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ACHRE Report Part I Chapter 1 The National Institutes of Health and The Veterans Administration |
Chapter 1: Footnotes1 . The "Common Rule" applies requirements for voluntary consent, prior review, and risk analysis to all federally sponsored research. This rule is discussed in chapter 14.2 . David Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: Basic Books, 1991), and Ruth Faden and Tom Beauchamp, A History and Theory of Informed Consent (New York: Oxford University Press, 1986). 3 . George J. Annas and Michael A. Grodin, eds., The Nazi Doctors and the Nuremberg Code; Human Rights in Human Experimentation (New York: Oxford University Press, 1992), 343-345. 4 . See Faden and Beauchamp, A History and Theory of Informed Consent, and Mark S. Frankel, "Public Policymaking for Biomedical Research: The Case of Human Experimentation" (Ph.D. diss., George Washington University, 9 May 1976). 5 . Stafford L. Warren, Chairman, Interim Medical Advisory Board ("Report of the 23-24 January 1947 Meeting of the Interim Medical Committee of the United States Atomic Energy Commission") (ACHRE No. UCLA-111094-A-26). The report summarized "specific projects" at twelve institutions. The projects at the University of Rochester included "Study of the Metabolism of Plutonium, polonium, radium, etc. in human subjects" (p. 8). In the case of Berkeley, the projects identified to Dr. Stone were (1) Studies in whole-body radiation of human subjects by external and internal radiation. (2) Studies on the metabolism of radioactive iodine in animals and man. (3) Joint studies with Dr. Joseph G. Hamilton to evaluate the therapeutic applications of the fission products and the fissionable elements. (4) Exploration and therapeutic application of other radioactive elements and compounds (p. 11). A 14 March 1947 memorandum from Austin Brues, director of the Biology Division of the Argonne National Laboratory, records that "clinical testing programs" had only been authorized, at least for the time being, at Berkeley and Rochester. However, Brues urged that Argonne also be included. On behalf of this request he cited the University of Chicago's "work using human subjects" with specific reference to a report on plutonium injections. He further noted that human subject work also included the Argonne project list provided at the January meeting. A. M. Brues, Director, Biology Division, to N. Hilberry, Associate Laboratory Director, 14 March 1947 ("Clinical Testing") (ACHRE No. DOE-050195-B). 6 . Stafford Warren, Chairman, Interim Medical Advisory Committee, to Carroll Wilson, General Manager, AEC, 30 January 1947 ("The opinion on Clinical Testing . . .") (ACHRE No. DOE-051094-A-439), 1. 7 . John L. Burling, Deputy General Counsel's Office, AEC, to Edwin Huddleson, Jr., Deputy General Counsel, AEC, 7 March 1947 ("Clinical Testing") (ACHRE No. DOE-051094-A-468), 2-3. 8 . Ibid., 3. 9 . Carroll L. Wilson, General Manager of the AEC, to Stafford Warren, the University of California at Los Angeles, 30 April 1947 ("This is to inform you that the Commission is going ahead with its plans . . .") (ACHRE No. DOE-051094-A-439), 2. 10 . Ibid. 11 . Ibid. 12 . Robert J. Buettner, Assistant to Chairman, Interim Medical Advisory Committee, AEC, to B. M. Brundage, Chief, Medical Division, AEC, 12 May 1947 ("Transmitted herewith for your information . . .") (ACHRE No. DOE-051094-A-439), 1. 13 . Note in medical chart of Cal-3, dated 18 July 1947 ("Elmer Allen chart") (ACHRE No. DOE-051094-A-615). For more information on this case, see chapter 5. 14 . Wilson to Warren, 30 April 1947. 15 . University of California at San Francisco, February 1995 ("Report of the UCSF Ad Hoc Fact Finding Committee ") (ACHRE No. UCSF-022495-A-6), 27. 