How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965–1991

Journal of Policy History

Volumn 21, Issue 1, 2009, Pages 3-37

  Schrag, Zachary M ^a  

^a GEORGE MASON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 78049426013     PISSN: 08980306     EISSN: 15284190     Source Type: Journal    
DOI: 10.1017/S0898030609090010     Document Type: Article

References (113)

1. Office of Science and Technology Policy et al. “Federal Policy for the Protection of Human Subjects: Notices and Rules,” Federal Register 56 (18 June 1991): 28002–28032.
2. Jeffrey M. Cohen, Elizabeth Bankert, and Jeffrey A. Cooper, “History and Ethics,” CITI Course in the Protection of Human Research Subjects, https://www.citiprogram.org (30 October 2006).
3. Robert S. Broadhead, “Human Rights and Human Subjects: Ethics and Strategies in Social Science Research,” Sociological Inquiry 54 (April 1984): 107. Broadhead cites two articles about controversial research, neither of which shows that such controversy led to IRBs’ powers.
4. Laura Stark, “Victims in Our Own Minds? IRBs in Myth and Practice,” Law & Society Review 41 (December 2007): 779.
5. Murray L. Wax, “Human Rights and Human Subjects: Strategies in Social Science Research,” Sociological Inquiry 55 (October 1985): 423
6. Rena Lederman, “The Perils of Working at Home: IRB ‘Mission Creep’ as Context and Content for an Ethnography of Disciplinary Knowledges,” American Ethnologist 33 (November 2006): 486
7. Robert L. Kerr, “Unconstitutional Review Board? Considering a First Amendment Challenge to IRB Regulation of Journalistic Research Methods,” Communication Law & Policy 11 (2006): 412
8. C. K. Gunsalus et al. “The Illinois White Paper Improving the System for Protecting Human Subjects: Counteracting IRB ‘Mission Creep,’” University of Illinois Law & Economics Research Paper No. LE06-016, 2006, http://ssrn.com/abstract=902995 (25 May 2007), 4.
9. Laura Jeanine Morris Stark, “Morality in Science: How Research Is Evaluated in the Age of Human Subjects Regulation” (Ph.D. diss. Princeton University, 2006), uses National Archives record group 443, but she reads different documents to answer different questions from those posed here.
10. Office of NIH History, “A Short History of the National Institutes of Health,” http://history.nih.gov/exhibits/history/index.html (3 March 2008)
11. Albert R. Jonsen, The Birth of Bioethics (New York, 1998), 142.
12. David J. Rothman and Sheila M. Rothman, The Willowbrook Wars: Bringing the Mentally Disabled into the Community (1984; reprint, New Brunswick, N.J. 2005), 260–66
13. Walter Sullivan, “Project on Hepatitis Research Is Now Praised by State Critic,” New York Times, 24 March 1971.
14. Elinor Langer, “Human Experimentation: Cancer Studies at Sloan-Kettering Stir Public Debate on Medical Ethics,” Science 143 (7 February 1964): 552.
15. Henry K. Beecher, “Ethics and Clinical Research,” New England Journal of Medicine 274 (16 June 1966): 1355.
16. James A. Shannon, Interview by Mark Frankel, New York City, 13 May 1971. Recording in author's possession.
17. House Committee on Government Operations, The Use of Social Research in Federal Domestic Programs: Part IV—Current Issues in the Administration of Federal Social Research, 90th Cong. 1st. sess. 1967, 217.
18. William J. Curran, “Governmental Regulation of the Use of Human Subjects in Medical Research: The Approach of Two Federal Agencies,” Daedalus 98 (Spring 1969): 575.
19. Public Health Service, PPO #129: Clinical Investigations Using Human Subjects, 8 February 1966, Res 3-1. Human Subjects Policy & Regulations 1965–67, National Institutes of Health, Central Files of the Office of the Director, NIH, 1960–1982, Record Group 443, National Archives, College Park, Md. (hereafter RG 443).
20. James A. Haggarty, “Applications Involving Research on Human Subjects,” 28 February 1966, Res 3-1. Human Subjects Policy & Regulations 1965–67, RG 443.
21. Biomedical Science and Its Administration (Washington, D.C. 1965), 130–31.
22. Psychology seems to have dominated. In Fiscal Year 1972, for example, the NIH awarded fifty-eight research training grants in psychology, thirteen in sociology, and six in anthropology.
23. Senate Committee on Labor and Human Resources, National Research Service Award Act, S. Report. 93-381, 93d Cong. 1st sess. 1973, 10.
