ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS
                                   - - -
                              PUBLIC MEETING
                                   - - -
                        MONDAY, SEPTEMBER 12, 1994
                                   - - -


          The Advisory Committee met in Federal Hall, The Ramada
Plaza Hotel at Ten Thomas Circle, N.W., Washington, D.C., at 9:00
A.M., RUTH FADEN,  Chair, presiding.


     PRESENT:

          RUTH FADEN, Ph.D., M.P.H., Chair
          ELI GLATSTEIN, M.D.
          JAY KATZ, M.D.
          PATRICIA KING, J.D.
          SUSAN LEDERER, Ph.D.
          RUTH MACKLIN, Ph.D.
          LOIS NORRIS
          NANCY OLEINICK, Ph.D.
          HENRY ROYAL, M.D.
          PHILIP K. RUSSELL, M.D.
          MARY ANN STEVENSON, M.D., Ph.D.
          DUNCAN THOMAS, Ph.D.
          REED TUCKSON, M.D.

ALSO PRESENT:

     PHILIP CAPLAN                                 I-N-D-E-X

                                                                       Page

Call to Order                                                             3
  Phil Caplan, Special Assistant to the
  President for Cabinet Affairs

Welcome and Orientation                                                   3
  Ruth Faden, Chair

New Staff Introductions, Staff Structure                                 10
  Jeffrey Kahn

Approval of Minutes of July 25-26 Meeting                                12
  Ruth Faden

Staff Report:  Update on Ethics Policies                                 13
  Jonathan Moreno

Staff Report:  Human Experimentation in                                  58
  Connection with Atomic Bomb Tests
  Greg Herken and Dan Guttman

Staff Report:  Management Theme: Pilot Case                             113
  Study
  Oak Ridge: Donald Weightman
  Los Alamos, Barbara Berney 

Update on Agency Data Collection Efforts                                148
  Ruth Faden

Reports from Subcommittees:

 Oral History, Sue Lederer                                              166

 Protocol Review, Ruth Macklin, Jay Katz                                184

 Outreach, Reed Tuckson                                                 232

Public Comment Period                                                   244

                           P-R-O-C-E-E-D-I-N-G-S

                                                           Time:  9:10 A.M.

          CHAIRMAN FADEN:  Phil Caplan, Special Assistant to the
President for Cabinet Affairs, is here, as he is at every meeting
as our designated Federal official to open the meeting officially
for us.  Phil?

          MR. CAPLAN:  Good morning.  Busy day.  At the -- As
Ruth said, as the designated Federal representative to the
Advisory Committee on Human Radiation Experiments, I hereby
declare this meeting open.

          CHAIRMAN FADEN:  Thank you, Phil.  You had a busy
morning.  Were you ever able to get over there?  Were you able to
get in?

          MR. CAPLAN:  Oh, yes.  No problem.  

          CHAIRMAN FADEN:  Obviously, we would be talking
differently if it had had a different kind of ending.  Okay.  Not
a time to be flying in airplanes.  For all of you that are here,
we're glad that you arrived safely.

          Let me welcome all of us to the sixth meeting of the
Advisory Committee on Human Radiation Experiments and, as has
become our tradition, let me just take a few minutes to orient
all of us together on what we see as the principal objectives for
the next two days.

          To begin, there are four.  Our first objective, as in
all of our meetings, is that of informing our deliberations from
input from the public.  Towards that end, we have time set aside
this afternoon for our public comment period, and also we will be
discussing our October meeting which will have an extended public
comment period, and our regional panels, which are expressly
designed for public outreach later today.

          The second objective of the meeting is to bring all of
us up to date on the work of the committee -- on the work of both
the committee and staff.  There are several items of our agenda
which are directed toward this objective.  

          This is where we can tell each other what we've all
been doing, basically.  Everybody here, all the committee
members, are on -- I think everyone is on two subcommittees at
least, some people on more, and the staff, of course, has been
working very had, as is evidenced by the quality of the
scholarship and commentary and analysis in the briefing book.

          So we're going to take some considerable time today to
educate each other as to the progress we have all made.  I will
be giving some brief updates with respect to interactions on the
part of the staff with the various agencies this morning, and
that agency update will be followed with reports from all of the
subcommittees, and those reports will begin, if we stay on
schedule, just before lunch and continue through much of the
afternoon until we get to the public comment period.

          Finally, also this morning we are going to have two
reports from staff.  These are in two arenas:  One, a report on
staff research with respect to experimentation in conjunction
with weapons tests; then, secondly, staff work in the development
of two prototype institutional case studies for our consideration
as a methodological matter, and those are on Oak Ridge and Los
Alamos.  Both of those committee -- rather, staff reports -- will
be in the morning.

          The third objective is to get committee action on two
immediate and, I hope, easily dealt with issues.  These are,
first, the issues having to do with our internal procedures for
review and evaluation of classified material. 

          We are now at the point where we are being told that
there is classified material that may be of interest, and we have
a proposal from staff as to how to proceed, and we will have a
discussion of that tomorrow.

          Also tomorrow, the other specific item that we as a
committee have to dispense with is the draft outline for the
preliminary report which, I hesitate to point out, is due October
21.  So you do not have that outline yet.  You'll get it tomorrow
morning.

          It's not tremendously -- We hope this won't be a big
issue, because the interim report is more procedural than it will
be substantive, and in that sense we think not terribly
difficult, although we know the various principles that say that
everything is always twice as hard and takes twice as much time
and all of that good stuff as you think it's going to take.

          We're hoping that these two issues, the question of our
internal procedure for dealing with classified material, which
basically is how many committee members are willing to volunteer
to read what kinds of stuff in what parts of the country kind of
issue, and committee endorsement of the outline that staff
proposes for the interim report, can be issues that we can deal
with tomorrow afternoon relatively quickly.

          A set of issues that we know cannot be dealt with
quickly and which constitute the fourth and most important
objective for this meeting are the issues that have to do with
refining our strategies for the selection and ethical evaluation
of experiments or groups of experiments.

          I really kind of hesitate to point out that we have
reached almost the halfway point in the scheduled life of
meetings for this committee.  Our October meeting in San
Francisco is exactly the midway juncture, by the way.  That will
be exactly the middle of our life together.

          At this point, it seems clear that we really need to
start biting the bullet or whatever relevant metaphor one would
like and commit to proceed in specific directions.  We need to
get tough on ourselves.

          Much of the agenda, including several items I've
already mentioned and virtually all of tomorrow, is specifically
structured to facilitate this objective, and these items include
a presentation tomorrow morning by Henry on the relevance of
dosimetry to the evaluation of human radiation research, which I
hope will, among other things, lead us into a preliminary
discussion of our methodology for evaluating the ethics of
research where information about consent and selection of
subjects is very scanty.  That is, we know we will have
innumerable instances where the information will simply not be
very much available about how subjects were selected and what, if
any, consent procedures were employed, and we need to start
thinking about how we as a committee wish to consider the ethics
of research where the empirical fact situation is quite poor.

          Also, the reports we will hear today from staff on the
institutional case studies, as well as reports from
subcommittees, most notably the Biomedical Subcommittee and the
Intentional Release Subcommittee, should position us well for our
discussion tomorrow.

          I think the kinds of discussion that we will have today
about the institutional case studies and about the proposals and
the work to date of these two committees, in particular, will
give us the kind of background we need to start thinking hard
about what I hope we will be debating and perhaps committing to
tomorrow, which is strategies for selecting or sampling studies
for intensive research and scrutiny by the committee.

          Now also to facilitate that discussion, the discussion
we will have on how are we going to select or sample the studies
or sets of studies that we really want to look at intensively --
In order to facilitate that discussion, you should also have
received in the blue packet memos by Gil, and old memos. 

          In the blue packet there are sampling memos which you
have seen previously, prepared by Gil  Whittemore and Duncan. 
They were circulated previously.  We have resurfaced them for
your consideration.  We know you all cherish every piece of paper
you keep from the Committee and can retrieve them all easily, but
since we didn't think about it until the last minute, we decided
we would just include them in the blue packet again.

          Also, there is a new sampling memo by Gil  which is in
the blue packet -- no, distributed today -- which will be
distributed later, and we would -- It would be nice if you would
find the time in your spare moments this evening to take a look
at the memos you've already seen and the new one from Gil, and
start thinking about the problems that we're going to be
discussing tomorrow.

          Well, that's it by way of orientation, and I will note
for the record that the air conditioning is working only too well
at this hotel.  We were asked to wait a few minutes and see if,
in fact, with more bodies in the room we would be comfortable,
but they assure us that, if we would like it to be warmer in
here, we just will let them know, and they will make it warmer. 
If at any point anyone wants to make a motion to change the air
quality, I have a feeling they will be very responsive to those
requests.

          Let me just turn the agenda then over to Jeff Kahn who
will give us an update on new staff  introductions and staff
structure.

          MR. KAHN:  Good morning.  There are four new people I'd
like to introduce to the Committee, some of whom have been with
us for a little while, since our last meeting was now two months
ago, and others who have just joined.

          Alphabetically, they are:  Robin Cochran -- Will Robin
stand up?  There she is.  She's recently joined us as a
librarian, and she has recently received her Master's degree in
library information sciences from the University of Texas.  She
has worked for the Congressional Research Service as a press
secretary for a member of Congress, and newspaper reporter as
well.  She did her undergraduate work at East Tennessee State
University.

          Second is Gail Javitt.  Gail is an attorney who just
completed Harvard University Law School where she graduated one
year ago.  She spent the last year as a law clerk for a judge --
district court judge, that is -- in California.  She's written
about exemption of medical device manufacturers from liability in
device related injury suits.

          Third is John Kruger.  John joins us recently from the
Center for Public Integrity where he worked on the current
administration's health reform policies, healthcare reform
policies, as well as foreign policy in the Clinton
administration.  He received his Master's degree in national
security studies at Georgetown in 1993 and did his undergraduate
work at the American University, also here in Washington.

          Suzanne White-Junod is the last of those who have
joined us recently, and Suzanne is on detail to us from the FDA. 
She's a medical historian who has recently received her Ph.D. in
American medical history from Emory.  She's with us to help out
on the oral history project.

          Those are the four new folks.  I will direct you just
to the information in the blue folder related to staff structure
and project organization.  It doesn't change terribly much from
the last time you've seen it.  So I would just say have a look at
that, so you will know where we are.  

          I'm happy to entertain any questions now or at another
time when it's more convenient.

          CHAIRMAN FADEN:  Thank you.  Are there questions for
Jeff?  Thanks.

          We now go to the formal part of -- the very formal part
of the meeting, which is approval of the minutes of the July 25-
56 session.  They were sent to you in a manilla envelope, I
believe, with your original briefing book.  So let me call now
for any suggestions for amendments, deletions or additions to the
meeting minutes.  

          Can I have a call for approval of the meeting?

          DR. RUSSELL:  So move.

          CHAIRMAN FADEN:  Thank you.  Second?

          MS. LEDERER:  Second.

          CHAIRMAN FADEN:  Thank you.  All in favor?  Any
opposed?  The minutes are approved.  Thank you.

          Now we can turn to our first business of the day,
Jonathan Moreno, who will give us an update on some very fine
work that staff has been doing, helping to advance our
understanding of policies and procedures with respect to ethics
and oversight of research.  Jonathan.

          MR. MORENO:  Thank you, Ruth.  I also want to
acknowledge the fact that Pat Fitzgerald has done a lot of work
on the ethics data collection update.   Even though he's not here
yet to take a bow, we've had tremendous help from him in the last
month.

          We continue to learn a great deal -- This is under Tab
I, by the way, in your massive briefing books.  I think we've
learned a great deal about at least the debates that went on and
the standards that emerged from the late Forties to the early
Fifties, especially in the Department of Defense and the Atomic
Energy Commission.

          Let me just remind you that perhaps the landmark so far
for us in the Department of Defense has been the much vaunted
Wilson Memorandum, February 26, 1953, in which Secretary of
Defense Wilson signed off on a policy that covered
experimentation, human experimentation, in the Department of
Defense related to atomic, biologic, and chemical warfare for
defensive purposes.

          That memo incorporated much of the Nuremberg Code and
added written consent and witnessed consent.  

          We knew that there was a great deal -- and reported
this last time, that there was a great deal of disagreement
within relevant policy advisory committees in the DoD about what
kind of standard there ought to be and whether there even ought
to be a formal standard on human experimentation, before the
Wilson Memorandum.

          I used, I think, the term intense debate last time. 
Now, having read with some of my colleagues some of the
transcripts of the Committee on Medical Sciences, I would even
say impassioned debate.  There were several long sessions within
the Committee on Medical Sciences on this question.

          One, in particular, that I said to a couple of
colleagues on the staff would make terrific reading for a medical
ethics course, because in one of these sessions, in particular --
and we've been talking about them with a couple of people earlier
-- just about every position that one could take on the question
gets expressed, in one way or another, gets tossed around.

          So it's clear that there was a lot of interest in this
question.  There was a lot of concern about it, and there was
also an awareness that elsewhere in the sort of defense
bureaucracy, defense nuclear bureaucracy, at the time there were
varying views on the question.

          I mentioned, for example, that there was an awareness
that Shields Warren has a specific position over in the AEC,
Division of Biology and Medicine, that is referred to.  So these
people were talking to each other about it.  There's evidence
that they talked to each other about this question outside of the
meetings and in correspondence and so forth.  So it was a hot
debate.

          I also report that the Committee on Chemical Warfare in
a November meeting was read a draft of Dr. Casberg's Armed Forces
Medical Policy Council proposal which ultimately Secretary Wilson
signed off on, and a remark that was made at the end of the
reading of that proposal is one that some of my medical
colleagues have made after I gave them a lecture on informed
consent.

          One of the members said, if they can get any volunteers
after that, I'm all in favor of it, and there was laughter
reported to that comment.

          Perhaps the most interesting single new document that
we've been analyzing that I want to talk about for a couple of
minutes with respect to the Army's implementation of the Wilson
rule, as it were, was on the Regulation 70-25 dated March 26,
1962.

          70-25 updates and supplements the Wilson Memorandum,
but it also includes three exemptions from coverage by those
ethics rules.  The first exemption 3-A excluded research that
involved -- I'm quoting here -- "intentional occupational hazards
to health or exposure of personnel to potentially hazardous
situations encountered as part of training or other normal
duties."  That was one exclusion from human experimentation.

          The second in that '62 Army reg was 3-B which exempted
disclosures to participants that would invalidate experiments
having to do with human factors.  In other words, I suppose it
would -- I'll let Ruth talk to this, but I gather this would
exclude the informing of subjects if informing them would skew
the results, that's fair to say, in some way.

          Thirdly and perhaps also of great interest to the
Advisory Committee, the third exemption for coverage by this reg
was therapeutic research, consistent perhaps with the temper of
the time, Helsinki and so forth.

          Well, I also want to turn your attention to a
supplement.  After I wrote this piece of the material for you
this week, I was able to take a deep breath until, of course, it
came back all edited from Dan and Ruth; and during the deep
breath I was able to think with colleagues more about AR 70-25.

          Then John Harkness, one of our historians, pointed out
some testimony in 1975 before the Kennedy committee in which the
Army included with its testimony a document that reported the
Surgeon General, the Army Surgeon General's working
interpretation of 70-25.

          If you look at the supplement in Tab I, you'll see that
the Surgeon General construed what were called operational
examinations of prototype machinery or equipment as falling
within the Wilson rule.  That is to say, they were to be
considered experiments.

          Now I take that -- If you put that next to the language
of 3-A, the original language in 3-A, I take that as a broadening
of the applicability of the Wilson rule.

          DR. TUCKSON:  Excuse me.  You said supplement?

          MR. MORENO:  I'm sorry.  I didn't see your tome.  It
should be under Tab I.

          CHAIRMAN FADEN:  It was sent to you.  So it depends on
whether you've put it yet in your Tab I, but it came separate
from the blue book.  

          MR. MORENO:  Let me read the salient paragraph in my
summary slowly:  "The effect of the Surgeon General's
interpretation reported in 1975 would be, I think, to include the
applications of rules on the use of human volunteers to
experiments involving what were called an operational examination
of prototype machinery or equipment."

          In other words, these kinds of experiments, experiments
involving prototype machinery and equipment, would not be
considered to fall within the range of a soldier's normal duties. 
Since they would not fall within the range of the soldier's
normal duties, they would be considered experiments and,
therefore, the standards articulated in the Wilson Memo would
apply, as of 1975 at least, according to the Surgeon General.

          Now with all those qualifications, you can see, we
don't quite know yet the reach of this broad interpretation of AR
70-25 by the Surgeon General.

          Let me move on because of the time limitations to the
Atomic Energy Commission, and perhaps in conversation we could
come back to some of these other matters, if you like.

          There was an exchange of letters between the head of H
Division at the Los Alamos National Lab, Tom Shipman, and Dr.
Runham at the AEC, the Director of the Division of Biology and
Medicine, that focused on the question of tracer doses.  In the
attachments, you'll see that essentially what Dr. Shipman said is
we've been doing tracer studies, and we need at this point to
have you articulate or re-articulate a statement that was made
sometime ago by Dr. Warren:  What is exactly the position?  I
think we should know.  We need to know.

          Dr. Dunham's reply was that, essentially, as long as
subjects were fully informed, these very minimal amounts of the
use of radioisotopes in tracers would be acceptable.  We still
don't know exactly how these rules were applied or the extent to
which they applied to those who were not Los Alamos National Lab
employees -- that is to say, for example, patients at area
hospitals -- but it's clear that this standard was on Dr.
Shipman's mind, because in 1963 in another memorandum he restates
the standard, but again we have questions about implementation.

          Turning to the NIH, those of you who are students of
the early period of the clinical center and its medical board's
position on these questions perhaps recall that not only do they
have prior board review of studies, protocols, proposals, they
also had a written consent standard in '53 for experiments that
involved unusual risks to subjects at the clinical center.

          Interesting, according to a 1952 letter from an NIH
attorney, the NIH council seemed to feel that that written
consent standard should apply to everyone who was a subject at
the clinical center and not just those who are going to be
exposed to unusually hazardous experiments.  

          The rationale given was that this is an important
record keeping device, that there are serious liability questions
for the NIH, and since written consent was by then the standard
for surgical procedures, surely, the council argued, there should
be at least as high a standard for experimental studies done at
the clinical center.

           The result was -- and there is also clear indication
in that letter, which is again one of your attachments, that
there was some resistance to that proposal in the medical board,
most of whose members at least seemed to feel that oral consent
would be enough.  The compromise I infer was written consent for
experiments involving unusual hazards or exceptional hazards at
the clinical center.

          We have a note on the proposal review and approval
process, and the importance of the earlier standards that we've
been talking about become important here.  For example, I allude
to a 1953 cold  study in the Department of the Army in which --
which would have taken place after the Wilson Memorandum was
signed off on.  It was signed in February.  This took place in
September.

          The memo states that the consent was solicited from the
128 personnel, but it's not clear from the material we have
exactly what they were told.  It doesn't appear from the evidence
we have -- We can't tell, I should say, whether there was written
consent and, interestingly, at one point in the memo describing
the study the participants are called "selected volunteers,"
language that I'm not quite sure how to interpret.

          In addition, the Army sent the Advisory Committee in
the last few weeks fifteen experiment proposals that had been
sent to the Secretary of the Army for approval.  The earliest of
these is dated 19 April 1963.  Each proposal cites Army
Regulation 70-25, which again dates from 1962.

          Finally, in the main body of the ethics data collection
report this time we describe all too briefly four examples of
studies that raise an interesting conceptual question for the
Advisory Committee, one that we could easily have our own ethics
seminar about for the next six or eight months.

          It will probably come up again, I would guess, when you
get to talking about intentional releases, namely, what exactly
is the difference between an experiment with a capital X and an
exposure that is combined systematically with risk measurement,
in this case perhaps a series of occupational exposures.

          This is a very puzzling issue.  The four examples that
we give are manned sampling of atomic clouds which took place for
about ten years from about '51 to '61, a beta hazard experiment,
fallout studies that involved urine testing, and flash blindness
studies.  

          I commend our summaries of these experiments or
exposures, however you choose to characterize them, to your
leisure reading.  I think they're quite interesting.  I
especially, I must say, personally found the manned sampling of
atomic clouds to be a fascinating story.

          Finally, let me just point out in the tab, the
supplement to Tab I, we also have received information about the
implementation in the Air Force of the Wilson Memorandum.  A
memorandum dated March 10, 1953 from the Deputy Assistant for
Atomic Energy conveys the Wilson rule to the Inspector General of
the Air Force, and if you look at that document, there is also
appended below the original memo a summary, I think a four point
summary, of the standard operating procedure that that would
involve.

          That's my report.

          CHAIRMAN FADEN:  Thank you, Jon.  Are there questions,
comments, discussion?  Reed?

          DR. TUCKSON:  Just given that we've been  struggling
with this question about what is the difference between an
experiment and an exposure with data recordings, since you're
raising it again in your report, how are we -- I mean, it's kind
of -- We need to kind of start to nail that down, I would think.

          I guess what I'm trying to understand now is how does
that occur?  I mean, I know that we can't do an ethics seminar
for nine months on it, but since it's so central to so much of
the work, how are we dealing with this?  

          CHAIRMAN FADEN:  Go ahead, Jay.

          MR. MORENO:  I'm not putting that aside.  I'd be
interested to hear what the Advisory Committee members have to
say about this.  We've been talking about this ad nauseam for the
last several weeks in the staff, and I think we've got lots of
views; but I also think we need to be guided by your views, to a
significant degree.

          MS. MACKLIN:  What we may have to do is make some
stipulative definitions.  We're not going to find by looking or
by examining, either in any literature or deep within our breasts
or minds -- we're not going to find clearcut definitions that
distinguish by virtue of some criteria experiments, research,
investigations.  I mean, these are all terms that generally are
viewed loosely.

          I think what we do have to be careful of, and Pat King
can speak to this, is not to get bogged down in certain kinds of
definitions which would exclude areas that we think properly
ought to come within the purview here.

          Now let me just say a quick word.  I mean, I think that
the word experiment is often taken in ordinary language to mean
some kind of -- or investigation is the broader term.  Experiment
is the narrower term where there is some manipulation of
variables.  That's usually a feature of experiments.

          So that it would be easy if we took that definition to
rule these things out and say, well, clearly it wasn't an
experiment, because they weren't manipulating variables.  I think
that would be -- and Pat could tell us more about how the word
research was used similarly with a narrow definition to exclude
certain kinds of things.

          Since we're not going to find in any books or in any
glossary of terms what are the definitions of these terms, I
think we have to look behind that to the intent.  If you want to
study something, and you want to find out something you don't
know, when you're manipulating variables or not, if you're doing
something intentionally that wouldn't -- and then studying the
results, although it might not narrowly be called an experiment
because it wasn't manipulating any variables, on the other hand,
it's certainly an investigation of some sort.

          Therefore, I think if we want to stipulate, we can say
that there is a narrow definition of the term experiment that's
often used, but we're not going to stick to that narrow sense,
because the word investigation or study -- that is, something
broader -- that is, the intent to study something and
intentionally do something in order to study it, is really what
this committee is about.

          I think that our charge of looking at the intentional
releases is a perfect example of something that could not be
called experiment in that narrower sense of manipulating the
variables, but could certainly count as an investigation in the
broader sense.

          MR. MORENO:  Can I just add to that?  Another way of
approaching the question is to look at what the published
standards seem to say, for example, in the DoD in '53 and then
in, say, in '62 and then the reinterpretation or interpretation
in '75, and at least in '53 it seemed to be the case that
whatever a military person's, say, normal duties were would not
be covered by ethics -- experimental ethics rules.

          Well, then the question becomes, well, what counts and
under what circumstances as someone's normal duties?  Sort of a
different cut on the problem.  So it's a multi-dimensional
problem.

          CHAIRMAN FADEN:  I've got Jay, Henry and Phil.  Ruth,
do you want to do your other point?  Yes,  do your other point.

          MS. MACKLIN:  Yes.  Two quick questions, the first
about the 1975 Army Surgeon General's account.  I'm so ignorant
of military activities.  What I don't understand is the
following.  The phrase  "an operational examination of prototype
equipment" and -- what else? -- equipment and something else --
is included within the meaning of that.

          Now does that mean that Army personnel -- I mean, if
it's not within their normal duties, does that mean that in order
to use any of that prototype equipment and involve Army personnel
in that equipment that one would -- that they have to, first of
all, volunteer and, secondly, that they have to sign consent to
volunteer?

          I mean, if that's what the meaning is -- I mean, I
think we need some background to ask whether that's reasonable
and likely to be implemented.  I don't know.  I'm asking that as
a naive question.

          CHAIRMAN FADEN:  Phil, do you want to respond on point?

          DR. RUSSELL:  I think that Ruth pointed out the core of
an issue that the military has been struggling with since
probably the Napoleonic wars, and it creates the discussions that
get very heated about where, when you're testing equipment and
using people to test equipment, and when you're testing, the
experiment revolves around the people.

          Everything the military did in those times was an
experiment.  They were shifting from the World War II
armamentarium and organization to a whole new world with a whole
new set of weapons.  They made an experimental reorganization of
the Army division.  They built what they called the Pentomic
Division which had a structure that was designed to function
optimally on an atomic battlefield.  It was a failed experiment
that was abandoned later.

          So the people in charge in the Defense Department and
the armed services during that period were going through a
tremendous set of experimental approaches to dealing with new
weapons, new doctrine, new ways of moving into the future, and at
that time, of course, they were focused on the Soviet empire.

          They knew they were going to have -- absolutely knew
that they were going to have to face the Soviet Union with atomic
weapons on the battlefield in Western Europe.  That was a given. 
They also felt that they were going to have to deal with other
unconventional weapons, biological and chemical warfare.

          Now the people in charge of fighting those future wars
were doing a set of evaluations of weapons and doctrine and
tactics, and they loved using people.  It also involved training
people.  Just about everything that was done was an experiment.

          Now where you drew the line between a test of equipment
and a test of human physiology, for example, was a -- is a debate
that is not resolved to this date.  You can set up any
experiment, and I've been involved with many of them, where the
question is, are you really testing the clothing or the
protective materials or were you testing the physiology of the
individual who was wearing those protective materials and
clothing.

          As you read through these materials, this debate was
raging at the time, and the folks that felt that the national
security depended on getting information about the interface
between troops in atomic blasts were pushed to draw the line in
one place, and the Surgeon General, the medical folks, obviously,
were drawing the line someplace else.

          MR. MORENO:  It's interesting.  Even on a couple of
occasions in the transcripts that we have from the RDB committees
at Department of Defense, Research and Development Board
committees, a couple of times people say things like, well, it's
very fine for the AEC, for Shields Warren to take that position;
he's not responsible for sending people into battle.