16 . J. C. Franklin, Manager, Oak Ridge Operations, to Carroll Wilson, General Manager, AEC, 26 September 1947 ("Medical Policy") (ACHRE No. DOE-113094-B-3), 2. Although the motivation for Oak Ridge's inquiry is not entirely clear, it seems to have come in part from concerns of Albert Holland, M.D., who became the acting medical adviser at Oak Ridge after Major Brundage retired. Holland served on the committee that oversaw the use of radioisotopes in human research, discussed in chapter 6. In November 1947 Holland wrote, in regard to the isotopes distribution program: "How far does the AEC's moral responsibility extend in this program?" Albert Holland, Jr., Medical Adviser, Oak Ridge, to J. C. Franklin, Manager of Oak Ridge Operations, 7 November 1947 ("Medical and Operational Decisions") (ACHRE No. DOE-113095-B-10), 2. 17 . Unknown author to the Advisory Committee for Biology and Medicine, 8 October 1947 ("It is the desire of the Medical Advisor's Office . . .") (ACHRE No. DOE-051094-A-502). 18 . Atomic Energy Commission, Advisory Committee for Biology and Medicine, minutes of 11 October 1947 (ACHRE No. DOE-072694-A-1), 10. 19 . Ibid. 20 . Ibid. 21 . Carroll Wilson, General Manager, AEC, to Robert Stone, University of California, 5 November 1947 ("Your letter of September 18 regarding the declassification of biological and medical papers was read at the October 11 meeting of the Advisory Committee for Biology and Medicine.") (ACHRE No. DOE-052295-A-1). 22 . Carroll Wilson, General Manager, AEC, to Alan Gregg, Chairman of the AEC Advisory Committee for Biology and Medicine, 5 November 1947 ("I want to thank you for your letter of October 14 concerning the questions raised by Dr. Stone in his letter to me of September 18 regarding declassification of biological and medical papers containing information on the experimental use of radioisotopes in human beings conducted under AEC sponsorship.") (ACHRE No. DOE-052295-A-1). 23 . Salgo v. Leland Stanford Jr. University Board of Trustees, 317 P.2d 170 (1957). 24 . Joseph Volpe, interview by Gregg Herken, Dan Guttman, and Debra Holland (ACHRE), transcript of audio recording, 6 October 1994 (ACHRE Research Project Series, Interview Program Files, Targeted Interview Project), 24-42. In a May 1995 interview, Volpe agreed that a letter written by the general manager constituted a "policy." The transcript of the interview records:
Interviewer: . . . today there are regular procedures for getting something recognized as a policy, including publication and so forth. In 1947, when the general manager writes a letter, is that a policy? Mr. Volpe noted that while the question of the precise authority of the general manager was not without controversy, Chairman Lilienthal "believed in delegation of authority and so always took measures to strengthen the general manager's hand on these things." Joseph Volpe, interview by Barbara Berney, Steve Klaidman, Dan Guttman, Lanny Keller, Jonathan Moreno, Patrick Fitzgerald, and Gilbert Whittemore (ACHRE), transcript of audio recording, 18 May 1995 (ACHRE Research Project Series, Interview Program Files, Targeted Interview Project), 37-38. 25 . Leslie M. Redman, Los Alamos Laboratory, to Dr. Alberto F. Thompson, Chief, Technical Information Service, DBM, 22 January 1951 ("I find myself concerned in the course of duty with the review of papers relating to human experimentation.") (ACHRE No. DOE-051094-A-609). 26 . Warren did not cite the context for Wilson's discussion of these conditions, that is, the need for criteria for declassification. 27 . Shields Warren, Director, DBM, to Leslie Redman, "D" Division, Los Alamos National Laboratory, 5 March 1951 (". . . to reply to your letter of January 22, 1951, concerning policies on human experimentation.") (ACHRE No. DOE-051094-A-603). 28 . Everett Idris Evans, M.D., Medical College of Virginia, to John Z. Bowers, M.D., Assistant to the Director, DBM, AEC, 8 April 1948 ("We have recently obtained approval from the Isotopes Division for human use of P32. . .") (ACHRE No. DOE-051094-A-64). 