Chapter 2: Footnotes

1 . A detailed recounting of the first series of Nuremberg Trials can be found in Telford Taylor, The Anatomy of the Nuremberg Trials: A Personal Memoir (New York: Alfred A. Knopf, 1992). Taylor describes the motivation for the second series of Nuremberg Trials in the introduction to this book (p. xii). He also mentions that he "hope[s] later to write a description of these subsequent trials" (p. xii). Taylor served as an assistant to chief American prosecutor Robert H. Jackson at the first series of trials; he was the chief prosecutor for the second series, which eventually included twelve separate trials.

2 . United States v. Karl Brandt et al., "The Medical Case, Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10" (Washington, D.C.: U.S. Government Printing Office, 1949). This two-volume set contains an abridged set of transcripts from the Nuremberg Medical Trial. A general timeline for the trial can be found on p. 3 of volume 1; the quotation of Taylor's charges can be found in the reproduction of his opening statement in volume 1, p. 27. The published trial transcripts provide extensive detail on the experiments carried out by German medical scientists on inmates at Nazi concentration camps. These experiments included a long list of brutalities carried out in the name of medical science. Some of these were specifically related to the Nazi war effort. German investigators conducted high-altitude tolerance tests for the Luftwaffe using a low-pressure chamber. Scientists forced prisoners to enter the chamber and subjected them to extreme pressure changes that resulted in excruciating pain and, sometimes, death. Among these experiments were human twin studies related to genetics and germ warfare. For example, a series of experiments involved injecting one twin with a potential germ warfare agent to test the effects of that agent. If the twin injected with the germ died, the other twin was immediately killed to compare the the organs between the healthy and the sick twin. Another series of experiments related to downed airman and shipwrecked sailors who were faced with deprivation of potable water. In these tests, prisoners were divided into four groups: the first received no water; a second set was forced to drink ordinary seawater; the third would drink seawater processed to remove the salty taste (but not the actual salt); and fourth group could drink desalinated seawater. Many of the subjects in the first three groups died. German researchers also compelled prisoners to engage in a variety of other cruel experiments, many of which were concerned with infectious diseases such as malaria, epidemic jaundice, and typhus. More information can be found on the Nazi prison camp experiments in several sources including Robert Jay Lifton, The Nazi Doctors: Medical Killing and the Psychology of Genocide (New York: Basic Books, 1986); Robert N. Proctor, Racial Hygiene: Medicine under the Nazis (Cambridge, Mass.: Harvard University Press, 1988); and 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).

Japanese medical scientists, especially those associated with a biological warfare (BW) research corps known as Unit 731, also conducted many cruel medical experiments during the war. Until recently, these experiments were virtually unknown because American military and medical officials struck a postwar deal with leading Japanese scientists associated with Unit 731: immunity from war crimes prosecution in exchange for exclusive American access to the results of the Japanese BW experiments. The Japanese experiments and the American cover-up have recently received coverage in Sheldon Harris's Factories of Death: Japanese Biological Warfare, 1932-1945, and the American Cover Up (London/New York: Routledge, 1994). See also Peter Williams and David Wallace, Unit 731: The Japanese Army's Secret of Secrets (London: Hodder and Stoughton, 1989); and John W. Powell, Jr., "Japan's Biological Weapons, 1930-1945," Bulletin of the Atomic Scientists 37 (October 1981): 44-53.

3 . American Medical Association, Board of Trustees, minutes of the May 1946 meeting, AMA Archive, Chicago, Illinois (ACHRE No. IND-072595-A), 156-157.

4 . A full-blown biography of Ivy remains to be written, but some biographical information can be found in the following brief notices: Carl A. Dragstedt, "Andrew Conway Ivy," Quarterly Bulletin of the Northwestern University Medical School 18 (Summer 1944): 139-140; Morton I. Grossman, "Andrew Conway Ivy (1893-1978)," Physiologist 21 (April 1978): 11-12; D. B. Bill, "A. C. Ivy--Reminiscences," Physiologist 22 (October 1979): 21-22.

