Saturday, July 13, 2013



Possible legal ramifications for testing such as this. Following is only a portion of the law and legal aspects which apply.  This will give us an idea of who makes these decisions, who is held accountable for damage and harm and what can we expect in the future.

Chapter 3: Footnotes

1 . For a discussion of the development of the Common Rule, see chapter 14. 2 . We relied particularly on Ruth R. Faden and Tom L. Beauchamp, A History and Theory of Informed Consent (New York: Oxford University Press, 1986). Other excellent sources include Jay Katz, Experimentation with Human Beings (New York: Russell Sage Foundation, 1972), and Robert Levine, Ethics and Regulation of Clinical Research (Baltimore: Urban and Schwarzenberg, 1981).
3 . U.S. Congress, The Select Committee to Study Governmental Operations with Respect to Intelligence Activities, Foreign and Military Intelligence [Church Committee report], report no. 94-755, 94th Cong., 2d Sess. (Washington, D.C.: GPO, 1976). Also, U.S. Army Inspector General, Use of Volunteers in Chemical Agent Research [Army IG report] (Washington, D.C.: 1975).
4 . In dissenting opinions, four justices of the U.S. Supreme Court (Brennan, Marshall, Stevens, and O'Connor) cited the Nuremberg Code. United States et al. v. Stanley, 483 U.S. 669, 687, 710 (1987).
5 . Thalidomide was only available in clinical trials in the United States at that time, but was approved for use in a number of other countries.
6 . Louis Lasagna, interview by Susan White-Junod and Jon Harkness (ACHRE), transcript of audio recording, 13 December 1994 (ACHRE Research Project Series, Interview Program Files, Ethics Oral History Project), 37-38. See also, Louis Lasagna, "1938-1968: The FDA, the Drug Industry, the Medical Profession, and the Public," in Safeguarding the Public: Historical Aspects of Medicinal Drug Control, ed. John B. Blake (Baltimore: The Johns Hopkins Press, 1970), 173.
7 . Food, Drug, and Cosmetic Act amendments, 21 U.S.C. [[section]] 355 (1962).
8 . Congressional Record, 87th Cong, 2d Sess., 22042, as cited in an attached memorandum, C. Joseph Stetler, Pharmaceutical Manufacturers Association, to James L. Goddard, M.D., Commissioner of Food and Drugs, DHEW, 11 October 1966 ("Regarding Statement Appearing in August 30, 1966 Federal Register Concerning Clinical Investigation of Drugs") (ACHRE No. HHS-090794-A).
9 . Keith Reemtsma et al., "Reversal of Early Graft Rejection after Renal Heterotransplantation in Man," Journal of the American Medical Association 187 (1964): 691-696.
10 . This research, conducted by Dr. Chester Southam of Sloan-Kettering Institute and Dr. Emmanuel Mandel of the Jewish Chronic Disease Hospital in 1963 and funded by the U.S. Public Health Service and the American Cancer Society, raised concern within PHS and brought about an investigation by the hospital. Drs. Mandel and Southam were subject to a disciplinary hearing before the Board of Regents of the University of the State of New York. The hospital's internal review and a suit against the hospital prompted concern and debate at the NIH. Edward J. Rourke, Assistant General Counsel, NIH, to Dr. Luther L. Terry, Surgeon General, 16 September 1965 ("Research Grants--Clinical--PHS responsibility--Fink v. Jewish Chronic Disease Hospital [New York Supreme Court, Kings County]") (ACHRE No. HHS-090794-A).
For a more thorough discussion of this case, see Katz, Experimentation with Human Beings, 9-65.
11 . In 1967 Dr. Southam was elected vice president of the American Association for Cancer Research and became president the following year. Katz, Experimentation with Human Beings, 63 and 65.
12 . For a fuller discussion of the Law-Medicine Research Institute, see chapter 2.
13 . The development of the Declaration of Helsinki is discussed briefly in chapter 2.
