Hostname: page-component-cd9895bd7-lnqnp Total loading time: 0 Render date: 2024-12-25T20:45:58.590Z Has data issue: false hasContentIssue false
  • English
  • Français

The Ethical Analysis of Risk

Published online by Cambridge University Press:  01 January 2021

Charles Weijer
Get access Rights & Permissions [Opens in a new window]

Extract

The institutional review board (IRB) is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality (142 articles) and considerably fewer on the assessment of risks and potential harms (40), study design (20), and subject-selection procedures (5).

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 28 , Issue 4 , Winter 2000 , pp. 344 - 361
Copyright
Copyright © American Society of Law, Medicine and Ethics 2000

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Weijer, C., “Thinking Clearly About Research Risk: Implications of the Work of Benjamin Freedman,” IRB, 21, no. 6 (1999): 1–5.CrossRefGoogle Scholar
Freedman, B., Shapiro, S., “Ethics and Statistics in Clinical Research: Towards a More Comprehensive Examination,” Journal of Statistical Planning and Inference, 42 (1994): 223–40.CrossRefGoogle Scholar
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles for the Protection of Human Subjects of Biomedical and Behavioral Research, DHEW Pub. No. (OS) 78–0012 (Washington, D.C.: U.S. Gov't Printing Office, 1978).Google Scholar
45 C.F.R. § 46.111(a).Google Scholar
National Commission, supra note 3.Google Scholar
Levine, R.J., “The Boundaries Between Biomedical or Behavioral Research and the Accepted and Routine Practice of Medicine” and “The Role of Assessment of Risk Benefit Criteria in the Determination of the Appropriateness of Research Involving Human Subjects,” in National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Appendix 1, DHEW Pub. No. (OS) 78–0013 (Washington, D.C.: U.S. Gov't Printing Office, 1978).Google Scholar
Levine, R.J., Ethics and the Regulation of Clinical Research, 2d ed. (New Haven: Yale University Press, 1988): At 37.Google ScholarPubMed
Chouinard, G., “A Placebo-Controlled Clinical Trial of Remoxipride and Chlorpromazine in Newly Admitted Schizophrenia Patients with Acute Exacerbation,” Acta Psychiatrica Scandinavica, 358 (1990): 111–19.Google Scholar
Weijer, C., “Placebo-Controlled Trials in Schizophrenia: Are They Ethical? Are They Necessary?” Schizophrenia Research, 35 (1999): 211–18.Google Scholar
Zimbardo, P., “Inducing Hearing Deficit Generates Experimental Paranoia,” Science, 212 (1981): 1529–31.CrossRefGoogle Scholar
Lewis, M., Zimbardo, P., “The Ethics of Inducing Paranoia in an Experimental Setting,” IRB, 3, no. 10 (1981): 9–11.CrossRefGoogle Scholar
Phillips, S., “Asking the Sensitive Question: The Ethics of Survey Research and Teen Sex,” IRB, 16, no. 6 (1994): 1–7.Google Scholar
Id.Google Scholar
Struewing, J.P. et al., “The Risk of Cancer Associated with Specific Mutations of BRCA1 and BRCA2 Among Ashkenazi Jews,” N. Engl. J. Med., 336 (1997): 1401–08.CrossRefGoogle Scholar
Glass, K.C. et al., “Structuring the Review of Human Genetics Protocols Part II: Diagnostic and Screening Studies,” IRB, 19, no. 3–4 (1997): 1–11, 13.Google Scholar
Levine, supra note 7, at 42–57.Google Scholar
Levine, , “The Role of Assessment of Risk Benefit Criteria in the Determination of the Appropriateness of Research Involving Human Subjects,” supra note 6, at 2.5–2.44.Google Scholar
Gray, B., “Bioethics Commissions: What Can We Learn from Past Successes and Failures?” in Bulger, R., Bobby, E., Fineberg, H., eds., Society's Choices: Social and Ethical Decision Making in Biomedicine (Washington, D.C.: National Academy Press, 1995): 261–306.Google Scholar