5 . The quotation is taken from Andrew C. Ivy, "Nazi War Crimes of a Medical Nature," Federation Bulletin 33 (May 1947): 133. Ivy first publicly offered this view of the Nuremberg prosecutors' confusion about the ethics and legality of human experimentation when he presented this paper at an annual meeting of the Federation of State Medical Boards of the United States on 10 February 1947--just a few months after the start of the Medical Trial. In this presentation Ivy said that he traveled to Germany in August 1946. In a similar description of his experiences with the Nuremberg prosecution team published a few years later Ivy reiterates a similar story except that the date of his initial travel is given as July 1946: A. C. Ivy, "Nazi War Crimes of a Medical Nature," Journal of the American Medical Association 139 (15 January 1949): 131. An editorial in JAMA confirms some of the essential elements of Ivy's early work with the Nuremberg prosecutors (his selection by the AMA Board of Trustees at the request of the federal government and his travel to Germany "a few months" before November 1946): "The Brutalities of Nazi Physicians," JAMA 132 (23 November 1946): 714. The basic narrative of Ivy's selection by the Board of Trustees and his travel to Europe can also be found in R. L. Sensenich, "Supplementary Report of the Board of Trustees," JAMA 132 (21 December 1946): 1006.

6 . American Medical Association, Board of Trustees, minutes of the 16 August 1946 meeting, AMA Archive, Chicago, Illinois (ACHRE No. IND-072595-A), 8-9.

7 . American Medical Association, Board of Trustees, minutes of the 19 September 1946 meeting, AMA Archive, Chicago, Illinois (ACHRE No. IND-072595-A), 51-52.

8 . A. C. Ivy, "Report on War Crimes of a Medical Nature Committed in Germany and Elsewhere on German Nationals and the Nationals of Occupied Countries by the Nazi Regime during World War II," 1946. This report was not published, but it is available at the National Library of Medicine. A copy also exists in the AMA Archive (ACHRE No. DOD-063094-A).

9 . United States v. Karl Brandt et al., "The Medical Case, Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10" (Washington, D.C.: U.S. Government Printing Office, 1949), 2: 181-182. The judges' preamble to the Code states that "[a]ll agree . . . that certain basic principles must be observed in order to satisfy the moral, ethical and legal" aspects of human experimentation.

10 . Ivy's recitation of his own set of rules does not appear in the published abridged transcripts of the trial. See the complete transcripts of the trial, which are available on microfilm at the National Archives (National Archives Microfilm, M887, reel 9, 13 June 1947, pp. 9141-9142). Throughout this chapter, we cite the abridged transcripts wherever possible and the full transcripts only if necessary.

11 . Leo Alexander later reproduced his 15 April 1947 memo in two publications: "Limitations in Experimental Research on Human Beings," Lex et Scientia 3 (January-March 1966): 20-22, and "Ethics of Human Experimentation," Psychiatric Journal of the University of Ottawa 1 (1976): 42-44. In the 1976 article, Alexander made a seemingly exaggerated claim to be "the original author of the Nuremberg Code" (p. 40). Side-by-side comparison of Ivy's rules, Alexander's memo, and the Nuremberg Code does, however, suggest that the judges drew two original contributions from Alexander's memo: clauses 6 and 7 of the Nuremberg Code are embedded in the 15 April memo (they do not appear in Ivy's rules).

12 . McHaney's closing statement can be found in the complete microfilm transcripts of the trial available through the National Archives. McHaney's closing statement and Alexander's memorandum (and Alexander's claim to authorship of the Code) are also reproduced in Michael A. Grodin's "Historical Origins of the Nuremberg Code," in The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation, 134-137.

13 . American Medical Association, Board of Trustees, minutes of the 19 September 1946 meeting, AMA Archive, Chicago, Illinois (ACHRE No. IND-072595-A).