24. House Committee on Government Operations, Special Inquiry on Invasion of Privacy, 89th Cong. 1st sess. 1965, 5.
25. Cornelius E. Gallagher, “Why House Hearings on Invasion of Privacy,” American Psychologist, November 1965
26. reprinted in House Committee on Government Operations, Special Inquiry on Invasion of Privacy, 397–99.
27. House Committee on Government Operations, Special Inquiry on Invasion of Privacy, 295.
28. Gresham M. Sykes, “Feeling Our Way: A Report on a Conference on Ethical Issues in the Social Sciences,” American Behavioral Scientist 10 (June 1967): 11.
29. “Minutes,” Social Problems 14 (Winter 1967): 347.
30. Margaret Mead, “Research with Human Beings: A Model Derived from Anthropological Field Practice,” Daedalus 98 (Spring 1969): 361.
31. American Sociological Association, Resolution No. 9, 1 September 1966, in House Committee on Government Operations, The Use of Social Research, Part IV, 256–57.
32. Public Health Service, “Investigations Involving Human Subjects, Including Clinical Research: Requirements for Review to Insure the Rights and Welfare of Individuals: Clarification,” 12 December 1966, Res 3-1. Human Subjects Policy & Regulations 1965–67, RG 443.
33. House Committee on Government Operations, The Use of Social Research, Part IV, 220.
34. Although there was no comprehensive study of IRBs before 1976, anecdotal evidence suggests that universities began applying IRB requirements to nonmedical research in a large way only after 1971. See Bernard Barber, “Some Perspectives on the Role of Assessment of Risk/Benefit Criteria in the Determination of the Appropriateness of Research Involving Human Subjects,” December 1975, p. 3, box 5, meeting #15(A), tabs 14–17, National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, Collection, National Reference Center for Bioethics Literature, Kennedy Institute of Ethics, Georgetown University (hereafter NCPHS-GU).
35. Eugene A. Confrey, “Status of action to revise policy statement on the use of human subjects in PHS-sponsored activities, and to improve the implementation of these policies,” 18 June 1968, Res 3-1. Human Subjects Policy & Regulations 1968–72, RG 443.
36. Stephen P. Hatchett, “Status Report of Experience with PPO #129,” 31 May 1968, Res 3-1. Human Subjects Policy & Regulations 1968–72, RG 443.
37. “Origins of the DHEW Policy on Protection of Human Subjects,” in Senate Committee on Labor and Human Resources, National Advisory Commission on Health Science and Society, 92d Cong. 1st. sess. 1971, 1–3.
38. Mark E. Conner, “Summary Minutes: DHEW Policy on Protection of Human Subjects, Meeting at Massachusetts General Hospital, April 30, 1971,” Res 3-1. Human Subjects Policy & Regulations 1968–1972, RG 443.
39. Department of Health, Education, and Welfare, The Institutional Guide to DHEW Policy on Protection of Human Subjects (Washington, D.C. 1971), 2.
40. James Welsh, “Protecting Research Subjects: A New HEW Policy,” Educational Researcher, March 1972, 12.
41. James H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (1981; reprint, New York, 1993), 1.
42. Senate, A Bill to Establish Within the Executive Branch an Independent Board to Establish Guidelines for Experiments Involving Human Beings, S. 934, 93d Cong. 1st sess. 1973.
43. Jacob K. Javits, remarks, Congressional Record, 15 February 1973.
44. Senate Committee on Labor and Human Resources, National Research Service Award Act, S. Report. 93-381, 93d Cong. 1st sess. 1973, 23.
45. Senate Committee on Labor and Human Resources, National Research Service Award Act, 15.
46. Sharland Trotter, “Strict Regulations Proposed for Human Experimentation,” APA Monitor 5 (February 1974): 8.
47. Mark Frankel, “Public Policymaking for Biomedical Research: The Case of Human Experimentation” (Ph.D. diss. George Washington University, 1976), 187 and 298
48. Richard B. Stephenson to Robert P. Akers, 4 October 1972, Res 3-1-A Study Group Review of Policies 1973–75, RG 443.
49. Frankel, “Public Policymaking for Biomedical Research,” 187, 202, 298.
50. DHEW, “Protection of Human Subjects: Proposed Policy,” Federal Register 38 (9 October 1973): 27882.
51. DHEW, “Protection of Human Subjects,” Federal Register 39 (30 May 1974): 18914, 18917.
52. McCarthy to Study Group for Review of Policies on Protection of Human Subjects in Biomedical Research, 3 May 1973, Res 3-1. Human Subjects Policy & Regulations 1973–82, RG 443; David F. Kefauver, cited by Frankel, “Public Policymaking for Biomedical Research,” 275 and 320. n. 406.
53. Charles R. McCarthy, “Reflections on the Organizational Locus of the Office for Protection from Research Risks,” in National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants (Washington, D.C. 2001), http://www.georgetown.edu/research/nrcbl/nbac/pubs.html (4 November 2006), H-8.
