. FADEN:  And the dog jumps.

          DR. ROYAL:  -- and then the new version is improve 

everyone's performance.

          DR. MACKLIN:  I agree, too, but I think that my only point 

in saying this is that if people know they can get away with 

sloppiness, sloppiness has a way of regressing into failure to attend 

to things like getting informed consent, etc., and when people don't 

-- I mean we had -- just one very, very brief anecdote.

          A case of egregious wrong-doing on the part of a researcher 

some years ago at our institution, multiple infractions, if not of 

actual regulations, of all kinds of other things and good patient 

care, and the IRB was -- well, I found myself somehow appointed





to be in the vanguard and to make some kind of statement that would 

merely censure this person, merely censure, take no other action, and 

when I used the phrase accusing him of unethical behavior and 

unprofessional conduct, the people said, oh, unprofessional conduct, 

that's a red flag, you can't -- you can say he engaged in unethical 

behavior, but God forbid you should call -- charge him with engaging 

in unprofessional behavior.  They wouldn't do it.  They wouldn't do 

it, and not only take any other kinds of things.

          So, I mean I don't like the phrase "sends a message", but I 

mean it seems to me that the lily-livered IRB that won't even censure 

someone for doing what they all agreed was wrong is allowing things to 

perpetuate.

          DR. FADEN:  Okay.  This is the time for lunch, unless we 

have -- anyone has a pressing need to speak.  I think we're going to 

be returning to Jonathan's chapter a little bit as we do the Remedies 

discussion.

          Before everybody goes, we're going to -- thank you very 

much, Jonathan.  I think what you're hearing is pretty high praise for 

a large part of that chapter, which is great.





          We're circulating something that Gary put together on staff 

about the no-fault context in preparation for the discussion this 

afternoon, which is entirely Remedies.

          You've got the chapter draft, and, so, this is a new -- it's 

not long, and you can, while you're waiting for the food to come, read 

this.  Isn't it wonderful?  You never get a break.  Never get a break.  

Cover your chairs or you'll find 20 more things.

          We are reconvening at 1:00.

          (Whereupon, at 11:50 a.m., the meeting was recessed, to 

reconvene this same day, Friday, February 17th, 1995, at 1:00 p.m.)































           A F T E R N O O N    S E S S I O N

                                             1:15 p.m.

             Committee Discussion:  Remedies

          DR. FADEN:  We need to start.  We're only 15 minutes behind 

schedule.  As Ruth pointed out, if we could get the restaurant to 

understand that we're not dining leisurely, and they would give us the 

menus right away, we would be much advantaged, but the food is good.  

So, you can't fault them for -- too hard.

          Okay.  We are going to start now.  The agenda for the rest 

of the day is Remedies.  We do have some time set aside at the end for 

what's called Committee Strategy and Direction.  That's a half hour, 

and that discussion is basically for Anna and Dan and me to ask the 

rest of the committee whether this -- a plan we have for how to get 

the drafts through people works well enough.

          If the Remedies discussion needs to take all that time, that 

could be communicated easily enough another way.  So, it's -- we 

really have the whole afternoon, if we need it.  If we don't need it, 

we have things to discuss having to do with how the committee's going 

to do business between now and the next month, that we could 

profitably do collectively or we could communicate to you some other 

way later.  So, we have a





lot of flexibility.

          The chapter draft -- oh, my.  Oh, no.  Back surgery?  That 

bad?  Mary Ann had surgery yesterday, but apparently is doing well.  

So, her back problem was more significant or more acute than -- huh.  

All because of the briefing books or so she says.

          (Discussion off the record.)

          DR. FADEN:  All right.  The draft -- the chapter draft on 

Remedies is clearly sketchy.  It's not really -- it's the beginnings 

of the structure of the chapter.  It's intended to provide us with the 

framework for the chapter, it is an early draft of it, so that we can 

reach some conclusions as a committee paralleling the kinds of 

conclusions that we reached with respect to ethics standards in the 

preceding two discussions -- two meetings.

          The goal is to get through this all the way through to the 

end.  If we can't, we'll pick up on the March meeting and finalize 

Remedies, but the strategy is this is retrospective remedies, not 

prospective remedies or recommendations for the future.  This is all 

looking retrospectively.

          The agenda on -- in March is intended to turn largely to the 

question of recommendations for the future or, the language some 

people have used,





prospective remedies.  If it turns out that we don't finish the 

retrospective story today, we'll pick up with that in March.

          This document reflects a couple of or at least one 

subcommittee meeting of the Remedies Subcommittee and that's Duncan, 

Pat, Ken is the chair, and myself, and Gary as the principal staff 

member, who's been working on these issues.

          So, this draft is a draft that's gone through a subcommittee 

review and been revised, and in line with that subcommittee meeting, 

and please chime in, Ken and Duncan and Pat, if I'm not getting this 

right, the chapter draft was basically divided into two parts, and the 

task -- and the two parts are the sort of two things that we would 

like the committee to do collectively.

          The first part of the document before us is a kind of 

taxonomy of kinds of events that it's argued hang together for 

purposes of thinking through remedies.  Okay.  And the first task is 

for the committee as a whole to decide if these categories are 

meaningful for the purposes that they are intended to serve.

          Once we get clear on a meaningful way to categorize the 

experiments for purposes of thinking





about retrospective remedies, then if all goes well, we'll have done 

that before the coffee break, if this works out right.  If not, not.  

          We come back from the coffee break, and we then look at the 

question of how to fit remedies to categories where this committee 

determines that some kind of remedy is in order.

          So, the first issue is A, B, C, D, D-1, D-2, do each of 

these categories make sense, and then, secondarily, do we think some 

kind of remedy is in order for this situation, or may be in order for 

this situation.

          We may decide to combine categories, eliminate categories, 

make up new categories, but that's what we're going to do first.  Once 

we get clear on that, then the idea is to go back and say, okay, for 

the 12 A-2 categories that remain, what are the fitting remedies, and 

the second part of the chapter draft then outlines, and you've seen 

some of this material before, the range of remedies that the committee 

could consider, and the notion is at the end of this, there is a 

series -- we would then have a series of guidelines for remedies that 

say here are the sorts of categories for which the guideline is 

certain kinds of remedies should be considered.  It's an attempt to --





there's a third part to this chapter draft, which relates to this 

question of how to link bad outcomes or risk of bad outcomes to having 

been a participant in research, and there, the issue is one of what 

criteria to use for establishing some presumption of causal connection 

between an outcome or a risk of harm and having been a subject in 

research, and the language in that third section comes largely from 

Duncan, and if there's time, we'll talk about that, whether that 

strategy that stands behind that language is the strategy that the 

committee wants to endorse for purposes of thinking through that 

question.

          But with respect to the initial task before us, we're going 

to pretend as if the committee already has or later will debate what 

guideline we would suggest for showing -- for a showing that there is 

a connection, and, so, the placeholder language was suggested of -- 

I've forgotten exactly the term that was used.

          DR. THOMAS:  Small PC and reasonable PC.

          DR. FADEN:  Something like that.  Reasonable probability.  

Was that it?  But it's literally intended as a placeholder, not 

because we want people to focus on the words "reasonable probability".  

          We'll later debate what the committee wants





to suggest as a guideline for deciding that there's enough of a 

connection between an outcome and being a subject that whatever -- if 

a remedy is appropriate, it would kick in.

          Is that helpful enough by way of background?  Now, there's 

one other new piece of paper that was waiting for you on your chairs.  

So, I don't know if you covered your chair, Eli, or not, but there was 

one waiting for you, and this is -- too late.  Duncan was kind enough 

to take the chaos of the A, B, C, D, E, stuff in the first part of the 

chapter and put it into a table.

          You want to describe the table for two minutes, and then we 

can just sort of -- my vision is we'll launch through the document.

          DR. THOMAS:  The table, I think, is self-evident.  The only 

comment I want to add is that in reading through the narrative, which 

described A, B, C, D, E, and so on, I found myself increasingly 

confused in part because there wasn't any parallelism in many 

circumstances.

          So that A, B, C and D sort of paralleled E, F, G and H, but 

the boundaries were defined differently.  So, this is my attempt to 

impose some order on that scheme.





          So, the numbers which are -- the letters and numbers which 

appear without parenthesis are exactly the categories as defined in 

the memo, and in various places, I identified holes, things which 

would be potential categories that one might want to be able to talk 

about and didn't have any labels attached to them.

          DR. FADEN:  Because they weren't in the chapter draft.

          DR. THOMAS:  Right.

          DR. FADEN:  And they don't exist.

          DR. THOMAS:  So, I have taken the liberty of then adding in 

parenthesis additional letters and numbers to identify those holes 

just so that we can talk about them.

          It's certainly not my intention to proliferate what is a 

one, two, three, four, five, six, seven -- 28 categories, and clearly 

some lumping is needed, but before we can lump, we've got to get the 

elemental units right, so that we can lump in an intelligent fashion.

          DR. FADEN:  There's also one other document that we were all 

handed before lunch, which is on no-fault arguments and sort of a 

little bit of a history about no-fault compensation in the context of 

research participation, and the arguments that the President's





commission -- is that right, Ken and Pat, if we just -- Duncan --

          DR. KATZ:  Where does Dignitary Harm come into this?

          DR. FADEN:  It shows it's going to come in.  Oh, on his 

table or in the memo?

          DR. KATZ:  In the table.

          DR. THOMAS:  Dignitary Harm, I think, would be in the last 

two columns.  Failure to follow ethical standards.

          DR. KATZ:  Oh, I see.

          DR. THOMAS:  So, I see it as sort of a cross classification.

          DR. FADEN:  Otherwise known as FTFES.

          DR. ROYAL:  And does physical harm include psychosomatic 

harm?

          DR. THOMAS:  I haven't really come to terms with that, but 

my conception, when we actually get to talking about what are the 

appropriate remedies, is that the psychosomatic harms come as a result 

of real or perceived increases in risk, and would not constitute a 

physical harm per se, but I'd like to address that under the headings 

of increased risk of harm, so that there's a remedy which might be 

appropriate, and to that circumstance, which might, for





example, be what they're calling not medical monitoring but the other 

terminology we used.  Medical evaluation.

          DR. ROYAL:  So, someone who had no physical harm but had 

psychosomatic manifestations, where would they fit in?

          DR. THOMAS:  I suppose you could think of them in one of two 

places.  You could either say there is a real physical harm, but it's 

not causally connected, and the connection is purely psychological, in 

which case it would fit under physical harm with small PC, or 

conceivably you could say that it's a consequence of an increased 

risk, which would now more broadly be interpreted as increased risk of 

any harm, physical or psychological.

          MS. KING:  Can I make a suggestion that we go through this 

first and then identify after we've discussed it fully what we think 

is missing before starting with what's missing?  Because it might be 

there.

          DR. FADEN:  I think that would be good, besides which, we've 

got to get right into it.

          So, if we all look at the document, the first category is 

the no-fault category, where either there is evidence that there is no 

wrong-doing on the part of the government or there's just no evidence 

to figure





out one way or the other whether anybody did anything wrong.  That's 

Pages 1, 2, and the very beginning of 3, and except for Category A, 

there's either the increased risk of harm or harm may materialize.  

Duncan?

          DR. THOMAS:  The major heading for this group of categories 

is categories where the government is not culpable of wrong-doing, and 

no where in this document is there any mention of anybody else as 

being culpable.

          DR. FADEN:  This is entirely -- let me just preface.  This 

is entirely government culpability.  We're only here talking about 

culpability on the part of the government, and remedies where the 

government is culpable or not culpable.

          DR. THOMAS:  So, is there to be another discussion later -- 

I mean another document in a future meeting which will address that?

          DR. FADEN:  Well, the issue is --

          DR. THOMAS:  Investigator culpability?

          MS. KING:  Can I ask a question?  And that is, the 

presumption is that if the government is culpable and remedies are 

appropriate, the legislature can on its own decide to do something, 

but if we talk about professional liability -- I'm trying to figure 

out how we can reasonably talk about investigator liability except to 

make the government responsible for





the investigator, which is another form of government culpability.

          DR. THOMAS:  Well, I thought about that, and it seems to me 

the one way in which the government might sensibly be involved is from 

issues of justice, and a remedy against a rogue investigator, let's 

say, for whom we decide the government was not at fault, but this guy 

is, would be -- I mean I think his victims would like to see justice 

done, and in that sense, there may be some role for either civil or 

criminal sanctions.

          MS. KING:  But what I'm trying to ask is really a question 

of sort of mandate or scope or our authority.  It seems to me that if 

there are individuals in their capacity as individuals that may be 

culpable, for our purposes, it's only of significance if they're 

government agents or for some reason government should pay for them.

          If they are indeed rogue whatever, we can't make any finding 

of civil or criminal liability, and if we say something, it doesn't 

mean they have to pay money.

          So, what I'm really asking is in terms of the question that 

you raise, for what purpose would we consider investigative 

responsibility outside of the





context of government culpability?  I'm not sure if I'm clear, but --

          DR. THOMAS:  You're very clear, and I don't really think 

that we would be looking to government to provide any of these 

remedies that are outlined here in that circumstance.

          But I -- having made the decision in the document we 

discussed this morning, that it's necessary to find judgments and 

moral judgment -- moral culpability against institutions or 

investigators other than the government, it seems a little funny for 

us to drop the ball at that point.

          DR. FADEN:  Well, I think the issue is whether you're 

dropping the ball, if you don't talk about remedies in connection with 

that.

          MR. FEINBERG:  My understanding is in response to Pat's 

question that either the government 

-- either the rogue researcher is part of the government for purpose 

of this discussion --

          DR. FADEN:  Or he's not.

          MR. FEINBERG:  -- or he's not, and if he's not, we have 

nothing to do with that, but based on the discussion we had last 

month, I thought that we recognized that for the most part, although 

it's a legal question, I guess, researchers working in





contract with the government or working for the government or working 

on a government-sponsored project are considered to be the government 

for purposes of this discussion.

          DR. FADEN:  Right.  That's right.

          MS. KING:  And it wouldn't mean that you might not on a 

different chapter in discussions of various other cases or other kinds 

of settings have a committee finding or a consensus about culpability 

and personal circumstances, but I don't think you can do any more than 

that.

          DR. THOMAS:  I would agree with you that our mandate does 

not extend -- to the extent that our mandate extends to talking about 

remedies at all, and that is quite clear to me.  It's clear it doesn't 

extend beyond any remedies that the government might provide, and if 

it's not to be seen as a government agent, then clearly our mandate 

stops abruptly there.

          Still, I'm troubled by that dropping the ball where we have 

assigned culpability, but I'm prepared to believe it's not part of 

this chapter.

          DR. FADEN:  In any event, we're all clear that we're talking 

about holding the government accountable in this context.  Okay.

          Can we just march in now?  I don't care how





we do it, but let's just march in.  We've got one, two, three, four, 

five, six, seven categories under this no-fault heading.  They're 

distinguished -- the issue is does it make sense to distinguish among 

them.

          Does anyone want to collapse any of them?  Do they all make 

sense to you?  The first one is clearly put in there with the proposal 

in it.  Otherwise, there's no obvious linking to them.  The first one 

says the government didn't do anything wrong, and nobody was harmed, 

so no remedy fits for this category.  It's there because it's 

important to state that there are such events out there, but it falls 

off from now on because there is no issue about remedies unless 

somebody wants to argue otherwise.

          So, in the spirit of getting us started on the right foot, 

does everyone agree that that category makes sense, and that no remedy 

is appropriate in that category?  It's good to start with a winner, 

right?  Okay.

          Now it gets a little harder.  At this point, it gets a 

little bit more difficult.  Henry?

          DR. ROYAL:  I'd like to make a general comment that's also 

applicable to B-1, and the general comment is we've heard about the 

public's frustration trying to get compensation in various different





programs that exist.

          So, it's very important that whatever we recommend in terms 

of remedies is doable, and whether or not it's going to be doable 

putting people in these little boxes, and also the implications of 

putting people in the boxes is important if, for example, there's a 

big difference in remedies, whether they're in Box A or B, then that's 

important for us to know because it helps define whether or not it's 

doable or not.

          If there's big incentives for being in Box A or B, and yet 

the distinction between Box A and B is fuzzy, then that's a big 

problem.  On the other hand, if the distinctions between A and B are 

clear, and there are different incentives, different compensation, 

okay.

          So, well, my basic general comment is that the remedies have 

to be doable.  We can't promise something that we're not going to be 

able to deliver on, and we need to understand the implications of each 

of these little boxes.

          DR. FADEN:  I would think that there's going to be kind of 

an iterative process, that right now we're just going to go through 

these categories and see if they make sense or not, and whether --





          DR. ROYAL:  They make sense from a --

          DR. FADEN:  Wait.  Let me just -- let me just finish.  If 

they make sense with an eye towards thinking about remedies, and 

whether a remedy seems appropriate in this category.

          When we then go to the second task of fitting remedies to 

boxes or categories, if it turns out that three categories actually 

get exactly the same range of remedies, we may collapse, make one 

category or whatever the deal is or we may decide when we actually go 

to work with the remedies that the categories don't make as much sense 

as we thought.