          DR. RUSSELL:  The psychological effects of troops
facing an atomic blast was clearly a major concern, and
obviously, the military psychiatry folks who raised the issue had
no way of really dealing with it; but for the people who had to
command the troops on the battlefield, that was a major concern.  

          Now how do they get the data, and how do you get
informed consent from large bodies of troops and still maintain a
coherent unit, which is essential for the military experiment? 
We could debate where to draw that line for the life of the
committee.

          Obviously, the line has shifted from very much on the
side of allowing operations in a hazardous environment to being
much, much more protective of the individual troop and to balance
the risk/benefit ratio more clearly.  Then it's clearly shifted,
and then there was a break point in 1975 when it was painfully
reexamined by the services.

          Also you can look and see that there were different
behavior in different parts of the services and the Defense
Department.  Some elements were very, very protective of the
individual soldier or sailor and their rights, and others were
much more aggressive in trying to get as much information as
possible and willing to take higher levels of risk.  

          I don't have an answer to your question.

          CHAIRMAN FADEN:  Jay?

          MS. MACKLIN:  One more small one.  That is on the
clinical center, at the clinical center the memo you referred to
or the letter.  When I read that, I thought, ha, legal liability
is really what they care about.  

          Now for our purposes, does it matter?  I mean, it's
quite clear that the attempt to put in place some protections
were happening at that time, but they weren't happening because
of the concern for the human subjects but because of the legal
liability.

          Now that seems to be not ethics, although it may in
fact have the same effect, if indeed the concerns about the legal
liability of the NIH clinical center were so great that they put
these protections for the clinical center in that it turned out
to be a surrogate for protection of human subjects.

          CHAIRMAN FADEN:  We, obviously, are continuing to do
work, and we'll hear more about it, to try to understand the
origin of that letter from that lawyer, as to where it fit into
all of that.  I agree with you.  It's quite telling.

          I'm concerned to keep -- in fairness, to keep going
around.  Jay?

          DR. KATZ:  I'll be very brief, because time is
fleeting.  Just two comments:  The first one is I was very much
surprised by your opening statement, and we can talk about it
later, that there was passionate disagreement about standards.

          From my reading of the documents, I saw no discussion
about standards, and that's really what is absent.  There was
some discussion about should we or should we not use human
beings, etc., but standards -- Indeed, that's one of my
conclusions, among a number of others, and you mean the standards
in a different kind of way.  We want to have you talk about this.

          The second point is a follow-up and very, very brief on
the cogent remark that Phil made.  As you all know, there has
been a debate going on in medicine, too, not just the armed
forces, of what constitutes research and experimentation.

          Some people still maintain that any human intervention,
any diagnostic treatment -- any treatment is an experiment
because of the uncertainty in medical practice, and some people
say observational studies are not research and only randomized,
double blind studies and experiments are research, etc., etc.

          The upshot of it all is -- also in the light of what
Phil said -- that we have to decide, are we going to start an
analysis on the issue of research or on the issue of
experimentation.  I don't think it makes any difference what your
starting point is, and then we have to devise functional
designations as to what we mean.

          That presents all kinds of subgroups of
experimentation, carefully defined.  Exposure of personnel
probably is going to have a different rubric than other kinds of
experimentations.  We won't make them up, but some people will
fault us and say this is not research, this is not
experimentation.  Fine, but this is what we mean by this, and it
serves our purpose and will bring some order into all this.

          Of course, it will be complicated by what Phil said,
that we have now different attitudes towards what constitutes an
experiment and what constitutes -- but does not constitute
experiments twenty, thirty, forty, fifty years ago; but we have
to capture it also in the way in which we discuss it.

          We need to sit down in a small group later to determine
some kind of criteria that serves our purposes.

          CHAIRMAN FADEN:  Thank you, Jay.  Jonathan, did you
want to respond to Jay's question?

          MR. MORENO:  Perhaps there's a difference in the recent
standards.  Certainly, there was not a debate about standards the
way you would see it in a biologics journal, but I think that in
those transcripts you do see various considerations playing back
and forth, risk/benefit for the personnel involved, military
strategic necessity in a dangerous world, military traditions;
and only one of the members does bring up a kind of Kantian
position, a naive Kantian position.

          So I think that you can tease out debates about
different -- with a small "s" -- standards or, perhaps better,
considerations that should go into a Defense Department policy on
this question.

          CHAIRMAN FADEN:  I should point out, we're a little off
schedule, but it's okay.  Ann and I built in -- As we continue
just now, your coffee break just continues, but the discussion is
more important than the coffee break, and there's a little
whatever in lunch as well.

          I had -- Phil, I had you on the list, but I assume that
your comment in response to Ruth was your comment or did you have
another comment that you wish to make?

          I have Reed and Duncan still, and Henry.  I'm sorry. 
Henry was before Reed and Duncan even.  Your name was sandwiched
between all the crossed-out people.  I'm sorry, Henry.  You have
the floor.

          DR. ROYAL:  I just wanted to link some of Jon's
comments with some of your opening remarks, and that is that
we're almost at the halfway point, that there's a limited amount
of time that we have to do our work.

          I think the committee is going to have to make some
arbitrary decisions about what sort of things it's going to look
into in depth and what sort of things that it's not going to look
into in depth.  I don't think it's going to hinge on what our
definition of experiments are, because by whatever definition we
use, there's too much work for this committee to do.

          I would just encourage the committee to start making
some of these difficult and, if they are going to be, arbitrary
decisions about what things we are truly going to focus on.  I
would suggest that even if we don't pursue something in depth
that just getting it out in the open and having raised the
question so that someone else can then pursue it further and give
it the attention that it deserves should be regarded as a
positive thing rather than a negative thing that we did not have
the time and resources to pursue it to its end.

          CHAIRMAN FADEN:  Thank you.  Henry is sharing my mid-
life panic with the committee.  I'm starting to feel it acutely. 
Reed and then Duncan.

          DR. TUCKSON:  Duncan was before me, you said.

          CHAIRMAN FADEN:  Do you all care?  Duncan, I'm sorry. 
I'm probably scribbling out of order.

     MR. THOMAS:  I just wanted to return to Ruth's last question
on the question of sort of legality versus ethical concerns.  I
see this reflected again in the Surgeon General's document.  I
started reading this.  So while this is all stuff I've seen
before --

          Then I was struck by the fact that, in fact, most of
that whole document is concerned with  rather convoluted legal
discussions about purchase of life insurance and covering of
liabilities and all these other things.

          You didn't mention in your context.  I was just sort of
wondering whether there is -- I couldn't figure out where they
were coming from, but it seems to me at least that there's an
assumption of government liability a decision to undertake some
of these experiments.

          MR. MORENO:  I think you are talking about -- Are you
talking about the 1953 Stevens, Secretary of War Stevens, memo?

          MR. THOMAS:  No, I'm talking about the 1953 Surgeon
General's interpretation of the Wilson memo.

          MR. MORENO:  Right, which was -- Well, that was a 1975
description of a report of the Army Surgeon General's
interpretation of Army Reg 70-25, which was published in '62,
which was itself an update of the original '53 Wilson memo.  I
apologize for -- I don't usually behave this way, but these are
all linked in a rather legalistic, codified fashion.

          I think my interpretation would square with that which
has been implied in previous comments from the members of the
Advisory Committee.  This is a -- To a very great extent, there
was a concern about exposure and legal liability, perhaps one
that increased through the Sixties and to the mid-Seventies.

          I must say that I think there was perhaps less concern
about this in the early Fifties.  This is my own personal sense
from reading these documents, less of a concern about legal
liability in the early Fifties in the Defense Department than
there was a concern about the backwash of Nuremberg and the
German "experiments," as they were often called.

          I think that the public awareness of what happened in
Germany under quasi-medical state auspices was at least as much
of a concern in the early Fifties in the Defense Department -- is
my read -- as was legal liability, and legal liability became
more important as we went through later decades.

          CHAIRMAN FADEN:  Dan?

          MR. GUTTMAN:  I get to look at this stuff as a lawyer,
and I was struck by the opposite.  What was really striking to
me, in particular, with the series of memos in the Army series,
and there's also things that Jon didn't put in, Judge Advocate
General series -- What happens, if you read the Army memo, it's
quite different than Secretary Wilson's.  

          It's not a set of general principles.  It's the statute
number XYQ says we have authority to do research and development,
and PQZ says we can do it on human beings.  Well, when you look
at the background memo, what's fascinating is that the Judge
Advocate General has asked who can we use, and the key question,
which is, obviously, Ruth's point, is it's a matter of, if we
hurt someone, do we have authority to reimburse?

          That gets to, well, what is the statutory basis for
reimbursing someone?  It turns out, and this is the thing that
was most intriguing to me because it goes to the question of
contractor subject liability, like in the Cincinnati case --
There is an assertion that there's an arcane government law, the
Gifts Act.  You can't take voluntary services without express
Congressional approval.

          So they reasoned that there's no express Congressional
approval to use private citizens as subjects.  Therefore, we
can't use them, because if something gets screwed up, then
there's no way to get the money.

          So it's almost coming from the other side of the fence,
saying, well, who we can use depends upon, if we screw up, who we
can reimburse.  Now you wonder why they are thinking that way,
and it's extremely interesting, and there's a separate memo we
had in the prior briefing book where in '53 -- in '52 in the
Nuremberg Code debate, they say, you know, if we screw up, there
will be a private bill through Congress getting this guy
reimbursed.

          I'm sitting here with Dr. Katz and others saying, well,
where are these things coming from?  Who's been bringing all
these private suits?  But the point I'm making is, if you look at
it as a strict legal matter, it really is interesting that
they're into quite rigorous, arcane analysis which actually comes
out expressly in both the '53 Army and the 70-25 which gets into
why it is there are all these things about insurance and private
volunteers.

          Now why they would have done that -- Are there two
trains that just -- you know -- ending up the same place or --
you know -- I don't know.  

          MR. MORENO:  My hunch is it's two trains, but we can
talk about that.

          CHAIRMAN FADEN:  Duncan, did you have more?

          MR. THOMAS:  I just want to clarify that it's not the
1975 document I was referring to, but the 1953 Army memo.

          CHAIRMAN FADEN:  I just would throw in a comment myself
here.  I find very compelling reading the excerpts from the
minutes of the Committee on Medical Sciences that we have in the
briefing book.  There, I think, at least -- Everybody's got a
different read, but when I read them, I hear at least in some of
the participants a real concern about, you know, somebody could
really get hurt here, and we have to find a way to compensate
their dependents.  I mean, we've got to do it.  It's got a moral
overtone in much of that discussion which, my guess is, then
relates to let's go find out from the lawyers how can we do it.

          You know, if we hurt somebody in this, we really ought
to do something for them.  Now let's find out from the lawyers
can we do it.  You know, how can we do it and, you know, we might
kill somebody.  There's even a reference in there that says, you
know, it could go really bad; if it goes really bad, what can we
do for this person's family?  How can we do something about it,
which has echoes of the continuing debate about setting up
mechanisms for compensation for research subjects which we have
as an unresolved public policy issue today.

          It's funny how some bad problems hang around for a long
time.

          DR. KATZ:  By proposing you kill them first and then
you get concerned.  

          CHAIRMAN FADEN:  That's not quite right, because we
know -- but, Jay, there's increasing debate about whether we can
use -- whether we ought to use human subjects at all and for
which ones.  Then it says, well, we do use them; we have this
problem.  

          DR. KATZ:  My reading is different.

          CHAIRMAN FADEN:  I think that where Jonathan says you
can hear a voice for everything -- There's a discussion, for
example, about prisoners in the committee minutes, which I found
very compelling, and one person says, well, we use prisoners
because who cares about them anyway, they have no value to
society, and then they're useful.  You know, we can just use
them, and then there's almost a tone of outrage, if I could hear
it, saying that's not why we're suggesting prisoners, not because
we don't think they're worth less than other people, but because
we've got a follow-up problem.  You know, we need to follow
people up for a long time, and people who are in there for life
are easy to trace, even easier than soldiers, because they leave.

          Well, you know, who knows how genuine people are in
their presentations at these minutes.  All I keep thinking when
I've been reading these minutes is that maybe, you know, forty
years from now somebody might actually be reading the minutes and
transcripts of these meetings.  

          So I'm sure when these people were talking, they were
not anticipating that there would be forty staff people pouring
over every line of everything that they said, trying to figure
out whether they were ethically motivated, legally motivated or
just, you know, nasty folks; but that's really the exercise that
we're engaged in.

          DR. KATZ:  Just ten seconds -- It's not pertinent for
now, but it's pertinent for six months down the line.  There are
all kinds of pertinent questions about the kind of report and how
do we interpret this kind of data.  Some of us may feel quite
different, and how are you going to accommodate this about how to
interpret these documents.

          CHAIRMAN FADEN:  That's going to be a talent.  I agree,
Jay, and obviously, assertions without points to evidence are not
very helpful.  So we have to look at the transcript and say, you
know, what line do you think gives you that impression, and what
you line do you think gives that impression.

          I've got Reed and then Pat.  Reed, you've got the
floor, and then Phil wants the floor back but after Pat.

          DR. TUCKSON:  Thank you.  I'm trying now to border my
thoughts.  I mean, there's so many balls in the air, and I really
feel the need to see where we are as a committee on these issues.

          First -- and I really like Henry's comment, which helps
me a lot -- Ruth's analysis earlier where she talks about intent
and, you know, did they do something that was not ordinarily done
and then -- you know, and then to evaluate and measure being ways
in which we kind of start to get into guidelines about what is at
least appropriate for us to look at or not appropriate to look
at, I think, is helpful.

          Henry says that, obviously, we can't do everything.  So
we're going to have a pretty wide boundaries of things -- a lot
of stuff to do, no matter how we define the boundaries, but even
discussing or laying out what we couldn't get to and raising the
critical questions is a major concern and of value.  I think
that's important.

          What I'm trying to understand then is that, first, if
the way that Ruth phrased it -- and I know she was speaking
extemporaneously, and she's head of that committee and is still
working, but the way that she phrased it -- will that hold up
over time as a legitimate way for us to cut this cake?

          Secondly, do the ethical discussions of the time that
you're giving us in this report -- Do those ethical discussions
in all of those various committees seem to be reasonable,
compared to the ethics of the time?  I'm not sure what your
conclusion is.  I'm not sure what you're saying.

          In other words, if these committees are grappling,
whether it be the legal -- whether they came on this train or
whether they came from this train, were those reasonably
intelligent and responsible discussions based on the history of
that time?

          Then, finally, did in fact the discussions and the
conclusions that came out of that process -- Were the rules
followed in reality, given how people actually behaved?  That's
what I'm trying to get the sense, and I'm not suggesting that you
know the answer to that, but what I'm trying to understand is, is
that in fact what we are trying to discover?  If we are, where
are we in that process?

          MR. MORENO:  I mean, I'm prepared to say that the
institution of the Department of Defense, just to take that
particular agency, I would say as not, obviously, for the
Advisory Committee -- it's your judgment, but my impression is
that, institutionally, they took -- they were responsible in the
sense that they took the issue, however you characterize what the
issue is, seriously.  

          Were the discussions always intelligent?  No, but
that's perhaps too high a standard to hold human groups to in
general.  Whether they were implemented?  Well, we know that at
least in some cases the Army has already concluded in '75 that
they weren't implemented with respect to chemical warfare
studies.  At least some of them weren't fully implemented.

          That's where we are now, I think. 

          DR. TUCKSON:  So that the -- Again, and I'm looking for
my colleagues to help me, Ruth.  So that the purpose -- I mean,
ultimately -- What we as a committee are responsible for doing
ultimately hinges, it seems, first -- I mean, that's why I think
this is -- whether the break is late or not -- It is first,
again, whether or not -- First, it is how we cut the ethical cake
about what, in fact, is within our purview to look at and what
was a reasonable set of things, Henry's point notwithstanding,
that even within that cut we will have to be selective about the
decisions, and he's absolutely right about what we can and cannot
explore in detail.

          Then once we've made that -- I mean, that's the
fundamental cut, seems to me, is Ruth's point.  Once you go from
there, then it is a matter of evaluating and deciding whether or
not the ethical discussions that happened within government were
legitimate discussions based on the standards of that time, and
based, I guess, in some way on a retrospective sense of the
standards of today.

          There is some relationship, which I'm not sure that
we've heard much about today, in terms of how we view today
looking back, but what I think I seem to be most interested in is
the relationship of the discussions in government at that time.

          So if we're -- I think you kind of answered it, but I
want to kind of get a sense of are we really clear that we know
the answer to that yet or is that what, again, we are focusing on
in the next half of the committee, to find that cut.  

          Then lastly, you mentioned one example of whether or
not the behavior of the governmental agencies was consistent with
its rule book that came out of these ethical discussions, and
whether behavior actually mirrored that.  I guess there is where
we will pick some examples, which I think we have pretty -- and I
guess we'll hear it in the other committee reports, what those
examples will be that we are going to focus on, and then compare
the actual behavior to the -- Is that where we are now as a
committee?

          CHAIRMAN FADEN:  Yes.  Now speaking personally, that's
exactly where we are.  What I'm hoping is that by the end of
today we will be -- we won't have filled in all of the specifics
in your characterization, but maybe tie down some of them.  Then
by the end of the October meeting, tie down almost all the really
important ones, so that the rest of the work of the committee can
be the doing of it.

          So I'm hoping that we can get further along.  I am --
In case you're wondering as I sort of take notes, what I'm trying
to do is take notes to myself of projects for staff -- Staff is
going to love this -- that would be helpful to advance the kinds
of discussions that we're having now between now and
October.       

          There are already like five major projects on this
list.  I'm going to try to keep doing this as we go along, and
then as part of tomorrow bring them up for discussion, so that
the committee can conclude which ones, if any, of these would be
useful for the staff to do between now and next time so that
October and November really become very directed types of
sessions.

          Pat has been waiting patiently, and before I ask Pat --
give Pat the floor, is there anybody else who needs to speak now;
because if not, we'll go on to our next topic after Pat.  Oh,
Lois, too?  Okay?  

          MS. KING:  I have just one brief question.        
CHAIRMAN FADEN:  No problem.  Okay, and Mary Ann.  So it's Pat,
Lois, Mary Ann.  Unless someone is really moved to speak after
their comments, we'll stop now.  Jonathan, it's obviously a
testament to the significance of the foundational character of
these discussions to the work of this committee that the
discussion goes on as long as it has, and tomorrow, just be on
notice, for you or Patrick to sort of come back to discuss this
more.  Pat?

          MS. KING:  I actually don't have very much to say. 
Reed said a lot of what I wanted to say.  I want to underscore
one thing, though.  I do think the question of legal versus
ethical motivation is irrelevant.

          CHAIRMAN FADEN:  Is irrelevant?

          MS. KING:  Irrelevant.

          CHAIRMAN FADEN:  So do I.

          MS. KING:  Because, first of all, you can't really
answer it.  That's the first thing, not retrospectively with the
kind of data we're working with.  

          Two, we are not talking -- lawyers or ethicists talking
in 1953.  We are talking about people responding to pragmatic
concerns and pragmatic needs, and to try and retrospectively
tease out which way they were going -- I just sort of think it's
an exercise in futility, but more importantly, I think, what they
were doing is establishing what we now call public policy.

          We can't -- It is of no interest, I think -- and I will
state this strongly -- that the public policy got fed in all
these different trains.  What is of interest is whether it is
acceptable, whether it was acceptable at the time.  That has an
ethical component. 

          That is a different task than trying to make an ethical
judgment about what went on then, and I'm not getting into that. 
I just think that, for our purposes, since we are a public policy
body, too, that in looking back at, clearly, people who were
operating in a public policy arena, who were faced with the kinds
of decisions that they were faced, we may judge them to some
extent by the standards of their times and what they purported to
be doing; but I think -- I can't figure out why you want to
figure out where they came out because of concerns about
liability, because of moral concerns.  I just think it can't be
done.

          CHAIRMAN FADEN:  I'm actually inclined that way myself.

          MS. KING:  I mean, there are statements there that we
can use to say that they were their standards perhaps, but
motivation?

          MS. NORRIS:  I just wanted to ask Jonathan whether you
have a feel for whether the failure to implement the Wilson
Memorandum in the field was tied to the inability or the lack of
understanding of the definition of experiment or research?  In
other words, would the people in the field perceive what was
going on as being an experiment?

          MR. MORENO:  That's, I think, a reasonable working
hypothesis, not the only one, but it's a reasonable hypothesis.

          CHAIRMAN FADEN:  And Mary Ann?

          DR. STEVENSON:  I have a technical question in regard
to the 70-25 memo.  This may have been covered before I came in. 
I'm concerned about the exemptions.

          MR. MORENO:  Yes, I mentioned that.

          CHAIRMAN FADEN:  Ask your question anyway.

          DR. STEVENSON:  First of all, how does it apply to
contractors or do we know?

          MR. MORENO:  Dan?

          MR. GUTTMAN:  We have been in discussion with the
Department of Defense about precisely this issue, and there are
different ways of looking at it.  Just in generality and what
we've been all saying is we've got to get more information, which
DoD is looking for.

          One cut is, if you look at the Wilson memo, it sort of
seems to talk bout military installations and military people or
government officials as opposed to citizens.  That's one cut. 
Another cut would be, but if you're talking about the Nuremberg
Code, it's a universal principle.  Why should it make a
difference if the Nazi doctor is a contractor or, you know, a
private citizen or an official?

          The next level is, well, why was -- What you look at as
either the intent or the implementation.  In terms of
implementation, we found documents which in part represented at
the last session where right after the Army implements it, there
is a Secretary Stevens memo.  We don't know what he was
responding to, but there was a chemical experiment proposed, and
he says, I don't see why there should be any difference between a
contractor and a government lab doing it, and it's not clear what
the parameters of that was, and there's a reference to another
one.

          So there's some evidence that it was then put into
effect in relation to contractors.  Another cut is what I was
referring to earlier, is that there is some indication in the
Judge Advocate General memo they didn't think they could use
private citizens, because they were not somebody who you could
compensate lawfully if you screwed up and, therefore, it didn't
get addressed because it wasn't part of the world of volunteers,
but, of course, we know that they did use contractors and they
did then have experimentation, say, in Cincinnati.

          We're tracking it down.  Without getting into it, John
Harkness is now on a trail about the possibility that there was a
contract clause that the Army actually had, and we're tracking
that down.  It's a very interesting story which John will,
hopefully, be able to tell about in the next meeting or so.

          DR. STEVENSON:  I guess, you know, you're talking about
the same things.  I mean, this has a great impact on how we are
going to view the CBI -- It makes me wonder whether it wasn't put
in because, clearly, these things had been going on.  If it's not
stated, does that mean it didn't count prior to this being
stated?  I mean, you know, just legally I'm wondering --

          MR. GUTTMAN:  Well, there are different answers.  One -
- Pat may say it -- is if you're talking about judgment of -- We
are here, and this is for the committee.  You know, you don't
necessarily have to be bound to what is a strict legal -- Right.

          DR. STEVENSON:  Oh, absolutely.  I'm wondering if that
was the thinking of the --

          CHAIRMAN FADEN:  The answer is we don't know.

          MR. GUTTMAN:  That's what we're trying to reconstruct.

          CHAIRMAN FADEN:  The third exemption for, effectively,
what we would call today clinical research is a huge exemption. 
Right.  It exempts any research on a patient by anybody, which
would mean that, in fact, what they are doing is thinking about
the Nuremberg Code the way the Nuremberg Code was set up, which
was for research on volunteers where there is no prospect of
therapeutic benefit, and they're saying that's the only kind of
thing that we think that this stuff applies to.

          Now what we don't know, and your question is quite
right, is since that first appears as far as we know in the '62
stuff, whether there was anything between '53 and '62 that
reinforced that interpretation or, in fact, merely behavior
enforced that interpretation, that they only applied it to
contexts that fit the description of what we used to call
nonclassic, nontherapeutic research.

          We don't know, but that third exemption is the kind you
can drive a whole bunch of trucks -- you know, not just one truck
through, but everything through, from a narrow point of view. 
So, yes.  I mean, that was the first thing I saw when I saw that. 
I said, well, okay, there's an interesting exemption.

          Phil, did you want to get in?  I know we had said --

          DR. RUSSELL:  I think it is quite clear that at that
time, as now, there is separate communities that were moving
along their own lines, and I think the legal community within the
Department of Defense was moving parallel to the medical
community in addressing these issues.

          Some of these indemnification questions came out of the
medical community trying to find ways to indemnify volunteers so
that they could be more successful in recruiting and feel better
about the issues.  Those didn't get adequately solved until very
recently.  

          One other aspect of this that, I think, is important is
the issue of training.  The military is very concerned about
adequate training of its forces, and the concept of realism is
always embedded in there.  During the Fifties training of
military troops included exposing troops to live machine gun fire
as a routine part of the training mission.

          They had to crawl through barbed wire under live
machine gun fire, a hazardous training exercise.  It also
included exposure to at least tear gas and perhaps some other
gases, and it also included field exercises with live artillery
fire going overhead.

          These were recognized by the military as essential to
season troops, get them used to the effects of weapons, and
enable them to continue to operate in the face of a high level of
hazards.  

          When they began to deal with atomic weapons, the same
issues were embedded in their thinking, and again where does
training leave off, appropriate military training, and when are
you doing human experimentation?

          Clearly, the various communities were drawing the line
in a different place, and the -- and I don't think that there was
any consistency within the Defense Department.  I'm sure that the
debate reflects the fact that all these communities were
approaching these issues separately.  

          CHAIRMAN FADEN:  Phil's comment is, of course, the
perfect segue into the next topic, which is continued discussion
of experimentation.

          DR. KATZ:  Why did you make so much about the Wilson
document?  Is that a legal mind at work?  I really think much
less of the Wilson document -- It seems to be at the moment we
have to discuss it, because it's an important issue of some kind.

          CHAIRMAN FADEN:  Well, maybe we'll try and do it
tomorrow.  Oh, you're not going to be here tomorrow, Jay.  So
we'll have to do it -- It's very important.  

          Nancy, are you comfortable holding off?

          MS. OLEINICK:  That's all right.  It's okay.  

          DR. GUTTMAN:  All staff knows is what they were taught
at Jay's institution.  All staff knows about this is what they
were taught at Jay's law school.  So that's the fifteen second
answer.  

          CHAIRMAN FADEN:  If we could go on, folks -- It's
really going to seem like much of the same discussion -- to what
was listed on your agenda as the 10:45 item, which is clearly not
at 10:45 anymore, but -- I'm sorry, not the 10:45.  I take it
back -- the 9:45.  Jonathan, thank you very much.

