ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS

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                                 THURSDAY
                             DECEMBER 15, 1994

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                             WASHINGTON, D.C.

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          The Advisory Committee met in the Empire Room of the
Omni Shoreham Hotel at 2500 Calvert Street, N.W., at 9:00 a.m.,
Ruth Faden, Chair, presiding.

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     PRESENT:

     RUTH FADEN, Chair
     KENNETH FEINBERG, Member
     ELI GLATSTEIN, Member
     JAY KATZ, Member
     PATRICIA KING, Member
     SUSAN LEDERER, Member
     RUTH MACKLIN, Member
     LOIS NORRIS, Member
     NANCY OLEINICK, Member
     HENRY ROYAL, Member
     PHILIP RUSSELL, Member
     MARY ANN STEVENSON, Member
     DUNCAN THOMAS, Member
     REED TUCKSON, Member     

     ALSO PRESENT:

     PHIL CAPLAN
     ALLEN BUCHANAN, Staff
     GIL WHITTEMORE, Staff
     JONATHAN MORENO, Staff
     GARY STERN, Staff
     VALERIE HURT, Staff
     DENISE HOLMES, Staff
     DENNIS GUTTMAN, Staff
                                 I-N-D-E-X

                                                                       Page

Opening Remarks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Ethics Criteria Discussion . . . . . . . . . . . . . . . . . . . . . . . 15
Guidelines for Remedies. . . . . . . . . . . . . . . . . . . . . . . . .110
Remedies and Ethics Link . . . . . . . . . . . . . . . . . . . . . . . .184
Contractor Culpability . . . . . . . . . . . . . . . . . . . . . . . . .211
Intent of Wilson Memo. . . . . . . . . . . . . . . . . . . . . . . . . .276
                           P-R-O-C-E-E-D-I-N-G-S

                                                                (9:13 a.m.)

          CHAIRPERSON FADEN:  Committee members, would you please
come to the table so we can begin the session?  I think we are
almost here.  We're enough here that we can begin.

          Phil Caplan is here from the White House to officially
open our 9th meeting.

          MR. CAPLAN:  Good morning.  My name is Philip Caplan,
Special Assistant to the President for Cabinet Affairs.  And I
hereby open this meeting of the Federal Advisory Committee on
Human Radiation Experiments.

          CHAIRPERSON FADEN:  Thank you, Phil.  Okay.  Welcome. 
This is our 9th meeting.  And as we discussed last week, this is
a different meeting than last month.

          This is a different meeting in character in the way we
are going to conduct it from other meetings we have had thus far. 
I'm having kind of a mixed reaction to the size of this table.

          On the one hand, we have more room.  On the other hand,
this feels very formal and very whatever.  I keep thinking
there's a way to bring this closer.  I don't know.

          This is no other way, especially since this is supposed
to be a different kind of meeting where we're supposed to have
more discussion and interaction and less presentation.

          Do you think we can work with it, Nancy?  Okay.  So,
let us not let our formal and distanced relationship to one
another affect how we're going to conduct the meeting.

          I usually start with a few comments that take the form
of the objectives for the meeting.  I'm going to dispense with
that and just emphasize how this meeting is likely to be
different or how we hope that it will be different from the other
meetings that we've had.

          We concluded at the end of the meeting last month that
now was the time to begin the hard work of examining alternative
frameworks for the ethics criteria and the guidelines for
remedies that the committee would need to adopt in order to
complete its charge.

          And those two agenda items that debating questions of
ethics criteria for evaluating or assessing experiments as well
as suggestions and alternatives for making recommendations about
a range of remedies, are the two things we're going to spend most
of our time on today.

          Let me just sort of walk us collectively through the
agenda.  The way we've structured it this morning, you'll notice
there are no reports on the status of agency efforts.

          There are no reports from subcommittees.  We've
dispensed with all of that at the suggestion of several committee
members.  So, we'll have almost the entire time for discussion.

          Let me just make one comment about the progress of the
agencies.  You'll note, and we have all had a chance to look at,
the documents that are included under Tab I.

          They are evidence of the success of the expanded and
continuing search by our staff and the agencies.  We are
obviously continuing to get important documents.

          We get them all the time.  And we need to keep the flow
coming.  So, that's all I'm going to say about data collection on
the part of the agencies in this meeting formally.

          Obviously, any of the committee members who are
interested in the progress of particular data collection,
document retrieval efforts of any particular type or from any
particular agency, we'll provide you with that information as you
ask for it.

          But we're not going to do this sort of run down agency-
by-agency.  Nor are we going to have any staff reports.  Nor are
we going to have any subcommittee reports.

          We're just going to get to work on the two questions of
retrospective moral judgment ethics criteria for evaluating
experiments on the one hand.

          And guidelines for a range of responses on the part of
the Government if we find wrongs or harms have occurred.  The way
the two days are set up, we are structured to begin with the
question of retrospective moral judgment and ethics analysis.

          We have the two manuscripts.  One by Allen Buchanan,
who I'll introduce in a minute, who has come to join us today. 
And the other by Ruth.

          We will spend a chunk this morning talking about those
two documents.  And actually, the purpose there is for us, as a
committee and each of us as individuals, to try to figure out
where we stand in relation to the various positions that are
reflected in those two manuscripts.

          We are then going to break for lunch and turn to the
question of remedies.  We have a memo from staff which will be
the basis of that discussion.

          And the subcommittee has worked with that document and
will lead us through that discussion.  We then are going to look
towards a third document, which is something that I've put
together.

          It's an attempt to try to link the question of ethics
assessments with remedies.  And we'll see if we can come up with
some kind of coherent schema putting the two together.

          Now, the way this is set up, we've given over the
morning and part of the early afternoon to this task.  But you'll
note that we have lots of time.

          In other words, if we need to take this through the
whole day, we will take it through the whole day.  Eventually, we
hope to get to the next step in the link of this analysis which
is fitting it into the particular fact situation, the particular
historical situation in which these experiments occurred.

          So, we'll go from the abstract discussions about ethics
criteria, more or less abstract.  And more or less abstracted
discussion about remedies to a discussion about our understanding
of what the circumstances actually were in which these
experiments were conducted.

          And that's referenced in the agenda as the discussion
about historical ethics policies.  We have documents from staff. 
We have a copy of a speech that Jay gave in which he comments on
his interpretation of some of the historical facts.

          And we will try to put this all together guided by a
memo that staff also has provided attempting to lay out one
position for us that we might take with respect to the central
question of Government culpability.

          So, the logic is something like the following.  We
start at looking at the retrospective ethics questions.  We turn
from that to remedies.

          We then turn to how to try to link the two together in
terms of developing a conceptual framework.  From there, assuming
we're still all talking to each other, we move onto a discussion
of the implications of the framework as we've tentatively adopted
it, or as we're trying it on for size.

          However, whatever degree of comfort we have with what
we've decided we want to play with.  We're going to move from
that to the historical situation, the period of primary interest
to us, the '44 to '74 period.

          And we have a position from staff with respect to the
question of Government culpability.  And we have an
interpretation not of the Government culpability question, but of
how one might come to understand the documents that we've been
reading, some of that as expressed by Jay from his speech.

          We will then try to put it even further together to see
if we can't get a more complete package.  If those tasks take us
all the way through a good chunk of tomorrow, we will take all
the time that is necessary to do that.

          We're mindful that we have a period of time, a block of
time set aside tomorrow morning for public testimony, which we
always have.  And we will preserve that time.

          That's the only time that's absolutely inviolable. 
Everything else can be shifted around as the discussion dictates. 
So, I'll just keep taking the sense of the group to see, are we
ready to go onto the next issue?

          Do we want to spend more time on this?  Do we want to
put it away and revisit it because we're kind of at a stalemate? 
I'll need to hear from you as the discussion progresses as to
what you think would be most useful.

          The only other thing we're going to try to do today if
possible is give some guidance to staff with respect to the
structure of our final report.

          There's a document that you will receive tonight.  It's
the only homework reading that you haven't been given in advance. 
And it's not terribly long.

          It's doable.  It's short.  It's commensurate with going
to dinner and having a walk and exercising and calling home.  And
you can do it.  It's not too bad.

          The hope is you will read it tonight, and we will have
time tomorrow afternoon to discuss the document, which is
essentially a proposal from staff for the beginnings of the
organization of the final work products of the committee.

          So, obviously, we need to get going with that as well. 
You will note that the briefing book this week for this month was
thin.  That's an illusion of course because you got two other
companion briefing books, but are twice the size of the briefing
book itself.

          But those document collections obviously do not require
being poured over line by line in order for the discussion to be
complete.  But we're hoping that the reasoning behind keeping the
reading load low for the session today was good.

          In other words, translation, that you read all the
documents and manuscripts really carefully.  With that, we have
only one piece of business which is the approval of the minutes
of the November 14th and 15th meetings.

          Are there any suggestions for amendments and
corrections?  Lois?  Is the mike on?  This is not a button
system, I believe.  Do you want to see if your mike is on?

          Mine is on.  Is anyone else's?  It's not on?  Who's
controlling them?

          DR. ROYAL:  What's your microphone number?  Does it
have a number?

          MS. NORRIS:  Four.

          CHAIRPERSON FADEN:  Can number four be turned on
please?  It is on?  Try it.

          MS. NORRIS:  I'll just speak up.  On page 3,
subcommittee report on the Cincinnati panel, it states that Drs.
Tuckson, Lederer, and Mrs. Norris were present for that panel.

          It was actually Drs. Tuckson, Stevenson, and Norris. 
And since Mary Ann got up at 4 in the morning to get there for a
9:00 meeting, I want to make sure she gets credit for her
presence.

          CHAIRPERSON FADEN:  That's an egregious mistake.  Thank
you for picking it up, Lois.

          DR. TUCKSON:  4 in the morning?

          CHAIRPERSON FADEN:  That is definitely an egregious
mistake.  No one should have to do that.  Mary Ann, we're
terribly sorry.  I apologize.

          You're right.  Points should definitely be given for
that kind of effort.  Are there other amendments or corrections
to the minutes?  Do I have a call for approval of the minutes?

          DR. GLATSTEIN:  So move.

          CHAIRPERSON FADEN:  Thank you.  Is there a second?

          MS. NORRIS:  Second.

          CHAIRPERSON FADEN:  Thank you.  All in favor?  Any
opposed?  Then the minutes of the November 14th to 15th meeting
are approved as amended.

          With that, we move right into retrospective moral
judgment criteria for evaluating the ethics of experiments.  And
I'd like to ask the relevant staff to come to the table,
including Allen Buchanan whom I need to introduce.

          Most of you don't know Allen.  We've got Jonathan whom
you all know.  Allen did visit us.  I forget which meeting that
was.

          DR. BUCHANAN:  July, I believe.

          CHAIRPERSON FADEN:  July.  So, some of you may have met
Allen.  His name now is familiar to all of us since he's the
author of one of the two manuscripts that we know you've pored
over line by line.

          We're very grateful to Allen for taking the time to do
this.  Allen is a very busy person as we all are.  So, we're
really very fortunate that we could get him to do this work for
us and to turn it around so quickly.

          There are no presentations.  Jeffrey, are you joining
the table too?  Are you going to join us as well?

          At the suggestion of some members of the committee, we
are not having any staff presentations.  We're just going to
plunge right into the documents.

          If this turns out to be a mistake, we'll make people
give presentations extemporaneously.  I've misspoken.  It's not
really so much plunging into the documents as plunging into the
issues.

          So, if we're ready to begin a discussion.  Some of you
have commented.  We have responses from several committee members
raising questions or concerns or objections to the positions that
they have read into manuscripts.

          And if people want to start sharing those, that also
would be good.  We're having a problem with the mikes, I think. 
You have to be right on top of them to get them to work.

          DR. KATZ:  These memos.  I saw one this morning, a very
interesting one.  But as soon as they are available, they should
be faxed.  Couldn't they be faxed to the members of the
committee?

          CHAIRPERSON FADEN:  Well, they could, yes.  But that's
not going to help us with the discussion.

          DR. KATZ:  No.  I'm just talking about in the future.

          CHAIRPERSON FADEN:  There's Jay's.  And then there was,
I think, Duncan also sent comments, and Ruth sent comments.  We
have yours.  They've been circulated.  Where are they?

          DR. KATZ:  I have a few extra copies, if anybody hasn't
seen them.

          MS. NORRIS:  Jay's were delivered to us as they
arrived.

          CHAIRPERSON FADEN:  Henry?

          DR. ROYAL:  Would you like to start the discussion?

          CHAIRPERSON FADEN:  I'd be very indebted.  Thank you.

          DR. ROYAL:  I had some problems with the discussion
that Allen wrote.  Let me tell you the things that troubled me
about the discussion and maybe reach in and decide whether my
discomfort is warranted or not.

          One of the things that troubled me was the concept of
being blameworthy or morally incorrect seems to be a binary
concept that things are right or wrong.

          And there's no hint about the magnitude of the right or
wrong.  Specifically, what troubled me was there was mention of
the Nazi experiments.  There was mention of slavery.

          There was mention of exorcisms.  Things which, to me,
were on a whole different moral plane than the radiation
experiments.  As a matter of fact, there's one line that I'll
read from Allen's note.

          "In particular, if the radiation experiments were in
some respects like the Nazi experiments, in particular they
involve violations of individual rights, then compensation was
owed."

          So, I guess the point I'm trying to get at is there's
this blurring between magnitudes of moral wrongs.  That troubles
me.  So, that's what I'd like to bring out for discussion.

          Whether or not there is such a thing as magnitude of
moral wrongs.  Or do we just have to decide that what someone did
was morally wrong?

          CHAIRPERSON FADEN:  This is really open, Allen.  If you
want to respond, please do.  That's why we're glad you're here.

          DR. BUCHANAN:  Yes.  I agree.  I think there is a need
for more sensitivity to the idea of -- I don't think the mike's
on.

          CHAIRPERSON FADEN:  It's on.  They just don't work
well.

          DR. BUCHANAN:  I'll try to project.  I agree that there
needs to be more sensitivity to differences in the moral wrongs.

          But one thing that I did try to do which I think is
relevant to this is distinguish between whether a wrongful action
was taken and, in particular, whether someone's rights were
violated as distinct from the question of the culpability of the
agent who performed the action.

          And I do think there is some language in my draft, and
it certainly should be beefed up, to indicate that once we make
that distinction, it's quite coherent both to say that someone's
rights were violated, and then to go on to consider questions
about compensation or remedy.

          But with a recognition that the culpability of the
agent who performed the action violated the rights may be
mitigated or diminished by various circumstances.

          I also think that, and I take it this is what you were
saying, also that with regard to the wrongful action itself,
quite apart from degrees of culpability for the agent that
performed the wrongful action, that some actions clearly are more
serious wrongs than others, and that it's important to make that
distinction.

          That distinction is not made sufficiently in this
draft.  So, I would want to beef up the discussion of both
different magnitudes of seriousness of wrongs and also the
discussion of different magnitudes of seriousness of culpability
for agents.

          Is that the kind of thing you're talking about?

          DR. ROYAL:  Absolutely.  And it seems to me that that's
the key issue, not whether wrong was done, but the magnitude of
the wrong.

          And the reason that I think that that's the key issue
is none of us lead perfect lives.  We all do some things which
are morally wrong.

          And it's the magnitude of those wrongs that we should
be making judgments about.  Not whether or not someone was able
to live up to some perfect ideal.

          DR. MORENO:  If I may?  I think what some people
sometimes find disturbing is the use of extreme cases in a paper
like this.

          And I think they're meant, as I understand it, Allen,
to be paradigm cases to set a framework that we can all agree on,
the Nazi experiments being probably the most obvious one for our
generation and not to presuppose questions about similarity.

          DR. BUCHANAN:  Right.  But I think that's not
sufficiently clear in the current version.

          DR. KATZ:  Just to briefly follow up on what Henry says
and then raise what, to me, is an important question.

          I just published an article trying to compare the Nazi
concentration camp experiments with current research practices,
asking myself the question, "What is really the crucial
difference between the Nazi experiments and research practices
during that same period of time?"

          The only answer I could come up with, because there
aren't fortunately many similarities to the way these subjects of
research were sadistically, brutally treated.

          They were treated worse than animals.  If they had to
be killed before the experiment was over or for purposes of
experiment, this was done.  This has never happened, except for
the Japanese experiments in the annals of the history of human
experimentation.

          That's the only difference.  But I think beyond that, I
really think that one of the important questions for us is,
before we even get into the discussions of these excellent papers
by Buchanan and Macklin, is, "For what purposes do we, as a
commission with respect to the radiation experiments, for what
purposes do we want to make moral judgments?"

          Why do we want to get into that very complex, and I
think, in my mind, impossible assignment which would take us
years to make retrospective moral judgments?

          Is it necessary for us to do so?  And if so, for what
purposes?

          DR. ROYAL:  I would also like to echo Jay's concern
about whether or not it's possible to make the moral judgment. 
For example, I had thought that it was the sentiment of the
committee that the fundamental problem with the plutonium
injections had to do with informed consent.

          And if that's true, then it's very unclear to me how 50
years after the event, we can have any idea at all about what
investigators, who are now dead, said to patients who are now
dead.

          I just don't understand how we could ever say that the
data that we need to make that judgment was made available to us. 
And I think it would discredit the committee to make judgments
like that based on insufficient information.

          CHAIRPERSON FADEN:  Ruth?

          DR. MACKLIN:  Sometimes it seems as if we're going back
to square one.  But I think we have to keep reminding ourselves. 
Certainly on Henry's last point, when the facts are missing, we
can't make judgments.

          That is, if relevant facts or facts that would be
necessary for being able to make a retrospective moral judgment
are absent, those are cases in which we simply cannot make the
judgment.

          We may say there was something suspicious, something
fishy.  We may wonder about plutonium injections.  But we may not
be able to point to either whole experiments or particular
individuals who were harmed or wronged especially in the case of
absence of consent.

          So, that almost goes without saying because the
retrospective moral judgments rely on relevant facts to be able
to make them.

          A second comment, and this goes to Jay's question,
reminds us of some of the distinctions that Allen made in his
paper.  And it's also relevant to Henry's question about degrees
of moral culpability or moral turpitude.

          We may make retrospective judgment about acts, about
culpability of individuals who performed those acts, about the
character of the individuals, which probably this committee is
going to have nothing to do with.

          But Jay's examples of the Nazis has everything to do
with.  That is, the character of the individuals who repeatedly,
who designed and repeatedly perpetrated these horrors, these
inhumanities.

          We can make judgments about their character.  I don't
think there's any circumstance in which we're going to be making
judgments about the character of individuals, even though if the
same individual performs enough heinous acts, then we can make
some judgments about character.

          But we may know enough to make judgments about the
wrongfulness of acts or actions according to Allen's schema
without having relevant information to be able to say enough
about the culpability of agents.

          So, in all of these cases, I think, or for all of these
elements, we may need relevant facts.  But it may make a
difference whether we're judging the wrongfulness of acts,
namely, whether people's rights were violated.

          And on the other hand, judging the culpability of the
people who performed those acts.  One more point, and I guess,
Jay, we may now have to begin a debate about this.

          You're questioning whether and why, whether we need to
make such retrospective judgments and why we need to, which may
be the same question.  Since part of our task in our charge is to
look back and determine whether, in all of these experiments,
wrongs or harms were done.

          And to follow that, what, if any, remedies should be
implemented or proposed or recommended, ranging from none to a
lot.

          Then I think we cannot fulfill our charge on this
committee unless we grapple with making some retrospective moral
judgments even if we don't indict particular individuals or make
judgments about their character.

          Even if we may lack, in some cases for some
experiments, information that would tell us whether or not oral
consent was obtained from patients.

          In those cases where we do have evidence and whether
that evidence comes from transcripts, discussions, patients
charts or whatever, then I think it's incumbent on us to decide
what kind of judgment, what degree of judgment, and whether it's
the agent, the victim or the recipient of the action, or the
institution.  In this case, perhaps a Governmental agency that
was at fault.

          DR. KATZ:  I just want to briefly respond to these
important comments.  In the brief memo that I distributed, I
borrowed a term from Buchanan.

          Namely, about moral appraisals in telling the story. 
And this could be our charge.  Of course we have to tell the
story of what happened.

          And in that story, certain moral appraisals will
emerge.  And we can tell the story, which is a horrendous story
in its own right, without apportioning culpabilities on this one,
that one, or the other one.

          Probably two people who, in my mind at the moment, are
most culpable are the officer who put the stamp of top secret on
the Wilson memorandum and probably Secretary Wilson himself for
promulgating this document without reading it.

          But beyond that, to go through the difficult task of
apportioning moral judgment, I'm just overwhelmed by that
assignment.  I think the Nazi concentration camp experiments were
horrendous.

          But if I look at them as a whole with respect to
certain conduct as I've already indicated, I can apportion moral
blame with respect to other things that they did.

          It's very, very difficult for me to hold them
blameworthy.  And I even find it difficult for a great many of
them to make judgments about their character.  Some, yes.  But
others, no.

          It's a very complex kind of story which after 30 years
I still haven't come to a conclusion.  And, of course, as I said
in my memorandum, I believe, unless I'm convinced or told
otherwise, that we can separate remedies and compensation from
the question of moral culpability of Government agents,
researchers, etc.

          CHAIRPERSON FADEN:  Can I interject to see if I've got
this disagreement clear in my own mind?  I think there might be a
way to show the difference using the same terms for the same
sorts of things.

          Jay, when I hear you speak, if you want to use the word
"moral appraisal," I don't know that it's any different.  I hear
you saying you do want to make judgments that certain things that
happened were wrong, that certain actions or outcomes were wrong. 
That, to me, is a kind of moral judgment.

          DR. KATZ:  By telling the story.  That's a very, very
important difference.  The story itself already as it emerges in
the draft documents of committee members.

          CHAIRPERSON FADEN:  I'm not sure.  That I'd have to
think about.  Whether there's a difference between an approach
that allows the moral wrongness to emerge in the telling of the
story rather than the committee calling the moral wrongness as a
formal conclusion of the committee.

          But the point is, I don't hear you saying that you
don't want the committee to be part of a process that makes it
clear that certain wrong things were done.  Is that correct?

          DR. KATZ:  That would be psychosis.

          CHAIRPERSON FADEN:  I just want to make sure we all
understand that.  As I think of it, that would be equivalent to
saying you want to draw some moral conclusions or some
conclusions about the rightness or wrongness of certain actions,
policies, experiences that people had or perpetrated on others.

          What you're strongly resisting is the committee
engaging in any judgment about culpability for those wrong things
that happened.

          DR. KATZ:  And beginning to figure out whether this
person, at least, belongs in tier three, four, five or whatever.

          CHAIRPERSON FADEN:  So, that's where I see at least
some of the disagreement.  And then the next step thinking ahead
to the remedies discussion or the responses discussion is that
you want to maintain that we don't need to engage in an analysis
of culpability whether it's of individuals or of institutions in
order to address the question of what responses are in order.

          In other words, you see a framework in which we make
judgments or appraisals about wrong things having been done and
people having been harmed or wronged and then move from that to
questions of what the responses should be to those wrongs or
harms without ever engaging in questions of culpability, let
alone degree of culpability of particular human agents or
institutional agents.

          DR. KATZ:  We're not judges here.

          CHAIRPERSON FADEN:  Is that characterization clear to
other people?

          DR. MACKLIN:  What's not clear to me, and I'd like Jay
to clarify it, is in your words telling a story in which it
emerges that there were wrongs done and drawing conclusions that
there were wrongs done.  I don't know whether extracting from the
story, elements of it --

          I mean, what the story gives us is, in fact, the flow,
the narrative, the background, then the details.  But those are
exactly the elements that one would extract in order to make a
particular moral judgment.

          Now, just to add one more thing.  Allen, in his paper,
refers to the correlation of rights and duties.  That is, if
there are rights, if we draw conclusions that there are rights
and, a particular subcategory, human rights, but let's just now
talk about rights of people who are experimental subjects.

          If there are rights, then there are duties that someone
owes to the individuals who are the bearers or holders of rights. 
Now we could debate on a more abstract level whether there is
always, whether that's a fixed correlation.

          That is, for every right, there must be a duty. 
Because there is the reverse that philosophers are aware of. 
There are so called perfect and imperfect duties.

          That is, we have duties where one can't always point to
a particular agent who has rights with respect to our duties. 
But setting that one aside, I want to hear what Allen has to say.

          But, Jay, if you think there are rights, and people's
rights are violated, and you speak that way in the essay, in the
lecture that we got, and in your conversations here, then it must
be the case that someone had duties towards those individuals
whose rights were violated.

          And if that's the case, even though we may not be able
to name or identify or specify who those individuals were and
know what the background was for them, we could certainly say
that someone in a position of authority or responsibility or in a
clinical or research setting failed in a duty towards those
people whose rights were violated.

          DR. KATZ:  I wish I were as sure about that as you are. 
That's just one of the problems.  Namely, that, yes -- And by the
way, you know that speech was a Jay Katz speech.

          It wasn't a committee speech which is also quite
different in terms of the context within which we are operating. 
Yes, rights were violated.

          In a certain sense, duties were not fulfilled.  But
what does it really mean?  Because all this happened in a
context, in a culture where this kind of way of behaving,
thinking, not thinking was the ethos of the time.

          In this wonderful document that Jonathan Moreno gave us
where he also, and should have highlighted, Dr. Fenn's opposition
to various things that were going on, one sentence needs to be
added.

          In my view, he was a lonely voice in the wilderness. 
The rest of them didn't behave that way.  What transpired in the
'40s, '50s, '60s, I found troublesome, upsetting, and feel
terrible about.

          But at the same time, in terms of my work over the last
40 years, I was not surprised.  These were the standards.  This
was the way of behaving.

          And to make too much of the Nuremberg Code, I think can
lead us astray.  It's that kind of nuanced discussion that I want
to have, to emerge in the story we are telling.

          And, of course, we'll make some judgment.  But we will
also make some judgments not about individuals, not about
institutions.  But about a way of thinking and behaving that can
engulf us again in the future.

          And therefore, what I'm interested in primarily is what
can the story teach us about what we need to do in the waning
years of the 20th century and beyond?

          CHAIRPERSON FADEN:  Allen, did you want to get in?

          DR. BUCHANAN:  Yes, if I may.  I guess I'd just like to
emphasize a couple of things.  And, of course, the experience I'm
having is one which some of you may have had.

          You thought you'd written something clearly, and it
wasn't written clearly.  That's obvious to me now.

          My first plea in the paper, but I'd like to make it
more clearly now, is just to avoid talking about retrospective
moral judgments en masse.  That is, we really have to sort out,
as Ruth said a moment ago, different kinds of retrospective moral
judgments.

          Judgments about rights violations, judgments about
other wrongs that don't come up to the level of rights
violations.  And this, I think, answers for the first point that
was made in the first comment that was made earlier, judgments
about culpability of agents, judgments about defects of
institutions, judgments about appropriateness of compensation or
remedy.

          And when it comes to one of the charges, as I
understand it, of the committee, that is, to make recommendations
for how to avoid these problems in the future, remedies will
obviously be an important piece of that.

          And there are really two different legs which remedies,
as a response, can stand on.  One doesn't involve appeal to
violations of rights.

          That is, we can just say, "Even if there were no
violations of rights, even if everything was done in the best way
it could have been done at the time, given the knowledge,
innocent people were harmed, and collectively we have an
obligation now to do something to respond in that way."

          It would be the analogy of soldiers who are injured in
a war, even if there was no negligence on the part of their
officers or Commanders in Chief.

          But there's another, and in fact, according to both
common sense and the law, more powerful kind of argument for
remedies and for compensation in particular.

          And that is, that it's an appropriate response to the
violations of rights.  And I think in a way we run a risk of
devaluing or dishonoring victims of rights violations, if there
were such, if we don't recognize that there's a case for
compensation on grounds that their rights were violated.

          Now I agree with the problems about knowing whether
informed consent was given or not.  But if there are, and I'm
saying this conditionally, if there are cases where individuals'
rights were violated, then I think in a way it would be a
devaluing of the injuries to them and to the persons themselves
if the committee only made out a case for compensation on grounds
which simply overlooked the fact that their rights were violated,
and just said, "Well, they were innocent people.  We've got a
responsibility to them, etc."

          There's something that's missed if a case for
compensation is not made on grounds of rights violation, if there
were rights violations.

          And also, I guess, beyond the whole issue of
compensation and the different grounds for compensation, either
that rights were violated or not, there's another aspect to the
forward-looking part of the committee's charge.

          And that is, I'm afraid that, if no judgments of
culpability are made about individuals in the most powerful and
influential roles in the institutions, that this will send a very
unfortunate message to present or future wrongdoers.

          Because they will be able to console themselves and
say, "Look.  Well, the worst that can happen is that there will
be some general statements about the culpability of the
Government or the liability of the Government to compensate or
supply remedies."

          But we, ourselves, in our capacities as leaders, as
figures of authority in the institutional structure will be
immune from any censure or negative judgment.

          That's what I'm worried about.  Now I don't know, and I
don't think the facts are in yet, to know whether this committee
would be in a position to make judgments that a certain
individual, perhaps Mr. Wilson in the memo referred to earlier,
in his capacity as occupying a certain role with great influence
and power and responsibility, failed in his institutional role.

          This is not a judgment about his character.  It's a
judgment about culpability in his capacity as filling a certain
institutional role.  I don't know whether the committee will have
sufficient data to make those judgments.

          But if the data is available, and the judgments can be
made responsibly and in good conscience, there's something to be
gained by making those judgments in addition to whatever
judgments about compensation are made, whatever judgments about
defects in the institutions.

          Because if those judgments about individual culpability
for important authority figures in the institutions are not made,
then in a sense, you're not attaching any price in the future to
these kinds of failures of responsibility.

          And this happens over and over again with scandals in
corporate America.  A corporation is fined, perhaps punitive
damages are brought against it for some kind of wrongdoing.

          But the individual corporate leaders who were in
control rarely suffer as a result of their wrongdoing.  But
again, I'm only making a conditional statement.