          So, in that sense, I think it will be iterative.  We may 

change our view about whether these categories are coherent when we 

actually start to work with them, but this is a first pass through 

with the key question being, is some sort of remedy in order for this 

category, without deciding what kind of remedy yet.  Just is a remedy 

in order for this situation.

          Now Pat, and then Ruth.

          MS. KING:  I just would follow up to Henry's concern.  I 

don't share his concern.  I would put the question a different way.  

It depends on what the committee sees its tasks as being.

          For example, we get to this next category, B-1, which is 

where the issue of doability obviously arises, it would be my own 

inclination that to the extent that doability question arises, that we 

take the position that we think something like medical monitoring 

might be warranted or not warranted.  If it is warranted, that we 

recommend the set-up of a system.  We don't try to set it up and try 

to specify every part of the system.  We're not constituted very well 

to do that.

          I do think that we could specify what such a system should 

have as broad factors or broad standards.  So that if you're 

approaching this task from that perspective, then there's only so far 

you can go with the doability question, Henry, if you wanted to really 

make that a big issue.

          A system of medical monitoring is doable, and I don't think 

that's the hard problem.  It can be done, and I don't want to try to 

figure out how to do it in specificity here.  I would be interested in 

trying to figure out what are the major components of what such a 

system would look like of that's what we wanted to recommend, and I 

would apply a doability test to major components.  I don't know if 

that helps.

          DR. ROYAL:  The doability problem I have is even the 

doability in fitting into a particular box. 





For example, B-1 says government culpability cannot be discerned.  

Now, what does that mean?  

          DR. FADEN:  That's what we should be talking about.

          DR. ROYAL:  How much evidence do we need in order to say 

that the government was culpable?  It's very easy to say the phrase 

"government culpability cannot be discerned", but is that a criteria 

which can practically be used to make decisions which the public is 

most interested in having us make decisions about?

          I have some concerns about whatever the guidelines are going 

to be to meet that particular phrase, and then the reasonable 

probability phrase is, you know, --

          DR. FADEN:  That's a separate debate, which we will have.  

I'm going to hold that. I've got Ruth and Ken.

          DR. ROYAL:  But it's hard to talk about B-1 when it's very 

unclear what B-1 means.

          DR. FADEN:  Well, that's what we should be talking about.  

I've got Ruth and Ken.

          DR. MACKLIN:  I want also to say that I thought this was 

very clear, and that I think all these distinctions are needed.  I 

mean I think this was a very fine start on this.  It's not only 

because I make





distinctions for a living.  

          No, no, there's no but that's going to follow this.  In 

fact, I'm defending the distinctions for the following reason.  I 

agree, Henry, that when it comes to looking at remedies, at matching 

the remedies to the categories, we may have to collapse them, but the 

reason I think that the distinctions as made in all these what you're 

calling little boxes are necessary is for us, whatever criteria we end 

up adopting for determining whether culpability did or did not exist 

or can or cannot be discerned, I think if we're going to look at 

particular experiments, we need all these distinctions.

          Otherwise, we have -- suppose we have a category that it 

cannot be discerned, but it doesn't say anything about harm.  Well, 

that's not going to help us very much.

          I think for every case that we have, every instance, the 

more we have -- more distinctions we have, the easier it's going to be 

to put particular experiments in a category.  We then have to decide 

whether it's the harm, the probability of harm, the culpability that's 

-- makes the match with the remedies.

          But I think if we want to -- for starters,





for a grid that enables us to be able to locate experiments according 

to categories, I think these distinctions are all needed.  We can then 

worry about what we collapse and what -- how -- what mapping goes with 

the particular remedies and these categories.

          So, I'm defending this as, I think, a very good job.

          DR. FADEN:  Ken?

          MR. FEINBERG:  Let me respond also to Henry in this way 

because I think your instincts are absolutely right on this.

          I think the real challenge before the break is simply to 

decide which experiments go in which category.  The categories 

themselves, I think, are fairly easy to defend and analyze.  The real 

-- I mean in theory, I think the distinctions in the classification 

are sound.

          What I'm interested in is finding out from the committee a 

point that Duncan and Pat made last time as well.  Which experiments 

go in which category?

          I just want -- the other point I want to make now, although 

it will be after the break, but it's in response to Henry, I do not 

believe, although I can be convinced otherwise, that we will ever be 

able to fit particular remedies to these categories.  I've tried.





          I don't think it can be done, and I'm anticipating the 

debate later on.  I don't think it can be done for the reasons that 

Phil has expressed last time and for what you have just said this 

time, Henry, which is, well, in theory, the classifications make 

sense, but if you try and plug in remedies to a particular 

classification on the basis of a finding that an experiment fits in 

Classification A but not in Classification B, I think we run into all 

sorts of evidentiary problems, factual problems.

          So, I'll be prepared after the break to explain how I would 

do this, but I do believe, as Ruth says, the real challenge before the 

break is can we agree that the experiments that we've documented fit 

into particular classifications.

          DR. FADEN:  Reed, and then Duncan, and then I think we 

should just start.

          DR. TUCKSON:  Ken, you really helped me on that, and I need 

to ask you, Ken.  I mean the reason that I thought that it was 

important to have this category of B-1 was that we were implicitly 

stating that it was possible to -- that we were stating that remedies 

could be due even when the evidence was not clear enough to be able to 

say with beyond a shadow of certainty that we could discern and define 

the





culpability.

          Now, what it sounds like I think you just said is, but I may 

be over-reading what you said, is that if you cannot determine beyond 

any certainty government culpability, then you're going to have a hard 

time determining that any remedy is in fact due.

          MR. FEINBERG:  I'm saying that to the extent that a remedy 

is due, that will have to be developed by the Congress or 

policy-makers down the road.  What we have to be able to do here to 

live up to our mandate, it seems to me, is classify, as Ruth says, the 

nature of the wrongs and the nature of the harms, lay out a menu of 

potential remedies, and I don't think -- I may be wrong about this, 

we'll see by the end of today, I don't think we can go further than 

that.

          DR. TUCKSON:  I see.  So --

          MR. FEINBERG:  But I know Duncan -- I don't think Duncan 

agrees with me.

          DR. FADEN:  I really think we have to do the work and stop 

talking about the work at the risk of being --

          DR. TUCKSON:  So, then I can get off of it.  If we're 

suggesting -- as long as -- the reason why I'm happy to see this 

category there is that it at least keeps the door open that says that 

when we get to a





place or an experiment where we just can't -- I don't know.  There's 

no way that we can know.  You cannot beyond any doubt say that it's 

clear, that that doesn't mean, all right, that takes it off of any 

further consideration, that goes into the dust bin of history, and we 

move on to another more certain case.

          What I want to make sure that at least our understanding is, 

is that we are, by moving forward, are leaving open the door to these 

cases as being still relevant.  Is that what we're saying?

          DR. FADEN:  Yes, and that's what this proposal suggests.  

Okay.  Duncan, did you want to --

          DR. THOMAS:  Yeah.  Just a parting shot on this thing that 

we've been arguing about.  I agree with the first part of what Ken 

just said, that the best way to try to figure out what we mean by 

language like "culpability cannot be discerned", and what we mean by 

"reasonable probability" is by trying to figure out what experiments 

fit where, and in so doing, we will uncover what we mean by that 

language.

          Now, I think that's going to be very difficult, and it's 

going to be very difficult for exactly the reasons in the second part 

of your comment; namely, that we're going to discover that the 

evidence isn't there and isn't all that clear-cut, and, so, we





don't really know quite what we mean.

          If we can solve that first part, if we can figure out 

whether, for example, certain I-131 experiments belong in Category 

B-1, then it seems to me it's very easy to figure out what remedies 

should flow from that.  That doesn't seem to me to be the hard part.  

The hard part's trying to figure out what fits where, and where these 

boundaries are.

          DR. FADEN:  Can we try it?  Okay.  Let's just try it.  All 

right.  Try this.  Okay?  See if we can unpack what's going on here.

          What's going on here in this category called categories 

where the government is not culpable of wrong-doing are a few things.  

One, there's a distinction made between cases where whatever criteria 

we end up using, Henry, the -- whoever makes the judgment concludes 

they can't figure out whether the government is culpable or not versus 

cases where you can figure out the government wasn't culpable.  Okay.  

Should there -- should they differ?  Okay.  There's sort of that 

distinction in terms of whether remedies are appropriate and what the 

remedy should be.

          Then there is an increased risk of harm versus the harm 

really materializes, and then the issue is the harm death or is the 

harm something else, and it





goes from there.

          The first -- underlying all of this is the assumption that 

remedies are appropriate at least in some cases where there's no 

fault, okay, which is a big issue, and that's why that other document 

staff prepared on the history of attempts to get no-fault remedy 

schemes in place for research subjects as background is provided in 

the little history about the recommendation of the President's 

commission to offer such a program generically for research involving 

human subjects, which went no where.  Okay.

          So, if we go forward, and I in fact am in favor of the 

general principle, and other people can state themselves, that there 

ought to be a remedy scheme that's no fault for people who were 

involved in research involving human subjects, but as Pat has reminded 

us in subcommittee calls, if we recommend this, that has implications 

obviously beyond the radiation area, and we would be joining a chorus 

of other committees that have similarly said this is a good idea, and 

it's never gone anywhere.

          So, just so everybody knows that, by way of shared history.  

Other committees and bodies have attempted to get a no-fault approach 

to research-related injuries and have thus far been unsuccessful. 





Now, maybe our call will be heeded or heeded -- if we decide to go 

that way or heeded in the specific instance of radiation experiments, 

I don't know, but there isn't like a rich tradition of success in this 

area.  So, that's by way of backdrop.  

          Is there anybody here who wants to propose in general that 

we ought to consider that there may be -- that one of the -- at least 

one of these boxes, there should be a remedy offered in the no-fault 

context for the arguments provided here and in the companion document?  

          The President's commission paragraph provides the sort of 

social policy justification for why the justification for why no fault 

-- a no-fault remedy might be appropriate in at least some cases, then 

we could go to the cases.  

          But if somebody wants to say forget it, if there's no fault, 

there should be no remedy, end of story, then we can move on to -- and 

that's the will of the committee, we move on to the next category.  

Henry?

          DR. ROYAL:  I think that we need to know what the 

implications are of recommending no fault.  For example, are there 

implications -- I guess I don't know who is going to provide this 

no-fault insurance.  Where is the money going to come from.  I just 

don't





understand the doability of it.

          DR. FADEN:  I guess this is a larger question, but any 

remedy that we might recommend is a remedy from the government.  Now 

exactly how it would be structured would not be our -- we would make a 

guideline that some kind of remedy is in order.  We would not tell the 

government how to work it out.

          So, if you're getting into large macro allocation questions, 

--

          DR. ROYAL:  Well, I mean it's a -- this fundamental problem 

of public trust, I hate for yet another government body to recommend 

something if it's never going to happen, and that's the problem I 

have.

          MS. KING:  Henry, if that's going to stop, believe me, if 

you do anything for the government, you'll never do anything, because 

at least 99 percent of the stuff -- I've served on a lot of 

commissions and panels, but every now and then, something goes some 

place, and you never know.

          DR. FADEN:  You can't predict.

          DR. TUCKSON:  Let me make sure I understand Henry's point.  

If we on the front end say that the doability, that all the 

complexities of doing it are so great that therefore we shouldn't even 

recommend it, doesn't that give us -- lead us down a road that takes





some of those -- the complaints and testimony of so many people that 

have talked to us and simply they've turned to us and say, well, 

because it was hard, you guys washed your hands of it.

          I mean it just says, well, because my problem didn't fit 

conveniently into a category, you all said the heck with me.  I don't 

think we can do that to those people.  I just worry if that's not the 

implication of that.

          DR. FADEN:  Ruth?

          DR. MACKLIN:  Taking the high road here, I want to contend 

that justice requires that we try to determine what people deserve.  

If the committee doesn't do that, then no one is going to look at 

questions of justice.

          So, I think it's our obligation to look at what people's 

just deserts are to the best we're able to do, and if someone else 

falls short of providing them, then at least we can hold our heads 

high and say that here's what we recommended.  I mean we're not here 

talking about something that's pie in the sky.  We're talking about 

something that someone has to have the political will to determine, 

but I think we have to look at the justice of it.

          DR. FADEN:  Ken?





          MR. FEINBERG:  For two reasons, I think no fault is 

appropriate.  First, it's appropriate from the perspective of the 

victim; that is, we've seen the whole story, and I think regardless of 

government culpability, if individuals were caught up in this cold war 

experimental era or whatever, I think the committee should reflect the 

view that regardless of government culpability, these individuals who 

were experimental subjects, it should be recognized that they were 

harmed, regardless of fault.  As a principle, I don't think this 

committee could do otherwise, to tell you the truth.

          Secondly, there's a much more practical reason why I think 

it ought to be accepted, and that is, as Henry correctly points out, 

since there's an evidentiary fine line in so many of these areas, 

between evidence of government culpability and a lack of evidence or 

sufficient evidence or what have you, I think that we should err on 

the side of recognizing that in the absence of a firm case of 

government culpability.  That's not to say that these victims weren't 

injured or that these subjects weren't injured.

          So, as a practical matter as well, trying to avoid fine line 

distinctions with cases that may be 30-40 or 50 years old or more, I 

think a no-fault





recognition is appropriate.

          Now, again, I anticipate now telling everybody that I don't 

think that a no-fault recognition resulting in injury to subjects 

necessarily leads to a specific remedy.  That's a separate question.  

But I do think that we'd be hard pressed after all the work we've done 

to say that in the absence of clear evidence of government 

culpability, we shouldn't recognize that subjects were injured, and I 

think we owe it to those subjects.

          DR. FADEN:  Okay.  So, that's a proposal for saying that 

some kind of remedy is appropriate in the no-fault situation 

generally.  Is there anybody who wants to argue against that?

          MS. KING:  Ken, are you arguing only in a situation where 

whatever reasonable probability is -- whatever that is, that physical 

harm will result, or are you just arguing that anybody who 

participated in  one of these research projects, there's no evidence 

of government culpability?  There's no harm.

          MR. FEINBERG:  There's no harm and no culpability, then 

that's not no fault.  That's nothing.

          MS. KING:  I know.  I didn't say.  I was very careful.  I am 

rarely precise, but I said no evidence of government culpability 

because Section B-1 says





government culpability cannot be discerned, and that is distinguished 

from A.

          So, I take it to be the case where -- oh, okay.  Well, I'm 

just sticking to B-1 for the time being, but Gary is correct.  But I'm 

only focusing on the difference between A and B, and that is, what we 

seem to be saying in B is that we can't -- there's not enough evidence 

for us to reach a conclusion -- wait, wait.  Then somebody has to tell 

me --

          DR. THOMAS:  Look at the table.

          MS. KING:  I want to look at the document.  I don't like the 

tables.

          DR. THOMAS:  It's A and B.  It's not culpability.  What 

distinguishes A and B is whether or not harm was likely.

          DR. FADEN:  It's actually both.

          MS. KING:  I thought that A -- that's what I thought, too, 

that A says no government culpability, and B-1 says experiments in 

which government culpability cannot be discerned.

          MR. FEINBERG:  That's why the ordering is illogical.

          MS. KING:  Don't confuse me.  Let me proceed on my logic 

right now.  I'm only trying to clarify one thing in my head, and that 

was what Ken said, because





I'm not proposing anything.  I just want to understand it.

          MR. FEINBERG:  I favor strict liability in B-1 and B-2.  B-2 

because there is no government culpability in B-2.  So, there's no 

mental state.  There's no wrong-doing on the part of government.  

There's no culpability.

          MS. KING:  But B-2 says physical harm, and that was the -- 

that was the thrust of my question.

          MR. FEINBERG:  No.  B-1 and B-2, the harm is the same.  The 

only difference is --

          MS. KING:  That's why I didn't go to B-2.  Everybody else 

went to it, and I will retract --

          MR. FEINBERG:  B-1 and B-2 say the same thing about harm.

          MS. KING:  Shh.

          DR. FADEN:  Duncan, let's relax here.  Let's get stretched.

          MS. KING:  Let me get my question out.  Everybody can answer 

the question.  I don't care.  But I haven't gotten it out yet.  This 

is only a clarification.

          I didn't understand the extent of Ken's argument for strict 

liability, and my question is, I will rephrase it, you tell me if this 

is what it





covers.  I thought that you were covering cases beyond no government 

culpability, but that also had to have physical harm, that it was not 

a case of your saying government culpability cannot be discerned, and 

no reasonable probability that physical harm will result.

          You did or did not include the latter?

          MR. FEINBERG:  I include --

          DR. FADEN:  Okay.  Let's -- is it -- can I try this?

          MR. FEINBERG:  I'm trying to understand the question.

          MS. KING:  If we just follow along on what's in the written 

paper, all I did was to take a look only at B-1.  I understand A, and 

B-1, I got to government culpability cannot be discerned.  I 

understood you on that one, Ken.

          What I didn't understand was what you were doing with 

respect to the harm requirement, whether your justification was a 

justification that only applied where there was physical harm or 

reasonable probability of physical harm.