14 . The AMA reports that the records of the Judicial Council for all of the 1940s have been lost. Personal communication between Marilyn Douros, of the AMA Archives, and Jon M. Harkness (ACHRE), 19 January 1995.

15 . "Supplementary Report of the Judicial Council," proceedings of the House of Delegates Annual Meeting, 9-11 December 1946, JAMA 132 (28 December 1946): 1090. The bracketed addition to rule 1 was added in the final version of statement, which was approved by the House of Delegates on 11 December 1946.

16 . William A. Coventry, "Report of the Reference Committee on Miscellaneous Business," proceedings of the House of Delegates Meeting, 9-11 December 1946, JAMA 133 (4 January 1947): 35.

17 . Robert Williamson, an AMA archivist, reports that in 1942, 65 percent of American physicians were members of the AMA, and in 1949, 75 percent of American physicians were members; he did not have percentage figures available for 1946. Williamson also provided the absolute number of members for 1946. Personal communication between Jon M. Harkness (ACHRE) and Robert Williamson, 4 January 1995.

18 . United States v. Karl Brandt et al., "The Medical Case, Trials of War Criminals before the Nuremberg Military Tribunal under Control Council Law No. 10," vol. 2, 83.

19 . Ibid.

20 . Complete transcripts of the Nuremberg Medical Trial, National Archives Microfilm, M887, reel 9, 13 June 1947, pp. 9168-9170.

21 . Susan E. Lederer, Subjected to Science: Experimentation in America before the Second World War (Baltimore: Johns Hopkins University Press, 1995), 105.

22 . Lederer recounts the historical details of the yellow fever experiment (pp. 19-23) and explores Reed's powerful legacy (pp. 132-134) in Subjected to Science.

23 . Theodore Woodward, interview by Gail Javitt and Suzanne White-Junod (ACHRE), transcript of audio recording, 14 December 1994 (ACHRE Research Project Series, Interview Program File, Ethics Oral History Project), 6.

24 . Interview with Woodward, 14 December 1994, 10.

25 . John D. Arnold, interview by Jon M. Harkness (ACHRE), transcript of audio recording, 6 December 1994 (ACHRE Research Project Series, Interview Program File, Ethics Oral History Project), 18.

26 . The list of participants exists in the extant records of the LMRI project available at the Center for Law and Health Sciences, School of Law, Boston University. The quotation explaining the goal of the meeting is taken from the first page of a summary of the conference prepared for the project's final report, which was not published: Anne S. Harris, "The Concept of Consent in Clinical Research: Analytic Summary of a Conference," chapter 6 in A Study of the Legal, Ethical, and Administrative Aspects of Clinical Research Involving Human Subjects: Final Report of Administrative Practices in Clinical Research, [NIH] Research Grant No. 7039 Law-Medicine Research Institute, Boston University, 1963 (ACHRE No. BU-053194-A).

27 . The National Institutes of Health awarded LMRI almost $100,000 on 1 January 1960 to begin this project, which concluded 31 March 1963. The general statement of the project's purpose appears in LMRI final report, chapter 1 ("Focus of the Inquiry"), 1.

28 . LMRI final report, chapter 6, 48.

29 . Louis Lasagna, interview by Jon M. Harkness and Suzanne White-Junod (ACHRE), transcript of audio recording, 13 December 1994 (ACHRE Research Project Series, Interview Program File, Ethics Oral History Project), 5.

30 . Ibid., 11.

31 . Extensive newspaper clippings related to the Nuremberg Medical Trial exist in Beecher's personal papers in the Special Collections Department, Countway Library, Harvard University. Beecher's first major publication on research ethics appeared in early 1959: Henry K. Beecher, "Experimentation in Man," JAMA 169 (31 January 1959): 461-478. Of course, he is best known for a 1966 article: Henry K. Beecher, "Ethics and Clinical Research," New England Journal of Medicine 274 (16 June 1966): 1354-1360. Significantly, Beecher acknowledged in a manuscript copy of the original version of the NEJM paper, which he presented at a conference for science journalists on 22 March 1965, that "in years gone by work in my laboratory could have been criticized." Beecher, "Ethics and the Explosion of Human Experimentation," 2a, Beecher Papers, Countway Library (ACHRE No. IND-072595-A).