          This is Greg and Dan reporting on some more of the
staff work on human experimentation in connection with atomic
bomb tests.

          We are going to try -- Let's do this, Dan and Greg. 
Let's try to take the break at eleven.  If the discussion needs
to continue, well continue it after the break, but rather than
have the break right on top of lunch.  

          So if we're not adequately finished with this topic
before the break, we'll take a break and come back to it; but I
think we can't have the break any later than eleven and still
have lunch, which is not moveable.  Lunch is at 12:20.  It's
slightly moveable.  So lunch will be at 12:20 as opposed to
12:10.  We will take a break at eleven, wherever we are in the
discussion.  

          MR. HERKEN:  I was asked to provide some historical
background on the creation of the Nevada test site or NTS.  

          Serious interest in a nuclear proving ground within the
borders of the continental United States dates from the fall of
1948.

          CHAIRMAN FADEN:  Greg, could I interrupt for just one
minute and just tell everybody to go to Tab F, in case you
haven't been following it.  The documents from which Greg and Dan
are making their presentations are in Tab F.  It was the big
packet that you got separately.  It's a fat one, and its marked
for Tab F.  

          MR. HERKEN:  Okay.  I think there are only five
documents pertaining to my presentation here.

          CHAIRMAN FADEN:  And then a whole bunch more behind
Dan's, but they came together, Greg.  So I'll just see if people
can find them.  I'm sorry.  Go ahead.

          MR. HERKEN:  Surely.  In 1948 when a secret military
study, Operation Nutmeg, was initiated to locate such a site
within the continental United States, Nutmeg concluded that there
were two possible sites for a proving ground.  One was along the
Carolina coast, and the other in the Nevada desert.

          Recognizing, however, that "continental operations
would, obviously, pose difficult domestic and possibly
international relations problems," the Atomic Energy Commission,
the AEC, concluded that a continental site "was not desirable,"
but the Commission left open the possibility of establishing one
in the future if there was a need for what was described as test
activities during a national emergency.

          Such an emergency arose in the summer of 1950 with the
outbreak of the Korean War.  Korea also highlighted two other
advantages to testing bombs within the continental United States. 
First was the ease of logistics compared to a mid-ocean proving
ground, which had been proven, in fact, in the tests in 1948 in
the Pacific; and second was the fact that both secrecy and
security could be more easily guaranteed.

          Significantly, during its early years at least, the
Nevada test site was still considered by the AEC to be an
emergency, and hence, by implication at least, a temporary
proving ground for nuclear weapons.

          NTS was created by Executive Order of President Truman
on December 18, 1950.  The first nuclear test in Nevada was one
month later.  Between 1951 and 1992 when testing was suspended,
more than 900 tests would be carried out at the site, the
majority of these and all tests, in fact, since 1963 being
underground.  

          The fact that continental testing posed a potential
threat to nearby civilians was, from the outset, the single most
controversial issue behind the creation of NTS.  The radiological
safety of the site also remained the most contested question
within the government -- between the government, I should say,
and the critics of NTS, and also within the government itself.

          In August of 1950 a group of AEC experts picked to
study the radiological hazards of continental testing concluded
that personnel on the site might be exposed to a maximum
permissible one-time dose of 25R without permanent damage.  Four
months later, only a week before Truman's order creating NTS, the
AEC concluded that 25 kilotons certainly, and 50 kilotons
probably could be exploded within acceptable safety limits in the
continental U.S.

          Parenthetically, these figures assume that the bomb
would be set off on a tower high enough so that the fireball
would not reach the ground and, therefore, entraining debris and
in bringing it up into the atmosphere and then having it rain
down as fallout.

          By late 1951, however, there was disagreement between
the Pentagon and the AEC and within the AEC itself over the
safety of proposed nuclear tests in Nevada involving the
stationing of troop observers some 7,000 yards from Ground Zero. 
Interestingly enough, the protagonists in this debate were some
of the same individuals who had previously disagreed in 1947 and
'48 over the wisdom of human subject research involving
radioactive isotopes, and in 1949-1950 on the use of prisoners in
experiments for the NPA or nuclear powered aircraft program.

          In the debate over troop participation at NTS,
Brigadier General James Cooney, head of the Radiological Branch
of the AEC's Division of Military Application, supported the
Defense Department's claim that 7,000 yards was a safe distance
for the troops.  Opposing Cooney in the Pentagon was Dr. Shields
Warren, Director of the AEC's Division of Biology and Medicine,
who raised mostly pragmatic objections to the military's plans.

          Warren's chief concern as he wrote the AEC and Cooney
was that nuclear testing remained "the responsibility of the
Commission both in fact and in the public mind," and hence that
any accidents at NTS might well have serious adverse effects upon
the future of continental testing.

          Cooney, in fact, evidently won this particular battle. 
The test took place as planned, but Warren succeeded in getting
the military, rather than the AEC, to take responsibility for the
results.

          The continued internal controversy over continental
testing led the AEC in January of 1953 to create a Committee on
the Operational Future of the Nevada Proving Ground.  The
committee's report four months later recommended that 35 kilotons
be considered a maximum yield for tower shots and 50 kilotons the
maximum for air dropped bombs.

          Just one month after this, however, in June 1953 NTS
would be the site for the test of a 61 kiloton bomb dropped from
an airplane.  The anticipated yield from that shot climax was, in
fact, actually 70 kilotons.

          At the same time, the Armed Forces Special Weapons
Project lobbied the AEC to raise the maximum allowed one-time
exposure at a test from 3.9R to 6R.  In July 1953, following the
61 kiloton shot, and also in response to charges by ranchers that
the Nevada tests were killing sheep, the AEC revived and expanded
its earlier panel.

          Now called the Committee to Study Nevada Proving
Grounds, this panel concluded in its report the following
September of 1953 that the United States needed a continental
test site and that Nevada was the best location for such a site.

          This conclusion was endorsed by the AEC's Advisory
Committee on Biology and Medicine, which considered it "essential
to continue the Nevada Proving Grounds in order to achieve
maximum speed in the development of weapons."  The panel also
recommended that the maximum allowable yield on air dropped bombs
now be raised to 80 kilotons.

          U.S. nuclear testing was suspended in November 1958 due
to a Soviet-American test moratorium.  In July 1959
responsibility for radiological safety at NTS was shifted from
the AEC to a Federal Radiation Council chaired by the Secretary
of Health, Education and Welfare.  However, when testing did
resume in September of 1961, radiological safety had virtually
ceased to be an issue at NTS, because the majority of tests were
now conducted underground.    

          Under the terms of the 1963 partial test ban treaty
between the United States and the Soviet Union, all subsequent
U.S. and Soviet nuclear tests would be conducted underground.

          CHAIRMAN FADEN:  Thank you, Greg.  I think this is,
obviously, by way of general background for at least some of us,
in which I include myself, who are not very familiar with the
background history of atomic bomb testing, so we can then
understand a little bit better where and to what extent human
experimentation may have fit in.  So, thank you.  Dan?

          DR. GUTTMAN:  We have been following the trail of a
group called the Joint Panel on the Medical Aspects of Atomic
Warfare which, as discussed at prior meetings, appears to have
been the central train station where in the '49-52 period all
kinds of questions relating to information and research and
experimentation relating to atomic warfare and medical aspects
were discussed and plans were made, including human
experimentation.

          At the June meeting the committee received and
discussed a September 1951 draft document in which the panel
drafted something called biomedical participation in future
atomic weapons tests.  The document identified general criteria
for bomb test related experiments, using the term experiments,
and identified twenty-nine "specific problems" as "legitimate
bases" for biomedical participation.

          The presently available document, as discussed in the
memo, and I'll summarize, indicates that at least four of the
items listed in the draft planning document, vision testing,
psychological observation of troops, testing of human body
fluids' radioisotopes, and human fly-through of atomic clouds,
appear to have been conducted.

          It should be emphasized at the outset, we're trying to
reconstruct a story, some of whose key aspects have long been
public.  Most prominently, it's long been known, even advertised
in places like Life magazine in the Fifties, that troop maneuvers
were conducted close to Ground Zero.  

          What appears to have been less well known, as far as we
can tell, has been not known until this putting it together, is
that the biomedical -- this set of activities was preceded or
accompanied by biomedical planning and related to the troop
maneuvers in further instances.

          There is a further piece of the puzzle.  When we
started the committee, as Jon Moreno has just been summarizing,
the trail that we initially started on was the Secretary of
Defense Wilson-Nuremberg Code trail.  We now know that that memo,
as it says on its face, was based on the recommendation of the
Armed Forces Medical Policy Council.

          It now appears that it was the Armed Forces Medical
Policy Council that initially, as shown in the memos in the
package, suggested that the joint panel consider and develop
criteria for the biomedical participation.  So one of the big
question is:  When you have the same people, often in the same
rooms, discussing seemingly simultaneously ethical codes and
subject exposure bomb tests and using the word experimentation,
how are those two discussions connected, if at all?

          The joint panel, as we've previously discussed, while
it was an entity within the Office of the Secretary of Defense,
was an entity that -- At that time, it was a small government,
encompassed representatives from the Public Health Service, from
the Atomic Energy Commission.  The National Academy of Sciences
sat in, and it now seems pretty clear that the CIA was a
participant in the human experimentation discussions.  This will
be discussed later.

          In 1951, September, as we've previously presented,
there was a list of twenty-nine specific problems for testing. 
Once again, at least four of them seemed, by clear implication or
expression, to suggest the need for human subjects.  These
included the effects of exposure of the eye to the atomic flash,
the after-image description and duration, light blindness
description and duration, measurement of radioactive isotopes in
the body fluids of atomic weapons test personnel, psycho-
physiological changes after exposure to nuclear explosions, and
orientation flights in the vicinity of nuclear explosions for
certain combat air crews.

          When we discussed this memo, we didn't have a document
that apparently was presented at the September meeting in
accompaniment with this memo, and that was a program guidance
document.  The joint panel was, among other things, supposed to
produce program guidance documents.

          That September '51 program guidance document had a
section entitled "Biomedical Participation in Future Atomic
Weapons Tests."  The conclusions and recommendations of that
section stated in full:  "4.1  To complete present program and
plan for participation in future tests, in light of results from
Operation Greenhouse..." -- an immediately prior test --
"...these plans should include studies on the effect of atomic
weapons detonations on a troop unit operating in normal tactical
support."

          In addition, the program guidance document had a
psychological studies component which included recommendations: 
Continue studies in psychology of panic; spread knowledge of
radiation tolerance, techniques of avoidance and possibility of
therapy through military and civilian populations, and measure
their acceptance; and prepare to make psychologic observations at
and after bomb tests.

          The program guidance report concluded with a list of
R&D recommendations, and among those singled out for emphasis the
most critical included the initiation of "troop indoctrination at
atomic detonations and psychological observations in troops at
bomb tests."

          In January of '52, another memo included in the
package, the Army Surgeon General wrote, in essence, saying that
-- it was a memo that asked for -- the people involved in running
the tests stated that the Surgeon General's Office has a
continuing interest in the conduct of psychiatric observations
regarding the effects of weapons on the participating troops, and
funds for the conduct of psychiatric observations which may be
approved will be made available through the Surgeon General,
concurred in by a series of medical officials.

          In February of 1952, the Joint Panel had convened an ad
hoc working group to actually study, dope out, the particulars of
the biomedical components.  As the documents included in the
package indicate, their first recommendations, if you looked at
them and looked at them in isolation, clearly expressly refer to
animals almost to the exclusion of human subjects.

          They talk about use of plans to fly through clouds, but
refer to animals and drones.  There is no reference to
psychological testing.

          In September of 1952, the Joint Panel met again, and at
that meeting there were several items of business, among which
the Joint Panel referred the  psychological component of its work
to the Human Resources Committee, which was a parallel committee
under the Research and Development Board's structure  and the
Secretary of Defense.

          In doing so, the panel stated, the portion of the
program guidance report -- It was a program guidance report in
September '52 as well as September '51 -- the portion of the
program guidance report dealing with psycho-physiological effects
of radiation in mammals and, when possible, man should be
transferred to that section of the panel report entitled
"Biological Effects of Radiation."  

          In other words, it appears that part of the work was
being parceled out to the Human Resources Committee, but the
psycho-physiological effects of radiation in mammals and, when
possible, man would be kept within the joint panel.

          In referring the psycho-physiological activity to the
Human Resources Committee, the joint panel passed a motion which
stated, in part, it's possible that inclination to panic in the
face of AW, atomic warfare, and RW, presumably radiation warfare,
may prove high.  It seems advisable, therefore, to increase
research efforts in the scientific study of panic and its
results.  The panel supports the point of view that troop
participation in tests of atomic weapons is valuable.  As many
men as possible ought to be exposed to this experience under safe
conditions.  Psychological evaluation is difficult, and results
can be expected to appear superficially trivial, but the matter
is of such extreme importance that the research should be
persisted in, utilizing every opportunity.

          The joint panel appears to have ceased its work
sometime in early 1953 when DoD, Defense Department, was
reorganized.  The Defense Department is looking for all the
documents that may bear on the joint panel's activities, and just
in the last few days in our own researches in the archives and
over the transom from friends of the committee, we've gotten
additional documents to fill out the picture, but the big puzzle
is the relationship between the joint panel and what happened,
and also the work of the joint panel in the bomb test protocol
development and the ethics code activity that were parallel.

          What does seem clear, and a lot of it is clear because
it's been in the public record for many years, is that activities
which were quite similar to those identified in the joint panel's
work were, in fact, conducted subsequently, very shortly
thereafter  in many cases, in relation to the atomic bomb tests
in Nevada and sometimes in the Pacific.

          Very briefly, vision testing, as explained in the memo,
in 1952 -- '51, '52, and '53:  Human subjects were exposed to
bomb tests from various distances in the air, in trailers and
elsewhere.  What's interesting about the vision testing is that
the vision testing apparently was included in the "biomedical
component" of the bomb test program.

          The bomb test, as can be expected, had many, many
different categories of research involved, and one of them was
this biomedical component which the joint panel, of course, was
addressing.

          The vision testing appears in the Defense Department
histories of the bomb tests under the biomedical section.  Why
it's interesting is it appears to be the only of the items that
we'll discuss that appears to have actually been effectuated
under the biomedical program.

          Measurement of radioactive isotopes in human body
fluid:  As indicated in the memo and shown in the attachment, it
appears that the Department of Defense and the AEC, with the
assistance of National Institute of Health and civilian doctors,
went on to prepare a program to study at least human urine
samples before and after tests.  

          The particular document attached is a Walter Reed study
related to the Teapot operation in 1955 where measurements were
taken of some soldiers at Camp Mercury, which is at the test
site, but also throughout the world.  Apparently, the intent was
to set a baseline for the future Pacific tests.  That Walter Reed
document refers at the onset to three earlier Secret urine
measurements.  

          What is interesting, going back to the biomedical
component, is if you read the Teapot Report, there is -- of the
Defense Department history, that so called Defense -- the NTPR
Blue Book -- you don't find any reference to a biomedical
program.  In fact, there appears to be an assertion that there
was none, and in the extensive bibliographies there is no
reference to the Walter Reed report.  

          So this appears to be something that has sort of fallen
between the cracks.  That doesn't mean it was secret.  In fact,
we've found that in 1959 the Walter Reed report seems to have
been a subject of Congressional testimony.

          Psychological testing and troop maneuvers:  Again, this
has been the subject of extensive public inquiry, starting at
least in the late Seventies.  There have been one or two books
written on the so called HumRRO George Washington University
psychological think tank testing, and one at Hopkins, oral.

          What again appears to be new is any connection of
psychologists to underlying biomedical planning involving M.D.s
in a medical panel, civilian doctors.  The relationship to link -
- The closest link between the HumRRO and the M.D. profession
appears to be the 1952 Surgeon General memo where you have the
Surgeon General and doctors signing off on psychiatric and not
simply psychological research.  

          It's a distinction that is important to me.  My mother
is a psychologist.  I'm not sure how important it is to other
people, but I always have that distinction clearly in mind.

          Finally, the cloud fly-throughs:  Again, this is a very
interesting story.  It turns out that there is a vast history of
the fly-through, of flying through atomic cloud.  We have been
privileged by the Defense Department.  

          The Air Force gave us a copy, declassified, of a
history of cloud sampling, which is really, as Jonathan Moreno
said, quite -- It's a wonderful book, and a lot of elemental
sense,  whether there are horrible aspects.

          It starts off by saying cloud fly-throughs -- This is
the story of one of the great adventures known to man in the
Twentieth Century, and it tells how the whole concept originated
in 1948 when a Colonel accidentally flew through an atomic cloud.

          As the work says, when they came back home and nobody
was dying a "sick and horrible death," they thought maybe this is
kind of a good idea.  Then this becomes a major program.  

          What, of course, we want to distinguish is a lot of the
cloud sampling was done to obtain measurements of the
radioactivity in the cloud or on the plane, but in addition what
seems clear is that, in some respects, human beings were used as
dosimeters.  Human beings were swallowing film capsules to
measure dosages.

          When the planes landed -- and this again is in the
Defense Department history Blue Book -- individual ground crew, I
guess, put their hands on the fuselage to see how much radiation,
to see what the contamination was that was remaining.

          How these subjects were selected for the fly-throughs
is not precisely clear.  We presume, as best as we can read it,
they were volunteers, but there's a quote in the cloud sampling
Air Force history in which one of the volunteers said something
to the effect of this is really interesting and educational; when
I was first selected, I just thought this was going to be a
guinea pig experience.

          Again, a lot of this was public in the 1950s.  The Air
Force cloud sampling history has a terrific quote which we
excerpted from the Las Vegas newspaper in 1955 which was
particularly interested in the people swallowing the film badges
and, interestingly enough, using the word experiment.

          The final point is that, even though some of this has
been known publicly, there's plainly a lot that isn't, hasn't
been.  I think one of the things that has just been declassified
is this Operation Plumb Bob report.  D&A just gave it to us.  It
bears a July 25 declassification stamp.

          We included that, because there seems to be a clear
statement, as quoted in the memo, that the purpose of that use of
human crews was not -- The number one purpose was to measure the
effect on air crews of radiation, to see if they could fire an
MB-1 rocket, and that experimental measurements were taken
towards that end, and there's a chart of before and after of
dosages received by the pilot, the person in the middle, the
person in the back.

          So that this appears to be a case where the primary
purpose was measurement of effect on humans, not simply an
incidental purpose going to the question of the relationship
between occupational exposure which happens to be measured versus
an intent to collect measurements.

          A final fascinating point on the cloud fly-throughs,
picking up on Greg's point, is that there is a running issue,
question, starting with the plutonium injections, going to the
NEPA, and now into the atomic testing, of where is the level of
safety, and who sets it?  Is there a setting by an independent
agency like the AEC, which in the respect of that world may have
been viewed as independent?  Is it by the Defense Department and,
if so, is it by the doctors and, if so, are the doctors
simultaneously engaged in promotional activities?

          This is an area where, in fact, there is a much more
well lit trail than might have been suspected.  Jon Moreno
excerpts from the air sampling story of the Air Force apparently
a debate between the Los Alamos folks, who were the AEC's
representatives in charge of the air sampling program in the Air
Force, about the extent to which planes should be decontaminated.

          The gist of the debate, as I read it, and you all can
read it, is the Air Force -- and this is an Air Force history --
wa saying, well, we already are under the acceptable Rad level. 
So it would be inefficient to spend more money decontaminating,
and Los Alamos seems to be saying, you know, do your best to get
this as clean as possible when you have people who are going to
be exposed to it.

          There is also a very interesting history written by a
DOE historian which hasn't been published, but was circulated for
review, which details in a blow by blow aspect the question of
how standards are set and then waived on an ad hoc basis, and who
-- you know, who waives them.

          The final point I want to make -- and Henry, I'm sure,
is waiting for me to make it -- is that as to the dosages
received, those of you that are involved with the issue of atomic
testing and exposure well know that there has been since the
Seventies serious efforts at dose reconstruction.

          The National Academy of Sciences has been involved. 
Henry and Duncan, I'm sure, and others know more.  Apparently,
there is some present effort.  So there is a large body of study
and data, needless to say, and accompanying dispute about what
happened, with a pretty clear understanding that a lot of the
actual dosages are, you know, either lost to history or only
reconstructible in some primitive manner.

          Finally, we conclude with a list of questions.  The
basic questions, of course, are, you know, what is the -- Where
are the missing links in this story?  Where did the planning of
the joint panel fit into the activities that actually took place? 
Was the joint panel simply echoing the work of Generals who said
that they'd like to do these activities or was it actually an
independent driving force?

          Pat is saying you can't ever expect to tease these
things out.  Nonetheless, they may be interesting questions, and
there is some documentation.

          Would access to complete documentation surrounding the
panel revealed a discussion of the bounds of experimentation in
bomb tests?  Would we see some connection between the Nuremberg
Code discussion and the bomb experimentation, if that's the word,
activities?

          In my own mind as I begin to look at this material, we
do see, as you see in the packet, that there was consent in
varying degrees in some of these activities.  The officer
volunteers who were within the 2,000 yard level plainly signed --
appear to have plainly signed consent forms.  

          So it may have been that, in fact, there was some
connection and some consent mechanisms of some sort worked out,
although it's less obvious with the masses of troops.

          What was the relation between the biomedical offices
and the implementation of these activities?  Obviously, the way
we -- The metaphor I use is when you look at the joint panel,
there's a stream, and the stream goes underground.  You see
activities on the other side and, when you see the cloud
sampling, it's not clear whether that's related to biomedical
activities.

          One little interesting thing:  Mark Goodman's memo on
intentional releases has cloud sampling in relation to one of the
intentional releases.  I think it's the Kiwi -- one of the Kiwi
tests, and that appears to be cast as a biomedical activity,
which is surprising; because in the bomb tests, it's not clear
it's cast as a biomedical activity, but in Kiwi the people
sampling the Kiwi effluent seemed to be deemed biomedical
subjects.

          Who inherited the planning work of the joint panel? 
The relationship among agencies:  Another important point is that
it's clear that there were interagency groups working on the
biomedical testing.

          We have as early as 1949 Chairman Lilienthal of the
Atomic Energy Commission saying Sheilds Warren, our friend, is on
the -- He's on the case.  He's working with Los Alamos's J
Division and the Defense Department on the biomedical planning.

          An AEC document shows that in 1952 there was an AEC
based committee with participation from the Public Health Service
and Department of Agriculture, and Los Alamos is a centerpiece
working on it.

          So there is a trail.  It's modestly well lit.  The
contours appear to be that there was planning, and there was
activity, and the in between and the details are questions.  What
you will do with it is another subject.

          CHAIRMAN FADEN:  Let me just get a sense of the group,
Dan.  We have a branch point here.  We can either have ten
minutes of discussion and the break at 11:10 or a break now. 
Break now?

          I think the group needs a break.  So while this is not
the best way to do it, I don't think we  have much of a choice. 
So let's break now and come back at 11:05 -- ten minute break,
please.  So that would be about five after eleven, we'll
reconvene.

          (WHEREUPON, the Advisory Committee recessed at 10:54
A.M. and reconvened at 11:15 A.M.)

          CHAIRMAN FADEN:  Could the committee members come to
the table.  Otherwise, we're going to each lunch about two
minutes after the break, which would be interesting but not very
efficient.

          Okay, group, we need to keep a pace here.  So let's
have fifteen minutes of discussion.  Aren't I mean?  If I'm not
nasty here, where will I be.  We'll see.  I mean, if we need to
go longer,          we need to go longer, but we've already
pushed the break to within ten minutes of lunch.  

          All right.  So we've heard from Dan and Greg. 
Questions, comments?  I'll just start keeping my list.  Duncan,
Nancy.  Wait a second.  I know this is stifling of natural flow. 
So what people need to do is not be shy.  If you have a comment
that's directly on what the other person said, insist on
interrupting, but unless I see this intense need to speak at that
very moment, I'm going to try to keep to as I see the hands.  

          So I saw Duncan, Ruth, Nancy.  I now see Jay, Lois,
Henry and Mary Ann.  I will ask again, but right now I've got
that order.  So Duncan, Ruth, Nancy, Jay, Lois, Henry, Mary Ann,
and I'll scan again.  Duncan, you start.

          DR. THOMAS:  I continue to be struck by what really
seems to me to be a discrepancy between what is being stated by
the joint panel and what was actually carried out.  I refer in
particular to this footnote at the bottom of page 6 of the memo
where the conclusions and recommendations from the 1952 program
guidelines say:  Item 4.2.  It's still necessary to institute
measurements of the effects of moderate doses of radiation in
man, and advantage should be taken of any opportunities for the
study of the biological effects of radiation, particularly in
man.           What we have are studies of non-radiation related
effects, such as effects on the eye, and we have studies of
psychological effects, neither of which are radiation related,
although radiation exposures wee involved in the experience, and
we have dosimetry studies such as the urine excretion studies.

          None of this would be what we would call biological
effects of radiation.  I'm also struck by the word moderate where
it talks about moderate doses.  Now it's not clear what's meant
by moderate doses.  They're certainly not saying low doses.  

          I presume, just by inference, that moderate is in this
range where they think that soldiers could get, actually, what we
would now consider good test results and yet still continue their
function, somewhere in the range of 25-100R.

          It seems to me that there's a piece of the puzzle
that's still missing.  It would be a very important piece if we
could uncover any such activities of actually biological effects.

          MT. GUTTMAN:  Actually, I have to think about your
question as you're stating it, and two comments, obviously
personal, not reflecting the committee or anybody else.

          One is that it looks like part of that gap, clearly the
whole body radiation experiments that we're looking at, the DNA,
Defense Nuclear Agency, predecessor -- Their portfolio, which is
probably a word that is not a bad one, at Cincinnati, Baylor,
Sloan-Kettering and M.D. Anderson -- in some respects, when you
look back from their own vantage, that was filling that gap in
the radiation to biological effects in man.  That's one piece.

          The other piece -- This is probably -- I don't think
that would be too difficult a point, too controverted; but the
much more controversial one might be this question of when the
military is concerned about effects at that point in time, they
were looking at immediate, not longstanding.  In fact what Stuart
Udall and others have been saying is that, hey, nobody has been
doing a follow-up and, if you're not exposing people to, you
know, 100-200 Rads, then there would be relatively modest,
immediate effects.

          So that, if we're just talking about putting troops in
the battlefield or flying through, there wouldn't be much.  I'm
just suggesting this in response to a question as a way of
puzzling out the logic of this missing piece, that if you're not
thinking long term, there wouldn't be a biologic effect.

          DR. THOMAS:  Although I'm not sure how well that was
known at the time.

          MR. GUTTMAN:  Well, that's a question.

          DR. THOMAS:  They may well have wondered about other
causes of biological effects.

