Protecting human beings: Institutional review boards and social science research

Academe

Volumn 87, Issue 3, 2001, Pages 55-66

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EID: 0012882865     PISSN: 01902946     EISSN: None     Source Type: Journal    
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References (48)

1. The social sciences encompass a wide array of academic specialties, but conventionally refer to the disciplines of anthropology, economics, geography, political science, psychology, and sociology. With apologies to historians, many of whom would not accept the designation of social scientist, this report will use the phrase social science to refer also to those branches of historical research that have been subject to the government's regulations.
2. The Common Rule, formally titled "Protection of Human Subjects," is part 46 of Title 45 of the Code of Federal Regulations (hereafter cited in the text as 45 CFR 46). Among the federal agencies that do not subscribe to the Common Rule is the National Endowment for the Humanities. Eighteen states and the District of Columbia have statutes for the protection of human subjects. Most of these laws focus on medical research or, more narrowly, on the treatment and care of the mentally ill. The states are Arizona, California, Delaware, Florida, Iowa, Louisiana, Minnesota, Montana, New Mexico, New York, North Carolina, Oklahoma, Oregon, South Dakota, Tennessee, Texas, Vermont, and Virginia.
3. Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program for Protection of Research Subjects (Washington, D.C., 1998), V-10. According to the same report, 37 percent of IRBs had used their authority to suspend or terminate approved research. The reasons for these actions included failure of the researcher to obtain approval to continue the study and the use of procedures not approved by the IRB.
4. Evaluation of NIH, II-8; C. K. Gunsalus, An Examination of Issues Presented by Proposals to Unify and Expand Federal Oversight of Human Subject Research (National Bioethics Advisory Commission, 1998), 9.
5. Evaluation of NIH, II-8; C. K. Gunsalus, An Examination of Issues Presented by Proposals to Unify and Expand Federal Oversight of Human Subject Research (National Bioethics Advisory Commission, 1998), 9.
6. Quoted in Bradford H. Gray, "The Regulatory Context of Social and Behavioral Research," in Ethical Issues in Social Science Research, ed. Tom L. Beauchamp, Ruth R. Faden, R. Jay Wallace, Jr., LeRoy Walters (Baltimore: The Johns Hopkins University Press, 1982), 331.
7. The policy is available at www.research.umn.edu/subjects.htm.
8. The organizations were the American Anthropological Association, the American Association of University Professors, the American Historical Association, the American Political Science Association, the American Sociological Association, the Oral History Association, and the Organization of American Historians.
9. "Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure," 63 Federal Register 60363. The codes of ethics of several organizations refer specifically to IRBs and the obligations their members may have under federal regulations. See, for example, American Historical Association, Statement on Standards of Professional Conduct (1991), American Sociological Association, Code of Ethics (1997), American Political Science Association, Guide to Professional Ethics in Political Science (1998), and Oral History Association, Guidelines and Principles (2000).
10. "Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure," 63 Federal Register 60363. The codes of ethics of several organizations refer specifically to IRBs and the obligations their members may have under federal regulations. See, for example, American Historical Association, Statement on Standards of Professional Conduct (1991), American Sociological Association, Code of Ethics (1997), American Political Science Association, Guide to Professional Ethics in Political Science (1998), and Oral History Association, Guidelines and Principles (2000).
11. "Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure," 63 Federal Register 60363. The codes of ethics of several organizations refer specifically to IRBs and the obligations their members may have under federal regulations. See, for example, American Historical Association, Statement on Standards of Professional Conduct (1991), American Sociological Association, Code of Ethics (1997), American Political Science Association, Guide to Professional Ethics in Political Science (1998), and Oral History Association, Guidelines and Principles (2000).
12. "Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure," 63 Federal Register 60363. The codes of ethics of several organizations refer specifically to IRBs and the obligations their members may have under federal regulations. See, for example, American Historical Association, Statement on Standards of Professional Conduct (1991), American Sociological Association, Code of Ethics (1997), American Political Science Association, Guide to Professional Ethics in Political Science (1998), and Oral History Association, Guidelines and Principles (2000).
13. "Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure," 63 Federal Register 60363. The codes of ethics of several organizations refer specifically to IRBs and the obligations their members may have under federal regulations. See, for example, American Historical Association, Statement on Standards of Professional Conduct (1991), American Sociological Association, Code of Ethics (1997), American Political Science Association, Guide to Professional Ethics in Political Science (1998), and Oral History Association, Guidelines and Principles (2000).
14. Testimony of Murray L. Wax (Anthropology), Washington University in St. Louis; Joan E. Sieber (Psychology), California State University-Hayward; and Linda Shopes, Pennsylvania Historical and Museum Commission. The full texts of all the remarks submitted to the advisory commission are available at www.bioethics.gov.