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research on the Fetus: Report and Recommendations, DHEW Pub. No. (OS) 76–127 (Washington, D.C.: U.S. Gov't Printing Office, 1975); National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Prisoners: Report and Recommendations, DHEW Pub. No. (OS) 76–131 (Washington, D.C.: U.S. Gov't Printing Office, 1976); National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Children: Report and Recommendations, DHEW Pub. No. (OS) 77–0004 (Washington, D.C.: U.S. Gov't Printing Office, 1977); National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Those Institutionalized as Mentally Infirm: Report and Recommendations, DHEW Pub. No. (OS) 78–0006 (Washington, D.C.: U.S. Gov't Printing Office, 1978); National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Institutional Review Boards: Report and Recommendations, DHEW Pub. No. (OS) 78–0008 (Washington, D.C.: U.S. Gov't Printing Office, 1978); National Commission, The Belmont Report, supra note 3.Google Scholar
Levine, supra note 7, at 297–98.Google Scholar
National Commission, Research on the Fetus, supra note 19, at 6.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id. at 73.Google Scholar
Id. at 74.Google Scholar
Levine, supra note 7, at 298.Google Scholar
45 C.F.R.§ 208(a).Google Scholar
National Commission, Research Involving Prisoners, supra note 19, at x.Google Scholar
Id. at xi.Google Scholar
Id.Google Scholar
Id. at 20.Google Scholar
Id. at 15.Google Scholar
National Commission, Research Involving Prisoners, supra note 19, at 20.Google Scholar
45 C.F.R. § 46.306(a)(2)(A); 45 C.F.R. § 46.303(d).Google Scholar
National Commission, Research Involving Children, supra note 19.Google Scholar
Levine, supra note 7, at 239.Google Scholar
National Commission, Research Involving Children, supra note 19, at xx.Google Scholar
45 C.F.R. §46.120(i).Google Scholar
National Commission, Research Involving Children, supra note 19, at 20.Google Scholar
Id. at 2.Google Scholar
Id. at 5.Google Scholar
Id. at 5–6.Google Scholar
Id. at 7.Google Scholar
National Commission, Research Involving Children, supra note 19, at 7–8.Google Scholar
Id. at 139.Google Scholar
Id. at 148.Google Scholar
See discussion in the text under the subheading “Ethical Analysis of Entire Protocols” supra.Google Scholar
Id. at 7.Google Scholar
45 C.F.R. § 46.102(i).Google Scholar
National Commission, Research Involving Children, supra note 19, at 2.Google Scholar
National Commission, Research Involving Those Institutionalized as Mentally Infirm, supra note 19.Google Scholar
Id. at 8.Google Scholar
National Commission, Institutional Review Boards, supra note 19, at xx.Google Scholar
Id. at 23.Google Scholar
Id. at 19–20.Google Scholar
National Commission, The Belmont Report, supra note 3.Google Scholar
Id.Google Scholar
Levine, “The Boundaries Between Biomedical or Behavioral Research and the Accepted and Routine Practice of Medicine,” supra note 6, at 1.9–1.10.Google Scholar
Levine, supra note 7, at 250–51.Google Scholar
45 C.F.R. §46.111(a).Google Scholar
Id.Google Scholar
45 C.F.R. § 46.208(a).Google Scholar
45 C.F.R. § 46.404–07.Google Scholar
45 C.F.R. § 46.111(a)(1)–(2).Google Scholar
Freedman, B., Fuks, A., Weijer, C., “Demarcating Research and Treatment: A Systematic Approach for the Analysis of the Ethics of Clinical Research,” Clinical Research, 40 (1992): 653–60; Weijer, supra note 1.Google Scholar
Freedman, B., “Equipoise and the Ethics of Clinical Research,” N. Engl. J. Med. 317 (1987): 141–45.Google Scholar