          MR. GUTTMAN:  Well, that's right, but then that goes
back to the history of the cloud samples where they say, well,
whoops, we flew through the cloud and nothing happened; so it was
okay.  

          DR. MACKLIN:  I just perhaps missed it in this morass
of materials here, but I didn't find the consent form that is
stated to be in Attachment 10.

          MR. GUTTMAN:  Yes.  We failed -- It just didn't get in
there.  I think -- Obviously, we have it, and we'll give it to
you, Ruth.

          DR. MACKLIN:  My other question is about the
psychological studies.  I want to connect this -- I mean, there
are the items 4.1.3 through 4.1.6 in Attachment 2.  Some of these
are studies, and some look like interventions of some sort.

          What I'm looking for -- two questions:  The first,
knowledge of radiation tolerance -- does that mean
psychologically what people -- It's not biological tolerance  or
it's psychological tolerance.  But, secondly, I wanted to link
the material that's here with what we heard from Jonathan Moreno
about the exemptions. 

          My question is:  Wouldn't these psychological studies
or might not these psychological studies be just the sorts of
studies in which it might be necessary to withhold information
from people so they don't skew the results?  That is, when you're
talking about psychological studies, that's precisely -- it's not
biological results that are going to skew the results, in the
urine, for example.

          So the question is:  Is this one of the areas in which
one might have argued that no consent or information to subjects
would be necessary precisely -- I mean one of the exempt
categories -- precisely because you were going to alter the
results of your experiment when you tell people whether that's
what you're doing.

          MR. GUTTMAN:  Well, I hate to say, especially in
response to one of your questions, that  I think it's clearly the
other way around; because -- suggests that I'm in the wrong, but
I think it seems to be clearly the other way around, because what
you're finding here -- It's very interesting.  Where you would
find informed consent, we see indoctrination.

          In other words, one of the essential aspects of this is
-- and they use the word indoctrination or emotional vaccination. 
So that, far from not telling people, part of the activity is
telling them, but the word indoctrination is --

          CHAIRMAN FADEN:  I think Ruth's point is to the purpose
of the research.  In other words, you say we want to talk to you,
because we want to see how panicked you get.

          MR. GUTTMAN:  Oh, I see.  Right.

          CHAIRMAN FADEN:  Now if you tell people that -- this is
the standard line in psych research.  Now that people know you're
looking at how panicked you're going to be, people are now going
to try to appear to be less panicked.

          DR. MACKLIN:  You're not even going to tell them it's
research.  Isn't that indeed what is more likely?  In other
words, you're exempting -- By exempting this as a category that
would fall under the regulations, you exempted to the point that
you don't even tell people that what you're doing is research.

          You're saying, now you're going to do the equivalent of
crawling under the barbed wire with the machine gun fire overhead
and not even acknowledging or notifying people that it's
research.  

          MR. GUTTMAN:  Yes, but except in the case of the
psychological, the HumRRO and so forth, they had people filling
out questionnaires and so forth.  I guess that -- You know, I
mean it's got the context.

          CHAIRMAN FADEN:  Jay?

          DR. KATZ:  I'm puzzled by something.  They were
studying panic, the psychology of panic.  Do we have any
information -- Can we get information?  How can you study panic
without telling the troops also the worst consequences of
radiation exposure.

          So I'm completely baffled by how they could study panic
without telling these young men, look here now, we are going to
exposure you to an atomic blast, and you'll be genetically
damaged for the rest of your life, or you may be, etc., etc.,
etc.

          MR. GUTTMAN:  That seems to be an easy one, too.  Here
are the too sharpest questions.   It's Henry's point.  You've got
the comic book, the Invisible Hulk and radiation.  It doesn't
require, you know, a technical manual description.  

          DR. ROYAL:  Jay, I hope that that's not what you mean
by informed consent, to tell people that they're going to be --
have genetic damage for the rest of their life.  

          DR. KATZ:  No, but you know what I'm driving at.

          CHAIRMAN FADEN:  Yes, but I think that Dan's point is
the concern here -- and again, I hope that we're not
misunderstood here.  In asking these questions, we're not
excusing or blaming or justifying.  We're just trying to figure
out what was going on here.

          The judgment issues are not what is happening at this
point in the discussions.  Let there not be any confusion about
that, but the question, I think, Jay, that you speak to is the
concern the military had was they thought the troops were scared
to death.  

          It's not that they had to tell them more so that they
would be more scared.  They thought the troops were scared about
the prospect, were already filled with fears about what would
happen to them or at lest there was a suspicion that that was the
case.

          DR. KATZ:  But we know they don't do much about it that
the troops were scared?

          CHAIRMAN FADEN:  Well, I don't know.  We haven't -- We
don't have the HumRRO documents and so on.  They did before --
some cases before and after, attitude studies is my inference,
things like, you know, how frightened are you or how bad do you
think it is or, you know, what will you tell your friends.  So,
presumably, they had some stuff like that.

          Now I'm violating the rule myself.  So I'm going to let
Phil -- This is in the spirit of right on point.

          DR. RUSSELL:  I don't know it for sure, but I expect
that these studies were recommended by the military psychiatric
community.  They had just gone through World War II where they
had immense numbers of casualties, many of them permanent
casualties from combat stress, battle fatigue, combat stress
syndrome, a variety of terms.

          It was recognized by this community that atomic warfare
was going to be another order of magnitude greater stress.  These
military psychiatrists felt an absolute necessity to understand
the psychologic effects of this.

          Now I don't think they were as concerned about panic in
the organized panic sense.  I think they were concerned
principally about the individual feelings of panic and the
emotional breakdown under stress.  I think that's what motivated
this.

          How they did it -- and, generally, that community had
to get consent to get the information out of the troops, at least
consent to be interviewed and consent to participate in the
psychiatric evaluation part of the experiment.  It doesn't mean
they had to get consent to go through the exercise, which is
another issue.

          CHAIRMAN FADEN:  Ruth, that was your question?  Then
Nancy has the floor.

          DR. OLEINICK:  I would like to ask a question which
actually relates to this subject as well as to the previous one
in terms of where does the military training leave off and the
experimenter begin.  This has to do with the number of
participants.

          Obviously, the military was concerned, and we have
documentation to it, that we train as many troops as possible in
how to be able to work on the nuclear battlefield, and one can
understand that.  On the other hand, when one is designing an
experiment, particularly an experiment with humans, at least
today, one would ask the question, what's the minimum number I
need in order to get the information that I want?

          What I haven't seen in any of my perusal of documents
is that side of the question.  How many of these experiments
needed to be done?  How many planes had to fly through the cloud
before we understood what was in the cloud, even though there are
different clouds?  There were some differences, but I don't see
any of that analysis.

          That's a question that, I think, really becomes rather
important in trying to decide what is an experiment an how these
were viewed, whether they were viewed as experiments or merely
extensions of military training.

          I don't expect to get an answer on this.

          MR. GUTTMAN:  There are a couple of points.  One is,
obviously, there's a terrific element of training.  I mean,
plainly, to exposure people to the situation where you
hypothesize they may panic and you get them to realize that
they're not going to panic -- I mean, that is training.  So
there's no question about that.

          The other aspect of it that is interesting -- this gets
into in part what Eli had talked about a couple of meetings ago,
the notion of attitude.  It comes out clearly in the
psychological discussions here, but it comes out in all the
documents we see at this time in the history of the country, an
incredible sense that we need to know things.

          There's no kind of precision about what's the
cost/benefit.  It's every opportunity.  If we can use it to get
information, you know -- It's sort of there's an excess of need
for information, and you know, resources to get it are, you know,
available.  It's this quote about psychologists may not be very
good, but we need the data.  Right?

          We had a conversation -- I hope I don't take it out of
context -- Don Weightman and I.  We met with the Defense
Department a couple of weeks ago, and we were talking about these
very documents.  One of the people in one of the defense agencies
said, boy, if we had a cloud to fly through today, we'd sure as
heck want to fly through it, because every bit of information you
can get about, you know, what the other side is up to is of
value.

          DR. HERKEN:  Also, I don't think the interest was so
much in the individual, but really a lot of the interest was in
how the unit performed, that there was talk about involving
everything from a platoon level up to a regimental combat team. 
There the interest was not again the effect upon the individual,
combat effectiveness of that individual, but the combat
effectiveness of the unit.

          CHAIRMAN FADEN:  Is this right on point?

          DR. THOMAS:  Dan's last comment sparked something that
I've been thinking in the back of my mind for sometime.  We are
interpreting this cloud sampling as human experiments and trying
to learn something about what -- the experience of pilots flying
through clouds.  

          I think there perhaps was an element of the military
wanting to know whether or not this was something that we could
expect pilots to do in a war; but I think there was another
purpose which was driving this and perhaps a much more important
purpose, and that's simply to get information -- so that they
could compute what the bomb was -- about this sort of thing. --
they could get that more efficiently in the relevant parts of the
cloud.  The fact that humans were being exposed in the clouds was
just incidental.  It had nothing experimental to do with it at
all.

          DR. STEVENSON:  It was stated, actually, in at least
one of the discussions that both of those were goals.  

          MR. GUTTMAN:  That's right.  I mean, there's no
question the preponderance might have been what's in the clouds,
but it's also clear --

          DR. THOMAS:  Coming back to Nancy's earlier point, how
many of these experiments do you need to do, you could perhaps
answer the question about the effectiveness of pilots with one or
two fly-throughs.  I don't know how many it would take, but there
wouldn't be a continuing need to do this.

          On the other hand, there would be a continuing need for
every one of the detonations to get the sampling data.

          DR. OLEINICK:  On the other hand, in order to
understand the physics, which is essentially what it is, the
physics of the blast and the products, one didn't have to swallow
dosimeters.  That's, obviously, a biomedical component.

          CHAIRMAN FADEN:  I hate to do this.  I feel like the
wicked witch of the west here to stop discussion, but I'm looking
at my growing list.  Jay, the floor is yours if you -- You have
already made your comment?  Okay.  Then Lois.

          MS. NORRIS:  This shouldn't take long.  I wonder if you
know why only the psychological research was bumped to the R&D
Board.  What was unique about that?

          MR. GUTTMAN:  Well, one thing, it may have been -- It
was bumped to the Human Resources Committee.  Relatively
speaking, it made quite a bit of sense.  There was a parallel
committee called the Human Resources Committee.  The entity that
conducted the psychological testing was a creature of this 
committee.

          We have -- Jim David dug out the minutes of the Human
Resources Committee in mid-1951 where they created and had the
contract terms, and it was called HumRRO, Human Resources
Research Organization.  So it's sort of -- That is relatively
easy to understand.  It fit right in.  

          Now whether there was something else going on there,
you know, whether someone said, well, maybe it's better to do it
this way for some other reason, we don't know; but on its face,
you know, human resources is -- If you'll note in the appendix to
the 1951 program guidance where they have the R&D listing of
what's high criteria, and they have the acronym, the code words
for each component of research, and they've got AW-1, 2, 3, 4, 5,
6, and those are the atomic warfare.  AW-6 is biomedical, but
then you had the psychological, PO.

          So that there was a bureaucratic distinction which may
have been just a perfectly reasonable explanation of why that got
bumped.  Whether there was something else going on --

          DR. KATZ:  Was Joe Aub responsible for this?  Joseph
Aub -- was he responsible for bumping it?

          MR. GUTTMAN:  Well, he was the Chairman, and there was
a motion moved.  Now whether someone said -- He was the Chairman
of the Joint Panel -- this is the way it's going to happen, you
know --

          DR. KATZ;  He was a teacher of mine, and he didn't
think much of psychology.  So --

          MR. GUTTMAN:  Well, that came across.  That comes
across in the documents.  Dr. Katz, there is a distinction
between psychiatry and psychology, I take it then.

          CHAIRMAN FADEN:  Yes, Lois, you still have a question?

          MS. NORRIS:  I do have one more.  Do I understand that
you are thinking that the elaborate education and involvement in
planning and consent procedures which surrounded the 2,000 yard
experiment were in fact part of the psychological testing?  In
other words, how are these people going to respond if they are
adequately educated and participate in the planning?

          MR. GUTTMAN:  That may -- That should be relatively
easily answerable through the HumRRO reports.  We just haven't
been able to access them yet.

          MS. NORRIS:  Well, as someone noted, we don't have the
consent form.  

          MR. GUTTMAN:  I'm sorry.  Actually, we can just get a
copy brought over.

          CHAIRMAN FADEN:  We can bring them tomorrow.  I mean,
it is an oversight.  It was just a screw-up.  This is just the
consent form.  The HumRRO documents presumably are -- Dan, you
keep saying they are available somewhere.

          MR. GUTTMAN:  Yes.  Ruth, you got a call from the
President of George Washington.  Of course, that beats me. 
Right?  It was a George Washington sponsored entity.  You can't
find these things in libraries where you would expect to find
them.  

          CHAIRMAN FADEN:  But there were reports, and there were
public reports.  It's not that these were classified documents. 
We can try and find them.  The reference to what we can produce
tomorrow, Jay, is that consent form that the pilots in the one
particular experience executed or the consent form for this
particular pilot.  Henry?

          DR. ROYAL  We covered one of the points that I wanted
to make, and that was what the purpose was of having planes fly
through these mushroom clouds.  I think it's become clear to
everyone that there was a purpose and rationale behind it.

          One of the things that I thought that hasn't been
mentioned is that I thought that there might have been some
concern about pilots taking some evasive action.  You know,
fighter planes had been sent up to shoot them down, that they
might fly into the cloud so that they couldn't be seen and might
be able to take some evasive action.

          So it wasn't just there's a cloud, let's fly through
it.  There was some purpose behind it.

          One of the things that I continue to be confused about,
and maybe someone else on the committee can help me, is in terms
of flying through the clouds.  It seems like if the exposure to
the pilots was incidental, that that was okay, but that if they
followed a film badge to get some additional information about
what their actual radiation dose was, that then that raises some
ethical questions.

          I guess I don't fully understand that.  It seems to me
that measuring their radiation dose shows an added level of
concern.  It shows the fact that you want to document what the
radiation dose is, so that then you can make some intelligent
judgment about whether or not the risk of that radiation dose was
worth the benefits of having flown through the cloud.

          So I'm having trouble with the logic that measuring the
dose somehow then raises ethical questions.

          MR. GUTTMAN:  This is back in the package.  John and
Ruth put out a set of questions that are raised by this.  This is
an entire discussion, but, yes, this is what John is saying we
discussed ad nauseam.  What is the boundary between what might be
called an experiment and what might be called occupational
monitoring.

          I think from staff's perspective, it's unclear.  To say
that you're on one side or the other does not itself suggest an
ethical judgment.  That's something -- It is an experiment
doesn't obviously mean that it's bad, because we all are asked
every year or two to engage in human experiments of one sort or
another.

          It's what are the rules once you're in the experiment
ballpark and what difference does it make, the so what.  A kind
of question, for example, would be if you are given the
opportunity to put people out and collect internal data, does
that mean that some part of the defense organization is saying
this is terrific, let's get some more people out there and put
them at risk?

          In other words, what are the operational implications? 
In part, that's Nancy's question.  It's perfectly fine to conduct
an experiment.  What are the implications?  Does it mean you
actually get information that is put into use in reducing risk in
the future or does it just mean you've got a continual incentive
to put people at risk so you can collect data?

          So in other words, it may be one of the questions is
not -- and it's Ruth's -- not, well, what's the metaphysics of
what's an experiment, but let's just stipulate this is A and this
is B, and what's the implications?  How do you look at it
operationally, and what kinds of judgments?

          That's one of the things we're trying to tease out.

          CHAIRMAN FADEN:  Thank you, Henry.  Mary Ann?

          DR. STEVENSON:  When you get a clearer idea of what the
relationship of the Armed Forces Special Weapons Project was
within the DoD, at one point in one of the summary statements it
says they were under contract to do some work; but if they were
part of the military, why were they under contract?

          MR. GUTTMAN;  I don't know.  Where does it say they
were under contract.

          DR. STEVENSON:  That's on page 9.  

          MR. GUTTMAN;  Oh, it should have been that the -- Oh,
it was the other way around.  It's the other way around.  

          DR. STEVENSON:  Now but it's still not clear what --
because as I read through in Teapot, the cloud flight -- all
seemed to get their chain of command of their -- or at least the
reports are issued from that body.

          MR. GUTTMAN:  Gregg can comment.  When the Manhattan
Project went out of business, part of it went to the Atomic
Energy Commission, and the military part went to AFS as the Armed
Forces Special Weapons Project, which is sort of an overhead
staff organization for the weapons test in which the services all
had their oars in.

          If you talk about the individuals, which may be
helpful, you see in this report we say that in 1951, in March of
'51, a Colonel Hartgering, H-a-r-t-g-e-r-i-n-g, chaired an AFSWP
panel on flash blindness.  What turns out, that when the joint
panel says they want to create an ad hoc group to study
particular bomb tests, Hartgering is the head of that.

          DR. STEVENSON:  He's the head of the body that
implements all of this?

          MR. GUTTMAN;  Right, and he's on the Walter Reed study,
too.

          DR. STEVENSON:  Right.  It seems like everything
ultimately is implemented through --

          MR. GUTTMAN;  Right.  That's right.  They're sort of a
-- 

          DR. STEVENSON:  Where do they fall in the organization
of the DoD?  Where --

          MR. GUTTMAN:  Yes, they are.  They're part of -- Gregg?

          DR. STEVENSON:  Are they operating semi-independently
or are they under the jurisdiction of some of these government
agencies?

          DR. HERKEN:  They are multi-service, and basically
their responsibility was for how the weapons would perform or how
weapons would be integrated into the strategy of all the services
in the military.

          DR. STEVENSON:  But they seem to always be involved
ultimately in these tests.

          DR. HERKEN:  Right.  Well, in fact, whenever a test
involved a component, whether it be troop observers --
ultimately, responsibility for that was taken by AFSWP.  AEC had
responsibility for the tests generally, but the involvement of
the troops was AFSWP.

          DR. STEVENSON:  Can we have good documentation about
their work?  It seems to me that they were --

          MR. GUTTMAN;  Okay, let me tell you where we are.  This
is an excellent question.  AFSWP is today what is known as the
Defense Nuclear Agency, and the brief history is that in '78 or
thereabouts when this atomic vets issue became a very important
public issue, the Defense Nuclear Agency said, we're going to go
back and try to get a list of everybody who participated, did the
dose reconstructions, in the course of which they did these blue
book histories of each test.

          So we have a good deal of knowledge about each of these
tests, blow by blow, from these blue books, which have
bibliographies.  Now we met -- General Hagaman from the DNA
called us up after the last meeting and said he wanted to do
everything he could to make sure that we get the information that
we need about DNA.

          In the book here you'll see that they've got an
extensive plan, which we understand they're in the middle of, to
go literally box by box through the archives.  The question about
their ability to access things -- this is again surprising
perhaps -- it's not clear that, even though they were in the
middle of it, they have all the documents in several respects.

          One, they say that, well, the implementation was not by
us but by the service.  If you're asking for a HUMRRO document,
we don't have it; you've got to go to the Army.  Well, the next
questions we asked, well, in these blue books that are the
histories of each test, it's got this terrific bibliography in
the back, and they've got things that are declassified, and we
can get those and they've got things that are classified, and we
asked for them.

          We've got to talk with them, but maybe those are not
even off the shelf.  So that the answer is DNA is actively trying
to go box by box in the archives, the record centers, to pull
what is useful and relevant.  A lot of it has already been
identified in the history development, has not been seen by the
public, because it's classified.  We've asked for that.

          DR. STEVENSON:  We would like to know more.  Were  all
branches of the service represented in this project?

          MR. GUTTMAN:  Yes.

          DR. STEVENSON:  And would there have been positions?  I
mean, what do we know about the people?

          DR. HERKEN:  I don't know.  Is there actually a history
of AFSWP?

          MR. GUTTMAN:  Yes, that's what we've got.  Yes.  In
fact, there -- I think -- Phil will tell you.  It was a rotating
-- People rotated in and out of AFSWP in part.  

          I'll give you an example.  In the book we have here,
you've got this affidavit of Captain -- Captain or Colonel --
Henson who was the volunteer, and he appears, as best as we can
track it -- He was with AFSWP.

          DR. STEVENSON:  Oh, definitely.

          MR. GUTTMAN:  Then it turns out there's an individual
with the same name who a year or two later becomes the head of
the Naval Radiological Defense Laboratory.  

          DR. HERKEN:  Sure it's the same person.

          MR. GUTTMAN:  Right.  It's not a common name.  So we
can track it out, but I'm saying --

          DR. STEVENSON:  By the same token, were they
responsible then -- We see all these reports happening.  They
seem to be issued from that project.  Were they responsible for
trying to digest the results of these experiments, planning?

          I mean, you look at the experiments, if you want to
call them experiments.  There was one in June of '50.  They were
at 7,000 yards.  Then the next day they had the volunteers who
actually were at 2,000 yards.  That's in '53, and then in '55
they're at 5,000 yards.  I mean, who is analyzing that, and why
do you have to do it so many times?

          I mean, the distances were changing a little bit, but
was anybody looking at what they learned from the first time?

          DR. HERKEN:  Initially, the maximum radiation exposure
was set by DBM.  In fact, that was appealed by AFSWP, that they
wanted to increase the exposure.  One of their arguments was
you're letting the pilots be exposed for 25R, you're only letting
the personnel on the test base be exposed to 3.9R; why don't you
allow some troops to be exposed to a higher rate.

          DR. STEVENSON:  The volunteers within 2,000 yards --
it's not a mile.  I'm just curious.  It was always being
performed in a vacuum, and they never looked back to see what was
learned.  

          DR. RUSSELL:  I'm not sure -- I don't think the
documentation, at least I've seen -- To explain part of the
relationship between the Defense Nuclear Agency and its
predecessor, that's part of the Defense Research Development and
Evaluation organization.  So they control all the money.

          The money for all of these operations flowed through
the Defense Department, controlled by the Defense Nuclear Agency,
and then went to the services.  

          So in that sense, they were making decisions, and they
were making the decisions through the budget cycle, basically. 
The services were the executing organizations, and in a sense,
the services were contracted for -- The reports surely went back
up the chain.

          Now how detailed they were or how condensed they were
and in what form they got to the top level, I don't know.

          MR. GUTTMAN:  DNA has now given us -- we were informed,
the first time any declassified headquarters histories have been
made public.  We've gotten some of them, and they've got
extensive listings of all of your favorite, familiar contracts.

          For example, the Medical College of Virginia appears
from 1950 to 1970.  Dr. Sanger in Cincinnati is a good case.  He
applied to the Army, but is picked up by the predecessor, AFSWP. 
So that they sort of had a portfolio.  Particular relationships
are not always clear, you know, what the Army was doing and what
AFSWP.

          Your question of, well, what we're looking for in the
case of, say, Sanger is, well, where in AFSWP does someone do a
memo saying we've got all this research, you know, and we're
doing all these bomb tests, and what's the relationship between A
and B -- Sometimes it's clear and it's obvious.  As Gregg will
point out, you do get these terrific high level discussions with
the Sheilds Warrens and the Cooneys about what's safe and what's
not, but it's not completely pegged to particular pieces of
research.

          DR. RUSSELL:  The piece of the action that we're
missing, of course, is what was going on in the operational --
the DS OPS of the Army and the other folks that were thinking
operational issues that were related to the data that was coming
out of these tests.  That's opaque to us.

          We're seeing only the research and development issues
and the results of the experiments.  What we're not seeing is the
parallel discussions that were going on among the operational
people, the personnel people, the people that were developing war
fighting doctrine, either within the services or on the Joint
Chiefs of Staff.

          One of the other questions that comes up in my mind: 
What kind of a message was the Department of Defense and the
various services trying to send to potential adversaries by
demonstration in front of the world that we were willing to put
troops in the field, blow off an atomic bomb, and then have the
troops charge through that Ground Zero.  

          That was -- There was a message in that to the
potential adversaries.  Where is the documentation for that? 
You're never going to find it in the R&D literature.  You're not
going to see it through the chain of command for research,
development and engineering.  It's buried in the war fighter's
discussions on strategy and tactics.

          DR. HERKEN:  The evidence for this is anecdotal, but in
fact it's clear that there was service competition.  It was a
matter of inter-service rivalry as to which one could get closer
to the bomb.

          At one point there's a paragraph in there to the effect
-- It was sent from AFSWP to DBM -- that unless you let the
Marines get closer than you did last time, they will not take
part in this engagement.           I wouldn't make too much of
that, but there is that element.

          MR. GUTTMAN;  Well, actually, one of the places we may
hope to find it is in the CIA.  I mean, you can begin to imagine
a role for the CIA's medical intelligence function, and in fact
we have in here.  Ruth will get to it, and Gary Stern.  The CIA
does a report on, of course, Soviet bomb capability, but also
their Rad warfare.  So that kind of connection is --

          CHAIRMAN FADEN:  I think we need to go on, just so we
can get halfway through the agenda, but there are clearly many
things.  If we have time tomorrow, we can pick up some more of
the threads of the discussion, but it's clear where we have need
of more information, given the complexities of the topic.

          So thank you very much, Gregg and Dan.  Now we're going
to have a head shift of a little bit, and we're going to have Don
Weightman and Barbara Berney come to give us overview of some
institutional case studies.   

          If I could just take one minute, in terms of -- By way
of background, sort of prompting me to think, as you  listen to
Don and Barbara's presentations and as we have our discussion of
the relevance of this presentation to the work we're going to do
tomorrow, one approach, one partial approach, one significant
approach, depending on how much we want to devote resources to
this direction, towards this issue of selecting how we want to
focus our energies as we go down the home stretch would be to
take it by institution, exhaust an institution as a case study
and see.

          Let's look at hard look at X place and look at all the
work done at X place and make some judgments about that
environment and those particular studies is one mechanism for
slicing through.  It's one of many that we can consider, but this
is an effort that's certainly worth serious attention, and Don
and Barbara can give us some sense of how the staff has
experienced going in that direction with respect to the two
institutions.

          So with that, you guys have the floor.

          MR. WEIGHTMAN:  Basically, what we were trying to do
was to answer some big picture type questions through some more
low level, grinded out research questions.  The big picture
questions are:  When you have an AEC announcing or trying to
promulgate a policy at the headquarters level, how was that
policy actually translated into research, clinical, human
subjects, practice at the field?

          It's one thing to have somebody in Washington signing a
document.  It's another thing to know whether and how that
document had any effect on how things were done with and to
patients.

          The second kind of big picture question is:  When
you're trying to figure out what the purposes were for a
particular experimental program, a good way to track it is to see
who was involved and figure out what kind of interest they would
have in sponsoring, supporting or otherwise conducting certain
kinds of research.