15. See, for example, Ethical Issues in Social Science Research and "Regulations Governing Research on Human Subjects: Academic Freedom and the Institutional Review Board," Academe: Bulletin of the American Association of University Professors (December 1981): 358-70.
16. See, for example, Ethical Issues in Social Science Research and "Regulations Governing Research on Human Subjects: Academic Freedom and the Institutional Review Board," Academe: Bulletin of the American Association of University Professors (December 1981): 358-70.
17. See HHS, Protecting Human Research Subjects: Status of Recommendations (Office of Inspector General, 2000); Jonathan Moreno et al., "Updating Protections for Human Subjects Involved in Research," Journal of the American Medical Association 280, no. 22 (9 December 1998): 1951-58; R. Alto Charo, "Human Subjects Have It Worse Than Guinea Pigs," Chronicle of Higher Education, 25 June 1999, A64; Lori B. Andrews, "Money Is Putting People at Risk in Biomedical Research," Chronicle of Higher Education, 10 March 2000, B4-5.
18. See HHS, Protecting Human Research Subjects: Status of Recommendations (Office of Inspector General, 2000); Jonathan Moreno et al., "Updating Protections for Human Subjects Involved in Research," Journal of the American Medical Association 280, no. 22 (9 December 1998): 1951-58; R. Alto Charo, "Human Subjects Have It Worse Than Guinea Pigs," Chronicle of Higher Education, 25 June 1999, A64; Lori B. Andrews, "Money Is Putting People at Risk in Biomedical Research," Chronicle of Higher Education, 10 March 2000, B4-5.
19. See HHS, Protecting Human Research Subjects: Status of Recommendations (Office of Inspector General, 2000); Jonathan Moreno et al., "Updating Protections for Human Subjects Involved in Research," Journal of the American Medical Association 280, no. 22 (9 December 1998): 1951-58; R. Alto Charo, "Human Subjects Have It Worse Than Guinea Pigs," Chronicle of Higher Education, 25 June 1999, A64; Lori B. Andrews, "Money Is Putting People at Risk in Biomedical Research," Chronicle of Higher Education, 10 March 2000, B4-5.
20. See HHS, Protecting Human Research Subjects: Status of Recommendations (Office of Inspector General, 2000); Jonathan Moreno et al., "Updating Protections for Human Subjects Involved in Research," Journal of the American Medical Association 280, no. 22 (9 December 1998): 1951-58; R. Alto Charo, "Human Subjects Have It Worse Than Guinea Pigs," Chronicle of Higher Education, 25 June 1999, A64; Lori B. Andrews, "Money Is Putting People at Risk in Biomedical Research," Chronicle of Higher Education, 10 March 2000, B4-5.
21. GAO/HHS, Scientific Research: Continued Vigilance Critical to Protecting Human Subjects (Washington, D.C., 1996), 72; National Bioethics Advisory Commission, Ethics and Policy Issues in Research Involving Human Participants, (Washington, D.C., 2000), 39. This report adds: "We recognize that the risks of such research differ both qualitatively and quantitatively across the spectrum of research." Gunsalus, Examination of Issues, 9.
22. GAO/HHS, Scientific Research: Continued Vigilance Critical to Protecting Human Subjects (Washington, D.C., 1996), 72; National Bioethics Advisory Commission, Ethics and Policy Issues in Research Involving Human Participants, (Washington, D.C., 2000), 39. This report adds: "We recognize that the risks of such research differ both qualitatively and quantitatively across the spectrum of research." Gunsalus, Examination of Issues, 9.
23. GAO/HHS, Scientific Research: Continued Vigilance Critical to Protecting Human Subjects (Washington, D.C., 1996), 72; National Bioethics Advisory Commission, Ethics and Policy Issues in Research Involving Human Participants, (Washington, D.C., 2000), 39. This report adds: "We recognize that the risks of such research differ both qualitatively and quantitatively across the spectrum of research." Gunsalus, Examination of Issues, 9.
24. HHS Fact Sheet, "Protecting Research Subjects" (23 May 2000). The bioethics advisory commission would go even further. In Ethics and Policy Issues, it recommends the creation of a National Office of Human Research Oversight, an independent, government-wide regulatory body to implement and enforce the oversight system for human research.
25. "Regulations Governing Research on Human Subjects," 361-62. See also John A. Robertson, "The Social Scientists' Right to Research and the IRB System," Ethical Issues in Social Science Research, 362-63.
26. "Regulations Governing Research on Human Subjects," 361-62. See also John A. Robertson, "The Social Scientists' Right to Research and the IRB System," Ethical Issues in Social Science Research, 362-63.
