DISCLAIMER

The following is a staff memorandum or other working document
prepared for the members of the Advisory Committee on Human
Radiation Experiments. It should not be construed as representing
the final conclusions of fact or interpretation of the issues. All
staff memoranda are subject to revision based on further
information and analysis. For conclusions and recommendations of
the Advisory Committee, readers are advised to consult the Final
Report to be published in 1995.

                    *****STAFF MEMORANDUM*****


TO:       Members of the Advisory Committee on Human Radiation
          Experiments

FROM:     Advisory Committee Staff

DATE:     June 27, 1994

RE:       Ethics Follow-Up


Executive Summary

     The staff continues to review materials from various agency
and other sources, including previously classified documents, that
are relevant to an account of ethical policies and practices
concerning ionizing radiation experiments and other medical
experiments on humans. Below is an update of the status of our
data-gathering efforts to date, with special emphasis on newly
acquired and integrated information on the history of ethics policy
development at the Department of Defense (DOD) and the Department
of Energy (DOE). For ethics discussion at the Central Intelligence
Agency (CIA) and the National Aeronautics and Space Administration
(NASA), please refer to the agency updates included in this volume
at Tabs J and K.

     Agency Highlights: At the DOD, we have learned that prior to
the 1953 adoption of the Nuremberg Code as formal policy by the
Secretary of Defense, there was strenuous debate within the DOD as
to whether to adopt any types of formal policy regarding use of
human subjects in medical experiments. Several committees reviewed
the matter, but the issue was finally left for the decision of
incoming Secretary Wilson, without agreement or recommendation by
the Joint Secretaries. At the Atomic Energy Commission (AEC), a
policy regarding use of human subjects was apparently in place in
1947; also, the head of the Commission's Public Information Service
informed the Associated Press in 1950 that the AEC had never
sponsored research on humans. NASA established human research
review committees in 1975, and formed a Medical Isotopes
Subcommittee in 1969. At the CIA, guidelines were issued requiring
informed consent from human subjects in all types of research
following a 1978 Executive Order; the CIA reportedly is attempting
to declassify one section of its most recent guidelines on this
subject.


                                 1
1.   Department of Defense

     a.  Status of Search: Staff continues to make relevant
document requests, including a request for the minutes of the Armed
Forces Medical Policy Council.

     b.  The Continuing Story Regarding DOD Adoption of the
Nuremberg Code: The Secretary of Defense's February 26, 1953
memorandum adopting the Nuremberg Code (See Attachment A,
previously included at Tab I, briefing book vol. 2) continues to be
a useful point of reference in our account of the development of
DOD policies. In the last ethics follow-up memo, we attached
memoranda leading up to the 1953 memo (see Tab H, briefing book
vol. 3). These earlier documents indicate a vigorous discussion
concerning the use of human subjects in the areas of biological and
chemical warfare, as well as radiation. It was widely believed
within DOD that this work could only progress with knowledge
acquired from human subjects.

         Documents received since the June Advisory Committee
meeting make it possible to reconstruct a strenuous debate within
DOD during 1952-53 concerning the advisability of adopting the
Nuremberg Code, or indeed any formal policy at all to govern the
use of human subjects in medical experiments. Documents on deposit
at the National Archives (provided by the DOD), make it clear that
these discussions began at least as early as December 1951, when
the Secretary of Defense expressed concern in a DOD Directive about
"our lack of readiness in chemical and biological warfare," and
ordered the three services to increase their activities in these
areas. (See Attachment B.) Similarly, a joint meeting of
representatives of all three service branches on February 11, 1952
was held to discuss "increased emphasis on CW and BW" (chemical
warfare and biological warfare). The minutes of that meeting
include the summary statement:  "That we have a serious need for
increased testing of these weapons, in particular, experiments
involving humans." (See Attachment C.) Reporting on these meetings
to the Secretary of Defense on April 25, 1952, the Assistant for
Special Security Programs emphasized the problem by stating: "If
the signal to retaliate were given tomorrow, or even within the
next year, the United States could make little more than a token
effort." (See Attachment D.) To concerns about what might be called
the "biochem gap" were gradually added similar worries about
radiation preparedness, and by some time in 1952 all three areas
were routinely considered together.

         Meanwhile, the Armed Forces Medical Policy Council (AFMPC)
was developing its recommendations for the Secretary of Defense on
the use of human subjects. In a December 21, 1952 memo to the
Secretary, the chair of the Council reported that it had
"considered this subject at great length." The concern that animal
models were no longer sufficiently informative for biological
warfare research was reported as having been expressed to the

                                 2
Council by the Army Surgeon General. Following a discussion the use
of human volunteers was unanimously approved by the Council on
September 8, 1952. At its meeting on October 13, 1952, the Council
adopted the ten rules of the Nuremberg Code, along with an
additional prohibition against the use of prisoners of war, as
suggested by the Council's legal advisor. The Council also
explicitly recommended that atomic and biological warfare agents be
included in further research. (See Attachment E.)