14 . Robert B. Livingston, Associate Chief for Program Development, Memorandum to the Director, NIH, 4 November 1964 ("Progress Report on Survey of Moral and Ethical Aspects of Clinical Investigation" [the Livingston report]) (ACHRE No. HHS-090795-A), 3.
15 . Ibid., 7.
16 . Ibid.
17 . Mark S. Frankel, "Public Policymaking for Biomedical Research: The Case of Human Experimentation" (Ph.D. diss., George Washington University, 9 May 1976), 50-51.
18 . The NAHC discussed the "general question of the ethical, moral, and legal aspects of clinical investigation" at its meetings of September and December 1965. Terry's interest in this was motivated in part by the concern of Senator Jacob K. Javits that the informed consent provisions of the 1962 Drug Amendments were not applicable to nondrug-related research. See (a) draft letter to Senator Javits from the Surgeon General, 15 October 1965; (b) Senator Javits to Luther L. Terry, Surgeon General, 15 June 1965; and (c) Edward J. Rourke, Assistant General Counsel, to William H. Stewart, Surgeon General, 26 October 1965. All in ACHRE No. HHS-090794-A.
19 . Transcript of the NAHC meeting, Washington, D.C., 28 September 1965. See Faden and Beauchamp, A History and Theory of Informed Consent, 208.
20 . Ibid.
21 . Dr. S. John Reisman, the Executive Secretary, NAHC, to Dr. James A. Shannon, 6 December 1965 ("Resolution of Council") (ACHRE No. HHS-090794-A).
22 . Surgeon General, Public Health Service to the Heads of the Institutions Conducting Research with Public Health Service Grants, 8 February 1966 ("Clinical research and investigation involving human beings") (ACHRE No. HHS-090794-A). This policy was distributed through Bureau of Medical Services Circular no. 38, 23 June 1966 ("Clinical Investigations Using Human Beings As Subjects") (ACHRE No. HHS-090794-A).
23 . In December 1966 the policy was expanded to include behavioral as well as medical research. William H. Stewart, Surgeon General, Public Health Service, to Heads of Institutions Receiving Public Health Service Grants, 12 December 1966 ("Clarification of procedure on clinical research and investigation involving human subjects") (ACHRE No. HHS-072894-B), 2.
In 1967 the Public Health Service required that intramural research, including that conducted at NIH, abide by similar requirements. William H. Stewart, Surgeon General of the Public Health Service, to List, 30 October 1967 ("PHS policy for intramural programs and for contracts when investigations involving human subjects are included") (ACHRE No. HHS-072894-B), 2.
24 . Frankel, "Public Policymaking for Biomedical Research: The Case of Human Experimentation," 161.
25 . Ibid., 161-162.
26 . U.S. Department of Health, Education, and Welfare, The Institutional Guide to DHEW Policy on Protection of Human Subjects (Washington, D.C.: GPO, 1971) (ACHRE No. HHS-090794-A).
27 . Ibid., 1-2.
28 . Beecher's criticism involved many aspects of the research, including the risk assessment, usefulness of the research, and the question of informed consent. On this last point, Beecher argued that while consent was important, he disputed the belief that it was easily obtainable. In his talk at Brook Lodge, Beecher questioned the "naive assumption implicit in the Nuremberg Code," that consent was readily obtainable. Beecher indicated the difficulty of obtaining truly informed consent may have led many researchers to treat the provision cavalierly and often to ignore it. Henry K. Beecher, "Ethics and the Explosion of Human Experimentation," unpublished manuscript of paper presented 22 March 1965, "a," Beecher Papers, Countway Library (ACHRE No. IND-072595-A).
29 . Ibid.,"a" and "b."
30 . Ibid., 2a.
31 . Ibid., 2.
32 . H. K. Beecher, "Ethics and Clinical Research," New England Journal of Medicine 274 (1966): 1354-1360.
33 . W. Goodman, "Doctors Must Experiment on Humans--But What are Patients Rights?" New York Times Magazine, 2 July 1965, 12-13, 29-33, as cited in Faden and Beauchamp, A History and Theory of Informed Consent, 188.
