Attachment 2 Set of Correspondence from the Weeks Prior to the Classified February 26, 1953 Wilson Memo AGENDA Armed Forces Policy Council Meeting for Tuesday, 17 February 1953 Item Secy's No. No. Description 1 Review of minutes A.F.P.C. meeting 10 February 1953 2 1 Use of Human Volunteers in Experimental Research (See attached memoranda) 3 2 Possible Communist Indoctrination of U.S. Captured Personnel in Korea (See attached memoranda) Ralph O. Moore Secretary Armed Forces Policy Council cc: Deputy Secretary Kyes Secretary Stevens Secretary Anderson Secretary Talbott General Bradley General Collins Admiral Fechteler General Vandenberg Asst. Secretary McNeil - for information Asst. Secetary Nash - for information Asst. Secretary Hannah - for information TOP SECRET SECURITY INFORMATION OFFICE OF THE SECRETARY OF DEFENSE WASHINGTON, D.C. February 16, 1953 MEMORANDUM FOR THE MEMBERS OF THE ARMED FORCES POLICY COUNCIL SUBJECT: Use of Human Volunteers in Experimental Research The Chairman of the Armed Forces Medical Policy Council in the memorandum, Enclosure 1, has recommended that the Secretary of Defense approve the memorandum, Enclosure 2, concerning the use of human volunteers in experimental research. Mr. Wilson has requested that this proposal be placed on the agenda for discussion at the Armed Forces Policy Council meeting on Tuesday, 17 February 1952, and the attached papers are submitted to you for your use in this regard. Ralph O. Moore Secretary Armed Forces Policy Council Enclosures cc: Deputy Secretary Kyes Secretary Stevens Secretary Anderson Secretary Talbott General Bradley General Collins Adm. Fechteler Gen. Vandenberg Asst. Secretary McNeil Asst. Secretary Nash Asst. Secretary Hannah Office of the Secretary of Defense Armed Forces Medical Policy Council Washington, D.C. January 12, 1953 MEMORANDUM FOR THE SECRETARY OF DEFENSE SUBJECT: Digest "Use of Human Volunteers in Experimental Research." The Problem Approval of the recommendation that human volunteers be used in experimental research in order to reach a realistic evaluation of protective methods against biological, chemical and/or atomic agents of warfare. Factors Bearing on the Problem 1. Research which has been conducted in this field has been restricted in most part to experimental animals. 2. Results based entirely on animal experimentation cannot be interpreted as conclusive evidence of identical human reaction to similar situations. Such methods of extrapolation have in the past and will continue in the future to lead experimenters into serious errors. 3. In order for realistic evaluations to be made of the defensive measure which should be adopted to protect our Nation against a potential enemy attack with any one of the three types of agents, it is necessary to secure additional information which can be secured only through the use of human subjects. 4. The use of human volunteers shall be subject to the principles and conditions laid down as a result of the Nuremberg Trials, which will afford adequate protection to the individual participant, as well as the Government. One other restriction is added in that prisoners of war shall not be used under any circumstances. Recommendation It is strongly recommended that a policy be established for use of human volunteers (military and civilian employee) in experimental research at Armed Forces facilities. Concurrences This proposal has been concurred in by the following: Assistant Secretary (Manpower & Personnel) Assistant secretary (Legal and Legislative Affairs) Research and Development Board Joint Staff (JCS) Military Liaison Committee Secretary of Joint Secretaries Director of Administration, OSD Melvin A. Casberg, M.D. Chairman Armed Forces Medical Policy Council SECURITY INFORMATION THE SECRETARY OF DEFENSE WASHINGTON JAN. 5, 1953 MEMORANDUM FOR THE SECRETARY OF THE ARMY SECRETARY OF THE NAVY SECRETARY OF THE AIR FORCE SUBJECT: Use of Human Volunteers in Experimental research 1. Based upon a recommendation of the Armed Forces Medical Policy Council, that human subjects be employed, under reciprocal safeguards, as the only feasible means for realistic evaluation and/or development of effective preventive measures of defense against atomic, biological or chemical agents, the policy set forth below will govern the use of human volunteers by the department of Defense in experimental research in the fields of atomic, biological and/or chemical warfare. 2. By reason of the basic medical responsibility in connection with the development of defenses of all types against atomic, biological and/or chemical warfare agents, Armed Services personnel and/or civilians on duty at installations engaged in such research shall be permitted to actively participate in all phases of the program, such participation shall be subject to the following conditions: a. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter ____ requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment, the method and means by TOP SECRET SECURITY INFORMATION SECURITY INFORMATION 5 JAN. 1953 which it is to be conducted; all inconvenience and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The consent of the human subject shall be in writing, his signature shall be affixed to a written instrument setting forth substantially the aforementioned requirements and shall be signed in the presence of at least one witness who shall attest to such signature in writing. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with immunity. b. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. c. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment. d. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. e. No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur. f. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. g. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. h. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. i. During the course of the experiment, the human subject should be at liberty to bring the experiment to an end if he has reached the 2 SECURITY INFORMATION 5 January 1953 physical or mental state where continuation of the experiment seems to him to be impossible. j. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. k. The established policy, which prohibits the use of prisoners of war in human experimentation, is continued and they will not be used under any circumstances. 3. The Secretaries of the Army, Navy and Air Force are authorized to conduct experiments in connection with the development of defenses of all types against atomic, biological and/or chemical warfare agents involving the use of human subjects within the limits prescribed above. 4. In each instance in which an experiment is proposed pursuant to this memorandum, the nature and purpose of the proposed experiment and the name of the person who will be in charge of such experiment shall be submitted for approval to the Secretary of the military department in which the proposed experiment is to be conducted. No such experiment shall be undertaken until such Secretary has approved in writing both the experiment proposed and the person who will be in charge of conducting it. 5. The addressees will be responsible for insuring compliance with the provisions of this memorandum within their respective Services. Copies furnished Joint Chief of Staff Research and Development Board GRAPHIC CHART 11 OFFICE OF SECRETARY OF DEFENSE 15 october 1952 FOR REFERENCE SEE (3bb02)