Ethical Considerations

Chapter 9: Footnotes

2 . Subcommittee on Energy Conservation and Power, Committee on Energy and Commerce, House of Representatives, American Nuclear Guinea Pigs: Three Decades of Radiation Experiments on U.S. Citizens, 99th Cong., 2d Sess., 3.

3 . Pacific Northwest Research Foundation, undated ("Policy and Procedures of the Pacific Northwest Research Foundation with Regard to Investigations Involving Human Subjects") (ACHRE No. IND-011195-A-1).

4 4. Bertram H. Schur to Dr. Charles L. Dunham, 13 May 1966 ("Use of Human Volunteers in Biomedical Research") (ACHRE No. DOE-051094-A-138).

5 5. Deposition of Mavis Rowley and Carl G. Heller, 19 July 1976, Poulsbo, Washington (ACHRE No. CORP-013095-A-2), 18.

6 . C. Alvin Paulsen, interview by Steve Klaidman (ACHRE), 8 September 1994, Seattle, Washington, transcript of recording (ACHRE Research Project Series, Interview Program File, Targeted Interview Project), 10-11.

7 . Pacific Northwest Research Foundation, proposal for Atomic Energy Commission, Division of Biology and Medicine, February 1963 ("Effects of Ionizing Radiation on the Testicular Function of Man") (ACHRE No. DOE-122994-A-2); Carl Heller, Pacific Northwest Research Foundation, 27 April 1967 ("Fifth Yearly Proposal, June 1, 1967-May 31, 1968") (ACHRE No. DOE-122994-A-2); Carl Heller, Pacific Northwest Research Foundation, May 1972 ("Effects of Ionizing Radiation on the Testicular Function of Man: 9 Year Progress Report") (ACHRE No. DOE-122994-A-2); Mavis Rowley, Division of Nuclear Medicine, Tumor Clinic, Swedish Research Hospital, undated ("The Effect of Graded Doses of Ionizing Radiation on the Human Testis: Progress Report, October 1, 1975-September 30, 1976") (ACHRE No. DOE-011895-B-3). The following is a staff-prepared abstract of Dr. Heller's research based on annual reports, the final report, and his research proposal:

I. OBJECTIVES

To determine the nature of the cytological changes, both somatic (Sertoli cell) and germinal (spermatogonia) induced by acute irradiation.

- To determine the dosage required to produce these changes, as well as the dose to induce permanent damage to spermatogenic cells.

- To determine recovery time.

- To determine radiation-produced alteration of testicular parameters, such as total gonadotropin, interstitial-cell hormone excretion, estrogen excretion, and androgen excretion.

II. METHODOLOGY

Subjects received varying doses of X-irradiation to both testes from 8- to 600-rad single dose. Testicular effects were determined by histological (light microscopy) examination of pre- and serial postirradiation biopsy specimens. Sperm counts, motility, morphology, and seminal fluid volume were monitored in serial postirradiation ejaculates. Hormonal excretion was to be monitored by serial urine and plasma analyses.

- Radiation exposure was controlled by a specially constructed device that assured uniform (plus or minus 5%) irradiation at a dose rate of 100 r/min, approximately 140 kVp with 5 mA tube current, and 2 mm Al filter.

- Some subjects received 10 uCi 3H-thymidine injected intratesticularly to assess (via autoradiography) effects of radiation on incorporation into spermatogonial DNA as a measure of chromosome replication.

III. RATIONALE FOR THE USE OF HUMAN SUBJECTS

- To determine radiosensitivity of germinal elements in man. According to Dr. Heller, man is unique among commonly studied species in being able to submit to serial testicular biopsy without damage and biopsy-induced testicular artifacts. (Mavis Rowley has pointed out that improved techniques have made it more practical to do biopsies on large animals.)

- To determine germinal cell recovery, thereby allowing prognosis in cases of accidental irradiation.

IV. FINDINGS

- Sperm count reduction and recovery of sperm count are both dose related. At 400-600 rad, sperm count was zero at 156 weeks.

- By autoradiographic studies of 3H-thymidine uptake into spermatocytes in nonirradiated subjects, it was shown that there are approximately four cycles of spermatogenesis of approximately sixteen days each, so that the complete evolution of spermatogonia to mature sperm is approximately sixty-four days. This is approximately the same as other mammalian species.