          MR. FEINBERG:  Yes.

          MS. KING:  That your justification would not apply where 

there was no reasonable --

          MR. FEINBERG:  That is correct.





          MS. KING:  We did an outstanding job.

          DR. FADEN:  That's very critical because what's missing here 

is the category where -- I mean there's no -- you can't tell whether 

there's government culpability, and it also looks like nobody suffered 

physical harm.

          Now, we have this nuance that Henry introduced, like where 

does psycho-social harm go, and the document doesn't speak to that 

sort of emotional upset or worry about being a research subject.  

We'll have to go back and all rethink that through right now -- later, 

after we get through this.

          So, Henry is right to say that the document as it's laid out 

here doesn't talk about that kind of an injury.  It talks about risk 

of physical harm, harm to health and physical well-being or risk of 

harm to health and physical being, and some notion that there's some 

causal connection between the participation in research and that risk 

of physical harm or the physical harm materializing.

          So, is everybody --

          MS. KING:  This is important to me.  That's why I was asking 

for the clarification.  Because I agree with Ken's justification for 

that category. 

          I personally have difficulty extending the





justification beyond reasonable probability of physical harm.  That is 

why I was seeking the clarification.

          MR. FEINBERG:  Well, you wouldn't have trouble extending it 

to cases involving dignitary harm, would you?

          MS. KING:  But the dignitary harms have got to do something 

on the culpability end for me.  I'm just trying to keep it narrowly 

focused because we haven't discussed what government culpability 

cannot be discerned means.

          MR. FEINBERG:  But are you suggesting that you would not 

favor imposition of strict liability in cases where there is no 

physical injury whatsoever --

          MS. KING:  No.  It may turn on --

          MR. FEINBERG:  -- when a person did not receive consent?

          MS. KING:  It may turn on what the culpability statement 

means.

          DR. FADEN:  Let's get concrete.  We want examples.  Okay?  

Let's imagine an example where we have an experiment of which we have 

legions, okay, where there is literally no evidence whether consent 

was obtained or not.  Zero.  Not a shred of evidence.  Nothing that 

bears on that question whatsoever.  All you have is a published 

journal article, which we have





how many of?  3,000 something of them.  Okay.

          It also looks, when you read the research article, that in 

some significant proportion of these experiments, there was no risk of 

harm or no plausible, whatever this language is.  Okay?

          Now, the issue is do the subjects of those studies, okay, 

where you cannot tell for the life -- there's no way.  Everybody's 

dead.  You can't go back and figure it out.  Nothing.  There's no 

evidence about consent one way or the other.  Okay.  And as best as we 

can tell from the journal article, nobody was put at a reasonable 

probability of physical harm.  Okay.

          So, Pat's saying in that case, you want to say no remedy.

          MS. KING:  Pat is saying that because I think that one has 

to -- cannot be purist, even when one is being theoretical.  If we are 

serious about calling people's attention to the need to do justice, 

then we cannot end up saying every conceivable situation deserves a 

remedy.  I am very cognizant of that.  

          DR. FADEN:  This document says the same thing.  The document 

intentionally excluded that case from the remedy realm, but the 

committee could conclude otherwise.

          MS. KING:  Differently, right.  But that was





only my statement of how I see it, and that is the way I read the 

committee document, to have left out some categories for some reasons, 

but that's just me, and I just wanted to make it clear, so that people 

would know what was on the table, so that everybody would now -- could 

now react to that, and we could get the issue joined.

          DR. KATZ:  Ruth, are those words, does result, may result, 

will result, are they very carefully --

          DR. FADEN:  No, they're not.  What I'm saying is -- what we 

are saying is the committee would then have to decide how -- to 

provide a guideline as to how to interpret that.

          DR. KATZ:  I understand that, but in the heading, do the 

words does result, may result, will result, introduce differences or 

were they just chosen --

          DR. FADEN:  Yeah.

          DR. KATZ:  -- without --

          DR. FADEN:  Let me just -- show me an example, and I'll tell 

you --

          DR. KATZ:  On B-1, it --

          DR. FADEN:  B-2 versus --

          DR. KATZ:  -- says will result.





          DR. FADEN:  Right.

          DR. KATZ:  On B- -- and on B-2, it says may result, and --

          DR. FADEN:  Well, I think the will and the may was meant to 

be the same.

          DR. KATZ:  And does result.

          DR. FADEN:  That is -- all right.  Let me -- I think the way 

it works, the difference between B-1 and B-2 should have been 

identical.  B-1 and B-2 -- it hasn't happened yet, but there's a 

reasonable probability that it could, the harm, and in the C category, 

it's actually happened.  The person has thyroid cancer.  As opposed to 

the fact that the person's gotten I-131, doesn't have thyroid cancer 

yet, but is still within the age span when presumably there's a link 

between the I-131 exposure and getting thyroid cancer.  I-131 exposure 

was 10 years ago, and the person's still within whatever the range is 

for when an I-131 exposure is theorized to -- that's assuming that it 

met whatever the causation threshold we set up, whereas the C category 

specifically says the person's got thyroid cancer.  

          Okay.  That's the distinction between the B category and the 

C category.  I've got Henry and Ruth.

          DR. ROYAL:  One of the things that I'm





struggling with is the categories seem to me that they have to somehow 

be related to the probability into the severity of the harm, because 

if you had, you know, a one-percent probability of getting an ingrown 

toenail, that's somewhat different than a one-percent probability of 

having a heart attack, and, so, I'm having trouble with that concept.

          DR. FADEN:  The issue is whether that distinction has to 

come in now or has to come in when you fit it with remedies.  I mean 

one position, for example, if you read the President's commission, 

they took an even tougher stand than the one, if you want to take it 

as stuff that Pat and I are articulating.  Not only did it have -- in 

the no-fault context, does it have to be physical injury, but it's got 

to be reasonably serious physical injury.  So that if you're nauseous 

for two or three days, you don't get a remedy, but if you are sick for 

a month, and you lose, you know, and you come away with a doability, 

you get a remedy.

          So, you're right.  I mean you could start to parse it so 

that you hold it up, but if the remedy that's fitted is something like 

an apology, then you would care less.  Okay.  So, the issue is -- 

that's why I thought we would refine the categories further when





we started the remedy fitting issue, if in fact the remedy fitting 

issue is -- works at all.

          Does that make sense?  This is sort of the general view of 

-- the discussion that just happened -- I'd like to go back to Pat's 

point.  I don't know, Ruth, if you're on it, to see if the committee 

agrees that no remedy is in order, where you don't have evidence of -- 

there's no evidence available on the subject of culpability, and it 

doesn't look like anybody was harmed.

          This document and Pat's articulation of it says we're saying 

that case, there's no remedy.  Does anybody want to argue otherwise?  

There is just no information available, okay, about -- from which a -- 

you know, no -- not enough information available from which to draw 

any kind of conclusions about government culpability.

          But the evidence that is available is pretty strongly 

suggestive that nobody was harmed or put at increased risk of harm, 

and what makes it concrete are the 2,000 experiments or whatever 

number we have that were radiation experiments conducted in this 

period. About all that remains at the moment is a journal article.

          Now, if somebody has more time than we do and





wants to research a particular case and discovers there is indeed 

evidence of culpability, they'd shift into another box, but right now, 

all we've got and all the world has on most of these is a journal 

article.

          DR. TUCKSON:  And your definition of harm for your example 

does not -- how do you include the dignitary into that?

          DR. FADEN:  We don't know that there's any dignitary.  We 

can't tell.

          DR. TUCKSON:  But does that include -- I'm just saying does 

your notion of no harm occur?

          DR. FADEN:  No.  Mine is physical harm.

          DR. TUCKSON:  You're talking physical harm.

          DR. FADEN:  Okay.  The bestest we can figure out, the dose 

to which the person was exposed should not have resulted in any 

increased risk of harm, and all we have is a journal article from 

which that could be told, and we can't tell whether consent was 

obtained or not or whether the subjects were poor people or not poor 

people or institutionalized people or free-living people.  We can't 

tell anything from that situation.

So, that's what's out there.  Ken?

          MR. FEINBERG:  What if you can tell?  There's no government 

culpability, no physical harm, but you can tell they never gave 

consent?





          DR. FADEN:  That's culpability.

          MR. FEINBERG:  That's culpability still.

          DR. FADEN:  That's culpability, because they failed to meet 

the ethical standard of consent.

          DR. THOMAS:  It seems to me we had already agreed that.  

That was essentially the missing box of Category A.

          DR. FADEN:  A-1.

          DR. THOMAS:  The only difference is what we had agreed 

originally was really A-1 where there is evidence of no-fault 

culpability.

          DR. FADEN:  That's right.

          DR. THOMAS:  And the missing box that wasn't in this memo is 

--

          DR. FADEN:  That's correct.

          DR. THOMAS:  -- not discernible.

          DR. FADEN:  That's correct.

          DR. THOMAS:  We're saying --

          DR. FADEN:  That was an oversight.

          DR. THOMAS:  -- that there is no --

          DR. FADEN:  Is everybody comfortable with that?  Is 

everybody comfortable with that?  The missing -- you're quite right, 

Duncan.  That was what was missing in that piece.  Everybody's agreed.  

That's important.  Okay.





          So, now we've moved out of that box into where we have at 

least evidence of increased risk of physical harm or physical harm 

actually materialized, and whatever threshold guidance this committee 

concludes about connection is a remedy of some sort in order for the B 

category, the C category, and the D category.

          Are we buying into a no-fault notion as Ken argued?

          DR. TUCKSON:  Well, one quick question, and I hope it 

doesn't take us away.  I'm just -- do I need to be -- and I'm asking 

more, I think, the lawyer-type folk.

          Do I need to be concerned about the statement on Page 2 of 

the Summary of Relevant No-Fault Principles, that says, "no court has 

yet found that strict liability or no fault should apply to research 

injuries"?

          For someone not sophisticated in legal things, I worry, are 

we talking about writing a new branch of law?  I mean how serious a 

parenthesis is this?  If nobody -- after all these people have talked 

about it, we got a president's commission, everybody.

          DR. FADEN:  Pat, do you want to respond?

          MS. KING:  It is difficult with research --





with respect to the research to successfully prevail in a lawsuit, not 

impossible, but it's tough, both in negligence and, Ken will correct 

me, negligence and clearly strict liability, only because of the 

theory of the lawsuits. 

          This is explained by the way and length of the President's 

commission's report.  If you wanted staff to give you a copy of it.  

And that is because negligence pre-supposes as a theoretical matter 

that you have standards against which to measure behavior, generally 

accepted standards.

          When it comes to research, that applies to a small area.  

Did the investigator do what would normally be expected of 

investigators in terms of did he get consent, did he follow the 

procedural steps?

          When it comes to trying to figure out the harm, was he 

negligent with respect to the harm that resulted from that?  That gets 

to be more difficult because you're by definition doing research.  The 

outcomes are unknown or you have an hypothesis, but you don't know 

until you go through it.

          This is very hasty.  It is hard.  Strict liability is even 

more difficult because you're talking no culpability.  You're saying 

that there's social -- I put it saying there's social welfare reasons 

for paying





compensation, that it is better that the injured person be 

compensated, that the maker of the product not have to pay or that 

they're in a better position to prevent accidents in the future, etc., 

etc.

          So, it is not a surprising statement, and I think it's an 

accurate one.  I know of no strict liability case with respect to 

research.  I only know of a couple of negligence cases with respect to 

research.  There are informed consent cases.  That's different.

          DR. TUCKSON:  So, in that regard, Pat, I guess the issue 

then is, is by our doing this, does that put us so far out there as to 

be hit from a lot of different places as being unsolid?

          MS. KING:  No, because we're talking about civil system.  

There are obviously other systems that we have put in place where we 

thought helping people was meritorious.  The whole veterans' 

department is set up on a system that says if you served your country, 

you deserve some recognition and something that society is going to do 

for you.  The G.I. Bill was a bill that said you went off and fought 

in a war, let us educate you.

          So, we're in that ball park.  It's not a question of common 

law liability that we're talking





about.  We're in the realm of are these meritorious -- does this 

provide something for society, that society thinks is valuable and 

good, and, if so, does it follow from this particular behaviors as 

opposed to some other behaviors, that we should be willing to take 

care of those who get hurt as a result of trying to help us accomplish 

some greater social good?  So, I think that we're well within.

          DR. FADEN:  Gary, did you want to get into it?

          MR. STERN:  Just to reiterate.  You need to distinguish 

between a court remedy and a statutory remedy.  In fact, the Congress 

providing a statutory remedy need not have any influence on what the 

courts are going to do. 

          In fact, often with many of the cases we've dealt with, the 

statutory remedy has been a result of the court saying we can't help 

you, the law -- the law, the legal system and the courts provides no 

remedy.  There's immunity.  You need to go to Congress to get it 

through a different method.

          DR. FADEN:  Okay.  So, with that clarification, we could get 

into a discussion about whether remedies are appropriate in the three 

different categories.  Maybe we should take the weakest one, the





B versus the C group versus the D group.  The B group is the weakest 

because it's increased risk of harm.  In C and in D, the harm has 

indeed materialized.

          So, we're saying where there's no fault, now defined to 

include you can't discern whether there's fault or there's proof that 

there's no fault, and harm hasn't yet occurred, but there's an 

increased probability of harm.  Are we saying a remedy is in order?  

Whatever the remedy -- we'll get to what the remedy is or -- if we can 

fit it to Ken's comment and the background, but we're saying that a 

remedy would be in order as long as people are put at an increase -- 

it would follow if you get a remedy for an increased risk of harm, you 

get it if the harm materializes.

          So, all we have to do is get through the B-1.  Ken?

          MR. FEINBERG:  Let me just remind everybody, this is where 

it's relevant what Henry said yesterday.  Increased risk requires a 

basis, a sound basis for concluding that there is in fact increased 

risk, and it gets to this question of a causal connection between the 

exposure and the harm, such that there is an increased likelihood that 

that exposure will cause the harm, and I'm all for this, but I just 

want everybody to understand that in my view, I look to Henry and





Duncan and Eli and others as to whether or not the test that one has 

to apply to find such increased risk is sound, and that is another 

problematic reason why I have doubts about a specific remedy applying 

to a specific classification of harm in this -- of a specific 

classification of remedy in this section.

          DR. FADEN:  Ruth?

          DR. MACKLIN:  I want a clarification to describe the 

physical harm, and it really does go back to Jay's question about the 

verb tenses.

          I think, Ruth, you just said physical harm has not yet 

occurred.

          DR. FADEN:  It may never occur.  In other words, there's a 

situation -- I'm sorry.  Go ahead.  Finish your thought.

          DR. MACKLIN:  Well, I mean the thought is we're talking 

mostly about things in the past.

          DR. FADEN:  Right.

          DR. MACKLIN:  Mostly about things in the past.  So, we're 

not talking about something in the future where harm may yet occur.

          DR. FADEN:  Well, in some cases, we are, because we have 

some people who were kids before, who are still --

          DR. MACKLIN:  Right.  I mean setting aside





those who were kids, children, these categories, I take it, are 

supposed to encompass past cases in which there may have been harm.  

See, that physical harm -- there's a reasonable probability that 

physical harm may result.  Sounds like it's got two probabilities in 

there; namely, reasonable probability, which is probability, not 

certainty, and then may result sounds also possible.

          However, that phrasing can include cases in which there was 

harm, but what's uncertain is whether or not the harm resulted from 

the research, from the experiment.

          So, I mean the reason I'm asking this is that it's important 

in looking at the past cases --

          DR. FADEN:  Right.  Can we -- Duncan, and then Ken, and I'll 

tell you what I think was meant here, but we'll see if it's already 

clarified by the time they speak.

          DR. THOMAS:  I made an effort to try to clarify this 

terminology because I was concerned about exactly Jay's concern about 

tenses, and I noticed that there was quite a lot of inconsistency in 

the way the categories were defined from one block of this to another.

          Let me highlight two or maybe it's three of





these inconsistencies, which led to the subdivisions that I created in 

this table.

          In Category B, there is no -- it simply says increased risk, 

and it doesn't distinguish whether or not this is increased risk in 

the past or increased risk into the future.

          On the other hand, that distinction is very clearly made 

when we move over to the E&F categories, where E-2 says increased risk 

but no harm materialized, whereas F is increased risk, which may -- 

has not yet been expressed, but may be -- may yet be expressed into 

the future.  

          That's one distinction which I think will help us because in 

my view, although strict -- let me go on record as saying that I think 

strict liability principles are quite appropriate for this whole 

category, B, C and D.

          The specific remedies that we will end up suggesting will be 

very different in those three circumstances.

          DR. FADEN:  Okay.  So, we can hold that out then.  In other 

words, that would distinguish between 

-- you're right about the language not being careful.

          For purposes of deciding that some sort of remedy is in 

order, we could conflate the issue of





where the person was put at increased risk, person's now dead, the 

harm never happened, or the person is now 80 and the harm is not 

likely to happen, but the point is the person was put at increased 

risk during that whole period, from the circumstance in which the 

person was put at increased risk and the risk could still materialize 

as a harm, and that might have different remedies, but they were not 

carefully enough distinguished here.  B was meant to cover both, and 

we may want to separate them for purposes of thinking about remedies.

