Tab I

Staff Memo--Progress Report on Collection of Agency Ethical Standards
on Human Experimentation




     

     				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.

                        Progress Report on
       the History of Agency Policies Regarding Research Involving 
     			   Human Subjects


     At the last Advisory Committee meeting, the staff was asked to 
research the history of agency policies regaining research involving 
humans. To this end, inquiries concerning "ethical rules and 
regulations" have been forwarded to the following agencies and 
departments: DOE, DHHS, DOD, CIA, VA, and NASA (see sample letter 
from Ruth Faden to Harold Gracey, April 26, 1994). In addition, 
contact persons have been identified and initial contacts made at all 
the agencies. FEMA has also recently been identified as potentially 
relevant, as its predecessor agency was the Office of War Preparedness.

     As of 1991, all agencies represented on the interagency Working 
Group subscribe to the Federal Policy for the Protection of Human 
Subjects. This has come to be known as the Common Rule, and is based 
on Subpart A of the Code of Federal Regulations 45 CFR 46-Protection 
of Human Subjects. The Common Rule applies to research involving human 
subjects, but does not include policies regarding research involving 
fetuses, pregnant women, children, or prisoners. Prior to its 
implementation in 1991, policies for research involving human
subjects were set agency by agency.

     Some material is already available concerning policies at several 
agencies. The status of our effort with each agency or department is 
described below.

   1.DHHS - The history of research involving human subjects funded 
     by the constituents of DHHS, NIH in particular, has received 
     considerable academic attention. Among the best treatments of 
     the topic are Faden and Beauchamp, A History and Theory of 
     Informed Consent (chapters 4 and 5 are appended); and Jay Katz 
     et al., Experimentation with Human Beings. The staff intends 
     to use these and other secondary sources as a guide for
     further.insight and understanding in the area of oversight of 
     research involving humans at DHHS and its precursors.

   2.DoE - As an example of the kinds of materials corning to light 
     in regard to DoE policies on human experimentation, a letter 
     from Carroll L. Wilson, AEC [Atomic Energy Commission] General 
     Manager, to Dr. Stafford L. Warren, UCLA, dated April 30, 1947, 
     is appended. This letter exemplifies the kind of policy 
     document that might only present itself through a search of 
     archival sources. The It does not require the AEC contractors 
     obtain signed consent forms, but that written certification of 
     informed consent be provided by the doctors as part of an 
     official record.

   3.DoD - Early policy documents elaborating conditions of 
     acceptable human experimentation, and one step in this policy's 
     dissemination, are appended. It is a classified memorandum from 
     the Office of the Secretary of Defense, from C.E. Wilson, to the 
     Secretaries of Army, Navy and Air Force: "Use of Human Volunteers 
     in Experimental Research," dated February 26, 1953. The second 
     document is the same classified memorandum, with a cover letter, 
     dated March 3,1953, disseminating the same document to the Joint 
     Chief of Staff.

     The substantive portion of this memorandum is a verbatim 
     recapitulation of the Nuremberg Code, without apparent 
     attribution.  Prof. Katz alluded to this policy during the First 
     Advisory Committee meeting. This document and evidence of its 
     dissemination raises a number of further questions, among them:

     -Why was it thought necessary to classify the Nuremberg Code?
     -How was it expected that a classified statement of policy would 
      be efficacious?

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     -What processes preceded, and in addition to the Joint Chiefs
      dissemination document,succeed the adoption of this policy?
     -How was the policy reviewed and approved?
     -Did any specific incident(s) or project(s) "trigger" the 
      promulgation of this policy at this time?
     -Was this policy intended only for DoD-funded projects or was
      it also to apply to contractors?
     -Did DoD-sponsored researchers need and have security 
      clearances?

     Further material provided by DoD to the Committee on May 10, 
     1994 includes no other documents before this memorandum and 
     none between it and 1994, leaving the question of policy 
     origins and implementation as yet unanswered. The staff seeks 
     Committee guidance in actively pursuing these and other 
     questions.

Conclusions and Options

     In addition to the above materials pointing to pre-1962 policies 
on research involving humans, our investigations to date also indicate 
that it will be important to look for standards and policies for 
research on human subjects that existed between agencies as well as 
for those within a particular agency.  For instance, a potentially 
informative piece of the prehistory of the Common Rule is illustrated 
in the appended exchange of correspondence between J.E. Moore, M.D. 
and Dr. A.N. Richards, dated October-November 1942). During WWII the 
Committee on Medical Research (CMR) distributed $25 million to 
universities, hospitals, and other institutions to benefit soldiers 
coping with various diseases in the field. Its contracts and 
organizational framework were later inherited by the NIH. The CMR was 
asked to -press its policy on human experimentation in general" by 
Dr. Charles M. Carpenter of the University of Rochester School of 
Medicine. Following some discussion within the CMR, Dr. Richards 
formulated statements dated October 31, 1942. In the statements human 
subject research involving risks requires that only fully informed 
volunteers are to be used, and consent forms signed that waive rights 
to damages. CMR wishes to know in detail from its contractors what 
human experiments are planned, but attempts to place legal 
responsibility for any claim of damages upon the investigator and 
his or her institution.

     As background, we have also appended materials from the 
Congressional Research Service and Bioethicsline. Neither the CRS 
overview of policies for the protection of human research subjects nor 
the bibliographic search reflect the information that we have already 
been able to gather concerning policies in DoE and DoD, nor do they 
reach back in time as far as these examples.

     What has been gathered so far already calls into question certain 
of the usual assumptions about this topic For instance, the CRS report 
states that "[r]egulation and professional standards for the protection 
of human subjects in research and informed consent, for the most part, 
did not exist before the late 1940s." (p. I) Yet the 1942 Moor-Richards 
correspondence indicates that fairly specific policies were already 
being applied. On the other hand, the 1947 Wilson letter, and the 
1953 DoD memoranda, raise questions about the adequacy of 
implementation of these policies.

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