34 . J. Lear, "Do We Need New Rules for Experimentation on People?" Saturday Review, 5 February 1966, 61-70.
35 . Henry K. Beecher, "Consent in Clinical Experimentation: Myth and Reality," Journal of the American Medical Association 195 (1966): 34-35.
36 . J. Lear, "Experiments on People--The Growing Debate," Saturday Review, 2 July 1966, 41-43.
37 . Both the New York Times and the Wall Street Journal ran stories on 24 March 1971. See Medical World News, 15 October 1971, "Was Dr. Krugman Justified in Giving Children Hepatitis?"
38 . Beecher, Research and the Individual: Human Studies (Boston: Little, Brown, and Company, 1970), 122-127.
39 . Paul Ramsey, The Patient as Person: Explorations in Medical Ethics (New Haven: Yale University Press, 1970), 51-55.
40 . In a letter to the Lancet, Dr. Stephen Goldby called the work "unjustifiable" and asked, "Is it right to perform an experiment on a normal or mentally retarded child when no benefit can result to the individual?" (S. Goldby, "Letters to the Editor," Lancet 7702 [1971]: 749). The Lancet editors agreed with Goldby. On this side of the Atlantic, however, the editors of NEJM and JAMA, among others, defended Krugman's work.
41 . Armed Forces Epidemiological Board, minutes of 24 May 1957 (ACHRE No. NARA-032495-B).
42 . S. Krugman, "Ethical Practices in Human Experimentation," text of lecture presented at the Fifth Annual Midwest Student Medical Research Forum, 1 March 1974 (ACHRE No. IND-072895-A).
43 . Ibid., 3-4.
44 . Louis Goldman, "The Willowbrook Debate," World Medicine (September 1971 and November 1971): 23, 25.
45 . James H. Jones, Bad Blood (New York: Free Press, 1993 edition), 114.
46 . Jones, Bad Blood (1981), 69-71; Levine, Ethics and Regulation of Clinical Research, 70.
47 . Charles J. McDonald, "The Contribution of the Tuskegee Study to Medical Knowledge," Journal of the National Medical Association (January 1974): 1-11, as cited in Faden and Beauchamp, A History and Theory of Informed Consent, 194-195.
48 . Jean Heller, "Syphilis Victims in U.S. Study Went Untreated for 40 Years," New York Times (26 July 1972) 1, 8, as cited in Faden and Beauchamp, A History and Theory of Informed Consent, 195.
49 . U.S. Department of Health, Education, and Welfare, Final Report of the Tuskegee Syphilis Study Ad Hoc Panel (Washington, D.C.: GPO, 1973), Jay Katz Concurring Opinion, 14.
50 . Ibid.
51 . Ibid., 21-32.
52 . Ibid., 23.
53 . Senator Jacob Javits introduced legislation that would have made the DHEW policy a regulation backed by federal law. S. 878 and S. 974, 93d Cong., 1st Sess. (1973).
Senator Hubert Humphrey introduced a bill to create a National Human Experimentation Standards Board--a separate federal agency with authority over research similar to the Security and Exchange Commission's authority over securities transactions. S. 934, 93d Cong., 1st Sess. (1973).
Also, Senator Walter Mondale introduced a resolution to provide for a "study and evaluation of the ethical, social, and legal" aspects of biomedical research. S.J. Res. 71, 93d Cong., 1st Sess. (1973).
54 . It is worth noting here that Senator Kennedy had convened similar hearings two years previously, in 1971, to consider the establishment of a national commission to examine "ethical, social, and legal implications of advances in biomedical research." Among the topics mentioned in this hearing was the total-body irradiation research sponsored by the Department of Defense at the University of Cincinnati, which we discuss in chapter 8.
55 . Jay Katz, "Human Experimentation: A Personal Odyssey," IRB 9, no. 1 (January/February 1987): 1-6.
56 . Protection of Human Subjects, 39 Fed. Reg. 105, 18914-18920 (1974) (to be codified at 45 C.F.R. [[section]] 46).