32 . Jay Katz, "Human Experimentation and Human Rights," St. Louis University Law Journal 38 (1993): 28.

33 . Stanley Joel Reiser, Arthur J. Dyck, and William J. Curran, eds., Ethics in Medicine: Historical Perspectives and Contemporary Concerns (Cambridge, Mass.: The MIT Press, 1977), 7.

34 . Otto E. Guttentag, "The Physician's Point of View," Science 117 (1953): 207-210; the quotation is from 208. Guttentag's article appeared in Science with three others that had been presented at the 1951 symposium: Michael B. Shimkin, "The Researcher Worker's Point of View," 205-207; Alexander M. Kidd, "Limits of the Right of a Person to Consent to Experimentation on Himself," 211-212; and W. H. Johnson, "Civil Rights of Military Personnel Regarding Medical Care and Experimental Procedures," 212-215.

35 . Guttentag, "The Physician's Point of View," 208.

36 . Ibid., 210.

37 . John C. Ford, "Notes on Moral Theology," Theological Studies 6 (December 1945): 534-535. Ford's discussion of human experimentation arose in a lengthy and discursive review of issues and ideas in moral theology. For several years, he contributed a similar review to each volume of Theological Studies.

38 . Transcripts of "Social Responsibility in Pediatric Research" conference, 1 May 1961, 7. LMRI records, Center for Law and Health Sciences, School of Law, Boston University (ACHRE No. BU-053194-A).

39 . "LMRI Final Report," chapter 6, 43.

40 . Ibid., 43-44.

41 . Ibid., 44.

42 . Ibid., 46-47.

43 . Committee member and historian Susan Lederer took principal responsibility for organizing the Ethics Oral History Project, with assistance from several members of the staff including two historians experienced in the techniques of oral history. The Committee also drew on advice from several outside experts, including historians and ethicists, to create a list of potential interviewees and to refine the list of questions that we wanted to explore during interviews. In total, the Committee conducted twenty-two interviews in the Ethics Oral History Project. Most of the subjects were medical researchers whose careers began in the late 1940s or early 1950s, but we also spoke with some research administrators. In general, we chose to interview researchers who had exhibited some particular interest in research ethics during their careers. But this does not mean that we held interviews only with researchers who viewed recent developments in research ethics in a positive fashion. The interviews were all recorded on audio tape and professionally transcribed. Interview subjects had an opportunity to review the transcripts. Complete sets of all transcripts can be found in the archival records of the Advisory Committee.

44 . Interview with Lasagna, 13 December 1994, 13.

45 . Paul Beeson, interview by Susan E. Lederer (ACHRE), transcript of audio recording, 20 November 1994 (ACHRE Research Project Series, Interview Program File, Ethics Oral History Project), 16-17.

46 . Leonard Sagan, interview by Gail Javitt, Suzanne White-Junod, Sandra Thomas, and John Kruger (ACHRE), transcript of audio recording, 17 November 1994 (ACHRE Research Project Series, Interview Program File, Ethics Oral History Project), 13-14.

47 . Ibid., 19-20.

48 . Stuart Finch, interview by Gail Javitt, Suzanne White-Junod, and Valerie Hurt (ACHRE), transcript of audio recording, 6 December 1994 (ACHRE Research Project Series, Interview Program File, Ethics Oral History Project), 52.

49 . Interview with Paul Beeson, 20 November 1994, 39.

50 . Thomas Chalmers, interview by Jon Harkness (ACHRE), transcript of audio recording, 9 December 1994 (ACHRE Research Project Series, Interview Program File, Ethics Oral History Project), 75.