          DR. THOMAS:  Right.

          DR. FADEN:  But the issue is, is some sort of remedy due, 

even if the person was put at increased harm, is now 80, there's 

almost zero probability that the person will not in fact have the harm 

materialize within her, but during that period, she was placed at 

increased risk, okay, as distinguished from the C and D categories, 

okay, what the person actually did experience a harm that's in sum 

whatever threshold we use or criteria we use attributable in some 

relevant respect to their being a research subject.

          So, the only controversial one for purposes of remedy is B, 

since it sounds like everybody's buying C and D.  No one's arguing 

against the category of --





is anybody arguing against no fault -- some sort of remedy being 

appropriate for the B category?

          MR. FEINBERG:  B was simply designed to get, as you say, get 

at the problem of latency, where the exposure took place, whatever, 

and it hasn't yet manifested itself.

          DR. FADEN:  Right.

          DR. MACKLIN:  So that is viewed -- it is temporal.

          DR. FADEN:  I'm saying that it's written sloppily now, as 

Duncan points out, and it covers both.  Now, we could distinguish and 

say only if the person continues to be at increased risk of harm is a 

remedy appropriate as opposed to the circumstance in which there's no 

fault, the person was put at increased harm, but as it turns out, as 

probabilities go, it didn't happen.

          So, anybody that was in a risky experiment, okay, and 

nothing bad happened, to use ordinary language, forget all the fancy 

probability, the bottom line is somebody was put in an experiment that 

was risky, okay, carried with it a significant -- a real risk, 

however, and we don't know whether anything unethical was done with 

respect to consent or with respect to subject selection.  We just 

can't tell. 





Okay. 

          But the person was put at increased risk, was a risky 

experiment.  The person's now dead or the person's 80, and it's clear 

the person that -- the bad thing that could have happened didn't 

happen.  So, is the person owed some sort of remedy in that 

circumstance?  And people are shaking their head yes.

          Is there anybody who says no?  If there is, then we'll take 

it out, if everybody agrees it should be taken out, and that's to be 

distinguished as Duncan and Ruth rightly point out in the situation 

where the harm could yet occur.  Okay.  The person is still young 

enough or the kind of disease that it is is such that it shows up when 

you're 70 or 60 or the person's only 50 now or whatever the deal is.  

Okay.

          So, does anybody want to argue about removing the group 

where the person is no longer at risk of a bad thing happening but was 

put at risk of the bad thing happening for some period of time?

          DR. THOMAS:  I think you have to view that increase in risk, 

which was never expressed, as a kind of harm.  There was --

          DR. FADEN:  Okay.  Fine.

          DR. THOMAS:  It's of concern because there is anxiety 

created, and as a result of that anxiety, which





may persist even today, although today unfounded because we're now 

saying that there is no real increase in risk, it may yet merit some 

form of counseling or being told about their past exposure.  That is a 

form of remedy, albeit a fairly minor one.

          DR. FADEN:  We'll get to that.  So we get to the remedies 

later.  Henry, and then Reed.

          DR. ROYAL:  I'm still having a very difficult time with this 

increased risk concept, and maybe it's because, as I said, I think, 

this morning, I review -- I regard medical research as being an 

intrinsically hazardous enterprise, and if that's true, then we're 

saying that everyone who participates in medical research is at 

increased risk, and that everyone deserves a remedy.

          DR. FADEN:  That's why that category is problematic.  I mean 

arguably you might want to say the remedy is only in order on a 

no-fault situation when the harm occurs.  If the justice argument goes 

that basically the people who are research subjects take on or are -- 

have placed on them an increased risk of harm, okay, to benefit all of 

us, when that harm occurs, it's unfair that they should bear the 

burden of that all by themselves.

          So, that's why we have -- you know, we all





benefit.  They actually experience the bad thing.  So, that's why as a 

matter of justice we ought to somehow remedy them for the harm that 

materializes.

          The question is, should we -- and that's the principle 

argument behind C and D or where we still don't know yet if the harm's 

going to occur, but B is 

-- that's why B was distinguished.

          DR. ROYAL:  But then the trouble with C and D is for some 

things, you're going to have to follow people out for their life time.

          DR. FADEN:  Well, you may not have to -- you may say to 

them, tell your doctor from now on in, okay, and let us know if this 

happens, take your consent form.  That's how -- take your consent form 

home with you, and you're now in -- you know, these are the outcomes, 

and if any of these things happen, come back to the no-fault 

compensation team.  That's looking prospectively.  In this case, it's 

more finite.

          But that's why B was distinguished with sloppy language for 

the temporal issues from C and D, because most no-fault remedy things 

have argued you only do it if the bad thing actually happened because 

otherwise you would be providing a remedy to everybody who was a 

research subject just for the logic you've provided, Henry.





          So, that's why B is in there, that if we started remedying 

people for just merely being put at increased risk of harm, then 

everybody who was a research subject by definition, unless it was zero 

risk research, would be due some sort of remedy.

          DR. ROYAL:  Which --

          DR. FADEN:  Pat?

          MS. KING:  I actually think that -- I think I'm going back 

to something Ken said that we ought not lose sight of.  The reason 

that B is acceptable to me is -- B-2 is what I'm really looking at, is 

because of the reasonable probability placeholder language we have 

there, and that is because we are -- increased risk is not so broad as 

it sounds, at least in my mind.

          If it is -- there is reasonable probability, depending upon 

what reasonable probability works out to be in this committee, then B 

may or may not make sense.  For example, I mean I actually --

          DR. FADEN:  I'm sorry.  There's a bird flying.

          MS. KING:  Oh, how lovely.

          DR. FADEN:  There really is a bird flying.

          MS. KING:  It's an old hotel.

          DR. FADEN:  There is a bird flying through here.  So, it's 

okay.  There really is one.





          MS. KING:  There is some evolution in tort law that -- tort 

law is now judge-made law, not legislative, to think of people who 

have been placed at increased risk of a physical injury actually 

suffering a harm, in this case a real mental harm, --

          DR. FADEN:  That was Henry's point.

          MS. KING:  Right.

          DR. FADEN:  That was Duncan's point.

          MS. KING:  And in some circumstances, I think the -- it can 

be quite compelling.  I'm trying to think of the cases where it's 

arisen, but usually it has arisen from exposure, sometimes accidental, 

to what are believed to be cancer-causing agents --

          DR. FADEN:  And people worry about it.

          MS. KING:  -- and people worry about it or too much x-rays, 

a whole lot of stuff, environmental risk, etc. 

          And, so, the real question that people may want to focus on 

is whether that kind of harm, which I take it most people think is a 

real harm, that it's real, it's not imaginary in any way, deserves 

some compensation.

          Now, this has actually been very troublesome for tort law in 

terms of what you do with increased risk.





          DR. FADEN:  Well, can we do the following in the interest of 

-- we're obviously not going to be able to do everything we need to do 

today.  There's no way.  In the interest of moving forward, could we 

agree about C and D and the no-fault principle that lies behind C and 

D, hold B off, and decide whether B is the place to put psycho-social 

harm, anxiety, worry, okay, along the lines that Pat has laid out?  

That would take of Henry's original concern, and Duncan's original 

concern, and that may be yet a massaging that may work for us.  Would 

that work for the group?  To summarize the proposal.

          If we could agree as a group in the C categories and the D 

categories, that some sort of remedy is indeed appropriate on no-fault 

lines, hold off on the B category, come back to it later and 

reconsider whether the B category should be the place-holder for where 

material physical harm doesn't result but there's psychological 

suffering and anxiety associated with being placed at increased risk 

and knowing about it all these years and worrying about it.  Eli?

          DR. GLATSTEIN:  I'm having trouble with this because it 

again -- I hate to repeat this, but we really have at least two 

separate kinds of problems





here.  One is the medical experimentation issue, and the other is the 

population exposure.  I don't think they're the same thing.

          DR. FADEN:  This is not intended to cover that.

          DR. GLATSTEIN:  Well, when we talk about culpability and 

then risk, we are lumping them together.

          DR. FADEN:  No.

          DR. GLATSTEIN:  If in fact we come to the problem of, let's 

say, cancer treatment, and you treat the patient, and the patient 

dies, there is no more risk.  The patient dies of his cancer.  If you 

cure that patient, and that patient lives another 20 years or 30, and 

then comes down with a new cancer, which may or may not be related to 

his treatment, I don't think we'd be able to establish that very 

clearly, you then want to give compensation, a remedy to that patient?

          DR. FADEN:  Well, you're asking -- now, let me step back and 

say two things, Eli.  First, I should have --

          DR. GLATSTEIN:  I'm trying to think what the impact of this 

is going to be on clinical research.

          DR. FADEN:  Right.  I want to get to that in just a minute, 

but the way this is set up here, the





intentional -- the population exposures are handled later in the 

document.  This is set up -- so, that's a first issue.

          But back to this -- yes, let's think about that.  That's 

important to raise.  So, if that treatment was experimental, --

          DR. GLATSTEIN:  And from the government's point of view, 

they would be best off for sponsoring treatment that didn't have any 

survivors.

          DR. FADEN:  No.

          MS. KING:  I don't think it works quite that way, but it 

does have implications for clinical research, and that -- in that 

sense, you're absolutely correct.

          I think the way we would currently be set up, if we could 

deal with the causation issues, which you raised, assuming we could 

deal with those, where there was death, I would think that people 

would call the loudest and the strongest for something to be done, and 

I have some recent actually research examples that are going on where 

those kind of calls are actually being heard.

          But I do think that, that's why Ruth reminded everybody what 

I said before, that when you think about strict liability, we can 

certainly think of the





justifications for why strict liability ought to apply, no fault ought 

to apply where there's harm, but it has vast implications for clinical 

research.  So, you need to think about that part.

          DR. FADEN:  The only way to constrain it, if we wanted to, 

and I'm not necessarily advocating this, is to say that this is -- to 

invoke the further justification that Ken provided.  There's the 

standard justice argument that was laid out here about these people, 

all research subjects take on a risk to benefit all of us, and then 

they get the harm, and we should as a matter of fairness help them in 

some way, remedy them when the harm occurs.

          We could constrain it to our particular circumstance and add 

the dimension that because we've got 40 or 50 years worth of time 

passed, the burden of proving culpability is so difficult, okay, 

evidentiary difficult, that in this case, we're particularly wanting 

to do the no-fault situation, without necessarily saying that we are 

endorsing no fault for the whole world forever.

          Now, some people could look at that and say we're weaseling 

our way out on what is perhaps the tougher issue, but it would get us 

out of having to decide as a committee whether we all agree about the





prospective position that from here on in, there ought to be a 

no-fault scheme.

          MR. FEINBERG:  Oh, I completely agree with that.  When we 

were talking about no fault up to now, I don't think we were talking 

about anything prospective.  I thought that we were discussing the 

whole story, and the last 50 years, and that prospective regulation 

comes later on.

          DR. FADEN:  That's correct.  It's a separate judgment 

whether we would want to recommend that what we're saying should apply 

to the situation we have of historical experiments and the doing right 

by people who are in studies 20-40 years ago, whether we think that 

same thing should apply for the future.

          MS. KING:  And, Eli, I am of the view that the stronger case 

is made for the people who are going to be hurt now rather than 

looking at scanty historical records.

          So, the two are linked.  We are discussing the past.  We 

will discuss the future, but when you vote on the past or you vote on 

the future, you do have to understand the implications for the other 

because it comes down to if you had to draw the line, what is the 

stronger justice argument for you?  Compensating of those who have had 

wrongs done to them in the past, but





so far in the past that many of the people who have been wronged are 

not here to -- so that we can do something for it or the people who 

might be injured here and now.

          I mean for me, that's very real.  I think it's inconsistent 

to say help all those people in the past because you know it doesn't 

cost us anything, but ignore the questions for the present where it's 

going to cost us a lot.  But we can debate the present next time, 

Madam Chair.

          DR. FADEN:  Right.  That's what I want to distinguish here, 

that we -- there are implications, but they're not necessarily binding 

implications because this is -- there's a second justification.

          DR. GLATSTEIN:  Well, the implications for the volunteer, 

and the appropriateness of this for the volunteer, I think, is 

unquestioned, but where I have trouble is when we talk about a patient 

who agrees largely because of the nature of his diagnosis to go on a 

study, to gain benefit, and does gain benefit, as I say, perhaps 

cured, and then, at a long-term down the road, suffers an ill effect 

that presumably but not necessarily is related to the treatment that 

he received, that's the part that I'm having trouble with here because 

I see that as the real problem --





          DR. FADEN:  What I'm trying to emphasize --

          DR. GLATSTEIN:  -- for clinical research.

          DR. FADEN:  And what I'm trying to emphasize, Eli, is that 

we should worry about that, but you could -- but that's one of the 

debates for next time.  Okay?  In the sense that --

          DR. GLATSTEIN:  Do you mean I'm ahead of my time?  This 

would be the first time.

          DR. FADEN:  We can ask Dr. Macklin, but the point is -- the 

point is it will turn on the arguments for this, but there are two 

arguments.  I mean one is the sort of general justice view, and the 

other is, look, these people -- where are you going to put the burden 

with 50 years past and how much trouble we've had digging all this 

stuff up.  If somebody's really been harmed, and we think it's because 

they were in a research experiment, and we're going to say to them, 

but first you got to find that there was no consent form in your chart 

or there is a consent form, there is no consent form, but you've got 

to then find the investigator and interview him and make sure he 

didn't tell your mother something anyway or whatever the deal is.  

Ruth?

          DR. MACKLIN:  That argument that you're giving, which I find 

persuasive, applies to B-1 but not





B-2, because B-2 presumes -- I mean in a sense, B-1 is the easier case 

for no fault because B-1 leaves open the possibility, not necessarily 

a presumption, but open the possibility that there was no consent 

form, nobody was told anything, and therefore if the government -- the 

government was culpable, even though we can't now discern it.

          So, the argument, the 50-year ago argument, applies to B-1.  

It does not apply to B-2 precisely because we were --

          DR. FADEN:  Well, even worse, it's true when you distinguish 

C-1 from C-2 and D-1 from D-2.  So, if you look at it, forget -- the B 

category is in dispute anyway.  We don't know what we're going to do 

with it.  So, let's go to the tough ones, which are C and D.  All 

right.

          When death occurs or the person actually suffered an injury 

that we think is attributable, your point's very well taken, Ruth.  

The second argument only applies to the one version of each of those 

cases, where you cannot discern culpability.  If you could actually 

discern that the government wasn't culpable, and you go ahead and you 

agree that there's a no-fault stuff, that it really does bind you into 

Eli's problem, so the more you look at this, the tougher it gets. 





Okay?

          Is everybody following what just happened?  The difference 

between the C-1/C-2 formulation?  Your argument, Ken, that the weight 

of the history makes it impossible to figure out what's going on 

wouldn't apply to C-2 and D-2, now because there, the claim is the 

government isn't culpable.  There's evidence the government wasn't 

culpable.

          Now, frankly, I don't know that we have that many cases of 

that.  So, as a practical matter, I don't think we have to beat 

ourselves over the bush, you know, because most of the problems have 

to do with where you can't tell.  Okay.  It's not -- like we don't 

have too many clear-cut cases that the government did everything 

wonderful.  Most of the problems seem to be that we can't tell.

          So, C-1 and D-1 for our purposes really are the important 

categories in this case.  Pat?

          MS. KING:  To put -- I think Ruth did it, but I want to 

underscore what she did, because we're getting all the options on the 

table.  One option is that you suggested that where you can't discern 

culpability, you have to do something.

          The other option to avoid dealing with the present or to 

cover the present in a different way is





to say that strict liability is not warranted now that we're -- don't 

forget that is also an option.  You may be persuaded by justice and 

all of that, that you should go down the strict liability route, but 

you may also be persuaded because of some of the problems that Eli is 

raising not to go down any strict liability route, but only to argue 

for remedies where there was culpability.

          DR. FADEN:  Okay.

          MS. KING:  Because if you follow through the other argument 

that says you're better off if you can't prove your case in some 

respects than you are if you got injured and you did in fact consent.  

That seems strange to some people.  It doesn't seem strange to others.  

And you are.  If you consent and the government was not culpable, but 

you were harmed, nothing.  But if you -- if your case is muddy, 

muddied by 50 years, so that you can't go either direction, then 

you're better off because you get something.

          DR. FADEN:  Whatever the something is.

          MS. KING:  Whatever the something is.  Yeah.  So, in terms 

of all the options and the ways to go, it seems to me that Ruth has 

given one.  I'm trying to make clear that there is a separate option, 

and did everybody understand what the separate option is?





          DR. GLATSTEIN:  Not entirely.

          DR. FADEN:  All right.  Let's try it this way.  Maybe now 

it's flip chart time.  We were anticipating at some point we would 

have to go to the board on this one.  Okay.  That's why -- two charts, 

right.  That gives us two choices.

          All right.  One position is no fault down the line for the C 

and D category, but that means that the clear implications by analysis 

to the present situation are there; that is, the justification is not 

turning on this --

          DR. GLATSTEIN:  Involved in medical experimentation in the 

past?