         At around the same time, the executive director of the
Committee on Chemical Warfare of the DOD Research and Development
Board, in a memo dated December 9, 1952, stated that the Committee
had issued its own recommendations on this matter, going "a step or
two beyond the AFMPC recommendation in calling for a system of
rewards for volunteers, and for recognition of government liability
in case of accident" That memo continued: 

         The whole need of the CW program for human
         volunteers, in the judgment of this Committee,
         cannot be met by an arrangement that allows
         acceptance of volunteers from personnel normally
         on duty at installations engaged in such
         research.  For this purpose the permissive
         statement should be subject to the
         interpretation that uniformed volunteers could
         be assigned to temporary duty at the
         experimental installation for the purpose of
         engaging in the program as test subjects. This
         is the essence of the British system, which we
         are advised has worked quite well. (See
         Attachment F.)

Thus the Committee on Chemical Warfare appears to have advocated a
recruitment approach that went substantially beyond that of the
Medical Policy Council. For example, the suggestion that paid
volunteers be assigned to temporary duty at special sites raises
the question whether such arrangements would have been in practical
compliance with the principle that human subjects must be free to
terminate their participation in an experiment at any time.

         A November 17, 1952 memorandum from the vice chairman of
the Research and Development Board to the chair of the AFMPC
indicates the Committee on Chemical Warfare was not the only group
to question the Council's proposal. The memo states that the chair
of the Committee on Medical Sciences (also of the Research and
Development Board) was "reluctant," but "realizes the probable need
for such a policy and said he would not oppose it" (See Attachment
G.) A few days before that, on November 12, 1952, the Executive
Director of the Committee on Medical Sciences wrote a memorandum to
the Vice Chair of the Research and Development Board in which he
reported the Committee's views on the matter in more detail. At its
October 30-31 meeting, the Committee agreed that "human

                                 3
experimentation has been carried on for many years by capable
investigators." The memo continues: 

         To issue a policy statement on human experimentation
         at this time would probably do the cause more harm
         than good; for such a statement would have to be
         "watered down" to suit the capabilities of the average
         investigator. Thus, it would be restrictive to the
         exceptional research worker.

The Committee also expressed the view that "human experimentation
within the field of medical sciences has, in years past and is at
present governed by an unwritten code of ethics," which is
"administered informally" and "considered to be satisfactory... To
commit to writing a policy on human experimentation would focus
unnecessary attention on the legal aspects of the subject" (See
Attachment H.)

         Considering the apparently grave internal ambivalence
about addressing the issue of the use of human subjects, why did
the DOD feel compelled to do so in 1952-53? Previously, staff has
speculated that a policy on human subjects research was given
special urgency at this time not only by the juxtaposition of
national security concerns and the notoriety of Nuremberg, but also
by a lack of internal DOD regulatory structure to govern this type
of experiment.  This theory is confirmed by a statement in a memo
from the director of the Executive Office of the Secretary of
Defense dated February 5, 1953, just three weeks before the
February 1953 Wilson memo: "This case involves the establishment of
a Department of Defense policy prescribing conditions which will
govern the use of human volunteers in experimental research in the
field of atomic, biological, and/or chemical warfare.  There is no
DOD policy on the books which permits this type of research."
(emphasis added) The memo
continues:

         This question has been under consideration for a
         long time. It was last considered at a meeting
         of the Joint Secretaries Group on 8 January
         1953, Dr. Casberg, Chairman of the Armed Forces
         Medical Policy Council, briefed Mr. Foster and
         the three Service Secretaries (Mr. Lovett being
         before the Congress at the time) on the proposed
         policy. Although no specific objections were
         raised by the four Secretaries, neither was
         there any expression of enthusiasm in favor of
         the policy. The only agreement reached was that
         the decision should be deferred to Secretary
         Wilson in view of the controversial aspects of
         the policy and the fact that his administration
         would have responsibility for administering the
         policy if approved. (See Attachment I.)

In view of the larger story, it begins to appear that the
"controversy" alluded to above was that within the DOD concerning
the wisdom of adopting the Nuremberg Code as the policy, or indeed
the wisdom of adopting any formal policy at all.

         In spite of the opposition, or lack of enthusiastic
endorsement, by other groups within DOD, on January 13, 1953 the
Armed Forces Medical Policy Council's memo to the Secretary of
Defense "strongly recommended that a policy be established for the
use of human volunteers (military and civilian employees) in
experimental research at Armed Forces facilities," and that such
use "shall be subject to the principles and conditions laid down as
a result of the Nuremberg Trials." (See Attachment J.) Driven
perhaps partly by a perceived need for regulation in this area,
Secretary of Defense Wilson finally signed off on the
recommendations of Dr. Casberg and his Council on February 26,
1953, ending months of vigorous debate within the DOD.