          Then there's a third gain, a practical one that is
probably of interest to the committee right now, which is that
because you have a whole lot of things going on at an Oak Ridge
or a Los Alamos or other kinds of institutions of that type at a
given time, and a great many experiments being conducted either
simultaneously or in sequence, you can get a lot of efficiency
gains where there's overlap.  You can see how a consent policy
worked across a variety of modalities, a variety of different
kinds of research, if you look at a particular institution at a
particular time.

          CHAIRMAN FADEN:  Don, let me just interrupt.  I
apologize again.  We should be drawing your attention to a memo
that was on your seat when you came back from the break. 
Hopefully, it was on your seat or at your place.  It looks like
this.  It's regarding outline of management theme institutional
case study.

          MR. WEIGHTMAN:  Yes.  Basically, what I have to say
about what we were trying to do in the Oak Ridge component that
we've been studying is outlined in that two-page memo.

          CHAIRMAN FADEN:  Sorry.

          MR. WEIGHTMAN:  We asked, basically, four kinds of
questions when doing these kinds of institutional analysis. 
First is sort of what people have taken to calling the start/stop
question:  How did a particular research program get started, and
why was it concluded?  What kind of approvals were involved?  Who
got to decide whether it would be done?  Who were the
experimenters?  Then what kinds of answers did they get to their
experimental questions that led them to conclude a particular
piece of research?

          A second practical question is:  Where did they get the
patients?  Where did they get the subjects?  Where did they get
the people that were the subjects of the experimental program in
question?

          A third kind of question wasn't one that we necessarily
really started with but one that kept coming up as we looked at
stuff, which was:  What kind of oversight was there?  In
contemporary terms, that might be what kind of IRB might be in
existence?  In older times, there seemed to have been several
committees that viewed themselves as, for example, out in Oak
Ridge with some kind of oversight role.

          What we were trying to find out was, in the context of
given experiments, how actually did that come into play?  Was the
oversight, for example, prospective or retrospective?  How often
would a particular committee meet to review particular proposals?

          With those questions in mind, we turned to Oak Ridge. 
The very first thing that we found out about Oak Ridge is Oak
Ridge is one geographic name, but it's many, many, many
institutions.  It got its start, to refresh people's recollection
on this, as the Clinton Engineer Works and the Manhattan Project.

          There was a research component to that work, in
considerable part driven by worker safety concerns, but with
other kinds of research going on as well.  After the War, as the
Manhattan Project became the Atomic Energy Commission, there were
many, many different institutions that developed at Oak Ridge.

          The AEC maintained a presence there, and it maintained
a presence, in particular, doing something called the Isotopes
Division which, among other things, was in charge of distributing
radioisotopes to the whole of the post-War civilian research
process that was beginning to look into the various applications
of these radioisotopes, specifically in clinical research.

          There was also a National Lab at Oak Ridge.  There was
also a very considerable inter-agency presence.  The Public
Health Service was there, and to take an organization that was
just discussed a few minutes ago, when you look at the Oak Ridge
organization chart for 1950, right at the top, right next to the
Office of the Director, there is a little box with dashes rather
than a black line, and there is the Armed Forces Special Weapons
Project.

          They had offices there, and presumably,  although we
don't have the details yet, they were in some kind of
coordinating role with the other things that were going on there.

          Oak Ridge was intended from the start to be a node in
the network of atomic research.  One of the specific jobs that it
had was, to the extent possible, to disseminate what had been
Secret during the War and make it public and available to
researchers in universities, hospitals, and other kinds of
research institutions.

          One of the first mechanisms for doing that, turning to
the second page of your outline, was something called the Oak
Ridge Institute of Nuclear Studies.  That was where one
considerable part of our focus on the staff's research on Oak
Ridge began.

          The Institute or what I'll call ORINS was a consortium
of southeastern medical research universities.  It specifically
set up shop to do medical research.  There was a medical division
formed right after it began, and it was doing research with
various kinds of short lived radioisotopes and also doing a
component of the research that is being looked at by another
chunk of the committee staff under the name of TBI.

          One thing that it was in charge of doing was to
coordinate what was going on at Oak Ridge with what was going on
with universities elsewhere, and it did so with the sponsoring
institutions that were part of the consortium, with other private
sector research, and with other Federal research.

          A particular example in the experimental program that
we looked at, gallium studies, was done in close coordination
with the Bethesda Naval Hospital.  

          Once we started in on Oak Ridge, we found out that
there were several things going on there that are of interest to
the committee, and that Oak Ridge as an piece of institutional
analysis is being picked up in several different places.

          The staff work on TBI is one example.  There seems to
have been work there that is being picked up on staff research on
radiological warfare.  There was the whole process of
distributing radioisotopes that took place under the aegis of the
AEC Radioisotope Distribution Committee which had a Subcommittee
on Human Uses and which was intended to perform a
licensing/regulatory function over this process.

          We also are looking at another piece of it where they
were in some kind of relationship, details still unclear, with
the Massachusetts General Hospital doing research on uranium
injections.

          When we focused on a particular piece of it to see how
it worked, how it got started, how the consent payoff actually
translated into practice and what concluded it and what kind of
oversight there was, we looked at a particular piece of research
on the effect of a radioisotope of the metal gallium.   Gallium
72 was studied there in the 1950-1953 period.

          The idea was to try and keep it simple, to take
something that was conducted by ORINS over a three year period
where they began the research, they did it, they completed it,
they published on it, and that was it, and see how much we could
learn about the key questions that are driving the committee.

          There's some good news there.  We were able to answer
some of our questions.  We know that the particular research was
very much driven by the post-War interest in use of radioisotopes
as potential therapies for cancer.  That was in part how the
ORINS Medical Division got set up.

          We know that gallium 72 was among a set of short lived
radionuclides that were chosen for experimental work at Oak Ridge
precisely because they had the pile there, and all those
radioisotopes were available for study, and the fact that they
were short lived meant that you couldn't ship them off someplace
else, because the half-life would be gone, and you couldn't use
them anymore.

          Gallium 72 was chosen for study, because there had been
some preliminary indications which, as it turns out, were
mistaken, that it might be a good therapy for bone cancer.  They
studied it for about three years.  The approval process seems to
have pretty much culminated in the Medical Division itself,
though there's some oversight questions that I'll get to in a
second.

          It was a three year program.  It seems to have involved
about 50-100 patients.  Numbers are unclear, because the data
just don't let you do a neat count.  They realized after
finishing up their research, which was coordinated with parallel
research done at the Bethesda Naval Institute, that it wasn't
going to work for the therapeutic purpose that had been hoped
for.  

          They published on it.  There were several journal
articles and a symposium piece on it, and then they stopped.  The
human subjects at ORINS generally, the ORINS Medical Division
generally, for this program were very much chosen because they
had the kind of bone cancer that was of interest to the
researchers.

          The way that seems to have worked is that the member
universities for the consortium basically looked for patients
with that kind of bone cancer, and then seemed to have told them,
look, if you want to get involved in a research program, we have
this one at Oak Ridge, would you like to do it.  

          Because there was so much hope at that point that
radioisotopes might be the answer for cancer therapy, it appears
that the people that were interested in being involved in this
exceeded the number of beds.  They didn't have trouble getting
people.

          We know, because they said so, that the way that the
patients consented to have the therapeutic research done on them
was that they signed some kind of waiver form as a condition of
admittance to the ORINS Medical Division hospital.  We don't have
an example of that 1950-1951 waiver form.

          We don't know yet what the translation was between the
AEC's headquarter policy on human consent was and how that was
meant to interact with the use of the waiver form as a matter of
having patients walk through the door at ORINS.

          Oversight, and here's where it gets tricky:  There were
at least three components of the organizations that were involved
in the ORINS Medical Division that had some kind of oversight
role.  We know, because they asserted oversight, that the Human
Use Subcommittee of the AEC's Radioisotope Licensing Subcommittee
expected to review research at ORINS before it took place.

          What we don't know is how much of a look they took, how
that translated into effect.  We know, because they reviewed it,
that some of the details of the gallium research that we studied
were subject to oversight by the Advisory Committee on Biology
and Medicine that was part of the Division of Biology and
Medicine of the Atomic Energy Commission.  

          What we can't tell is how close that oversight was in
practice.  We reviewed the minutes of the Advisory Committee for
the whole three year period that the gallium research was
underway, and there's just no discussion worth further mention or
making available to you of this particular piece of research.

          So it may have been oversight in theory rather than
practice, but they were, in general, reporting to the Advisory
Committee.  So we know that it was there.

          We know, because ORINS has said so, that there was
something called the Medical Advisory Committee which was
expected to exert some kind of oversight role at ORINS.  What we
don't know is what they did, because we haven't been able to get
hold of their records yet.

          Oh, yes, one final piece:  The Medical Division -- or
the Cancer Research Hospital at Oak Ridge had a Human Use
Committee, but that committee was not formed until 1966.  

          That gives you a case study in brief.  Lessons?  One is
that you can, by doing this kind of case study, get a lot of
information together about a bunch of different research.  What
we found out, to our regret, is that, even there, there turned
out to be unanswered questions.

          We don't know, for example, what was told to people
when they signed that waiver form to be admitted to the hospital. 
Those details just haven't come back to us.

          With that, I'm going to turn it over to Barbara who
will sketch the work that's going on for  Los Alamos.

          CHAIRMAN FADEN:  Duncan, I saw you had a question.  Let
me just take -- It would be more efficient to get both
presentations and have questions afterwards, but if you think
that it would be more clarifying to do questions to Don and then
Barbara's presentation and then questions to Barbara, we can do
that.  What is the preference?  Questions now?

          DR. RUSSELL:  I'd just like to make a quick comment
now.  

          CHAIRMAN FADEN:  Why don't we just go ahead then and
have five or ten minutes of questions to Don now.  I'll call it
earlier than I would ordinarily call it, let Barbara do her
presentation, questions specific to Barbara, and then, Don, you
stay up there in case we need to revisit Oak Ridge as a general
issue about doing these case studies.  Henry?

          DR. RUSSELL:  Just to complete the gallium story, I
wanted to make sure that the other members of the Advisory
Committee know, number one, that gallium is routinely used today
as a tumor and infection seeking radiopharmaceutico.  

          The second thing that I want to make sure everyone on
the Advisory Committee knows is that, even though gallium has not
worked for the treatment of bone tumors, there is a
radiopharmaceutico strontium that is used to treat bone tumors
today.

          MR. WEIGHTMAN:  Yes.  I should distinguish between the
short lived isotope gallium 72 that they studied at ORINS during
the time and the stable isotope that Henry is referring to.  So
as with a lot of other science, and we chose gallium specifically
for that reason, it was something that was in some senses -- yes,
it didn't work, but it also led to information that has since
been of benefit to biomedical research.

          CHAIRMAN FADEN:  I saw Duncan, Ruth, and Susan. 
Duncan?

          DR. THOMAS:  On our way up here, Barbara was saying
that the gallium experiments were also included as a
toxicological effects component.  I just wondered if you could
elaborate on that a little bit more.  Was this an add-on to the
same patients?

          MR. WEIGHTMAN:  What I do know is that there is a
reference in one of the ORINS annual reports of the Medical
Division to a toxicological component.  I think they used the
word toxicity studies, and they mentioned that such studies were
conducted on people as well as on rats and other animals.

          DR. THOMAS:  Would this be like a Phase I study?

          MS. BERNEY:  They also reported in the documents that
you showed me dose levels and toxic effects occurring at
different dose levels, actual -- you know, toxic effects.  I
can't remember exactly what they were.

          MR. WEIGHTMAN:  What we don't know is that -- Gallium
has a chemical toxicity effect as well as a radiological toxicity
effect, and we don't know which they were studying.  What we have
are a couple of fragmentary references in reports. 

          We're following this up, and if we learn more about how
that worked, then we'll be happy to share it with you.

          DR. THOMAS:  I guess the point is to distinguish
between what might be a normal sequence of clinical research,
starting with the Phase I toxicity study, versus an intention to
try to learn something further about biological effects through
the mechanism of clinical trial.

          MR. WEIGHTMAN:  Yes, and we just don't have enough
information to know how that sequence worked or what was done in
particular orders.  We're still chasing that issue.

          CHAIRMAN FADEN:  Ruth?

          DR. MACKLIN:  I'm always interested in these waiver
forms that seem to be lumped together with informed consent.  I
think I heard you say, though, you don't have a copy of those. 
Is that right?

          I mean, what I'm interested in knowing is what's the
content.  Is this a waiver which has a particular legal meaning,
as I understand it.  You're waiving your rights to something or
other, in contrast to a consent form, however  incomplete.  That
is, both the intention, the purpose and even the content are
going to differ.  

          So can you say something more about the waiver form?

          MR. WEIGHTMAN:  I'll tell you what I know about the use
of the term waiver, which as of 1950 there were -- there's other
evidence for stuff that was going on at Oak Ridge later on, but
since I'm trying to keep the contemporary evidence to sort of not
get into side issues, I will tell you what I know about what they
were doing then.

          There is a reference in one of those annual progress
reports to the fact that they were using -- and I think I'm
quoting now rather than paraphrasing -- a waiver and release
form.  The context is one of wanting to avoid legal liability
rather than the kind of ethical process of consent that is
usually associated with things like consent and disclosure.

          One of the things that we're still working on in terms
of doing this particular case study is was this meant as a
substitute for the process of consent?  Was it meant to be a
complement for the process of consent or what the relationships
were, what they were understood to be, who drafted which form,
who administered which form.  Was it all part of a bunch of paper
that you signed when you walked into the hospital or was there
one discussion you had with a doctor at one point?

          CHAIRMAN FADEN:  Don, this is breaking news.  I can't
resist this.  Usually, we have this policy that new stuff
shouldn't come out at a committee meeting, because we need to
digest it or not; but John Harkness has been going through
Latimer's dissertation.

          Why don't you take one minute?  He just found it.  It's
exactly on this point.  So it's new to everybody, which we should
never, ever do.  Okay?  So we never, ever do this, but since it's
an answer in part to Ruth's question -- then we'll try to follow
it up.

          MR. HARKNESS:  Sorry.  This is a Doctor of Law thesis
written by Ervin Latimer who was an NIH attorney in 1953 and
actually was instrumental in forming the policies at the NIH
clinical center that was opened in '53.  

          The title of the thesis is "Legal and Ethical
Implications of Medical Research on Human Beings."  It's over 200
pages long.  It's a pretty serious document, written in 1958.

          He is discussing the clinical center handbook which was
distributed to all people who came to the clinical center, and he
says here that the tenor of the clinical center handbook is one
of careful notice to the patient that he is a partner in science.

          He then goes on on the next page to discuss the --
Well, I'll just read the paragraph:  "A parallel project review
procedure and closely similar approach to patients characterize
the medical clinical units of the Atomic Energy Commission,
agencies under contract with the Federal government.  Those
installations like the clinical center are modern research
hospitals, primarily engaged in research on diseases which may be
cured or arrested by radiation, such as cancer, or in diagnostic
studies utilizing isotopes.  Study patients at Los Alamos and Oak
Ridge, for instance, are likewise admitted by invitation,
maintained without charge, and expected to participate in
research.  Indeed, the Commission's brochure goes on further than
the NIH handbook, although the intent is the same, advising
prospective patients not to come if they cannot commit themselves
to a period of research."

          CHAIRMAN FADEN:  So we'll have to see if we can't get
this brochure.  

          MR. WEIGHTMAN:  We will certainly ask for it.  

          CHAIRMAN FADEN:  We'll certainly ask for it.  This
violates like every rule that I've said, is no new documents ever
get presented to the committee until we have a chance to look at
it, check it out, and so on; but John was right, in that it's
just too temptingly right on point.

          DR. KATZ:  Just very quickly, just to add to this, John
Latimer was a good friend, and he was really one of the pioneers
of studies in experimentation and has not received the
recognition he deserves.

          This thesis was published in part and modified and, if
you need the reference, I have it.  It's a very, very interesting
article.  I believe it was probably in law journal, but I'm not
absolutely certain.

          MR. HARKNESS:  The Journal of Public law.

          DR. KATZ:  Journal of Public Law.  We have that.

          CHAIRMAN FADEN:  We started with that, and then John
went backwards to get the dissertation, but I think Jay is right
and, hopefully, our report can do something to place Latimer more
properly where he ought to be in the evolution of thinking about
research ethics in this country.

          MR. WEIGHTMAN:  I had a little help, Dr. Macklin, but
did that answer your question?

          DR. MACKLIN:  Partly.  I mean, to get to the question
about a disclosure in a brochure, there's a slightly different
question from the distinction between a waiver and a consent
form.  So the things  you're still going to look into would be
relevant, if we're going to look both at what the intent was in
making people sign a waiver.

          CHAIRMAN FADEN:  It certain bears on it.  We will try
to track all of this down.  Why don't we have Susan's question be
last and then go to Barbara, so we can have lunch, which we will
wait until after the discussion on Los Alamos.  Susan?

          DR. LEDERER:  I guess, like Ruth, I had some questions
about the patient waiver form.  You mentioned that there were
some unanswered questions, particularly what it is that patients
were told.  I wondered if those are actually unanswerable, if,
for example, you had access to patient records and could contact
maybe family members who were present.  Are these things that
you've chosen not to pursue?

          MR. WEIGHTMAN;  We certainly haven't chosen not to
pursue them, but what we wanted to do today was to present you
with where we got, and then as part of this and then the
discussions tomorrow talk about, well, where else we might go in
terms of how hard to chase this stuff down.

          The nice thing about using a case study method to do
this is that you're at least limited geographically, although it
turned out to be less of a limitation in the case of Oak Ridge
than we thought; because part of the patient selection process
didn't happen at Oak Ridge.  It happened in the consortia
institutions, and presumably some of the discussions that would
be of interest or the records that would be of interest wouldn't
be at Oak Ridge.  They would be at Vanderbilt or whichever member
institution sent the patient along.

          I guess the answer there is that, if you think it's
worth chasing, then we'll chase it.  What you've heard is what we
know about what went on.  My guess, but it's just nothing more
than an investigator's hunch at this point, is that there
probably were discussions, doctor/patient type discussions, as
part of the intake process, just because they wouldn't have sent
the people along to Oak Ridge without sort of having told them at
least, you know, what they were likely to find there and what
would happen to them.

          Whether and how that can be reconstructed now for this
set of experiments forty years after the fact, there may be
pieces around that we can find by going to the member
institutions.  There may not.

          DR. LEDERER:  Did you look at patient records as part
of this?

          MR. WEIGHTMAN:  We have not yet done so.  That wasn't a
choice not to.  It was just what you've heard is how far we got
with the research.  I mean, there are a bunch of questions.  

          If the committee wants us to keep going on Oak Ridge,
in particular, we're told that the records there are particularly
rich and that there are a lot of things to look at there.  If you
want us to go forward doing this kind of work, then presumably
patient records, assuming we can deal with things like Privacy
Act issues and that kind of stuff, would be a further place to
look in terms of researching that kind of information.

          CHAIRMAN FADEN:  Thank you.  Let me turn your attention
now to Tab G which does have a report on Los Alamos which Barbara
is going to summarize, and then we'll have a discussion about
that.  Thank you.

          MS. BERNEY:  We were looking at Los Alamos basically in
the same mode as we looked at Oak Ridge, to see if there were
patterns and consistencies across experiments, to see if there
were institutional and organizational imperatives and culture
that affected the kinds of experiments that went on, and the
response to or the consideration of ethical issues that the
committee is concerned with.

          We're also concerned with trying to figure out how Los
Alamos fit into the many institutions that were involved with
funding and setting up and carrying out experiments of the sort
that we're looking at.

          I want to talk a little bit about the nature and scope
of the experiments that did go on at Los Alamos, the issues
raised by the information that we have so far, and then maybe say
something about the value of case studies for looking at these
kinds of things.

          Now Los Alamos has had a team of rather high level
people going through all the documents at the institution, and
they have provided us with a great deal of extremely helpful
information.  In going through those documents, we have found
questions that are not answered in them, and have in turn
requested additional documentation that we're waiting for.

          Now Los Alamos was, and is, primarily a center for
weapons development and testing.  The research that has gone on
there has certainly in part been related to these more primary
functions.

          You have in Tab G a list of ten series of experiments
that were identified by the Los Alamos search committee, and I'm
not going to read them to you.  I'll talk about some of them, and
you can ask questions about whichever other ones you want.

          Now in relationship to Los Alamos' primary mission in
terms of designing and testing nuclear weapons, you've heard some
discussion about the fact that one kind of experiment that was
done there was related to bomb tests, the cloud fly-throughs, the
relationship of troops on the battlefield to Ground Zero, the
kinds of testing that was done on those troops, and that's
already been discussed.  I'm not going to go over it again.  

          Then in addition to those tests, there were a series of
intentional releases, the largest group of which are the ROLLO
tests, 254 implosion tests releasing lanthanum into the
environment in Bayou Canyon.

          Now the actual radiological hazard, and certainly the
human exposure, of these tests is infinitesimal as compared to,
say, weapons tests, but these definitely fit into the category of
intentional releases.  

          Most of the information about these tests is still
classified.  The Los Alamos staff is trying to prepare a report
for us that will give us some information on dose exposure and
other related issues.  They, basically, told us that giving us
documents without -- with all the classified material crossed out
would be like giving you a piece of Swiss cheese.  They would be
totally useless.

          Now a third type of experiment are experiments that
are, in some sense, related to the treatment of radiation
exposure.  One of the big functions of the Los Alamos Medical
Division was to figure out how to take care of the workforce in
the radiation industry and to also, by extrapolation, figure out
what might be done for people exposed in the event of a nuclear
war or accident, etc.

          So there's different groups of experiments that sort of
fit into this category, but also can be used for and interpreted
in other ways.  There's a series of tracer experiments, including
chelation experiments.  That is where they looked at the action
in metabolism of chelating agents.

          Chelating agents are things that you give people in
order to try and remove heavy metals from their body.  They
looked at both, as I said, the metabolism of these agents by
actually attaching radionuclides to the agents, and they also
looked at the effectiveness of the agents in removing different
metals by either using radioactive isotopes of heavy metals that
aren't -- The radioactive elements are heavy metals, but so are
mercury and lead and other things.

          Then there's a series of experiments related to
cholesterol metabolism.  At this point we're not sure exactly
whether there is a  motivation to these experiments outside the
basic science questions of how is cholesterol metabolized.  There
are additional tracer experiments besides those.

          Then there is a series of experiments that relate to
the use of radioisotopes in medical treatment and diagnosis.  The
most extensive of these are the use of radioactive iodine in
treating and diagnosing thyroid disease.

          Now, obviously, radioactive iodine is relevant to other
issues besides thyroid disease.  It comes out of exploiting
atomic weapons.  It's related to fallout, and it should be stated
that in the work done the use of radionuclides in diagnosis and
treatment of disease resulted in the ability to greatly lower the
amount of radioactive material used to diagnose disease,
sometimes by three orders of magnitude.

          Now one of the other important things that went on at
Los Alamos was the development of instrumentation, in particular,
whole body counters; and a lot of the experiments that were done
at Los Alamos were related to the development and calibration of
those instruments.

          It would appear that they didn't involve extensive
exposure, but those experiments were basically retention and
excretion experiments and then experiments, basically, to
calibrate the machine.

          Now one of the things that we saw briefly in the 1956
annual report of the Health Division was a comment that Los
Alamos was in the process of changing the focus of its research
from looking at acute effects of high dose exposures to the long
term effects of low dose exposure, and we don't have anymore
information about that at this time; but we've asked for
additional information, because that seems like a significant
turn of events.

          Now in terms of the issues raised by the experiments
that we've looked at so far -- and one of them is this issue that
Don spoke of, where do the subjects come from, who are they --
now it appears that in much of the research that was done at Los
Alamos, employees were used.

          While we don't have direct documentation of consent,
some of the people who participated in those experiments as
subjects are, in fact, on this Los Alamos search team, and they
certainly sound like they were both informed and gave consent. 
What the  social setting was for that happening, we don't know.

          Now there were other groups that were used.  In
particular, calibrating the whole body counter required the use
of a lot of subjects.  So when they ran out of employees, they
turned to the Kiwanis Club. 

          Here's a memo from Lushbaugh to Shipman where he says
that we are having trouble getting sufficient numbers of normal
persons to establish normal values.  In the past we've used
ourselves and others in the group from the Los Alamos Medical
Center.  After five years we have used up our welcome, if not our
permissible levels of exposure to radioisotopes with these
people.  

          So he goes on.  This is in the transition from the old
machine to the new machine.  So they need to recalibrate.  So
he's saying that we are faced with reestablishing our normal
values with the new machine.  It was suggested to me that we try
obtaining volunteers for this purpose from several of the service
groups in town.  The Kiwanis Club and the hospital women's
auxiliary were approached by me to test the feasibility of this
idea.

          He goes on to say that they seem perfectly willing and
that one of the problems, which, of course, is relevant to all of
the work at Los Alamos and Oak Ridge and other such sites, is the
need for secrecy.  He says they realize that we cannot publicize
our need for such normal people and that, therefore, they cannot
use their participation in such a program for publicity purposes.

          He goes on to talk about the dose levels that he
expects people to exposed to, but -- and other groups of patients
that were used were both indigent and other interesting patients
at the Los Alamos Medical Center, and we have very little
information at this time about how those patients were recruited,
what they were told, any of that.

          So we don't -- While it appears that within the Los
Alamos community people were in fact bona fide volunteers, it's
not so clear about other people.  One of the things that we're
trying to figure out is whether different categories of subjects
were treated the same or treated differently in terms of consent
issues.

          We do have some information that shows that there was a
process by which you had to get experiments approved.  They don't
-- They talk a lot about risk and dose,but they don't talk about
consent.            For example, here's one talking about
radiozinc studies in humans, and it says we would like to
administer radiozinc to male laboratory personnel, and 1
microcurie of zinc 65 would be given as a chloride, blah-blah-
blah, and the purpose is to obtain data concerning the uptake of
zinc from the gastrointestinal tract.

          They are hoping to -- that the result and data will be
of value in establishing body burden values for the accidentally
exposed lab personnel.  We have other documents where the studies
are to be done on patients as opposed to laboratory personnel.

          We have documents that talk about concern with consent,
and consent policies.  What we don't have is information about
how those policies were implemented.  We know that there's a 1951
memo that refers to 1947 AEC policies requiring informed consent,
written informed consent, and we have a response to some inquiry
-- the inquiry, we don't have -- asking for information about
consent.

          So the stage that we're at is we know that there were
policies, and we don't know how or whether they were implemented,
although we do know that there was concern at the institution.  

          I think I'll stop there.

          CHAIRMAN FADEN:  Thank you, Barbara.  Questions for
Barbara about Los Alamos?  Duncan, Jay, Lois.  Let's just start
there, and then I'll look for hands while Duncan is speaking. 
Duncan.