29 . John Z. Bowers, Assistant to Director, DBM, AEC, to Everett Idris Evans, M.D., Medical College of Virginia, 27 April 1948 ("Thank you for recent letter requesting information regarding isotopes.") (ACHRE No. DOE-050194-A-480). 30 . Nathan H. Woodruff, Chief Technical Division, Isotopes Division, to Everett I. Evans, M.D., Medical College of Virginia, 14 May 1948 ("Your letter of April 8 to Dr. Bowers has been referred to me for answer.") (ACHRE No. NARA-082294-A-10). 31 . U.S. Atomic Energy Commission, Advisory Committee for Biology and Medicine, agenda of 14 February 1948 (ACHRE No. DOE-072694-A), 2. 32 . In addition to the document discussed above, there is some indication that the AEC Isotopes Division was charged with ensuring that consent was obtained. In the early 1970s, when the AEC conducted an investigation into the plutonium experiments, Shields Warren told the investigators that his recollection was that ethical issues were addressed at the time by the issuance of prospective policies. Warren stated:
I think the way it [concern about the plutonium injections] was handled was that Alan Gregg and I agreed the best way to do [it] was to see that the rules were properly drawn up by the . . . Human Applications Isotope Committee, which had then come into being, so that use without full safeguards could not occur, and that we saw no point in bringing this up after the fact as long as we were sure that nothing of this sort could happen in the future. Shields Warren, interview by L. A. Miazga, Sidney Marks, Walter Weyzen (AEC), transcript of audio recording, 9 April 1974, 10-11 (ACHRE No. DOE-121294-D-14). 33 . Unknown author, unpublished draft, 29 March 1948 ("The Experimental Use of Radioactive Materials in Human Subjects at AEC Establishments") (ACHRE No. DOE-050194-A-267). 34 . Subcommittee on Human Applications, minutes of 22-23 March 1948, as discussed in the minutes of the 13 March 1949 meeting. S. Allan Lough, Chief, Radioisotopes Branch, to H. L. Friedell, G. Failla, J. G. Hamilton, and A. H. Holland, 19 July 1949 ("Revised Tentative Minutes of March 13, 1949 Meeting of the Subcommittee on Human Applications of Committee of U.S. Atomic Energy Commission, AEC Building, Washington, DC") (ACHRE No. DOE-101194-A-13), 5. 35 . The subcommittee was not definitive about when larger doses were permitted, however. The policy was to apply in "instances in which the disease from which a patient is suffering permits the administration of larger doses for investigative purposes." U.S. Atomic Energy Commission, Isotopes Division, September 1949 ("Supplement No. 1 to Catalogue and Price List No. 3, July 1949") (ACHRE No. DOD-122794-A-1), 3-4. 36 . While these statements were perhaps more than was told to patient-subjects in other institutions, they did not necessarily provide details about the research. In the application for admission, the applicant agreed to "such operations and biopsies as are deemed necessary and advisable by the hospital." Oak Ridge Institute of Nuclear Studies, 1950 ("Application for Admission to the Medical Division Hospital") (ACHRE No. DOE-121494-C-1), 1. 37 . Oak Ridge Institute for Nuclear Studies, 1950 ("Waiver and Release") (ACHRE No. DOE-121494-C-3). 38 . Program Committee of the Division of Biological and Medical Research of the Argonne National Laboratory, minutes of 22 January 1951 (ACHRE No. DOE-051095-B), 3. 39 . Thomas Shipman, M.D., Health Division Leader, Los Alamos Laboratory, AEC, to Dr. Charles Dunham, Director, DBM, AEC, 18 June 1956 ("Two questions have recently arisen--one of them specific, the other general--wherein we need an opinion from you.") (ACHRE No. DOE-091994-B-1). 40 . Charles Dunham, Director, DBM, AEC, to Thomas Shipman, Health Division Leader, Los Alamos Laboratory, 5 July 1956 ("This is in response to your letter of June 18.") (ACHRE No. DOE-091994-B-2). In addition to consent, Dunham indicated that the research should proceed so long as (a) the doses were small, "true tracer doses"; (b) the proposal was approved by a senior medical officer; and (c) the work was supervised by a licensed physician. 