          I'm not saying that you know enough to make judgments
about individuals in high places.  I'm just saying if you do,
then there's something to be said for considering whether they
should be censured.

          And by the way, censure is different from punishment or
penalty.  That's a quite different question, even if you decided
that a certain individual in a high institutional role failed in
his or her obligations in that role and was subject for that
reason to judgments of culpability or censure.

          It's quite a different question as to whether, if the
person's still available, they should be punished whether they
should be penalized.  Those are different issues.

          But if you forgo the culpability judgment, I think in a
way you provide a consolation for future wrongdoers and an
incentive to do wrong.

          CHAIRPERSON FADEN:  Henry?

          DR. ROYAL:  It would be nice to have the evidence that
we need in order to find individuals or agencies culpable.  But
it would be wrong to feel that we had to find someone culpable in
order to give the committee credibility.

          DR. BUCHANAN:  I agree.

          DR. ROYAL:  In terms of the moral appraisal, and maybe
it's in terms of finding culpability, I guess the problem that
I'm having is that, as I indicated before, we all as individuals
lead lives that are of various moral quality.

          And it's not surprising if you look at how the
Government behaves that they're not going to live up to the
ideal.  There's going to be some shortcoming.  And the problem
that I'm having is, you know that glass being half empty or half
full problem.

          We clearly know that wrongs were done.  But it would be
impossible for governments or individuals to function always
making the right moral choices.

          So, the trouble that I'm having is not with the concept
that wrongs were done, because it's inconceivable to me that any
organization could ever function without some wrongs at some
time.

          The problem that I'm having is I don't know how empty
the glass can be before you should say that person has some moral
problem that should be highlighted in some public forum.

          Dr. Katz mentioned Dr. Wilson.  I feel like I know -- I
don't know if it was Dr. Wilson.  Secretary Wilson, I guess.  I
feel that I know absolutely nothing about Secretary Wilson.

          What I know is that his name must have been on
thousands of documents.  And there has been four or five
documents that have been brought to our attention which he may
have made the wrong decision about.

          And I feel very uncomfortable, based on such a
selective choice of documents, making some sort of moral judgment
about whether he did what was morally right or morally wrong.

          CHAIRPERSON FADEN:  Eli?

          DR. GLATSTEIN:  I'd like to support what Henry's
saying.  I think there are a number of problems here.  Focusing
on culpability is very difficult for most of us.

          We're not judges and jury, didn't join this committee
to do that.  The charge that we had was, as has been said, to
tell the story and to try to see if we could do something that
would give guidelines to prevent a repeat of this.

          And I think we should be focusing on that kind of
remedy.  The issue of culpability raises a question, in my mind,
of why we still have difficulty in getting all the facts.

          There are a number of experiments, if you will, that
are still partly classified that we can't get all the information
on.  I cannot help but believe that a component of that is some
bureaucratic desire to want to protect an agency from
culpability.

          And I just think that the most important thing we can
do is get the information out.  And experiments that took place
30, 40 years ago, I cannot believe need to be classified today.

          But I think it's also important to realize that, at the
same time we sit around this table, a major reason why this
committee was able to be formed was that the Cold War has ended.

          It's the first time in 40 years.  If that hadn't been
the case, I doubt very much if this committee would have been
formed.  Rather than go back to try to fix culpability, I think
it's important to try to get all the facts out and get them
declassified.

          I think if we can't succeed in that, I think the
committee's basic function, basic purpose, is really undercut
tremendously.  And how we interpret those facts 30, 40 years
later, I think it makes it very difficult to know what really
took place.

          There is a paper trail.  There's probably a verbal
trail that we'll never find that so and so was told to do
something by someone else.  We won't have that trail at all.

          And I personally feel very uncomfortable and do not
wish to fix culpability.  I wish to address the issue of how to
prevent this in the future.  That, I think, is the most important
thing that we can do.

          DR. BUCHANAN:  Ruth, could the committee indulge me for
just one brief statement, then I'll shut up?

          CHAIRPERSON FADEN:  Allen, if we didn't want you to
talk, we wouldn't have had you come.  So, it's okay.

          DR. BUCHANAN:  I guess the way I think the discussion,
at this point, might be framed is not, "Should the committee
focus on trying to prevent bad things from happening in the
future or focus on culpability?"

          My question, and it's really just a question, is
whether as part of the effort to prevent these kinds of problems
from recurring in the future, it's important to make any
judgments of individual culpability for individuals in
responsible positions if there's sufficient data for it."

          In other words, I think it's worth discussing whether
the most effective approach to avoiding difficulties in the
future or minimizing the risk of difficulties in the future will
include or will not include judgments about culpability for
actions of individuals in responsible role positions if there's
data to back it up.

          And I don't know whether there's data to back it up in
any case.  I'm just saying I wouldn't rule that out as a
possibility and that there is an argument to be made whether you
would ultimately find it persuasive or not, that the most
effective approach to preventing future wrongdoing will include
the making of judgments of culpability for some individuals in
the past.

          And I would like to see that discussed rather than just
assume that we have a choice of either focusing on preventing
problems in the future or making judgments of individual
culpability.

          And by the way, I think judgments of individual
culpability are only one part of the picture.  I wouldn't want to
focus on that to the exclusion of other things which I think are
equally or more important.

          CHAIRPERSON FADEN:  Let me just see that I've gotten
everybody's.  I've got Jay and Ruth and Henry.  Is there anyone
else wanting to join the discussion at this point?

          I'll keep looking.  Jay, Ruth, and Henry in that order.

          DR. KATZ:  Allen, I wish you would respond to this
statement/question because of the very, very important point
you're making.

          Underlying your point of cause is that, if you only
tell the story with the papers, etc., interposed, we must write
it in such a way that it will be plain to most people who have
any kind of sensitivity that terrible things happened.

          But I'm not so sure about your argument that, unless we
establish culpability of individuals, we will not make any, what
you also call, moral progress.

          Recall that, in terms of medical experimentation, one
of the great advances in the regulation of research came in the
wake of the -- tragedy.

          And nobody, though some of them should have, was judged
morally culpable.  The Federal regulations were the result of the
Tuskegee syphilis study.  Usually tragedies lead to advances.

          And nobody was held culpable.  And I have every
expectation, and I hope that whatever we are ultimately going to
come up with, will lead to better regulations of human research.

          Particularly also when the Government is involved.  And
also, it's these historical examples that come to mind including,
of course, the most celebrated one.

          Namely, that we hanged some of the doctors at
Nuremberg.  The allied military tribunal promulgated the
Nuremberg Code, and we went on sinning.  Tuskegee went on until
1972.

          These experiments were conducted despite the fact that
we held people culpable for terrible kinds of behavior.  I don't
have much faith in culpability doing very much.

          What I have faith in is that, if we can develop
meaningful regulations as to conduct that we consider intolerable
even the name of progress, that this may possibly improve the
situation.

          Though moral progress not withstanding, as these
examples indicate, we haven't come very far.

          DR. BUCHANAN:  May I reply to that?

          DR. KATZ:  Yes.  I wish you would.

          DR. BUCHANAN:  I think the case of citing the hanging
of the Nazi doctors, it's hard to know how relevant that is.

          Because I don't think that most American experimenters
would have any reason to think that the same standards were going
to be applied in the same way with penalties to them as they
would toward the recently defeated heinous enemy in a world war.

          So, I think it may be a mistake to say, "Well, that had
no effect because the Tuskegee experiment occurred later."  I
don't mean to say that moral progress can't be made without
judgments of culpability.

          And again, I'd like to emphasize, I don't know whether
you'll ever have the data to make judgments about individual
culpability.  All I'm saying is that it may make for more
effective recommendations for preventing future wrong.

          To add the regulatory approach or to include within the
regulatory approach a clear message that there will be not just
remedies, there will not just be vague reference to institutional
or Governmental culpability, but that individuals in roles of
responsibility who should know better, and who act wrongly, will
themselves bear some consequences for their actions.

          DR. KATZ:  In the future.

          DR. BUCHANAN:  Yes.  In the future.  But I think it
will be difficult        to get that message about the future
without at least considering the question of the culpability of
agents in the past.

          Now, you may consider it and conclude that you just
don't have the data, but the exercise of considering it might be
extremely hopeful for making the case that part of the future
oriented response should include a clear message that people will
not be able to simply hide behind the institutional veil and
console themselves with the thought that they, themselves, will
not bear the consequences of their actions when they violate
their institutional role duties.

          DR. KATZ:  Just, and then I'll shut up.  Allen, I think
you just made an important point which brings me to different
conclusions.

          We may not have all the data to assign culpability or
degrees of culpability, etc.  But we do have sufficient data to
say all kinds of things about terrible kinds of conduct.

          And if we had to rely as a court of law on good
evidence, then we may not be able to say very much with respect
to culpability.  And that would be a mistake.

          That would actually go in the other direction.  We have
enough data to say, "Look.  How could the Government, how could
physicians, how could all kinds of people behave this way?"

          And at the same time saying, in some instances, we
understand why they behaved this way.  And hopefully, we're
beginning now to learn some lessons from all of this.

          DR. BUCHANAN:  If I understood you properly, you did
consider the possibility that, in the recommendations regarding
the future, there might be some serious language indicating that
when current standards are violated in the future, that there
will be consequences for individuals in positions of
responsibility.

          In other words, it seemed to me that you were
distinguishing between whether we make judgments about
culpability of individuals in the past and whether, as part of
the message for reducing risk of these wrongdoings in the future,
there's something included about the liability for censure or the
liability for judgments of culpability to individuals in the
future if they clearly violate standards.

          That seems to me to be an important distinction.

          DR. KATZ:  Allen, talking about voices in the
wilderness, for decades I've advocated sanctions.  I've always
been shut down by everybody.

          DR. BUCHANAN:  I know.

          DR. KATZ:  Because you don't impose sanctions on people
who, after all, are only working for the benefit of mankind.

          DR. BUCHANAN:  Well, you haven't been entirely alone. 
I've been echoing your voice on that.

          CHAIRPERSON FADEN:  I've got Ruth and Henry and now
Phil, too.

          DR. MACKLIN:  Now, I'm going to try to interpret Jay. 
But he can speak for himself.  That when you say we have enough
data or we have enough facts to know that terrible things were
done, that you are prepared to make judgments about actions or
classes of actions.

          Something that doesn't immediately identify a culpable
agent, but for which we can only infer that there was some agent
somewhere around who did something.

          But the actions, you're saying we have enough data to
say things about actions.  And that seems to be an important
step.  That's one important step.

          The second thing, I think we can say, Henry earlier
said, "I don't know anything about Wilson."  We don't know about
Wilson.

          We do not know about all these people enough to make
the kinds of judgments we would have to make or that we could
make contemporaneously if it were a court and you gathered the
kind of evidence that courts gather.

          However, and here again, not going to the culpability
of agents, but to the judgment that someone in this position
ought to have done "x, y, or z."

          I mean, this goes to the notion of role responsibility. 
If someone is in power and if someone has a certain authority,
and the Nuremberg Code crosses his desk, and then he sends out a
memo.

          I mean he has seen these words.  He or someone read
those words.  Unless these people were just mindless agents,
robots, someone saw those things, thought they had some
relevance, knew it had some relationship to Nuremberg, put this
on a piece of paper, stamped it, and sent it out.

          Now, who did what or failed to do what?  Who stamped it
top secret?  We're never going to find out.

          But we can make the kind of retrospective judgment that
says, when you have something that says as clearly as the
Nuremberg Code said, what it said about experiments and the
consent of the subject is absolutely essential, someone, and I
think this is partly Allen's point about people in positions of
power and authority, someone dropped the ball.

          Someone at some point failed to do what that role
required morally.  And even if we can't know all those facts, and
therefore can't make the kinds of judgments about culpability, we
can make a retrospective moral judgment that wrongs were done by
errors of omission you might call them, by whoever was in a
position to implement those kinds of policies.

          CHAIRPERSON FADEN:  Henry and Phil.

          DR. ROYAL:  Just another glass half empty, half full
question.  Allen, you said that informed consent was obtained or
not, that rights were violated or were not, again, making it
sound like a very binary kind of thing.

          And again, the problem I'm having is I see it as this
continuum.  And I don't know where to put the dividing point on
that continuum about what we mean when we say that informed
consent was obtained, what we mean when we say informed consent
was not obtained.

          Because I doubt that the perfect informed consent is
ever obtained.  So, it's always somewhat less than perfect.  And
I don't know how much less than perfect is morally acceptable.

          DR. BUCHANAN:  I agree almost completely.  I guess what
I'd say is that you don't want to go too far in saying, "Well,
informed consent can never be perfect even now under the best
conditions, so we can't make any judgments about informed
consent."

          That applies now as well as 50 years ago.  That's not
what you want to say, I'm sure.  But it might be that in trying
to follow my suggestion about not making blanket statements about
whether you can make retrospective moral judgments or not, but
looking at particular cases you might, in fact, come to the
conclusion that, say in the 1940s, or at least in the 1950s,
there was a rather clear accepted standard that consent was
required.

          But not at that time a clear accepted standard that
informed consent was required or, even if there was, that there
wasn't much consensus on what counted as adequately informed
consent.

          And those are the kind of nuance judgments I take it
which you're saying we need to look at, we need to think about. 
And I agree entirely.

          And I guess this is, in a way, an apology and in a way
an excuse for not having done that in the paper.  I was trying to
just sort of lay out some possibilities and categories.

          And to, in a way, get us past the initial hurdle of
someone who just says that we can't make any judgments of any
kind.  You know, human rights have no meaning in the past, etc.

          And I wanted to sort of set that extreme position aside
and make room for the kind of nuanced considerations which you've
been advocating.  And I think there are a number of nuances.

          One is, as I said, even if there were a standard of
consent, was there a standard of informed consent?  And if there
was a standard of informed consent, is it the same one we're
operating with today?

          I don't think so.  That's one area.  Another area is
can we distinguish kinds of wrongs, perhaps the more egregious
wrongs which we would consider to be violations of human rights.

          And then a number of other wrongs which it would be, in
a way, inappropriate, insensitive, and uncharitable to classify
along with violations of human rights, put them in the same
basket as slavery and Nazi experiments, etc.

          There may be a whole range of wrongdoings which don't
come up to the magnitude of violations of human rights that
either involve other kinds of rights that are not human rights,
but are more context or institution specific.

          Or they don't involve rights at all.  That are just
other kinds of wrongs.  And I think, at most what I've tried to
do is to make room for that discussion.

          I haven't engaged in that discussion.  You're bringing
the content of that discussion out.

          DR. ROYAL:  The other comment I would like to make is,
when trying to think of an ethical framework to think about these
problems, I must say I've been having a difficult time with these
multi-tiered approaches.

          Maybe it's just because of my naive background.  Let me
tell you, as a non-ethicist, naive person how I would make a
moral judgment about an experiment.

          The way I would make a moral judgment about an
experiment is I would say something like, "If I were in the
patient's place, or if one of my family members were in the
patient's position, would I agree to participate in this sort of
experiment?"

          And it's not clear to me where that fits into this
multi-tiered judgment about the moral rightness or wrongness of
these experiments.

          But to me, what I just described, is the most
meaningful yardstick that I personally have about making a moral
judgment.  So, I'm hoping that you can help put my yardstick into
your multi-leveled, ethical framework.

          DR. BUCHANAN:  Well, I may not have understood you
properly, but I agree that probably one of the best general tests
we can have in moral judgment is the role reversal kind of
technique or put yourself in the place.

          In almost every culture, there's something like that. 
The Golden Rule.  Some version of that kind of technique of moral
reasoning.  And it has wide application.

          I guess I have some doubts about how broad this
application is about questions of informed consent.  Because as I
understand it, the requirement of consent or of informed consent
is a requirement of an actual consent by a particular individual.

          It's not sufficient that most people or most reasonable
people would agree.  It's something much more individual and much
more an act of will and explicit consent on the part of the
individual.

          So, you may view it as paradoxical, or it may raise
questions about our whole notion of consent or informed consent.

          But it does seem to be part of those notions that the
mere fact that others would agree, even the majority of
reasonable persons, is not taken to be sufficient or equivalent
to saying that you agree or that you give your consent.

          DR. ROYAL:  But to me the dilemma is that the only way
you can judge the interaction of an investigator and an
individual patient is to have been there and to watch the
interaction.

          So, we're not able to make a decision on that level. 
And I don't see how we would ever be able to make a decision on
that level.

          So, the only alternative we have is the reasonable
person alternative it seems to me.  Because I don't think that
the other more ideal approach is possible.

          DR. BUCHANAN:  That goes back to your question about,
given that we're not present, we don't have audio or video tapes
of what actually transpired, there's a huge problem of knowing
whether consent or informed consent under various interpretations
of the adequacy of the information took place.

          I think that's right.  And the only thing to do, I
guess, is to just say, "Well, look at each of these classes of
experiments case-by-case." and ask the question you're asking,
"Do we know?  Do we have enough information to make a judgment?"

          Now it may be that you don't have enough information to
make a judgment about any particular subject as to whether there
was consent in that case.

          But you still may be able to make judgments about
whether the institutional procedures for determining whether
there was informed consent were adequate.

          It may be possible to reconstruct a paper trail for
that.  And it even may be possible to make the kind of judgment,
perhaps I don't know, that Ruth was talking about.

          Namely, that even though we don't know in individual
cases whether someone had informed consent, we do know that
someone in a position of authority failed to exercise sufficient
oversight to determine whether there were procedures in place
which would make it more likely that individuals were given the
opportunity to give informed consent.

          Again, it's just a plea for sorting out a number of
different kinds of judgments that you might make and asking in
each case, "Do you have the data for it rather than making a
blanket assumption?"

          DR. ROYAL:  But we already know that those
institutional oversights were not present.  That was the whole
reason why IRBs came about in 1973.  So it seems like a self-
fulfilling prophecy.

          Everyone already knows that the institutional oversight
that was necessary to make informed consent be more likely were
not in place during the time period that we're looking at.

          Is that really what the committee was created to
discover, that these institutional oversights were not present?

          DR. BUCHANAN:  But were there ideas and was there
sufficient consensus among medical professionals or among people
who were aware of the Nuremberg Code such that they should have
been making some efforts to ensure that there were appropriate
procedures?

          I guess that's the question that I would ask.  That's
not to say that it would be appropriate to hold them responsible
for not having put in place the full set of procedures that we
now have which has been an historical product that's come in fits
and starts and with a lot of effort and a lot of trial and error.

          But the question is not of holding them to that
standard, but just asking the question.  I don't know the answer. 
I just don't want to preempt the question.

          Asking the question whether, given a knowledge of and
acceptance of some general principles about consent whether it
was informed or not, people in positions of authority acted
responsibly in doing something to try to see that these standards
were met?

          And I guess, reading the stories about the experiments
in the paper this morning pushes me in the direction of saying
that perhaps something more should have been done.

          Because as I understand the two articles that I read,
the claim is that something that influenced policy decisions
about the radiation experiments at the highest levels was fear of
legal liability and fear of adverse publicity if it were known
what was going on.

          Now, that indicates that at least there was the belief
that there were some standards that were clear enough and widely
accepted enough that they could serve as a basis for legal
liability and public censure.

          So, given that there was a knowledge of some
principles, maybe not the same principles we have now developed
to the same degree, and given that these people were in positions
of responsibility, it seems reasonable to ask the question.

          We may not have the data to answer it.  Whether given
their knowledge of those standards, given their belief that those
standards were widely accepted enough to cause problems for them,
if they violated them, should they have done something to see
that they weren't violated other than just trying to cover up and
make it impossible for people to find out that they were
violated?

          I guess that's one way you might raise the question. 
And again, I don't know the answer to the question because I
don't know whether the data is there or whether the data will
ever be there.  But I think that question ought to be asked.

          DR. KATZ:  They were concerned about the ingeniousness
of the trial bar.  It's not so much the legal in part, the legal
liability facing them.  They may not have thought it had to do
with anything that really they ought to be morally concerned
about and ethically concerned about.

          But when ingenious lawyers of the American Trial
Lawyers Association get a hold of it, then we're going to be in a
mess of trouble.

          DR. BUCHANAN:  I don't think the lawyers were that
ingenious in that generation.

          CHAIRPERSON FADEN:  Just as a point so we can feel
where we are with respect to the discussion, I have Phil waiting. 
Ken has signalled he would like to say something.

          And Ruth as well.  I'm inclined to do something like
the following when we have those three comments and discussion
about them.  I'd like to sort of summarize briefly where I think
we are and have the break if that's congenial.

          Is there anybody else who wants to participate in the
discussion before the break besides Phil, Ken, and Ruth?

          Obviously, if something they say prompts something you
really want to comment on, please do.  But other than that, I'll
assume we'll pick up again.  Phil, you've got the floor.

          DR. RUSSELL:  I think we have to be very careful in
describing culpability within large organizations.  It's been my
experience that sometimes large organizations can become severely
dysfunctional and do some very terrible things.

          And you find on looking through the whole thing that
everybody in the organization thought they were doing the right
thing, were properly motivated.

          The information that was available to some wasn't
available to others.  The persons making certain decisions
thought they were making the right decisions.  In fact, they were
misled by facts.

          And the outcome produces some terrible events.  Now,
the military tradition, in kind of a humorous fashion, is to
first relieve the commander and punish him.  Then conduct an
investigation to find out what really went wrong.

          And that's the simplest way of doing it because the
commander is ultimately responsible for the behavior of all these
people.

          When you get to a large organization as large as the
Defense Department, the fundamental principle of the Defense
Department is far removed from medical research.

          And the concerns of everybody are on different issues. 
The person who stamped that document secret was probably
following a regulation that was totally unrelated to anything
having to do with medical research or human rights and thought he
was doing the right thing.

          And it was somebody else's responsibility to deal with
making sure the medical researchers did the right thing with
regard to their subjects or their patients.

          The legal folks certainly were concerned about
protecting the organization and are probably concerned about the
protection of human rights as well.  But they had no realization
of some of the things that were going to happen downstream.

          So, we have an organization that wound up doing some
very bad things.  I'm much more concerned about making
recommendations that ensure that large organizations don't do bad
things downstream than about what I think is going to be a futile
attempt to ascribe culpability to individuals.

          First, I don't think we're ever going to find the kind
of information that would make us comfortable in making the
judgments.

          And the second thing is that, in most cases, I don't
think there's enough single, individual culpability to be
ascribed in many of these large organizations.

          Now when you get down to the proximal issues of the
investigator and the subjects, then the purpose of the activities
and the information and the knowledge and so forth all come
together.  Then it's much easier to be judgmental.

          At the upper levels, it incredibly difficult.  And I
think we have to be very careful.  And I think we have to look,
in many of these instances, at the probability that we're not
going to be able to.

          And we have to deal with recommendations to prevent
reoccurrences.  Not by punishing or ascribing culpability, but by
wise recommendations that take into account the behavior of large
organizations and the incredible difficulty in managing them
especially around issues that aren't their central focus.

          A large part of the problem we got into is because of
the classification.  And the classification was done for reasons
that the whole society thought were essential to national
security.

          All of the regulations that created the classification
were related to national security.  People followed those
regulations.  The consequences to medical research were terribly
unfortunate and created great harm.

          But I'm not sure I'm going to be able to ascribe a lot
of blame regarding this outcome on the people who wrote those
security regulations.  They were a serious cause of the outcome.

          But on the other hand, they had no way of comprehending
the consequences of their actions.  They didn't have to put in a
"but."  This applies in all cases unless there's human rights
involved.

          There are very difficult downstream consequences of
what were apparently very appropriate and necessary actions at
the time.  I think the legal issues are the same thing.

          And I think the issues of trying to protect the public
image of the organizations, the Atomic Energy Commission, the
Department of Defense, the other organizations, was generally
regarded as essential to the national defense.

          Although the outcome was very unfortunate.  It caused a
lot of harm.  It's pretty hard to blame the public affairs
officers of the Atomic Energy Commission for the outcome because
it was part of the dysfunctionality of a very large organization.

          So, I think we can get closer to culpability assessment
when you get down to the investigator level or the program
manager level where they were consciously interacting with the
human experimentation issue.

          It's very difficult when you move up.  These, I think,
are the same reasons why in corporate America and corporate
issues it's so hard to ascribe culpability.

          Sometimes it just isn't even there.  Sometimes it is,
but is well hidden by the organization too.  Thank you.

          CHAIRPERSON FADEN:  Ken and Ruth.

          MR. FEINBERG:  This discussion has important
ramifications to me as to how we proceed, for example, with the
remedies chapter.  I hear Allen, to his credit, about a half a
dozen times begging the question posed by Henry.

          It's all well and good to say that a report should be
drafted in a certain way to assess culpability IF the facts are
there to justify it.  I hear Henry saying, after an hour really,
the facts aren't there to justify it.

          They're not there.  I hear Phil saying be careful about
assessing blame on institutions as you go up the hierarchy.  The
facts aren't there.

          That's why Jay strategically seems to say, "Tell the
story and leave it to others."  That's all we can do if the facts
aren't there.  Even Allen says, "But of course we can't go too
far on the culpability chain in assessing blame if the facts
aren't there."

          And he says, "Of course, if the facts aren't there,
then that's a different story."  And Henry is saying, "Well, the
facts aren't there."  So what are we to make of this?

          Eli says, "That's why we should really be looking
prospectively.  Because the facts aren't there.  They're old. 
It's 50 years ago or 30 years ago.  The best we can do is tell
the story because the facts aren't there."

          And Eli says in a convincing way, "What we really ought
to be doing is making sure it doesn't happen again,
prospectively, by laying out rules and regulations and sanctions
that govern the future."

          Well, if this is true, and in my mind I'm listening to
what everybody says, but one begins to question, it seems to me,
whether we should have a 15-page remedies chapter that lays out
all sorts of distinctions and discriminating degrees of
culpability for policy makers to react to in the Congress and in
the Executive Branch, if at the end of the day, there isn't
anybody that falls into these culpability categories.

          Because there is no evidence in sufficient detail to
hold Charlie Wilson liable 20 years after Charlie Wilson probably
passed away.

          I mean, Henry makes a very good argument that we better
be careful about labeling people culpable when we don't have all
the facts.  They're not here to defend themselves.

          We don't know what happened.  We don't have the whole
story.  I mean, I am glad to have a hand in a chapter on remedies
that is retrospective as well as a chapter on remedies, as Eli
says, that should be prospective.

          But it may be that the committee is word-smithing here
with discussions of knowledge, recklessness, negligence, harm,
causation.

          If when you try to establish or apply those general
guidelines, the nine or ten that we've got in the chapter, to
specific examples, you throw your hands up in despair and say,
"It just can't be done."

          Why buck the issue to policy makers when we've spent
months and months and months looking for the evidence?  And the
evidence is marginal.  It's interesting.

          It tells a story.  But it's hardly the stuff for
recommending to the Congress that somebody get $50,000 or medical
monitoring or a life insurance policy or health insurance or even
a letter of apology.

          So, this is why it was a little slow coming to me.  My
mind didn't react as to why some members of the committee have
been telling me for weeks on remedies, "We've got to factor in
this whole issue of retrospective moral judgment and how it plays
out."

          But clearly the discussion in a few minutes dealing
with the remedies chapter, I think has to factor in whether or
not it is, as a practical matter, particularly helpful to the
committee's charge.

          DR. RUSSELL:  Why can't you have organizational
culpability without being able to ascribe individual culpability
and have the same outcome, vis-a-vis, the restitution and so
forth?  I think that's where we're at.

          MR. FEINBERG:  Let me ask.  If Henry says to me, using
Henry as an example because of the argument so far, that even
that can be done based on the factual record and taking into
account your previous concerns about an institutional trail as
you go up the ladder?

          I mean institutions are made of individuals too.  I'm
all ears on that.

          DR. RUSSELL:  I don't see any problem with holding the
Defense Department culpable for the outcome and the harm that was
done to individuals in the course of human experimentation.

          I am very concerned about attributing the culpability
to individuals where we don't have the facts.  But the
restitution, as far as I'm concerned, would come out the same
way.

          MR. FEINBERG:  Let me just say this, Phil.  I don't
disagree with that.  I would be interested to hear from other
members of the committee how the Defense Department, that you
don't have any trouble, how the Defense Department can be held
culpable?

          And I'm not saying it can't be.  But what the report
says as to why and what evidence there is that the Defense
Department, which is after all an inerrant agency, I mean, who
are the people?

          Can you make that case in a convincing way that
explains why there is a committee recommendation that the Defense
Department is culpable?

          How do you make that case in the report that the
Defense Department is culpable?  It sounds to me like there are
people in the Defense Department that are culpable.

          DR. RUSSELL:  But if you can't find them and you can't
identify them and there's no way of sorting that out because of
lack of facts, you could still make the case that the
organization, whether it's Defense Department, Atomic Energy
Commission, Veterans Administration, whoever, I think we can do
that.

          MR. FEINBERG:  I want to see that.

          CHAIRPERSON FADEN:  Ruth?

          DR. MACKLIN:  I have to jump in here, but then go back. 
We may have the facts that are sufficient for relating to another
element that you didn't mention, Ken, as you went around and said
what everybody said.

          And that is whether people were harmed or wronged.  If
we have sufficient factual information, how exactly to affix
culpability, how much was this person, how much that person, how
much this office versus that office, is something we can't engage
in now.

          But clearly, these were all human agents who were in
some official capacity related in acting on behalf of the Defense
Department.  And that's the connection.

          I don't know if that's a sufficient theoretical
structure for hanging all of this on.  But at least that might be
one way to sort of slightly reframe what you've just said that
would still allow us to get somewhere.  I don't know.

          I can't possibly now do what Ken did.  But I just
wanted to point out a difference between the way Henry is
speaking and the way Phil is speaking.

          And it goes to our task.  Henry's comments are usually
and understandably made with reference to specific individual
physicians.

          Unless you witnessed with somebody who was there and
did videotaping, which they didn't even have then, of the process
in which oral consent was obtained, we're never going to have
those facts, and we're never going to know.