- Urinary and plasma gonadotropins rose in proportion to testicular dose and fell with germinal recovery. Plasma FSH and LH also rose. Urinary estrogen remained unchanged. Urinary testosterone fell slightly after irradiation.

- Histologically, spermatogonia were the most radiosensitive. Spermatocytes were damaged above 200-300 rads. Spermatids showed no overt damage.

- Germinal cell recovery time increased as radiation dose increased. Complete recovery occurred within nine to eighteen months for doses of 100 rad and below. Complete recovery required five or more years for doses of 400-600 rad. Germinal tissue appears to be somewhat more radiosensitive in humans than other studied species.

V. FINANCIAL SUPPORT

Contract AST (45-1) 1780, U.S. Atomic Energy Commission

8 . Mavis Rowley, interview with ACHRE staff, 8 September 1994 (ACHRE No. ACHRE-051795-B) 6.

9 . Ibid., 12-13.

10 . Deposition of Mavis Rowley and Carl Heller, 19 July 1976, 32.

11 . Harold Bibeau, telephone interview with ACHRE staff, 11 August 1994 (ACHRE No. IND-081194-A).

12 . Depositions of John Henry Atkinson, 54; Ivan Dale Herland, 22, 68; Donald Eugene Mathena, 94; taken 14 October 1976 in Donald Mathena et al. v. Amos Reed et

al. Civil nos. 73-326, U.S. District Court, Dist. Oregon (ACHRE No. CORP-013095-A).

13 . Deposition of Carl Heller, 19 July 1976.

14 . L. C. Wertz to Warden C. T. Gladden, 10 July 1964 ("Dr. Heller stopped in the office . . .") (ACHRE No. IND-061594-A-1).

15 . William B. Hutchison, M.D., Joseph E. Primeau, and Carl G. Heller, M.D., Ph.D., to Dr. John C. McDougall, Assistant Director for Operations, National Institute of Child Health and Human Development, National Institutes of Health, 12 May 1966 ("This letter is in response . . .") (ACHRE No. DOE-082294-B-70).

16 . C. T. Gladden, Warden, to Mark Hatfield, Governor, 8 May 1963 ("I am glad to provide . . . ") (ACHRE No. IND-061594-A), 2; C.T. Gladden, Warden, to Hon. Robert Thornton, Attorney General, 9 September 1963 ("Carl Heller, Medical Research Programs") (ACHRE No. IND-061595-A); undated ("Consent and Release") (ACHRE No. IND-110994-A).

17 17. Mavis Rowley, interview with ACHRE staff, 8 September 1994, 36.

18 . Pacific Northwest Research Foundation, undated ("Policy and Procedures of the Pacific Northwest Research Foundation with Regard to Investigations Involving Human Subjects").

19 19. William Boly, "The Heller Experiments," Oregon Times Magazine, November 1977, 45.

20 . Robert Case v. State of Oregon et al., Civil no. 76-500; Paul Tyrell v. State of Oregon et al., Civil no. 76-499.

21 . Tom Toombs, Administrator of Corrections Division, undated testimony before Oregon legislature (ACHRE No. IND-101294-D-1), 7.

22 . Ibid., 11.

23 . James Ruttenber, telephone interview with Steve Klaidman (ACHRE staff), 20 July 1995 (ACHRE No. IND-072095-E).

24 . C. Alvin Paulsen, proposal to Atomic Energy Commission, undated ("Study of Irradiation Effects on the Human Testis: Including Histologic, Chromosomal and Hormonal Aspects") (ACHRE No. IND-110994-A-2). The following has been abstracted by staff from Dr. Paulsen's research proposal and annual progress reports:

I. OBJECTIVE

- To determine the dose-dependent relationship between external irradiation and cell kill and inhibition of mitosis in spermatogenic cells. The cells in question are spermatagonial stem cells, and the dose response would be expected to differ from other kinds of cells.

II. METHODOLOGY

- Subjects with normal ejaculates received 7.5-400 rad to both testes. The details of irradiation are not specified.

- Weekly seminal fluid was examined for the end-point response of azoospermia. Duration was not specified.

- Subjects and some controls received periodic unilateral testicular biopsies. Number not specified.

- Irradiated subjects agreed to be vasectomized at the completion of the experiment.

