J.C.S. 1865/39 3 March 1953 Pages 215 - 219, incl. NOTE BY THE SECRETARIES TO THE JOINT CHIEFS OF STAFF ON USE OF HUMAN VOLUNTEERS IN EXPERIMENTAL RESEARCH The enclosed memorandum by the Secretary of Defense, dated 26th February 1953, for the Service Secretaries, is circulated for information. W. G. LALOR, E. H. J. CARNS, Joint Secretariat SECRETARY OF DEFENSE Washington 26 Feb 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 recognized safeguards, as the only feasible means of 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 defense 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. (1) 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 element 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 Downgraded to UNCLASSIFIED 22 Aug 75 per S. Clements DDR&E OSD(PA). 1 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. (2) The concept 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. (a) In experiments were personnel from more than one Service are involved the Secretary of the Service which is exercising primary responsibility for conducting the experiment is designated to prepare such an instrument and coordinate it for use by all the Services having human volunteers involved in the experiment. (3) The duty and responsibility of ascertaining the quality of the consent rest 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 impunity. 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 number of volunteers used shall be kept at a minimum consistent with item b., above. d. 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. e. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. f. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur. g. 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. Downgraded to UNCLASSIFIED 22 Aug 75 2 h. Proper preparation should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. i. 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. j. 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 physical or mental state where continuation of the experiment seems to him to be impossible. k. 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 continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. 1. 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 proscribed above. 4. In each instance in which an experiment is proposed pursuant to this memorandum, the nature and purpose of the 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 the experiment proposed, the person who will be in charge of conducting it, as well as informing the Secretary of Defense. 5. The addresses will be responsible for insuring compliance with the provisions of this memorandum within their respective Services. /signed/ C.E. WILSON Copies furnished: Joint Chiefs of Staff Research and Development Board 3 TOP SECRET SECURITY INFORMATION DOWNGRADED TO UNCLASSIFIED J.C.S. 1865/39 3 March 1953 Pages 215 - 219, incl. NOTE BY THE SECRETARIES to the JOINT CHIEFS OF STAFF on USE OF HUMAN VOLUNTEERS IN EXPERIMENTAL RESEARCH The enclosed memorandum by the Secretary of Defense, dated 26 February 1953, for the Service Secretaries, is circulated for information. W. G. LALOR, E. H. J. CARNS, Joint Secretariat E N C L O S U R E SECRETARY OF DEFENSE 26 February 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 recognized safeguards, as the only feasible means for realistic evaluating 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, biologic and/or chemical warfare agents, Armed Services personnel and/or civilian 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. (1) 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 element of the subject matter Downgraded to UNCLASSIFIED -216- involved as to enable him to make an understanding and enlightened decision. This latter element 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 which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. (2) 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. (a) in experiments where personnel from more than one Service are involved the Secretary of the Service which is exercising primary responsibility for conducting the experiment is designated to prepare such an instrument and coordinate it for use by all the Services having human volunteers involved in the experiment. (3) 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 impunity. 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. -217- Enclosure 1. 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 the experiment proposed, the person who will be in charge of conducting it, as well as informing the Secretary of Defense. 5. The addressees will be responsible for insuring compliance with the provisions of this memorandum within their respective Services. /s/ CHARLES E. WILSON Copies furnished: Joint Chiefs of Staff Research and Development Board NOTE TO THE HOLDERS OF JCS 1865/39, 3 MARCH 1953 on USE OF HUMAN VOLUNTEERS IN EXPERIMENTAL RESEARCH 1. Pursuant to OSD/Classified Control Section Regarding Action #013-75, 26 September 1975, the Enclosure to JCS 1865/39 is downgraded from TOP SECRET to UNCLASSIFIED. 2. Accordingly, JCS 1865/39 is downgraded to UNCLASSIFIED. Joint Secretariat 1st N/H of JCS 1865/39 3 Mar 53 REPRODUCED AT THE NATIONAL ARCHIVES