          So, we're at one distinct disadvantage.  But at least
it says something about what kind of retrospective moral
judgments might be possible when we're talking about individual
and physician and patient encounters probably in the privacy of
some medical office or hospital setting.

          Phil's reasons, or the difficulty of holding
individuals responsible are very different, very different
reasons.

          They have to do with chains of command, responsibility,
institutional and organizational complexity, and the way things
work in such big organizations.  And that's a different kind of
reason from Henry's reason.

          It's not so much not knowing all the facts.  But even
if you know all the facts, it's very hard, as I heard what Phil
was saying, to ascribe responsibility to particular individuals
given an organizational structure chain of command and so on.

          So, I think we have to look at the examples
differently.  We're talking about all of these things that the
case studies are supposed to provide some illustrations for us.

          And I think this is just a cautionary note that we may
not be able to make the same conclusions.  And we should not draw
the same kinds of conclusions because retrospective looks are
going to vary tremendously depending upon the kind of institution
and whether we're looking at doctors or secretaries of defense or
whatever.

          So, that's just one little observation.  Now I can't
resist just pointing a couple of things out.  And this goes back
to Jay's comment.

          It actually flows from Allen's reading of the
newspapers today which I didn't yet see.  And I'm very eager to
see.  But I did read these documents that are the basis for
whatever was in the newspaper.

          And I think these are very instructive in some ways. 
And I, at least, provisionally disagree with Jay that the whole
thing was a bunch of smart lawyers looking at what people might
have legal liability for.

          There is a very strong sense here of public response,
reaction, and outrage.  And I want to just pick out a couple of
things since someone's going to have to do this work eventually.

          And I think giving the examples of looking at the
context of the time and whether retrospective moral judgments are
apt because people never even thought about consent.

          So, I have four very brief examples.  I'm not going to
read them because they're all in our book here.  These are all
under Tab I.

          And it's interesting that these are all
contemporaneous.  They all took place somewhere between 1946 and
1948.  So, that's all pretty close.  Of course, it's different
agents, different places.

          The first is this memo.  It's referred to in the memo,
but it's T. S. Chapman, Chief Operations Branch of the Research
Division speaking on the subject of human experimentation.

          Okay.  This was the area engineer written to the area
engineer Berkeley.  Item number 2 in this memo says, "These
doctors state that the injections would probably be made without
the knowledge of the patient and that the physician assumed full
responsibility.

          Such injections were not divergent from the normal
experimental method in the hospital, and the patient signed no
release or release was held to be invalid."

          Now I presume that that means -- Well, maybe it doesn't
matter what that means, that it's invalid.  It just probably
means that, even if a patient signed a release, still the patient
could bring some action or some lawsuit.

          Just like people when they say today that informed
consent isn't worth the piece of paper it's written on.  The
doctor means you can still be sued.

          Now, what this clearly suggests is that someone has
evidence or believes that the injection would be made without the
knowledge of the patient.  It also makes the second point that
such injections were not divergent from the normal experimental
method.

          Now I don't think he meant such injections, but such
injections without consent or knowledge of the patient were not
divergent.  But the very fact that there is that observation
suggests that someone thinks or knows that maybe you should get
permission of patients.

          Otherwise why even mention that they're done without
the permission of the patient and that it's in accordance with
what's done at the time? 

          So, at least somebody is thinking that it might be a
good idea or it's something we have to suppress.  That's example
number one.

          Now, right at the same time or about the same era, this
is the staff memo that begins on page 3.  It's Roman Numeral II. 
It's reclassification of plutonium injection information.

          I mean I know this is all about secrecy and
classification, but it really reveals a lot of other stuff here. 
All right.  Here's this example.

          This was written by C. L. Marshall, identified
elsewhere as Deputy Declassification Officer and from the AEC,
and he writes, "This document appears to be the most dangerous
since it describes experiments performed on human subjects
including the actual injection of the metal plutonium into the
body."

          Then it says, "It is unlikely that these tests were
made without the consent of the subject."  And granted Jay's
point that he always makes, "Yeah, what does consent mean?  It
wasn't informed consent."

          But at least here, they're saying they got somebody's
permission to inject something into them, and this was in 1947 or
thereabouts referring to the past.  But no statement is made to
that effect.

          So, that's the key.  They didn't document in this
particular case that there was consent of the patients.  They go
on to say, "The coldly scientific manner in which results are
tabulated and discussed would have a very poor effect on the
general public."

          Now, they're not saying it would bring a lawsuit and
that we better get the lawyers in here.  But that the public
wouldn't like this.  Now why wouldn't the public like this?

          I mean, if this was if nobody even had the foggiest
that you got to get consent for people before you inject
plutonium or metals or other things into them, why would that
bother the public?

          They were being viewed as human guinea pigs.  A couple
more quick ones.  I don't understand this one, but this is our
former hero, Shields Warren.

          This is a letter written to him.  This is from Albert
Hollin, Medical Officer at Oak Ridge.  "In my opinion, we were
unable to declassify the document for general medical publication
since it specifically involves experimental human therapeutics."

          Now, obviously it's the experimental part.  The reason
why you can't declassify it isn't completely clear.  If it's
because of the experimental, that's one thing.

          If it's because of the kinds of things that would have
to be written up in publication were secret information, that
would be another reason.

          Further he says, "It appears almost impossible to
rewrite in an acceptable manner which would not jeopardize our
public relations."

          And Warren writes, "I'm in complete agreement with you. 
I also agree it would be difficult to rewrite it."  So, why
couldn't you publish it?

          You couldn't publish it because it involved general
experimental therapeutics?  I think we have to know what that
means and why it couldn't be declassified for that reason.

          And finally, again, I'm talking here about publicity,
not liability because I think that's the key.  If you're talking
about publicity, then someone might react to this in a bad way.

          It's really on the next page from the one I just read
on the memo, page 8.  Dr. Stone petitions Shields Warren
regarding a report that was being kept secret because it might
result in adverse publicity and even encourage litigation.

          Now, this is also an interesting point.  He says with
regard to the first statement concerning adverse publicity, Stone
wrote, "I thought that this item was taken care of when we stated
in the paper that the patients were incurable by any known means
of therapy."

          Now that goes to the point that people at the time, the
public, might not have been at all concerned.  Even though we may
think differently now if you experiment on people who are dying
and are incurable and this is kind of a last ditch hope so it's
okay, and the public might accept that.

          However, if there could be adverse publicity, even if
that fact were disclosed, then the question is, "What kind of
sense did the public have, or might the public have had, that
people were being harmed or wronged or treated like human guinea
pigs?"

          I use these as examples.  I'm sorry to go on so long. 
As examples of how reading particular things written by people at
that time gives us a sense of the level of awareness of whether
there was any kind of wrongdoing.

          So, you can't just look back and say, "Nobody ever
thought of these things.  They didn't have any rules back then. 
Informed consent wasn't practiced."

          I mean, there's a body of data that says things.  Even
if we cannot point to any individual as culpable, we can
certainly say that, from the standpoint of the awareness of the
people writing these things, and possibly of the general public,
that people were wronged.

          CHAIRPERSON FADEN:  Henry, Pat has signaled that she
wanted to respond.  I'm dispensing with what I said before
because the discussion is clearly progressing in a way that I
think it needs to go.  Henry, did you want to respond?  And then
Pat.

          DR. ROYAL:  I want to talk about the points that Ruth
just brought up.  And I'm just going to talk about the first two
memos.

          One of the things that has struck me about these memos
that we haven't covered is their remarkable terseness.  And it
allows us to interpret them any way we want to interpret them.

          For example, that first memo that says that the
injections would probably be made without the knowledge of the
patient, what does that really mean?

          It's not conceivable, at least to me, that you would
inject someone, collect their urine and stool for several months
without the patient having some knowledge that they were
participating in some experiment.

          I don't know if you read.  There's a memo in here
somewhere about how they actually did the plutonium assays.  And
they were talking about using spatulas to clean out bed pans.

          So the patient had to go to the bathroom in a bedpan. 
And that these collections were done over a period of 40 to 60
days.  Again, it's hard to imagine that they weren't told
something.

          So, I'm not sure what the phrase "without the knowledge
of the patient" means.  The other thing that I'd like to point
out is that the people by and large who were in favor of
publishing this stuff in the open literature were the people who
actually did the investigations.

          And the people who were against publishing the material
in the open literature were the bureaucrats.

          And I don't understand, if the people who had done the
experiments believed what they were doing was wrong, why they
would want to publish this in the open literature where everyone
would find out what a terrible person they were.

          CHAIRPERSON FADEN:  Pat?

          MS. KING:  This is a terse observation.  It seems to me
all of the discussion boils down to somebody like me who doesn't
have a stake on either side to a demonstration of what can or
cannot be done.

          I'm willing to make a judgment if there's enough
evidence on which I think I have sufficient evidence on which to
make one.  That hasn't been demonstrated either.

          I'm willing to make a judgment if it's not there.  And
I like Jay's idea of trying to tell a story.  And I'm willing to
do that.

          I think part of the problem is at the theoretical level
at which we're having the discussion.  But we can't have a
demonstration ad hoc.

          Because what Ruth just did, if left just there, has
convinced me that we have to go in Jay's direction.  Because
that's not the kind of evidence I think that allows you, in my
opinion, to draw strong judgments about culpability.

          It is the kind of statement that allows you to draw
more generalized inferences where you can speculate about what
must have gone on if we get to this point to find a statement in
a document.

          That is not what I would consider a judgment made about
wrong done to human beings.  But it is the kind of evidence that
allows you to draw some kinds of inferences.

          So, for me, the issue comes down to what do we have? 
I'm actually willing to go in either direction.  It depends on
what we have in terms of trying to do that.  And I would also
like to keep one thing, I think, distinct.

          People can be injured and not have been wronged.  And
one of the problems, and I deliberately say "injured" rather than
"harmed," injured without having been wronged.

          So, I don't have a problem in concluding that the fact
of injury with certain kinds of inferences that are of a more
generalized nature might lead to appropriate compensation in
terms of trying to deal with a remedies chapter.

          But I'm really concerned about where we are going with
the debate because it seems to me to be going around in circles. 
Because we need a case.

          CHAIRPERSON FADEN:  I'm not sure about that yet, Pat. 
But let me try this.  We probably do need to take a break.

          And let me just tell you where I think we are in the
discussion and see if this is, at least, one potential
characterization of where we are.  If there are others, maybe we
should get them and stop, and then proceed.

          It seems to me that at least the following things are
going on.  One is that there is some degree, and this is probably
the only area where there is any degree of consensus or
agreement.

          It will be possible to make moral appraisals or moral
judgments or to tell a story in a way in which our moral
appraisals are clear.  One of the three.

          About there having been instances of wrongdoing, where
wrong things were done.  Judgments, in my world of thinking,
judgments about actions that morally wrong things happened.

          Put that away, it seems to be that there is a sense
that we will be able to do that in at least some circumstances. 
However we do it.

          Whether we say, "Here are the wrongdoings." or we say,
"Here is the story.  And it will speak for itself that this was a
wrong thing."  And I'm not sure about the difference there.

          But to use the analysis in Allen's list of questions,
that would be judgment about actions.  When we get to
culpability, we've got at least three problems.  We have the
question, "Why would we be interested in culpability or degree of
culpability for these wrong actions if we find them?"

          And two proposals have come forward.  One because they
may affect the remedy.  They may not be the sole reason why.  In
other words, we can decouple it in this sense.

          It may be possible to speak meaningfully about remedies
in the absence of being able to make judgments about culpability. 
But there may be a relationship between culpability and remedy.

          The other is the argument that it would function as a
deterrent.  That if we could make judgments about culpability
with respect to the past, it might have a deterrent function with
respect to the future.

          But we haven't, by any means, resolved either of those
matters.  The relationship of culpability judgments to remedies
or the relationship of culpability judgments to deterrents with
respect to future behavior.

          So, one question about judgments about culpability is,
"Why make them?"  The second is, "Culpability by whom?"

          And we're having this struggle about whether we're
talking about individual, identifiable human agents, or we're
talking about role responsibility, culpability, the Official
rather than John Smith or Sally Smith or whatever.

          And then there's the issue of whether we can speak
meaningfully of the culpability of an institutional agent.  So,
we've got that problem.

          First, it's why make judgments about culpability?  Then
it's who is the agent whose culpability would be judged? 
Individual, identifiable human agents.

          People in a role responsibility.  Or can you make a
meaningful judgment of culpability of an institution or an
institutional setting?  And within that the characterizations
that -- Well, let me just leave that.

          Finally, there's the evidentiary base.  Do we have the
empirical evidence to make judgments about culpability at any of
those levels?  Which is where you were ending up, Pat.  Let's
look and see whether we've got the data base.  Right?

          Do we have enough evidence to be able to make
culpability judgments either about individual agents or about
role responsibility failures or about whole institutions, if we
can make sense about what it means to make a judgment about a
whole institution?

          MS. KING:  But when you separate it, going from
culpability as I understand what you just said.

          CHAIRPERSON FADEN:  Yes.  I said you can look at an
action.

          MS. KING:  Well, the point I made would go to both. 
I'm not yet sure about making moral judgments and making
culpability judgments, what the distinction is.

          And I'm not yet willing to go on the line based on what
I've heard about making a moral judgment.  I think I understand
the difference between moral and culpability.

          CHAIRPERSON FADEN:  No.  I don't want to make a
distinction about moral and culpability.  They are two different
kinds of moral judgments.  One a moral judgment about the
rightness or wrongness of an action.

          The other also a moral judgment about the culpability
of the actor of that action.

          MS. KING:  I'm not ready to go to either of those.

          CHAIRPERSON FADEN:  That's important.  That's an
important articulation.  So, we've got these three issues.  Can
we make judgments about the rightness or wrongness of acts?

          Can we make judgments about the culpability of the
person whose actions or the institutions, or if it's a matter of
policy, those actions or policies are?  And we are struggling
with both.

          DR. MACKLIN:  And can you separate them?  Pat's comment
to you was that she doesn't understand how you could make a
judgment about the wrongness or the moral action without implying
something about the moral agent.

          CHAIRPERSON FADEN:  Well, without implying would be one
thing.  But without actually judging would be the other.  But,
yes.

          And within the culpability, the last issue is, "Do we
have the fact base for making any kinds of judgments about
anybody's culpability?"  Have I got it more or less right in
terms of what we're confused about?

          MS. KING:  My point was we don't have the facts.  I'm
also concerned about to the extent you separated the two, that I
don't yet understand.  My factual point goes to both.

          CHAIRPERSON FADEN:  Goes to both.  Fine.

          DR. BUCHANAN:  Excuse me, Pat.  Did you also say that
you weren't sure about judgments about whether individuals had
been wronged?  That is, whether their rights have been violated?

          That's a third category.  Because someone might say,
"Yes, we're sure that some rights were violated in some cases. 
So, we know that they were wrong actions and that they were the
kinds of wrong actions which violated rights."

          But we still have question about what kind of blame, if
any, we ought to attach to the agents who did it.

          You were also expressing some doubt about whether there
was sufficient information to make a judgment that rights were
violated too.  Is that right?  In any case.

          MS. KING:  You may be right, Allen.  I haven't gotten
to that.  Because that brings me to a whole separate question
that I would reserve, which is to see if there's a consensus or
common understanding on the term "rights."

          Because I can't argue about whether they were violated
or not violated.  The language is used so loosely that I'm not
sure there's any kind of common meaning here that we all
understand yet.

          And I'm particularly troubled whenever I get into the
area of human rights.  Although I find it appealing for obvious
reasons when you used the example of slavery.

          So, I have some linchpin for some of the things that
you talk about.  I'm trying to look for the core under there. 
And so that would take a discussion.  But you may be right that
that's a third category, depending upon what we understood to be
rights.

          DR. KATZ:  There are so many things to comment on.  But
just to be very, very brief is I think something else has to come
before your three items in order to be responsive to Pat's
concern about going around in circles, etc.

          Isn't it time now for us to briefly discuss the
question and get the preliminary views of all members of the
committee in the light of what we've heard and in the light of
what we've read whether we believe that terrible things happened?

          Just that simple question that terrible things happened
in the '40s, '50s, and '60s to human beings.  My initial comments
were not meant to suggest, and it wasn't a tribute to me, but I
want to make my position clear.

          Real facts notwithstanding and having to rely maybe to
a great deal on solid inferences that terrible things happened in
that period and that we can talk about it and speak to it and
also say all kinds of things for the future in the light of these
terrible occurrences.

          If there are still many committee members, and I'm not
sure now anymore, who are not willing to go that far, it will be
nice to hear what their reasons are.

          Because, to me, all this comes before the general
question of moral culpability, evidentiary evidence, etc.  They
are important.  But I think they come after that first question. 
And I'm not clear how the members of the committee feel.

          CHAIRPERSON FADEN:  I understand what you're saying,
Jay.  My personal response is that what I was trying to
articulate as the first issue, is that issue without saying that
we've reached a decision or not about it.

          But that it is possible for the committee now to make
judgments.  Of if not now, a couple months from now.  Its final
judgment whether to use your language, in some cases terrible
things happened.  I would say that that's a way of saying that
morally wrong actions --

          DR. KATZ:  Or to put it most neutrally.

          CHAIRPERSON FADEN:  Right.  But if you put it sort of
in ordinary language, yes, at least in some cases things happened
that were wrong.

          I don't know whether a calling for a kind of individual
"Where are you now on that issue?" is something that we should be
doing or not.  I don't know.

          It bears a lot of thought.  But I would take that as a
more dramatic restatement of my first point.

          MS. KING:  I think the problem is that the first one
that, judged by current standards, maybe I'm wrong, I don't think
anybody would have any trouble reaching a conclusion that wrong
things happened back then.

          The question is, when I reach that conclusion, where
does that take me if I'm judging it by what I know now?  It's
sort of like I wouldn't go back and be 13 unless I could take
back with me what I now know and be 13 again.

          But that's the problem for me.  And so the question is,
judged by what I think are moral standards today, how do I feel
about those things happening in the past?

          I can make that judgment.  The whole issue, it seems to
me, is how would I feel from the perspective, and no matter how
people try to dissuade me, I have not been able to get out of
this bind, how do I feel about that in terms of what happened in
1948 or '48 or even for a ten-year period?  It's very different.

          CHAIRPERSON FADEN:  Well, I think even if we start with
that.  We can start with that first issue.  And that is an
important moral judgment against the standards of today.  Did
wrong things happen?

          And the next step is, and that's where you move
immediately into this question of how you do look at judgments in
different cultural context.  But even that first point, whether
that first point is all the kind of moral judgment we want to
make, if we just stop there.

          I'm kind of concerned about whether we want to take a
break or not.  Anna says we do.  She's declared it for all of us
that we want to take a break.

          Let me just raise a practical matter with respect to
the agenda because it affects sort of the lives and timing of
people.  Right now, we are scheduled to go onto the remedies
discussion.

          Do we want to hold off on the remedies discussion and
consider this more?  Is the answer, "Yes?"  All right, so we want
to go forward with the remedies discussions.

          We could also move immediately to the practices
discussion.  Hold it, Jay and Pat.  If we could just have it for
two minutes, we're trying to figure out what to do next which is
whether to go to remedies or not go to remedies and continue with
this discussion, go to practices or whatever.

          DR. MACKLIN:  We're already talking about remedies. 
Any time anybody talks about culpability and what its
implications are, we're already talking about it.

          So, I think if we postpone it, we're artificially
postponing it.  I think we should go to remedies and continue
this discussion in light of remedies.

          CHAIRPERSON FADEN:  One of the key questions is what is
the link between whatever we might conclude we feel we do want to
make moral judgments about, and where we feel we can't make moral
judgments, and what the response would be with respect to
remedies?

          So, that was the rationale originally for doing it this
way.  Two hours or an hour and a half of debating this until we
don't know what we think anymore.

          Then remedies until we don't know what we think
anymore.  Then we come back and try to put it together.  So, we
take a break.  It's now 11:15.

          We're going to have to delay lunch, if that's okay. 
We'll come back in ten minutes and go until 11:30.

          (Whereupon, the proceedings went off the record at
11:17 a.m. and resumed at 11:37 a.m.)

          CHAIRPERSON FADEN:  Will the committee members please
come to the table?  I think we should just begin the discussion
please.  We need people to come to the table.

          We can postpone lunch until 1:00.  And for committee
members, there are some things to help you wait until 1:00.

          We need to begin our discussion please.  If we could
just get started?  Ken, I don't know whether now, in the light of
what's happened this morning, you want to make a few comments
about the memo that's ahead of us just so people will know.

          The Remedy Subcommittee is Ken, Duncan, Pat, and I've
been on it.  And also, Gary, could you come to the table?  The
memo before you is from staff.

          But it's been reviewed and changed and whatever by the
subcommittee.  But it is not coming forward as a subcommittee
proposal.  But it's certainly been examined and worked on by the
subcommittee.  Ken, do you want to say something and get us
started?

          MR. FEINBERG:  Fine.  Let me start off by begging the
same question that was begged this morning in discussing
articulation of guidelines concerning retrospective moral
judgment.

          Namely, that if you took out the words in this memo
dealing with radiation, it could probably be a blueprint for a
compensation plan involving Agent Orange, Dalkon  Shield, breast
implants, leaking pipe in your basement.

          It could be any number of mass disasters or disasters
involving wrongs or wrongdoing done to individuals.

          So, this first draft of a remedies chapter, it seems to
me, especially in light of the conversation this morning, is
valuable only in the sense that it lays out a general blueprint
that might guide policy makers, Congress, the Executive Branch in
deciding whether to provide some sort of remedy to wronged
individuals.

          And if some sort of remedy is appropriate, what remedy
grounded in what prerequisites?  In other words, this chapter as
drafted says that if people were wronged and if the Government
was either culpable or even if it wasn't culpable, we may want to
just impose a strict liability standard if a person was wronged.

          And that's it.  Here are some potential remedies that
might be appropriate.  But we, I think, wisely leave it to others
to decide whether specific remedies should be made available in
specific cases.

          Now the chapter lays out a series of nine guidelines
which are each general and, again, designed to offer help to
those who have to decide whether to fashion a remedy in a
particular case.

          The guidelines range all the way from where
circumscribed by our charter as to what we can consider, even
consider.  The charter speaks for itself.

          And the guidelines then discuss general principles
without reference to specific situations.  Thank goodness in
light of this morning's discussion.  For example, guideline 1
deals with the charter.

          Guideline 2 lays out a series of potential remedies if
there are individuals who the Congress or the Executive Branch
concludes should be subject to such remedies.  Cash, official
apology, medical monitoring, health insurance, medical
evaluation.

          It lays out a series of remedies.  Guideline 3 is a
very important guideline in light of our discussion this morning. 
The guideline says that remedial measures must, not may, must be
based on considerations of Government culpability and harm.

          And also an important second paragraph points out, "Oh,
yes.  There is also the issue of causation."  Did the Government
culpability cause the harm?  Adding in an important parentheses
that may be presumptuously established as a possibility.

          But guideline number 3 begs much of what we talked
about this morning.  Guideline 4 is very important.  Because
guideline 4 says this.  It's Henry's point.

          There is culpability and there is culpability. 
Culpability may go all the way from a knowing, willful violation
of an ethical standard all the way to the other end of the chain
which is there is no culpability.

          A point that Ruth, at least, discussed this morning. 
There is no culpability.  So what?  There's harm, and the person
ought to be compensated, ought to have a remedy.

          So, guideline 4, as you can see, spells out in some
detail variations of culpability, mental state of the Government
actor ranging from a knowing, willful violation all the way to,
to recite Pat's point, "I did nothing wrong at all."

          And to the extent that somebody's been harmed, not even
accidents, to the extent that somebody is harmed, people get
harmed everyday in various forms of life, that doesn't mean the
Government's responsible.

          And that's just a discussion of a guideline, guideline
4.  Guideline 5 is at the other end of the equation.  Not talking
about the Government's culpability, but the degree of harm to the
individual.

          The Government may be very culpable and nothing
happened to the individual.  There was no harm.  The whole effort
was aborted or short-circuited, all the way to a person dies.

          Now guideline 5, I find interesting in light of the
discussion this morning because I'm not sure we've got facts in
guidelines 4 and 5.  This is why I made the point this morning
that demonstrates this type of micromanagement of Government
culpability.

          Or for that matter, I'll be intrigued.  The harm is
there.  I'm interested in how much evidence there is, for
example, deaths caused by Government wrongdoing.

          But that's again a guideline that would not only guide
the committee in discussion, but guide policy makers.  Guideline
6 is the causation issue, particularly in mass exposure cases.

          It's the old problem that the Congress has tried to
deal with, and the courts deal with every day.  In a situation
involving a mass exposure, how do you decide which people are
harmed by that exposure, as opposed to "They would have been
harmed anyway?"

          Epidemiological questions about increased incidents of
disease or injury caused by exposure.  There are some
interesting, innovative ways to deal with that problem.

          The Congress has dealt with it in the form of
presumptions.  If a person is located "x" yards or "x" feet or
"x" miles from the detonation site, we'll presume that person was
injured.

          If that person has an injury, we'll presume it was
caused by the exposure.  And then there are some others.  When I
gave a presentation a few months ago talking about proportionate
recovery based on increased incidents of harm, there are other
ways to deal with the problem.

          But guideline 6, I think, articulates a concern that
the Congress and the Executive Branch have tried to address
repeatedly in the last dozen or 15 years.

          There's nothing new about guideline 6.  It articulates
a problem.  Guideline 7 is very controversial.  Guideline 7 says
there's one Government.  One Government.

          And if an agent, a researcher, somebody contracting
with the Government does the harm, it causes the harm, and is the
culpable party, it's the Government.

          Although the guideline is printed in terms of "may"
affect, if you read the annotation, it sort of implies that
there's one Government.  And if a researcher does something
"wrong," the Government is culpable.

          That's a very provocative point of view that bears, I
think, some discussion on the part of the committee.  Guideline 8
says that, for the most part, injuries occur to the victim him or
herself.

          Not to their family.  Not to relatives.  But
particularly dignitary injuries, absence of consent, failure to
have informed consent, those are really injuries that are limited
to the victim and do not pass onto spouses, relatives, the
estate, etc.

          The guideline points out there may be situations where
an injury resulted in lost earnings, or other impact on the
estate of a target or of a subject.

          That may be different.  But for the most part, and this
is important as a practical matter, to the extent that we have
evidence of injuries done many decades ago to individuals long
since deceased, the guideline certainly states that there is no
remedy.

          Or the remedies are sharply curtailed as to what should
be available to relatives or descendants.

          Guideline 9 was added, and it was Phil's point at the
last meeting, the importance of making sure that any evaluation
of claims, if there are any, any evaluation of potential remedies
being made available to individuals be done in a way that ensures
a perception and a reality of fairness, lack of bias, efficiency.

          So that any substantive decision made by policy makers
as to remedies be supported by a process that implements those
remedies in a fair and equitable way that sends a perception to
the general population that the claims are being evaluated
appropriately.

          Finally, the memo talks about a culpability harm grid. 
It lays out the obvious visually which is the general sense of
the memo that, as the culpability of the Government increases and
the degree of harm increases, the remedy, the effectiveness and
the persuasiveness of the remedy increases.

          And as the culpability of the Government is reduced,
and as the harms suffered by the victim is relatively minimal,
then whatever remedy is available should be less.

          There's nothing magical about that.  What's magical
about the visual guide and the grid is where you place the harms
and the culpability on the grid.  It's a self-fulfilling
prophecy.

          If you decide that a failure to obtain adequate
informed consent, you'll notice on the grid is less, is a
relatively less harm than death.  Then implied in the grid is
that when you fill in those boxes as to what the remedy's going
to be, the remedy will be less.

          At some point, I'm not sure that's our business.  That
is the business of those who are going to decide whether and to
what extent a remedy should be made available.

          And the last grid, again, is I think very self-evident. 
It is a causation grid that says, "Look, especially as to mass
exposures, you've got to decide at what minimal level of exposure
does one trigger the remedy?"

          Does somebody living 500 miles from a mass exposure who
now claims lung cancer, is that person entitled a remedy?

          Or has he or she gone below the de minimus line from
which, epidemiologically, one concludes that there should be some
increased risk, some increased incidence, and therefore, some
remedy?

          I think that last chart really has applicability as a
practical matter only to mass exposure cases.  But Duncan may say
otherwise.

          In any event, that's just a summary of the remedies, a
first draft of the remedies chapter.  I think that it is a
helpful first draft but obviously begs many of the questions
discussed this morning.

          And that's why I think probably the discussion of this
morning followed by this discussion sort of, in a sense, closes
the circle as to what the practical impact of this morning's
discussion is.

          For example, if you conclude this morning, that one
cannot provide sufficient detail to hold individuals culpable,
then the culpability quotient for a remedy begins to totter.

          That leads to two alternatives.  One, even if you can't
find individuals, after the fact, culpable, is an agency
culpable?  The point that Phil made this morning.

          That's one solution, culpability of an agency as being
knowing or reckless or negligent.  Put strict liability aside. 
So, I guess just to use a simple example, one has to decide how
important is the guideline talking about culpability?

          That leads to a second possibility raised by Ruth for
discussion.  Strict liability.  Forget culpability.  Forget it
completely.

          Was the person harmed?  And if the person was harmed,
here are the variations or relative degrees of harm.  And maybe
the Government is liable in the sense of maybe the Government
should provide a remedy.

          These are all decisions, choices that the committee may
have to make.  Or the committee may lay out a general remedies
primer and leave to others the decision as to whether and to what
extent certain remedies should be available.

          But this sort of, I think, sets the stage for a
discussion of interweaving the discussion this morning with a
remedies discussion now.

          CHAIRPERSON FADEN:  Thank you, Ken.  That's a good way
to start, and we appreciate it.  And I appreciate your linking it
to the discussion this morning so we can keep things going.  I
see Duncan.  We'll just start the discussion there.  Pat, if you
want to join in.

          Let me just get some hands.  I was looking to Duncan
and Pat first.  There's other members of the subcommittee.  Maybe
we should do that real quickly.  And then let everybody else pull
in.  Duncan?