III. RATIONALE FOR THE USE OF HUMAN SUBJECTS

One cannot directly relate animal data to the human male with security. Among other things, the rate of spermatogenesis in man is different from that in various animal species.

IV. FINDINGS

- The average presterile period was 142 days.

- The maximum sterile period was 501 days.

- Spermatogenesis in man is more radiosensitive than in rodents and recovery time is longer. Man is more radiosensitive to complete sterility than rodents.

- Testicular biopsy by itself can reduce seminal fluid sperm concentration.

V. FINANCIAL SUPPORT

AEC contracts AT (45-1) 1781 and AT (45-1) 2225.

25 . C. Alvin Paulsen, telephone interview with Steve Klaidman (ACHRE), 20 July 1995 (ACHRE No. IND-072095-D).

26 . C. Alvin Paulsen, telephone interview with Steve Klaidman (ACHRE), 7 March 1995 (ACHRE No. ACHRE-030995-A).

27 . C. Alvin Paulsen, interview with ACHRE staff, 8 September 1994, 9.

28 . T. W. Thorslund and C. Alvin Paulsen, "Effects of X-Ray Irradiation on Human Spermatogenesis," Proceedings of the National Symposium on Natural and Manmade Radiation in Space, ed. E. A. Warman (NASA Document TM X-2440, 1972), 229-232.

29 . "Prison Inmates Sought in Prison Experiment," The (Portland) Oregonian, August 1963.

30 . C. Alvin Paulsen, proposal to Atomic Energy Commission, undated ("Study of Irradiation Effects on the Human Testis: Including Histologic, Chromosomal and Hormonal Aspects").

31 . C. Alvin Paulsen, interview with ACHRE staff, 8 September 1994, 56-57.

32 . C. E. Heffron, M.D., Prison Physician, to All Inmates Interested, 2 November 1964 (ACHRE No. WASH-112294-A-1).

33 . Harold Bradley, Director, Adult Corrections Division, to Hon. Daniel J. Evans, Governor, Washington State, 9 March 1976 ("Secretary Morris has asked . . .") (ACHRE No. WASH-112294-A-2).

34 . Paulsen, telephone interview with ACHRE staff, 20 July 1995.

35 . Ibid.

36 . University of Washington, Research and Clinical Investigations Committee, proceedings of 10 December 1969 (ACHRE No. WASH-112294-A-3), 4.

37 . Bradley to Evans, 2.

38 . George Farwell, Vice President for Research, University of Washington, to John Totter, Division of Biology and Medicine, 16 July 1969 ("Thank you very much for your prompt response") (ACHRE No. DOE-082294-B-71).

39 . Audrey Holliday, Research Administrator, Department of Institutions, to William Conte, Director, Department of Institutions, 18 March 1970 ("I received the

review . . .") (ACHRE No. WASH-112294-A-4), 2.

40 . Ibid.

41 . Research Review Committee, Department of Institutions, to Audrey Holliday, Research Administrator, Department of Institutions, 13 March 1970 ("Disposition of Division Review Committee in Regard to Irradiation Project of Dr. C. Alvin Paulsen at the State Penitentiary") (ACHRE No. WASH-112294-A-5), 2.

42 41. Audrey Holliday to C. Alvin Paulsen, 23 March 1970 ("The Department of Institutions received copies . . .") (ACHRE No. WASH-112294-A-6).

43 . Bradley to Evans, 9 March 1976, 2.

44 . Karen Dorn Steele, "Experiments A Life Sentence," Spokane Spokesman- Review, 19 June 1994, 1.

45 . C. Alvin Paulsen, telephone interview with ACHRE staff, 7 March 1995 (ACHRE No. ACHRE-030795-A).

46 . Nell Fraser to Oscar Bennett, 23 December 1975 ("Contracts AT[45-1]-1780-1781, Irradiation of Prison Volunteers") (ACHRE No. DOE-082294-B).

47 . Ibid.

48 . Karen Dorn Steele, "State Agrees to Find Victims of Experiments," Spokane Spokesman-Review, 16 December 1994, 1.