          DR. THOMAS:  In the context of the recruitment  of
subjects, you didn't mention -- I think there was something in
here, and I assume we've heard about it before, laboratory
workers' children being recruited.

          MS. BERNEY:  Well, they were used in this whole body
calibration process, and I don't think we know more than they
participated.

          DR. THOMAS:  Do we know anything about the informed
consent?

          MS. BERNEY:  No, we don't.  

          CHAIRMAN FADEN:  Is there an inference there that you
would like to find out?

          DR. THOMAS:  Oh, absolutely.  

          CHAIRMAN FADEN:  We'll mention later that Sandra Thomas
on our staff has been doing some interesting preliminary work
trying to put together what we know about research on children
involving ionizing radiation anywhere, but this level of detail
has eluded us, I gather.  Jay?

          DR. KATZ:  You might find there are two questions
remaining.  Well, the second one I'd like to get an answer to,
but it would be interesting to find out how many janitors and
secretaries were considered staff, you know.  When we talk about
staff, we think about laboratory workers.  

          Secondly, the documents that express concern about the
informed consent -- are they the usual kinds of documents that
raise questions about oral versus written consent or do they go
beyond that issue, because most of the ones that I've seen so far
have raised questions only through the verbal or written.

          If you have them, I am sure the committee would like to
see them.

          MS. BERNEY:  We can certainly make sure that you have
them.  Dan, can you speak to that?   

          MR. GUTTMAN:  They're the ones that are included in
Jonathan's ethics update, and they're actually -- the ones that
are in his package that Jonathan had mentioned briefly are the
sort of key Los Alamos documents.

          DR. KATZ:  Those, we have already, but they dealt
mainly with oral versus written consent.

          CHAIRMAN FADEN:  Lois?

          MS. NORRIS:  Do you have any indication of whether the
accumulated effects of lab workers volunteering more than once or
repeatedly for experimentation were monitored and controlled?

          MS. BERNEY:  No.  I've seen one document that said that
the results from the studies on workers would be put in their
medical records, but, you know, it's a single reference in a
single document.  

          I don't know whether there was cumulative monitoring,
although this memo suggests that if they are concerned that they
are reaching maximum tolerances, that somebody must be keeping
track, but we don't have documentation to that effect.

          CHAIRMAN FADEN:  Henry?

          DR. ROYAL:  There is a fifteen minute CNN documentary
on the Los Alamos workers and their participation in experiments,
including some interviews with children that participated.  They
were children of the researchers there.

          I think it would be worthwhile for the committee to get
a copy of that documentary and take a look at it.

          CHAIRMAN FADEN:  Thank you.  I didn't know it existed. 
Thank you.  We will certainly -- Do you know, is it recent?  Have
you seen it?

          DR. ROYAL:  I just happened to have seen it on
television without knowing that it was going to be on television,
and I saw it three or four months ago.

          CHAIRMAN FADEN:  Okay.  Well, that's easy to track
down.  Thank you.  Are there other questions or comments about
Los Alamos as a case study?  We will revisit, not necessarily the
particulars of Los Alamos or Oak Ridge, tomorrow but the concept
of proceeding through the mechanism of focusing on discrete
institutions tomorrow.  So Barbara and Don should stay on notice. 
Please be back tomorrow, so that we might be able to ask you
questions.

          I want to start by apologizing to people from the
agencies who were hanging around for the update on the work with
their agencies.  I don't see how we can get to that before lunch. 
I have a feeling that we're in need of food.  Yes?  Yes.  I think
that there's a felt need that we eat.  So the agency update will
be the first thing on the agenda after lunch.

          Let us convene now and try to get back about ten of
two.  I'm sorry.  Reed?

          DR. TUCKSON:  One thing.  Henry, the Outreach Committee
folks, if I could have you -- We need to sit separately at the
lunch room, have a little bit of a quick working meeting.  It's
kind of important.  

          CHAIRMAN FADEN:  The Subcommittee on Outreach should
sit  at one table.

          DR. TUCKSON:  We're actually having a special table
arranged, and we have some of the people from the -- that came up
on our last conference call will be sitting with us.  Thanks.

          (WHEREUPON, the Committee recessed for lunch at 12:48
P.M.)

                                    --



                     A-F-T-E-R-N-O-O-N   S-E-S-S-I-O-N

                                                           Time:  1:56 P.M.

          CHAIRMAN FADEN:  Should we go ahead and start?  I'm
afraid we should.  What we're going to do is pick up on the
agenda where we left off, which means that I'm going to start
with an update of activities and interaction between our staff
and the agencies with which we continue to work.  

          After that, we'll begin our subcommittee reports, and
we'll just take them in the order that they were on the original
agenda, which means we'll start with Oral History and keep on
going.  If we don't get to them in time for the -- If we don't
get through all of them before the break, we will spill into
tomorrow.  

          What is not negotiable is the time for the public
comment period, because that's announced, and people arranged
their lives to be there for that.  So we cannot put that part
over.  So we'll keep that going.

          So let me start with the agency reports.  I feel a
little badly in doing this without everybody here, but -- Okay. 
They'll figure it out.  It's very short.

          These reports come from my meeting with the staff
members who are doing the work, and I would list everybody, but
it's basically the whole staff.  We sit down, and we go through,
basically, what's the situation right now in relation to our work
with the agency.  What are the most noteworthy things that we
should share with the whole committee.

          Let me start with NASA.  There are four specific areas
that we are pursuing with NASA, four themes or four areas of
inquiry, and these are presented in no particular order of
importance, just to let you know the kinds of things that staff
is working on in collaboration with NASA.

          One area is the extent and nature of research
collaboration between NASA and the School of Aerospace Medicine. 
There were clear links between NASA and the School of Aerospace
Medicine, and the issue is to which extent was the collaboration
engaged in research involving human subjects in ionizing
radiation.  Is that a thread to pursue?

          The second area is an area that we have heard reports
on in the past, and that is NASA's funding of TBI studies at Oak
Ridge.  That's all part of the continuing work on the TBI story.

          Third is discussed in the intentional release memo in
Tab L.  We are pursuing NASA's involvement in the nuclear rocket
program.  In the text that's referred to is the Kiwi Series, and
there will be some discussion of that.

          Finally, we continue to work on developing a history of
NASA's policies governing research involving human subjects.  I
should let you know that we are encouraged by NASA's having let
us know recently that they are going to be adding about -- I
think it's two to three new staff members, 2.5 staff members, to
this effort at Headquarters, as well as some additional staff in
the field.  So we are expecting the amount of documents flowing
to us from NASA to increase dramatically in the near term as they
now have an enlarged staff resource directed to this effort.

          Maybe I should say for benefit of the audience, I'm not
exactly sure why half the committee isn't here.  It's four
members, Lois, Reed, Ruth, Henry, Phil.  They're on their way
back?  Thank you.

So we're plunging ahead.  

          I should have mentioned.  I'm sorry.  I failed to
mention that Ken Feinberg who was to be with us for the whole
meeting was called away suddenly this morning out of town, and
plans to be with us tomorrow.  So I'm sorry.  I should have
explained his absence earlier this morning.

          The next agency is Veterans Affairs.  Here again, four
points worth mentioning:  First, VA's review of their
headquarters is proceeding.  That's a positive development since
our last meeting.  There is much more work coming our way from
the VA, and we're very pleased to see that happening.

          We are awaiting VA's first stab at a list of human
radiation experiments.  You may recall that even before we
existed, and certainly now, we have asked of all the agencies,
and the administration has asked of all the agencies, to provide
a list of human radiation experiments.  

          We should emphasize that we certainly realize that no
list from an agency can be definitive or exhaustive of every
study ever conducted or supported with respect to ionizing
radiation and human subjects, but we know that whatever lists
agencies can put together will be helpful.

          Our understanding from VA is that we will get the list
by the end of September.  We are also working with VA to identify
VA medical centers most likely to have conducted research of
interest to the committee.  

          This is in line with the strategy of developing
institutional case studies, that perhaps it would be useful to
take one or two particular VA medical centers and use that as the
strategy for looking at VA funded and VA conducted ionizing
radiation research, if we can flag those VA medical centers that
were the hubs of activity of this sort.

          Finally, I should mention that Denise Holms on our
staff has had good luck because of her hard work in her
independent research with Stafford Warren's papers at UCLA. 
Denise went out to UCLA and, as she puts it, enjoyed herself
tremendously, mucking around in Stafford Warren's papers.

          In those papers she found some potentially interesting
documents about VA, and she is in the process of sharing those
with VA.  We're just beginning to digest the import of those
documents and, hopefully, by the next meeting we may be able to
report to you more about what was learned from Stafford Warren's
papers about VA involvement in the early period of human
radiation research.

          For the committee members who just joined us, I was
urged by our colleagues to plunge ahead with the agency update,
in the interest of getting as much work done as we can.  I have
reported on NASA and on VA, and for those of you who missed it, I
will give you the transcripts highlighted of those two pages, so
you can read -- it will be a paragraph -- what I have said -- in
the minutes, excuse me.  I meant the transcript.  We can give you
the exact transcript, if you like, of the sections that you've
missed.

          Let me move on to HHS.  HHS is working hard to uncover
its relationship to what we have sometimes called Cold War
related human radiation research.  They have put additional
resources to this task, and currently HHS is combing its
archives. 

          We're very pleased about this activity, and we're
looking forward to getting the results of that work as quickly as
possible.  Simultaneously, Faith Bulger and Jim David of our
staff also have just found some interesting documents in the
National Archives that bear on HHS's involvement in Cold War
related human radiation research.  

          We just recently shared those documents with HHS, and
we'll be working together with HHS's independent effort to
develop as much of an understanding of the role of HHS -- HEW at
that time -- and Public Health Service and NIH in the Cold War
related human radiation studies.

          I would also like to report, and I do this with some
delight, that Charlie McCarthy has joined us as a consultant to
the project.  Some of you know Charlie.  He's the former Director
of OPRR, and Charlie has joined us as a consultant to help us
reconstruct and better develop the HHS history with respect to
research ethics, as well as to help us with some of the early
Cold War stuff.  

          He's already proved an invaluable resource.  It's
wonderful to have as a consultant someone who has so much of this
information in his lived experience.  It's very good news for us.

          We hope -- You may recall that either last meeting or
the meeting before I mentioned that we have basically told HHS
not to worry for the time being about what we have sometimes
referred to as the great unwashed problem, the huge number of
studies funded over the years by HHS involving ionizing
radiation.          I hope by the end of this meeting, in line
with what I said earlier this morning about the need to bite the
bullet on questions of selection and sampling, that we will be in
the position to give HHS direction with respect to this great
unwashed problem.  We'll see how that goes, either that we can
conclude it by the end or that we will have designated some
subset of the committee to finalize the problem and then work
with HHS in execution, but we really can no longer afford to put
the great unwashed problem off.

          Finally, we have been working closely with HHS to
develop the database for the protocol review study of FY '93
funded projects.  We'll be hearing a little bit about that later
this afternoon from the subcommittee.  

          HHS has been very cooperative in preparing for us
printouts from their computerized record system for FY '93 funded
projects and in providing abstracts of research projects in
ionizing radiation funded in that fiscal year.  So we are moving
ahead in that arena, and HHS is very helpful in getting us to
move forward.  

          We, obviously, need the cooperation of all the
departments in this effort, but HHS certainly has funded the
greatest bulk of work in modern times.  So their cooperation is
key.

          Let me move on to the Department of Defense.  Dan
already alluded to the fact that Defense Nuclear Agency has
become very active and very cooperative.  This a noteworthy
improvement since our last meeting.  So I am delighted to concur
in reporting with Dan that the Defense Nuclear Agency is now
engaged in a thorough search of its record.  

          We have received several important new documents in
recent weeks, including, as Dan made mention, declassified DNA
histories which are very helpful to us.  Enclosed in -- and I
forgot to put in my notes which tab -- Tab -- Is it in Tab H?  I
guess it must be in Tab H.  Yes, it is Tab H.  -- Tab H is a copy
of an internal protocol document that DNA has, which describes
its current efforts.  It's there for your reading to show you how
that agency is working to comply with our request.

          Let me move on to DOE.  DOE has assured us -- You may
remember that our last meeting -- I'm interrupting myself here --
I mentioned that DOE was working on its basic description of the
relevant record collections in the field, as well as at
headquarters.

          They assure us that this very important basic search of
their core records and the descriptions of the records that may
be relevant to our work, both in the field and at headquarters,
will be completed by the end of September, and that will be very
good news when that's done.

          DOE also is working with the universities associated
with the plutonium injections to review and retrieve relevant
documents.  This is good for us.  DOE has taken the lead in
contacting the universities, and DOE will provide us with the
material that the universities provide to DOE.  These are all the
universities that had an involvement in the plutonium
experiments.

          Also included in Tab H of the briefing book is a report
-- It's actually a letter from DOE and some accompanying memo
kind of documentation that indicates that it's very unlikely that
the records of the Intelligence Division of DOE for the period of
interest to this committee will ever become found or available.

          The memo describes or explains why this  is the case. 
This is not good news, obviously.  It would be nice if the
records of the Intelligence Division were found.  It would
probably be of great assistance.  Of course, it's a kind of a
catafactual. We don't know, since we don't have them, how helpful
it would have been to get them, but it doesn't look good at this
point that they will be available to us, and the memo from the
Department of Energy gives an explanation in some detail of why
it appears that these records are no longer in existence.

          Finally, we are working closely with DOE and also with
DoD on getting records declassified and on identifying high
priority documents for declassification.  Dan has already
mentioned several documents that we've received very recently
that had been declassified very recently.

          There's always a bit of an ambiguity as to whether
documents were declassified per our request or just in general as
part of the openness initiative of the various departments or of
the administration, but it's pretty clear that at least some of
these documents have been declassified because we asked them to
be declassified, and that's no small accomplishment on our part.

          The general topic of how we're going to plow through
documents that are not yet declassified but where there's a
question of whether they should be declassified in the sense of
whether they bear on the work of this committee is that issue I
made reference to in my opening comments this morning, that we
will revisit tomorrow.  

          Staff has a particular procedure which they'd like to
put forward for our consideration for how to facilitate this
process along.  So we'll talk more about this tomorrow, but in
general it is encouraging that the flow of formerly classified
material has started to flow.  The flow is flowing.

          Finally, the CIA:  Again, Dan has made reference to
those.  As you know, the CIA has told us that they have been
unable to find any documents indicating either that the CIA 
conducted or sponsored human radiation experiments or that the
CIA held records that included information about studies
conducted by other agencies.

          I'm looking at Lois, because I remember visibly the
question that you asked, and the answer that you got.  Since the
last committee meeting, our staff has found in documents provided
by DoD and DOE and in the National Archives evidence of CIA
participation in policy committees at which human radiation
experiments were indeed discussed.

          Now rather than do a disservice to this complex topic,
I am going to turn the agenda over for a few comments by Gary
Stern, who has been leading the data collection efforts with
respect to CIA, so that we can get a better sense of what, in
fact, we've learned, and a memo from staff on these developments
can be found in your briefing books at Tab H.

          So, Gary?

          MR. STERN:  Thank you.  I will be very brief.  In
short, what we found that we didn't know before -- I don't think
the CIA knew before -- was that the CIA was an associate member,
I guess it's called, of the Committee on Medical Sciences of the
Research and Development Board, and attended many of those
meetings at which -- a number of which of those meetings, the
issue of human experimentation was discussed and considered and
contemplated.

          Moreover, they also appeared to have attended some of
the meetings of the Joint Panel on medical aspects of atomic
warfare.  They are listed on an entry roster for a meeting in
1952, and they are also -- Well, there is also an interesting
item in the agenda of the Joint Panel of a Joint Panel meeting
from 1951 which says that "an intelligence agency will give a
briefing on medical intelligence."

          We still haven't identified for certain what that
intelligence agency is, but it's quite possible it was CIA and it
was to give a briefing and take requests for tasking for medical
intelligence related to the Joint Panel's work on the medical
aspects of atomic warfare.

          So it suggests clearly that the CIA was  participant
and a party to and had some knowledge of these activities.  We
have -- Upon getting this information, we've sent it over to the
CIA, and they have been trying to respond and refocus their
search more specifically on some of these records.

          We got the names of who those participants were, and so
they've been searching for those individuals.  It turns out that
the CIA officials who attended these meetings were from the
Office of Scientific Intelligence which, we reported to you
before, was the office in the CIA that also had responsibility
for the Joint Atomic Energy Intelligence Committee and, in
addition, they were active in what was the precursor to MK Ultra
which, as we've described, was the CIA's human behavior funding
program starting in 1953.  

          Prior to '53, there were projects called Artichoke and
Bluebird which were coordinated jointly in some levels between
the Office of Scientific Intelligence and the Security Office of
the CIA.  

          In response to sending information over to CIA, they
were able to come up with some additional documents to flesh this
out, one of which I just passed around which they just had
declassified for us last week.  It gives us just a little more
information about Project Artichoke.

          If you just look at the bottom of the first page, they
talk about the necessary fields to explore, Item 3, and then Item
3(d), other fields.  They say, in addition to hypnosis, chemical
and psychiatric research, the following fields have been
explored, and they list nine topics.  Number 7, it says other
physical manifestations, including heat and cold, atmospheric
pressure, radiation.

          As they've explained it to me, they were aware of this
reference to radiation.  They have searched high and low through
all their other related Artichoke documents, and haven't been
able to find any other references to radiation.  They've found
none to ionizing radiation.

          One conjecture is that possibly -- It's just pure
conjecture that maybe this is talking about ultrasonic radiation,
because they did find a document that they also released to us in
which they -- someone mentions research that they were pursuing
or looking into in ultrasonics and other radiant energy, and
perhaps this was a reference to ultrasonic radiation.

          It's not certain that that would be the case, in
particular in light of Item No. 4 on that same list, talks about
sound and ultrasonics is a type of sound and, therefore, it may
already be -- this document -- The additional document that they
found may be covered in the sound category.

          So in any event, when it says has been explored,
there's no indication that that was through human
experimentation, like this document on ultrasonics that they
found.  It could have just been an inquiry into an expert of,
well, would there be anything here, and an academic response
saying perhaps no.

          So that's essentially what -- you know, the key core of
the additional documents and information that we've come across
to date.  The agency is continuing to look.  They have responded
to the information that we've found and have refocused their
search to do as thorough a job as they can in this area, and
we're anticipating that we'll be getting quite a bit more
information from them

          I guess that's -- Finally, I would just say that the --
You know, it does raise questions still about the links the CIA
has within this whole area of human experimentation at the same
time that the DoD is doing the radiation stuff, and CIA is on
this committee.  They're beginning their own human behavior and
human experimentation as well as these same committees were also
the ones that were discussing the ethics policies leading up to
the Wilson Memorandum and, you know, the question just comes up
as to what role or what effect that may have had within CIA.

          CHAIRMAN FADEN:  Thank you, Gary.  Are there questions
for Gary about this development with the CIA?  Ruth?

          DR. MACKLIN:  I think I probably didn't understand
exactly what you said when you expressed the uncertainty about
radiation.  I understood the distinction you were making between
ionizing and non-ionizing, but then were you questioning whether
whatever they have -- whatever they did explore, as they say that
these have explored, would have been the use of radiation in
human subjects for their purposes?

          MR. STERN:  That's right.  I mean, this doesn't -- and
we just don't know, but it doesn't -- It gives us no indication
whether --

          DR. MACKLIN:  Well, but the main work -- I mean, Item 2
-- I mean, I'm only asking about this -- As you know, I've just
seen this document.  Item 2 describes the work of Artichoke, and
all of those items as this project and Bluebird, which I just
knew a teeny bit about before I came to this committee -- All of
them had to do with control of human behavior, behavior control.

          I mean, that was the focus.  That's what all of these
were.  So when they describe (a) through (d) under o. 2,
extraction of information, preventing extraction, control of
activity, preventing control, all that has to do with behavior
control.

          So how -- What other -- I mean, when they describe in
(d) the following fields have been explored, under (7) other
physical manifestations -- I mean, that only -- The way I would
interpret that is they're using this word manifestation to
describe these other things, all of which would be used in the
service of those goals which are behavior control.

          I mean, what else could it have been?

          MR. STERN:  I think there's no question the objective
of the research was into what effect it would have on human
behavior.  I think the question is did they -- and I don't know
the answer, but did they use every one of these on a human
subject to explore that or did they do preliminary research to
see whether it would even make sense to use gas, sound, light,
electricity and radiation on a human subject before they actually
did it.

          They clearly did some of these things on humans, and we
just don't know and they haven't come up with anything, and we
haven't yet come up with anything to say that (a) is ionizing
radiation; (b) it was done on human subjects, as opposed to
exploring with someone else, well, is this something we should
even try on a human.

          DR. MACKLIN:  I see.  So explored then could just mean
preliminary inquiries of some sort.

          MR. STERN:  That's right.

          CHAIRMAN FADEN:  Other questions for Gary?  Are there
other questions just in general about agency data gathering
activities?  I felt just a teeny bit bad, because this five
minute, ten minute summary represents I don't know how many hours
of staff time and work, not only by our staff but in the
agencies. 

          So just because we don't spend a lot of time on it
doesn't mean that we don't appreciate it, value it, and know how
much work stands behind it.

          With that, then let us turn to the agenda for the rest
of the afternoon, which we'll go as far as we can go with until
the time for the break and the public comment period, and that is
reports from our subcommittees.  I propose we just follow the
order in the agenda, if that's all right, and pick up where we
would have been, had we been on time, with a report from Sue
Lederer on the Oral History project.

          By the way -- I'm sorry.  Let me just mention that for
some of the subcommittees there are reports under Tab E, not for
all but for some.  Sorry, Sue.

          MS. LEDERER:  -- As we move closer to actually doing
more of the oral history project, we've been engaged in writing a
set of core questions that will be used for each of the
interviewees.  Keep in mind that these are a flexible list of
questions that, depending on the life experience of the person
interviewed, the questions can be tailored to that person.

          I will just add, in light of our discussion this
morning, particularly on the use of the word experiment and
investigation, I going to propose that we add to that list of
core questions a question about how the word experiment was used
by investigators at the time.  Did they distinguish an experiment
from a study?  In what way did they distinguish that from an
investigation, and perhaps also to define for us their use of the
term volunteer, which is bandied around quite a bit.

          We've also been engaged in creating the list of
interviewees for our topic.  We have identified a priority list
of people that we hope to interview in the next few weeks, and we
will be providing to the committee a list of our interview
subjects and the rationale for their selection, but it will be
forthcoming.

          Finally, we are in the process of acquiring the
appropriate technology equipment to conduct the interviews that
we hope to begin once we get IRB approval by the end of this
month.

          So that's my report.

          CHAIRMAN FADEN:  Thank you.  Henry?

          DR. ROYAL:  i just wanted to make a comment about the
questions.  I thought the questions were very good.  There was
just one additional distinction that I thought might help in the
questions.

          One of the questions was:  Was consent taken seriously
in the profession or was it done in a pro forma fashion?  My
concern is to distinguish between taking consent seriously versus
taking the bureaucracy that comes along with doing informed
consent seriously.

          I think there -- At least I hope that most researchers
believe that consent is an important thing that should be take
seriously.  I think that if there's something that they may not
take seriously, it's whether or not the bureaucracy that's put in
place to ensure that informed consent is obtained really does
work, and making that distinction, I think, would be important.

          CHAIRMAN FADEN:  Other comments or questions.  Duncan?

          DR. THOMAS:  Just two quickies.  I, too, like the list
of questions, and just wanted to ask you to add under Item 14,
which asks about self-experimentation -- You might ask simply
about experimentation on their kids.

          The other quick one has to do with the recruiting of
the interviewees.  I gather that the focus of this is on clinical
radiation research or maybe also basic science radiation
research.  Right?

          DR. LEDERER:  I understand it to be clinical radiation
research.  This is to evaluate the practice of clinical research,
both radiation and nonradiation, in this period.  

          DR. THOMAS:  Okay.  But it wouldn't include then --
Well, certainly the whole area of the environmental radiation
things that we've talked about or the things like the
toxicological studies, the plutonium injections, that sort of
thing.

          DR. LEDERER:  What was the last thing that you
mentioned?

          DR. THOMAS:  Well, the plutonium injection series, that
class of things that we've talked about.

          DR. LEDERER:  If they were conducted by clinical
researchers, that would be included in this group.

          DR. THOMAS:  Even though the purpose was  not
therapeutic or diagnostic.

          DR. LEDERER:  Yes. It has to do, I think, with the
personnel rather than the motivation driving the experiment.

          DR. THOMAS:  Can you elaborate just a little bit
further as to how you go about selecting your interviewees?

          DR. LEDERER:  Sure.  What we're hoping to do is to use
oral history to supplement what we have from the written record
about the actual practice of clinical research in this period. 
What we're attempting to do is to find people who were well
placed to observe and actually engaged in practices and able to
report on them to us.  

          We're hoping to identify people in certain sort of
broadly defined sub-areas within clinical research.  So, for
example, someone engaged in surgical research primarily, someone
whose specialty was infectious disease. 

          We plan to interview someone whose area primarily was
military medical research to map out those broad sub-fields
within the broader complex of clinical research.

          DR. KATZ:  It's an interesting document.  I'm just
wondering if it possibly could be contained in the general
questions, but a number of -- and I haven't given it all the
thought I should have given it, the kind of questions that should
be asked, a number of more specific questions like what is your
understanding of informed consent?  What does it mean to you? 
Have you read the Federal regulations of research?  Have you read
the assurances that your institution has provided to HHS?  What
do you think about these regulations?  Do you think they are
really much too cumbersome, and isn't it much better to go back
to the good old days when the integrity of the investigator was
the best protection for the subjects of research?

          Do you really believe that subjects can understand the
forms that they have to sign or the informed consent process?  To
what extent do you think they are really capable of
understanding?  It's hard enough to understand consent in
ordinary medical situations.  Here you have to inform them also
about --or you're supposed to inform them about all kinds of
scientific information.  What do you think of this?  Isn't this
all crazy and beside the point?

          DR. LEDERER:  We're trying to avoid leading questions.  

          DR. KATZ:  Pardon me?

          DR. LEDERER:  We were trying to avoid leading
questions.

          DR. KATZ:  You avoid leading questions?  These are not
leading questions.  These are probing questions, and I guess --
and I know about -- I guess I have lived too much with lawyers,
but leading questions, unleading questions -- I don't know what
the difference is.

          Whatever way they are posed, and maybe in a less
leading way than I just put it, but it's these kinds of questions
that really might give us a better idea, but about this all good
people can differ.  