41 . T. L. Shipman, Health Division Leader, Los Alamos Laboratory, to Staff Distribution, 12 July 1956 ("Administration of Tracer Doses to Humans") (ACHRE No. DOE-091994-B-3), 1. Also, T. L. Shipman, Health Division Leader, Los Alamos Laboratory, to "Distribution," 3 September 1963 ("Administration of Tracer Doses to Humans For Experimental Purposes") (ACHRE No. DOE-091994-B-4), 1. 42 . Isotopes Extension, Division of Civilian Application, U.S. AEC, "The Medical Uses of Radioisotopes, Recommendations and Requirements of the Atomic Energy Commission" (Oak Ridge, Tenn.: AEC, February 1956), 15. 43 . U.S. Department of the Army, AR 40-210, The Prevention of Communicable Diseases of Man--General (21 April 1925). 44 . Charles W. Shilling, Medical Corps, USN, Retired, undated paper ("History of the Research Division, Bureau of Medicine and Surgery, USN") (ACHRE No. DOD-080295-A), 74. 45 . The Secretary of the Navy to All Ships and Stations, 7 April 1943 ("Unauthorized Medical Experimentation on Service Personnel") (ACHRE No. DOD-091494-A-2). 46 . J. E. Moore, M.D., to Dr. A. N. Richards, excerpt of letter dated 6 October 1942 ("I have recently received an inquiry from Dr. Charles M. Carpenter of the University of Rochester School of Medicine who believes that he may be able to work out a human experiment on the chemical prophylaxis of gonorrhea.") (ACHRE No. NARA-060794-A-1). 47 . A. N. Richards to J. E. Moore, 31 October 1942 (" Revision of Dr. Richards' letter of October 9, 1942") (ACHRE No. NARA-060794-A-1). Stafford Warren, the Manhattan Project medical director, also came from the University of Rochester. It is not clear how, if at all, the CMR's views on human experiments were accounted for in Manhattan Project research. 48 . Rothman, Strangers at the Bedside, 30-50. 49 . The Chief of the Bureau of Medicine and Surgery to the Officer-in-Charge, Naval Laboratory Research Unit No. 1, University of California, Berkeley, California, 6 March 1943 ("Proposed Clinical Evaluation of Influenza Antiserum, and Messages concerning Influenza Virus Specimens") (ACHRE No. DOD-062194-C-1). 50 . Ibid., 2. 51 . Institute of Medicine, National Academy of Sciences, Veterans at Risk: The Health Effects of Mustard Gas and Lewisite (Washington, D.C.: National Academy Press, 1993), 66-69. 52 . Ibid., 214. 53 . Robert S. Stone, unpublished paper, "Irradiation of Human Subjects as a Medical Experiment," 31 January 1950 (ACHRE No. NARA-070794-A). 54 . American Medical Association, Judicial Council, "Supplementary Report of the Judicial Council," Journal of the American Medical Association 132 (1946): 1090. 55 . The Under Secretary of the Navy to the Secretary of Defense, 24 April 1950 ("Recommendation that the Armed Service conduct experiments on human subjects to determine effects of radiation exposure") (ACHRE No. NARA-070794-A). 56 . Atomic Energy Commission, Advisory Committee for Biology and Medicine, transcript (partial) of meeting, 10 November 1950 (ACHRE No. DOE-012795-C-1), 28. 57 . Ibid., 28-29. 58 . J. G. Hamilton, University of California, to Shields Warren, DBM, AEC, 28 November 1950 ("Unfortunately, it will not be possible for me to be at the meeting on December 8 . . .") (ACHRE No. DOE-072694-B-45), 1. 59 . Ibid. 60 . Adam J. Rapalski, Administrator, the Armed Forces Epidemiological Board, DOD, to Chief, Legal Office, 5 January 1952 ("Draft of 'Agreement with Volunteer'") (ACHRE No. DOD-040895-A). 61 . Lieutenant Colonel Robert J. O'Connor, Chief, Legal Officer, JAGD, to Colonel Frank L. Baier, Army Medical Research and Development, 23 October 1947 ("Protection of Research Project Volunteers") (ACHRE No. NARA-012395-A-4). 