Attachment H Series of correspondence regarding the AEC position on human experimentation, 1949-1953 7 December 1949 Dr. Joseph C. Aub Director, Cancer Commission of Harvard Massachusetts General Hospital Boston 14, Massachusetts Dear Doctor Aub: At the last meeting, you will recall your Panel approved the NEPA proposals for human experimentation. When I presented this to the Committee on Medical Sciences, they endorsed the action of the Panel, without however very much discussion. Subsequently, Dr. Penn particularly has been concerned about the propriety of an unqualified endorsement. He has written me at least one letter on this subject and yesterday told me on the telephone that in conversations with Dr. Shields Warren, he learned that Dr. Warren and his group are not in favor of these studies. This morning I called Dr. John L. Bowers. While it is true that we can only acknowledge Dr. Warren's opinion as his own personal opinion, it is nevertheless Dr. Bowers' feeling that the AEC Advisory Group in Biology and Medicine does not favor the general principle of human experimentation. Having in mind the possibility of bring this matter up again at the next meeting of your Panel, I asked Dr. Bowers whether he would be in a position to make an official statement. Since his group has taken no official action he cannot make any such statement. Therefore, I would suggest that you take advantage of the opportunity to talk with your friend, Shields Warren, in Boston some time before the Chicago meeting. I will bring Dr. Penn's letters with me and we can discuss together the advisability of bring up the matter again at the Panel meeting. Sincerely yours, JAMES E. McCORMACK, M.D. Executive Director Committee on Medical Sciences JEMcC;cc 74F11 25 July 1950 MEMORANDUM TO: ASTRID SUBJECT: Problem of Experimentation with Human Volunteers REFERENCE: Your memo, same subject, dtd 21 July 1950 1. As requested in your memorandum the following is an account of the action taken by the Committee on Medical Sciences relative to the subject of human experimentation in the field of radiation. 2. The Joint Panel on Medical Aspects of Atomic Warfare, at its first meeting on 3 June 1949 in principle the of human experimentation for the purpose of determining levels of human tolerance to radiation in the establishment of militarily acceptable dosages. The Panel posed the following resolution: " that it is desirable and necessary for the national defense to human experiments in the effect of total body radiation to the limit of what is psychologically and socially possible." This action was taken by the of the observation that a serious gap in the departmental research program existed in that no adequate provision was made for studies on human tolerance to radiation. In order to further this preliminary action a working group was appointed to study the problem and make recommendations as to how this type research could be prosecuted. 3. At the second meeting of the Panel, the working group which had membership with the NEPA Medical Advisory Committee presented a report of the NEPA Committee as its recommendations. The Panel reviewed the recommendations noting that a great deal of time and careful deliberation by the NEPA Committee had been spent in their preparation. The Panel endorsed the recommendations ( 9/1) and a protocol for research ( 10/1) and resolved that the matter of human experimentation, in order to find the effects of dosage up to 105 r, is so important that it should be given high priority. The Panel recognized, in making its recommendations, that certain sociological and political implications in human experimentation exist and must be satisfactorily resolved. It cited the following reference as a basis for proper ethics in this type of experimentation: "Ethics Governing the Service of Prisoners as Subjects in Medical Experiments", Page 45, 136, 1949. 1 4. This Panel action was referred to the Committee on Medical Sciences and at its 10th meeting on 8 November 1949, the Committee endorsed the action of the Joint Panel on Medical Aspects of Atomic Warfare at its 2nd meeting, 7 October 1949, in approving the recommendations of the NEPA Medical Advisory Committee with regard to human experimentation, both in principle and according to the suggested protocol for human studies ( 10/1) with the stipulation that other phases of research in the medical aspects of atomic warfare (such as thermal burns) should not receive any less emphasis because of the Committee action on this matter. 5. Following this Committee action, one of the Committee members who had held certain reservations in the endorsement of human experimentation in this particular research field through personal contact with the Director of the Medical and Biological Division of the AEC learned that the AEC Medical Group did not favor human experimentation. It is obvious but should be noted at this point that the AEC Medical Group can quite feasibly adopt this attitude since it has no military responsibilities in this field. However, in view of this development it was believed by the Committee members to be of sufficient importance to request re-study of the problem in the light of the implications of this policy of the AEC Medical Group. 6. At its 11th meeting, 1 February 1950, the Committee revealed its previous endorsement of the action of the Joint Panel on Medical Aspects of Atomic Warfare in approving the recommendations of the NEPA Medical Advisory Committee with regard to human experimentation, and voted to refer the matter back to the Joint Panel on Medical Aspects of Atomic Warfare for further consideration. 