          DR. THOMAS:  Forgive me if I begin by treading on some
of the issues that we're going to come back to when we talk about
the linkage this afternoon.

          But it's already been raised.  I was listening to the
discussion this morning with growing unease as we started doing a
lot of wringing our hands about the evidentiary basis by which we
would make moral judgments.

          And the increasing concern that I too share, don't get
me wrong, that there may be no situation in which we're prepared
to judge any individual as being culpable.

          I heard things stated like it's all a gray area. 
Particularly with regard to informed consent that we never have
perfect informed consent.

          And drawing the guideline between what is acceptable
consent is something people have been trying to define for many
years now without a great deal of success, exactly pinning down
where that line ought to be drawn.

          And I agree completely that it may be very difficult in
many instances to decide whether or not a particular instance is
above or below that line.

          On the other hand, I still come into this with the
feeling that there are, nevertheless, instances that we've come
across where it will be possible to say that wrongs clearly were
committed and whether we're actually able to define the line or
not.

          It's one of these situations where we'll know it when
we see it.  I have to admit that every time one tries looking for
examples, you always find these gray area problems.

          But one which I still have great difficulty dealing
with in terms of the informed consent question is the plutonium
injections.

          The mere fact that investigators were not allowed to
reveal to the patients the substance with which they were being
injected, it seems to me a prima facie case for the fact that
there could not possibly have been informed consent in this
circumstance.

          And then we have the various other supporting pieces of
information like some of the quotes that Ruth read to us.  Now, I
too have been wringing my hands over this question of evidentiary
basis.

          We are not a court of law.  And there are few
protections in place for the individual investigators here.  We
don't really hear evidence.

          And nobody's under oath and so on.  So, my take on this
is that it's not our job, nor is it necessary for us to actually
pass judgment against individuals.

          But that shouldn't shy us away from trying to set up
the procedures or at least recommend to the Government the
procedures which it should use in order to investigate the
question of, "Is anybody, in fact, culpable?" using all the
proper legal safeguards for answering those questions.

          In other words, we may come back later and say, "Yes
indeed, we clearly believe that harm was done, and you ought to
try to decide whether Mr. "X" or Dr. "X" is a responsible,
culpable player in this."

          We're not actually, in so doing, saying that he's the
bad guy.  But we're going to make a recommendation that whether
or not the evidence in this particular class of experiments is
sufficiently compelling that the Government should entertain the
idea of pursuing some sort of sanctions.

          I'm sure there will be much more to say about this
question.  But let me move onto a few other points.

          Sort of a corollary to that one is what I see as a
certain level of passing the buck the Government.  And it comes
in this guideline 7 where we talk about the Government as sort of
a unitary agency and these concerns about strict liability that
perhaps the Government ought simply to indemnify all of the
various investigators in some sort of no-fault insurance plan.

          Now actually I think that might be a very good idea. 
But I'm not sure that that should preclude us again from making
recommendations that, in some circumstances, we ought to consider
passing moral judgment against the investigators.

          So, that was point two.  The third point is a very
brief one responding to Ken's comments on the causality
criterion.

          He presented that as if this were something which is
really only applicable in the mass exposure situations.  And I
don't see that at all.

          The issues are exactly the same, as I see it, in either
case.  The only difference is that, in some circumstances, for
some mass exposures one may have epidemiologic data relating
specifically to that exposed population.

          But that's just one piece of data which you're going to
put in the hopper together with all of the rest of the world
literature that is relevant to that particular situation.

          In any event, one has to pass judgment both at, what
I'm calling, the population level and at the individual level as
to whether a particular exposure outcome association represents a
causal event.

          If any of the biomedical individual patients were to
come back to us alleging, I don't know, a hangnail or case of
diabetes, heart attack, whatever, things that for which there's
really precious little, if no scientific evidence that there's
any causal relationship between them, we should exclude this case
out of hand.

          That's what I'm talking about at the population level. 
In other words, is there any evidence that this exposure could
cause this outcome in general.

          And then one moves on, if you pass that first hurdle,
to considering, "Well, now let's consider the specifics of this
particular case.

          Is it likely that a causal connection could be
established in this case?"  I'm a firm believer that the
presumptions that are talked about in this guideline is a good
way of dealing with it.

          But I just wanted to point out that that doesn't enable
you to weasel out of the causality issue completely.  You have to
address causality in coming up with those presumptions in the
first place.

          And I think Ken acknowledged that point.  And I think
that'll do for now.

          CHAIRPERSON FADEN:  Pat, did you want to add something?

          MS. KING:  My own inclination, as Ken and Duncan both
know, is that this chapter is less important than the chapter
that we were discussing previously because it sort of sets the
direction for this one.

          So, I only point to one thing about this chapter that
the committee might think about, but we don't need to focus on. 
And that is, in guideline 4, which deals with culpability about
the scale of culpability, that the terminology there comes from
the criminal code not from civil compensation.

          I think that needs to be explored if we get down to
that about why we should go there, whether than from civil
liability terms.  That's one question.

          But the other is, to the extent that they depart from
common usage, I raise the question of, "Does it cause unnecessary
confusion?"  Because the terms are terms that not only are legal
in nature, although more broadly used in the population, I would
like to see reasons for defining them differently.

          Because I think this creates confusion rather than
clarity.

          MR. FEINBERG:  Welcome to the subcommittee.

          CHAIRPERSON FADEN:  I don't know if I'm formally a
member of the subcommittee or not.

          MR. FEINBERG:  Yes.

          CHAIRPERSON FADEN:  I am?  Okay.  Just to clarify one
point and then we'll open it up.  Two points actually.  One is on
this matter of guideline 8 in terms of implications where there
are no survivors.

          I just wanted to clarify.  I'm not sure I understood or
heard Ken on this point.  Certainly the matter of apologies, it
would seem to me, would apply to surviving family members if
there are no survivors.

          That's what it says.  It says so in the text.  But it
may be unclear from a cursory look of the document.  And
certainly we also have a discussion in there.

          And again, this is just for proposal.  All of this
stuff is just for proposal, for debate and discussion.  The
committee wanted something to chew into.

          It also in there points out that, if people were
blocked from seeking redress during their lifetime because
information had been kept from them, that too would change, in my
view, the implications for what family members might be able to
do.

          Those kinds of subtle problems, I think, bear
discussion.  But I'm really stuck on this.  In my own mind, a
kind of chick/egg question on the last point or one of the points
Pat made about which of these two discussions is more important.

          I think for advancing the whole package, and I really
do see it as a whole package, we do need to have some sort of
discussion, airing about how critical judgments about culpability
are to establishing remedy schemes.

          What is lost by going to something like a strict
liability account?  If anything, does it matter?  Just sort of
what hangs here as a practical matter.  What hangs?

          What's at stake, if we were to drop judgments about
culpability out of the schema?  What implications would they
have, if any, for how we might make recommendations for
guidelines about remedies?

          I don't mean we have to start with that discussion. 
But I think that it's all kind of a piece because it's possible
that at least some of our positions with respect to willingness
to make judgments about culpability may be a function of the
consequences of failing to make judgments about culpability with
respect to remedies if indeed there can be no decoupling.

          So, to me it's kind of a rolling ball.  And I'm not
sure how to break it apart.  But having said that, there were at
least a few hands.  Henry I think I saw.  Henry, Ruth.  And I'm
just starting to collect.

          DR. ROYAL:  One point is the burden-of-proof fairness
issue.  It seemed to me when I listened to victims testify before
the committee, one of the big issues is who's going to have that
burden of proof?

          And I'm very confused about burden of proof and how
burden of proof would fit into our suggested remedies.

          I was struck a long time ago, when Ken addressed the
committee, about the advantages and disadvantages of a lenient
system for compensation versus a more strict system for
compensation.

          If you have a lenient system for compensation, you
actually end up compensating many people who were not harmed.

          And because you have a lenient compensation system, you
end up compensating everyone at a lower level than you would if
you had a more strict compensation system.

          So, that whole issue of burden of proof and how
compensation should be divided I think needs further exploration.

          The other fairness issue is not only how the
compensation is divided among injured parties, but also whether
or not this scheme is supposed to be applied to all medical
experimentation and whether or not the committee is going to
recommend that not only people who fit somewhere on this grid due
to radiation experiments, but also people who were fit into this
grid somewhere because of non-radiation experiments.

          And I guess conceptually or ethically or whatever, I
don't understand why we would exclude other people in our
recommendation.  So, that's one point.

          The second point is in terms of where the fear of
latent disease is listed along the harms access.  It's listed as
being equal to having an acute illness that you recover from.

          And it's very unclear to me that that's where it should
fit along that access.  The third thing is you mentioned that
someone working for the Government, that the Government was then
liable for their actions.

          And yet, we have this whole policy of sovereign
immunity.  And I guess I would like to know more about where
sovereign immunity came from.  Why is it that the Government
isn't responsible for any of the bad things that happen?

          So, I need to be educated about sovereign immunity. 
And the last point that I'd like to make is turning over the
actual remedies to Congress.

          I'm troubled with that as a recommendation because I
think that Congress understandably makes political decisions as
opposed to ethical and moral decisions.

          Not that they would ever be different.  So, I'm
troubled by the recommendation that Congress would recommend
remedies.

          CHAIRPERSON FADEN:  This is a very, very interesting
morning.

          DR. MACKLIN:  I guess I wanted to ask Ken about his
presentation.  My question is a version of what Ruth Faden began
by asking.

          Guideline 3, "That remedial measures must be made based
on an analysis of the Government's culpability and the nature of
the harm to the individual."

          Now, I guess I'm questioning the following.  Let's go
to the grid.  Suppose what we have is a fairly well-documented
instance of one of those harms along the grid?

          Let's for the sake of argument here put it in the
middle, fear of latent disease or acute side effects with full
recovery.  Acute side effects with full recovery is easier to
document than fear.

          We have testimonies for fear.  But let's say we have
acute side effects with full recovery or long-term or permanent
disease or disability as a result.

          So, we have a demonstrable harm that can be documented
by data that we have.  And yet, in light of what we discussed
this morning, what we lack is the kind of data or evidence that
would enable us to assign to particular individuals culpability.

          What follows from this, given guideline 3?  In other
words, guideline 3 almost makes it sound as if, "Well, sorry.  No
remedies."

          And yet, since we have one element on the grid that may
be established, we have only an inference that there is
culpability on the part of some particular agent or agents,
although we don't know who those are.

          Do we automatically then say that the Government was
culpable?  I don't mean that.  What I mean is does it follow that
the only way of addressing it is with regard to strict liability?

          MR. FEINBERG:  No.  As Phil said, that's not the case. 
It's easy to answer your question.  I have three answers to your
question.

          One.  It doesn't matter whether there's any evidence of
liability or not because we're going to say that if you're
harmed, it doesn't matter.  Strict liability.  There's injury and
you ought to have a remedy.  That's one answer.

          Answer number two.  Well, we can't find culpability as
to individuals.  But using the slippery slope argument, the
Defense Department was culpable.

          If you look at Jay's telling of the story, the bottom
line is that, without reference to any individuals, the Defense
Department was culpable.  That means the Government was culpable. 
And they were either negligent or reckless.  And that's enough. 
So, there's a remedy.

          Option number three.  Well, whether you say that
there's strict liability or whether there's some culpability,
what's the remedy?  Beg the question altogether.

          You can say, "Look.  If you can't find any culpability
on the part of the Government, but there's a demonstrable harm,
send the person or the estate a letter of apology at least."

          I mean there are remedies and there are remedies.  And
one should not fall into the trap of assuming, as Allen -- It
wasn't a trap.  Allen's too smart for that.

          But Allen talked this morning about interchanging
remedy with compensation, which I think is a dangerous game.  I
think compensation is very, very inappropriate and loose to talk
about remedies being a euphemism for compensation.

          I don't think that necessarily follows.  So, my third
response to you is, "All right.  Forget the whole culpability
problem or even if it's the DOD instead of individuals.

          There is still some remedy that might be applied by
Congress in the way of an official letter of apology." for
example.

          Four.  Again begging the question.  Forget this whole
discussion of remedies for past wrongs in the absence of any
culpability, and let's focus on prospective guidelines using the
story as a sorry example of what went before.

          And let's focus our attention on prospective guidelines
that make sure it doesn't happen again.  And if it does, there
will be censure.  There will be all sorts of appropriate
remedies.

          So, those are judgment calls I think we have to make. 
We can go in any direction we want along those lines.  And the
question is, "What is the sense of the committee?"

          CHAIRPERSON FADEN:  Ruth?

          DR. MACKLIN:  One quick follow up.  I don't remember
which one you were counting.  It was the middle one before you
got to four.  I thought there were going to be three.  But you
added four.

          MR. FEINBERG:  What is the remedy?

          DR. MACKLIN:  No.  This is point about when you
referred to Phil's observation that the Government can be
culpable even if one cannot find the individuals in the chain of
command or whatever who performed those actions.

          Now, in the case of contractors, in the case where the
Government simply contracted out, gave the money, the people who
got the money were individual doctors at different universities
as we've seen.

          Is that the same relationship between the individual
actors, when we may not have the evidence to assign culpability,
and the Government as it would be if we're talking about going
down the chain of command in the Defense Department?

          MR. FEINBERG:  Legally, clear not.

          DR. MACKLIN:  Then what are we talking about?

          MR. FEINBERG:  There's a difference.

          DR. MACKLIN:  Ethically?

          MR. FEINBERG:  Well, not even ethically.  Practically. 
One may conclude that, if there was a wrong done, a harm done to
an individual subject by an independent contractor, one can
conclude, if one wants to conclude, that not withstanding the
absence of any legal liability on the part of the Government, if
the independent contractor is acting beyond the scope of his
authority, or retrospectively wasn't even doing anything wrong,
one can conclude, if one wants to as a policy maker, that the
Government will indemnify as between the injured victim and the
contractor and the Government.

          We want to make sure that the injured victim gets a
remedy.  So one can make a policy judgment that Government
sovereign immunity not withstanding, there's one Government as
vis-a-vis the victim.

          And we want the victim to receive some remedy.  That
again is a policy choice that Congress makes all the time.

          All the time, Congress concludes and the Federal
Government concludes that in certain high-risk ventures, although
the Government has sovereign immunity and cannot be prosecuted,
we will, nevertheless, stand in the shoes of the independent
contractor and indemnify the contractor for any wrongs that the
contractor inflicts on innocent third parties.

          It happens.  The Government doesn't admit liability. 
But the Government says, "We want to make sure that independent
contractors continue to perform a valuable public service."

          And the only way they're willing to do it is by knowing
that they're immunized from liability by the Government standing
in the shoes of the contractor.

          Again, how far we want to get into that, and how far we
want to recommend or suggest to policy makers that independent
contractors are the Government as opposed to independent
contractors, for purposes of providing remedies, there's a policy
choice.

          CHAIRPERSON FADEN:  Can I ask for just a clarification,
Ken, on your four points?  I don't know whatever number they are.

          MR. FEINBERG:  A lawyer's trick.

          CHAIRPERSON FADEN:  In terms of options that the
committee could consider, if the committee were to put aside or
choose not to go to questions making judgments about culpability
with respect to individual human agents which we may still choose
to do, the issue is what would be the implications for a remedy
scheme?

          So, if I'm hearing you right, and other people please
chime in if you heard something else again.  One fall back
position for the committee -- Maybe I shouldn't use fall back.

          One alternative open to the committee is to adopt a
strict liability mode and say, "Look.  We're just going to hold
the Government liable without delving into questions about
culpability when the following general facts apply." whatever
those general facts are.

          And then our remedies guidelines would focus entirely
on some notion of harms and wrongs.  However that would be set
up.

          Probably, on the wrong side, with respect to reference
to contemporary moral standards or something of that sort.  So,
there's the strict liability approach.

          The other approach would be to go to questions of
Government culpability to try to make that argument.  That we can
somehow assess degree of Government culpability, finessing
questions about the individual human actors who actually stand
between an action and the Government since a corporate entity
doesn't do stuff.  But we would finesse it in some fashion.

          The third one was the one I was a little confused
about.  Are you suggesting that one option would be to say,
"Look.  Since we can't draw inferences about culpability, we will
not have a very elaborate remedy scheme?"

          Either the kinds of remedies offered or the
sophistication with which we examine the question of remedies
would be reduced?  Is that the third option?

          MR. FEINBERG:  That's right.

          CHAIRPERSON FADEN:  Okay.  And then the fourth one
would be forget retrospective remedies altogether and just go
prospective?

          MR. FEINBERG:  Right.

          CHAIRPERSON FADEN:  So, those are four ways of
conceptualizing how we might structure things should we determine
we don't or can't make meaningful judgments about the moral
culpability of individual human agents.  Ruth?

          DR. MACKLIN:  Well, it just seems to me bizarre that we
might agree with Jay's formulation that terrible things were
done.

          And somehow or other, at the same time say, "But, since
we don't have the facts to ascribe culpability or assign
culpability, there's little we can do retrospectively.  It's only
prospectively."

          That just seems bizarre.  If terrible things were done,
regardless.  I want to hear what Jay says.  I feel those were the
words you used.

          DR. KATZ:  I agree with you.

          DR. MACKLIN:  Yes.  But we can't just settle for it and
say, "Well, that's our conclusion."  It's bizarre.  "Terrible
things were done" is a judgment, a moral judgment, an appraisal.

          Now we have to figure out, in light of the fact that
terrible things were done, what if any remedies are appropriate
given what might be likely?  Namely, the difficulty of having the
adequate information to be able to ascribe specific culpable acts
to individuals.

          CHAIRPERSON FADEN:  Henry?

          DR. ROYAL:  The difficulty I have is the distinction
between terrible things and wrongs.  And we've heard from
different people around the table describe that the decision
should be made that we identify whether terrible things were
done.

          And then we've heard other people say to decide whether
wrongs were done.  And in my own mind, they're two very different
things.

          And I personally agree with you that, if terrible
things were done, that we should try to find out who is
responsible for those terrible things.

          CHAIRPERSON FADEN:  Henry, could I just ask you real
quickly?  Is a terrible thing a terrible wrong as opposed to any
kind of wrong?  Or is it a qualitatively different thing?

          DR. ROYAL:  That's the question I'm asking.  I hear
people talking around the table about terrible wrongs and wrongs. 
And I don't know if they're supposed to be synonymous.  And if
they're different, how they're different.

          DR. MACKLIN:  Well, let me just give an example.  We'll
never be able to do this by definition.  But we can do it by
example.

          Injecting plutonium into people without their knowledge
or oral consent, forget informed consent, is a terrible thing. 
Failure to get written consent, but getting oral consent from
people, permission to do something, is by today's standard a
procedural wrong.

          But it's neither a terrible thing nor an egregious
wrong.  Failing to get oral consent, but telling people what
you're going to do or taking people who are in a position of
vulnerability, even if they know what's being done, there's
little they could do to refuse, as we heard from some testimony,
is a pretty bad wrong.

          Because they don't have the opportunity.  But not as
terrible as the other.  Maybe it's intuitive, but it's a way of
trying to get -- I mean you asked before.

          And it was a very good question when Allen Buchanan was
here.  Is there a hierarchy of wrongs and things?  And terrible
wrongs, we should ask Jay since he used the word, terrible things
were done.  A terrible thing would be harm and wrong.

          DR. ROYAL:  I agree with your characterization of the
plutonium experiments that they could be a terrible wrong if in
fact people were injected and were not told what was happening to
them, and if they did not consent to the procedure.

          I agree with you that that would be a terrible wrong. 
My difficulty is knowing what really happened and knowing whether
or not it fits into the terribly wrong category, the wrong
category, or not.

          CHAIRPERSON FADEN:  Let me just suggest that that's
very important obviously.  And what I'm kind of playing with,
hoping, is that we get as far as we can today and tomorrow with
this discussion.

          And the grand plan was, in January, we would go back to
visit case examples with some sort of schema in mind and see what
we've got.  So, there's a strategy.  Now maybe that strategy was
misguided.  Maybe we should have started with the case materials
again.

          But the results of the issue of the documents keep
coming in.  So, that was the reasoning.  That if we could agree
about the terrible wrong formula, that would be something.

          It's a tentative try-on.  And then we test it against
some cases and see, "Now, we've got a framework that we're trying
on for purposes of seeing if we can live with it against the
documents we have about particular cases."  Something like that.

          DR. ROYAL:  It's my bias that I think that we probably
would agree on what's terribly wrong, definitions of what's
terribly wrong.  But maybe the difficulty has to do with the fact
that the evidence is incomplete.

          And it has to do with how much evidence each of us
would require in order to feel comfortable categorizing a
particular experiment in one of those categories.

          So, I'm not so sure that there's that much disagreement
about what's terribly wrong.  Although it would be nice to give
some hypothetical examples.

          We use plutonium.  And plutonium is that wonderful
word.  It's enough to just say to inject someone with something
and not tell them what it is and what's going to happen.

          DR. MACKLIN:  There might have to be some possibility
of harm.  I don't know if it was normal saline if we'd say that
was a terrible wrong.  It might be a bad thing.

          But Henry, I'm always mindful of the question you
raised at the very first meeting we had which is, "What if we
don't agree?"  Now I think we go a long way towards agreement, if
as a committee and individuals, we agree on the scale, given
hypothetical examples.

          Actually, I would use the word instead of
"hypothetical" because some of them may have been real,
"paradigms."  Paradigm cases.  What would be a paradigm of a
terrible wrong?

          What would be a paradigm of a moderate wrong?  And
where would we say that someone may have been wronged minimally
or wronged by today's standards?

          So, we go a long way if we would fit the same paradigms
into that intuitive moral appraisal scale.  The second thing, I
think, if we agree, and we haven't tested this yet, that it is
meaningful and legitimate to make retrospective moral judgments.

          That was a question that was being raised at the
outset.  And I think we've come a long way at least to coming to
some view that it is meaningful.

          And the thing that you keep emphasizing, and I entirely
agree, is, if we don't know the facts, we can't make these
judgments, or we can't make them accurately, or we can't make
them sufficiently.

          And I think as a committee dealing with ethical
judgments, if we can agree on the moral matters, namely, the
criteria for making judgments and the meaningfulness and
appropriateness of retrospective moral judgment, then we're
basically agreeing.

          And then there's that final step, how willing one might
be in the absence of additional evidence.  That is, what is our
threshold for the amount of evidence needed?  And I think that's
the hardest part of doing this applied ethics.

          CHAIRPERSON FADEN:  We've got Ken and Jay.

          MR. FEINBERG:  I just want to reemphasize one point in
light of Ruth's comments.  I made it before, but I think it's
important.

          We shouldn't get too hung up on Henry's legitimate
point about the absence of evidence or gaps in the data.  And
that's because I think that we have to ultimately acknowledge the
fact that there should be some remedy for people who clearly,
demonstrably were wronged.

          My solution to that problem, I think, taking Henry's
statement as valid and credible based on what I've heard the last
few months, is that there are remedies and there are remedies.

          It may be that we should think long and hard about
Eli's point that most of our attention should be drawn
prospectively on where we're going now.  And in terms of past
wrongs with gaps concerning culpability, there were wrongs.

          It's the story.  And maybe these people, now most of
them long since deceased, should receive a letter of apology from
the United States saying that wrongs were done.

          But I don't think it necessarily follows that we should
spend an inordinate amount of time trying to reconstruct a
factual basis for finding culpability unless the committee
decides we want people paid.

          We want them to have free life insurance.  We want them
to have free medical monitoring.  When you get into those items
on a remedies' scale, not only does it divert attention from a
prospective discussion of where we go from here, those are highly
provocative issues which, it seems to me, you have to then get
further and further.

          And it's a scale.  It's a slippery slope.  The more the
remedy in terms of monetary value or compensatory value, the more
it seems you address some of these black hole issues governing
culpability.

          And the less you can avoid that with a prospective
discussion, the story that Jay says, some type of official
apology may make it easier for us to move onto a further
discussion.

          I just throw that out as a political solution.  I'm not
saying everybody buys into it.  I'm just throwing it out for
further discussion.

          CHAIRPERSON FADEN:  Jay?

          DR. KATZ:  Well, I'm getting more and more confused. 
For example, Ruth, I don't think, speaking for myself, I haven't
yet agreed to the proposition that it's all right to make
retrospective moral judgment.

          And I don't think we're really there yet.  Before
making some very general comment about how we might proceed, let
me just say if one wants to, we've been talking so much about the
plutonium experiments, I wouldn't want to, for different reasons,
make the argument.

          But I can make the argument that's been made in other
contexts by responsible physician investigators that it would
have been the most cruel and unprofessional thing to do, to
inform these patient subjects that plutonium was injected.

          Because they didn't really know what this entailed, but
couldn't explain it to them.  For a long period of time, they
would go around with the idea that metal is now roaming through
their bodies.

          And the best thing to do is, for the physician
investigator, to assume the heavy burden of being the guarantor
of the patient subject's health.  And that is the ethical thing
to do, very much in line with the Hippocratic tradition of
medicine.

          So, I merely mention this, whether we can even
establish paradigms.  And really paradigms, I have questions
about.  But it's a direction which to go.

          I think, and probably this can't be done until the next
meeting, we've got to get away from some of the specifics.

          For example, does it make much sense at this point to
spend time on having a discussion on what criteria should apply
for judgments of culpability when we haven't yet discussed how
far we want to go and in what way would we want to talk about the
issue of culpability?

          CHAIRPERSON FADEN:  But that's what we're talking about
now, Jay.

          DR. KATZ:  Yes.  But we're often getting into
specifics.  And I don't get the sense, at least I haven't got the
sense, what are really the basic fundamental questions that for
awhile we are talking about?

          We're very quickly getting into specifics and have
discussions on specifics.  What is consent?  What is informed
consent?  What is the basic question that is before us now?

          What will be the basic question before us in the
afternoon?  At least for me, I'm now lost.  All the specific
things on remedies.  All the things which have been clearly
enunciated to us.

          Like, for example, guideline 3.  What about the
culpability issue?  Must it be based on culpability?

          CHAIRPERSON FADEN:  Well, that's the question I asked
when we started this.  That's one of the questions before us now.

          Do we have to have a structure that links
recommendations with respect to remedies to assessments about
culpability?  And we've been having a discussion on that point.

          DR. KATZ:  But then shouldn't we just table it for a
moment?  Must we talk about the culpability issue first?  How we
think about it, or not?

          CHAIRPERSON FADEN:  Could I ask one question, Jay?  I'm
confused about your response to Ruth.  And then I'll let the
floor open.  Because I'm real confused.

          Let me see if I get this right.  I heard you say that
you have not yet agreed that you believe it's meaningful to make
retrospective moral judgments.  Is that correct?

          DR. KATZ:  Yes.

          CHAIRPERSON FADEN:  You've also said that you believe
that terrible things happened.

          DR. KATZ:  Yes.

          CHAIRPERSON FADEN:  Is that not a judgment?

          DR. KATZ:  You know, I'd like sometimes -- Yes and no.

          CHAIRPERSON FADEN:  Could you explain it to me?  I just
want to know how you can hold both those things?  I'm trying to
figure it out.

          DR. KATZ:  That's a nuanced kind of way.  We are not
really going to address culpability kind of issues.  But we will
somehow draft a story.  In which to our satisfactions, it will
emerge.

          What has happened?  That terrible things did happen. 
And also put it in the context of what the climate of human
experimentation was.

          CHAIRPERSON FADEN:  I have no trouble with that.  But I
don't see how that doesn't constitute a characterization.  If a
terrible thing happened, and you are willing to say that
something terrible happened in the past, you are making a
judgment about the past.

          If you put it out as a narrative, or you make it
conclusion one, or you tell the story, and it's laid out before
you, I guess I just don't understand the difference.

          DR. KATZ:  Well, I would make it then, probably in a
very general kind of way, that maybe somebody eventually wants to
use, for purposes of establishing degrees of culpability, but we
wouldn't get into at all any kind of judgments about degrees of
culpability.

          CHAIRPERSON FADEN:  So, that's a position I can
appreciate.  That we would make a judgment.  We would fashion it
either by telling a story or judgments A, B, C.

          I'm not interested in that at the moment.  But we would
be willing to say we would be committed.  And I think that was
the force of Ruth's summary, that we would be willing, together,
to agree that a terrible thing happened if we all agreed a
terrible thing happened.

          That is to say if we all thought to use the paradigm
case if we all thought that somebody had been injected with
something without their knowledge.

          And we said that was a terrible thing.  That we would
be all agreeing that retrospectively we're saying, "Looking at
the past, a terrible thing happened in the past."

          But then you want to stop there and not go to any
analysis of degree of culpability for that terrible thing that
happened.

          DR. KATZ:  Yes.

          CHAIRPERSON FADEN:  Are we all agreed about the
willingness to call something a terrible thing if we all agree a
terrible thing happened?

          It sounds so inane to me.  But I just want to make
sure.

          MS. KING:  I'm genuinely puzzled.  If we know that a
current standard says that you have to inform a subject of the
substance of what is being injected and that is a benchmark of
current research ethics, and we look in the past.

          And we find an injection given to a subject without
telling the subject what was in the injection.  And Ruth would
add, I think, that the substance was potentially harmful.

          To now, we've done two things.  We've said, "What is a
current standard?"  And we've looked at the past, and we've said
we find an example 50 years ago where somebody or some group did
not adhere to a currently articulated standard.  Some of us say,
"So what?"

          CHAIRPERSON FADEN:  Are you willing to say that's a
terrible thing?

          MS. KING:  But why am I saying it is a terrible thing? 
What am I saying when I say it is a terrible thing?  It is a
terrible thing by today's standard.

          If it happened today, I would compensate somebody.  If
it happened today, I would do perhaps lots of things.  It
happened 50 years ago.

          I don't know what the current standards were 50 years
ago.  I know a bit about what the current standards were 50 years
ago.  Or I have some evidence of what the current standards were
50 years ago.

          I think what's bugging me is I don't mind saying we do
things differently today than we did 50 years ago.  And then my
next question is, "Why is that such an important thing to say?"