62 . John R. Paul, Director, AEB, DOD, to Dr. Joseph Stokes, Jr., Children's Hospital, Philadelphia, Pennsylvania, 18 February 1948 ("This is in reply to your hand written request for a comment [from] me re your letter to Dr. Macleod dated 11 February on the subject of funds for the reimbursement of volunteer prisoners . . .") (ACHRE No. NARA-012395-A-1). 63 . Ibid. 64 . Committee Appointed by Governor Dwight H. Green of Illinois, "Ethics Governing the Service of Prisoners As Subjects In Medical Experiments," Journal of the American Medical Association 136, no. 7 (1948): 457-458. 65 . C. J. Watson, M.D., Commission on Liver Disease, Army Epidemiological Board, to Colin MacLeod, President of the Board, AEB, 5 April 1948 ("I have given considerations in the past few weeks to the matter of using volunteers in penal institutions for experimentation . . .") (ACHRE No. NARA-012395-A-2). 66 . Ibid. 67 . "Prisoner Dies After Injection in Disease Study," Washington Post, 6 May 1952, 3. 68 . L. M. Harff, Contract Insurance Branch, to File, 25 April 1952 ("Research and Development Contracts--Medical Investigations) (ACHRE No. DOD-012295-A). 69 . Adam J. Rapalski, Administrator, AEB, to Chief Legal Office, 14 October 1952 ("Applicability of Section 5, Public Law 557-82d Congress") (ACHRE No. NARA-012395-A). 70 . Adam J. Rapalski, Administrator, AEB, to Members of the AEB, undated memorandum ("Applicability of Section 5, Public Law 557-82nd Congress") (ACHRE No. NARA-012395-A). In congressional hearings, the activities used to illustrate the purpose of the indemnification provision included test piloting, damage that might be caused by cloud modification research, and cataracts caused by the operation of a cyclotron. In addition, however, biomedical human experimentation was specifically addressed in the following exchange between Representative Edward Hebert and Colonel W. S. Triplet, from the Army Research and Development Division:
Mr. Hebert. Colonel, would you expand on the proposal to make the Government liable for losses and damages? . . . Subcommittee Hearings on H. R. 1180 to Facilitate the Performance of Research and Development Work by and on Behalf of the Departments of the Army, the Navy, and the Air Force, and for Other Purposes; House of Representatives, Committee on Armed Services, Subcommittee no. 3, 6 June 1952, 621 (ACHRE No. NARA-10495-D). 71 . Colonel George V. Underwood, Director, Executive Office, Office of the Secretary of Defense, to Mr. Kyes, Deputy Secretary of Defense, 5 February 1953 ("Use of Human Volunteers in Experimental Research") (ACHRE No. DOD-062194-A). 72 . Melvin Casberg, Chairman, AFMPC, to the Secretary of Defense, 24 December 1952 ("Human Volunteers in Experimental Research") (ACHRE No. NARA-101294-A-3). 73 . Ibid. 74 . Jackson recommended changes to the Nuremberg Code: the elimination of the Nuremberg Code exception for self-experimentation by physicians and the express provision that prisoners, but not prisoners of war, could be used. We do not know what Jackson had "previously submitted." See Stephen Jackson, Assistant General Counsel in the Office of the Secretary of Defense and Counsel for the AFMPC, to Melvin Casberg, undated memorandum ("The standards and requirements to be followed in human experimentation") (ACHRE No. NARA-101294-A-3). 75 . Ms. Rosenberg, a high-ranking official in the DOD, was an expert in labor relations and a New Dealer. Her role was recorded in Stephen Jackson to Melvin Casberg, Chairman, AFMPC, 22 October 1952 ("I discussed the attached with Mrs. Rosenberg . . .") (ACHRE No. NARA-101294-A-3). 76 . Colonel Adam J. Rapalski, Administrator, Armed Forces Epidemiological Board, DOD, to Colin MacCleod, President, Armed Forces Epidemiological Board, DOD, 2 March 1953 ("The attached copy of letter I believe is self-explanatory.") (ACHRE No. NARA-012395-A-5). 77 . F. Lloyd Mussells, Executive Director, Committee on Medical Sciences, RDB, DOD, to Floyd L. Miller, Vice Chairman, Research and Development Board, DOD, 12 November 1952 ("Human Experimentation") (ACHRE No. NARA-071194-A-2). 