57 . National Research Act of 1974. P.L. 348, 93d Cong., 2d Sess. (12 July 1974).
58 . U.S. Department of Health, Education, and Welfare, Office for Protection from Research Risks, 18 April 1979, OPPR Reports [The Belmont Report] (ACHRE No. HHS-011795-A-2), 4-20.
59 . Interestingly, this committee included Henry Beecher, who, as was discussed in part I, chapter 3, had objected to the imposition of these requirements to contract research in 1961. Beecher's presence on the committee testifies to the common relationship between military and private research during this time. Like many of the
60 . Department of the Army, Army Regulation 40-37, 12 August 1963 ("Radioisotope License Program [Human Use]").
61 . Department of the Army, AR 40-38, 23 February 1973 ("Medical Services--Clinical Investigation Program").
62 . Ibid.
63 . Ibid.
64 . Commanding Officer, Naval Medical Research Institute, National Naval Medical Center, to Secretary of the Navy, 30 November 1964 ("Authorization to use human volunteers as subjects for study of effects of hypoxia on the visual field; request for") (ACHRE No. DOD-091494-A), 2.
65 . Department of the Navy, "Manual of the Medical Department," 20-8, Change 36, 7 March 1967 ("Use of Volunteers in Medical or Other Hazardous Experiments") (ACHRE No. DOD-091494-A).
66 . Department of the Navy, SecNav Instruction 3900.39, 28 April 1969 ("Use of volunteers as subjects of research, development, tests, and evaluation").
67 . Department of the Air Force, AFR 169-8, 8 October 1965 ("Medical Education and Research--Use of Volunteers in Aerospace Research").
68 . Ibid.
69 . Ibid.
70 . National Aeronautics and Space Administration, Manned Spacecraft Center, MSCI 1860.2, 12 May 1966 ("Establishment of MSC Radiological Control Manual and Radiological Control Committee") (ACHRE No. NASA-022895-A), 3.
National Aeronautics and Space Administration, "Ames Management Manual 7170-1," 15 January 1968 ("Human Research Planning and Approval") (ACHRE No. NASA-120894-A), 3.
71 . Ames required the voluntary, written informed consent of the subject and stipulated that consent be informed by an
explanation to the subject in language understandable to him . . . [including] the nature, duration, and purpose of the human research; the manner in which it will be conducted; and all foreseeable risks, inconveniences and discomforts.
"Ames Management Manual 7170-1," 15 January 1968, 3.
72 . The Ames director was authorized to waive the consent requirements (a) when the requirements would "not be necessary to protect the subject"; (b) when the research uses "classes of trained persons who knowingly follow a specialized calling or occupation which is generally recognized as hazardous," including "test pilots and astronauts"; and (c) when the research "would be seriously hampered" by compliance. "Ames Management Manual 7170-1," 15 January 1968, 3.
73 . For example, one review from this group recommended changes in a consent form to include
[T]he part of the procedure you are consenting to which principally benefits the research program and is not part of your treatment is known as arterial puncture. . . . These risks will be explained to you in detail if you so desire. The entire procedure, including the diagnostic radioscan, takes about an hour.
Although this proposed consent form does not delineate the medical risks posed by the procedure, its statement that the patient's participation is incidental to treatment may provide a greater opportunity for the patient to make an informed decision about participation. George A. Rathert, Jr., Chairman, Human Research Experiments Review Board, ARC, to Director, 20 January 1969 ("Proposed Investigation entitled 'Measurement of Cerebral Blood Flow in Man by an Isotopic Technique Employing External Counting,' by Dr. Leo Sapierstein, Stanford University") (ACHRE No. NASA-022895-A), 4.
At MSC, the instruction establishing the Medical Uses Subcommittee was rescinded in 1968. In 1969, formal combination of the medical operations and medical research functions at MSC led to the reestablishment of the instruction as the Medical Isotopes Subcommittee at MSC. No evidence suggests what factors, other than risk, were considered in this form of prior review is available currently. National Aeronautics and Space Administration, Manned Spacecraft Center, MSCI 1860.2, 12 May 1966 ("Establishment of MSC Radiological Control Manual and Radiological Control Committee"); and National Aeronautics and Space Administration, NMI 1156.19, 28 August 1969 ("Medical Isotopes Subcommittee of the MSC Radiation Safety Committee") (ACHRE No. NASA-022895-A).