          DR. FADEN:  That's right.  Right.  Some of which is going to 

be therapeutic.

          DR. GLATSTEIN:  Post-World War II.

          DR. FADEN:  Right.  Some of which is going to be 

therapeutic, some of which is not going to be therapeutic.

          DR. GLATSTEIN:  Yes.

          DR. FADEN:  Okay.  All right.  So, the one position that we 

could take in this first group of things.  We're putting the B 

situation aside for awhile because we don't know what we're doing with 

that.  So, these are all people who experienced a harm that by





whatever threshold we agree can be attributed for these purposes to 

their exposure.  The harm was either death or some sort of physical 

injury.  Okay. 

          So, one way to go is to say no-fault justification on 

fairness grounds.  That has implications for, you know, if you do it 

for these people, why not for all people, for all time.  Okay.

          The other option is to single out the C-1 and D-1 versions 

only, which is what Ruth Macklin pointed us to, where the argument for 

what no-fault compensation turns on the burden of having to prove 

culpability given the 50-40-30 years of time lag.  Okay.

          That does not necessarily bind the future.  Okay.  And the 

other option is just say forget it, no remedies where there's no 

culpability, which is what Pat just pointed out.

          MS. KING:  Which makes us probably more consistent with the 

present because it is not impossible if there is culpability in the 

present and you were harmed being able to recover maybe, but that is a 

third option.

          MR. FEINBERG:  Let me just say one thing.  I mean Eli's 

argument is in one sense sort of cute because you could argue --





          DR. GLATSTEIN:  You sound like my mother.

          MR. FEINBERG:  You could make an argument that a person who 

was dying of an illness and received therapeutic radiation thereby 

extending his life for 30 years, when he would have been dead after 

two, and 30 years later, with a net benefit of 28 years gets harmed is 

not physically harmed under these categories.

          So, I mean I understand Eli's point, but I think that one 

has to read an annotated discussion of a guideline before one would 

conclude that the government in the situation like that has physically 

harmed anybody.

          DR. GLATSTEIN:  Well, that's a good way to put it, because 

the problem I have is just the impact, this potential impact, negative 

impact, that this would have clinical research, and that's a real 

issue.

          MR. FEINBERG:  That's right, and I defer to you on that real 

issue.  All I'm suggesting is that when we drafted --

          DR. GLATSTEIN:  The patient got the benefit that he sought.

          MR. FEINBERG:  That's right.  When we drafted these 

guidelines, we weren't thinking, you know, what about somebody who's 

physically harmed 30 years after having a net benefit of 28.  We were 

talking about a





situation where a person's physically harmed and dies next week or is 

permanently injured or whatever, and that might have to be detailed.  

I don't think it's so simple.

          DR. FADEN:  We can detail it out so that it says you've got, 

you know, the net harm over whatever the deal is, so that you work it 

out that on balance the person was harmed.  It's not that a harm was 

--

          MR. FEINBERG:  It's not far-fetched. 

          DR. FADEN:  No, it's not, but it --

          DR. GLATSTEIN:  At one point virtually every Hodgkins' case 

was incurable.  Following modern treatments, when they put radiation 

and chemotherapy together, in particular, the new problem evolved.  

Treatment-induced leukemia.

          DR. FADEN:  I know that.

          DR. GLATSTEIN:  nobody saw it when everybody died.  You had 

to cure patients in order to see it.

          DR. FADEN:  But it's also the case that in the very 

beginning, there were probably some people who were harmed more than 

they were benefitted as the --

          DR. GLATSTEIN:  Without question.

          DR. FADEN:  And that's --

          DR. GLATSTEIN:  As we discussed last night around the dinner 

table, the first 40 patients who





underwent the lung transplant all died.

          DR. FADEN:  Right.

          MR. FEINBERG:  I would be sore-pressed to give up on strict 

liability for 50 years of the cold war experimentation because of 

Eli's very sound concern that prospective guidelines have to 

distinguish between, you know, true physical harm and net benefit over 

28 years resulting in an ultimate cancer, and I think that that is 

something that has to be spelled out prospectively, but I don't think 

that that means we should have over 50 years --

          MS. KING:  But there are other clinical implications, and I 

think that the best thing to do is just to lay them out on the table.

          The big issue for not going to -- the big debate for not 

going to prospective compensation for injured subjects don't have to 

do with Eli's problem so much, although it's real, it is the problem 

in therapeutic research for trying to understand what Henry raised 

earlier, the increased risk, and that is, did these people die of the 

disease that they had or did they die as a result of being involved in 

the research protocol?  That's a modern question, or whether they 

seriously injured in a research protocol today.





          The reasons that -- in addition to money and that it costs 

money that people don't want to get into prospective compensation have 

been that people don't know how quite to deal with therapeutic 

research.  So, I would not dismiss, even though the example -- that 

one particular example can be argued away, I wouldn't dismiss the 

legitimate concerns and implications for clinical research.

          Although, Eli, in my own mind, -- but I don't do clinical 

research.  In my own mind, I would resolve those in favor of 

compensation, but I think that your concerns should be addressed.

          DR. GLATSTEIN:  Let me point out that one of the reasons why 

this is so critical is that virtually every insurance company in the 

country has a small print rider which excludes payment for research, 

and once the patient has a malignant diagnosis, his premium goes up 

sky high, unless he's got very good group insurance, that the health 

care for such people can be a very vanishing thing, and especially if 

it comes under the heading of research, they don't pay a damn penny.

          DR. FADEN:  I saw Henry, and we have the issue of when to 

take a break.  I would like it if we could reach some sort of closure 

on the no-fault





business.  I'm giving up on the notion that we're going to go all the 

way through Remedies today.

          MS. KING:  I apologize --

          DR. FADEN:  This is going to go into March.

          MS. KING:  -- in advance, Ruth.

          DR. FADEN:  No, that's okay.  I don't think anyone ought to 

apologize.  This is tough going, and we have to get clear on what 

we're doing.

          I would like it, my faint hope, is if we could resolve at 

least something tentative with respect to the no-fault stuff, have a 

break, and pick up on the rest of this part of the document, and I see 

Henry and Ruth.

          DR. ROYAL:  Part of the problem, at least for myself, is 

unlike some other people at the table, I haven't thought about the 

concept of no fault for very long, maybe an hour.  So, you have to 

sort of help me along here.

          Today, women with breast cancer may sign up for a research 

protocol where the consent form will say you have a 30 percent chance 

of dying from this treatment, and then 30 percent of the patients may 

in fact die.

          I guess I'm having trouble from the justice point of view.  

If you have informed the patient about





what the risks are, if -- informed them honestly, if -- I guess I'm a 

little bit worried about the whole concept of compensation, saying to 

them, well, you know, if you die, we'll sort of pay you some money --

          DR. FADEN:  No, no.  Be careful, Henry.   The issue now is 

not -- we don't know it's compensation yet.  We're saying remedies.  

We haven't said what the remedy will be yet.  Okay.  And in fact, if 

you look at the recommendations of the President's commission, you'll 

see it.  I mean this gets -- this gets -- the issue on the table now 

is whether some sort of remedy is in order, not what the remedy is.  

Okay?

          DR. ROYAL:  Well, again, because of my own unfamiliarity 

with the issue, --

          DR. FADEN:  Right.

          DR. ROYAL:  -- it's hard for me to appreciate it --

          MR. FEINBERG:  It's also remedy retrospectively only.

          DR. FADEN:  Right now, it's remedies retrospectively only.  

The issue about the clinical things is because logically people are 

worried about what -- they don't want to be inconsistent, and, so, 

they're worried about if I recommend something for the past, unless I 

see that it's morally different from the





future, I'm sort of -- you know, that's like Eli's thinking is, you 

know, what am I binding myself to, if I want to be a consistent 

person.

          I mean that's really -- that's really Eli's question.  So, 

we can -- you know, we can reverberate back and forth or we can agree 

on the C-1 and D-1 case only now or whatever the group wants to do and 

hold off till we do the prospective to see what we're doing, but to 

your point, Henry, be careful.  We aren't necessarily saying what the 

remedy is yet.  Okay?  In fact, we're clearly not saying what the 

remedy is yet.

          We're simply saying is this in the remedy category as 

opposed to people for whom -- cases for whom no remedy is appropriate, 

like what we decided was A, and then we might -- failing to put A-2 

in.

          So, A and A-1 we've said no remedies for those experiments.  

So, now the issue -- the B-1 we said we're going to wait and figure 

out what to do with the B-1s.  In C and D, do we want to say some sort 

of remedy is in order for the C and D people or only for the C-1 and 

D-1 people or for none of them.  That's really -- and if we could just 

get the sense of the group on that now.  Okay.

          DR. ROYAL:  I guess it doesn't make a lot of sense to me if 

patients are fully informed about what





the risks are, and they voluntarily accept those risks, that there 

needs to be any remedy.  

          The potential justification in C-1 and D-1 has to do more 

with whether or not they were told about what the risk, and I don't 

know what to do about that.

          DR. FADEN:  I've got Ruth, and then Phil, and then Reed, and 

then figure out if we can get some sense of the group, and then try to 

go on.  We may have to do this again.  Ruth?  Was it Phil and Reed?  

Was that how we had it?  Okay.

          (Pause)

          DR. FADEN:  I can't remember whether it was Reed and Phil or 

Phil and Reed.  Reed?  Okay.  It was Phil.  Okay.  Phil, Phil.  All 

right.

          DR. RUSSELL:  I tend to favor the strict liability concept 

for the retrospective part, including the B-2, because I think some of 

Henry's concerns can be related to the issue of where there was no 

possible or no substantive benefit to normal volunteers.  Nothing was 

done wrong, yet injured occurred, and it's a matter of simple justice 

to compensate for injury.

          Now, whether in the instance of a patient where there was a 

potential benefit, in addition to a potential for harm, it's a little 

more problematic, but I think the -- most of the issues that we're 

dealing





with in the B-2 category are not related to patients.

          DR. FADEN:  Reed?

          DR. TUCKSON:  I'm scared to ask this question.

          DR. FADEN:  We're going to let Ruth answer it.  So, it's 

fine.

          DR. TUCKSON:  Ruth will answer it.  If I was struggling over 

this issue of trying to determine -- in case of C-1, where, you know, 

harm or death, and you're not sure about the culpability --

          DR. FADEN:  Can't tell.

          DR. TUCKSON:  You can't tell.  If I was looking at that 

today, in the clinical environment, if it's in the medical record, -- 

if it ain't in the medical record, they didn't do it, bad people.  I 

mean, in other words, if you didn't document it, and you didn't tell a 

clear story, then you didn't do it, and you don't agonize over it a 

whole lot.

          Is there any -- and we haven't, I don't think, talked about 

this, but is there any notion like that that's applicable to looking 

back?  A person was harmed.  You can't tell that their rights were 

protected.  You just don't know.  Because you can't find out and 

because no one in an official position is in a position to assure you 

in any way that those





issues were dealt with, they didn't put it in the medical record, so 

forth and so on, therefore the presumption is that the person -- that 

they didn't do it.

          Is there any applicability to now on the past in that 

situation?

          DR. FADEN:  Pat, and then Reed.

          MS. KING:  I would rephrase what you said just a little bit.  

I don't think there's presumptions about did you do it, did you not do 

it.  I think that what you're asking for is presumptions on which way 

should you go in trying to furnish relief.  So, that was the first 

clarification of your question.

          Other people have different experience, but I'll give you 

two arguments, and I'll show you how hard this problem is.  One of the 

arguments for strict liability is difficult of proof; that is, in 

addition to social welfare arguments, one of the arguments has been 

made, and this is most clearly in products liability and some other 

areas; and that is, that it is impossible for deserving plaintiffs to 

be able to prove their cases, and there may be other reasons that you 

want to compensate them.

          So, there is a role for making an argument about problems of 

proof beyond the victim's power to





have had any influence over it.

          On the other hand, there are concepts like statute of 

limitations, which say at some point, we have to draw a line that says 

problems of proof are now unfair to the other side, and we shouldn't 

argue in favor for remedy.

          So, we'll set some outside time beyond which we will not go 

back.  So, it seems to me that you can make an argument both sides on 

how you want to deal with and be comfortable about it, Reed, going 

down either direction about how you want to deal with the record not 

being there, and there are lots of instances where you hold the person 

that you think should have been responsible for creating a record as 

bearing the burden in the absence of a record, and I think that you 

could be -- believe me, you don't have to worry about how it fits. 

          This is all a question of which argument you like the best.

          DR. TUCKSON:  That helps me a lot, and it helps me to be -- 

becuase I'm very worried, also, as a person who's committed to 

clinical research, I'm -- you know, Eli's cautions worry me.

          Bottom line is the mandate for this committee was in the 

very fact that you couldn't get information. 





The very fact that the whole world in this area was closed and locked 

up.  The very fact that we had a whole staff of extremely talented 

people who have just busted their cookies for the last nine months or 

a year, digging stuff out, and finding every which you could to get 

it, is the whole notion -- I mean this is what this whole thing is 

about, and I think that that's ultimately the way I have to come down, 

is being extremely influenced on the fact that if you -- that you 

cannot hold a whole government that was pledged to secrecy and loss of 

records and telling all these dog-gone people that testified in front 

of us that their records don't exist anymore because the place blew up 

in St. Louis.

          DR. FADEN:  Got it, but, see, just to point out that that 

goes to the C-1/D-1, and not -- let me just point out, just so you 

know -- now wait a minute.  I want to emphasize again that I think 

we're talking about a null set here.  Now, it's a principled issue.  

It's a principled issue, but as a practical matter, we don't have a 

whole lot of C-2/D-2 type experiments floating around where there's 

clear proof the government was blameless and somebody was harmed.  We 

don't have a whole lot of those going.

          Because when we look back, the biggest





problem is in almost all cases, either it does look like the 

government was culpable or you can't tell.  Okay.  So, it depends on 

how much time we want to spend on what's a very important principled 

matter, but as a practical matter, for the people who fall under the 

scope of this committee, probably not lots of people.

          MS. KING:  But, Ruth, it does have enormous practical import 

for next month's discussion.

          DR. FADEN:  I agree.

          MS. KING:  That is why --

          DR. FADEN:  I agree, but --

          MS. KING:  -- we've got to make a hard cut on just those 

categories.

          DR. FADEN:  Well, but what we can do, okay, which is what 

we're proposing, but I'm going to let Ruth go in here, you could just 

say for right now, let's vote on the C-1/D-1 case, that no evidence or 

insufficient evidence case, and hold off on the other two, till we 

have a prospective discussion.

          But, Ruth, can you tell us what to do now, please?

          DR. MACKLIN:  No, I can't do that.  But what I can do is 

make the following proposal, and -- but this is really summing and 

reiterating.  I'm not going to say anything new, and that is, the 

proposal is that





we accept all of these categories that we're talking about as no 

fault, and the argument for that is -- in other words, to accept them 

as deserving of remedies, even in the no -- according to the no-fault 

categories, the ones here.

          DR. FADEN:  The ones.

          DR. MACKLIN:  I'm sorry.  The twos.

          DR. FADEN:  The ones and twos.

          DR. MACKLIN:  Ones and twos.  And the reason is that I would 

argue that it has less implication for what we may decide or what may 

happen prospectively than people around the table are arguing; that 

is, it's an inference, but we can -- since we are going to make some 

recommendations for the future, we can detach what we claim should be 

the remedies or the compensation or remedies in the past from what we 

propose in the future.

          So, that's the general argument for doing so.  Now, Eli said 

something interesting about the only way -- how people get into 

research.  Now, I'm always 

-- in other words, the insurance company will pay for routine care but 

won't pay if they're in research.

          Now, one of the things that could -- and you're worried 

about the effect this may have on clinical research.  One of the 

things that --





          DR. GLATSTEIN:  We have about the lowest rates in the 

Western countries for patients who participate in research, much lower 

than the Europeans, much lower than the Canadians.

          DR. FADEN:  Because they pay.

          DR. GLATSTEIN:  Beg your pardon?

          DR. FADEN:  It's paid for.

          DR. GLATSTEIN:  Largely because it's paid for, but largely 

because the European countries pay for -- the European countries pay 

for it, too, but the European countries are much more supportive of 

this sort of thing than we are.

          DR. MACKLIN:  Well, there are other differences, too, but 

they seem to be going to where we are and what else.

          But I was only going to make this point.  Since we are 

talking retrospectively, whatever the remedies are or will be, they of 

necessity have to be retrospective, and if people are no longer alive 

but fall into Category D, for example, then whatever the remedy is is 

something other than continued medical care.

          The thing that has always struck me about the clause on the 

consent form, on today's consent form, that say in the event of injury 

from this research, you





will only be compensated for short-term or treated without charge for 

short-term medical care.

          Well, I mean you could make the argument that I thought I 

heard Henry make before, this is what they accept, people sign on to 

it, and indeed that's -- that may be so.  It would seem to me fairer 

if there were a promise, if there were injury, that could be properly 

traced, I know Pat's giving us the difficulty of evidence, to being a 

research subject, if longer-term medical care were provided, since the 

injury resulted from the research.