          DR. LEDERER:  Well, certainly those are some of the
answers that we hope to get.  I mean, I don't know about the
exact phraseology of the questions.  We've worked a great deal on
the current set of core questions, but we will take suggestions.

          DR. KATZ:  But you have to watch it and see whether you
get these kinds of answers, really, from the questions as you
pose them.

          DR. LEDERER:  That's right, and we hope after sort of a
few preliminary that we will be able to adapt our questions in
order to elicit just the kinds of --

          CHAIRMAN FADEN:  What we can do, just to make Sue's
life easier, is look at the page or half or whatever it is that
has those suggestions that have just come out for additional
questions in the transcript to you, and you can think which, if
any, need to be specifically added or which you think you're
going to get the answers to anyway.

          DR. MACKLIN:  Some of these are in there.  I know Jay
gave us such a wonderful list, but I can say, being on the
committee -- I mean, for example, some of them are all lumped
together.  Number 6 on page 1 of the draft list:  How have you
responded to the various changes that have been made in the
regulations -- or, no:  What was the impact on your research
practices of the vastly increased regulation of human
experimentation, etc.?  This is a bunch of questions under 6.

          That was meant to invite without making these leading
questions -- invite these kinds of responses.  So I think some of
those were in there and, similarly, asking people have you read
the Federal regulations and do you know about this or the other -
- The subcommittee struggled a bit with some of the wording,
because people don't want to admit that they're idiots.

          Look at Number 15:  Were you or are you aware of the
literature concerning human experimentation?  Have you ever heard
of Nuremberg, Helsinki, Ivey, Beecher?  This is meant, again, to
elicit.  You know, somebody can say, Huh, or they can, you know,
give a more knowledgeable response to the question.

          DR. KATZ:  Okay, now, Ruth, what will you do with me? 
I'm being interviewed?  First do you pose to me, how have you
responded to the various changes that have been made in the
regulations, the earliest 1970?  I think they are wonderful, that
these changes have occurred, because for the first time they give
data protection to the subjects of research, and it's very, very
important that we take the interest of subjects seriously, and
that we've gone away from the bad old days where patients,
subjects, were just recruited for research.  I am delighted that
finally HHS and other governmental agencies adopted these kinds
of regulations.

          DR. MACKLIN:  Well, I, of course, as an ethicist lack
the expertise to answer your question.  So we'll have to ask Sue
how she and the oral historians --

          DR. KATZ:  You can't get away from that, Ruth.  You
have the expertise.  You live with these people like I have.  

          CHAIRMAN FADEN:  Does anybody want to answer Jay's
question?  Sue?  We have to do it this way, because everything we
do here has to be recorded.  So anything that is said is part of
the discussion has to be on the record.  

          MS. WHITE-JUNOD:  I think you have to understand that
with these questions what we are doing is -- and the reason we
are seeking IRB approval is because we're trying to generalizable
conclusions, but what you do when you go into the interview is
you tell it to the person.  You don't let them get away with
that.          You say, well, what in your experience -- I mean,
there's a lot of follow-up questions that will be to every one of
these core questions.  What did you do in the course of your
research that changed?  What about your early career?  What about
your later career?            

          We're looking for specifics in these interviews.  We
want anecdotes.  We don't just want their opinions.  Their
opinions are of very little value in terms of drawing
generalizable conclusions unless they're backed up with factual,
anecdotal, very definite answers.  These are things that you can
really only get as you go through the interview, and they give
you one anecdote, and it will suggest something as you're going
through this.

          That's why it will take a team of people to interview. 
You'll have someone concentrating on the core questions to make
sure you don't skip major areas, but someone else very much
attuned to the individual person that you're interviewing whose
done all the background information on their career and that kind
of thing.

          DR. KATZ:  One or two more questions then:  You plan to
do these interviews over a period of time?

          MS. WHITE-JUNOD:  A very short period, actually, yes.

          DR. KATZ:  What short period?  What period?

          MS. WHITE-JUNOD:  We're looking at one every week or
one every week to two weeks.

          DR. KATZ: Look, the first one that you do, if the
committee agrees, could you get a speed transcriber to transcribe
it, and send a copy of it to all of us, as you are still in the -
- are you're still going on and doing these interviews; because
then we might be able to give you -- some of us could give you
some additional input.

          MS. WHITE-JUNOD:  Exactly.  The first ones that we've
picked are very good ones for that kind of analysis, for people
to give us feedback on what went well and what didn't go so well.

          DR. LEDERER:  We can certainly do that.

          MS. WHITE-JUNOD:  They were certainly chosen with that
thing in mind, as learning experiences both for the interviewees,
and certainly learning experiences for the committee to give us
feedback on what to do better the next time.  

          DR. KATZ:  Good.  Thank you.

          CHAIRMAN FADEN:  Is it likely that you will have one or
two done before the next committee meeting?

          DR. LEDERER:  Yes.

          CHAIRMAN FADEN:  So that we might use some committee
time next time.  If we could get transcripts out to people, then
we could have a short discussion.  That would be your report.  

          I see -- Let me just -- I see Lois and Pat and Henry. 
Lois?

          MS. NORRIS:  This one is an easy one.  Do you have in
mind identifying these subjects by name and/or institution, by
specialty or not at all with assurance of confidentiality?

          DR. LEDERER:  You mean the interviewees?

          MS. NORRIS:  Yes.

          DR. LEDERER:  They will be identified by name.  I mean,
there is no confidentiality in their participation in this oral
history project.

          MS. NORRIS:  Is that biased?

          DR. LEDERER:  Usually, oral histories are done with the
interviewee's name.  

          MS. NORRIS:  Thank you.  You've just educated me.  

          CHAIRMAN FADEN:  Pat?

          PROF. KING:  I just wanted to know when this starts and
when is the scheduled date for completion.

          DR. LEDERER:  That's a good question.

          PROF. KING:  I'm keeping in mind April.  That's why I'm
asking the question.

          DR. LEDERER:  I guess the -- We're planning to start
with IRB approval this week.  We will begin the first interviews
the week of September 21st.  Depending on how quickly we schedule
these, I would certainly hope that we would be through the bulk
of them by December, but I would welcome feedback from other
members of the committee -- the subcommittee.

          DR. OLEINICK:  How many are involved?  How many
interviews are you planning?

          DR. LEDERER:  We haven't actually identified the total
number.  We've given a range of between fifteen and twenty-five,
and I think that the final number will be determined by how well
the initial interviews go and how productive we find them for the
purpose that we've identified.  

          CHAIRMAN FADEN:  With luck, we might have some
preliminary, overall impression no later than January of the
findings.  We may be able to draw some inferences or some working
hypotheses earlier, perhaps for the December meeting, depending
on how things go, but the goal is clearly to get the information
in time for the committee to use it in some useful fashion, I
hope.

          Henry and then, Ruth, did you want to -- No?  Henry?

          DR. ROYAL:  What are interviewees going to be told when
they are recruited.  In particular, are they going to know about
what the general content of the interview is?  I assume they're
not going to be given the core questions beforehand.

          DR. LEDERER:  Had we decided about circulating the core
questions to the interviewees before the interview?  I didn't
know whether that had been resolved.  I'm asking either John
Harkness or Suzanne Junod.  

          CHAIRMAN FADEN:  The answer  was not to circulate them. 


          DR. ROYAL:  Those documents don't exist yet.

          CHAIRMAN FADEN:  There's a consent form.

          DR. LEDERER:  There's a consent form that you can
certainly see that they will know that this is being conducted
under the auspices of this committee.  There are certain warnings
that need to be conveyed to them as a result of their
participation and their interview with the consent form.  They
don't all have it, just members of the subcommittee.

          CHAIRMAN FADEN:  We can circulate -- If people would
like, we can circulate the rest of the documentation.

          DR. MACKLIN;  What this document is is the actual
protocol, the application that's going to the CIC at University
of -- Penn State, and then there is a consent form in there.

          CHAIRMAN FADEN:  It's being circulated as we speak.  Do
you have enough copies, John?  Perfect.  So everybody can see it.

          DR. KATZ;  I forgot.  Will the names be kept
confidential of the people interviewed?

          CHAIRMAN FADEN:  No.

          DR. KATZ:  Will you give them Miranda warnings?  

          DR. MACKLIN:  They get plenty.  Wait until you see all
the warnings in here.

          DR KATZ:  There are warnings about the possible
consequences?

          DR. MACKLIN:  Yes, there are warnings.

          DR. KATZ:  And they can bring their lawyer with them?  

          CHAIRMAN FADEN:  We certainly hope not.

          MS. WHITE-JUNOD:  These are very prominent people who -
- not all of them.  We're not aiming for that exclusively, but
some of them are -- I don't think I'd be concerned about that.  

          CHAIRMAN FADEN:  Are there other questions?  Obviously,
I think we all think this is going to be very exciting and
interesting, and we should surely learn a lot from this.  Fingers
crossed, we hope to learn a lot from this project.  It should be
an important legacy to the committee to leave, among others.

          DR. LEDERER:  If committee members have other questions
that come to mind, we're happy to receive them.  So as you reread
this list, and if you have certain corrections or additions,
please send them to the staff, in particular, Sarah, so that we
can integrate them into our core question set.

          CHAIRMAN FADEN:  Would you like them to come to you
directly or to Suzanne or John at the Advisory Committee offices? 
What's most efficient?

          DR. LEDERER:  I think to Sarah.

          CHAIRMAN FADEN:  To Sarah?  Okay.  So that questions --
If you have things you would like to see added, changed,
whatever, get them to Sarah at the Advisory Committee, and then
Sarah, who organizes almost everything, it looks like, from time
to time, will find a way to get it to the appropriate staff and
subcommittee members; but I think Jay's point -- If I understand
this, this is kind of an iterative process and you learn from
each interview how to do the next one better.  

          So it's not as if you've got a randomized clinical
trial and the protocol has to be identical.  Once you commit
yourself to doing it X way, even if you know you made a mistake,
you got to keep doing it or you risk not being able to use the
data.

          It's not like that.  So it's fine that we keep thinking
of things as we proceed to get the most out of this investment as
we possibly can.  

          Anymore questions?

          DR. KATZ:  By the way, I just wanted to say in the
first issue of the Kennedy Journal of Ethics -- What is it
called?  

          CHAIRMAN FADEN:  Kennedy Institute Ethics Journal or
whatever.  I don't remember.

          DR. KATZ:  There is a short article by me where I
disclose some of my research practices of the 1950s, and you
might want to take a look at it.

          CHAIRMAN FADEN:  Unfortunately, we can't interview you,
though.

          DR. KATZ:  Well, it's in print.

          CHAIRMAN FADEN:  We're going to jump out of order. 
Reed said that he would be late coming back from lunch, and that
we could go out of order, that it was all right.

          Let me just mention to you that Phil had also warned us
that he would not be able to be here for part of the afternoon. 
He will be coming back before the afternoon is over.  

          Ruth, are you -- Do you mind if we just jump ahead to
Protocol Review, and there is something in Tab E from that
subcommittee.

          DR. MACKLIN:  Right.  There were essentially three
different elements to report here.  The Protocol Review or
Research Proposal Review Committee -- it's now being called -- is
split into two parts.  

          Now Jay and I didn't discuss who would make this report
or how we would do it, but since -- All right.  There are really
two separate elements here, and the third is the status of the
information from the agencies from when we're asking for the
protocols, and Jeff Kahn is going to help out with that in a
moment.

          So, first, we want to report the inclusion of a journal
review component.  This is under Tab E, and those paragraphs
succinctly describe that one element in this proposal review,
research proposal review, project will be a look at some research
studies reported in journal articles.

          We had to use some criteria for selection here, and the
main criterion is that the study involves more than minimal risk. 
Although we're not as scientific as we might have been, the
decision was made that, to enhance the validity of the journal
review project, the subcommittee suggests retaining the
denominator and reporting the results.  For example, X research
protocols out of a study of Y raised concerns and were,
therefore, pursued.

          Now what was not yet determined and, I think, is a
subject for the committee to discuss now is whether these journal
articles will report only on Federally funded research.  It may
not actually be clear from the research.  I mean, there's usually
an acknowledgment, but other than the acknowledgment, it may not
be clear whether all or some of the research was supported by
Federal funds, and that's a policy decision that we have to make.

          So that's one item, I think, for discussion.  Next let
me say just a word about the sampling issues.  The subcommittee
had determined that it would look at all human research protocols
that were approved in FY 1993 that involved ionizing radiation,
and the request was made to each agency to provide an abstract of
all of those protocols that involve ionizing radiation.

          The subcommittee had initially decided that they should
-- to give them a target date, and that was September 7, which is
now past; but that has been revised, and Jeff, I think, has a
very up to date report here on just what has been requested and
what has been responded.

          DR. KAHN:  I should say, first of all, this reflects
the work not so much of me but of Sarah Shandros and Kathy Taylor
and Don Weightman in keeping on the agencies and pulling this
stuff together

          The deadline was extended from the 7th to the 9th of
September, in light of the fact that we were a little bit slow
getting out the request.  As Ruth Faden mentioned earlier, HHS
has been very helpful in helping us plumb the depths of their
very large database to pull out what we find or will find to be
important.  So that has been a big help, and they have been very
cooperative in that regard.  So HHS has provided what we have
asked.

          We have received an incomplete response from NASA.  The
request was actually for abstracts of all of the ionizing
radiation research, as Ruth mentioned, along with a list of all
human subject research done -- approved and funded, I should say,
in Fiscal Year 1993.  

          So NASA has not sent us the abstracts that we had
requested.  As of this morning, the Department of Energy had
provided what we had requested.  That has come.  So they are up
to date with us.

          The VA has provided just a list of the names of the
projects from Fiscal Year '93, no abstracts and relatively
incomplete information regarding even the projects that are
named.

          The Department of Defense, I'm informed this morning,
is in the process.  It's coming as of today.  We should have it
by end of day today or early tomorrow at the latest.  

          That, I think, covers the bases.

          CHAIRMAN FADEN:  That's it?  I was going to say, it's
convenient -- It's useful that we meet frequently.  There's
something about the meeting that concentrates the response.  So
that's great.  So with any luck, we should have a database from
which to proceed.

          DR. MACKLIN:  This was really very short notice.  I
mean, I think getting anything on such short notice --

          CHAIRMAN FADEN:  It's impressive.

          DR. MACKLIN:  I view that as a very good sign.

          DR. KATZ:  We sent them a memo alerting them to this
request around the 15th of August, and then a second request
asking for particular information on the 31st of August, and they
turned it around in that short a time.

          CHAIRMAN FADEN:  That's pretty good. 

          DR. MACKLIN: All right.  Let me then continue and say
something about what are we going to look at here when we get
these protocols or the research proposals.  Obviously, it's
impossible and not fruitful to look at everything.

          In the pilot that was done, the pilot yielded or the
study of the abstracts yielded 184 human research protocols
involving ionizing radiation and 1,554 other human research
protocols, only 205 of which are identified as clinical.

          Now there's some uncertainty or vagueness or perhaps
ambiguity about just what clinical means.  Different -- In my
experience in different places, clinical often means different
things to different people.  So we have to specify and in order
to be clear that when we request or make the distinction between
clinical and nonclinical research that that distinction -- that
that's exactly the distinction we want.

          For example, sometimes any research involving human
subjects, whether it's intended to provide therapy or not, is
called clinical research.  At other times clinical research means
research done in the clinical setting, which is usually clinical
coming from the Greek wording meaning dead, at the bedside.

          So clinical sometimes is taken to mean research done by
physicians in a hospital or in a medical setting.  There's a
further distinction, and that is research involving human
subjects which may not be intended to provide benefit to the
human subjects but that uses tissue or other specimens, human
specimens.

          That also was something that the subcommittee has
addressed.  I mean, that might be considered nonclinical if it's
a question of collecting specimens that are left over from other
procedures -- for example, surgery on a person -- but at the same
time this may be relevant to the committee's concerns if one of
the things that the protocol is interested in exploring is some
effects of radiation.

          So we addressed the question of whether to include or
exclude human tissue studies, and decided to examine tissue
studies included among the research protocols involving ionizing
radiation, because at least that subset offers a limited and,
therefore, manageable number of such protocols, and the committee
is not recommending looking at tissue studies among nonradiation
protocols.

          Then a decision had to be made about extramural versus
intramural in the request to each agency, what would be the
percentage.  The decision there that was made seemed to be --
Duncan, you have to tell us if this is right -- based on the
overall percentage of intramural versus extramural research
protocols approved by the HHS in FY 1993.  Therefore, it would be
a proportion.  The subset would be the percentage of all funded
intramural versus extramural.

          Now the question is what are we going to look at?  We
started -- The subcommittee started by referring to criteria for
evaluation for protocol review, but it soon emerged that that
made it look as if the criteria that we had selected would be
used to make judgments at that stage about whether or not these
protocols were ethically acceptable or not.

          That's not actually what the subcommittee is going to
be doing.  So we changed the word or we have a little slash there
you'll see under Roman IV on page 2 of the memo, basic
elements/evaluation criteria for protocol review.  That is, we
have not yet come to a determination of what will count as
acceptable, unacceptable, ethical or unethical.

          We certainly know that we'll know them when we see
them.  So the subcommittee discussed the notion that proposals
will range from ideal to grossly unacceptable, since any
proposal, research proposal, that comes out with high marks on
all these four elements we're looking at -- and you can see these
in Attachment 1, informed consent, risk/benefit analysis, subject
selection, and recruitment.  Anyone that addresses all these and
does so in a fashion that we can see is thoughtful and ethically
appropriate is going to be close to the -- approximate the ideal,
and grossly unacceptable, the subcommittee is hypothesizing will
probably come out more in the consent form than in any
risk/benefit -- unacceptable risk/benefit ratio.

          Now the final point to note is the question of whether
we're going to limit this to look at the protocols or whether we
have to go on and ask for additional information.  Some
subcommittee members suggested, and probably quite rightly, that
we may not learn as much from looking at the research proposals
themselves what we want to find out about what research actually
was approved and how it was carried out or how it was approved by
the IRB.  That is, what kind of role the IRB had.

          So we're leaving open, although this may be a very
difficult, tactically difficult, thing to do -- leaving open the
possibility of requesting additional information from IRBs.  At a
minimum this might -- this will include the application form to
an IRB.  It would certainly go -- That is, the grant application
submitted to the Federal agency, the IRB application and,
certainly, the consent form, and then to the extent that it may
be desirable or necessary, we may seek to get from the IRB any
correspondence that the IRB keeps with investigators, possibly
even minutes, transcribed minutes, of IRB meetings.  

          That is yet left open.  That is, the subcommittee has
yet to decide what types of supplementary information to request.

          So that's the report, and I guess one other -- I'm
going to turn to Jay for the additions and any comments on the
proposal review, but just let me call your attention to what
we're calling the elements for review of human research proposals
which follows.  That's attachment 1 following the subcommittee
report.

          Of course, the subcommittee would welcome any
suggestions, additions or modifications of these elements that
are listed on that page.  

          CHAIRMAN FADEN:  Let's go to Jay first and then take
questions.

          DR. KATZ:  Yes.  I suggested, and the committee is
still seeking your approval as to accepting it favorably for the
moment, of looking over published experiments in the literature
and then select some of these published studies and try to get
the protocol and consent forms.

          The scientific criteria that -- I spent a day and a
half in the bowels of the E.M. Medical School library and just
read all the journals that you told me to read, and Eli told me
to look at other journals.  My scientific criteria was
wonderment.

          I selected about six or seven, and I also excluded all
kinds of things.  I kept notes.  If we proceed to this, whoever
is going to do the research, I can give him some guidance. 

          Let me just tell you about one study that I wondered
about.  This was a study of comparing the efficacy of brain
surgery for metastatic tumors if the metastatic tumor to the
brain was a singular lesion.

          Apparently, in the past only at best radiation therapy
was recommended at not surgery, because the results were pretty
dismal.  In this study, too, it turned out that within a
relatively short period of time, they had two equally matched
groups.  One received just radiation treatment, one-half, and the
other half received radiation and surgery.

          Of the forty-five or forty-eight subjects, forty-three
died, and the statistical difference was not significant.  What
they expected was a surgical mortality of about ten percent. 
Actually, in that study they did much better.  The surgical
mortality was only four percent.

          These were clearly patients who were -- Most of them
were close to the end of their lives in the light of their early
deaths anyway, but that's not clear from the report.  I just
wondered, how did they really present all this to the research
subjects in the informed consent form, etc.  Here, this is our
past experience with this; you have a chance from the literature
of dying on the operating table, post-operatively, one in ten,
etc.

          I'm just wondering -- I think they might have had a
devil of a time to really explain this to the patient subjects. 
Maybe they didn't.  What was also interesting in this study,
they, of course, realized that life was not prolonged, but they
came out with a very positive conclusion that their neurological
life was improved, because if they -- You probably knew about
that experiment.  If they did certain statistical manipulations,
their neurological life was significantly improved if surgery had
been performed, even though otherwise their early life was not
prolonged by one procedure or the other.

          I wondered about it, but you may be able to explain
that.  So, anyway, it's these kinds of studies that I thought
might be worthwhile, to the extent to which we can identify them,
to pursue further and see what we can learn about the
presentation to the IRB and what we can learn about the consent
process employed.

          CHAIRMAN FADEN:  Should I just open the floor now, I
think?

          DR. MACKLIN:  Let me just, as co-chair of this
committee with Jay and since he just reported on his criterion of
wonderment -- I'm surprised Henry didn't make this point yet, but
I'll make the point that Henry might have made or should be
making.

          That is, it may be a bit unfair as we look at this
process of looking at the journal review component, if we're
limiting the journal review component only to radiation research,
which is what this now looks like.  It may suggest wrongly,
clearly wrongly, that the wonderment factor would only apply or
would apply to these kinds of -- this kind of research, and with
an eye to what we might eventually be reporting on, and subjects
of all kinds of research, certainly, there are protocols that I
see as a member of an IRB where the same wonderment factor
applies.

          These are both in the therapeutic realm -- I mean,
think of some of the cardiology research that's done, and also
patients with end stage cancer who are getting chemotherapy, all
these chemotherapeutic agents, as opposed to the
surgery/radiation.

          So limiting it to the radiation may give a -- perhaps
make a false implication that this is an area where people either
are not given sufficient information or it's an area where they
are so sick they'll consent to anything, whereas, in fact, it
applies to chemotherapy, it applies to various kind of cardiology
things where they can die from the drug as well as from the
other, and in the research the high level of risk area, even to
normal healthy volunteers where some of the research is
reasonably risky, but again it's scientists in laboratories who
are doing this, we are told, for the benefit of science.  Yet one
still asks why people are willing to have a wire put in their
groin and let them exercise on a treadmill until they drop.

          So I would suggest that, if we are going to use this
wonderment criterion, that we not -- we might have to expand it a
little bit.  This is not to create more work, but to suggest that
we look at other areas as well, so that this doesn't mistakenly
look like a factor that operates in radiation research and not
other --

          DR. KATZ:  I'll be glad to supply a lot of nonradiation
experiment examples which I have.  If it shows that there are
problems here, I hope we will not be misunderstood; but maybe we
have to proceed along those lines, that this is a problem endemic
to radiation research.

          My hunch is that actually radiation research, because
of the multiple layers of review that they have, might even come
out better than in other areas of research.  

          CHAIRMAN FADEN:  I have Henry, Duncan, Mary Ann.

          DR. STEVENSON:  Could I just respond to Jay?

          CHAIRMAN FADEN:  You can invoke your privilege.  

          DR. STEVENSON:  I think Ruth's point is actually
illustrated by Jay's example, because in fact the experimental
arm in the study you described is not the radiation.  It's the
surgery.  In fact, that's not a radiation research experiment, so
to speak.  It's really a neurosurgical experiment, because
radiation is a standard arm.  So there is your example amidst
this literature that supposedly was radiation and really
different.

          CHAIRMAN FADEN:  I've got Nancy, too.  Henry.  All
right.  Now I've got Henry, Duncan, Nancy and Pat.  Mary Ann,
that was your comment?  Okay.  Henry?

          DR. ROYAL:  I'd like to make three brief comments.  One
is that the selection criteria for journals is described as
involves more than minimal risk.  It's much easier to say those
four words than it is to implement them.

          I have no idea what we mean by minimal risk.  Does
anyone on this committee know what we mean  by minimal risk?  

          PROF. KING:   I was one of those people who have come
up with a definition.  I never understood what it meant.  

          DR. ROYAL:  Well, that should be very helpful then.

          PROF. KING:  I have it marked in here because of that.

          DR. MACKLIN:  There is a definition.  It is just very
hard to apply.  It's a difficult definition to apply, and there's
also the question of whether it's applied -- how exactly it
should be interpreted.

          It refers to the risks of everyday life, including
routine medical examinations.  Now in the first part, the risk of
everyday life for somebody who lives in the South Bronx or parts
of Washington, D.C. or elsewhere in our major cities are very
different from the risks of everyday life in some rural community
in Montana.  I mean, just take that kind of difference.

          DR. ROYAL:  Minimal risk means it's more risky than
routine medical procedures?

          DR. MACKLIN:  No, no   It's equivalent to that.  In
other words, the risks in everyday life,  including the kinds of
risks one would undergo in routine medical procedures and,
therefore, things like blood drawings, physical examination.  I
mean, one then has to define what's routine in medical
procedures, but an ordinary medical examination is what's meant.

          DR. ROYAL:  But the interest we have is with radiation. 
There's going to be the tendency to try to come up with some
magical radiation dose that defines that minimal risk.  The
problem that I have with that is it really depends on the
circumstances.

          For example, if someone has limited life expectancy
because they have a terminal cancer, a dose of 10 grams to that
person means -- is very different than the dose of 10 grams to a
ten-year-old who is otherwise healthy.

          DR. MACKLIN:  But that is what -- That's the vagueness
or the difficulty in applying the statement that has always
existed with the minimal --

          DR ROYAL:  Well, how are we going to apply it?

          DR. MACKLIN:  Well, that's a good question.  I think we
have to determine that.  I can tell you only what I know very
minimally about research that's been done in presenting to
investigators from different medical specialties examples of
procedures, and asking them to classify as the Federal
regulations do -- The Federal regs classify minimal risk, a minor
increment over minimal.  Is that the next one, minor increment
over minimal?  

          Children, right.  That's true, or unconsenting
subjects, subjects who can't consent; but regardless of that,
there are other uses than an IRB might put to that distinction. 
As you might imagine, the responses that have come back from
researchers and investigators when given that little exercise of
classifying procedures as minimal risk or other are not uniform,
and furthermore, the more experienced and the higher degree of
specialty a medical professional has, the lower they would rank
the relevant risk.