74 . National Aeronautics and Space Administration, NMI 71008.9, 2 February 1972 ("Human Research Policy and Procedures") (ACHRE No. NASA-022895-A). See also, National Aeronautics and Space Administration, NMI 7100.9 ("Power and Authority -- To Authorize Human Research and to Grant Certain Related Exceptions and Waivers") (ACHRE No. NASA-022895-A).
75 . Commission on CIA Activities within the United States, Report to the President, (Washington, D.C.: GPO, 1975).
76 . U.S. Congress, The Select Committee to Study Governmental Operations with Respect to Intelligence Activities, Foreign and Military Intelligence [Church Committee report], report no. 94-755, 94th Cong., 2d Sess. (Washington, D.C.: GPO, 1976), 394.
77 . For general information on the CIA program, see the Church Committee report, 385-422, and J. Marks, The Search for the "Manchurian Candidate": The CIA and Mind Control (New York: Times Books, 1978).
78 . Church Committee report, book 1, 389.
79 . Church Committee report, book 1, 400, 402. In 1963 the CIA inspector general (IG) recommended that unwitting testing be terminated, but Deputy Director for Plans Richard Helms (who later became director of Central Intelligence) continued to advocate covert testing on the ground that "positive operational capability to use drugs is diminishing, owing to a lack of realistic testing. With increasing knowledge of the state of the art, we are less capable of staying up with the Soviet advances in this field." The Church Committee noted that "Helms attributed the cessation of the unwitting testing to the high risk of embarrassment to the Agency as well as the 'moral problem.' He noted that no better covert situation had been devised than that which had been used, and that
80 . Ibid., 402.
81 . Executive Order 11905 (19 February 1976).
82 . Executive Order 12036, section 2-301 (26 January 1978) and Executive Order 12333, section 2.10 (4 December 1981).
83 . U.S. Army Inspector General, Use of Volunteers in Chemical Agent Research [Army IG report] (Washington, D.C.: GPO, 1975), 2.
84 . One noted exception involved using LSD as an interrogation devise on ten foreign intelligence agents, and one U.S. citizen suspected of stealing classified documents. Army IG report, 143.
85 . Army IG report, 87.
86 . Ibid.
87 . The CIA paid death benefits to the Olson family after Frank Olson's death, and the Army secretly paid half of an $18,000 settlement that the Blauer family negotiated with the state of New York in 1955. The state ran the psychiatric institute that administered the drugs, but which never disclosed the Army's involvement. Both agencies feared that the resulting embarrassment and adverse publicity might undermine their ability to continue their secret research programs. Barrett v. United States, 6660 F. Supp. 1291 (E. D. N.Y., 1987).
88 . Feres v. United States, 340 U.S. 146 (1950).
89 . United States v. Stanley, 483 U.S. 669 (1987).
90 . 483 U.S. 669, 682.
91 . 483 U.S. 669, 687-88.
92 . 483 U.S. 669, 709-10.
93 . George Annas, a scholar of human experimentation and biomedical ethics, has traced the history of the Nuremberg Code in the U.S. courts. The first express reference in a majority opinion, Annas found, was in a 1973 decision in the Circuit Court in Wayne County, Michigan. The decisions in which the Code has since been cited, Annas concluded, reflect the proposition that the Nuremberg Code is a "document fundamentally about nontherapeutic experimentation." Thus, the "types of experiments that U.S. judges have found the Nuremberg Code useful for setting standards have involved nontherapeutic experiments often conducted without consent. . . . Many of these experiments were justified by national security considerations and the cold war." George J. Annas, "The Nuremberg Code in U.S. Courts: Ethics versus Expediency," in 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), 218.


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