          So, there is a possibility of looking towards prospective 

recommendations.  That seems to fit the situation much better than 

whatever we're thinking of retrospectively.

          So, I don't see in sum, in conclusion, I don't see that the 

harms or the worries about the future damage to research are an 

inevitable consequence of accepting the no-fault position.

          DR. GLATSTEIN:  Well, I want to support the idea of no fault 

for this group that have already been experimented upon, largely 

because I want to see patients that go on studies rewarded as best we 

can.

          Now, I say that without defining what the remedies are yet 

because that's a separate thing to do,





but what I want to be clear on is that I'm not committing myself on 

the future to something that might actually be damaging to clinical 

research.

          DR. FADEN:  Fine.  That's --

          DR. GLATSTEIN:  I don't want to be inconsistent.

          DR. FADEN:  Okay.  Now, at the risk of pushing things and 

because some of us need to take a break, especially those of us who 

had a lot of water to drink during this discussion, can we reach some 

sort of closure on the C and D?  Okay.  I don't hear anybody saying no 

remedies for these -- for all -- for C-1/D-1 -- for the whole lot.  No 

one is proposing that, right?

          (No response)

          DR. FADEN:  Does anyone want to propose remedies for -- that 

C-1, C-2 -- I'm putting B away for the moment.  That C-1, C-2, D-1, 

D-2 all are deserving of some kind of remedy.  Does anyone want to 

propose that?  Was that what you were proposing?  Ruth was proposing 

that.  Anybody else want to propose that?  Pat?

          MS. KING:  No.  I'm going to abstain.

          DR. FADEN:  From that.  All right.  Now, I just want to see 

how many proposals there are.  The





other proposal, I take it, is remedy for C-1 and D-1 people, the 

evidentiary problem people, and we're going to put away the C-2/D-2 

people till we think about it some more.  Okay.  So, those are -- my 

sense of the group is those are the two --

          DR. GLATSTEIN:  I'm willing to lump them together.

          DR. FADEN:  That's the first one.  The first proposal is C-1 

through D-2 are all appropriate for some kind of remedy.  Proposal --

          DR. GLATSTEIN:  Not defining it?

          DR. FADEN:  Not -- no, we're not defining what the remedy 

is.

          DR. GLATSTEIN:  All right.

          DR. FADEN:  Okay.  The alternative is the committee is ready 

to say C-1 and D-1 should get some kind of remedy.  We don't know what 

to do with C-2 and D-2 yet.  Those are the two options.

          I would like to call for a sense of the group.  Unless 

anyone wants to give me a third option, I take it those are the two 

options.  That's all we can hold in our head at the moment.  Okay?

          DR. TUCKSON:  Just -- the only thing -- just if you combine 

C-2 and D-2, it does sort of imply because of the D-2 part what he 

said, which is because





they're already dead.

          DR. FADEN:  I know, but they're dead in D-1, too.

          MS. KING:  Can somebody give me the argument for when we're 

sure the government is not capable of any wrong-doing and death 

results and harm results, why a remedy is appropriate?  I'm trying to 

-- because I'm truly struggling because it has to be somehow tied to 

be past and leave out the future, and I haven't heard an argument like 

that yet.  I've heard one for C-1 and D-1.

          DR. FADEN:  Ken?  Ken?

          MR. FEINBERG:  The argument I would make is, again putting 

aside whether there will be a specific remedy, I want to put that 

aside, the argument I think I would make is that as a historical 

matter over the last few months, even if the government was not 

culpable at the time, even though they did all they could do that was 

appropriate at the time, upon reflection, the -- 50 years later, the 

price paid by certain individuals in terms of harm and death is such 

that the -- whether it be an apology or some other remedy --

          MS. KING:  I cannot separate that from the future.  I can 

separate Ruth's argument for C-1 and D-1





because that's Reed's argument.  That's Reed's justification.

          DR. FADEN:  All right.  Let me point out something.

          MS. KING:  C-2 and D-2.  This is no government culpability, 

but harm results as a result of --

          DR. FADEN:  Let me give you -- let me give you the --

          DR. KATZ:  This can happen in the future again, is that it?

          MS. KING:  Right.

          DR. KATZ:  Yeah.

          MR. FEINBERG:  Let me just add by saying I think it will be, 

to my way of thinking, notwithstanding Pat's concern, relatively easy 

to distinguish prospectively from what happened 50 years ago, and that 

therefore the idea of strict liability in the future will easily be 

distinguished.  I would oppose it, I think, in the future, but I can 

see why concerning 50 years of experiment it's relatively 

straightforward for me to make the distinction and provide a remedy 

for people, regardless now of a finding of no government culpability.

          DR. FADEN:  Are we ready to try it?  Okay. 





Whichever way it breaks, mind you, if, by next time when we start to 

fit it with remedies, if we want to change our mind, we will.  I mean 

as we start to do that.  It's going to be very interactive, and we may 

decide to change it.  We have to do something.

          All right.  The one proposal is the whole kit and caboodle, 

C-1, C-2, D-1, D-2, are deserving of some kind of remedy, a remedy of 

some kind is in order.

          How many people are in favor of that one?

          MS. NORRIS:  Are we on the whole --

          DR. FADEN:  Right.  The whole -- C-1, C-2, D-1 and D-2 are 

deserving of some kind of remedy.  Okay. And how many are in favor of 

the only C-1 and D-1?  Okay.

          MS. KING:  This is an abstention.

          DR. FADEN:  Essentially abstention from the first one, and, 

Reed, you want to -- all right.  So, we have a sense of the group for 

right now.  That's about all we can do at the moment.  Okay.

          What I'd like to do is take a break, come back in 10 or 15 

minutes, and move to the category where there's culpability, which is 

going to prove at least -- Ken has a suggestion or -- do you want to 

tell the suggestion or do you want us to go on the break first?





          MR. FEINBERG:  My only suggestion is for reasons stated by 

Henry and others, it may be very useful at some point before we 

adjourn in the anticipation of next month to talk a little bit about 

the second half of your afternoon agenda, which was where do the 

remedies fit, and the only reason I say that is because I think that 

there's an argument to be made that the remedies don't fit anywhere, 

and that no remedy can be tailored to a particular classification.

That may help people.

          DR. FADEN:  Well, one alternative would be to try to take 

the C-1 and D-1 categories and see if we can fit them with remedies.

          MR. FEINBERG:  Well, all -- I'll do whatever the Chair 

wants. 

          DR. FADEN:  We can do that rather than go on to the -- we 

can do that.

          MR. FEINBERG:  I'm just suggesting it.

          DR. FADEN:  It all has to be done.

          MR. FEINBERG:  For reasons Henry stated, it might be 

beneficial before we adjourn to have everybody get a flavor of the 

debate as to whether remedies can be tailored to a particular 

classification or should be.

          DR. FADEN:  Yeah.  Let's try it.  All right. 





Why don't we instead shift around?  We'll come back, and we'll try to 

-- we'll take the C-1 and D-1 categories, where everybody seems to 

think some sort of remedy is in order, and see what would work.

          (Whereupon, a recess was taken.)

          DR. FADEN:  Ruth has suggested, and I think it makes sense, 

that we're going to go to Ken's let's see if we can fit remedies to 

categories.  We had two categories that we agreed deserve a remedy of 

some sort, where remedies are appropriate, and those -- that was in 

the language of the document C-1 and D-1.  Those are both no fault.

          For purposes of fleshing out the discussion, Ruth proposed 

can we find a case where there's culpability that we can all agree 

deserves some kind of remedy, and then we'd have three cases to work 

with.

          So, if we could decide on this point only.  If we go to Page 

4 of the chapter draft on Remedies, the situation, G-1.

          MS. KING:  The situation --

          DR. FADEN:  Pardon?

          MS. KING:  The situation on Page 4 that you're pointing us 

to?

          DR. FADEN:  Yes, G-1.

          MS. KING:  G-1.





          DR. FADEN:  Category G-1.  Okay?  If everyone could read 

G-1, and the call now is do we think that some sort of remedy is in 

order.  This is a culpability context, so that we would have three 

cases to work with, two no fault and one fault fault.  Is that the 

sense of it, Ruth?  That would -- then we can go to this issue of 

fitting remedies to categories, would it work.

          DR. GLATSTEIN:  This is now open for population experiments.

          DR. FADEN:  No, none of this is population experiments.  

This is all bio-medical experimentation for right now.  We have the 

whole separate part.  We may decide later that all of this stuff works 

for population experiments or not.  We have other proposals that have 

been put in here for population experiments, but we'll have to see.  

But, no, this is still in the context of bio-medical research, but 

would include therapeutic and non-therapeutic, Eli. 

          So, it would include the experiments in connection with the 

bomb testing maybe but probably not, because we have another category 

for that.  Anyway, we've debated separately how they get handled at 

another time.

          This is the bio-medical experiment.  So, G-1. 





Okay.  The call -- question here is can we agree that some sort of 

remedy is in order for the situation where the government is culpable 

for failing to follow ethical standards or otherwise acting 

improperly, and there's a reasonable probability that the subjects 

suffered physical harm attributable to their participation in 

research?  This is supposed to be a no-brainer.  Is it a no-brainer?  

Okay.  Ruth was probably right.  We should have started with these 

first as opposed to the tough ones, but -- okay.  So, this is a 

no-brainer.

          So, we now have three categories to keep in mind.  All 

right.  C-1, D-1 and G-1, and the issue is fitting remedies to the 

categories can they be done.  Ruth, do you think we should start with 

the no-brainer first?  All right.  Ruth wants to start with the 

no-brainer first.  Okay.

          So, we have a situation for G-1.  The simple-minded thing to 

do would be to march down the list of remedies, okay, and see whether 

we think they fit.  So, this is a case -- now, we immediately get into 

this situation.  If you notice, as this is refined further, one of the 

key issues for G-1, when we think about remedies, is, is the person 

who was the subject still alive or not, okay, which might affect the 

remedy.





          Let's start with the assumption that the person -- the 

subjects that would fall under G-1 are still living.  Then we can deal 

with the subjects -- the people in G-1 are no longer living.  Okay.  

But for right now, let's start with the category that we've got G-1, 

and there are subjects alive who are -- former subjects alive who are 

still living.

          Let's make it easy and say they are.  Okay.  We'll go to the 

tougher ones later.

          MS. KING:  We didn't hear the question.

          DR. FADEN:  The question Susan raised was an important one 

because this gets refined very quickly.  Do they know they were 

subjects of research as opposed to knocking them on the door and 

saying, excuse me, but you don't know this, you were subject of a 

research for which the government is culpable, and -- so, we'll go to 

that one.

          So, the people know they were subjects of research.  They're 

still alive.  Okay?  Let's try the remedy, march through that one.  

The remedies list begins on Page 9.  The harm has already 

materialized.  Okay.  That's the case here.  The harm has already -- 

whatever it is.  The injury has already occurred.  The physical 

illness has already occurred.

          The first remedy -- I'm doing this really





like a formula, okay, without discussion, see how far we can get.  

Once we break down, we start to have a discussion.  Okay?

          Is an apology in order?  Yes.  Nobody argues otherwise.  

Okay?  Apology is in order.  The government was culpable for failing 

to meet ethical standards.  The persons who were subjects in the 

research were harmed, an apology is in order, yes.

          The next one is, is medical evaluation or medical monitoring 

in order.  No.  The harm's already occurred.  Okay?  So, there's no 

point doing medical evaluation and medical --

          DR. ROYAL:  I'm confused.  These people are alive.

          DR. FADEN:  They're alive still.

          DR. ROYAL:  The harm's already occurred.  How do you know 

that they're not at risk for additional harm?

          DR. THOMAS:  To the extent that that's still true, yes, of 

course, further medical monitoring may be appropriate, except I think 

it's going to happen automatically when we get to the next item.

          DR. FADEN:  Because the next item is health care.  Should 

they get their health care covered from now on?





          DR. THOMAS:  Yes, but --

          DR. FADEN:  Health care specific to the illness or injury 

that resulted from their subject.  Yeah, Ken, it's open.

          DR. THOMAS:  And to deal with Henry's question.

          DR. FADEN:  Right.  You would include --

          DR. THOMAS:  Possible future -- health care related to 

future problems.

          MR. FEINBERG:  Other than an apology perhaps, I would have 

problems with any of these remedies being tailored to this particular 

classification.

          DR. FADEN:  Okay.  You want to tell us why?

          MR. FEINBERG:  There are a lot of reasons, and I've come 

full circle on this, frankly.  There are three or four reasons that I 

think override in our effort to tailor remedies to particular 

classifications that pose problems that we have to discuss at length, 

I think, and I want to hear what everybody has to say.

          First, there are the fact-based problems of tailoring 

remedies to particular classifications.  First, on the fact-based 

problems, there's Phil's point made last month, whether or not our 

determination to place a particular experiment in a particular 

classification based on the history, the facts that we





do know, justifies going from that story and placing it in a 

particular classification to the next step, which is providing a 

remedy.

          It's one thing to say that on the basis of what we know 50 

years later, this story seems to promote government culpability, seems 

to promote a reasonable probability of harm, that allows us to put it 

in the classification.

          Whether or not on that limited basis, we're prepared to 

recommend a remedy, I think, is very problematic.  That's first.  The 

first fact-based problem I have.

          The second fact-based problem I have is Henry's problem.  

Notice that G-1 talks about a reasonable probability.  For purposes of 

a remedy, what is that probability?  How do we define it?  What is the 

minimal dosage level or the minimal evidence of causation that 

justifies our concluding on the basis of a few months of deliberation 

that we are providing health care to this person?

          Maybe there is an epidemiological or a scientific medical 

causal link which everybody will agree is such a flaw, a prerequisite, 

that we conclude reasonable probability can be met.  But that is, 

based on what I've heard Henry say, very problematic, and I'm





not sure that that can be done.

          The third fact-based problem I have is again Henry's point, 

the nuances of these classifications.  To talk about tailoring 

remedies to one classification but not another, when the 

classifications themselves are so problematic, although I favor them, 

I favor them, but to again conclude on the basis of these defective, 

everything's relative, classifications --

          DR. FADEN:  That's all right.  I'm not going to take it 

personally.

          MR. FEINBERG:  -- we're going to then take a leap and 

propose other remedies, I mean specific remedies, I have problems with 

that.

          So, the first of my concerns are all of these fact-driven 

concerns that lead me to conclude that we're in deep water if we 

provide specific remedies for a specific experiment in a specific 

classification on the basis of the story that we've developed over the 

last few months.  That's first.

          My second concern to put on the table with any remedies 

being tailored to specific classification is a political concern, and 

that is the divisiveness that this will cause among members of the 

groups out there assembled.

          I think it is a noble, well-intentioned





motive that drives the committee to try and tailor specific remedies 

to specific classifications, but I think in my experience in the world 

of mass torts, the minute we write a report that says this group is 

entitled to this remedy but this group isn't, I think promotes more 

harm than good, and I think instead of putting the history of this era 

behind us, with a recommendation, it's just going to exacerbate 

questions over why did this committee put me in this tailored remedy 

and leave me out of this tailored remedy.

          I belong in this remedy, not this remedy.  In this 

classification, not that classification, and I think that as 

well-intentioned as it may be, I've concluded subject to changing my 

mind on the basis of what my colleagues around this table say, it's a 

bad idea, and it's fraught with harm.

          My third concern with tailoring remedies to particular 

classifications is that I'm not sure to this day, as Duncan points 

out, it's part of our mandate.  That's a problematic question.  It's 

one thing to call for a series of remedies, a menu, and leave it to 

policy-makers to decide after lengthy hearings where and whether a 

particular remedy goes into a particular classification.

          For this group to do that, I think is





somewhat problematic in terms of mandate. 

          My final concern is again if we tailor remedies to 

particular classifications, and if a remedy calls for compensation, 

why?  How much compensation?  How will it get paid?  Who pays it?  Is 

5,000 enough?  25?  50? 

          I mean I think the minute you go down that road, I think 

it's not enough to simply say, oh, we think compensation.  I think 

that is not going to -- poses more problems than it addresses.

          So, for all of these reasons, I have with some reluctance, I 

want to -- with some reluctance, I've concluded that what we should do 

is define the classifications, fit experiments in those 

classifications to the extent that on the basis of the factual record 

that we know they're presumed to go in certain classifications, list 

as the chapter does all of the available remedies, pointing out 

Henry's point about -- and I think Eli's, the point of trying to 

decide what constitutes reasonable probabilities in this area of 

radiation, but leave to others the assignment of whether and to what 

extent a particular remedy should be fit and tailored to a particular 

classification.

          I've got enough problems deciding the





classifications and whether an experiment fairly goes in a 

classification without making what will be perceived to be invidious 

distinctions between people on the basis of what their remedy ought to 

be.  I don't think that's our task.

          DR. FADEN:  Questions to Ken for clarification, and then we 

can have responses.

          DR. KATZ:  Now, what do you -- you still want us to classify 

it?

          MR. FEINBERG:  I think yes.

          DR. FADEN:  Why?

          DR. KATZ:  And what do you -- by doing that, don't we run 

into the dangers that you already had alluded to earlier?