78 . Ibid. 79 . In a 10 November 1952 meeting the Committee on Chemical Warfare was read a draft of the AFMPC policy. One member remarked to general laughter: "If they can get any volunteers after that I'm all in favor of it." Committee on Chemical Warfare, RDB, DOD, transcript of the meeting of 10 November 1952 (ACHRE No. NARA-102594-A), 128. H. N. Worthley, Executive Director, Committee on Chemical Warfare, RDB, DOD, to the Director of Administration, Office of the Secretary of Defense, 9 December 1952 ("Use of Volunteers in Experimental Research") (ACHRE No. NARA-101294-A), 1. 80 . This, at least, was the 1994 recollection of Lovett's military assistant, General Carey Randall, who served in the same role for Lovett's predecessor and successor. General Carey Randall, interview by Lanny Keller (ACHRE), transcript of audio recording, 20 September 1994 (ACHRE Research Project Series, Interview Program File, Targeted Interview Project), 17. 81 . George V. Underwood, Director of the Executive Office of the Secretary of Defense, to Deputy Secretary of Defense Foster, 4 January 1953 ("I believe that Mr. Lovett has a considerable awareness of this proposed policy.") (ACHRE No. NARA-101294-A-1), 1. 82 . Melvin A. Casberg, Chairman, Armed Forces Medical Policy Council, DOD, to the Secretary of Defense, 13 January 1953 ("Digest 'Use of Human Volunteers in Experimental Research'") (ACHRE No. DOD-042595-A), 1. 83 . Secretary of Defense to the Secretary of the Army, Secretary of the Navy, Secretary of the Air Force, 26 February 1953 ("Use of Human Volunteers in Experimental Research") (ACHRE No. DOD-082394-A). The second paragraph of the memorandum stipulates its application to "Armed Services personnel and/or civilians on duty at installations engaged in such research. . . ." The Advisory Committee takes this stipulation to be in recognition of the separate authority of the medical services, as distinct from research and development commands. 84 . W. G. Lalor, Secretary, Joint Chiefs of Staff, to Chief of Staff, U.S. Army, Chief of Naval Operations, Chief of Staff, U.S. Air Force, 3 September 1952 ("Security Measures on Chemical Warfare and Biological Warfare") (ACHRE No. NARA-012495-A-1). 85 . Irving L. Branch, Colonel, USAF, Acting Chief of Staff, to the Assistant Secretary of Defense (Health and Medicine), 3 March 1954 ("Status of Human Volunteers in Bio-medical Experimentation") (ACHRE No. DOD-090994-C), 2. 86 . Ibid., 3. 87 . Ibid. 88 . Brigadier General John C. Oakes, GS, Secretary of the General Staff, Department of the Army, to the Chief Chemical Officer and the Surgeon General, 30 June 1953 ("CS:385--Use of Volunteers in Research") (ACHRE No. DOD-022295-B-1) (CS385). This document was originally classified as Top Secret then downgraded to Confidential and declassified in June 1954. "Research Report Concerning the Use of Volunteers in Chemical Agent Research." Inspector General and Auditor General, 1975 (Army IG report), 77. 89 . Oakes, sec. 3(a). 90 . A series of memorandums from the Office of the Judge Advocate General preceded and shed light on the 30 June 1953 memorandum: Colonel Robert H. McCaw, JAGC, Chief, Military Affairs Division, to the Chief, Research and Development, Office of the Chief of Staff, 6 April 1953 ("Volunteers for Biological Warfare Research") (ACHRE No. DOD-082294-B). Colonel Robert H. McCaw, JAGC, Chief, Military Affairs Division, to the Chief, Research and Development, Office of the Chief of Staff, 10 April 1953 ("Volunteers for Biological Warfare Research") (ACHRE No. DOD-082294-B). Colonel A. W. Betts, GS, Executive for the Chief of Research and Development, to Mr. J. N. Davis, Office of the Under Secretary of the Army, 15 April 1953 ("Use of Volunteers in Experimental Research") (ACHRE No. DOD-082294-B). 91 . CS:385, sec. 3(d). 92 . Army Office of the Surgeon General, 12 March 1954 ("Use of Volunteers in Medical Research, Principles, Policies, and Rules of the Office of the Surgeon General") (ACHRE No. DOD-120694-A-4). 