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. (supplement) MEMORANDUM TO: Members of Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: September 1, 1994 RE: Supplement to Ethics Data-Collection Update 1. 1953 Army Implementation of Wilson Memo 2. 1975 Army Surgeon General Interpretation of AR 70-25 (1962) 3. 1953 Air Force Implementation of Wilson Memo _________________________________________________________________ This supplement provides further background on the development of Army and Air Force policies on the use of human subjects. It will be recalled that on February 26, 1953, Secretary of Defense Wilson signed off on a memorandum that established a policy on the use of human volunteers in atomic, biological and warfare chemical experiments for defensive purposes. 1. 1953 Army Implementation of Wilson Memo This document was distributed at the June 11, 1994 Advisory Committee meeting but was not entered into a briefing book. It has acquired increased importance as a result of further analysis of the evaluation of Army policy on the use of human subjects. The document is a memorandum dated June 30, 1953 from the Army Chief of Staff to the Army Surgeon General. It implements the Wilson Memo in the Department of Army. Like the Wilson memo itself, this document pertains to the "use of volunteers in research in defense against atomic, biological and chemical warfare." Therefore, this document does not necessarily establish such rules for volunteers in experiments on conventional warfare or on offensive measures. (By contrast, AR 70-25 (1962) states that this kind of research is "included" in the reach of the rules. See this briefing under Ethics Data Collection Update.) This document also reiterates the Wilson Memo's specific requirements of written and witnessed consent, as well as the prior written approval of the Secretary of the Army following comment and review of the Surgeon General. 2 TAB I (supplement) 2. 1975 Army Surgeon General Interpretation of AR 70-25 (1962) For text of AR (Army Regulation) 70-25 (1962), see this briefing book under Ethics Data-Collection Update. In support of its testimony during the 1975 Senate Hearings on "Human-Use Experimentation Programs of the Department of Defense and Central Intelligence Agency" (S.25515), the Programs of the Department of the Army presented the statement that is appended ("III.C. Army Projects from Outside the Medical Department," August 22, 1975). This statement appears to eliminate an exception to AR 70-25. The exception exempted "hazardous situations encountered as part of training or other normal duties..." from coverage by rules governing human experimentation. According to the Army's 1975 statement, the Office of the Surgeon General (OTSG) interpreted AR 70-25 broadly. The effect of the OTSG interpretation appeared to be to include the application of rules on the use of human volunteers to experiments involving "an operational examination of prototype machinery or equipment." (See development of Ethics Standards, Department of Defense -- Early 1960's" in this briefing book.) In other words, these kinds of experiments would not be considered to fall within the range of a soldier's "normal duties." The original text of AR 70-25 seems to be ambiguous on this point. 3. 1953 Air Force Implementation of Wilson Memo Dated March 10, 1953, this memorandum from the Deputy Assistance for Atomic Energy conveys the Wilson Memo to the Inspector General of the Air Force. Note the summary of standard operating procedure appended below the original memo. This memorandum, which establishes the Air Force response to the Wilson Memo, has just been received by Advisory Committee staff.