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Appendix D SECRETARY OF DE"NSE Washington MEMORANDUM FOR THE SECRETARY OF THE ARMY SECRETARY OF THE NAVY SECRETARY OF THE AIR FORCE SUBlECT: Use of Human Volunteers in Experimental Research 26 Feb 1953 Based upon a recommendation of the Anned Forces Medical Policy Council that human subjects be employed, under recognized 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 defense of all types against atomic, biological andJor 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: 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 88 1 Retyped for this report from illegible copy.

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Appendix D 89 sufficient knowledge and comprehension of the elements of the subject matter involved as to enable hun 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) 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. In experiments where personnel from more than one Service (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. 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 experunentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the perfonnance of the experiments. e. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. Downgraded to UNCLASSIFIED 22 August '75 per S. Clemenis

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9o The ALL Thyroid Function Study f. No experiment should be so 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. 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 experunent 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. I. 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 experunents 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 Downgraded lo UNCLASSIFIED 22 August '75 per 5. Clemerlis

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Appendix D 91 shall be undertaken until such Secretary has approved in writing the experiment proposed, the person who wile} 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. /signed/ C. E. Wilson Copies furnished: Joint Chiefs of Staff Research and Development Board Downgraded to UNCLASSIFIED 22 August '75 per S. Clements