Peto, R. et al., “Design and Analysis of Randomized Clinical Trials Requiring Prolonged Observation of Each Patient: I. Introduction and Design,” British Journal of Cancer, 34 (1976): 585–612; Peto, R., Baigent, C., “Trials: The Next 50 Years,” British Medical Journal, 317 (1998): 1170–71; Weijer, C., Glass, K.C., Shapiro, S., “Why Clinical Equipoise, and not the Uncertainty Principle, is the Moral Underpinning of the RCT,” British Medical Journal, 321 (2000): 756–57.CrossRefGoogle Scholar
Freedman, supra note 66.Google Scholar
Taylor, K.M., Margolese, R., Soskolne, C.L., “Physicians' Reasons for Not Entering Eligible Patients in a Randomized Clinical Trial of Surgery for Breast Cancer,” N. Eng. J. Med., 310 (1984): 1363–67.Google Scholar
Freedman, supra note 66.Google Scholar
Freedman, B., “Placebo-Controlled Trials and the Logic of Clinical Purpose,” IRB, 12, no. 6 (1990): 1–6.CrossRefGoogle Scholar
World Medical Association Declaration of Helsinki, “Ethical Principles for Medical Research Involving Human Subjects” (October 2000) (visited Dec. 11, 2000) <www.wma.net/e/policy/17-c_e.html>..>Google Scholar
Kane, J., “Schizophrenia,” N. Engl. J. Med., 334 (1996): 34–41.Google Scholar
Freedman, B., Glass, K.C., Weijer, C., “Placebo Orthodoxy in Clinical Research. I: Empirical and Methodological Myths,” Journal of Law, Medicine & Ethics, 24 (1996): 243–51; Freedman, B., Glass, K.C., Weijer, C., “Placebo Orthodoxy in Clinical Research. II: Ethical, Legal, and Regulatory Myths,” Journal of Law, Medicine & Ethics, 24 (1996): 252–59; Weijer, supra note 9.CrossRefGoogle Scholar
45 C.F.R. § 46.102(d).Google Scholar
45 C.F.R. §46.111(a)(1).Google Scholar
45 C.F.R. § 46.111(a)(2).Google Scholar
Freedman, B., “Scientific Value and Validity as Ethical Requirements for Research: A Proposed Explication,” IRB, 9, no. 6 (1987): 7–10.CrossRefGoogle Scholar
Weijer, C., “Protecting Communities in Research: Philosophical and Pragmatic Challenges,” Cambridge Quarterly of Healthcare Ethics, 8 (1999): 501–13.CrossRefGoogle Scholar
Weijer, C., Goldsand, G., Emanuel, E.J., “Protecting Communities in Research: Current Guidelines and Limits of Extrapolation,” Nature Genetics, 23 (1999): 275–80.Google Scholar
Weijer, C., Emanuel, E.J., “Protecting Communities in Biomedical Research,” Science, 289 (2000): 1142–44.Google Scholar
Australia National Health and Medical Research Council (NHMRC), National Statement on Ethical Conduct in Research Involving Humans (Canberra: NHMRC, 1999); Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (Ottawa: Public Works and Government Services Canada, 1998); Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1993); Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo: European Treaty Series, 1997); Royal College of Physicians of London, Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects (London: Royal College of Physicians of London, 1996); 45 C.F.R. § 46.Google Scholar
45 C.F.R. § 46.102(i).Google Scholar
Freedman, B., Fuks, A., Weijer, C., “In Loco Parentis. Minimal Risk as an Ethical Threshold for Research upon Children,” Hastings Center Report, 23, no. 2 (1993): 13–19.Google Scholar
45 C.F.R. § 46.102(i).Google Scholar
Id.Google Scholar
Kopelman, L., “Estimating Risk in Human Research,” Clinical Research, 29, (1981): 1–8.Google Scholar
Freedman, , Fuks, , Weijer, supra note 84, at 16.Google Scholar
Id.Google Scholar
45 C.F.R. § 46.110(b).Google Scholar
45 C.F.R. § 46.102(i).Google Scholar
Freedman, supra note 78, at 9.Google Scholar
45 C.F.R. § 46.111(b).Google Scholar
Weijer, C., “Research Involving the Vulnerable Sick,” Accountability in Research, 7 (1999): 21–36.Google Scholar
National Bioethics Advisory Commission, Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity (Rockville: National Bioethics Advisory Commission, 1998).Google Scholar