93 . Ibid., 1. A copy of this document was found in the files of John Enders, Ph.D., Nobel Laureate in Medicine and Physiology, 1954, Yale University. 94 . Ibid. 95 . John Fox, M.D., Professor of Epidemiology, Tulane University School of Medicine, to Captain R. W. Babione, Executive Secretary, AFEB, 27 June 1956 ("Finally I am able to complete and send to you the application for a research contract to study . . . ") (ACHRE No. NARA-012395-A). 96 . Ibid. 97 . W. McD. Hammon, M.D., Director, Commission on Viral Infections, AFEB, to John Enders, Children's Medical Center, 20 November 1958 ("This is to confirm our telephone call this morning, November 20th, regarding approval of the AFEB for the protocol of the experiment which you propose to carry out . . .") (ACHRE No. NARA-032495-B), 1. 98 . Max H. Brown, Contracting Officer, to Vice Chancellor, Schools of the Health Professions, University of Pittsburgh, 12 March 1957 ("This is in reply to letter . . .") (ACHRE No. DOD NARA-012395-A-6) The DOD has not located the Pittsburgh contract itself, which may have been long since routinely destroyed; therefore, it cannot be said for certain that the 1954 surgeon general provisions were made a contract requirement. 99 . Herbert L. Ley to Colonel Howie, 8 January 1969 ("Review of Department of the Army Policy on Use of Human Subjects in Research") (ACHRE No. DOD-063094-A). 100 . Max H. Brown to Contracting Officer, OTSG, 5 August 1957 ("The Use of Human Test Subjects in Medical Research Supported by the Office of the Surgeon General") (ACHRE No. NARA-012395-A). 101 . Donald L. Howie, Assistant Chief, Medical Research, 10 July 1962 ("Memorandum for the Record, Use of Volunteers for Army Medical Research") (ACHRE No. DOD-120694-A-3). It is worth noting that prior to this memorandum, in March 1962, the Army promulgated its first regulation specifically directed to the conduct of clinical research. This regulation (AR 70-25, 26 March 1962) specifically exempted "clinical research," which apparently included research conducted on patients. See chapter 3. 102 . Army IG report, 1975. 103 . Department of the Navy, Bureau of Medicine and Surgery, "Manual of the Medical Department," sec. IV, research article 1-17 (26 September 1951). 104 . On the question of written documentation, interestingly, the manual stipulated: "[V]olunteers" should not "execute a release for future liability for negligence attributable to the Navy," but the manual required that a statement be "entered into the Individual's Health Record" indicating the project number and the physical and psychological effects, or lack of same, resulting from the investigation. "Manual of the Medical Department," sec. IV, art. 1-17. 105 . Ibid. 106 . Loren B. Poush, Code 11, USN, to Code 74, USN (Bureau of Medicine and Surgery), 18 October 1951 ("Legal comments relative to proposed means of proper authorization and safeguard in use of radioisotopes") (ACHRE No. NARA-070794-A-4). 107 . Code 74, USN, to Code 11, USN, 18 September 1951 ("Proposed Means of Proper Authorization and Use of Radioisotopes") (ACHRE No. NARA-070794-A-4), 2. 108 . Paul O. Wells, Chief, Radiological Service, Letterman Army Hospital, to Elmer A. Lodmell, Chief, Radiological Service, Walter Reed Army Hospital, 14 January 1955 ("I am writing this letter at the suggestion of General Gillespie after having discussed with him the matter of requiring patients to sign a permit for radioisotope therapy.") (ACHRE No. DOD-012295-A). 