51 . Herman Wigodsky, interview by Gail Javitt and Suzanne White-Junod (ACHRE), transcript of audio recording, 17 January 1995 (ACHRE Research Project Series, Interview Program File, Ethics Oral History Project), 14.

52 . For an analysis and translation of the 1931 German rules see Hans-Martin Sass, "Reichsrundschreiben 1931: Pre-Nuremberg German Regulations Concerning New Therapy and Human Experimentation," Journal of Medicine and Philosophy 8 (1983): 99-111. A similar analysis and translation of the same set of rules appears in Grodin, "Historical Origins of the Nuremberg Code," 129-132.

53 . Full trial transcripts, 9142.

54 . Abridged trial transcripts, 83.

55 . Interview with Dr. Herman Wigodsky, 17 January 1995, 16-17.

56 . Ruth Faden and Tom Beauchamp, A History and Theory of Informed Consent (New York: Oxford University Press, 1986), 96.

57 . Ivy's several examples ranged from Walter Reed's turn-of-the-century experiments with yellow fever to wartime malaria experiments in American state and federal prisons. See page 9119 of the full trial transcripts for Ivy's discussion of the Reed experiments and pages 9125-9129 for his description of the malaria experiments that had taken place in the United States during the war.

58 . David J. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: Basic Books, 1994), 62.

59 . Interview with John Arnold, 6 December 1994, 9-10.

60 . Herbert Abrams, interview by Jon Harkness (ACHRE), transcript of audio recording, 12 January 1995 (ACHRE Research Project Series, Interview Program File, Ethics Oral History Project), 25.

61 . Dorothy Levenson, Montefiore: The Hospital as Social Instrument, 1884-1984 (New York: Farrar, Straus & Giroux, 1984). For information on the presence of Jewish refugee physicians at Montefiore, see pages 154-155.

62 . Rothman, Strangers at the Bedside, 62-63.

63 . Katz, "The Consent Principle of the Nuremberg Code," 228.

64 . William Silverman, interview by Gail Javitt (ACHRE), transcript of audio recording 14 February 1995 (ACHRE Research Project Series, Interview Program File, Ethics Oral History Project), 61-62.

65 . Ibid., 87-88.

66 . "Why Human 'Guinea Pigs' Volunteer," New York Times Magazine, 13 April 1958, 62.

67 . See, for example, John L. O'Hara, "The Most Unforgettable Character I've Met," Reader's Digest, May 1948, 30-35; Thomas Koritz, "I Was a Human Guinea Pig," Saturday Evening Post, 25 July 1953, 27, 79-80, 82; Don Wharton, "'A Treasure in the Heart of Every Man,'" Reader's Digest, December 1954, 49-53 (condensed from "Prisoners Who Volunteer, Blood, Flesh--and Their Lives," American Mercury, December 1954, 51-55); Howard Simons, "They Volunteer to Suffer," Saturday Evening Post, 26 March 1960, 33, 87-88

68 . "Experiments on Prisoners," Science Newsletter (also Science News), 21 February 1948, 53, 117.

69 . "C.O.'s Offer Selves for Atomic Experiments," Christian Century, 20 October 1954, 1260.

70 . Robert D. Potter, "Are We Winning the War Against TB?" Saturday Evening Post, 15 January 1949. Cited in Marcel C. LaFollette, Making Science Our Own: Public Images of Science 1910-1955 (Chicago: University of Chicago Press, 1990), 138-140.

71 . Renee C. Fox, Experiment Perilous: Physicians and Patients Facing the Unknown (Philadelphia: University of Pennsylvania Press, 1974, first published 1959). Fox describes her long days of observation on page 15; she discusses the Nuremberg Code at 46-47.

72 . Michael B. Shimkin, As Memory Serves: Six Essays on a Personal Involvement with the National Cancer Institute, 1938-1978 (Bethesda, Md.: U.S. Department of Health and Human Services, 1983), 127.