          And that's not the answer that I'm hearing.  Because I
can only go back to what I heard this morning.

          The reason that I would want to say, it's important to
say that, is because I want to make it clear that the standard I
have articulated as the current standard is the one that I want
to see carried prospectively until something else comes along
that perhaps will change a current standard.

          But if that is all we're doing, then instead of getting
agreement about retrospective judgments, what we probably should
be getting agreement about is, "What are the current standards?"

          So, the discussion seems out of sync.  I mean, when we
keep pushing this judgment about what went on in the past, we
keep saying, "For what?  For what?"

          If it's not for the future, one possible "for what" is
a linkage with remedies for people who actually carried away from
those things, for injuries.

          Now if we do that, we have several different kinds of
problems.  One, we have Henry's problem which is, "I cannot
believe that the only people who were experimented on 50 years
ago without their consent were injected with plutonium."

          I mean, I'm sure that there were a lot of things that
people were injected with that were harm producing.  So, part of
it says, "Why are we singling out this area?"

          A short answer to that is because that's what the
President told us to do.  I don't think that's very convincing. 
But I do think you get into the problem of choosing among some
past, I hate to say victims, but victims versus other potential
victims because we haven't gone into that kind of search.

          A second problem says, and you can't avoid it, in order
to make anything more than a generalized apology, which is Ken's
point, so I'm repeating what he said, anything more than a
generalized apology, at some point, you've got to make some
further cuts to justify, already in light of what I just said,
medical monitoring for some group or medical assessment for some
group.

          That's the way I see it.  So, I think that the issue
is, "What are the standards?"  Now that we're clear about what
our modern standards are, are there things that went wrong in the
past?

          And what can we say about those things that went wrong
in the past?  I happen to like your memorandum which tries to
link the two.

          Because the point that I made about the real issue
being what constitutes modern standards, and what constitutes
actions, or in your memorandum, those are the things that are
troublesome.

          What constitutes an action is quite a difficult issue,
to my way of thinking, to flush out.  Also sound moral judgments,
I think is not an easy thing to flush out.

          But I would add one thing.  To what end are you asking
us to make this judgment?  Because if I know the end, I can tell
a lot of other things about how I feel or what I'm thinking.

          CHAIRPERSON FADEN:  Jay, Duncan, Ruth.  This is very
helpful.

          DR. KATZ:  This is in part a response to Pat.  It may
be clarified just things that I haven't articulated until now. 
If I was satisfied that the current regulations and surely the
way they're being implemented, but working well, which I do not,
then I would have entirely different kinds of thoughts about what
the commission might best do.

          I do not believe that the current regulations work
well.  I do not think that the current regulations are
sufficiently protective of the kind of language.

          I'm talking about the Nuremberg Code now.  If you want
to implement the Nuremberg Code and hold people responsible for
not implementing the Nuremberg Code, you can charge the present
regulations with not being respectful of the Nuremberg Code.

          And secondly, if we here as a group were to talk about
what we consider to be the ethical practice in the context of
research, my hunch is there would be a lot of disagreements among
us as to what we consider ethical and unethical practices.

          So, it's these kinds of things that sort of influence
my thinking.  It's complex.  I don't know what to do about it. 
But in the light of what Pat said, I hope I made a little bit
clearer by making it confusing.

          CHAIRPERSON FADEN:  I think that's the course of the
day.  My hope is that at some point a light bulb will go off and
somebody will pull this together for us.

          But my sense is there's going to be increasing
confusion until there's clarity.  Whatever metaphor we want for
that experience.  Duncan?

          DR. THOMAS:  I'm very confused by Pat's last statement. 
Maybe I'm misrepresenting her.  But she seemed to be saying that
the standards of the day would modify our judgment about whether
terrible things were done.

          It seems to me inconceivable that, if we were to
conclude that today injecting somebody with hazardous substances
without telling them and without getting their proper consent
that that was a terrible thing, that it would be a terrible thing
whenever it had been done.

          I can see that the prevailing ethical standards and
practices of the day would modify what we might conclude about
the investigators culpability.

          But whether or not a terrible thing had been done or
not would seem to allow, that to be modified by the standards of
the say, would seem to me to be a form of extreme cultural
relativism that I'm not prepared to accept.

          MS. KING:  Can I answer Duncan?

          CHAIRPERSON FADEN:  Sure.

          MS. KING:  He's exactly where I am.  I expect 25 years
from now, in fact, I fervently hope and pray that we will have
progress in our moral judgments.

          And things that we do today will be unacceptable to a
generation 25 years from now.  And I am not troubled by that.  I
don't think that I have to get into a philosopher's discussion of
cultural relativism.

          I'm actually dealing with a very simplistic notion. 
And that is, when I look back at history in general, there seems
to be a slow, I hope steady, change in what we're willing to do
to other human beings.

          Slavery was a part of the ancient world.  It was a part
of our own history.  And it still goes on in parts of the world
today.  I think that there would be some general consensus in the
room probably that it's a bad thing.

          And without trying to tease apart all the cultural
relativism and all this kind of thing, I'm willing to just say
that these are the standards I have here, and I can look back and
see that these standards were not followed then.

          I find by today's standards that's troublesome.  I
think to do what Duncan says to try to find general immutable
principles, I mean general God principles, that will last for all
time is, for me, very hard to do.

          And I've actually been trying to avoid that because
that, I think, will split the committee.  And my approach,
Duncan, to doing that is always the pragmatic one which is, "Why
are you asking me to solve this question?

          Where are we going?"  You tell me why we're trying to
solve this problem, and I'll figure out a way to solve it.  And I
would like to avoid some of those general philosophical questions
in the doing of it.

          So, I do keep emphasizing to what end are we asking the
question rather than trying to deal with the question in the
abstract.  I'm extraordinarily uncomfortable doing that.  So, you
got me right.

          DR. MACKLIN:  I don't shy away from philosophical
things because I'm a philosopher.  But I'll avoid them for the
moment and try to answer Pat's question, "To what end?"

          I think there are "ends" and not one "end."  And if
you're concerned as Henry is concerned, and as I think we all
are, that if we're only singling out radiation that there's some
injustice there.

          But it really is what we're supposed to do.  And one of
our recommendations can be that someone else should look farther
or do more or look at other things in order to rectify what might
be an injustice in having singled out radiation.

          But we're doing that because obviously that's our
charge.  But at least one end.  And I don't think it's the only
end.

          But at least one end, as I see it, stems from all the
people who come up here in these public testimonies and all the
people who have felt or been or suspect that they have been
harmed or wronged.

          If this committee were to say, "We can't make
retrospective moral judgments.  Therefore, we just can't say
anything about what happened then 40 or 50 years ago to you or
your relative who's now deceased."

          I think that would be a terrible conclusion for people
who feel harmed or wronged.  And if our answer is we can't even
make these judgments because we don't have the philosophical
apparatus, or all we can talk about is today's standards, then I
think there would be a legitimate response of outrage.

          If we can talk about slavery having harmed or wronged
people in the past, even though none of them except their
descendants are now alive, if we come to the view and we can make
that retrospective moral judgment, if we can make any, then we
can make more than one.

          And if we can make more than one, it's at least
meaningful to make them.  So, if you ask to what end, we can tie
that into something very practical that's gone on here which is
people who have come forward and believe that they or their
families have been harmed or wronged.

          And at the very least, even if all we can say based on
the evidence or lack of the facts is that at least an apology is
owed you because you were harmed or wronged, it seems to me
that's one justifiable end.

          MS. KING:  I can't apologize, Ruth, for making a
judgment that, by my standards of today, looking back, you were
wronged by my standards of today.  I'm having trouble doing that.

          I can't say.  And this I find very troubling.  And I
think what we are doing is, some of us are saying that, in order
to make a certain kind of judgment, here there is a link to
remedies and a link to culpability, I need to know something
about the standards of that day, which is what the issue is.

          I am not willing to make certain things, judgments,
that I would make if I were satisfied that the standard in
existence then was you cannot inject plutonium without consent.

          If I knew that was the standard 50 years ago, I would
go down one route.  If I know that's the standard today, and it
happened to people 50 years ago, what I'm suggesting is I might
go down a different route.

          And I might make different kinds of judgments and that
it's not no judgment, by the way.  Because what you just said
implied that I have nothing to say to people who have come and
talked to me.

          The first thing I've been able to say is  about what I
think is a current standard, something happened to you 50 years
ago that ought not happen to you today.  I can say that.

          Whether I can say what happened to you 50 years ago
ought not to have happened to you 50 years ago in accordance with
the standards of 50 years ago, that jury is still out on that
one.

          And that, for me, is an important statement not to be
smushed together.  Now, Duncan was right when he said he was
troubled about what I had to say because this is the point of
difference.

          And I think it's a clear point of difference in the
committee.  So, when we say, "Are we willing to make a
retrospective judgment?" you mean one thing by it.  I think I
mean something different.

          And maybe it will just be more useful to keep it
clarified by saying, "I'm willing to judge so far by today's
standards."  The jury's still out on judging by what were the
prevailing standards then.

          Other people, I think, are willing to say, "I'm willing
to judge by today's standards, and I'm willing to impute to the
past, knowledge . . ."  This is to use a lawyer's term.

          ". . . impute to the past existing knowledge of today's
standards and judge you by those standards in the past."  We call
that super-strict liability.  And I'm not willing to do that.

          CHAIRPERSON FADEN:  I think this is all very helpful. 
We also have a problem which is we have to eat.  Not that we have
to, but they're going to make us eat.

          So, let me just see the hands that I see.  I see Eli,
Ken, and Phil.  And unless somebody has something that either the
comment is directed to you or you have something right on that
point, we'll close with Eli, Ken, and Phil.

          Because we have to have lunch at a certain time, or we
don't get it at all.  Given that choice, I think it's probably
the easiest decision we have to make all day.       Eli.

          DR. GLATSTEIN:  I'll try to be brief.  It was not
uncommon 50 years ago in this country for patients not to be told
their diagnosis if it was cancer.  I lived through that period.

          The major reason why that changed was litigation. 
Quite frankly, you learn to tell the patient everything in this
country today because some patients come in with a little
microphone and say, "Speak into the microphone, doctor." as they
tape everything that you say.

          That happens.  I think we have two different problems
here.  And I think we need to keep them somewhat clear in our
mind.

          There are problems of medical experimentation on
patients.  When you look at the number of experiments and the
number of examples we can come up with to point fingers at, it's
a very small proportion that we can point fingers at of being a
major problem.

          I don't want to make light of those that are major
problems.  But it's a small proportion.  Coming on this
committee, the thing that really stunned me is the business of
population exposure.

          The intentional release or the intentional
experimentation of populations of people who were not told a damn
thing.

          Whether they're in the military or whether they're in
the Marshall Islands or whether they live close to some nuclear
reactor, that was the part that I had the most trouble
swallowing.

          And that's the part that I think needs the most
attention.  And I think the more we get hung up on the medical
experiments, not that they're immune or should be immune from
attention, but I think that the population experiments are
overwhelmingly the most serious part of what we have to deal
with.

          CHAIRPERSON FADEN:  Thank you.  Ken?  Ken is passing. 
Phil?

          DR. RUSSELL:  One of the things that came immediately
to my mind when you asked the question to what end, Pat, was I
think the overall purpose of the existence of this group is to
provide a structured insight and perhaps some wisdom to the
citizens, answering questions of, "What happened, and why did it
happen, and how did it happen?"

          And in order to do that, I think it's important to make
some level of judgment.  I do think that the reluctance to make
judgment based on today's standards is a very valid one.

          But I also think that we do have a body of information
about what the standards were at the time that's in many of these
documents.  We don't know how broadly they were accepted in all
parts of the community.

          But we can make at least some inferences about that
especially since we know what the practices were in some segments
of the medical community about informed consent.

          Some of these patient issues, I'm not as concerned
about the level of informed consent as I am concerned about
whether the physicians carried out their responsibility to the
patients.

          That may or may not coincide with informing them.  And
I think in some instances we found that that was not true.  That
we had physicians doing experiments that were palpably not in the
best interest of those patients.

          And they were not volunteers who were knowingly putting
themselves at risk.  So, I don't shy away too much from using the
knowledge that we do have about standards that were in existence
at the time and making some judgments about whether something was
morally wrong at the time.

          I am very concerned about ascribing the individual
culpability because of the factual issues.

          CHAIRPERSON FADEN:  Jay, did you want to say something?

          DR. KATZ:  I think what you're saying has to also be
put in the context of something that I've written about and
mentioned in my Harvard lecture which is going back to my own
medical education from 1945 to 1949.

          The idea of patient consent surely we were not taught
anything about.  It wasn't part of the ethos of medicine at the
time.  We were taught how to carefully evaluate our patients
diagnostically, etc.

          But consent wasn't really necessary because we would
make the decision of what we considered to be in the best caring
interest of patients.

          The idea of consent didn't really begin to percolate
except here and there in medicine until the very late '50s, early
'60s with the informed consent doctrine emerging.

          And I think all of this extended to research.  And so
there was sort of a climate there where it was part of the ethos
of medicine of the time that these are not questions that anyone
has to even think about.  I didn't begin thinking about them
until I joined the law school in the very late 1950s.

          DR. RUSSELL:  I'd be interested in hearing the
historical perspective about how much informed consent was being
used during the same time period in the very extensive infectious
disease experiments.

          At the exact time that these experiments were
occurring, there was a whole community of folks vigorously
studying hepatitis, for example.

          And they made some mistakes that are on the record. 
But there was a general use of informed consent in the
volunteers.

          Now, you can argue about whether the prisoner issue was
a moral right or wrong and, in the context of the time, whether
that was a bad thing or not.  But they were using informed
consent.

          DR. KATZ:  Yes.  But we have to know here.  And if we
know, that would be fine.  Not merely that they said they got
informed consent, but what the informed consent process was
really like.  And that's generally something we know very little
about.

          DR. RUSSELL:  Right.  But it was there.  That's my
point.

          DR. KATZ:  Then it was there --

          DR. RUSSELL:  It was being used.

          CHAIRPERSON FADEN:  Okay.  Let's do this.  We do need
to break for lunch.  I saw Sue wanting to say something.  Let's
let Sue have the last word.  No matter how much we may be
compelled to respond after Sue, we will not.

          And we will save it for after lunch.  Sue, go ahead.

          DR. LEDERER:  Let me just say, it seems to me that the
exercise of retrospective moral judgment seems to me to tell us
much more about ourselves as we are today than it does about how
people were in the past and how they came to be us, or how we
were descended from them.

          And that we have two sort of antithetical aims here. 
We want to explain to people who are here today how this could
have happened.

          This is why we are investing so much in what the
standards of the day were, so that we can evaluate their actions
in the cultural, social, political, intellectual context in which
they operated.

          But we also need to understand ourselves today, which
is what it seems to me the retrospective moral judgment is about,
understanding ourselves.

          CHAIRPERSON FADEN:  A very good comment on which to
end.  Let me just tell you where we need to go for lunch.  A
quick plea.  If you could read the memo that's Tab H or look at
it again?

          I'm sure you've all read it.  But look at it again, as
well as the memo from me which was in your packet that we
circulated to refamiliarize yourselves with them before the
afternoon's discussion.

          We are eating in Monique's which is on the main level,
two floors up, in the east wing of the hotel.  There are tables
reserved for the committee.  Monique's, two floors up.

          (Whereupon, the proceedings went off the record at 1:07
p.m. and resumed at 2:25 p.m.)                     A-F-T-E-R-N-O-O-N   S-E-S-S-I-O-N

                                                                (2:25 p.m.)

          CHAIRPERSON FADEN:  Could the committee members please
come to the table?  All right.  The  two memos I need are -- Did
we ever get an extra briefing book?  I guess we did.

          I hope that someone has had some very good
inspirational moments over the course of lunch so that we can
make progress.  Are we going to have coffee back here?

          We're going to see if we can't get coffee back here. 
The combination of lunch and the dimness of the lighting is
having an undesirable effect on my ability to focus.

          But we'll proceed ahead.  What we're going to try to do
now is continue with the discussion and try to perhaps focus or
sharpen or whatever the decision, I'm not sure what the right
verb is, by referring to two memos that the committee has.

          I've asked Allen and Jonathan to join us again for this
part of the discussion.  One is a memo that you all received, not
as part of the briefing book from me, which are just talking
points basically for the committee that bear on how we might link
the approach that Ruth and Allen have put before us with the
question of remedies.

          And then there is a more detailed memo done by staff. 
And Jonathan was the key architect of this memo which attempts to
go specifically to the fact situation as we have it.

          And it address the question of whether we have an
evidentiary base for looking at questions of Government
culpability.

          So, it's going from the general, theoretical
discussions we had this morning to a kind of bridging memo on my
part, six points that we might consider as ways to link an
abstract framework with questions of remedies through an attempt
by Jonathan and others to see if we can't, drawing on the
documents available to us already, reach some conclusions.

          Or if not reach firm conclusions, reach some shared
inferences about where the Government sits or is situated in
relation to questions of culpability.  And whether we want to
retain even that term after the discussion this morning is up for
grabs.

          Should we just plunge into the discussion?  Or would it
be helpful to have a quick run-through on the two memos?  Dan?

          MR. GUTTMAN:  This is at the risk of just adding
another confusing point.  From the staff's perspective, we're
really in a world where, if we're going to tell a story, part of
the retrospective justice, metaphysical discussion --

          I guess I shouldn't use the word "metaphysics" because
I'm sure it's very real to Ruth.  Right?  -- will drop out
because, in fact, in the course of telling the story, we are
finding that there were ethical codes.

          And so there's a question, at least to staff, of, if in
1953, the Secretary of Defense issued a code, if he issued the
code today, and we had reason to believe it wasn't followed, we'd
probably say there's a problem there.

          So, that's not a problem of retrospective justice. 
It's a problem of what do you make about that evidence.  Now
there are questions about the reach of that code and who might
have known about it and various levels of culpability.

          But we're relatively speaking, as fragmentary as the
information we have is.  What the staff has been doing is very
hard work and, to some extent lucky, fortunate work piecing
together the structure which permits us to see where the rules
were.

          Now, as Jay was saying, and others of you have
obviously pointed out, that doesn't mean that the rules were
understood and known by all the doctors in this society.

          But if you're looking at the Government, which is where
we're focused, there clearly was a formal, legal rule, order, at
the Department of Defense, and what Jonathan has put together
with Valerie and others, in the AEC starting from its creation.

          There were clear, articulated Governmental policies. 
This is not a mystery.  And it's not necessarily we're well
beyond having to say, "Well, we know what we feel or think today. 
And we can't say anything about the past."

          We've got some pretty good evidence about the policies
at the level of the United States Government, some of which are
legal, formal policies.

          And this is where, I think, Jonathan's presentation, I
suppose, in some respects is going to make a case saying, "Well,
can we start from the premise that there were rules that were
recognized at the highest levels of the United States Government? 
And if so, what does that mean?"

          CHAIRPERSON FADEN:  Are people familiar enough with the
memos that we can start attacking them?  Or do we want a run-
through?  I'm sort of going right to the quick here.

          DR. MACKLIN:  Which memos are we referring to?  I know
one of them is your six points.

          CHAIRPERSON FADEN:  It's from me to the rest of the
Advisory Committee members dated December 13th.  And Anna, that
was sent to people separately.  It's the only one that comes from
me personally.

          DR. MACKLIN:  It doesn't say December 12th?

          CHAIRPERSON FADEN:  December 13th is the one I have in
front of me.  December 13, 1994.

          DR. MACKLIN:  What's the heading on it?

          CHAIRPERSON FADEN:  It's for discussing the six points
attempting to link.  Does yours say December 12th?  Now there may
be a slight change then between the December 12th and December
13th one.

          Or it's possible that somebody printed out the same
memo on a different day.  We have had problems like this before
with dating.  So, we don't know.

          Let's hope that it's not substantively different.  So,
everybody has that memo.  The other memo, you should have put
under Tab H.  And it is also dated December 12th, and it is
called Ethical Standards and Government Culpability.

          And this is the memo that Dan just made reference to
which speaks to the question of do we have an evidentiary base
sufficient to call it with respect to at least some level of
Government culpability in at least some context above, if you
want to go back to the remedies memo, the strict liability?

          MR. GUTTMAN:  If you take the word "culpability" and
throw it out in the terms that everybody seems to be comfortable
with, in telling the story of the past which is what the
President asked us to do.

          In 1953, there was a Secretary of Defense's code. 
That's the story.  And what we now see is that it may not have
been effectuated in many respects.

          So, what do we make of that evidence in telling the
story?  What commentary, I guess, do you have there.  And, of
course, you have enough questions with Jonathan and the staff as
to whether that is the story and what facts are missing and so
forth and so on.

          But the premise we're presenting is that there is
enough solid ground to state that there were official policies.

          CHAIRPERSON FADEN:  Should we just start with the
discussion as opposed to summaries of the memos?  Pat?

          MS. KING:  I'm much more interested in Jonathan's memo
because unless I can understand Jonathan's memo, it's hard to
apply the linkage memo because it helps flush out some of the
issues about culpability.

          What I'm interested in, and he has two scenarios there,
and I understand that what we've been trying to do is do the
skeleton.  But I have to confess that the skeletons need flesh
for me.

          So, what I'd like to ask Jonathan is can he take
scenario one and scenario two, or he can start with scenario one,
whichever one he believes in, and flesh it out in terms of trying
to apply it to a set of experiments or an experiment?

          I won't hold him to this.  I just need some flesh into
these scenarios, what the scenarios are and how they might be
applied if the committee were interested in thinking about the
applications further.  Does that question make sense, Ruth?

          CHAIRPERSON FADEN:  It does.  It makes a great deal of
sense.  Jonathan, before you answer, I thought you were
responding to this sort of general point about the summary.

          Leave your question out there.  But Henry, I didn't
want to overlook.  Is that okay with you?  Because I saw that you
also wanted to say something.  All right, Jonathan, answer Pat.

          DR. MORENO:  The scenarios that we formulated up here
on page 3 of the memorandum that's titled Ethical Standards and
Government Culpability, scenario one is there were officially
sanctioned ethical standards.

          But the standards were not widely disseminated,
implemented, or practiced.  Scenario two, if you can't accept
that one, is they were articulated, but not widely accepted
standards at the time.

          Now, by officially sanctioned ethical standards, I
think we have sort of a couple of braces of examples.  And I'm
not sure exactly how many experiments they directly relate to.

          But let me give it a shot.  The first brace of examples
that I'm thinking of have to do with statements that were made
1947, 1948, 1949 by the then new Atomic Energy Commission.

          These statements appear to have been made, and Ruth
read some of the bridging statements this morning.  These
statements appear to have been made in light of the injection
experience.

          An experience that, in the hand-off period between the
Manhattan Project and the AEC, various kinds of concerns were
raised about these injections if it were generally known that
they had been performed under the circumstances in which they had
been performed.

          There also arose, it should be added, not only public
relations and liability questions, but also secrecy concerns. 
Concerns about doing this kind of work in secrecy and what that
meant in a society like ours and how that seemed to put people in
a bad position.

          The people who had administrative responsibility were
put in a bad position when these things were done in secret and
so forth, put the AEC in a bad position and so forth.

          There was a brace of statements that comes in '47 and
'48 to the effect that these kinds of things ought to be done
with consent, that what is being done ought to be explained to
the people to whom it's being done, that they should be in an
"understanding state of mind."

          And at one point, that they should actually give
written consent.  Now, the written consent portion was changed. 
There was a matter of some negotiation between the AEC central
office and Dr. Hamilton apparently.

          And that was withdrawn.  So, that in the 18th plutonium
injection, you might recall, there was oral consent that was
apparently witnessed by three physicians.

          So, there we have one brace of standards that were
linked at least to the plutonium injection experience, an
experience that seemed to have given in the hand-off period from
the old Manhattan Project to the AEC, seemed to have given people
some pause, some reason for concern.

          I can't put it any more conservatively than that.  I
have to say as a footnote, if I might be allowed that, that it's
very hard for me to believe that there was a solar eclipse that
changed the standard from 1946 to 1947 so that whatever people
were worried about in 1947, whatever label you use, it's likely
that it bore some emergent relation to the world in 1946 and
1945.

          So, I don't think we can say that these were somehow
standards that were created from whole cloth in 1947.  In
retrospect, that they were exercising their retrospective moral
judgment.

          And therefore, what they said about '46 and '45 didn't
count.  I think rather what they thought they were doing was
codifying practices that they thought should have characterized
the period of 1946 and 1945.

          I'm obviously liable to be wrong about that.  But that
is my distinct impression.  I think it's the most reasonable
characterization for what's going on here.

          Now the second brace of standards or policies or
official statements, however you'd like to put it, comes through
the Department of Defense and from roughly '51 to '53, '54 in two
stages.

          And this is what I talk about, and others have worked
on this as well.  These are multi-authored documents I can assure
you in the Defense Department memorandum.

          The first stage of that discussion happens in the wake
of the so-called NEPA discussion, the Nuclear Energy Powered
Aircraft.

          The second stage happens really in '53 when there's an
awareness in the -- rather in '52 when there's an awareness in
the Pentagon that, after the Reorganization Act of 1950, there is
no regulatory apparatus that makes it possible for human beings
to be used in atomic, biological, and chemical warfare studies.

          So, that's a two-part discussion.  Running through that
discussion are several themes though.  Both parts are concerned
with the empirical lack of information about what a permissible
exposure, a safe exposure is to a human being.

          Running through it are concerns about compensation, if
anybody is to become injured.  Another theme that runs through it
is how to deal with people at the AEC and Shields Warren, the
DBM, who are resistant to doing radiation studies in large doses
with human beings.

          But not, I should point out, resistant to doing
radiation experiments at tracer levels.  And it's important to
keep that distinction in mind, I think.

          So, there are a number of themes that run through these
two parts of the discussion.  And by the way, while this is going
on, as Dan has pointed out to me on many occasions, while that's
going on, while they're saying, "Gee, should we do experiments
with human subjects?" they're continuing to fund projects using
human subjects at places like M. D. Anderson.

          But they involved sick people, not people who were
otherwise healthy.  And that, I think, is a very important
distinction.

          Therapeutic intent is a territory through which you can
drive an ethical truck.  And I think that's an important part of
the story.

          At all events, let me return to the central issue which
is, "How did it happen that the Nuremberg Code became the
standard that was proposed to the new Secretary of Defense in
1953?"

          The Armed Forces Medical Policy Council had been part
of these discussions for awhile under Dr. Meiling first as Chair,
and then under Dr. Casberg.

          What happened apparently was that, because the AFMPC
was the highest advisory body closest to the office of the
Secretary of Defense, they were chosen as the group to formalize
a proposal to the Secretary.

          What seems to have happened is that Stephen Jackson,
the Assistant General Counsel for Personnel and Manpower, looked
at the Nuremberg Code and decided that since that had been an
American show basically, the doctors' trial was not a foun-power
show, it was an American show.

          It was an American trial, that at the very least,
American officials and scientists and others had to be held to it
if we were going to hold German officials and scientists and
physicians to it.

          So, he stated in a memorandum in '52 that this is the
standard to which we have to apply to ourselves.  And it has to
be accepted in totality.

          Because if we pick and choose, and we don't take part
of one, and we only take part of three, and throw some pieces
out, people will say that we're not adhering to the standard,
that is, international law.

          So, Jackson proposed to the AFMPC for which he was the
counsel, that they adopt the Nuremberg Code as the standard.  He
ran it by his immediate superior who was the Assistant Secretary
of Defense for Manpower and Personnel, Anna Rosenberg who was the
human relations and labor relations expert, a New Dealer.

          Anna Rosenberg added written and witnessed consent to
the first statement of the Nuremberg Code.  Mr. Jackson added an
11th commandment to the Code which said "Thou shalt not
experiment on prisoners of war," which as Jay pointed out earlier
is probably redundancy if you understood the Code.

          But he added it in very legalistic language.  This
proposal was then passed on by the AFMPC.  And then in an
appropriate fashion, they sent it around to the Research and
Development Board committees, about five of them I believe, for
comment.

          We only have transcripts from two of those five
committees, the Committee on Chemical Warfare, the Committee on
Medical Science.  And the transcripts make fascinating reading.

          Jay's alluded to them.  And I reprinted rather large, I
hope representative, portions of those discussions.  Basically
what the transcripts indicate is, at best, a lukewarm reception
to the idea of having any kind of written policy in this area.

          For various reasons, some people argued that you didn't
need it because we've done very well in the history of medical
research without such codes.

          You just get the lawyers involved if you write things
down like this.  We should have a British system in which we
actually select whole troops or units of troops and move them to
special facilities where we do experiments and for which they're
specially compensated.

          There are lots of other counter-proposals.  They didn't
wash.  They didn't make any difference.

          The service secretaries had a meeting near the end of
Secretary Lovett's administration in January of '53 in which they
said, "We've got to move this forward.  We've got to get a
signature on this.  We've got to make a recommendation."

          Secretary Lovett, that day as it happens, January 8,
'53 was testifying before Congress.  He wasn't at the meeting.

          The secretaries couldn't reach an agreement about
whether this should be commended to the new Secretary of Defense
or not.  They simply decided to send it on to him rather than
suggesting that Secretary Lovett sign it.

          Apparently, and there was some discussion about this
this morning, let me give you my speculation.  Bureaucratically
what happened is you had a new administration in '53.

          The new Secretary walked into his office with a lot of
paper on his desk, a lot of things awaiting his signature.  It
was a few days after his confirmation.

          He was told that this was something that was important. 
Atomic, biological, and chemical warfare had to go on using human
subjects.  It couldn't be done the way things were right now.

          The alumni of the previous secretarial administration
had said that this is something that needs to be done.  We need
to move forward on this in spite of the internal controversy.

          And he did.  He signed it.  Now one can say that this
pattern fit scenario two, articulated but not widely understood
perhaps.  Not widely implemented or practiced standards.

          Or one can say, considering how much discussion there
was, and there has been by the way in the uniform services, a
long history of using volunteers for experiments, normal
volunteers.