109 . Standard Form 522 (SF-522), "Clinical Record--Authorization for Administration of Anesthesia and Performance of Operations and Other Procedures," was proposed for use "in those instances when authorization for administration of radioisotope therapy is desired." Eugene L. Hamilton, Chief, Medical Statistics Division, to the Chiefs of the Medical Plans and Operations Division and the Legal Office, 3 August 1955 ("Permit for Radioisotope Therapy") (ACHRE No. DOD-012295-A). In response to an inquiry from Walter Reed Army Hospital concerning the use of consent forms for patients, the Medical Statistics Division, recommending the use of SF-522, indicated that consent should be obtained when a procedure "carries an unusual risk." Additionally, the Medical Statistics Division recommended that patients should be "counselled as to the nature, expected results of, and risks involved in procedures." Eugene L. Hamilton, Chief, Medical Statistics Division, to the Chiefs of the Professional Division, Medical Plans and Operations Division, and the Legal Office, undated memorandum (probably November 1956) ("Forms for Authorization of Radiation Therapy") (ACHRE # DOD-012295-A). 110 . U.S. Air Force, Research and Development, "Clinical Research," AFR 80-22 (11 July 1952). 111 . The Deputy Commander for Research and Development of the Air Force R&D Command to RADC, WADC, APGC, AFCRC, AFSWC, AFMTC, AFMDC, AFFTC, AFBMD (ARDC), AFOSR, 12 September 1958 ("Conduct of Hazardous Human Experiments") (ACHRE No. HHS-090794-A). 112 . Richard R. Taylor, Surgeon General of the Department of the Army, testimony before the Subcommittee on Administrative Practice and Procedure of the Judiciary Committee and the Subcommittee on Health of the Labor and Public Welfare Committee, U.S. Senate, 94th Cong., 1st Sess., 10 September 1975 (ACHRE No. DOD-063094-A), 1. 113 . Charles V. Kidd, Director, Research and Planning Division, NIH, to Rear Admiral Winfred Dana, Medical Corps, USN, 30 April 1952 ("In accordance with our telephone conversation of this afternoon I am enclosing a copy of draft statement which we have developed.") (ACHRE No. DOD-111594-A), 2-3. The context of this statement is not known. Perhaps it was formulated in response to an inquiry from the DOD about the NIH's research requirements during the discussions that led to the drafting of the Wilson memorandum. 114 . National Institutes of Health, 17 November 1953 ("Group Consideration of Clinical Research Procedures Deviating from Accepted Medical Practice or Involving Unusual Hazard") (ACHRE No. HHS-090794-A), 4. 115 . Director, NIH, to Institute Directors, 15 November 1954 ("Participation by NIH Employees as Normal Controls in Clinical Research Projects") (ACHRE No. HHS-090794-A), 1. Although this memorandum referred only to NIH employees, Advisory Committee staff and NIH staff have concluded it applied to all healthy volunteer subjects. 116 . National Institutes of Health, policy statement of 17 November 1953 ("Group Consideration of Clinical Research Procedures Deviating From Accepted Medical Practice Or Involving Unusual Hazard") (ACHRE No. HHS-090794-A). 117 . Edward J. Rourke, Legal Adviser, NIH, to Mr. John A. Trautman, Director, Clinical Center, 5 December 1952 ("At your invitation, I presented to the Medical Board of the Clinical Center on December 2 a proposal that, in view of several factors in some degree peculiar to the Clinical Center, it would be advisable from the legal point of view among others to accept certain procedures relating to patient admission that are more formal than might otherwise be considered necessary") (ACHRE No. DOD-111594-A), 1. 118 . Ibid. 119 . For a more detailed review of this history see Faden and Beauchamp, A History and Theory of Informed Consent, and Frankel, "Public Policymaking for Biomedical Research: The Case of Human Experimentation." 120 . George M. Lyon, M.D., Assistant Chief Medical Director for Research and Education, presentation to the Committee on Veterans Medical Problems, National Research Council, 8 December 1952 ("Appendix II, Medical Research Programs of the Veterans Administration") (ACHRE No. VA-052595-A). 121 . Ibid., 558. 122 . Guy H. Birdsall, General Counsel, Veterans Administration, to Chief Medical Director, 25 June 1958, ("Op. G.C. 28-58, Legal Aspects of Medical Research") (ACHRE No. VA-052595-A). |