73 . Ibid., 128.

74 . Ibid., 127.

75 . The quotation is a translation from the French in which Pius XII delivered the address: "Il faut remarquer que l'homme dans son être personnel n'est pas ordonné en fin de compte à l'utilité de la société, mais au contraire, la communauté est là pour l'homme." The French text can be found in the Atti del Primo Congresso Internazionale di Istopatologia del Sistema Nervosa/Proceedings of the First International Congress of Neuropathology, Rome, 8-13 September 1952. English translations of the pope's address appear in a variety of publications including The Linacre Quarterly: Official Journal of the Federation of Catholic Physicians' Guilds 19 (November 1952): 98-107 and The Irish Ecclesiastical Record 86 (1954): 222-230.

76 . Saul Benison, Tom Rivers: Reflections on a Life in Medicine and Science (Cambridge, Mass.: MIT Press, 1967), 498.

77 . Louis J. Regan, Doctor and Patient and the Law, 2d ed. (St. Louis: C. V. Mosby, 1949), 398.

78 . Louis J. Regan, Doctor and Patient and the Law, 3d ed. (St. Louis: C. V. Mosby, 1956), 370-372.

79 . Report on the National Conference on the Legal Environment of Medicine,27-28 May 1959 (Chicago: National Society for Medical Research, 1959); the quotations are from pages 91 and 88, respectively.

80 . Henry K. Beecher, "Experimentation in Man," Journal of the American Medical Association 169 (1959): 118/470.

81 . Ibid., 121/473.

82 . Ibid., 122/474.

83 . Ibid., 109/461.

84 . Ibid., 119/471.

85 . Harvard Medical School, Harvard Medical School Administrative Board, proceedings of the 6 October 1961 meeting (ACHRE No. HAR-062394-A-3).

86 . Memorandum to "GPB" [Harvard Medical School Dean Berry] from "JWG" [Assistant Dean Gardella] ("Criticisms of 'Principles, Policies and Rules of the Surgeon General, Department of the Army, relating to the use of Human Volunteers in Medical Research Contracts awarded by the Army'") (ACHRE No. IND-072595-A), 1.

87 . Ibid., 2.

88 . Ibid.

89 . Ibid., 3.

90 . Harvard Medical School, Harvard Medical School Administrative Board, proceedings of 23 March 1962 (ACHRE No. HAR-062394-A-3).

91 . Joseph W. Gardella, Assistant Dean, Harvard Medical School to Henry K. Beecher, Massachusetts General Hospital, 27 March 1962 ("I write to confirm my impression . . .") (ACHRE No. HAR-062394-A-4).

92 . Ibid.

93 . Harvard Medical School, Harvard Medical School Administrative Board, proceedings of 8 June 1962 (ACHRE No. HAR-062394-A-3).

94 . Henry Beecher, undated ("Statement Outlining the Philosophy and Ethical Principles Governing the Conduct of Research on Human Beings at the Harvard Medical School") (ACHRE No. IND-072595-A).

95 . Henry K. Beecher to Lieutenant General Leonard D. Heaton, 12 July 1962 ("I have just returned to Boston . . .") (ACHRE No. HAR-062394-A-2).

96 . World Medical Association, "Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects," adopted by the Eighteenth World Medical Assembly, Helsinki, Finland, 1964.

97 . "Draft Code of Ethics on Human Experimentation," British Medical Journal 2 (1962): 1119; "Human Experimentation: Code of Ethics of the World Medical Association," British Medical Journal 2 (1964): 177.

98 . Faden and Beauchamp, A History and Theory of Informed Consent, 156-157, and Paul M. McNeill, The Ethics and Politics of Human Experimentation (Cambridge, U.K.: Press Syndicate of the University of Cambridge, 1993), 44-47. For a more detailed comparison between the Nuremberg Code and the Declaration of Helsinki, see Jay Katz, "The Consent Principle of the Nuremberg Code," 231-234.