          One can say equally well, I think, that scenario one
might apply.  In any case, the secrecy problem was one I think
that people were aware of.

          And almost as soon as the document was signed, it
seems, at least at the service secretary level, certainly in the
Army, and I think in the other services as well, we have reason
to believe there were efforts made to lower the level of
classification.

          Ultimately, it seems it was declassified.  As a matter
of fact, Jon Harkness was just showing me this morning some
information that, of course, Jim David has come up with that
suggests that in March of 1954, about a year and a month after
the Wilson memo was signed, a general advisory went out using the
language of the Wilson memo, which was basically the language of
the Nuremberg Code from all of the service secretaries indicating
that these were the rules.

          So, ultimately it does seem that there was an
implementation process.  At that point though, we don't know how
far down the line that process went.

          Now, I'm not sure that I satisfied everything, all the
charges that Pat gave me in the beginning.  But it does seem to
me that there were articulated standards that the Army in '75 in
its IG report on chemical warfare experiments itself said that
the Wilson memo had not been adequately implemented in the Army
at least.

          There's really no debate about that, I think.  The
question for the Advisory Committee is how seriously to take the
standards that were articulated?

          CHAIRPERSON FADEN:  Pat, did you want to comment?

          MS. KING:  I have several questions.  This is a
personal question to Jonathan.  Just a judgmental call that he
may retract later based on the fact that he's very familiar with
these documents.

          But the way it sounded to me is that the Wilson
memorandum and the documents that you have in connection with
respect to dissemination, implementation, etc., with respect at
least to those documents and the experiments which is an
unspecified step now, they should have applied because they were
Defense funded experiments.

          Or it was Defense policy, that you really are arguing
for scenario one.  You think the documents justify scenario one.

          And I take it that the key word is "officially
sanctioned." because you got a policy statement.  With respect to
the AEC and the plutonium experiments where the documents, at
least the way you characterize them, don't sound like what I
understand to be official agency policy coming from the head of
the agency.

          Are you suggesting that with respect to the plutonium
experiments, because those are the ones that you mentioned, that
this scenario two there were articulated standards?

          And we ought to be able to say from what they pull from
those documents, they were not widely accepted, but they were
available by which to judge at least the plutonium experiments?

          CHAIRPERSON FADEN:  So, you're asking is there a
difference for those two agencies?  Does scenario two fit the
AEC?  Scenario one, the Department of Defense?

          MS. KING:  Yes.

          DR. MORENO:  I'd have to think about that one. 
Unfortunately, Dan already has a reaction.

          MR. GUTTMAN:  No.  Jon, go ahead.  I think what
Jonathan is saying is that the plutonium took place in '45 to
'46.  And the AEC wasn't created until '47.

          So, what Jonathan is saying is that it's not a question
whether official or not official, there was no AEC in '45 and
'46.

          DR. MORENO:  Exactly.  There was an interim medical
committee in '46.

          MS. KING:  But it could have been official Manhattan
Project too.  What I'm focused on here is whether we have -- The
neat thing about the Wilson memorandum is that it's ahead of an
agency or ahead of some kind of operating -- that we could make
some assumptions about dissemination, even if it didn't actually
happen.

          MR. GUTTMAN:  Jonathan will tell you about the earlier
tradition, the Committee on Medical Research, for example, would
be relevant, Jonathan, to the plutonium.

          DR. MORENO:  It's been a long time since we talked
about the Committee on Medical Research.  But back in, was it
June or July, we gave the committee some correspondence from
A. N. Richards, who was the University of Pennsylvania professor
who was the Chair of the Committee on Medical Research during the
Second World War.

          A question was raised about doing gonorrhea
experiments, exposing servicemen, I gather, to gonorrhea.

          And at that time, A. N. Richards took the position and
the CMR took the position that you had to use informed volunteers
with, they used the word "consent forms" I believe, that waived
rights to damages.

          Kind of a mixed bird.  But nevertheless, a form that
was signed using volunteers.  I went to Penn a few weeks after
that meeting and read some CMR transcripts in which there was a
discussion about these kinds of issues in 1943.

          And it's quite plain from those transcripts that the
articulated view, at least, was that service people are not to be
used as "guinea pigs."

          And one of the members of the Committee of Medical
Research says that the Army is quite clear that service people
are not to be used as guinea pigs.

          So, it doesn't seem to me that at least the rhetoric,
the officially articulated standards were all that novel in 1946,
1947.  Whether they were acted upon is a different matter.

          CHAIRPERSON FADEN:  Does that satisfy your question,
Pat?

          MS. KING:  The reason I was asking is because what
Jonathan says, and I like to repeat things because we
misunderstand so many things including in this committee.

          What he seems to be saying is, although he ducked my
scenario two question a little bit, that we can articulate a
standard other than the Wilson memorandum, because I think that
was always clear about that.

          And then we can take that standard and measure it
against what we know about categories of experiments, which may
not be all there is to know, but what we know.

          And that we should be able to reach some conclusions
about, and I don't know how to put them in remedies language, but
we can reach some conclusions about blameworthiness or reach some
conclusions about Government culpability.  Am I correct?

          DR. MORENO:  Fortunately, I was not asked to write
about individual blameworthiness.

          MS. KING:  I'm very clearly staying away from that
because I have serious doubts about the individual culpability
question.

          DR. MORENO:  I think we see an institutional failure.

          MS. KING:  Okay.

          DR. MORENO:  And there are several instances of
institutional failure.  I'm not sure how much more we will be
able to say about it than that.

          But I think we can at least establish, as a threshold
for getting the discussion going, that there was institutional
failure and that the institutions were Governmental institutions.

          CHAIRPERSON FADEN:  Phil?

          DR. RUSSELL:  I very much agree with that position.  I
wonder if the documentation relates to extending the standards
beyond the work done in-house by Defense Department personnel.

          The issue of extending Government standards to civilian
grant recipients or contractors is a big one, probably the
partial explanation of the failure of the system because they had
no structure in which to do that.

          Neither did I believe that, at that time, did
Government personnel, especially the science managers at the
time, feel that they were empowered to impose their ethical
standards on the civilian academic medical community.

          But there was, I think, an implicit understanding that
the civilian academic medical community were the setters of
medical ethics and standards.  So, I would be interested to know
whether the documentation speaks to that in any way.

          DR. MORENO:  I have two immediate thoughts.  One is, of
course, many of the physicians who were advisors, as is the case
today, to the Pentagon were civilians.

          Many of them, I'm sure, had been commissioned officers
during the war, but were civilians when they were advisors to
these research and development committees in the early '50s.

          So, they played a dual role.  I'm not a sociologist of
the late '40s and early '50s, but probably through their
experience in the military, they were prepared to accept the
culture of the military to some extent when they were in
Washington and accept the university culture when they were
there.

          And I'm not sure how they meshed.  So, I don't quite
know what to draw from that those roles.  We also know, and this
is work that Jon Harkness has been doing, that there were efforts
to insert the Nuremberg-like rules into DOD contracts.

          We haven't yet, we're still working on this, been able
to glean the full story about how that went and how extensive
that was.

          But at least in 1962, there was an attempt, and I think
we've talked about this in these meetings before, to make it more
explicit.

          Right around the same time that the Wilson memo was
turned into AR 70-25, Army regulation 70-25, also at that time if
not earlier, there was an attempt to insert into all Pentagon
contracts with civilian physician researchers, physician
investigator rules that were roughly the same.

          But we don't know the whole story yet.  So, I think the
hypothesis is a provocative one.  Were military medical
administrators inclined to defer to the customary medical ethics
of their civilian physician investigators?

          The hypothesis has intuitive appeal to me.  On the
other hand, the people who were doing the advising were in both
worlds.

          DR. RUSSELL:  There were more than two worlds at the
time too.  There was a civilian and the military worlds.

          But within the medical community, there was the
infectious disease investigative group that was deeply involved
in using very large numbers of healthy volunteers for infectious
disease experiments.

          A totally different culture than the patient care
situation especially with regard to carcinoma and other terminal
illnesses.  Very different cultures.

          CHAIRPERSON FADEN:  Dan?

          MR. GUTTMAN:  Two points.  As always, your question's
on point.  We have found in the implementation of the Army's 1953
version of the Wilson memo, the 1975 Inspector General report and
documents we have show that, right after it was implemented, the
first proposals when they actually put it into effect apparently
involve contractors.

          And Secretary Stevens, in signing off, says, "This
governs the contractors as well."  Now we don't know whether it
was Harvard, Yale.

          DR. MORENO:  That was June 30th, '53 that Stevens said
that.

          MR. GUTTMAN:  It actually involved contractors.  The
other point is, clearly at the AEC, they had no problem -- The
most powerful document of the AEC is this November 30, 1947
letter which is referred to in a 1951 letter, where General
Manager Wilson uses written informed consent.

          And that was to Robert Stone at the University of
California.  So, the reality may have been, of course, that they
didn't back up their letters with strength.

          But the letter that is the most seminal, strong AEC
1947 letter, is to a contractor.

          DR. RUSSELL:  That sure does speak to scenario one,
doesn't it?

          CHAIRPERSON FADEN:  Pat?

          MS. KING:  My next question goes to, and maybe this is
not appropriate for Jonathan or Dan or maybe you, Ruth.

          And that is, that of the major experiments that we have
focused on, now thinking of breadth question in your judgment,
for how many of those, I'll just deal with the major ones, are
there existing documents that might support either scenario one
or two, in your opinion?

          MR. GUTTMAN:  To answer that qualitatively in a way
that I think will make sense.  After 1953, from '53 to '74, the
Navy reported about 100 human radiation experiments, the Army
150, the Air Force about 100.

          So, that's 300, 400 experiments.  The Navy clearly
actually followed, got approval it looks like in some of those
cases.  And other cases they might have documentation.

          There doesn't look like we've got documentation in many
of the cases of the Air Force or the Army.  Now the point that
Ruth will then make --

          There's clearly hundreds of human radiation experiments
that were done by the Army, Navy, and Air Force from '53 to '74.

          Now Ruth is going to make the point that the Secretary
of Defense's memo applied specifically to atomic, biological, and
chemical warfare and not every kind of experimentation.

          So, within that, let's take a couple.  The biomedical
experiments and atomic bomb tests, there are several to which
this probably clearly would apply.

          The most striking is we have that memo that Jonathan
alluded to, I think.  In '54, the belated recognition that they
were doing these flash blindness tests, which is retinal injury,
in connection with atomic bombs, and someone says, "We got
injury.  Is there any policy that applies?"

          And there's a memo attached saying, "We asked around. 
There was this top secret secretary's memo nobody told us about."

          So, that clearly subsequent flash blindness test,
whether that's radiation or not, that was an experiment, also,
probably I would suspect the psychological testing in connection
with the bomb tests.

          People were put out there.  It was clearly labelled
experimental.  It was in connection with the bomb tests.  The
question you might have then to go through the committee's cases
is the Dr. Saenger, where there was clearly an atomic warfare
related purpose.

          Then you have the question, of course, which Phil is
alluding to, whether the Defense Department, at the least, is
responsible for the non-application of that at the contractor
level.

          So, that's the DOD.  The AEC, there were, to take two
or three cases, numerous, hundreds and hundreds of radioisotope
experiments, most of which were probably tracer doses.

          But say, for Fernald, for example, took place, and I
guess folks out there know, '48, '49, '50.  But it would have
been after '47, plenty of other isotope experiments.

          To give one that has got clearly a more gripping risk
in a sense would be the injection of the comatose patients at
Mass General in 1954 with uranium.  It was a joint project
involving MGH and Oak Ridge.

          So, there is one that theoretically has some very
troubling aspects.  That would have been an AEC.  Total body
irradiation in the '60s.  And one of the interesting questions,
Oak Ridge, cancer.

          The hospital at Oak Ridge where we're doing a case
study did lots of tracer, and ultimately ORINS was involved in
the total body irradiation.

          And one of the questions, of course, is they had
starting in the early '50s is kind of a legalistic consent form. 
Should they have been subject to this much clearer, more powerful
1947 AEC thing.

          So, we've got both at the Defense Department and the
AEC some real cases.  As everybody will point in many of those
cases, we don't know enough to know if there was consent or not.

          But we should know enough, and this is staff's
viewpoint, to know there were standards.  And if anybody could
come forth with evidence, these are the standards.

          The final point I want to make is the AEC, of course,
was giving out isotopes to almost everybody that was doing
radioisotope experiments, with the exception of what was coming
out of the cyclotrons at Washington University or MIT or
Rochester or CAL.

          And we're trying to track down whether the rules that
the AEC had were generic without regard to where you got your
isotopes from.  That's a complex question of swapping of legal
obligations.

          The point I want to make is that when the VA was doing
its radioisotope research, which according to the VA resulted in
literally thousands of experiments, there is a question of the
extent to which people acting on AEC isotopes, which if you knew,
if your rule of judgment was that anybody using AEC isotopes was
to be judged by AEC rules, then that would be an enormous
quantity of experiments.

          MS. KING:  Last question.  I noticed that the memo
clearly doesn't go into degrees of culpability.  You kind of
shift that over to the remedies memo.

          But this is a judgment question again for the staff. 
And that is, is there enough information, in your views, to be
able to make a degree of culpability judgment?

          CHAIRPERSON FADEN:  About Government?

          MS. KING:  About Government.

          CHAIRPERSON FADEN:  I just wanted to clarify it for the
discussion.

          MS. KING:  No.  It's very important that we're still
just talking about Government.

          CHAIRPERSON FADEN:  Defense Department or the AEC and
not --

          MS. KING:  Right.  Because I take it that we can make a
judgment about Government culpability if we know there are
standards, -- case, if there are standards that have been
promulgated.

          And if there's evidence that the standards, we don't
have to ask a lot of questions about how it happened, but that
there's some evidence that the standards were not implemented in
certain kinds of experiments.

          And I'm comfortable with that.  So, the question then
becomes, is there a way, based on the documents, some picture
that is emerging from the documents that suggests that thinking
about finding degrees of culpability for Government makes sense?

          Is it effort worth trying to do?  This is for whoever
is the relevant person to answer.

          CHAIRPERSON FADEN:  Just to clarify that, Pat.  Let me
see if I've got it straight.  I think the question Pat's asking
is to differentiate between evidence that would establish a
threshold level that, yes, we can speak about the Government
being culpable.

          We have an evidentiary base for that in at least the
following scenarios versus we have enough evidence or enough
understanding to talk about how culpable.

          But zero culpable would be off.  The proposal here is
zero culpability is off where the Wilson memo would apply.

          MS. KING:  Right.

          CHAIRPERSON FADEN:  So, then the issue is do we have
enough of an evidentiary base, in a sense of history, to be able
to say degree of culpability for the failure of the Wilson memo
not to have been --

          MS. KING:  Please understand that I am not trying to
pin you down.  I'm trying to get a sense from the most informed
people, which would be the people who have been through all these
documents.

          MR. GUTTMAN:  And needless to say none of this should
be taken for judgment.

          MS. KING:  Right.

          MR. GUTTMAN:  Obviously, the way I guess we internally
phrase this question is, "Do we set a situation where there was a
standard?"

          But as Jay was saying, it's not followed today.  And
anybody who was near an isotope in 1956, is it going to be a
meaningless -- Where further can we go?

          And where I think that takes us is the case study.  So,
that, for example, in the TBI case study, and this is not the
statement of facts, but just speculative, what you've got as
presented by Ron and Gary at the last meeting, it's not Dr.
Saenger out there as a lone person.

          But there's a group of difficult experiments undertaken
by the Defense Department.  And other people are doing TBI, but
they're not doing by and large this kind of risky stuff.

          So, it's a pattern.  It's not one experiment.  It's not
even got to do with consent.  And when does that set of
experiments begin to take place?

          Well, what Ron and Gary said at the last go around was
after this debate on human experimentation and to decide because
they can't do it, then they go find these sick people.

          And they do the same thing, but they don't call it an
experiment.  Now that's not directly addressing the Wilson.  But
you begin to see a pattern.

          And we all can make judgments of the facts.  And
there's new documentation which suggests that there's even more
to that pattern.

          So, the point I'm making is that, I guess as an
operating rule from the staff's perspective, and we are where we
are, we have the sense that there were standards.

          We obviously have a limited amount of information, a
limited amount of time, but we're into some cases where you can
begin to flush things out.  And the issue is not simply, "Was
there a consent document or not?"

          MS. KING:  I understand.

          MR. GUTTMAN:  But was there a program where people
generally knew there were these rules, but that had a portfolio
of ten TBIs and nobody put the patient risk together with the DOD
purpose?  And you get to see a pattern.

          MS. KING:  So, what you're saying is you can't say
firmly, "Yes.  We have enough to be able to, with confidence,
talk about degrees of culpability.  But we might be able to
because there are some interesting trends and patterns in the
documents that we have.

          And depending upon what comes in and how this continues
to develop, it may be possible in some cases to actually talk
about degrees of culpability."  Is that what you're saying?

          MR. GUTTMAN:  We can put before you things that will
make for very interesting discussion.  Which in our judgment,
you'll have an interesting discussion.

          MS. KING:  You notice I keep saying staff judgment. 
I'm not assuming that that will be our judgment.  But I do think
it's important that those of you who have been working most
closely, at least have some reason for reaching some conclusions
in your own minds at this point.  Thank you, Ruth.

          CHAIRPERSON FADEN:  Henry?

          DR. ROYAL:  I'm trying to make sure that I understand
what I think we know.  It's my understanding that the DOD was
actually ahead of the rest of the Government in terms of
discussing these ethical issues.  Is that a fair statement?

          MR. GUTTMAN:  Yes.  But with the AEC being actually
ahead of the curve.  Right?

          DR. MORENO:  Well, the DOD in the sense that the Navy,
at least in the '30s, was talking about making sure that they had
secretarial approval.  Whether that was ethics or law or
manpower, I don't know.

          DR. ROYAL:  So, for whatever reason, they were ahead of
other Government agencies.  Who was the Government agency who was
responsible the ethics of medical experimentation in general?

          DR. MORENO:  Well, there was no such large civilian
bureaucracy until the NIH.  And then with the beginning of the
NIH clinical center, you have the emergence of prior peer review
and signed consent forms experimental subjects, of some
experimental subjects.

          DR. ROYAL:  So, the question I have about culpability
is, "Having articulated and discussed these ethical issues makes
you more culpable than not having talked about these ethical
issues?

          DR. MORENO:  No.  Ignorance is no excuse.

          CHAIRPERSON FADEN:  Right.  That's exactly right.

          DR. MORENO:  Ignorance is no excuse, but as a good
Socratic philosopher would say, "It's even worse to do evil
knowingly."

          CHAIRPERSON FADEN:  Henry, the question you raised was
one that, I know, the staff has to bear.  We've talked together
about it.  And it goes to the next step.

          If you start with the premise that Jonathan has laid
out before us, let's put the AEC aside for the moment because
that would bear more scrutiny looking hard and forming the
judgment about whether the statements that go back and forth
constitute official policy or not.

          I think Dan and Jonathan think that scenario one
applies there as well.  But it's unambiguous, I believe, with
respect to the Defense Department.

          That once the Nuremberg Code was made Defense
Department policy through the Wilson memo, that you then had a
scenario-one situation with respect at least to the research that
fell under the reach of the Wilson memo.

          So, you're stuck with atomic, biological, chemical with
respect to warfare research.  Then comes the issue first within
the Defense Department.

          What about other kinds of research that didn't fall
under the A, B, C warfare heading?  Was it the fact that the
Defense Department didn't have a policy that specifically spoke
to those situations?

          Does that change the Defense Department's culpability
in that context?  Because there they didn't have this written
policy.  And you go one step further.

          And what about some other department of the Government
that also supported research involving human subjects, in this
case, our focus radiation research, that also didn't have a
written policy at the time that the DOD did for this particular
arena?

          Do we say that somehow they're less culpable because
they didn't have the policy?  Or do you want to say they're
differently culpable?

          Or is it the one Government argument that once one
branch of the Government adopted a policy that applied to a
certain context, it should have been applied to all relevantly
similar contexts?

          So, taken from a victim's point of view, why should the
victim care if the victim was treated in the same way?  If it was
conducted by the Defense Department, then it would be somehow be
a wrong thing, in a technical sense.  I don't mean in a moral
sense.

          But if it was supported by then HEW, it was an okay
thing because HEW didn't adopt the Wilson memo?  That's the next
sort of level of analysis that we would need to go to, I think,
in the context of discussion about Government culpability.

          But first, can we get clear on where we stand as a
group with respect to how to understand the Wilson memo in its
most narrow construction?  But I agree with you.

          DR. ROYAL:  What I don't understand about the Wilson
memo is that a hypothesis was presented saying that we don't, at
this time, know whether or not the inability to implement the
Nuremberg Code was due to failure on the Government, or whether
it was lack of receptiveness on the part of the medical
community.  Is that true?

          CHAIRPERSON FADEN:  No.  I think that's not right.  I
don't think we've said that yet.

          DR. ROYAL:  I thought Phil had made that suggestion. 
And I thought Jon had agreed with it.

          DR. MORENO:  It's one explanation.  I don't think we
have the explanation.

          DR. RUSSELL:  There is an historical trend though that
in order to get the highest level of compliance to those
regulations, the Government across the board had to put in a very
comprehensive, bureaucratic superstructure to assure compliance.

          CHAIRPERSON FADEN:  Which they didn't.

          DR. RUSSELL:  So, I think you have a combination of a
community of medical researchers, and I would argue that there's
very little distinction between Government agencies.

          There's a large number of civilians who were serving
both as advisors and as contractors and grant recipients to all
the Government agencies.  So, there is a level of responsibility
across the biomedical research community here that pertains.

          I think the subsequent events, especially in 1975,
speak to the fact that the community was resistant to falling in
line with stated regulations.  And it took the superimposition of
almost a regulatory bureaucracy to effect that.

          And in the early period, there were no capabilities
within the Government to do that.  They could write all the
regulations they wanted to.  They had no way of enforcing it on
the contractors.

          They could write it into the contractors' law, but that
had very little effect.

          DR. MORENO:  There are many factors here.  Another one
may well have been that there's a conceptual problem about
whether the Wilson memo applied through physician investigator
contractors to people who were actively ill.

          And so, I think that perhaps if a civilian physician
investigator had gotten a DOD contract to do work on the normal
volunteer population, that the Wilson memo quasi-rules might have
driven through.

          But it wasn't clear that they were to drive through
with people for whom there might be conceivable therapeutic
benefit.  And so that was one of the disconnects, I think.

          And the reason I also feel rather strongly that that
was the case, that is, in 1962 when the Wilson memo becomes
AR 70-25, therapeutic work is specifically excluded.

          Clinical research with potential therapeutic benefit is
specifically excluded from those rules.

          So, I think there's a good reason to be intellectually
confused about how those kinds of rules apply when the physician
believes acting in the dual role in which physician scientists
often have to operate as clinician taking care of a patient and
as a scientific investigator.

          Which is which?  And what kind of rules apply under
what circumstances?

          DR. KATZ:  And informed consent requirements in 1962
were severely curtailed and no longer had the broad language of
the Nuremberg Code.  Correct?

          CHAIRPERSON FADEN:  We can check.

          DR. MORENO:  I have to check that, Jay.

          CHAIRPERSON FADEN:  Jon, do you know the answer to that
question?  Did the '62 Army regulations change the consent
provisions?

          DR. MORENO:  I believe the language is identical, but I
may be wrong.

          CHAIRPERSON FADEN:  I thought it was the same too.  But
I'm not sure.

          DR. MORENO:  This is the AR 70-25 as it was issued on
the 26th of March 1962.  And under basic principles, it says
simply, "Voluntary consent is absolutely essential.

          "The volunteer will have legal capacity to give consent
and must give consent freely without being subjected to any force
or duress.

          "He must have sufficient understanding of the
implications of his participation to enable him to make an
informed decision, so far as such knowledge does not compromise
the experiment."

          DR. KATZ:  You see --

          DR. RUSSELL:  You go get them, Jay.  It's been changed. 
It's all right.

          CHAIRPERSON FADEN:  An ethical truck is what we're
driving now.  I think we're going to drive a legal truck.  We can
pursue that one further.

          Going backwards, I'm still lost on if we have any
consensus in the committee with respect to how to understand the
Wilson memo as it would apply to judgments about experiments that
unambiguously fell under its mandate.

          And we have the ones, "Well what about this with other
ones?"  But if we start with A, B, C, in our case, we're only
interested with atomic, research related to atomic warfare with
healthy persons where there's no ambiguity about its reach done
by Department of Defense people and not by contractors.

          Let's start with that.  That's the simplest.  The
plainest case.

          MS. KING:  It's a plain case.  And I think that's easy. 
Dan pointed this out to me earlier this morning.  I think he's
quite correct.

          And that is, we certainly don't want to be the
committee that says that it's okay for the Government to have a
policy and then to ignore it.

          CHAIRPERSON FADEN:  Ruth?

          DR. MACKLIN:  Well, that's certainly true.  But if
we're talking about degree of culpability or locating the area of
culpability, I'm not talking about individuals, but area, it
certainly does make a difference whether that policy was ever
disseminated and who knew about it.

          CHAIRPERSON FADEN:  I think Pat's only speaking -- All
we're speaking to is Government culpability.  Not anything else
right now.

          MS. KING:  And I haven't raised degrees.  I asked the
second question where the evidence is apparently more ambiguous,
is not quite as clear about, "Can you put it into a category of
culpability?"  Even for Government.  We're not doing that.

          CHAIRPERSON FADEN:  This is just to establish a
threshold level of Government culpability in the most
straightforward case that we probably have.  Can we start there? 
Jay?

          DR. KATZ:  Well, you know, I have no problem with what
Pat and, I think, you are saying now.  But I would only be
satisfied at this point at putting it this way.

          If we also point out to the meaninglessness of this
whole document.  They created a document that even people like
Beecher criticized and others too as not being responsive to the
need of human experimentation.

          It's in his writing.  It's in his book.  If we add that
to this, well I would hold them culpable.  Not really culpable,
but say it's terrible that they didn't follow their own
directives.

          I would have to say, if they had wanted to follow their
directives, they would have fashioned a different document. 
Maybe Attorney Stephen's original document, I wish we could get a
hold of it, that he drafted, however clumsy it was.

          And he considered this one so much better.  I can't
understand that.  It was a much better document for policy
reasons than what he finally stole from the Nuremberg Code.

          In fact, we should thank the Nuremberg Judges for
developing this document because somebody accepted it into the
present form.

          CHAIRPERSON FADEN:  Ruth?

          DR. MACKLIN:  Maybe one of the problems here lies with
talking about the whole document.  If, in fact, our question is,
"Are there ethical standards?  And were those standards there?

          And was the Government in some way culpable for not
disseminating them or not implementing them?" we can answer that
question I think.

          When it comes to how good that document was and whether
it was flawed and whether Beecher or other great gods of ethical
experimentation criticized it, there I think we have to look at
the specifics.

          And I think we're using the words, and this is not to
criticize Jonathan or anyone who drafted this, but we're using
the words "ethical standards" perhaps too loosely or too
generally.

          Some things are standard.  Some are procedures.  Some
are rules.  We might have to be more precise.  And let me just
say what I mean here.

          Whether anyone followed them or whether standards were
ridiculous or not might depend on what element or what item we're
talking about.

          So, on page 2 of the memo that we're talking about,
Jonathan's memo, the examples given, "The Government had ethical
standards to govern human radiation research."

          These standards date back at least to the 30s,
Department of the Navy.  That was a document that talked about
consent of volunteers.  It used the word volunteers, didn't it,
World War II, the Committee on Medical Research in the post-war
era.

          And then there's the Nuremberg Code, which is another
example.  And then it says the clinical center of the National
Institutes of Health created a system of prior peer review.

          Well, that's a very important mechanism for maintaining
ethical standards.  It's not itself a standard.  But it is a
procedure that may be an ethically necessary procedure in some
form or other.

          IRBs is one form.  Because that's to make sure that the
science is good.  But the Nuremberg Code, Jay knows it by heart,
whichever item in the Code refers to the highest scientific
standards and knowing about the science and basing it on good
science and so on, the one way of implementing that mechanism,
that precept, that item in that Code is by availing one's self of
mechanisms of peer review.

          Because otherwise, you can get sloppy science, and you
can't be assured of that provision.  So, we shouldn't, I think,
be confusing the mechanisms or the modes of implementation with
the standards.

          And then we'd have to see what a policy says.  Policy
sometimes has mickey mouse stuff in it that has very little to do
with ethics or ethical standards and a lot to do with procedures.

          So, that's just an observation about these words that
are being used.  And when Jay is critical, or says that others
are critical of the Nuremberg Code and what did it mean, I think
we have to take it element by element.

          If we're talking about consent, there's nothing
ambiguous about the statement in the Nuremberg Code that
voluntary consent of the individuals is absolutely essential.

          If, however, we're talking about whether people got
consent in writing or whether there was a consent document or
whether it was a signed consent document, then we're talking
about different mechanisms by which to ensure the understanding
of the subject.

          Which is another element in the Nuremberg Code, that
is, the understanding of the subject.  So, I'm sorry to go on so
long about these distinctions.

          But if we're going to talk about degrees of culpability
and try to locate them, it seems to me these distinctions are
relevant in some way.

          CHAIRPERSON FADEN:  Phil?

          DR. RUSSELL:  I find it hard to criticize documents
from the early days especially in the light of 50 years of
progress and ethical understanding.  I don't have any trouble
criticizing the execution of the policy and the vigor and
enthusiasm with which         this was carried out.

          And I don't think we're going to get very far with
dealing with the quality of those documents because I think they
were kind of the first real organized effort of a major
Government agency to set standards and promulgate them.

          What we can point out is that at least two agencies had
very large activities in those areas that needed monitoring.

          They set some level of standards, which effectively
followed-up through policy and administration, probably would
have prevented most of our difficulties.

          So, I think we ought to focus on the execution, not on
the quality of the documents back in the '60s.