54. Richard A. Tropp, “A Regulatory Perspective on Social Science Research,” in Tom L. Tom L. et al. eds. Ethical Issues in Social Science Research (Baltimore, 1982), 39.
55. “Mechanisms for Applying Ethical Principles to the Conduct of Research Involving Human Subjects: The Institutional Review Board,” preliminary draft, 5 November 1976, p. 7, box 11, meeting #24, tabs 5–6, NCPHS-GU.
56. Lamont-Havers, “Discussion Paper re DHEW Administration of Ethical Issues Relating to Human Research Subjects,” draft, 3 April 1974, Res 3-1-b-1. Interdept. Work. Group Uniform Fed. Pol. RG 443.
57. Lamont-Havers to Deputy Director, NIH, 5 September 1974, Res 3-1-B. Proposed Policy Protection Human Subjects 1974, RG 443.
58. Department of Health, Education, and Welfare, “Protection of Human Subjects: Technical Amendments,” Federal Register 40 (13 March 1975): 11854–11858.
59. Bradford H. Gray, Robert A. Cooke, and Arnold S. Tannenbaum, “Research Involving Human Subjects,” Science, new series, 201 (22 September 1978): 1094–101.
60. Survey Research Center, “Research Involving Human Subjects,” 2 October 1976, box 11, meeting #23, tab 3(a), NCPHS-GU.
61. E. L. Pattullo, “Modesty Is the Best Policy: The Federal Role in Social Research,” in Beauchamp et al. eds. Ethical Issues in Social Science Research, 382. The same could be said for studies conducted by the federal government itself. In 1979, officials within the Department of Health, Education, and Welfare found that most surveys were conducted without IRB review, “and there is no evidence of any adverse consequences.” “Applicability to Social and Educational Research,” attached to Peter Hamilton to Mary Berry et al. 27 March 1979, Res 3-1-B. Proposed Policy Protections Human Subjects 1978–79, RG 443.
62. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHS), Appendix to Report and Recommendations: Institutional Review Boards (Washington, D.C. 1978)
63. NCPHS, Transcript of the Public Hearings, April 5, April 15, and May 3, 1977 on Institutional Review Boards (Bethesda, and Springfield, Va. 1977), 692.
64. In recent years, the federal officials suggested that some scholarship, including most oral history, does not require IRB review because it is not generalizable. Since the term “generalizable” was introduced primarily to distinguish research from the practice of medicine, this recent usage has scant relation to the intent of the commission. See NCPHS, Transcript, Meeting #15, 13–16 February 1976 (Bethesda, 1976), 317–18
65. James D. Shelton, “How to Interpret the Federal Policy for the Protection of Human Subjects or ‘Common Rule’ (Part A),” IRB: Ethics and Human Research 21 (November–December 1999): 6
66. Bruce Craig, “Oral History Excluded from IRB Review,” Perspectives, December 2003.
67. NCPHS, “Institutional Review Board; Report and Recommendations,” Federal Register 41 (30 November 1978): 56175, 56182.
68. NCPHS, Transcript, Meeting #23, October 1976 (Bethesda, 1976), 2-52–2-57
69. Survey Research Center, “Research Involving Human Subjects,” 2 October 1976, box 11, meeting #23, tab 3(a), NCPHS-GU.
70. NCPHS, Transcript, Meeting #39, February 1978, 44.
71. “Applicability to Social and Educational Research.”
72. “Applicability to Social and Educational Research.”
73. “Proposed Regulations Amending Basic HEW Policy for Protection of Human Research Subjects,” Federal Register 44 (14 August 1979): 47693.
74. “Proposed Regulations Amending Basic HEW Policy,” 47688.
75. Pool to F. William Dommel, 8 November 1979, box 24, Human Subjects Mailings 2/4, Pool papers
76. Pool, “Censoring Research,” Society, November–December 1980, 40
77. Pool, “Prior Restraint,” New York Times, 16 December 1979
78. Pool, “Protecting Human Subjects of Research: An Analysis on Proposed Amendments to HEW Policy,” PS 12 (Autumn 1979): 452.
79. Robert J. Levine et al. panelists, “The Political, Legal, and Moral Limits to Institutional Review Board (IRB) Oversight of Behavioral and Social Science Research,” in Paula Paula, ed. PRIM&R Through the Years: Three Decades of Protecting Human Subjects, 1974–2005 (Boston, 2006), 38–40.
80. Edward L. Pattullo, “The Political, Legal, and Moral Limits to Institutional Review Board (IRB) Oversight of Behavioral and Social Science Research,” in Knudson, ed. PRIM&R Through the Years, 40.