49 . The Advisory Committee calculated the risk from the testicular irradiation study as follows:

The radiation dose to the testicles ranged from 7.5 to 600 rem. The Committee's risk analysis was based on a 600-rem dose and the following three assumptions:

1. The testicles have average radiation sensitivity.

2. The risk of cancer is linearly related to dose.

3. The risk of cancer is linearly related to the amount of tissue exposed.

Based on these assumptions, the Committee calculated the maximum risk expected to any of the prisoner subjects using the following two steps:

1. Calculate effective dose by multiplying a 600-rem testicular dose by the proportion of the body exposed: (2 x 25 grams/70 kilograms), or (50/70,000) x 600 rem = 429 mrem.

2. Calculate the risk (assuming average radiosensitivity) by multiplying this effective dose by the age-specific risk for males age 25: (0.429 x 921/1,000,000 person rem), or a risk of about 0.4/1,000 for males age 25.

50 . Lee Davidson, "Did Secret Radiation Tests on Inmates Doom Offspring?" Deseret News, 10 November 1994, A1.

51 . Lowell A. Woodbury, Radiological Safety Officer, to Dr. A. Ray Olpin, President of the University of Utah, 9 July 1959 ("Resume of Activities While Acting as Health Physicist and Radiological Safety Officer to the University of Utah Isotope Committee") (ACHRE No. UTAH-111394-A-2). A 1964 article titled "The Kinetics of Granulopoiesis in Normal Man" appears to describe the experiment. The article compares methods of labeling white blood cells with various radioisotopes and formulates a concept of forming white cells in normal man based on information obtained using a DFP32 (diisopropylfluorophosphate) label. G. E. Cartwright, J. W. Athens, and M. M. Wintrobe, "The Kinetics of Granulopoiesis in Normal Man," Blood 24, no. 6 (December 1964).

52 . Everett Evans, Professor of Surgery, Medical College of Virginia, to W. F. Smyth, State Penitentiary, 13 December 1951 ("We continue to enjoy and appreciate . . .") (ACHRE No. VCU-012595-A-17).

53 . Matthew Block to John Lawrence, 10 April 1969 ("I have met a very serious . . .") (ACHRE No. DOE-121294-B-7).

54 54. Matthew Block, Text-Atlas of Hematology (Philadelphia: Lea & Febiger, 1966), 503.

55 . Henry De Bernardo, "University of Pennsylvania and the Holmesburg Connection," Philadelphia News Observer, 12 October 1994, 12; Shelby Thompson, Director (Acting), Division of Information Services, AEC, to H. C. Baldwin, Information Officer, Chicago Operations Office, 21 August 1953 ("Information Guidance on Any Experimentation Involving Human Beings") (ACHRE No. DOE-051094-A-473); "10 San Quentin Felons Used for Atom Tests," source unknown, 12 April 1949; Oak Ridge National Laboratory Human Studies Review Taskforce, University of Oklahoma Human Studies Reviews, undated ("Findings for License 35-03176-01") (ACHRE No. NRC-012695-A).

56 . C. Alvin Paulsen, M.D., interview with ACHRE staff, 8 September 1994. The meeting Paulsen referred to took place on 19-21 May 1969. The proceedings of the conference are reported in the Annals of the New York Academy of Sciences 169 (21 January 1970): 293-593. Paulsen is not listed among those who offered formal presentations.

57 . Published accounts of this research include Alf S. Alving et al., "Procedures Used at Stateville Penitentiary for the Testing of Potential Antimalarial Agents," Journal of Clinical Investigation 27, no. 3 (part 2) (1948): 2-5; Joseph E. Ragen and Charles Finston, Inside the World's Toughest Prison (Springfield, Ill.: Charles C. Thomas, 1962), 391-395; Nathan F. Leopold, Jr., Life Plus 99 Years (Garden City, N.Y.: Doubleday, 1958), 305-355. David J. Rothman, in Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: Basic Books, 1991), gives some considerable attention to this tropical disease research in Illinois in a chapter entitled "Research at War," 30-50.

58 . These rules, as approved by the AMA House of Delegates on 11 December 1946, read as follows:

1. The voluntary consent of the individual on whom the experiment is to be performed must be obtained; 2. The danger of each experiment must be previously investigated by animal experimentation, and 3. The experiment must be performed under proper medical protection and management.

From "Minutes of the Supplemental Session of the House of Delegates of the American Medical Association, Held in Chicago, December 9-11, 1946," Journal of the American Medical Association 133 (4 January 1947): 35. For more background on the development of the AMA standards for human experimentation, see chapter 2 of this report.

