Protecting subjects who cannot give consent: Toward a better standard for "minimal" risks

Hastings Center Report

Volumn 35, Issue 5, 2005, Pages 37-43

  Wendler, David ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; BIOMEDICAL AND BEHAVIORAL RESEARCH; CHILD; DISABLED PERSON; ETHICS; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; JUVENILE; LEGAL ASPECT; PRACTICE GUIDELINE; RESEARCH ETHICS; RESEARCH SUBJECT; REVIEW; RISK ASSESSMENT; SOCIAL WELFARE; VULNERABLE POPULATION;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

ADULT; CHARITIES; CHILD; DISABLED PERSONS; ETHICS, RESEARCH; GUIDELINES; HUMANS; INFORMED CONSENT; MINORS; NONTHERAPEUTIC HUMAN EXPERIMENTATION; RESEARCH SUBJECTS; RISK ASSESSMENT; VULNERABLE POPULATIONS;

EID: 31544450293     PISSN: 00930334     EISSN: None     Source Type: Journal    
DOI: 10.2307/3528332     Document Type: Review

References (29)

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3. L.H. Glantz, "Research with Children," American Journal of Law and Medicine 24 (1998): 213-44.
4. The British Medical Research Council Working Party on Research with the Mentally Incapacitated used the term "negligible" and defined negligible risks as "those ordinarily encountered in daily life or during the performance of routine physical or psychological tests." British Medical Research Council Working Party on Research with the Mentally Incapacitated, The Ethical Conduct of Research on the Mentally Incapacitated (1991), available at http:// www.mrc.ac.uk/pdf-ethics-mental.pdf.
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6. Department of Health and Human Services, U.S. Code of Federal Regulations, 45 CFR 46; revised 1991.
7. British Medical Research Council Working Parry, The Ethical Conduct of Research on the Mentally Incapacitated; Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda (1997), available at http://www.hhs.gov/ ohrp/international/HSPCompilation.pdf;
8. Tri-Council Working Group, Final Report of the Tri-Council Working Group on the Ethical Conduct for Research Involving Humans (1997) available at http://www. ethics.ubc.ca/code.html.
9. National Bioethics Advisory Commission, Research involving Persons with Mental Disorders That May Affect Decision Making Capacity (Rockville, Md.: National Bioethics Advisory Commission, 1998);
10. Attorney General's Working Group, Final Report on Research involving Decisionally Incapacitated Subjects (Baltimore, Md.: Office of the Maryland Attorney General, 1998);
11. J.H. Karlawish, "Research involving Cognitively Impaired Adults," New England Journal of Medicine 348 (2003): 1389-92.
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13. D. Barnbaum, "Making More Sense of Minimal Risk," IRB: Ethics & Human Research 24, no. 3 (2002): 10-13.
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16. G. Briefel, J. Stiff, and R. Nelson, "Nontherapeutic Research and Minimal Risk," IRB: Ethics & Human Research 24, no.3 (2002): 14-15.
17. Institute of Medicine, Ethical Conduct of Health Research Involving Children (Washington, D.C.: National Academy Press, 2004), 5;
18. National Bioethics Advisory Commission, Research Involving Persons with Mental Disorders, 83, NHRPAC 2002. Clarifying Specific Portion of 45 CFR 46, Subpart D that governs children research; available at http://ohrp.osophs.dhhs. gov. nhrpac/mtg04-01/child-workinggroup4-5-01.pdf.
19. B. Freedman, A. Fuks, and C. Weijer, "In Loco Parentis: Minimal Risk as an Ethical Threshold for Research upon Children," Hasting Center Report 23, no. 2 (1993): 13-19.
20. For a discussion of the problems in quantifying the minimum risk standard, see D. Wendler et al., "Quantifying the Federal Minimal Risk Standard: Implications for Pediatric Research without a Prospect of Direct Benefit," Journal of the American Medical Association 294 (2005): 826-32.
21. 45 CFR 46.102 i.
22. L.M. Kopelman, "Minimal Risk as an International Ethical Standard in Research," Journal of Medicine and Philosophy 29 (2004): 351-78.
23. Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research (2002), commentary on guideline 13.
24. Nepal Health Research Council, National Ethical Guidelines for Health Research in Nepal (2001);
25. Indian Council on Medical Research, Ethical Guidelines for Biomedical Research on Human Subjects (2000), available at http://icmr.mc.in/ethical.pdf.
26. American Sports Data, Comprehensive Study of Sports Injuries in the U. S. (Harrsdale, N.Y.: American Sports Data, Inc., 2002).
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28. Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries, "Fair Benefits for Research in Developing Countries," Science 298 (2002): 2133-34;
29. Conference on Ethical Aspects of Research in Developing Countries, "Moral Standards for Research in Developing Countries: From 'Reasonable Availability' to 'Fair Benefits,'" Hastings Center Report 34, no. 3 (2004): 17-27.