          CHAIRPERSON FADEN:  Could we follow-up on Phil's
analysis?  I'm trying to get a sense of the extent to which the
committee is comfortable with the way in which Phil has expressed
this, one characterization of what's going on here.

          I really want to step back from degrees of culpability
for a minute because I think we're going to lose people and start
with this threshold issue of culpability.

          We had this whole discussion this morning, "Can we make
any judgments about culpability?  Can we make judgments about
Government culpability?"

          That's what's on the table now.  Are we positioned to
make judgments about the culpability of the Government with
respect to what may turn out to be some, from today's vantage
point, inappropriate conduct involving human subjects?

          We have one seemingly clear case which is the Wilson
memo and its narrowly understood reach, and I don't quite know
what to do with Jay's qualifier with respect to commenting on the
document.

          But if we hold that to the side for a moment, is there
agreement that we can make culpability judgment, threshold
culpability, that there's an issue of Government culpability here
with respect to experiments that would fall under the expression
of that in the Wilson memo?

          Is there anybody who wants to argue against that?

          DR. KATZ:  I have a question with respect to the
discussion this afternoon.  If we don't say anything one way or
the other, that doesn't mean that the individual necessarily
agrees or disagrees.

          CHAIRPERSON FADEN:  I'm looking for a sense of the
group, Jay.  I'm trying to get a feel of how many people want to
try this on for right now.  We've got to know where to go.

          DR. KATZ:  You want to get a group expression.

          CHAIRPERSON FADEN:  Well a sense of the group as it
were with respect to whether this is a promising way to proceed. 
We have to do something about the fact that the Wilson memo
existed.

          And we have to draw some kind of inferences about the
reach of the Wilson memo for the task before this committee.

          And then it gets more complicated once we get beyond
the clear reach of the Wilson memo.  Things get tougher.

          We can't keep pushing this off forever.  There are only
so many more meetings.  There are only so many more times.

          MS. KING:  We've got to get used to voting.

          CHAIRPERSON FADEN:  Right.  We've got to get used to
starting to sort of own up.  We may try to change our mind.  We
could change our mind.

          But for right now, does this sound like a plausible way
to go?

          DR. GLATSTEIN:  Don't change now.  This is the first
progress we've had today.

          CHAIRPERSON FADEN:  Okay.  So, Eli, you would take it
that -- Okay.  Pat, you've already registered.

          MS. KING:  Can we just have a show of hands of the
people who are willing to take this small little step?

          CHAIRPERSON FADEN:  Are we clear about what the small
little step is?

          MS. KING:  You can always change your mind.

          CHAIRPERSON FADEN:  Yes.  You can take it back.  You
can do what you want with it.  But for right now --

          DR. ROYAL:  I'm not sure what we're voting on.

          CHAIRPERSON FADEN:  Do you want to restate it, Pat? 
You state it.  Because I'm not going to do it this time.  Or
somebody else try it who hasn't spoken.  That might be better
yet.

          Is there someone who thinks they understand what's
going on who would like to say what's going on?

          DR. GLATSTEIN:  I think we're voting on the concept
that the Government has articulated a specific standard in 1953
with the Wilson document that can be used for purposes of
designating responsibility for actions of the Government itself.

          MS. KING:  Where we can show that they were
inconsistent with the standard.

          CHAIRPERSON FADEN:  Where the conduct was different
from the standard and where it was clear that the Wilson memo
applied.

          DR. GLATSTEIN:  Yes.  From early '53 on.

          CHAIRPERSON FADEN:  Mary Ann?

          MS. STEVENSON:  This is assuming --

          CHAIRPERSON FADEN:  No.  We're talking about Government
culpability.  Because the document existed, the Government is
potentially culpable for violations of what was required by that
policy.

          MS. KING:  If you were subject to the standard.

          CHAIRPERSON FADEN:  If it fell under the standard. 
It's that simple.

          MS. KING:  Let me explain.  Maybe what's puzzling
people is, the reason I didn't focus on disseminated,
implemented, or practice is, as evidence comes into those terms,
you really can then start to refine what you're talking about
culpability in terms of whether it was knowing or reckless.

          But I'm not even trying that.  I'm just trying to see
if we're ready to bite the bullet about Government culpability
being based on having standards that are there, that were signed
by an official.

          In effect, holding them responsible for not
implementing them if we can't find any information that they, in
fact, tried to implement them.

          DR. RUSSELL:  Merely the conclusion that the IG came to
in 1975.

          CHAIRPERSON FADEN:  That's right.  That's exactly
right.  The reference there is the IG's report with regard to
chemical experiments done by the Department of the Army.

          We're asking, "Can we reach that same conclusion that
the IG reached in 1975 about experiments that would fall under
the Wilson memo?

          Is the Government culpable if we find the conduct was
not in accord with what was in the Wilson memo for experiments
that fell unambiguously under the Wilson memo?"

          A show of hands of how many people are comfortable with
that?  How many people are comfortable with that position?

          DR. THOMAS:  One more point of clarification.  At this
point, when you say in situations where it's applicable, are you
generalizing outside of DOD?

          CHAIRPERSON FADEN:  No.  I'm starting with the most
narrow construction, Duncan.  The most narrow construction is
even narrower than just DOD.

          It's DOD.  It's radiation research in relation to
warfare.  It's got to have that connection.  It's nontherapeutic.

          And it's not even contractors.  It's whatever the
Wilson memo says.  The next step is, "Okay, what inference do we
want to draw for other research funded by the DOD, for example,
that involved human radiation research that didn't, in the
narrowest sense, fall under the memo?"

          We've got a show of hands of a tentative agreement of
nearly everyone on that point.  This is progress.  This may not
seem so to the audience.

          But this is progress.  It's very hard for committees to
do this.  We're all very independent minded.  It's difficult to
do.

          Now the AEC is a bit of a tougher case.  We could do
two things now.

          MS. KING:  Before we go to the tougher case, would it
be out of line as a next step, just with the narrow case, to have
given to us -- I know we have lots of documents.

          But to have and pull from all those documents we
already have, the Wilson memorandum, documents related to
experiments circled with the relevant parts that suggest that the
Wilson memorandum applied and documents to show that there was
conduct inconsistent with that.

          So that next month, the committee can take a look at
the Wilson memorandum and a set of experiments that clearly,
unambiguously fell within the Wilson memorandum reach and the
evidence that supports or detracts from a finding of culpability
so the committee can read it and reach a conclusion that we have
at least one example, two examples for documents.  Does that make
sense to push along in the next step for that one small area?

          MR. GUTTMAN:  Do you have any free time?

          DR. MORENO:  An hour or two we can spend on that.  And
I think that's a good idea, and we'll be happy to comply with it.

          CHAIRPERSON FADEN:  Now the question is since we can't
magically make those packages appear, that worked on in the next
two minutes -- I realize given that it has to be done on January,
what should we now do with the rest of our collection?

          MS. KING:  See if we can develop some more work for
January.

          CHAIRPERSON FADEN:  That's what I was thinking.  Should
we stay within the Defense Department?  I'd like to take this
ultimately back towards my memo.

          But I think it's all going to fall in place if we keep
working at it incrementally this way.  Duncan?

          DR. THOMAS:  Just another point of clarification for
what we just agreed to.  When you said "not contractors?"

          CHAIRPERSON FADEN:  That's the way we'll go next.

          DR. THOMAS:  Let me anticipate where we're going.

          CHAIRPERSON FADEN:  Okay.  Let's go there now.

          DR. THOMAS:  I'm assuming you mean we didn't say
anything or other about the culpability of the contractors
themselves.  But did we just finish agreeing that the Government
agents who were responsible for overseeing --

          CHAIRPERSON FADEN:  No.  I don't think so.  I think
that's the next step.  The next limited step is moving to
research that would fall under the Wilson memo that was conducted
with Defense Department funds by contractors.

          And we're still going to Government culpability, not
the culpability of the contractor, whether the contractor is
understood as a university or the particular investigator or
both.

          Put that aside.  It's now work that would otherwise
fall under the Wilson memo.  But instead of its being done at a
DOD facility, is done by a DOD employee, is done by a contractor
with DOD funds.

          How do we want to understand that scenario?  Duncan?

          DR. THOMAS:  Generally, I'm inclined to say that the
Wilson memorandum would still apply to those agents of the
Government who are responsible for overseeing this activity and
that those would be clearly culpable.

          The one problem area that I'm having would be a
situation, and I don't know whether we have any examples of this,
where the Government contractor deliberately misled the
Government and there was really nothing much the Government could
have done to properly inform itself.

          CHAIRPERSON FADEN:  So, you want the link in there
assuming that the Government did not do all the Government
reasonably could have done to ask its contractors to comply with
the Wilson memo, some language or analysis to that effect?

          DR. THOMAS:  Right.  Clearly they should have had
implementation guidelines which tell the contract officer what
steps he ought to have taken to make sure that this guideline was
adequately enforced.

          The failure of these guidelines even to exist in the
first place would be clear liability, clear culpability.  Or the
existence of the guidelines and the failure for the contract
officer to enforce them would be another example of a clear
violation.

          But if the guidelines are in existence and the
Government contractor does everything they ought to do and the
contractor willfully misinforms them, then I'm inclined to
exonerate the Government in this case.

          The only question remaining then is should we look more
closely at what those guidelines actually consisted of and see
whether or not they were adequate.

          CHAIRPERSON FADEN:  Ruth?

          DR. MACKLIN:  Well, I think there's a problem with the
word "enforcement" here.  That is, if we're talking about
dissemination and asking for assurances of some sort from the
contracting agency, that's clear enough.

          But what does enforcement mean in this connection?  And
let me only make the analogy from today's research that's
Government funded.

          If the NIH which has elaborate guidelines in the
Federal Regulations -- I mean elaborate policies, not guidelines,
regulations in the Code of Federal Regulations, they seek
assurances from the institution that the institution has set up
these things and is going to be in compliance.

          But it's not the NIH itself, or the Office for the
Protection of Research Risks, that is in some immediate sense
responsible for enforcing them.

          It's the institution that's responsible for enforcing
them.  If, of course, a report were made or the NIH found out
about a violation, then it would be responsible.

          CHAIRPERSON FADEN:  Can I introduce something which is
sort of out of school here?  As a practical matter, it is
unlikely that we're going to find evidence that requires such a
fine point distinction.

          Frankly, it doesn't look like there's much evidence
that the Government put a lot of energy into working with
contractors to make sure that contractors --

          The fact pattern is not likely to occur.  So that
Duncan's worry and Ruth's refinement of Duncan's worry, it's just
not likely to happen.  We can have language in there.

          But the reality is, if we find such a case, we can
start working harder on the subject.  But the reality is we're
not going to find such a case.  At least right now it doesn't
look like we're going to get one.

          DR. THOMAS:  I'm not aware of any cases.  If this is
the true state of nature, I'm happy to accept your qualification.

          But my point is, in other arenas we do have examples. 
I'm thinking of the example of scientific fraud, for example.

          CHAIRPERSON FADEN:  Sure.  We can make sure we have a
clause that covers what we mean by that.  But we don't have to
get so refined as to worry about what enforcement is because
we're not even going to be close is what I'm suggesting.

          DR. MACKLIN:  But I want to hear what Phil was going to
say anyway.

          CHAIRPERSON FADEN:  I'm sorry.

          DR. THOMAS:  Well, there's a shared responsibility
between the contracting agency, the contracting authority for
oversight, and the university for carrying out the terms of the
contract or the grant and assuring that their people follow the
rules that are written down.

          And there's been an evolution that's been very clear. 
The first thing they did was they wrote requirements into the
grants and contracts.

          And then there were people who didn't follow the rules. 
So, then the Government got blamed for it.  So, they put in more
oversight.

          And finally, now we have the immense bureaucracy that
we have a Federal bureaucracy overseeing a university
bureaucracy.  Everybody overseeing the investigators.

          CHAIRPERSON FADEN:  And Jay says it's not working.

          DR. THOMAS:  And the fact is, in order to control
behavior at that level, that's what historically has been proven
to be necessary.  That wasn't known back in 1962.  You can't say
that it was an inadequate Government oversight.

          They had no experience in how to regulate the behavior
of a whole emerging generation of biomedical research scientists. 
It was not known.

          They thought initially, naively, that if they wrote it
into the contracts, people would follow the rules.  NIH found the
same thing.  It's not one agency of the Government that evolved
over 30 years.  And here we are.

          CHAIRPERSON FADEN:  Okay.  So, we're agreeing with the
proviso about the sorts of things that have just been discussed? 
Is the sense of the group that the Wilson memo could properly be
held to apply to research that related otherwise --

          DR. STEVENSON:  Do you have a copy of that?

          CHAIRPERSON FADEN:  We'll get copies for everybody so
we can all look at it.  We'll get the language.  We'll get them
right now.

          But the general sense of what's on the table would
apply to research that was conducted on contract funded by the
DOD, that the Government would also still be considered culpable
if the research failed to be conducted in line with the Wilson
memo.

          We're all going to the same sort of analysis.  I like
Phil's reminding us that the IG in 1975 reached this conclusion,
that if the Government has a policy, the Government is
accountable for conduct in relation to that policy.

          Quite apart from why the policy was there and how
anomalous it might have been relative to what else was going on
in the field.  The point is the Government had a policy.

          While we're waiting for this to get copied, part of me
just reacts in the sense that there's a way in which there's
something to me very offensive about a Government having a
policy, particularly one that speaks to human rights type
questions, has the policy then fails to do anything with it or
fails to do enough with it.

          And if we're in a position to hold Government
accountable for being in just such a situation, clearly we ought
to do so.

          DR. MACKLIN:  This is just a question.  But we don't
need to answer this right now, but it might help if we had a good
analogy from another area.

          CHAIRPERSON FADEN:  Nancy?

          DR. OLEINICK:  That was what I was coming to.  It
seemed to me that, for example, the Department of Defense puts
out contracts to build a new tank or some other weapon.

          And there must be some mechanism in place to ensure
that the contractor fulfills the obligations as they're paid. 
So, that there must be some mechanism for quarterly reports or
something as to what's being done.

          DR. RUSSELL:  They're the same mechanisms.  They use
the same Federal procurement regulations for research contracts
as they do for buying tanks.

          DR. OLEINICK:  No, no.  Not just the procurement, but
to make sure that the contractor is living up to his obligations.

          CHAIRPERSON FADEN:  It's the same thing.

          DR. RUSSELL:  You're buying services.

          DR. OLEINICK:  Okay.  I've got the wrong terminology.

          DR. MACKLIN:  I think I would like an example that had
some ethical teeth in it.  But I think that's important if you're
talking about contract specifications for building a tank or
something.

          But any area where there is a Government agency, and it
doesn't have to be a military agency.  But just to get the sense
of what it means for understanding rather than possibly anything
else.

          What it means for a Government agency that has
contractors and are out there to have oversight and enforcement
and implementation of things that bear on ethics, rights,
treatment of human beings.

          Is there something in labor, child labor?  I don't
know.

          CHAIRPERSON FADEN:  Sure there are lots.  Pat?

          MS. KING:  I don't know all those examples, but calling
these people independent contractors to reach a conclusion, if we
go back and think about this in terms of somebody else carrying
out a master's interest without labels where the master doesn't
properly instruct or hasn't given a lot of information, and then
the servant goes out and really messes up and injures somebody in
some way, the question would seem to arise, "Can the person who's
injured go after the master and think of the master as culpable
in addition to the agent if that's applicable?"

          And I'm not having any trouble with that at all.  The
only way that you start to argue that that shouldn't be the
result is to argue that somehow the servant --

          And I'm using legal analogies, but I intended to be
sort of ethical because I don't think the law sort of comes out
of nowhere.

          I think the question for some people then becomes
whether you want to think of the servant as so separate,
distinct, own operation that you want to consider it sort of a
separate entity.

          But I would ask here what the evidence -- I'm using
that term loosely, the ties are between how the Defense
Department once its purpose is carried out, I don't see any
reason not to think of Defense as culpable.

          DR. RUSSELL:  Your analogy, I think, is totally wrong.

          MS. KING:  Okay.

          DR. RUSSELL:  And I'll tell you why.  I said it a
minute ago.  The Government purchases services and goods through
a procurement system that's uniform generally across the board. 
The procurement regulations are about a 30 ft. shelf of detailed
regulations on how you do it.

          And it doesn't matter whether you're buying tanks, or
guns, or paper clips.  You follow those regulations.  And that's
how you contract for biomedical research using exactly those
regulations.

          And that contractor, legally, has fundamentally the
same responsibilities as a contractor providing a non-medical
service.

          Then the responsibility of assuring that the contractor
or grant recipient follows the rules, that's a legal auditing
oversight kind of responsibility.

          DR. OLEINICK:  How long have those regulations been in
effect?

          DR. RUSSELL:  They were in effect at the time we were
talking about.  They go back prior to World War II.  That's for
sure.

          CHAIRPERSON FADEN:  This is not a matter of regulation,
I think, though.  It's sort of irrelevant.

          DR. RUSSELL:  The relationship between the investigator
in the university and the Government is one of somebody who
accepts a contract, he is an independent contractor in both the
legal and the real sense.

          MS. KING:  But Phil, I'm not trying to hold an
independent contractor liable or culpable for a Wilson memoranda
standard.  I'm trying to hold the Defense Department, the
Government culpable.

          And that makes a difference.  If the Government in this
case, and I'm not trying to think about it in legal ways, needs
information from human subjects in connection with carrying out
its mission, information about its soldiers, to help the health
of his soldiers, and it decides that it doesn't want to do the
work itself, and it wants to go get somebody else to do the work,
I understand they got to go through all those procurement
regulations.

          What I'm asking myself is did the Government, where
human beings were involved and where human beings may be harmed,
have an obligation to see to it that the research was conducted
in accordance with its policy?

          Now it may not have done that.  It probably didn't. 
But my question is, "Should it?"  And I don't have any problem
answering, "Yes.  It should have."

          DR. RUSSELL:  I don't believe that releases the
contractor from ethical behavior in regard to the general ethics
of the community at the time.

          MS. KING:  I didn't say that.

          CHAIRPERSON FADEN:  We'll get to that in a minute. 
We're still working on the Government's culpability.  We will
later on, somewhere, at some point get to the culpability of --

          MS. KING:  With Duncan's caveat, I might add.  Because
Duncan's caveat was where a contractor willfully keeps
information or does something that the Government would have no
way of knowing about it.

          That actually raises a different question about whether
it had an obligation to have in place a monitoring system that it
might pick up some things like that.

          But I didn't want to get into that.  The bigger point
is obligation.

          CHAIRPERSON FADEN:  We don't need to.  We get it with
the understanding from Phil that we're not exculpating anybody. 
We're just looking at this point focusing on the Government
culpability.

          We're not saying it gets anybody off or anything else. 
We're simply saying, as Pat puts it, do we want this sense that
the Government had a responsibility to extend to research done by
contractors?

          Am I hearing anybody saying no?  No.  So, I can take it
that, in the same situation that we would hold the Defense
Department culpable under the Wilson memo for work done by a DOD
employee, we would also hold the Defense Department culpable with
Duncan's proviso if there was a failure to conduct research in
line with the Wilson memo if the work was done by a contractor
that otherwise would fall under the Wilson memo.  Should we get a
show of hands?  Or can we take it that people are pretty much
comfortable?  Again, we can change our minds later.  But we're
making a little bit of progress.

          MS. KING:  You may want a show of hands because we've
got to get in practice.

          CHAIRPERSON FADEN:  All right.  Let's do a show of
hands.  Because as tough as it is, we've got to get used to it. 
Are we ready to do a show of hands on this issue for those of us
who are here?

          Ready?  Are we ready to go to contractors with all the
provisos we've just talked about?  Okay.  And Jay's not here so
we don't know.

          Now we have a practical matter, which is do we want to
take a break this afternoon or not?  No?  No break.  We're on a
roll.  People that want to go, they can get up and go and they
come back.

          MR. GUTTMAN:  We moved past the IG already, right?

          CHAIRPERSON FADEN:  Well, we are a little, I think.  In
having gone to contractors, I think, we have moved a little
beyond that.

          DR. ROYAL:  Do we have the 1975 IG report?  Is that
something we've been given?

          MR. GUTTMAN:  Oh, yes.  We got it in the office.  And
we can give it to you tonight.

          CHAIRPERSON FADEN:  Now the issue is, do we give it to
the committee members?

          DR. MORENO:  We published a chapter, the chapter on
informed consent.  Chapter 4 or 5, I believe, months ago.

          CHAIRPERSON FADEN:  Which briefing book?  I don't
remember.

          DR. MORENO:  Months ago.  Ruth, please.

          CHAIRPERSON FADEN:  We'll find out which briefing book
it's in.

          DR. ROYAL:  I would like to see it again.

          CHAIRPERSON FADEN:  It was obviously relevant, bears
directly because it draws on the same memo, but it spoke to
chemical, research related to chemical warfare as opposed to
research related to -- Okay, Duncan.

          DR. THOMAS:  Can I please revisit just a little bit
longer my concern, which you seem to dismiss as being academic
because we have no real incidence of it.

          And I can't think of an incidence involving human
radiation experiments.  And yet, it seems to me there must be
numerous examples, contemporary examples, of failures of IRBs to
do their job properly.  

          The first one which comes to mind is the recent story
about the UCLA schizophrenia experiment.  I assume it's just one
of many.

          Now, in this situation, let us suppose for purposes of
argument, and I don't know whether this is true, that -- never
concerned itself with ethical concerns.

          The project officer was never aware that there were any
problems and so forth.  Let's take it as assumed, if this is
something that the IRB should have thought about beforehand, they
should have had the foresight.

          And I've debated about this, and they either discussed
it and came to the wrong conclusion or they never even thought
about it.  One way or another, they fell down on the job.

          Now, I would have a hard time saying that this is an
instance where the Government ought to be held liable, unless we
get to the next stage where reports start coming in.

          They are sent to the Government, and the Government
ignores them.  And that would be a clear case of Government
culpability.        

          CHAIRPERSON FADEN:  Well, I think that the issue would
come up, Duncan, if we had such a case.  We would probably debate
whether we thought the level of Government oversight was adequate
or not.

          And you might say it was adequate and the Government
should be left alone.  And somebody else would say, "See there's
an illustration that the Government should be doing more
auditing."

          And the Government still retains some level of
culpability, and we could start discussing that.  All I'm trying
to say is I agree about the general importance of such a clause.

          I don't want to spend a lot of committee time worrying
about particular fact situations in the hypothetical and whether
or in the real in the future and whether we would always have
consensus that this was adequate level of Government enforcement
unless we find ourselves with cases where this becomes live for
us.

          DR. THOMAS:  That's reasonable. 

          DR. RUSSELL:  I think it's impossible to deal with that
issue unless you're willing to set standards for a level of
enforcement or oversight.

          That's where you get into difficulty, how much is
enough, and it's only known after there's damage done.

          CHAIRPERSON FADEN:  And frankly, I don't think we need
to worry about it because we're going to find the level was so
low, that it's not like angels on a pin, or, Dan, give me the
right metaphor here.

          MR. GUTTMAN:  The real world point is, in fact, you
probably do have a case, which shows the relevance in the facts
that it looks like what happened with the AEC is part of the
reason they were active not simply the plutonium, but in '48 the
wise men of science are writing to the University of California
saying, "What are you doing with human experiments?"

          CHAIRPERSON FADEN:  But I want to wait until we get to
the AEC to do that one.  

          MR. GUTTMAN:  But it shows, the question then why then
the AEC didn't continue to keep up with everybody else having
been sensitive to California.

          CHAIRPERSON FADEN:  Okay, but we'll get to that one
when we get to that one, which is going to be hard.  Okay, so
we've made two tentative steps with respect to the Department of
Defense.

          MS. KING:  So, the next month's work can now include
people who were contractors and have examples so that we can
actually debate the case studies.

          CHAIRPERSON FADEN:  Correct.  In other words, what Pat
is saying is that in January, staff will try to pull it together
with a couple of examples where staff thinks, in fact, we have
conduct in violation of the Wilson memo, either as performed by
DOD people or as performed by contractors that fell under the
Wilson memo.

          DR. KATZ:  Could we also include some documents in the
perspective point one and two where staff feels that they were in
compliance with the standards?

          CHAIRPERSON FADEN:  In compliance with the Nuremberg
Code?

          DR. KATZ:  In compliance with standards?

          CHAIRPERSON FADEN:  I don't know if we have any.

          DR. KATZ:  If there are such things, there may not be,
but if there are, it would be nice.

          MR. GUTTMAN:  What we have is the evidence that the
Navy in fact followed     a review process, to respond directly
to Jay's point, isn't clear whether it was in the Nuremberg Code.

          DR. KATZ:  That they complied with the Nuremberg Code?

          MR. GUTTMAN:  No, the review process.  But it's not
clear that they did something to actually get their human
experiments reviewed according to some standard.  What is not
clear is that it was the actual Nuremberg Code.

          DR. KATZ:  So, we don't really know.  With this,
anything showing that there was compliance with this memorandum
would be very nice.  There may not be anything.

          CHAIRPERSON FADEN:  Jonathan, did you want to get on
point?

          DR. MORENO:  No, this is not on point.  I noticed that
people are taking a great interest in the Wilson memorandum.  And
I want to point out that there is a Talmud to the Wilson
memorandum.

          In the Defense Department memo, there's a line by line
analysis, it starts on page 24 and goes on for a few pages.

          CHAIRPERSON FADEN:  Well, maybe you should get that. 
How many people have the Defense Department memo in front of
them?  It's in the folders?

          It was in one of your big fat separate ones, but if you
go to your blue folder, we pulled out for you, because we figured
people wouldn't lug around the blue folder that was waiting for
you, is a memo called, "Working Draft of the History of the
Department of Defense Ethics Policies."

          Just so you know we are actually right on schedule with
respect to the agenda.  We are supposed to be doing this now. 
So, this is good.        This document also appears in the ring
binder that's marked The Defense Department Ethics Policies.

          On anticipating that people did not want to carry three
fat ring binders with them, it was also provided for you in your
folder.  And what pages, Jonathan?

          DR. MORENO:  It starts on page 24 and several pages,
about two or three pages.

          CHAIRPERSON FADEN:  Jonathan, while people are looking
at this, can you review, and I don't know that this is
necessarily the next step to take, but can you review for us what
evidence there is suggesting or limiting the reach of the Wilson
memo to the healthy subject as opposed to clinical research?

          What is the reason for thinking that that was the
intent of the Wilson memo, if that was indeed the intent?

          DR. MORENO:  Well, I guess the reason is that we seem
to be lacking, and I'm going to defer to people who are doing the
oral histories.

          In their interviews, I think that information isn't
finished yet, but we don't seem to have instances in which the
contractors in relevant periods knew about -- being careful here,
I'm looking at my colleagues on the staff, knew about the Wilson
memo.

          CHAIRPERSON FADEN:  I would step back from that, Jon. 
The first point is, is there anything in the Wilson memo itself
that says it's only supposed to be healthy volunteers?

          DR. MORENO:  No, that exception does not.  The
exclusion of coverage for so called therapeutic research doesn't
come, so far as we know, until 1962.  Though that might have been
the practice between 1953 and 1962.

          CHAIRPERSON FADEN:  Henry?

          DR. ROYAL:  The memo says the policy set forth below
will govern the use of human volunteers.

          DR. MORENO:  Right, not normal volunteers.  It doesn't
say normal volunteers.

          CHAIRPERSON FADEN:  It just says human.

          DR. LEDERER:  But maybe that's an important distinction
between volunteer and patient.

          CHAIRPERSON FADEN:  Well, that's the issue.

          DR. MORENO:  That I think is part of the ambiguity that
I was eluding to a little earlier.  Is a patient somebody who's
sick and might in somebody's imagination derive therapeutic
benefit from this or deriving an ounce of hope from this?  Is
that person a volunteer?

          CHAIRPERSON FADEN:  I think the issue is exactly right
where Mary Ann is going.  Clearly, this isn't intended to apply
to clinical research in radiation, where the purpose is to
advance diagnostics or radiotherapy.

          But the issue is if you use an ill person, a patient,
to answer a question having to do with atomic defense, you can
all guess where we're going here, would it fall under here?

          Clearly, it's not if the purpose of the study is to
develop a new radiotherapy or a better imaging technique.  That's
not the intent of this and it happened to be funded by the
Defense Department.  That's clearly not the intent of this
policy.

          But if the subjects were ill persons, but the purpose
was to advance a question having to do with atomic defense, would
this policy have applied to such research?  They're not excluded.

          DR. MORENO:  Some scholars in medical ethics have
argued that the Nuremberg Code itself was not intended to apply
to sick people or, what we would call today, therapeutic
research.

          So, it's entirely possible that the culture presupposed
that this applied to normal healthy volunteers and not to people
who were sick and not, therefore, to what we would call
therapeutic research.

          CHAIRPERSON FADEN:  But, Jonathan, I think we're
conflating two issues.  One is therapeutic research and the other
is research on people who are ill.

          You can do research on people who are ill with no
therapeutic intent or purpose.  They just happen to be sick. 
You're answering a question that has no potential or benefit on
that.

          DR. MORENO:  I think that conflation also is part of
the -- I know I'm getting ahead of myself and you probably,
probably part of the plutonium injection story also that that
conflation applies in that case.

          So, we're not the first generation to conflate them.

          CHAIRPERSON FADEN:  Right, I'm just teasing it apart
for now.

          I guess the next step is would we want to hold as our
tentative standard that this would apply to research in which the
subject happens to be ill?  But the purpose of the research is
atomic warfare advancement, to answer a question about atomic
warfare.  Yes?  Yes, the sense of the group is yes.

          DR. LEDERER:  Do you think that was the intention of
the writers of this memo to cover that situation?  Does that
matter?

          CHAIRPERSON FADEN:  I don't know that they ever thought
of that.  I don't think we know, and do we care?

          DR. LEDERER:  Does the intention matter in evaluating
the conduct against a standard?

          CHAIRPERSON FADEN:  No.

          DR. LEDERER:  No?