59 . "Ethics Governing the Service of Prisoners as Subjects in Medical Experiments: Report of a Committee Appointed by Governor Dwight H. Green of Illinois," Journal of the American Medical Association 136 (14 February 1948): 457-458.

60 . "Abstract of the Proceedings of the House of Delegates Meeting, Denver, 2-5 December 1952," Journal of the American Medical Association 150 (27 December 1952): 1699. The Illinois delegation to this meeting introduced the resolution. It is likely that the Illinois group was motivated by the possibility that Nathan Leopold, who had participated in a highly publicized kidnapping and murder that had been dubbed by the press as "the crime of the century," might be paroled as a result of his participation as a subject in the wartime tropical disease research at Stateville Prison.

61 61. Martin Jaffe and C. Stewart Snoddy, "An International Survey of Clinical Research in Volunteers," in Appendix to Report and Recommendations: Research Involving Prisoners, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Washington, D.C.: DHEW, 1976).

62 62. Aileen Adams and Geoffrey Cowan, "The Human Guinea Pig: How We Test New Drugs," World (5 December 1971): 20.

63 . Jon M. Harkness, "Vivisectors and Vivishooters: Medical Experiments on American Prisoners before 1950," paper presented at "Regulating Human Experimentation in the United States: The Lessons of History," Columbia College of Physicians and Surgeons, New York, 23 February 1995.

64 . National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Report and Recommendations: Research Involving Prisoners (Washington, D.C.: DHEW, 1976), 36.

65 . Walter Rugaber, "Prison Drug and Plasma Projects Leave Fatal Trail," New York Times, 29 July 1969, 1, 20-21.

66 . Jessica Mitford, "Experiments Behind Bars: Doctors, Drug Companies, and Prisoners," Atlantic Monthly 23, January 1973, 64-73.

67 . Jessica Mitford, Kind and Usual Punishment: The Prison Business (New York: Alfred A. Knopf, 1973), 138-168.

68 . For an analysis of the chain of events leading up to Senator Kennedy's hearings, see Mark S. Frankel, "Public Policymaking for Biomedical Research: The Case of Human Experimentation" (Ph.D. diss., George Washington University, 1976), 190-192. For the transcripts of the actual hearings, see U.S. Congress, Senate, Committee on Labor and Public Welfare, Subcommittee on Health, Hearings on Quality of Health Care--Human Experimentation, on S. 974, S. 878, and S. J. Res. 71, 93d Cong., 1st Sess., part 3, 7 March 1973 (Washington, D.C.: GPO, 1973).

69 . A record of the National Commission's work can be found in a complete set of the commission's papers in the archives of the National Reference Center for Bioethics Literature, Kennedy Institute of Ethics, Georgetown University. For a useful (and critical) overview of the commission's work with regard to prisoners see Roy Branson, "Prison Research: National Commission Says 'No, Unless . . .,'" Hastings Center Report, February 1977, 15-21.

70 . The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Report and Recommendations: Research Involving Prisoners, 8.

71 . Branson, "Prison Research," 17; National Commission, Staff Paper, "Biomedical and Behavioral Research Involving Prisoners," 5 March 1976, 12-13, Archives, National Reference Center for Bioethics Literature, Kennedy Institute of Ethics, Georgetown University, National Commission Papers, Box 6; form letter sent to randomly selected prisoners for permission to conduct an interview, 3 November 1975, Archives, National Reference Center for Bioethics Literature, Kennedy Institute of Ethics, Georgetown University, National Commission Papers, Box 22.

72 . National Commission, Report and Recommendations: Research Involving Prisoners, 16-19.

73 . Frankel, 402; see also the enabling legislation for the commission, the National Research Act, P.L. 93-348.

74 73. Joseph Califano to Kenneth J. Ryan, Chairman of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 2 May 1978; see also a memorandum from Julius P. Richmond, Assistant Secretary for Health, to Califano, 26 July 1977. Both documents can be found in the Office of the Director (OD) Files, National Institutes of Health, Central Files, "Human Subjects" folders.

75 . For the proposed DHEW regulations see the Federal Register 43 (5 January 1978), 1050-1053; the final regulations can be found in the Federal Register 43 (16 November 1978), 53652-53656. These regulations remain essentially unchanged today and can be found at 45 C.F.R. part 46, subpart C. These regulations have also been adopted by other federal agencies that have any concern with human experimentation as part of the so-called Common Rule, with the exception of the FDA (see below).