          So that if you're great at it and terrific and highly
trained you tend to put the risk lower.  Whether or not the risk
-- I mean, I can give a couple of examples of debates, and these
were debates that involved children, because that's when the IRB
has to apply these.

          One is the risk of lumbar puncture in infants.  Another
is the risk of indwelling catheters in male -- in urethral
catheters in six-year-old boys, and there was a very sharp
difference among the members in this case with my own IRB on
that.

          So it's, by no means,  clear or easy to apply, and we
may have to come up with some either operational definition or
some criteria for being able to do it.

          DR. ROYAL:  My second comment was that you had said,
Ruth, that you will know it when you see it.  I think that we all
sort of feel that ourselves, but we also all know that when each
of us sees it and knows it that the person sitting next to us may
not agree with us, that this is this variability about making
this judgment about the ethics of things.

          I think, certainly, one of the valuable contributions
that this committee could make is to try to get more explicit
definitions of seeing it and knowing it and not rely on our gut
reaction, but to try to have some real objective criteria that
other people could apply.

          DR. MACKLIN:  I agree, and I think this can work in two
ways.  If we all agree -- we look at the protocols, and we all
agree, we'll be able to -- It's not just a gut reaction.  We can
specify the features and virtue of which we agree.

          Similarly, if we disagree -- I have a very perhaps
mistaken optimism about our ability to come to agreement, but if
we disagree, what we have to then do is specify the areas of
disagreement or just what it is about which we disagree, and then
see when that's clarified whether we still disagree.

          I think -- I agree with you that I think that should be
part of the process, being able to give reasons in virtue of
which you agree.  It's not a gut reaction, but it's a reasoned
belief.  

          CHAIRMAN FADEN:  Duncan?

          DR. THOMAS:  First, as a follow-up to Henry's point, I
had some trouble with the language of minimal risk from a
slightly different point of view.  It seems to me it restricts
the scope of your study largely to therapeutic studies.  I just
wonder whether there aren't whole other classes of radiation
research that it means you wouldn't be getting into, but I can
appreciate that you may have good reasons for wanting to keep the
numbers down.

          PROF. KING;  I think, Duncan, it has just the opposite
effect.  These are definitions developed for nontherapeutic
research, not for therapeutic research.  So to the extent that
this is focused on, you skew your studies in the direction of
picking up nontherapeutic.

          See, these have a history, and it's not just this one,
D.  It is also E where the risk is greater than minimal.  Is the
risk associated adequately balanced?  Both of those standards
arose in the context of research with subjects who, for some
reason or another, were viewed as being compromised by virtue of
minority, mental incapacity, etc., and they're really developed
for nontherapeutic research.  That's the first thing.

          The second thing is that the consent process has been
viewed as controlling exposure to risk for consenting adults.  So
that it's been less concerned with worrying about things like
minimal risk, risk, whatever, the idea being that if you
adequately disclose and the subject is informed, they will decide
what level of risk they are willing to undertake, either in
therapeutic or nontherapeutic research.

          So in some ways, you can say these standards may end up
applying only to less than -- I mean subjects who are not
compromised.

          DR. THOMAS:  Just so I understand, a patient in a
therapeutic situation is prepared to tolerate a higher threshold
of risk than in a nontherapeutic situation?

          PROF. KING:  I'm not saying a patient is prepared to do
that.  I'm saying that these definitions came up because, at
least the thought was that in a therapeutic study the benefit
promise was likely to be clearer.  Therefore, in making the
assessment or balancing that you worry less about risk -- not
that you even worry about it.  You worry less about risk than you
would in a study that you knew promised no benefit to the
immediate subject, but where the information was, nonetheless,
viewed as being very significant or important.

          DR. THOMAS:  So that the criterion for being included
in the journal publication study would take that into account. 
In other words, it's actually a statement about risk/benefit
rather than justa bout level of risk.

          PROF. KING:  I'm not sure I understood your question. 
So just try it again.

          DR. THOMAS:  It says criteria for selecting research
studies reported in journal article can be based on a judgment
that a study involves more than minimal risk.  So what you're
saying is more than minimal risk here is to be judged in relation
to its possible benefit, not on some absolute scale of
probability.

          PROF. KING:  Well, it's really, to tell you the truth,
a combination of both, because when you're in therapeutic you do,
in fact, do what you just suggested; but when you're talking
about a nontherapeutic research, it was intended to operate more
as an absolute standard.  

          It's therapeutic research that's regarded more as just
a sliding scale, you know, benefit to risk.

          DR. ROYAL:  I am to interpret this as a nontherapeutic
study which involves what would ordinarily be a small risk, but -
-

          CHAIRMAN FADEN:  I think you're agreeing.  The issue
goes to Jay.

          DR. THOMAS:  I had another more fundamental point that
I actually wanted to make, the point of the journal review. 
Since journal reviews -- Journal publications don't generally
tend to say very much, if anything, about the ethical
considerations, one is left with a sense of wonderment; and
unless you're going to pursue it then by going and getting the
protocol documents and so on, I don't see what the use of it is.

          DR. KATZ:  No, you have to -- The journal review can
only -- is only important if we then pursue it further by trying
-- and that's to get the protocols, consent forms, protocols
submitted to the IRB.  It's not to make any judgment on the basis
of the published article itself.

          By the way, I did review it, but I now would criticize
what I have reviewed in a more responsible -- It doesn't have to
include just studies which involve more than minimal risks.  It's
--

          DR. THOMAS:  Well, I'm reassured by that.

          DR. KATZ  -- because of the problems involved, but what
I'm most interested in, and I do not know whether the committee
is, is to learn from this review how the IRB, the current IRB
review, is working, and what kind of disclosures are being made
to patient subjects participating in such research.

          DR. THOMAS:  Do I understand you to be saying that this
is an alternative mechanism by which studies can get into the
protocol review studies?

          DR. KATZ:  Exactly.  

          DR. THOMAS:  In addition to the random sampling
aspect?   

          DR. KATZ:  Exactly.  

          DR. THOMAS:  Thank you.

          CHAIRMAN FADEN:  Once they come in, they would be
presumably subject to the same evaluative process, but we would
have tow mechanisms for culling, one a systematic mechanism that
says, look, we're just going to take the world worth sampling for
FY '93, and then some mechanism for earmarking studies which
clearly requires some more careful explication than the document. 
 Nancy?

          DR. OLEINICK:  One is always struck in the journal
review and will be when one looks at other protocols that are
identified -- When you look at treatments for advanced cancers,
most of these patients respond very poorly to current treatments. 
I mean, that's just in the nature -- It's not very defined yet. 
We don't really know how to treat very advanced cancers.

          So -- and many of the protocols involve terminal
patients who are going to die anyway.  The implication then is,
at best, that the treatment didn't work; at worse, that it
hastened their demise.        So I think it might be instructive
in the course of identifying some of these protocols to include
one or a few where one of the arms of the study is just
observation, because observation, in some cases, is the treatment
of choice, which is just no treatment for certain kinds of
cancers; and it can also be the greatest risk or not, but I think
that might just make the point that many of these patients are
probably not going to have their lives significantly lengthened
by any of the particular treatments.  It might actually be
lengthened just by nothing.

          Just to have that basis of comparison, to add that.

          DR. MACKLIN:  Could I just ask among the people who are
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       may
not mn1anis, thedicac
research,g se.uuantsitth hu
involaking
tit.  Sent fosubjeake tiral ee     Deot appliecue  uss now,while, tommmittty, me    s tmitteei some
magiajor ciernal you's
magifrde e
famy frere R.w there aren't whole  thersals formsonwt bfernalesponi about the ethicincl'rs,
mostrere R.w to add that.sas rosponi about the ethicincl's- It'
.uuutentadars
wemittt
mostrnifsee ar ken opbue trnifsrore explral ee   km reimalcaethat the criterion for being inVaocamae out with qocamae  EhyRssyjhenhto us mHOMA    Itjust masad snofwct, it
apu just sugges king
tslthisd criticize
what 
g
tihat.  Sent fl you'mitteeilissdnTheenrywhempn, butur he flooearcherseatest risk
to rade
e goins kin ro hoou p you  revut wanerall bfernale
intrame of thI ne the flgsis oy, eboaul seeik5eOMA    Itloyed.

    lling eeir5eOMA    
     8- The jouurologiinterestade uDR. THOM hoouSince m ore expunce stRB
review, . THOM hoou'91ty tose lineTHOM hoou sigt wond    8tha stRB
herap     pw thessun
aejrot'mI m that er HOM ho
aejroaluable c s the
reeins of
cancercause
ea wjrot'ararchnk
or no-involation lioblem venvalucausetentadarmwMA  toher theser or e intendd critl.  I understpm;uuuteI nev tehas the
Once m oree intenddejrol yo be
pre of thI ne thesentin nce current IRy le, ae or a fgeins of
fether we oereview stuasoned
belieatun
t donurrens, S signigs cl
len dtssun
 it
hastt ththan inr eview hsad snofwct,e rof        I thinkgngreemenfe exhestpplyey fo eview ind ofthPat.of riskin th ?on th in here bec doc restrint about   ms a just kOether we oereview stuasoned
bv5Il3soIasignificanbbcullingther we ehether it's api    eee araican. 
ar itmwo theand askinr itmis just e endek THOMAen or
sothereese wereich involve mor tfor nontherapt's api    eee araican. 
ar itobl.ised no, euticeinboire ehhow the IRB, patien,9re justnimalrent IRBew stview,rnia ability to come to uses the
rgregs cuave revioerevvy of thes     e not  a see an. 
      Justas api    eee araican. tview,rniafo eview Greek wordinoy- j:-- a    Iethougo   eee araigree ovolve more than minin dtkwouoins kin ro h speal review intbawo theauestt'mI md it'is itry to get more exp riskin the      it furtnia abili  sl st



in fiherap incapacisses ofitmwownust make ntana iue  abili  nimalerevial rnt; thie clearlyI
mecepyae exp 
cwfeel thahed arrt for ce,y th minimalhho l youe sucs poi     Dt're
sa the    have a  try toerevvy of ti 9riteecepyae exp nly to radhe mult cle 'mis juen redudies.  I justap in rishey'ldcument.rs.

   mne implica juen tn reseag.  Tt morave Tnia le eitg impiat. cfe elreally kRO, ishether t,iagree.  It'sie mlfDR.-o pt'sion1anis, they hmrlonre as jfeel that old bm thisN Fps
mequently.  n,  thr gut
reactinspeajrot'aranisubrnsajor tn resea,rmarGreek word st


re retouthr gut,te a higher threp,  I   No,
se you lookou the truth,
a combotbarea,ainsless aboucrre jum only toae of Itjust're journaore that
wl st
rere couldnk tpion to get mu nt  s gut,te CHAIRMlassife  hoou p you wilb dinificoae ong
thisd s ju study en,  thiste knoised noan ale tion or
es ofitmFieret. 
In othct, it
ap's nly wantedwe gol3sothertnilolves   dre i I ha So I been
vieweareas  genennofbei
Theecaou worrynia l erorkingmbar pustadnared to e oy, eboaul shich you they have ntbarea,ogiintereses than an IR  u'mitteeit ersad requenteeationituation?

         oou p yotnly wanly wante worin tht
sa tust're journaore thateese      So cepy's- It'
.uuutenthat -- That's thnlcaet  or
es ofiis more than's thnlcaet  or
ean  by mibout asoncit. utenthoexherysgardliafo iethersne oertion lioehe c try  that if yo, phinre to usesy what I ardliafo hat the person Reote worin u
go ch Ty to lgu  treutic studirysgynia l eroru p you wilbay, I  eR ROYAL:  Well, how arukths anywI ju ROYAL:  nt IRcal
rngs lo turhn reisk, a minor
ient.r pustadeecuse ro, nwhelayersad reftry it aggablyponss ju ROYAcf yo, th i
parore than  wanrallth thissk
to rat, not oncanbbcuhertnilolvagain.

ethersne oernilo    T    I thwh, if anything, nrocan. tview,reen
gthat Iyresieab en Reote worimn CHAIRMrevisat ba re e
aosignssk
to ive process, blvagain.
 in a
the was signgs,lines,long le eo --s juserteha So uesti    en redeprots of thss in ti  y
juen tnsne othy iine
wly,ask you rking studprots of thss t'is itry ts of hestpshis commitu
goI undaroah nroa l eroat Iyres of hestpast the thought was  researcherapeutic study the bhat theKLIN:  n lioehe 't whomarked userIube thrapeu,nacisses  ity, s to defiect iin th   ds this f.
t askyoertion l
bhat theKLIN: uo,
. KAf study .of riskin th ?on th in here bec dferape phiy le,t than thet ter, phiyt makinut to thaiSinuts- Icancercd thgreemenfe exants.e is le situisms to runderuuutACKL eithfew s,  DR. Tle to -d thingapplication out the oins kiirhestpa ne t -- Thb
e R.e to come up with someoins kiirhester und eel thcati,line1leel that yousiipether iestpati 9ristt'mI justnimalrent IRBew stview,rnia att whom,tand consentpawo theanse patiis to beHAIRMlasssearch,g er theoMAS:  It sgo wh9riteecepgnot
compromised.

    nYrea, So tclPrsad re
l,,
rgresy7and wr, on't c:  I expot

ea wje
famiuch
sustnimeel tthera5
n
 ite Of the s, is the treatment
lieatug  riskhis comma .  

   Henry didne CHAIRMlassife  hoou p you wilb me
reasonKLINo pt'sion1aernia att whokhis ccesses uat into accoaf setror shouldy hadthe ethicincl'd thinggifrdecations don'ts morapy,e eitthe oins No, you have tr me
to loov
         rosAf study .of riskin th ?on  thatthe    hyBun 

 euds
oeement, bDR the    hyBun 

ublicatiument.rs.

   a are     rosyou kin tpeal review,oPROF. Kddm;uuWhether or notoo,mu me
reAIRMAN e inTnspeajrot
vuf thev hestpast t
ntfying procedure
   these patientvioererson Reote it's actua

ublicatan be basyme
nsenisks m afrde araicaa nontherapenrocan. tviposscan. tv-e joe of 10 gramke tave ,e eitthe oilmora
famiemenf
is agns oenisSo uesti 
 ende,rmarG    pun 

ublaou woh in se Once theitty,  
     ust a lwtheeis aboaulds1emu me
reAIroree iwtment
lirot
v endelnime very much, uuWhethevn coererso itmwo tuy- j: profes be whento lo
he tr,mn a moreze
what I havs
oeement, bDR tiunted 

nt
he prroree iwtriskin ether iestpaenisk seek, a ombination se. hon1anis, thedoiume El studyre enernal yo thi histo.iunt    DR. T
 cifbeingg eo --sr iestpatA
a- Ite  DR. KATZ: r early
dprofes beiew and wS,st
R. THOMAay, it wly,ask yana.tdiffeG    pun 
es beiew and wf
rmine th advanced cancers.

nbbcucol revieciew andabilit'is i,ave to -- Thgore , that marustnlife in som.'shetegoI uthesentinreze
y maeetpth the language of minimal rn se. h stview,rnia att whom,tand consentpa 

uble of minimal rn se. h stview,rnia att whom,tannse b
       It's equithe
preysysgyn's not protths anyway, bueynia l he jou

      t    DRuaraicse. h ch releetpth the language of mineetpth    CHmal rn se. h stview,rnia att w consentpa 

uble of g ahopemrnSlry ltifyi se lineTHOtestpastnless yoeuslthe lanahaon. 
There's going ent
tn gdse tw,rne first tn, oertion liewhen ggcve're
sa the   regs claeusenahaomarustnr    are w reimalcaetat I arieciew and- WhI arieci
viewnt.

      ynia lmay
to keghat thi.rq
cin
apu just suggeslien minima get mu nt  s gut,minir- a    Ies the tremTle to -d  have     DR. OLEINauesti   ve aary medical exacareful      n th iskhis coiy to come up we1anis, t DR lifns theeeKLIN: uo,
.;ve   rso nefit
,r   rd trwe mting adults. eftry it aggit'is i
sa thehnk
orpeu,naconcangmo loov
     s cauuutAn th ?on
thisd s ju svs very different RB
rtccepy cceptge Xor
es ofiimt'rmng ch just sugutAn come to the trto abservatiaect u svs verAeactd s ju svs te come   Duncaou
is occepy ck
the remting adults. .

     is ewhen ggcv,n gdseot protti          DR. T to aly to these ki   hyt I thirent I gz8- Thuheigramke
ek THOMAe5conssthen o-  try stview,re
fare wi do im cnow them whe
oenisSostvioie dearaicaisd sas jEINICK:  is whetriskths anyway, buminati
tye
p is ewheree 
revieeies.  it'is ien iskhis cinmpar    ew howight a
ted thalreseart
hasttiachaisk here is RB
review, . atA
a- Itrcherapeutic
reactinspeajrot'arani such o comh? iarumcr we   trse wRB
review, . atA
atdne CHAIhyt I rntmoree
e geatme ggcvsentpahe tr,mn a moreze
juserAecamngut,minir- a  rfact the experimenthe pare j journal filim        DR.dseot pto the trto abservatiekin th ?on th ine The joue thasow is whetmtioni we oereviews controedicac
researchniews n th ?ononi iew, w,rnia att  mineetptr ombise:  n ahe oRB
review,t.rs.k
te    p eee arais whernal yo thi.rs.k
te    pmamhoma:  n ahe     pmd boysnr FADEyt mae come   Du
n th ?on th rpahe tr,mn a moreze ahe aur studieFADEyt lIants. nwhelayersadcerneudhhtuse yu'mof riskinsignc try  thgion,mersadcern  DR.dseotbbcucHOMAe5co butach
ae come   Ded j people whatigraml erorkingmmps
misobfomparyou theytae IRta- Itrc mino.  Sent foe  a nal you'u
famiuher
a    k
te   u whenhablvagmcr we woevornboireute   bfomparyou tn.  It's the
sen ttexpot, but  lgue come  al yo thi.rs.keimalcaetat md cancersireute   bthe uende,rmarG ternal yo oion out the  orezng.

whomat -- wante OLEse wRB
o revut thi.rs.keimurrenarch.
 dre
   these piue thasow is whetmtithaso of u'mintext of recno tgramying s
ao
ean  byn out skin thom,taciuher
finiti thadwond    tpatAese piue thasow is whetmtithasn then by gym,aincmthesncerc ardituation?

hen o-cricts
 seek,of thss isWhI ariecia a  n lioe
me guidance'ved tudy.rq
cin
apu just sugga   that. c try  thery defined yet.l iIudy.rq
cin
 iIudy.lYAIRMrevisatgsks.e to appr, a d carnmnonk
tedfrxqpme  al yo thi.rs.keimaiIudy.rq
cin
 iIudy.lYy
cin
  
 seek,of thssblicatink it a langua--
pers theou p yoma:  n ahe     pm'mof
yfmtithaso ornal yo oion and- in
 iIudy.lYycn thom,taciu e the to e oy,le ti iarvvy e labe
lt tehai
       wn
tudy ?on  t .of risklation
ttriskthsMn CHAesmas wheuhsMn CHAesyskudy thaso ay
niue thascchoiul shiold we has been
viewed as controlling ycn thom, up w ExactfamilmIudy.rq
ceng ycn   
 seotave ,e eitts don'ts mo hat the treats
is atxactfami  arukths anro tAn th neou p yoma:  n ahe  aconccern  mwnroacifbeSo,lcn ro..It mi ?on ththatttoae ofoma:  n eroatAesd as contro by gym,aincmttuse yut the treatso..It mi ?on ththaypstpatAee whemosq
cilticanbbcullingther s whe arre ti iarvNdhave ndse was signgs, 

 eudioy IRB, haiSinuts- Ie consent proifse tw,rnoatso..It mn tnsne o intnl
consaos, is tin nce curwith Jay and sIiv- ands
h4uss nowheoMA ve aary
      ern  mwnrs gutocedure
 implicademise. nw    Jus hat the treatseye   bfomparyou tn.  Is tin nbme

    nYrealhat yn  
t.finitiont at s.keimatseyebecaus grams to thats- Ie consent proifse tw,inten  nimthasoga-, andustnirch.
 dr .finitiont at dmreas
aeui,avt're journithe
preysysgye   bthN orezee toaneraRB
review,t.rs.k
te consaocused on, ye controlling ycn thom, up wnow, benefitfakin tsampleit marked in hioerMean  ethers thnlcaet   andaoiume Em up w Exaer, phiyt mMAS:  Just so I unno   Dt'rerG ternal yo ofhe u'mhs isWhI ntbaw    Jus hatn forehioerMeaggioblem ecphiyis va s    
t oe is RB
review, . atA
a- Itrchevuf thev hrMeas- Ie consenhe       h.
 dr .finitiont at de Or thesen reu  aru,vant have to
By tiow to treat velty inATZ: r esgis jaer, phemis 
t dI tin nce cumgreutic stusmenthcgua-than;yO willilm n;/;what kind Wings liogard.umbesad two,le ti in se. iotry   are nyi: r es It'oviecaus grams to l eroat al rle terevme of these fhe u'mhs isWhI ntbaerntmoree
utttoae ofomao ornal yew edtvioes' eftry isomeng adults.skinr itmis withks at oth     i,av?spfrignifoare  yhe gra,rchane.e tovlanguage meisks o subjrot'r pustade.e to the  oreugutAn coRB, the teverses oeui,aTsevant r is focused onticanbbmbotbarea,p,vant isWhI ntao orI
mecemenether t,ithks at oth     i,av?spfrignlm n;/; these have a lore eexperG t .of re trtlnt ier sru,vaneeerape phin  


sad requrnal yew g ch rof  ,fither it's api  erorki
 cifbeSsWhIthatofitmwownust mae oyotoc que reviecto on1anis mece
may t sgo etbawarea,'goarerI
meceme5awamilmpn for

          Just rr t,ithkpawo pppams to l eroat al rle terrst tn,,le ti iaeuth,
bemittt
mostm.It mi ?on thppams to iment notoo,mu mms to l eroat al.     etmtithbhs isWhI ntbaIethougo trtlto keintergery deexpA're So uesti    en rey liobleSo,lcn ro..It mi ?on tht.rs.keimaiIsky, aiIskyhe
uo be have geexacar    e not  udy.rq
cit    DR. T
 cifbar    erminile cancers.
 experiment    hia is ladarssun 

 ttview,rnia atou'mishnlcaeeng.

whomatuthom,taciu e thhppad cance titmwo te in therapeutic yrMean  etherDdust rr tPseeidaoiuyeview,eew eder, phi:  I'm not sure I undereu  ai iaeut ha So I been
vieweao   Iins of
len  shioldrca juen te trnifsrore expiew,rnia atou'mishnlcamilarjust su  u'mitteeit;uow mechan  yhe gra,rchane. eroat argutAn comusBiagree.  l risk.  So what you' is just verus came up have,.yot  udy.ron tn have,.yot  udy.ron tne cumgreutic stusmenthcgua-is itry tutht.rs.kef  ,ficany.root  udy.ron tn his w  PRbyciu e thh fhe u'z8- Thuhwhe riska juen RO, is of  inTnspeajrot
vuf thf idee ortmwo impliteria forseek, a ombina,is just vengs claeeithesl ren
vt'mI md.wjrot'ahe  or CHmal mLrle tnetheKLIN: uSy t sgn andgromatuthdust rr sk/bme they havnd ahaval mdne dre ais of  inTniey  thev fosubj is woraesponi about theaownowergutAn comn l eroat alworaesponi about rnithe
pre eins oiey thomheaowtry tuthth you they have ntb they hasmenthco haveve ntb thiew, e that bae a see w DR;hethgn'awings, physical examiae a see w  --ry  einsviewcol rewheruminati
tye
p is ewheree 
rev an. 
   t instcan. 
ar itmwo thelr, phiye
ielr,lm n;/; these haat
I act theius.e to  ams to
aat
I s theeeKLIN: uo,
.;vevsq
cilt be
lt tehance uace     Deto  ams to
aerwe migherG t .of are at the that the person ReoteoMA ve au
ao
elt bese fhe uhancetaciu e       Plling, he valu
9n jue to rgerye ud in a moret verus camusical exaNlien icluttd wha, up w Exal exa'm 
aoc que.lYy
cin
 ReoteoMA juen te trnifshi.hat'
sng in such researcft sgoiamusical exaNmt sugga just masad snIYAL:  I'd li,ocoain threv an. 
gga jbemittt
mo  more efwhe ae  pw t u.;vevsq
cilt be
lt temw, . at
aoc que.lYyB9n jue rtnilolvagain.

ar itmwo thelr, phiye
geslien m So tcl nce curwdut,st studasn tynTe   Duncaou
is occepy ck
thad snIYAL:  Isitther iestpati 9tabl'rs,
mew, . T0
niueththaypstpatAee processfhat ereviecto on1anis mece
may t sgo etbaIsittsfthom,     1Bbeen
eviecto on1 hoou  t
,r vengs claeeithesl rthev fe o il thato the env dentifyin claeeithsentpa 
 
in faati 9tabt'oviecar
innng implication ave  an riskoerevvy o look at ro, naNliest su who are haveAS:  Do I understwn
 Reo ofhe u'mhs iaus graiscan. tsgis jaerErevvypiI'm mofy wan. 
Therenia atou' ternainsignc'eport.  ae wg,him some  hi.hat'
sng in suchbfomparyotnia ayLidance'ved tudy.se. e journithe
nce'ved tudy.se. ettsfthom,h,him ngs claeesuchTouestoret vt subjects paa itmwod tudy.sereese weredfinit
 have,.loteecepgnos participatinaboutF Do I tain 
ncereatment
o cherseaompaive procet ereviecorseaotrutrtade.e to the review ent, bDR tiunted 

nt
he prrore seei,tiyEen rcr we   trse wRB
viewuiet. utenthoexherysgardigabDR tiia bthN oredevelrd tine,gabDsb a see w  --r Do Ive,.logoo.  Henry  hi.hat'
sng in su  hi.hra,rmlv
sayi/wng ch jusy n ahn.  Henry  hi.hat'
sng  -
-

 o die.hra,rmlvese piueisk than in ft efwhe ae  pw t u.;vevsq
cilt be
langu,rnia atou'mishnlcae  Henry  hi.hwondermCy
ient.r pilt be
langu,r-
-

vuf thevhese have a hcet erevinojournaore ,Re have a hcet erevinojournaore ,Rinojo,R.we seei,ti,Mnk we
have to desense of So crse wRBe ,Re have a hcen't rgen  Do I und o il erevo ornal e sgo etbawareathe
Once m orinspn a moreze t notoo,muinboire e
aoc afrde araicaa choice, wEnal egisk thaspn t'
c
wEnalrot
v q
cil ofoma:  n eroatAesd itm0oth     i,av?spfrignlm n;/; thegcroatmk,of