7. The Joint Panel on Medical Aspects of Atomic Warfare at its 4th meeting reconsidered its former action of endorsement of the recommendations in the light of specific reservations and objections held by some Committee members, and by the Director of the Division of Biology and Medicine, AEC. After analysis of the objections cited against human experimentation in this field, and discussion of the urgency of military requirements for information obtainable only by observations upon human volunteers, the Panel reaffirmed its position concerning the endorsement of the recommendations of the NEPA Medical Advisory Committee ( 9/1, 10/1) and formulated a statement of Panel opinion on the subject to be transmitted to the Committee ( 10/2). 8. The Committee on Medical Sciences, at its 12th meeting, on 23 May 1950, reviewed the Joint Panel's reaffirmation of its original action and Panel's statement of opinion ( 10/2). After deliberation, the Committee passed the following motion: 2 "The Committee on Medical Sciences endorses the view that it is essential to obtain all necessary scientific information concerning radiation doses and the effect on man by all means of biological experimentation, as promptly as possible, including if necessary human experiments under established principles of such experiments." 9. This matter has never been presented to the Board for action. Meanwhile, the following developments have taken place: The Director of Medical Affairs in the Office of the Secretary of Defense, Dr. Meiling, discussed the matter with the three Surgeons General (the secretary of the NEPA Group had earlier discussed this matter with Dr. Meiling. This independent initiative made it possible for us to avoid bringing this matter to the for statement of official position. Such action did not seem appropriate since the Committee itself had been somewhat wavering in its attitude. Besides one of the members of the Committee, the Surgeon General, USAF, was a member of the group that discussed this with Dr. Meiling. The undersigned was present at that meeting and can report unofficially that the action taken was to refer the matter to the AEC on the present data, I have no knowledge of the reply from the AEC but it is reasonable to expect that the reply will be a negative one. What subsequent developments may be can only be conjectured. 10. The most significant difference between this matter and the matter referred to in your memorandum is that nowhere was there any suggestion that the hazard be appraised on the basis of an offensive weapon. The problem is entirely one of protection of our own personnel, specifically crew of nuclear powered aircraft. The symbol NEPA, as you know, is an abbreviation for "Nuclear Energy for the Propulsion of Aircraft." Similar considerations would apply to the use of nuclear power plants in submarines. Signed: James E. McCormack, MD. JAMES E. McCORMACK, M.D. Executive Director Committee on Medical Sciences JEMcC;cc:74311 3 MEMORANDUM FOR THE CHAIRMAN, ARMED FORCES MEDICAL POLICY COUNCIL Subject: Policy and Procedures in Connection With the Use of Human Beings as Subjects in Experimentation 1. In accordance with your memorandum of 8 April 1952, above subject, I am forwarding to you the attached memorandum for your information and retention. WALTER G. WHITTMAN Chairman Attachment TS Log No. 50555, Copy 2 Hand carried by A. Decatur 4-16-52 HICole/AKSmith 78105 4/11/52 MEMORANDUM FOR THE SECRETARY OF THE ARMY THE SECRETARY OF THE NAVY THE SECRETARY OF THE AIR FORCE CHAIRMAN, RESEARCH AND DEVELOPMENT BOARD SUBJECT: Policy and Procedures in Connection With the Use of Human Beings as Subjects in Experimentation 1. It is requested that any statements of policy which may have been issued for the guidance of the Services and directives bearing upon related procedure in connection with the use of human beings as subjects of experimentation be furnished to the Armed Forces Medical Policy Council for information and study. Melvin A. Casberg, M.D. Chairman Armed Forces Medical Policy Council 700.2 15 May 1952 SUBJECT: Human Volunteers TO: The Chairman Research and Development Board Department of Defense Washington 25, D.C. The following resolution was passed by the Armed Forces Epidemiological Board at its spring meeting on 8 and 9 May 1952: "The Armed Forces Epidemiological Board regrets the unfortunate occurrence of a death in the hepatitis studies being conducted at McNeil Island, Washington. These studies in human volunteers are of the utmost importance to the Armed Forces, both in the United States and abroad. Further, this study is valuable for the protection of all patients who need blood or its products. However, the Board is fully appreciative of the gravity of such occurrences and recommends utmost vigilance in assessing the merits of such studies in relation to potential hazards. It is sincerely hoped that this highly regrettable death will not cause any disruption of the plans for continuation of these most significant studies." FOR THE ARMED FORCES EPIDEMIOLOGICAL BOARD: ADAM J. RAPALSKI Colonel, M. C. Administrator 12 November 1952 MEMORANDUM FOR THE VICE CHAIRMAN, RDB (DR. FLOYD L. MILLER) SUBJECT: Human Experimentation 1. At its seventeenth meeting 30-31 October, the Committee on Medical Sciences briefly discussed the problem of human experimentation. The committee agreed that before it could issue or endorse any policy statement on this subject, it would want to have the matter studied by a special ad hoc working group which would report to the committee. The committee is cognizant of the fact that human experimentation has been carried on for many years by capable investigators. To issue a policy statement on human experimentation at this time would probably do the cause more harm than good; for such a statement would have to be "watered-down" to suit the capabilities of the average investigator. Thus, it would be restrictive to the exceptional research worker. 