76 . Federal Register 43 (5 January 1978), 1051.

77 . Federal Register 45 (30 May 1980), 36386-36392.

78 . Henry Fante et al. v. Department of Health and Human Services et al., U.S. District Court, Eastern District of Michigan, Southern Division, Civil Action No. 80-72778. The records from this case are now kept at the National Archives, Great Lakes Regional Archives, Chicago, Accession No. 21-88-0016, Location No. 331792-332283, Box No. 269. FDA officials announced the decision to stay indefinitely the regulations in the Federal Register 46 (7 July 1981), 35085. The current "stayed" status of the FDA prison research regulations can be found at 21 C.F.R. part 50, subpart C.

79 . Charles Miller, as quoted in Stephen Gettinger and Kevin Krajick, "The Demise of Prison Medical Research," Corrections Magazine 5 (December 1979): 12.

80 . On 1 January 1960, NIH awarded $97,256.00 to the LMRI of Boston University to carry out this study. Irving Ladimer, who had completed a doctor of law dissertation at George Washington University in 1958 on the legal and ethical aspects of human experimentation, served as the project's principal investigator through June 1962, when he left Boston University. Ladimer was replaced as principal investigator by his chief assistant, Donald A. Kennedy, an anthropologist by training, who saw the project through to completion. The first characterization of the purpose of the project is taken from page 1 of Kennedy's preface to the final report: "A Study of the Legal, Ethical, and Administrative Aspects of Clinical Research Involving Human Subjects: Final Report of Administrative Practices in Clinical Research, Research Grant No. 7039," Law-Medicine Research Institute, Boston University (1963) (hereafter cited as LMRI final report); both chapter and page numbers will be provided because pages within chapters are numbered separately. The second, and lengthier purpose statement is taken from page 1 of chapter 1 of the LMRI final report, "Focus of the Inquiry." This unpublished report is in the collections of the Mugar Memorial Library, Boston University (ACHRE No. BU-053194-A). This report, which is more than 360 typewritten pages, is a wealth of information that has remained largely untapped by recent scholars interested in the development of research ethics in this country. The few citations of the project that do appear in the published literature almost all refer to a threummary that appears in William J. Curran, "Governmental Regulation of the Use of Human Subjects in Medical Research: The Approach of Two Agencies," Daedalus 98 (spring 1969): 546-548. In this very brief reference to the project, Curran makes no mention of the "invitational work conferences," which the project staff identified as the investigational technique that "yielded the most valuable information." This characterization appears on page 8 of chapter 2, which is devoted to research method; pages 3-5 of the same chapter provide more details on the specific methodology employed in these conferences.

81 . LMRI final report, chapter 8, Roger W. Newman, LL.B. [of the project staff], "The Participation of Prisoners in Clinical Research: Analytic Summary of a Conference," 1-2. A collection of documents related to the project is located in the files of the Center for Law and Health Sciences, School of Law, Boston University. This entity is the successor to the Law-Medicine Research Institute (ACHRE No. BU-062394-A).

82 . Newman's "Analytic Summary" is more than 100 pages of typescript and seems to cover the conference in considerable detail. Also, comparisons between the transcripts of other LMRI "invitational work conferences" that have survived with the related summaries produced for the final report reveal a skillful and fair rendering of the meetings.

83 . LMRI final report, chapter 8, 27.

84 . Ibid., 18.

85 . Ibid., 31.

86 . Ibid.

87 . Ibid., 85.

88 . Ibid., 71.

89 . Ibid., 72.

90 . Ibid., 74.

91 . Ibid., 88-89.

92 . Ibid., 85-86.

93 . Ibid., 93.

94 . Ibid., 89-90.

95 . Ibid., 96.

96 . Deposition of Carl Heller, 19 July 1976, 32. Heller said he avoided the word cancer because "I didn't want to frighten them [the prisoners]." Dr. Paulsen said in a telephone interview on 12 September 1995 that he explained to the inmates that data from Hiroshima and Nagasaki "showed no additional incidence of testicular cancer." Undated consent forms from the Washington experiment differ. Some specify an "extremely small" risk of testicular cancer, and others do not specifically mention cancer. C. A. Paulsen, interview with ACHRE staff, 12 September 1995 (ACHRE No. ACHRE-091295-A).