          CHAIRPERSON FADEN:  No, I don't think so.

          MS. KING:  Well, it might matter for degrees of
culpability, if we start getting into the digress of culpability. 
Yes.

          CHAIRPERSON FADEN:  Right now, I'm just getting into
threshold, is there Government  culpability at all?  Pat, I'm
going to push you away for a moment.

          MS. KING:  I just wanted to say that it does come up
later.

          CHAIRPERSON FADEN:  To answer Susan's question.  All
right.  Yes, Ruth?

          DR. MACKLIN:  Just to say a word about the intention,
it may not have been the intent of the framers in a positive
sense, that is, they may have been silent.  It may not have been
their intent to include patients.  I mean sick people.

          But if in fact someone got the bright idea that we got
some dying people here who can't be benefitted by anything so
let's do this kind of research, then the policy should apply
whether the people who framed the policy had the idea that that
would or should be done.

          CHAIRPERSON FADEN:  Okay, let me see if I can pull this
one to where we are.

          So, now we're saying that the notion here clearly
extends to research in which, it's irrelevant whether the person
who is the subject is well or ill.

          The point is that the purpose of the research is, as
put here, "related to the evaluation or development of effective
preventive measures of defense against atomic agents."

          So, it goes to the purpose of the research.  The reach
of the memo goes to the purpose of the research and whether the
subject is ill or well is not relevant.

          DR. KATZ:  Could I just ask a question?  On page 26 and
27 of the Moreno document at the bottom of the page and moments
later the chair falls down, whatever you want to call it.

          And then he says he just was handed the Wilson
document, and he threw out all the people who didn't have top
secret clearance.  And then they had an off-the-record
discussion.

          And finally, on March 12, Dr. Coggershall sent a letter
saying, "The Committee on Medical Science is desirous of the
receiving the official legal implication of all the clauses of
the document and the rationalization of the prime discrepancies."

          And now, we're making all kinds of judgments.  What is
the relation of the preliminary judgments we are making now and
this very perceptive statement by the Committee on Medical
Science?  Couldn't we understand what this was all about and
wanted clarification?

          CHAIRPERSON FADEN:  Fine, maybe they got it.  We don't
know.

          DR. KATZ:  Well, it's possible.

          CHAIRPERSON FADEN:  We don't know.  Arguably, Jay, even
if they did.  The point is this was the policy.  Nobody took it
back.  We're talking now in the sense of holding the Government
accountable for it's policy.

          Even if people in the Government thought it was stupid
and dumb and unimplementable, nobody took it back.

          I mean, nobody officially said, "We made a mistake,
we're modifying it, we're softening it, we're changing its
reach."  It stayed the policy of the Government even if people
objected to it who didn't understand it.

          Maybe they got clarification, but even if they didn't. 
That would be my response to the weight of that.  It didn't go
away.  It stayed the policy.

          DR. GLATSTEIN:  Top secret.

          CHAIRPERSON FADEN:  Top secret, which is all part of
the whatever, and we're still tracking down when it became un-top
secret or how it was disseminated, but for all of that, it stayed
the policy of the Defense Department.

          What we're working on is its reach, how we're to
understand its reach.

          DR. RUSSELL:  I don't think we should overestimate the
importance of what a top secret classification is.  My guess is
that all the way down to the officers who were doing the actual
contracting for the research that had top secret clearance.

          CHAIRPERSON FADEN:  That's a very good point, Phil.

          DR. RUSSELL:  So, I don't think there was any
probability that this classification inhibited the flow of
information down to the captains and majors that were working in
the granting and contracting agencies of the Army and the Air
Force and the Navy.

          DR. MORENO:  There is one counter-example, though,
Phil.  The flash blindness study that Dan referred to earlier.

          Early in 1954, the officer in charge of taking care of
those men said that he heard a rumor about a policy and didn't
know anything about it.

          CHAIRPERSON FADEN:  But the issue there Jonathan --

          DR. MORENO:  There's always somebody that doesn't get
the word.

          CHAIRPERSON FADEN:  The issue there though, to go to
Phil's point is, did he not know it because he wasn't cleared and
the policy was top secret?

          Or did he not know it because they weren't
disseminating this top secret policy to everybody who had
clearance and who had a need to know?

          MR. GUTTMAN:  He clearly found out about it.  When he
asked, he found out about it.

          CHAIRPERSON FADEN:  Right, it could have been the
classification was not the bar to his not knowing.  It could have
been something else.

          DR. MORENO:  I don't think that's necessarily the case. 
On page 34, now it's called mine, but it's not mine.

          The quote is, referring to this note, this was written
by this fellow from the Navy, I believe, Lt. Com. Browning, "It
is intended that this letter shall point out the need for some
relaxation of the grip in which this document is now held."

          I'm not sure how to interpret that, but it certainly
doesn't rule out the possibility that the grip was a grip of
security.

          CHAIRPERSON FADEN:  No, not at all.  But it could be
something else.  But, yes, you're quite right.  I think you're
right.

          DR. MORENO:  I think I'm right.

          CHAIRPERSON FADEN:  Right now, I'm sure you're right. 
Okay, now.  The next step, which some of you may have figured out
where I was going here.  I didn't know I was going anywhere until
this started.  But now that this started, I know I'm going
somewhere.

          If we are saying that the Wilson memo as policy of the
Department of Defense applied where the purpose of research was
to advance knowledge in relation to atomic warfare, regardless of
whether the person was ill or well, what happens when we move to
something where the research had multiple purposes, one of which
was to advance questions in relation to atomic warfare?

          I'm sorry, Mary Ann, I forgot.

          DR. STEVENSON:  It was actually a minor point.  Talking
about whether or not this applied to ill people or healthy
volunteers, page 2D talks about knowledge of the natural history
of the disease or other problem under study.  So, there's sort of
an implication I think that ill people might be used.

          CHAIRPERSON FADEN:  It could be ill people could be
included or whatever.  That's interesting.  Okay, I'm sorry, I
got wrapped up and forgot.

          But the next step is, well what if you've got a
multiple purpose study in which part of the purpose indeed is to
address the question in a clinical arena, and maybe there is a
prospect of benefit to the patient subject, and part of the
purpose of the study is to advance a question in relation to
atomic warfare?

          And obviously, this would be one way of characterizing
the total body research funded by the Department of Defense with
several purposes.  Phil?

          DR. RUSSELL:  We finally got around to assessing the
Defense Department as culpable on the basis of a published
standard that was imperfectly carried out, and I think
appropriately so.

          I would argue that there was a shared responsibility in
the biomedical research community.  That community also had
standards of behavior and standards of professional
responsibilities.

          Unfortunately, I think we're going to have a greater
difficulty in documenting it because it's a more diffuse
community and doesn't keep the kinds of records its Government
does.

          But I would say that we should use the same kinds of
thinking in assessing that community because I feel there's a
shared responsibility here.        The responsibility was shared
between those who were promulgating and paying for this R&D and
those that were carrying it out.

          They came from two communities.  Both communities had
its standards of behavior where holding the Government to a
proper standard, I believe.

          Now, I think we need to look at it from the other side
and hold the biomedical community which is largely a university
community to its standards.

          And I would argue that the reason that the Wilson
memorandum came into being was because that was a community
standard.

          It wasn't codified in the civilian world, but the
people that generated it were largely civilian advisors to the
Government.  At least a large number of them were.

          And there was a tremendous interchange between
Government and the military especially in the biomedical
community in the 1940s and 1950s.

          I would wonder if there are ways to get the same kind
of information from either large civilian biomedical research
centers, university centers, major clinics, and so forth about
their standards for biomedical research informed consent.

          CHAIRPERSON FADEN:  Well that's obviously an enterprise
the staff also has been involved in, and we can speak to that,
too.  We will speak to that, but I'm not sure exactly what
conclusions we'll reach there.  Ruth?

          DR. MACKLIN:  The only reference that we have and it's
in the two scenarios document memo, and this was something that I
saw too, but I had forgotten what it said was the 1946 American
Medical Association document.

          Now, it's clearly a civilian document.  It's one thing
to look at the level of the institution for policies and there
might not have been any.

          The AMA does not stand in the same relationship to
academic doctors though as the armed forces of the Department of
Defense does to the people who work under it.

          I mean, you don't have to belong to the AMA.  The AMA
is a professional society of physicians and yet one could argue,
I mean, people often point to the AMA code of ethics for other
purposes.  So Jonathan, what did the AMA code say in 1946?

          I was surprised, and I thought it had the words -- It
did have consent, but not informed consent?

          DR. MORENO:  It's the version that probably Ivy used to
draft the version that became the Nuremberg Code, but Harkness is
the expert.  You want to say something about what that code was
like?

          CHAIRPERSON FADEN:  We can get it for you.  The three
principles we have, we can pull it out.

          DR. MACKLIN:  But the question is whether or not it
applies in just the same way.  Phil is asking for an analogy in
the academic professional medical community.

          And one of the dis-analogies, there are several dis-
analogies.  One of the key dis-analogies is the mode of
dissemination or implementation.

          Unlike the Wilson memo that says here at the end on
point number 5, "The addressees will be responsible for ensuring
compliance with the provisions of this memorandum within their
respective services."

          Nobody is responsible for ensuring either compliance or
dissemination with what may have appeared in an AMA code.

          So, I think that one dis-analogy lies in the absence of
any authority that exists over physician researchers.

          DR. RUSSELL:  We weren't speaking to authority.  We
were speaking to community standards as a basis on which to
assess culpability, not authority.

          DR. MACKLIN:  All right, that's fair enough.

          DR. RUSSELL:  I think there are many organizations in
addition to the AMA, the American College of Physicians, the
Young Turks, the Old Turks.

          Those organizations that have been concerned with
biomedical research have spoken to these issues over time.  And
we need to hear that.  We need to find out what those were.

          DR. MACKLIN:  Okay.

          CHAIRPERSON FADEN:  We are in the process of finding
that out.  And then there's also the community standards as
established by practice which is part of the oral history project
agenda.

          That's a large part of what I understood the purpose
for doing the oral history project was, to establish essentially
what the community standards were of the biomedical research
community of the period.

          We'll be ready to hear something about that in January?

          DR. MACKLIN:  Yes.

          CHAIRPERSON FADEN:  Okay, so that will be useful.  We
can ask staff to put together your preliminary findings from the
oral history project with whatever articulated statements we can
collect and the collective interpretations of members of the
committee.

          We'll hunt down as many of them as we can find that are
of the period from relevant professional organizations.

          DR. KATZ:  With respect to that, I read four of the
first transcribed interviews, and I had questions about their
value.  But Susan and staff are really commended and
congratulated for undertaking this project.

          The four that I've read so far are good -- in
summarizing for the entire committee and probably not everybody
will be --.

          CHAIRPERSON FADEN:  Jay, can you speak in the mike
please?

          DR. KATZ:  As I plan to do, but so far the first four,
by and large, or three of the four.

          I'm, of course, also particularly delighted because
those three really support everything that I've been saying about
the, no state of ethical deliberations and reflection during that
period.  They are very wonderful documents.  Thank you.

          CHAIRPERSON FADEN:  So what may happen, Phil, is that
we may find a real disjunction between the policy of the Wilson
memo and the practice of the biomedical community by and large,
with perhaps with some very notable exceptions in certain
traditions like the tradition in infectious disease.

          DR. STEVENSON: --

          CHAIRPERSON FADEN:  Exactly.  That's jumping ahead, but
that's not an unlikely outcome in terms of --

          DR. MORENO:  What did Mary Ann say?

          CHAIRPERSON FADEN:  Pardon?  Isn't this a nice ending? 
Do people want to go home yet?

          DR. MORENO:  We didn't hear what Mary Ann said.

          CHAIRPERSON FADEN:  What Mary Ann said is with the
Wilson memo being ahead --

          DR. GLATSTEIN:  The memo being ahead, but there's some
question about the Department of Defense.

          CHAIRPERSON FADEN:  Well that's it.  The policy, not
the practice.  The practice may in fact be the same all the way
around, but the policy was way ahead.

          And we're taking the position, at least tentatively,
that the Government should be held accountable for conducting
itself in accord with its own policy.  We can get to the
complicated question later of what about those agencies that
didn't have a policy.

          Do we want to say it's one Government and if the
Government had that policy, if it was good enough for the goose
it was good enough for the gander, and that kind of stuff?

          We'll get to that, but right now, we're sticking with
the Defense Department because it had a clearer policy.

          The AEC is the next case where there's an argument to
be made that it had a policy, but it's not something signed by
the head of the AEC with a thing at the end that says everybody's
got to disseminate it and monitor it and stuff.

          Then we can go to HEW and the Veterans Administration
and so on.  Pat?

          MS. KING:  I have a question about the TBI experiments
and that is to those staff members who have been working with
documents that work with that class of experiments, what do the
documents suggest, if anything, about the understanding of those
who were conducting the experiments?

          To rehearse where we were, this was the example of the
mix purpose experiments.  So, and Phil is correct, the mixed
purpose, I agree with him, that you would look both to the Wilson
memorandum and to community standards because they both might be
relevant where there are mixed purposes.

          But do our documents suggest, if anything, about what
those who were involved in the experiments understand to be the
standards at the time?

          CHAIRPERSON FADEN:  Gary or Ron, do you want to comment
on that?

          MR. STERN:  Well, there's two ways of looking at it. 
One is, for example, in the Cincinnati experiments, we have the
review documents of the Army reviewers in which they clearly, one
in particular says, well this experiment could be useful for the
advancement of cancer research, as well as understanding and
knowledge with respect to the effect of atomic weapons.

          In terms of what did the doctors think or know, I guess
it's not entirely clear.  For example, Dr. Saenger, in the
Cincinnati experiments, described how he was very careful to
separate the medical therapy from the Defense Department research
in that he kept the money separate and kept the work separate so
that, for example, he was interested in the DOD part.

          He had no part whatsoever in picking patients and
prescribing the therapy for patients.  So, at least in his mind,
he had a very clear distinction, or that's how he described it. 
That's the best that we know.

          CHAIRPERSON FADEN:  Dan, did you want to comment?

          MR. GUTTMAN:  The doctors that we have interviewed,
Gary interviewed Dr. Saenger and Gil interviewed Col. Pickering
who was related to the M. D. Anderson, suggests there was some
notion of consent.  The documents do not show any implementation
from the DOD downward of the DOD code.

          What they do show, and this was in the memo, and it
really can't be expressed as anything but a calculated decision
because it's quite clear.

          That after this debate on human experimentation in
1950, where it was decided at the "highest levels" not to go
ahead with it, they went ahead and used the cancer patients.

          And I don't know how you can say it other than saying
that that was some way of an exception.  And that to me raises
very obvious questions that relate to the things we are talking
about.

          MR. STERN:  If I can just add one thing.  With respect
to the actual policies, the Wilson memo, as well as the 1962 70-
25 memo, when we asked Dr. Saenger explicitly if he was familiar
with these,  he said no, he had never seen them before.

          We showed him the 1962 policy, and he said he'd never
seen that before.  And we asked him as well, if he got any
instruction or training from the Department of Defense either
with respect to the specific contract or any other worker contact
that he had had regarding ethics, and he said no, there was never
any type of communication on the issue.

          MR. GUTTMAN:  The key point there was that Dr. Saenger
was in the Army contemporaneous with the issuance of the Army
version of the Wilson memo '53 to '55.  Right, Gary?

          MR. STERN:  Right, and even then, he was not trained or
that never came down to his level as he said.

          DR. STEVENSON:  Also, Gary, I may not remember this,
but I think from the Saenger interviews, he said he instituted a
more formal written informed consent at the behest of the
university.

          And then, he subsequently heard from the Department of
Defense, but didn't he say he started his more rigorous informed
consent before something formal came down from the DASA?

          MR. STERN:  His experiments went from 1960 to about
1971.  According to him, there is oral consent from the
beginning.  They instituted a written consent in 1965 in response
to a directive from the Army regarding use of consent for drugs.

          And he decided radiation was like drugs and so it might
was well apply here, even though that memo didn't apply to the
radiation.

          And he says that was two years before the university
itself required written informed consent which was 1967.  So, he
was doing written consent in 1965, even before the university
required it.

          CHAIRPERSON FADEN:  Henry?

          DR. ROYAL:  Did Dr. Saenger have security clearance
where he would have been able to see top secret documents in 1953
when you said that he was --

          MR. STERN:  He did have a clearance, yes.  I don't know
if it was top secret, but he was cleared.  He said that he never
did classified research of any kind, but presumably he was top
secret because he was at Sandia lab for example.

          MR. GUTTMAN:  We know the answer.  I think it was, but
we have the answer to that, '53 when he was in the military. 
We'll check it.

          CHAIRPERSON FADEN:  This is of course useful to go back
and forth between what we know about a particular case and the
context.  We draw back to the question.

          The question before the committee is whether the
Defense Department should be held to having applied the Wilson
memo in dual purpose context, which is not to speak at all to the
issue of whether to what extent the medical research community in
the private sector what role they had.

          This is to go solely to the question of the Defense
Department's responsibility.  When you move to a dual purpose
context, the question before the committee is does the Defense
Department's culpability with respect to failing to make sure
that the Wilson memo was followed assuming there was such a
failure, would it now be gone because it's dual purpose research?

          If at least one purpose of the research fell under the
stipulation under the Wilson memo, that it was related to atomic
warfare?

          MR. GUTTMAN:  Does it matter if there's no protocol for
the other purpose?

          CHAIRPERSON FADEN:  Put that away.  That gets too
specific.

          MS. KING:  I actually heard the exchange at the end of
the table, and I'm not sure that what Dan says is not relevant. 
I think it may be hard to make a generalized judgment about dual
purpose experiments.

          CHAIRPERSON FADEN:  That could be one problem that we
face.

          MS. KING:  It may be hard to try to figure how to judge
dual purpose experiments asking a lot of specific questions about
the dual purpose experiments to give us some idea of what the
terrain looks like.

          In my mind, if it starts to look more like they may
have had dual purposes, but the engine driving that train was the
Defense Department and everything that was done, then I'm much
more inclined to want to write a more nuanced statement about it,
but ultimately perhaps to conclude that the Wilson memorandum
should have applied.

          If it starts to look like this engine was really the
patients' needs and there were tag-ons, then I'm much more
inclined in the other direction.

          So it may not be that we judge each set of experiments
separately so much as we need some specific information about the
dual purpose experiments to take us in one direction or the
other.

          CHAIRPERSON FADEN:  That's very  helpful.  Duncan? 
Then, Ruth?

          DR. THOMAS:  I think I'm going to end up back what Pat
just said.  In my views, the Wilson memo would apply to those
components of the experiment that were procured with Government
funds.

          What do I mean by those components?  Suppose for
argument sake, that for the purpose of the clinical
investigation, certain additional laboratory studies were
commissioned that had nothing at all to do with military purpose.

          Then we would not be looking into the ethics of those
additional clinical investigations and judging them in light of
the Wilson memo.  So, I would say it would not apply to the
totality of experiment which would include both clinical and
therapeutic pieces.

          But one thing in particular that would apply to would
be the ethics of irradiating people in the first place.

          Because they wouldn't be doing the additional
biomedical investigations that were what were specifically
procured in the Government contract if they hadn't been doing the
radiation.  Right?

          So, the radiation is therefore an inherent part of it
even though it may have had another purpose.  To judge this,
then, it isn't necessary, and this is where I might have a subtle
difference with Pat, to decide whether the engine that's driving
the study is the military purpose or the clinical purpose.

          Instead, you simply have to investigate which
components of the study are those that are essential to the
Government purpose.

          CHAIRPERSON FADEN:  Either way, it sounds as if we need
to be working in a contextualized way around these dual purpose
experiments.

          We need to be steeped in a better understanding of
particular dual purpose experiments.  Maybe characterize the
situation in more refined detail before we can say that we will
hold the Government culpable.

          This may be a case where degrees come in, the extent to
which we will hold the Government culpable for conduct in
relation to those experiments.  It failed to conform with the
Wilson memo.

          DR. MACKLIN:  I'm just having trouble with dual
purpose.  I need a little more elucidation.  Is it one research
maneuver that has two purposes?

          One the benefit of the patient and the second to find
out this information?  Or is it multiple maneuvers where one is
the therapeutic maneuver and a different maneuver is whatever is
required or procedure for the Governmental information?

          CHAIRPERSON FADEN:  That, too, maybe we can only work
out in the context of particulars.  I think that relates to some
extent where Duncan was going, that the whole project overall had
dual purposes.

          Whether it's meaningful for a particular project to
slice it out that this part was done because there was a military
question, that needed to be answered.

          And this part was done because there was a clinical,
medical question that was to be answered that might have benefit. 
Some experiments may lend themselves to such an analysis.

          Others might not.  They may be completely -- all of a
piece with two questions.  And so what I'm hearing is all of
these refinements of how we might think about this problem in
relation to the culpability of the Defense Department vis-a-vis
the reach of the Wilson memo would await analysis in specific
experiments.

          And it suggests that clearly something that has to
happen in January is a revisiting of at least one or two of these
punitive dual purpose experiments in a more refined way in the
light of this charge or this problem of the reach of the Wilson
memo.

          And I want to just be careful.  We're not now judging
the ethics of the experiments.  We are judging the culpability of
the Department of Defense for failing to implement the Wilson
memo in that instance.

          The analysis of judging the experiments, the ethics of
the experiments overall, would be a separate, but perhaps closely
related, but nevertheless separate enterprise.  Susan?

          DR. LEDERER:  I guess I just wanted to ask whether or
not you can tease apart those dual purposes in the documentary
evidence that you have available?

          MR. STERN:  Whether we could tease apart those
purposes, I think with respect to the TBI experiments we can.  I
think it's fairly straightforward.  The clinical therapeutic
aspect was to see if total body irradiation would have a
palliative effect on the patient on that type of cancer.

          Would it prolong their life for any number of months or
years?  And the military interest was a number of things.  One
is, could you find the biological dosimeter by analyzing the
urine or the blood or any aspect as a result of the irradiation?

          Two was, what were the effects?  Did it cause people to
vomit or go nauseous?  How would that affect their ability at
different doses on the battlefield?

          I think though what Duncan was saying, in either
instance, the military purpose required the initial irradiation. 
So that would seem to be still an essential element of evaluating
the military experiment even if that same irradiation had a
clinical purpose as well.

          MR. GUTTMAN:  To lead the discussion from the staff
perspective, and Phil knows the answers to these questions.  The
problem you're going to have, the TBI is going to be relatively
easy.

          Because those were often in the public literature.  In
fact, we have a lot of documentation.  The more difficult
question is the questions posed by the kind of memos that were
the stories in the press.

          What happens when there were sort of rules that we are
only beginning to understand or may never understand about code
words and cloaking things?

          So that if there's a document, as we had last month,
where there's, let's use the word "nutrition", for a fall-out
study, the problem is going to be that there are a lot of these
things we'll never know.

          And it's an impossible expenditure of time.  So, you're
going to have to assert some principles about the role that
secrecy made play in judging whether nor not things ultimately
may be dual purposes.

          TBI is an easy case.  But then there are these great
number of things where it's not clear.  Many of them were just
single purpose.  Nutrition.  But some of them may have been fall-
out.

          We won't be able to know.  And we're going to have to
recognize that as a decisional principle for people later on.

          CHAIRPERSON FADEN:  Jonathan?

          DR. MORENO:  Henry raised the question earlier about
some content from the Army IG report.  If you like, I can read
some excerpts from the first paragraph and the last paragraph of
the informed consent chapter.

          CHAIRPERSON FADEN:  Sure.

          DR. MORENO:  I note parenthetically that there is no
chapter on retrospective moral judgment.  I guess the Army IG
didn't have that problem.

          CHAIRPERSON FADEN:  They were probably lucky enough not
to know that they had to raise the question.

          DR. MORENO:  I do want to say, however, that from a
scholarly point of view, this is a superb document.  It's well
written.  It evidences a lot of good clear thinking which I have
found to be a wonderful model in the last few months.

          "The absolute essentiality of voluntary consent has
been the stated policy of the Department of Defense and the
Department of the Army since the inception of authority to
conduct experimental research with human subjects.

          "Secretary of Defense Wilson's memorandum allowed that
participation of any human was subject to the condition of
voluntary consent."

          And then they go onto cite the Wilson memo that
voluntary consent is essential and so forth.

          Then it goes on, "This guidance came after a thorough
evaluation of the results of the Nuremberg trials and lengthy
deliberations by the Armed Forces Medical Policy Council and was
signed personally by the Secretary of Defense."

          I think that's somewhat hyperbolic, that
characterization of the discussion, but never mind. 
Unfortunately, the guidance, sound as it seemed, was available to
very few due to the top secret classification placed on it.

          In fact, it was not declassified until August 1975
during the conduct of the Inspector General inquiry.

          However, on 30 June 1953, the Chief of Staff of the
Army published a memorandum through the Assistant Chief of Staff,
G-4, for the Chief Chemical Officer and the Surgeon General of
the Army which implemented the Secretary of Defense's guidance.

          This directive was initially classified top secret. 
However, it was regraded confidential, and there to unclassified
in July 1954 at the urging of the Secretary of the Army."

          The classification history is obviously complicated. 
The last paragraph, and this is in regard to chemical warfare
experiments at Edgewood Arsenal.  This is the study on the LSD.

          "In summary, the evidence clearly reflected that every
possible medical consideration was observed by the professional
investigators at the Medical Research Laboratories.

          "Volunteers were not fully informed as required prior
to their participation.  And the methods of procuring their
services in many cases appeared not to have been in accord with
the intended Department of the Army policies governing use of
volunteers in research."

          CHAIRPERSON FADEN:  That's pretty strong.  Thank you. 
Henry.

          DR. ROYAL:  Did the IG report result in any remedies?

          DR. MORENO:  I don't know.

          DR. RUSSELL:  I can answer that.

          CHAIRPERSON FADEN:  Thank you, Phil.

          DR. RUSSELL:  The main thing that happened was putting
all of biomedical research under the Army Medical Department and
the responsibility under the Army Surgeon General.

          Prior to that report, the Army Medical Department
carried out all the biomedical experiments relating to therapy,
relating to infectious disease, all areas except the chemical
warfare agent.

          There was a single laboratory at Edgewood Arsenal under
the Chemical Corps that was the principal subject of the report. 
There are two things.

          They rewrote the regulation and gave the Surgeon
General both the power and the responsibility to oversee all
human volunteer research.  That was a very, very tremendous
impact from that report.

          DR. MORENO:  It should be pointed out that they did not
find anybody was hurt by the work.  They found that they were
wronged, in our language, but not harmed.

          DR. ROYAL:  Were the people sent letters of apology? 
How did they address the fact that they were wronged?

          CHAIRPERSON FADEN:  We don't know the answers.

          DR. RUSSELL:  I don't know the answer to that.

          CHAIRPERSON FADEN:  But we will find out the answer. 
It's quite possible that nothing was done.  But we will pursue
it.

          DR. ROYAL:  The reason I ask is it's such a strong,
clear statement that they were wronged.

          CHAIRPERSON FADEN:  Right.

          DR. ROYAL:  And it would be interesting to see what
that resulted in.

          CHAIRPERSON FADEN:  In line with our discussion
earlier, the bulk of the impact was prospective.

          DR. ROYAL:  Yes.

          CHAIRPERSON FADEN:  In terms of changing policies to
make sure this was less likely to occur in the future, the major
outcome of that investigation and that interpretation.

          DR. ROYAL:  I had actually thought that there was a
death.

          MR. STERN:  That was CIA.  The CIA was doing LSD
experiments, sometimes in coordination with the Army Chemical
Corps at Edgewood, also at Ft. Detrick.

          There was a death of an Army scientist in a CIA
experiment which was just recently settled in the courts after
many years of litigation.  There wasn't monetary compensation,
but there was that lawsuit.

          And there were several other lawsuits related to CIA
chemical experimentation that have ultimately resulted in some
compensation.

          DR. ROYAL:  But that was not the focus of the IG
report?

          MR. STERN:  No.  Explicitly excluded from the IG report
was the CIA work.

          DR. RUSSELL:  Not the purview of the Army IG.

          CHAIRPERSON FADEN:  That's right.  Not the purview of
the Army IG in that one.  This was an Army Inspector General's
report.

          We are close to 5:00.  Unless I hear an objection, we
have accomplished a lot this afternoon.  Whether it stands the
test of time with this committee, I don't know.

          But we have accomplished a lot in terms of tentative
movement forward.  Unless I hear otherwise, we would end 15
minutes early.  Pick up at 8.

          Just a note that we are picking up at 8:00 tomorrow
morning.  That was the understanding on the second day since
people are staying, by and large, overnight.  What I don't know
is the dinner arrangements.

          DR. MORENO:  Seven o'clock at New Heights.

          CHAIRPERSON FADEN:  Seven o'clock at New Heights for
members of the committee.  New Heights is a restaurant within
walking distance.  It's a block away from here.  Very convenient
and very pleasant.

          DR. MACKLIN:  Ruth, you referred earlier to something
we were supposed to be reading?

          CHAIRPERSON FADEN:  Yes.  And you don't have it?

          DR. MACKLIN:  I don't know if I have it.  What is it?

          CHAIRPERSON FADEN:  I'm sorry.  I don't know whether
it's in your packet or not.  I don't even know what it looks like
in it's final form.  But I can tell you its content.

          One thing is a memo from Dan to me.  I think it stayed
in that format.  And it's gone back and forth between us for
awhile, which represents a conception or a tentative conception
of the approach for the final report.

          And appended to that is a description of the potential
appendix volumes.  Is it not there?  Do we have Anna or Jeff in
the room?

          Don't go anywhere group until we find the answer to
that question.  Does anybody know where Anna or Jeff went to?

          Could somebody see if you could find Anna or Jeff out
in the hallway?  Does anybody in staff know what the status is of
this memo?  Nobody knows?

          Is anybody on the staff listening?  Could somebody just
go out and see if you could see Anna or Jeff in the hallway and
bring them back?

          (Whereupon, the proceedings were adjourned at 4:47
p.m.)