2. Human experimentation within the field of medical sciences has, in years past, and is at present governed by an unwritten code of ethics. This code of ethics which is administered informally by fellow workers in the field is considered to be satisfactory. 3. To commit to writing a policy on human experimentation would focus unnecessary attention on the legal aspects of the subject. The legal aspects have in months past, and are currently receiving intensive study by the United States Public Health Service, which will shortly open a new Clinical Center devoted to human experimentation. One of the main issues involved in the discussion of the legal aspects is whether the human volunteer is truly a volunteer, or whether he is motivated to "volunteer" by the perquisites that he assumes, rightly or wrongly, will accrue to him as a result of volunteering. F. LLOYD MUSSELLS, M.D. Executive Director Committee on Medical Sciences COMMITTEE ON CHEMICAL WARFARE CW 107/17 13 November 1952 MEMORANDUM FOR CHAIRMAN, RESEARCH AND DEVELOPMENT BOARD SUBJECT: Use of Human Volunteers in CW Experimentation REFERENCE: Ltr from Chairman, Armed Forces Medical Policy Council to Chairman, HDP, subject, Use of Human Volunteers in Experimental Research, with inclosure, 29 October 1952 1. The subject of the reference was discussed during an October meeting of this Committee's Panel on Toxicology and Medicine and recommendations were included in a draft of the Committee's Program Guidance report. 2. The reference was considered by the Committee at its meeting on 10 November and the following statement was adopted for inclusion in the Program Guidance report: "Need for Human Volunteer Test Subjects - Dependence upon extrapolation from animal experimentation in arriving at judgments regarding the effects of CW agents on human beings has greatly retarded progress in this field, and raises continuing doubts as to the validity of these judgments. The most important need of the program is a suitable arrangement for the employment of human volunteers under proper safeguards. It is recommended that the need for arrangements to use human test subjects in the CW program in and medicine be brought to the attention of the Armed Forces Medical Policy Council. It is further recommended that provision be made for a system of rewards for such volunteers, similar to that employed by the British, and for recognition of government liability in case of accident, including insurance coverage." H. E. WORTHLEY Executive Director 12 March 1953 MS 207/2 MEMORANDUM FOR THE CHAIRMAN, RESEARCH AND DEVELOPMENT BOARD SUBJECT: Human Experimentation Reference: (A) Letter to Chairman, Committee on Medical Sciences, from Chairman, Division of Medical Sciences, National Research Council, dated 10 Feb. 1953 (B) Letter to Chairman, Division of Medical Sciences, National Research Council from Chairman, Committee on Medical Sciences, , dated 10 Feb. 1953 1. The following motion was passed at the Eighteenth Meeting of the Committee on Medical Sciences, , held on 26-27 February 1 53. The Committee on Medical Sciences concurs in the recommendations of the Subcommittee on the Sterilization of Blood and Plasma of the National Research Council and the Armed Forces Epidemiological Board that further experimentation, using human volunteer subjects, is essential to the studies of the transmission of hepatitis, and to the sterilization of blood and blood products. The great importance of these latter products in both military and civilian medicine, and the total lack of any animals susceptible to the disease, justify the use of the essential minimum number of volunteer human subjects, despite a small risk of death and a somewhat greater risk of disability. This concurrence is permissive in nature and is not to be interpreted as a directive to any agency or individual. (SIGNED) T. COCCESHALL, M.D. Chairman Committee on Medical Sciences LCM/74311/6 Mar. 1953 MEMORANDUM FOR ASSISTANT SECRETARY OF DEFENSE (MEDICAL AND HEALTH) ATTN: COL. SHELDON S. BROWNTON, USAF, M.C. SUBJECT: Human Experimentation REFERENCE: (a) MRC, Div. of Medical Sciences, ltr to Dr. Coggeshell, Chrmn, RDB Cmte. on Med. Sci., dtd 10 Feb 53. 1. The referenced letter advised the Research and Development Board Committee on Medical Sciences of a resolution adopted by the Armed Forces Epidemiological Board at its meeting on 30 January 1953, concerning the use of human volunteers in the study of hepatitis and of the concurrence of the Subcommittee on the Sterilization of Blood and Plasma of the National Research Council. This matter was brought before the Committee on Medical Sciences at a recent meeting by its Chairman, Dr. L. T. Coggeshell. The following motion was passed by the Committee: The Committee on Medical Sciences concurs in the recommendations of the Subcommittee on the Sterilization of Blood and Plasma of the National Research Council and the Armed Forces Epidemiological Board that further experimentation, using human volunteer subjects, is essential to the studies of the transmission of hepatitis, and to the sterilization of blood and blood products. The great importance of these latter products in both military and civilian medicine, and the total lack of any animals susceptible to the disease, justify the use of the essential minimum number of volunteer human subjects, despite a small risk of death and a somewhat greater risk of disability. This concurrence is permissive in nature and is not to be interpreted as a directive to any agency or individual. 2. This action by our Committee on Medical Sciences is being forwarded for your information. R. W. CAIRNS Vice Chairman cc: Dr. M. C. Winternitz, MRC