27. Academic Affairs-IRB Guidelines for the School of Journalism and Mass Communication (University of North Carolina at Chapel Hill, 2000); "Use of Human Subjects in Student Projects, Pilot Studies, and Oral Histories (Non-Medical)," available at www.stanford.edu/dept/dor/ nonmedhs.
28. According to the Common Rule, minimal risk "means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." 45 CFR 46.102.h.i.
29. "In the present study, chairs [of IRBs] reported that about one-third of protocols eligible for exemption were actually exempted from review." Evaluation of NIH, VII-3.
30. "Regulations Governing Research on Human Subjects," 368.
31. Gray, "The Regulatory Context of Social and Behavioral Research," 348.
32. Ethics and Policy Issues, 7.
33. See 8 above.
34. Evaluation of NIH, V-12.
35. Department of Health, Education, and Welfare, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Washington, D.C., 1979). This seminal document, known as the Belmont Report, is reprinted in Ethics of Research with Human Subjects: Selected Policies and Resources, ed. Jeremy Sugarman, Anna C. Mastroianni, Jeffrey P. Kahn (Frederick, Md.: University Publishing Group, 1998): 19-30.
36. Department of Health, Education, and Welfare, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Washington, D.C., 1979). This seminal document, known as the Belmont Report, is reprinted in Ethics of Research with Human Subjects: Selected Policies and Resources, ed. Jeremy Sugarman, Anna C. Mastroianni, Jeffrey P. Kahn (Frederick, Md.: University Publishing Group, 1998): 19-30.
37. See the essays in Ethical Issues in Social Science Research under "Informed Consent and Deception"; Marian W. Fischman, "Informed Consent," Ethics in Research With Human Participants, ed. Bruce D. Sales and Susan Folkman (Washington, D.C.: American Psychological Association, 2000): 35-48. For issues of informed consent in the setting of Internet research see Mark S. Frankel and Sanyin Siang, Ethical and Legal Aspects of Human Subjects Research on the Internet (Washington, D.C.: American Association for the Advancement of Science, 1999): 6-10.
38. See the essays in Ethical Issues in Social Science Research under "Informed Consent and Deception"; Marian W. Fischman, "Informed Consent," Ethics in Research With Human Participants, ed. Bruce D. Sales and Susan Folkman (Washington, D.C.: American Psychological Association, 2000): 35-48. For issues of informed consent in the setting of Internet research see Mark S. Frankel and Sanyin Siang, Ethical and Legal Aspects of Human Subjects Research on the Internet (Washington, D.C.: American Association for the Advancement of Science, 1999): 6-10.
39. See the essays in Ethical Issues in Social Science Research under "Informed Consent and Deception"; Marian W. Fischman, "Informed Consent," Ethics in Research With Human Participants, ed. Bruce D. Sales and Susan Folkman (Washington, D.C.: American Psychological Association, 2000): 35-48. For issues of informed consent in the setting of Internet research see Mark S. Frankel and Sanyin Siang, Ethical and Legal Aspects of Human Subjects Research on the Internet (Washington, D.C.: American Association for the Advancement of Science, 1999): 6-10.
40. This follows Gray, "The Regulatory Context of Social and Behavioral Research," 347. Also 45 CFR 46.117.c.2.
41. "Use of Human Subjects in Student Projects."
42. Testimony of Murray L. Wax before the National Bioethics Advisory Commission.
43. See n. 10 above.
44. "Categories of Research That May Be Reviewed . . . Through an Expedited Review Procedure."
45. 46 Federal Register 8392 (26 January 1981).
46. Evaluation of NIH, IV-19, found that 84 percent of expedited reviews were completed in eight to thirty days. For data on the frequency of IRB requests for changes in research proposals, see V-12.
47. The Common Rule anticipates the problem of insufficient expertise. It states that an IRB "may, at its discretion, invite individuals with competence in special areas to assist in review of issues which require expertise beyond or in addition to that available on the IRB." This is a useful approach to the problem, but a limited one, for the rule adds: "These individuals may not vote with the IRB." 45 CFR 46.107.f.
48. Cited in Gray, "The Regulatory Context of Social and Behavioral Research," 354-55. The 1991 Common Rule states that research approved by an IRB may be subject to further review for approval or disapproval by officials of the institution, but the officials "may not approve the research if it has not been approved by an IRB," 45 CFR 46.112. A researcher whose project is approved by an IRB is unlikely, to say the least, to seek further review, but not so a third party, for example, a member of the community at large or even a senior administrator at the university, who believes that the IRB has erred. It is worth emphasizing that the Common Rule does not require disapproval of IRB-approved research by another IRB. Action by "officials of the institution" apparently suffices.