81. American Association of University Professors, “Regulations Governing Research on Human Subjects,” Academe (December 1981): 363.
82. The full text is printed as J. W. Peltason, “Comment on the Proposed Regulations from Higher Education and Professional Social Science Associations,” IRB: Ethics and Human Research 2 (February 1980): 10.
83. For a range of critics, see Society (November–December 1980).
84. “Issues Related to HHS Human Subject Research,” c. 20 May 1980, Res 3-1-B. Proposed Policy Protections Human Subjects 1979–80, RG 443.
85. “Applicability to Social and Educational Research”
86. Richard A. Tropp, “What Problems Are Raised When the Current DHEW Regulation on Protection of Human Subjects Is Applied to Social Science Research?” in NCPHS, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Appendix, Volume II. (Washington, D.C. 1978), 18–21.
87. Joan Z. Bernstein, “The Human Research Subjects H.E.W. Wants to Protect,” New York Times, 24 January 1980
88. Ithiel de Sola Pool, “Censoring Research,” Society (November–December 1980): 39.
89. Alexander Capron, “IRBs: The Good News and the Bad News,” in Knudson, ed. PRIM&R Through the Years, 72.
90. Department of Health and Human Services, “Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects,” Federal Register 46 (26 January 1981): 8369, 8373, 8386.
91. Tropp, “A Regulatory Perspective on Social Science Research,” 398.
92. Richard T. Louttit, “Government Regulations: Do They Facilitate or Hinder Social and Behavioral Research?” in Joan E. Joan E. ed. NIH Readings on the Protection of Human Subjects in Behavioral and Social Science Research: Conference Proceedings and Background Papers (Frederick, Md. 1984), 180.
93. Bettina Huber, “New Human Subjects Policies Announced; Exemptions Outlined,” American Sociological Association Footnotes, November 1981, 1.
94. Robert Reinhold, “New Rules for Human Research Appear to Answer Critics’ Fear,” New York Times, 22 January 1981.
95. E. L. Pattullo, “How General an Assurance?” IRB: Ethics and Human Research 3 (May 1981): 8.
96. Pattullo, “How General an Assurance?” 8–9.
97. Pattullo, “Governmental Regulation of the Investigation of Human Subjects in Social Research,” Minerva 23 (1985): 529.
98. “Concurrences of Departments and Agencies Including Proposed Departures from Model Policy,” 3 May 1985, RES 3-1-D Proposed Mondel [sic] Federal Policy Protection of Human Subjects, National Institutes of Health, OD Central Files, Office of the Director, NIH.
99. Office of Science and Technology Policy, “Proposed Model Federal Policy for Protection of Human Subjects,” Federal Register 51 (3 June 1986): 20206.
100. “Federal Policy for the Protection of Human Subjects: Notice and Proposed Rules,” Federal Register 53 (10 November 1988): 45663, 45672.
101. Office of Science and Technology Policy et al. “Federal Policy for the Protection of Human Subjects: Notices and Rules,” Federal Register 56 (18 June 1991): 28007.
102. “Applicability to Social and Educational Research.”
103. Louttit, “Government Regulations,” in Sieber, ed. NIH Readings, 179.
104. Office for Protection from Research Risks, “Exempt Research and Research That May Undergo Expedited Review,” OPRR Reports 95–102 (5 May 1995), http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc95-02.htm (22 August 2007).
105. Christopher Shea, “Don’t Talk to the Humans: The Crackdown on Social Science Research,” Lingua Franca, September 2000
106. Patricia Cohen, “As Ethics Panels Expand Grip, No Field Is Off Limits,” New York Times, 28 February 2007.
107. Carolyn Fluehr, “Informed Consent in Anthropological Research: We Are Not Exempt,” Human Organization 53 (Spring 1994): 4, 5, 9 n. 7.
108. Alan Sica, “Sociology as a Worldview,” American Journal of Sociology 102 (July 1996): 254.
109. American Association of University Professors, “Research on Human Subjects: Academic Freedom and the Institutional Review Board” (2006), http://www.aaup.org/AAUP/comm/rep/A/humansubs.htm (2 September 2008).
110. Charles R. McCarthy, “Introduction: The IRB and Social and Behavioral Research,” in Sieber, ed. NIH Readings, 8–9.
111. Laud Humphreys, Tearoom Trade: Impersonal Sex in Public Places, enlarged ed. (Chicago, 1975), 171, 199–203, 217.
112. Lauren H. Seiler and James M. Murtha, “Federal Regulation of Social Research,” Freedom at Issue (November–December 1979): 30.
113. DHEW, “Protection of Human Subjects,” Federal Register 39 (30 May 1974): 18914.