2.   Department of Energy

     a.  Status of Search: Staff is devising a target strategy for
DOE document requests, and continues to follow-up on
documents received.

     b.  Interesting Findings:

         AEC Policy Development: In briefing book volume 2 at Tab
I, we included a contract letter dated April 30, 1947 from Carrol
Wilson, AEC General Manager, to Stafford Warren of the University
of California.  The letter specified that "treatment..will be
administered to a patient only when there is expectation that it
may have therapeutic effect," and that each patient must give clear

                                 4
consent while in "an understanding state of mind." The letter also
stated that in accord with Dr. Warren's recommendation, two doctors
should certify in writing to the patient's state of mind, the
explanation provided, and willingness to accept treatment, rather
than obtain a "written release" from the patient.

         Documents recently obtained from the DOE help tell the
story of the development of this policy and its subsequent
modification. The first are memoranda from March 7 and 10, 1947,
which record the results of discussions with the ABC's General
Counsel's office regarding elements of patient understanding,
explanation of the nature of the treatment, and the expressed
willingness to accept the treatment. The March 7 memorandum also
records Dr. Warren's recommendation to forego written consent from
the patient in favor of two doctors' certification. These memoranda
formed the basis for the General Manager's April 30 letter. (See
Attachment K).

         However, a recently reviewed document indicates that a
different policy statement was provided by Mr. Wilson later in
1947. In 1951, an inquiry was sent to the ABC regarding its policy;
in a March 5, 1951 response from Shields Warren (see attachment L),
the AEC quoted a November 5, 1947 letter from General Manager
Wilson to Dr. Robert Stone, also of the University of California,
which stated that the Advisory Committee had set the following
conditions for the use of "substances known to be, or suspected of
being, poisonous or harmful":

         (a) that a reasonable hope exists that the
         administration of such a substance will improve the
         condition of the patient, (b) that the patient give
         his complete and informed consent in writing, and (c)
         that the responsible next of kin give in writing a
         similarly complete and informed consent, revocable at
         any time during the course of such treatment.

Thus the policy referred to in this letter retained a reference to
therapeutic benefit, required written patient consent rather than
the investigators' certification, and also required written consent
by next of kin. This constitutes a formidable consent standard.
Certainly it was far stricter than the policy expressed in the
April 30, 1947 letter from Wilson to Stafford Warren. 

         In his March 5, 1951 letter, Shields Warren goes on to
cite with apparent approval remarks critical of secrecy in research
unless required by national security, and an observation that the
public's acceptance of the need for secrecy in the ABC creates
"special conditions for the clinical aspects of its work."  Perhaps
this is an oblique reference to an obligation to maintain high
scientific and ethical standards under such conditions.

         Human Research Denial: On November 29, 1950, The Baltimore
Sun ran an Associated Press article on twelve Arizona State Prison
convicts volunteering to undergo experiments for an ABC "medical
research project" in "skin grafting and blood transfusions." (See
Attachment M.) On December 7, 1950, Shelby Thompson, the Chief of
the Atomic Energy Commissions Public Information Service, wrote the
Associated Press to deny involvement, saying "the AEC not only does
not sponsor this particular project but it also has never sponsored
a medical research project where human beings are used for
experimental purposes" (emphasis added). (See Attachment N.)     

                                 5
     Given this denial, it is interesting to recall that in 1947
Colonel Hayward of the ABC had ordered classified any document that
referred to experiments-with humans and that may have "an adverse
effect on public opinion or result in legal suits." (See Attachment
O.)

3.   Department of Veterans Affairs

     Staff is in the process of clarifying the scope its ethics
requests, with priority given to Department policies and procedures
concerning human research prior to the mid-1960's. 

4.   Department of Health and Human Resources

     Staff continues to develop a targeted search strategy for the
Department, and to follow-up on previous document requests. 

ATTACHMENTS

A:   Secretary of Defense memorandum, February 26, 1953

B:   Secretary of Defense Directive, December 21, 1951

C:   Minutes of February 11, 1953 meeting of Department of Defense
     service representatives

D:   Assistant Secretary for Special Security Programs memorandum
     to Secretary of Defense, April 25, 1952

E:   Armed Forces Medical Policy Council memorandum to Secretary,
     December 21, 1952 

F:   Committee on Chemical Warfare memorandum, December 9, 1952

G:   Research and Development Board memorandum to Armed Forces
     Medical Policy Council, November 17, 1952

H:   Committee on Medical Sciences memorandum to Research and
     Development Board, November 12, 1952

I:   Executive Office of the Secretary of Defense memorandum,
     February 5, 1953

J:   Armed Forces Medical Policy Council recommendation, January
     13, 1953

K:   Atomic Energy Commission memoranda of March 7 and 10, 1947 

                                 6

L:   Letter from Shields Warren to Leslie Redman, March 5, 1951 

M:   Associated Press article, November 29,1950

N:   Letter to Associated Press from Shelby Thompson of the Atomic
     Energy Commission, December 7, 1950

O:   Letter by Col Hayward of the Atomic Energy Commission, April
     17, 1947

                                 7