          MR. FEINBERG:  Yes, yes.

          DR. KATZ:  I feel very stupid this afternoon, but --

          MR. FEINBERG:  Yes, I think we do run those dangers, and I 

think everything's relative.  If you say to me what is our obligation 

as a committee, I don't think we can avoid those classifications.  

I've thought about that, and I think, I think probably the story as we 

know it requires us to put the stories, the different experiments in 

different classifications.

          But for the reasons that Phil has mentioned





before and Henry has mentioned before, I am extremely concerned about 

taking the next step and saying therefore you get dollars, you get 

medical care and you will have to accept an apology as the sole 

remedy.

          DR. KATZ:  That's the major thing you want to avoid.  Okay.

          DR. FADEN:  Okay.  Now, let me -- I've got Duncan, Henry, 

Ruth and Pat, is that -- and Eli.  Okay.  Duncan?

          DR. THOMAS:  This to me seems to me to be an advice of 

paralysis, which I think would be even worse than the risks of 

divisiveness which has Ken so concerned.

          For me, the real difficulty is with the step of 

classification of experiments into categories, and I would have great 

difficulty trying to decide for certain whether the appropriate place 

to put the TBI experiments is in Category G-1 or somewhere else.

          I have no difficulty with the principles, the philosophical 

principles which says that if the following facts are true, namely 

that the government is culpable and that there was an outcome which is 

reasonably attributable to that exposure, then the following remedies 

would be appropriate.

          So, if I had the draw the line here,





attempting to avoid the kind of divisiveness that you'd suggest, I 

would suggest that we proceed with the exercise of trying to say what 

remedies are appropriate to different philosophical circumstances, and 

leave the classification bit aside.

          We've done the best job we can to tell the facts.  So, let 

me be clear as to what your recommendation is.  It seems to me that if 

you had an experiment for which you were absolutely certain that there 

had been a failure to maintain ethical standards, and that there was a 

reasonable probability, which for practical purposes let's say is 95 

percent or 99 percent, let's say you were pretty damn certain that 

this person's bad outcome was directly attributable to his 

participation in the experiment, if you were faced with such a 

hypothetical, you would have no difficulty then deciding as to what 

the appropriate remedies are, would you?

          MR. FEINBERG:  Yes, I would for the following reasons, for 

the following reasons.  First, if you make the assumption as you have 

that the story is clear, Phil's satisfied, Phil says the Wilson memo, 

do we know the whole story 50 years later to the extent that we're 

going to place blame and call for a remedy.

          So, my first point is theoretically, you





posit that we do know the whole story, I'm not sure on any of this we 

know the whole story, but all right, if we know the whole story, then 

we go to the second point in your hypothetical, which is there is a 

reasonable probability, if Henry's satisfied and Eli, that that 

reasonable probability, 95 percent or whatever it is, that that -- 

that as a practical matter, that element has been met.  

          Now we have culpability per your hypothetical, and we have 

harm per your hypothetical.  Will I then recommend a remedy?  No, and 

the reason I won't, I think, I think, is because the person who's not 

in that classification, where the story isn't a hundred percent but 

it's 80 percent, and the reasonable probability is not 95 percent, 

it's 88 percent, reads this report and says seven percent difference, 

and I'm getting an apology.  

          I don't think that it's fair to do that.  I think it's 

loaded with problems in trying to place the history of this period 

behind us, and put aside the mandate question about whether it's 

appropriate for us on the basis of this to tell Congress we recommend 

that even though you have a compensation program for atomic vets, and 

you have a compensation program for uranium miners, you don't have a 

compensation program for





Cincinnati victims, and we think you should.  Again, put that aside.

          I think that for these other reasons, I am not prepared to 

say, unless the other committee -- Pat and Phil and Henry and the 

others convince me otherwise, I think we are doing an injustice to the 

victims, as well as raising serious political problems about what 

we're trying to accomplish here.

          DR. FADEN:  Okay.  I want to let other people go around, 

Duncan, and I'll put you back on, if that's okay.

          DR. THOMAS:  That's fine.

          DR. FADEN:  Henry?

          DR. ROYAL:  I'd like to add a couple of other things to 

Ken's list.  To me, one of the things that's also equally bad about 

this proposal is that it subverts science.  That is, it's making the 

assumption that we can calculate these probabilities of causation and 

probabilities of harm with some certainty.

          Duncan was referring to 99 percent.  You were referring to 

88 percent.  The truth is that a reasonable estimate is going to range 

from, you know, 20 percent to 80 percent, and I -- and then what 

happens is scientists are put into this decision about, well, you 

know, if you say it's 50 percent, we're going





to compensate.  If you say it's 20 percent, we're not going to 

compensate, and the scientific process gets tied up in political 

matters, and it's -- as I said, it subverts science.  I don't think 

it's a very good idea.

          The other problem with some of the remedies being proposed, 

medical monitoring, are we talking about what I call Neiman-Marcus 

medicine, which means that anything -- I mean it's very hard to define 

what constitutes medical monitoring, and then there were going to be 

all kinds of arguments about, you know, is this really medical 

monitoring?  Don't I deserve more than this?  How come you did 

something more for this other guy?

          I think, again, the potential for divisiveness is great, and 

what I would like to do is I would like to do something that I felt 

comfortable was going to help the situation more than harm the 

situation.

          MR. FEINBERG:  Let me just say one other thing.

          DR. FADEN:  All right.  And then Ruth has the floor.  That's 

fine.  That's good, Ken, because it's your proposal we're debating.

          MR. FEINBERG:  I am not suggesting that people in various 

categories are not entitled to





compensation.  There's a whole section in this report dealing with the 

atomic vets and others.  I am not suggesting that those people have 

not received a bum rap or are not getting fair play from the 

government.  I really want to emphasize that.

          I'm suggesting that we lay out a menu of remedies for others 

to evaluate, and, frankly, in the report, there's some talk about 

recommendations of the committee proposed that would improve the 

atomic vet legislation or would improve the uranium miner legislation.  

I'm all for that.

          I just -- I think that's helpful and constructive.  I just 

think that we can't come out and say this type of category entitles 

the beneficiary to that type of remedy.

          DR. FADEN:  Ruth?

          DR. MACKLIN:  Well, Ken, you just -- in what you just said, 

you answered half my question because I was going to ask two 

questions, the second following from the first.

          The first was does it follow that no remedies are 

appropriate for victims, and I think you just answered that by saying 

they very may well be appropriate, which then comes back to your 

bottom line, your conclusion, which is, that's not our business to





do it.

          Now, the other arguments that you gave, I mean you said your 

third argument or your third -- I guess your third reason, your third 

argument was that policy-makers.  It's not clear that it's within our 

mandate, but let's say that it's unclear, and we could or we couldn't.  

I mean rather than having it rolled out of our mandate.

          Your position was that policy-makers are the ones properly 

to do it.  Now, all the worries that you gave in Reason Number 1 and 

Reason Number 2, all the fact-based reasons and all the justice and 

the political implications are as likely to arise no matter who makes 

these judgments, and because the concern or your concern was that we 

might be doing a dis-service and failing to secure justice for these 

victims, if this committee were to specify those particular remedies, 

somehow the implication or the alternative is if somebody else does 

it, these policy-makers, who shall be nameless, that there may be more 

justice likely to follow from these things.

          My guess would be it's likely there would be less justice 

because, among other things, this body, those of us who do it for a 

living and others who have joined us in this enterprise, we care about 

ethics, and





that seems to be one of the primary concerns, and the motivating 

factors for the activities of this committee; that is, trying to 

secure justice and dealing with the ethics.

          So, the alternative to me, if you've answered my Question 

Number 1, namely that you think that remedies might very well be 

appropriate, I'm not saying nobody could do it better, that's not my 

argument, but the implication -- I mean all I can take away from it, 

and I'm interested in your response, is that if we do it, we'll be 

blamed for failing to secure the justice, for the bad categories, for 

the invidious distinctions, and for making the scientific seven 

percent difference that nobody is in any position to make, and yet 

whoever devises these remedies, they're going to have to be doing the 

same thing.

          MR. FEINBERG:  I think that's right.  I suggest to you, 

though, that the political process being what it is, that's precisely 

where those remedies have to be developed.  The Congress in its wisdom 

enacted the Atomic Vets Act.  It doesn't work as well as it should.  

We'll make recommendations.

          The Congress enacted Uranium Mining legislation to 

compensate uranium miners, and vaccine legislation and black lung 

legislation.  It seems to me





that whatever expectations consumers of those plans may have, it seems 

to me that probably Congress after lengthy hearings and volumes of 

debate will ultimately make that choice.

          I think there's a certain elitism to the notion that 

ethically we can make that choice.  I'm concerned on the basis of the 

record, Ruth, that we have in front of us, I'm concerned about our 

well-intentioned attempt to distinguish remedies for Victim A versus 

Victim B.

          DR. MACKLIN:  I understand.  Let me -- I want to just say I 

don't -- that none of my argument would rest on elitism.  The 

difference between putting ethics in the forefront and putting 

politics in the forefront, when the Congress decides -- quite clearly, 

they're responding as you are pointing out and know much better than 

I, are responding to the array of things that a political, elected 

body, and especially at a particular time in history, is going to be 

influenced by.

          Now, it's not elitism, it's just to say that in other 

respects, this is a disinterested body or, by taking ethics, by 

disinterested here, I mean one that doesn't have to answer to other 

masters besides what we would argue and try to determine is right, 

whereas the Congress, of course, has to look at what it did in the





past, and also has very many other pressures on it.

          So, I don't think it's elitism as much as the difference 

between trying to use ethics as a basis for judgment and using 

politics.

          DR. FADEN:  Okay.  I've got Pat, Eli, Duncan, Susan, Phil 

and me, and then, Ken, we have 10 more -- no.  When do we go?  4:15?  

That's okay.  This is important.  Some have to go at 4.  So, we should 

try to keep our questions, our comments briefer, so that everybody can 

hear benefit of it, and it's clear we're not going to get beyond 

thinking this through and pick it up in March.  Pat?

          MS. KING:  First of all, if I had more time, I'd take on 

both Ken and Ruth, but I'm going to avoid -- I'm going to spare the 

committee that.  I hope to offer what I consider a constructive 

suggestion, and that is that it seems to me from listening to the 

discussions so far, that we're all arguing from positions of 

conviction and broader sets of experiences, and that we will continue 

to do that and talk past each other unless we change our methodology.

          It seems to me that the question that we are raising here, 

what can we do in the remedies area, can only be resolved by using the 

crudest sort of putting -- having the rubber meet the road, and that 

is, we





can't talk about this in the abstract.  We're going to have to take a 

case, and we're going to have to go through this case, and we're going 

to have to be very clear when we're going through this case that we're 

not doing anything except conducting consistent public.

          We don't want to be misleading, and I think that what we 

should do is make proposals for what we discuss.  Now, this is what 

I'm intrigued with.  I am intrigued with the idea that what I saw with 

respect to our chapter on children opens up the possibility of 

considering medical follow-up, whatever you want to call it, medical 

care, medical monitoring, as a range of remedies that might be 

appropriate.

          That's the only one in my own mind, by the way, so far I 

have really identified where I have been able to make that connection, 

but I'm sure that other people have their favorite candidates for 

where or should -- because some people are advocating remedies, should 

have candidate for testing the proposition about whether we really -- 

a lot of which we can't test any other way, about whether we have 

enough evidence, whether we can reach any agreement about 

culpability/non-culpability, whether we can reach an agreement about 

reasonable probability, whether we can reach any agreement about 

anything.





          Absent something like that, because that takes time, I can't 

see any way to resolve this, other than by political means, which is 

by the vote, and, again, it will all be based on our experiences, 

because we're all talking from the perspective of theoretical 

frameworks.

          So, I'd like to hear, if people are agreeable, other 

candidates where people think there may be the strongest cases, based 

on what we've heard so far, for making a case of trying to carry this 

all the way through with all of the qualifications, all of this -- 

anything anybody wants to put on it, that we're not binding ourselves.

          But, Ruth, I see no other way of proceeding to -- other than 

this back and forth across the table, if we don't do something like 

that, and I'd like to hear the suggestions for what to look at.

          DR. FADEN:  I hear what you're saying, but in the interest 

of everybody who wants to say something, this is so important, I think 

we should hear from everyone where they are or whoever wants to 

volunteer.  Eli, you have the floor next.

          DR. GLATSTEIN:  Well, I was going to get specific.  I was 

going to offer you a very specific problem.  Suppose you have a 

protocol looking at cervix





cancer, looking at surgery versus radiation, very simple.  Lady gets 

randomized radiation therapy, suffers the complication of radiation 

enteritis.  Chronic diarrhea.  Mal-absorption.  Weight loss as a 

consequence.  No question about the diagnosis.  No question about what 

the problem may be, confirmed by histology and so forth.  Unequivocal.  

Not a reasonable chance for a non-equivocal association, and one which 

is going to require chronic treatment and expenditure and care, and as 

a consequence of having cancer, although she's cured of her cancer, 

she loses her insurance.

          You don't think that that should be remedied in some way?

          MR. FEINBERG:  Yes, I do.

          DR. GLATSTEIN:  Okay.  So, we're talking about degree of 

uncertainty as far as you're concerned.

          MR. FEINBERG:  I think that is a clear case for a remedy.  I 

don't think we should recommend the remedy.

          DR. FADEN:  Duncan, Susan, Phil, me and whoever else wants 

to -- and Jay.  Duncan?

          DR. THOMAS:  Pat's made a very constructive suggestion, and 

normally I would support it to the hilt inasmuch as it's something 

that I've been arguing for





for a long time.

          I'm beginning to wonder whether that's the most sensible way 

to proceed, though.  We have in fact a specific staff recommendation 

here in this Section G-1 that we've been debating, namely, -- well, 

actually, two specific recommendations relating to two sub-sets of the 

PPI series.

          So, if we were going to pick a specific example to pursue, 

that would -- one or the other of those would seem to me to be the 

obvious cases, and we could pursue them.

          Now, the --

          DR. FADEN:  We can't do it now.

          DR. THOMAS:  -- reason why I hesitate --

          DR. FADEN:  Okay.  But we can't -- finish your thought.  We 

can't do any case now.

          DR. THOMAS:  No, no.

          DR. FADEN:  Okay.

          DR. THOMAS:  No, but the reason why I hesitate is what I can 

see is that debate very quickly degenerating into all of the 

uncertainties about facts and never getting down to the philosophical 

principles of if the following hypothetical facts were true, the 

following would be the appropriate response.

          I was very moved by Ruth's comment, Ruth





Macklin's comments a few moments ago, and I really think that as an 

ethics committee, we should be taking a high moral ground here, and 

saying that we should be -- we should serve as an advocate here for a 

particular procedure, and if we don't do it, the political -- there 

will be no particular impetus for the political process to do its 

thing, for the policy-makers to go and make these decisions for them.

          I had a number of other points, which I think I will just 

let other people speak.

          DR. FADEN:  Thank you.  I appreciate that because we're 

running out of time.  Susan?

          DR. LEDERER:  I was struck in Ken's comments by his 

unwillingness to tailor remedies to the fact that we may not be able 

to tell the whole story, and I guess I have some concerns about what 

you mean by the whole story, inasmuch as we have the staff committed 

and enormous resources to telling the best reconstruction, historical 

reconstruction we can, and we won't be able to tell everything, but we 

will have a reasonable reconstruction.  So.

          MR. FEINBERG:  Just quickly, I was referring to the point 

made last month by Phil, when we got into this discussion of whether 

or not for purposes of finding fault and implicitly at least providing 

a





remedy, whether it was "fair" to go that far in light of the fact that 

so much time has gone by and so many documents are lost, and Wilson's 

not available to rebut the charge.  That was what I was talking about.

          DR. FADEN:  We're not charging Wilson.  Okay.  Phil, do you 

want to respond?  You're next on the list anyway, as it happens.

          DR. RUSSELL:  I totally support the sound military principle 

of taking the high ground and holding it.  I think the -- I'm more 

concerned about eventual outcome.  We're all concerned about doing the 

best possible job in retrospect in terms of doing the right thing for 

the individuals that were involved in these experiments.

          We're all concerned about the -- assuring that in the 

future, we do the best job for both subjects and for the advancement 

of bio-medicine, the bio-medical research.

          I have -- I'm seriously concerned that this -- the process 

of being -- attempting to put the experiments into specific categories 

and relating those categories to specific remedies will get us so 

bogged down in the judgments, that we won't get there, and what I 

would ask for is an alternative methodology.

          Ken has made some allusions to alternatives,





but they aren't spelled out very clearly for me, and I think that we 

-- I just quickly reread our charge here, and the charge really gets 

very specific when it says the order is intended only to improve the 

internal management of the Executive Branch.  It's not intended to 

create any right, benefit, trust, etc.

          So, that seems to support Ken's view that our charge stops 

short of recommending specific remedies for specific categories and so 

forth.

          On the other hand, what's the best way to put the most -- 

the greatest possible charge forward to those who can, and I think 

that's what we need to look at.  The money is going to have to come 

from the public treasury, and that comes from Congress, and it's 

administered by the Administration.

          How do we put the most effective pressure on those two 

organizations in the future?  And I see the dangers that Ken has 

pointed out in this current process.  Because of the issues of 

probability, of  cause and the factual issues, and -- but I don't have 

the -- any clear idea of what the alternatives are, and I'd like to 

hear one or two alternatives, and I think both Ken and Pat have 

somewhere in the back of their minds alternatives that they have not 

yet put on the table, and I'd like to hear them.





          DR. FADEN:  Actually, that fits with what I wanted to ask 

Ken in terms of what would you propose as an alternative, but one 

specific alternative I'm not sure whether you would endorse, the 

committee has already taken, painfully taken steps to acknowledge that 

there is a role for remedies.  Remedies are due in at least two 

no-fault circumstances.

          Are you saying that you would -- would you -- I mean you 

haven't said this.  Would you support a committee recommendation -- 

I'm trying to see which alternative -- that would say here are the 

cases under which this committee believes remedies are appropriate?  

Here are the range of remedies that should be offered?  We recommend 

that Congress fashion a statutory -- some sort of statutory response 

that offers all the people who fall into these categories one or more 

of the following remedies.  Is that what you're saying?

          MR. FEINBERG:  I couldn't say it better myself, and it 

doesn't take the Speaker of the House to recognize that in a case 

involving a classified harm of serious government culpability, serious 

harm, not reasonable probability, one of the classifications that 

we've got G-2 or whatever it is, here's the list of remedies that the 

committee recommends that Congress consider.  Medical monitoring, 

compensation, insurance,





apology, etc.

          Congress, here's the remedies, here are the classifications, 

here are the experiments within those classifications.  Now, if you 

take the worst classification and you look at the most pervasive 

remedy, that's up to you.  We've laid it out for you, and we think 

that we recommend that you consider these remedies to deal with these 

classifications.

          DR. FADEN:  But you would support a committee recommendation 

that Congress respond with some sort of statutory remedy for --

          MR. FEINBERG:  You know, we'd have to -- I'm with Pat.  

We've got to see what the language looks like, but --

          DR. FADEN:  Something in that order.

          MR. FEINBERG:  Something that gives a clear blueprint, if 

Congress so desires, as to what they ought to do, plus I would even go 

further than that, and in the case of the atomic vets and some of 

these other organizations that have testified, and that Duncan's 

pointed out ways to improve an existing statutory framework, I think 

that we ought to be willing to go to Congress and say, by the way, 

here's what we think is wrong with the existing statutes in the area 

of our mandate, you might want to consider it.





          DR. FADEN:  Let me just point out that I don't know what to 

do with the suggestion about doing particular cases, but I also was 

quickly rereading the charter, and we are asked in the charter to 

identify whether we think any subjects of human radiation experiments 

or their descendants should be notified for potential health risks or 

the need for medical follow-up.

          So, we have to do the childrens one anyway.  I mean quite 

specifically, whatever else happens, we have been asked on the point 

of medical follow-up to identify whether -- to identify to the 

Administration whether there are any folks who need to be followed up 

in order -- they give you a reason, in order to protect the health of 

individuals.

          So, quite apart from everything else we do, I'm just 

reminding us that that task remains for us.  Thank you, Ken.  I just 

wanted to -- and any other alternatives that people want to propose.  

Jay?

          DR. KATZ:  Well, I'm confused, but I just want to make a few 

general remarks.  I've been persuaded by some of the things that Pat 

talked about and Ken talked about, and for example, you know, just the 

last thing that Ken talked about with respect to problems that we see 

in statutory enactments already





existing, that's probably easiest job for us to address because there 

are statutes, and we can point out, look, we are deficient in this, we 

are deficient in that, and we have an existing structure, and that 

would be easy.

          Somehow, I am very much most moved to -- of course, I may 

have misunderstood him, by the General, and namely about alternative 

methodologies.  I wonder whether we have boxed ourselves into these 

boxes.

          DR. FADEN:  Let's unbox ourselves.

          DR. KATZ:  And I had trouble with the boxes as I was reading 

them, when I got the first preliminary draft, and it goes to something 

I think that Ken pointed out to us, that to really put different 

situations, different categories, into these boxes may create an 

inordinately difficult task for us, and I just wonder whether we can 

find some other groupings, in addition to those veterans and 

non-veterans already covered under statutory enactments, and in a 

general way talk about the need for remedies without boxing them in 

too narrowly, to surely talk about the remedies that Congress should 

consider, and really in the light of everything that we've learned 

ourselves and what we've learned from our hearings, to really 

ultimately appeal to the conscience of the American society, to the 

conscience of Congress, and say you must do





something about it, the time is now.  50 years have gone by.  You sat 

on your hands, and you must go into action.  To the extent to which we 

can be most generally specific, we should do so.

          But to the extent to which we become over-specific, I think 

as Ken suggested, we're getting ourselves into trouble, and we can't 

really do this, and it was to proceed along these lines.  I think 

that's what Phil has been telling us, and staff should talk with him, 

and, of course, talk with all of us, too, but somehow I have the 

feeling that everything I've heard, that's the direction in which I 

would go.

          DR. FADEN:  Okay.  My list is done amazingly.  Now, are 

there people who would like to comment again?  I'm not sure that we 

can have -- we're so near our closing time.  This is not an 

opportunity to do new things.  So, I think it's continuing on this 

discussion.

          Are there other comments that people want to make or are we 

just overwhelmed by what we have to debate yet still together?  I feel 

moved to make one observation myself, so let me just make it.

          I don't know which way the committee is going to go or how 

many different ways the committee can go, and that awaits to be seen, 

but I do think that it is 





-- we didn't march our way through these categories, and maybe the 

boxes are inappropriate, maybe they're helpful.

          What I'm hearing are sort of two different kinds of views.  

One view is the tough part, as Duncan expresses it, is putting 

experiments into the boxes.  That's what's hard.  And then what I'm 

hearing Ken say what's hard or unwise, depending on how you frame it, 

is fitting -- fitting -- making a tight fit between remedies and 

categories.  Those are different kinds of tasks, and I'm not sure on 

that point myself yet.

          But if you march your way through the categories, we already 

did one, and that was the no fault.  We didn't resolve it.  Also in 

the list of categories is this case -- are the cases where there are 

no harms that are physical, but there is culpability, violation of 

ethical standards, and we are saying -- and the committee will have to 

decide whether remedies are in order there, and my guess is where it 

will go is there, but the point is that a recommendation that says 

remedies are due to people who have been -- whose -- who have had 

dignitary harms, whose -- who have not had physical harm but who have 

been used without consent, and a recommendation that says remedies are 

due people, even where culpability





cannot be proven, but because they've been harmed, is saying something 

that hasn't yet been said in the arena in which we're working.

          So, that's important to hold on to.  Now, we didn't march 

our way through that category of -- the categories that speak of no 

physical harm and violation of ethical standards.  So, I'm not -- we 

haven't yet had a committee expression on that.

          But I just lay that out as background.   I see Ruth and 

Duncan.

          DR. MACKLIN:  Well, it seems to me there's one clear way to 

discover whether or not experiments can be put in those categories, 

and that is to give it a try.

          Now, probably the staff is best equipped to do that, but we 

on the committee should commit ourselves to looking at some such 

tentative list.  So, even if it's not exhaustive, if we could get a 

first cut.  I mean if we discover it's not possible, then we abandon 

it.  If we see that there's unanimity, that the staff makes proposals, 

takes the experiments, puts them in the categories, and lo and behold, 

it all falls out there, then at least we've discovered something, if 

that's reasonably easy.

          So, I'm requesting, if that would be possible





-- I mean it's a finite list, and we're not dealing now with the 

releases and those things, right?

          DR. FADEN:  Pat?

          MS. KING:  I made the proposal for a specific reason, and, 

so, maybe you'll disagree with the reason, and, if so, it would mean 

that the committee shouldn't do it.  But I really think -- I've seen 

this happen in the life of other committees, where you reach an 

impasse because we are inter-disciplinary, and we do come with our own 

values to the problem.

          But the only way you get any sort of realignment at all and 

break through the impasse is for the committee to see if it is doable, 

what it thinks or at least some good number thinks it is possible to 

do, and, so, we actually have to watch the process ourselves in order 

to be convinced one way or the other.

          So, the reason I made the proposal, I don't care, staff can 

write it up for us in the sense of this is the case, this is the 

evidence for culpability, this is the evidence of reasonable 

probability, this is the evidence -- but the actual debating about 

whether you can make inferences, if we do it at all -- after hearing 

the rest of you, I'm not sure we ought to do it, but the only value, 

it seems to me, in doing it at





this point is to prove to ourselves that it can or cannot be done, 

and, so, we have to do it, and I don't know what will come out 

actually, and I just suggest that maybe staff can give us our 

strongest cases because they know them better, but I think we have to 

do one case ourselves.

          It's not going to work until all of us see it go, and we 

have some good sense of how far you can go and how far we can't go.  

Otherwise, I don't think that it helps much to have the staff put them 

in the categories.  I mean my proposal was for another reason.  It was 

for us -- it was a demonstration to us, which I think we actually 

need, one way or the other, depending on how it comes out.

          So, I guess I'm speaking against what Ruth has proposed.  

I'm sorry.

          DR. THOMAS:  I now endorse one of your two suggestions.  I 

guess I withdraw my reservation about the case study method.  I think 

we do have to try it, whether we do it -- one way or the other, I 

don't care, but I have a second suggestion, which I'd also like to 

make.

          In addition to not even attempting the linkage part of it 

today, we didn't get through the second of your aims, which was to go 

through the list





of remedies, and I'd like to suggest a variant of that approach.

          We go through the list of remedies, not today, next time, in 

the same way that we did Part 1.  In Part 1, we didn't just identify 

the categories, we also identified what are the philosophical 

foundations for whether a remedy would be appropriate in each of these 

categories, and, so, in the similar vein, I would suggest that we go 

through now each of the remedies, and without trying to put them into 

boxes per se, we identify what are the philosophical criteria for 

which the various remedies would be appropriate.

          I mean simple-mindedly, we would say that, for example, 

health care is not appropriate for people that are dead.  I mean we 

would all agree with that, but then there are other subtleties in 

that.  Clearly, there will be lots of subtleties on the medical 

monitoring issue, the case identification problem, a lot of these 

other things that we have talked about, which I think we would learn a 

lot by trying to understand what are those philosophical foundations.  

So, that would be an exercise that I'd propose for next time.

          DR. FADEN:  Well, I'm happy for us to do next time whatever 

it is that will help the committee reach





some sort of resolution.  I have a feeling, if I understand, Ken, some 

of your concerns, that even if we were to march through a case and to 

find that in fact the committee could manage to agree about what 

remedies were in order for that case, that it would not resolve -- it 

might resolve your fact-based objections, but it's not going to 

resolve your other objections to the committee going in that way, if I 

understand the --

          MR. FEINBERG:  That's right.

          DR. FADEN:  -- arguments you've raised.

          MR. FEINBERG:  Well, that's right.  But I'm perfectly 

prepared to see what develops.  I've learned over the years to listen 

to Pat carefully, and if Pat thinks that it would be helpful, I'm for 

it.

          I do think that no matter how --

          MS. KING:  Always be careful when you hear a slippery 

tongue.

          MR. FEINBERG:  I am -- I am concerned -- I am concerned that 

after we go through a particular experiment and gain satisfaction as 

to where it ought to fit, I am concerned, and I've said this from the 

outset, about the charge that we, you know, we were unfair to other 

people in not doing the same thing or doing the same thing and not 

coming to the right conclusion as to where they belong and in what





category.

          It may be the compromise is (a) Pat, we go through some of 

this, and (b) Phil, maybe there are ways to restructure the chapter so 

that instead of 15 categories or 13 categories, there's five 

categories, and as to those five categories, here are seven remedies, 

and there they are.  There's a menu of remedies.  Whether we say that 

in any one of these categories, a remedy is appropriate, I tend to 

doubt that, but it may be that what we say is here are seven 

categories, here's a list of remedies from A to Z, and policy-makers 

will decide which, if any, remedy goes with any category.

          DR. FADEN:  Pat?  

          DR. KATZ:  I don't understand something, Ken.  You're 

concerned about unfairness.

          MR. FEINBERG:  In part.

          DR. KATZ:  No, no, no.  I know it's in part, but you 

mentioned it just now.  Whatever we do or don't do, we'll be accused 

of unfairness.  It's inevitable, as I see it.  There are too many -- 

too many forces at work outside.

          Aren't you really saying that you don't think going down 

that road will really work, and that it's really unfair to you, to us, 

to go down that road, and





that is really your concern, not unfairness to others?

          MR. FEINBERG:  Oh, no, I wouldn't say not unfairness to 

others.  I would say that I am concerned --

          DR. KATZ:  You're concerned about it, but that will get 

anywhere.

          MR. FEINBERG:  I mean I just remember what Phil has said, 

what Henry said, what Eli said, about reasonable probabilities, about 

the whole story, about -- I mean how do we -- how do you -- how do you 

-- at the end of the -- at the end of the day, how do you say -- how 

do you say these people should get cash, and these people shouldn't?  

I don't --

          DR. GLATSTEIN:  But the issue is really going to be not 

categorizing the experiments but categorizing the patients.  Isn't 

that what you're saying?

          MR. FEINBERG:  Yes.

          DR. RUSSELL:  Probability of success is going to be greater 

with broader, more sweeping solutions than detailed solutions, and if 

we get too detailed, what we're going to do is get beaten in detail.  

It will take them apart one by one and point out all the 

-- we need a sweeping solution.

          DR. KATZ:  And you can't defend them.

          MS. KING:  You can't -- we are not convincing





each other with words.  That is the only -- I'm envisioning how this 

chapter is going to look.  Some place in the chapter, I think we have 

to explain whatever it is we do and why we will do it.

          I don't want to have a justification there that says it was 

a factual impossibility, unless I'm assured that.  I don't want to 

have a justification in there that says that I can't live with. 

          Now, I assume that everybody is going to have to go through 

that same exercise with respect to how they feel about the chapter, 

but I am convinced of several things.  The more agreement honestly 

reached that the committee can have on this issue, the more credible 

we will be, and I think that the only way that there's likely to get 

agreement is that if we satisfy or attempt to satisfy the concerns 

raised by everybody and meet them either with argumentation or 

whatever.

          There is some processes of the deliberation we have to go 

through.  I think it would be remiss if we don't have an explanation 

in the chapter for what we do, that we decided to do this, and we 

decided not to do that for the following reasons, and that is the 

language that is concerning me.  Whatever the this is and what the 

this is not, I want to be sure that I feel comfortable about the this 

is and the this is not, and





the only way to sort of do that -- Ken is comfortable.  My sense 

around the table is that not everybody is comfortable with the 

justifications that Ken put on the table, and that means that we've 

got to test those assumptions to our satisfaction, disagree with them, 

agree with them, change our minds, maybe change his.

          In order to get a report written, this clearly would be one 

of the most important parts of the report.  It is the part that 

everybody is going to pick up and look at.  So, it is important that 

we -- that we keep that in mind as sort of we march through this, and 

my suggestion is not now about doing a lot of things, except to see -- 

to look for methodologies, so that we end up one place or another, but 

we end up, rather than being sort of stretched out in different 

directions.

          And I'm not convinced as, for example, Ken's statement was 

that if I could -- if I could, to my satisfaction, reach some 

conclusions with the case.  I'm perfectly willing to make a 

recommendation about a remedy, Ken.  That's a part that I could 

justify that as giving the Congress my most informed judgment based on 

what I have seen.

          They're always free to do whatever they want to do.  

However, in evaluating whether I want to do that or not, it might be 

quite useful for me to have





under my belt a stronger feeling about how -- what the factual case 

looks like in individual instances.

          It may be I don't want to do it across the board.  It may be 

that we want to do it in certain cases.  You know, one of these things 

may leap out at us, so that we say, based on everything we looked at, 

this is egregious, and we want to do something.  We want to say 

something about that.

          I don't make the sweeping justifications.  I think that 

Phil's statement of moving where we think there were things remiss, 

the discussion and the resolution as far ahead as possible ought to be 

what our shining beam is.

          Now, we all know that the Congress, especially this 

Congress, is going to do whatever it wants to, and I think we 

understand that.  The problem is this is not the last Congress.  All 

we can do is move it as far as what the evidence will allow, and I 

agree with Ken on that general principle, but I think that we all have 

to be on board about the state of the evidence, and I sense that there 

is real difference on the committee about the state of the evidence 

for beginners, how we assess it, and that's my plea.  I always peter 

out at the end.  But, anyway, that was my suggestion.





          DR. FADEN:  That's actually a fitting end to end.  We're at 

a little past 4:15.  So, I don't know, but we'll do something, and 

somehow or other, we will 

-- we will prevail.

          Dan, can you formally close us as our designated federal 

official here, and we will close the meeting?

          MR. GUTTMAN:  As a designated federal official, I declare 

the meeting closed.

          DR. FADEN:  We're closed.

          (Whereupon, at 4:20 p.m., the meeting was concluded.)