Local IRBs, multicenter trials, and the ethics of internal amendments

IRB Ethics and Human Research

Volumn 27, Issue 4, 2005, Pages 7-11

  Jansen, Lynn A ^a,b  

^a John J Conley Department of Ethics   (United States)

^b NEW YORK MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 27944505617     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3563955     Document Type: Article

References (33)

1. But see, Freedman B. Multicenter trials and subject eligibility: Should local IRBs play a role? IRB: A Review of Human Subjects Research 1994;16:1-6;
2. Levine R. Ethics and Regulation of Clinical Research. 2nd ed. Baltimore, MD: Urban and Schwarzenberg, 1986.
3. For a more general discussion see, Weijer C, Fuks A. The duty to exclude: Excluding people at undue risk from research. Clinical Investigative Medicine 1994;17:115-122;
4. Silverman H, Hull SC, and Sugarman J. Variability among Institutional Review Boards' decisions within the context of a multi-center trial. Critical Care Medicine 2001;29:235-241.
5. Weijer C. Placebo-controlled trials in schizophrenia: Are they ethical? Are they necessary? Schizophrenia Research 1999;35:211-218;
6. Michels KB, Rothman KJ. Update on unethical use of placebos in RCT. Bioethics 2003;17:188-204;
7. Kane JM, Schizophrenia. NEJM 1996;334:34-42;
8. Zipursky RB, Darby P. Placebo-controlled studies in schizophrenia - ethical and scientific perspectives: An overview of conference proceedings. Schizophrenia Research 1999;35:189-200.
9. Roberts LW, Laureiello J, Geppert C, and Keith SJ. Placebos and paradoxes in research: An ethics perspective. Biological Psychiatry 2001;49:887-893; ref. 2, Weijer 1999.
10. See ref. 1, Levine 1986.
11. Berg KS, Latin RW. Essentials of Modern Research Methods in Health, Physical Education, and Recreation. Englewood Cliffs, NJ: Prentice Hall, 1994, pp. 164-174.
12. Antman K, Amato D, Wood W, et al. Selection bias in clinical trials. Journal of Clinical Oncology 1985;3:1142-1147.
13. Marcus SM. A sensitivity analysis for subverting randomization in controlled trials. Statistics in Medicine 2001;20:545-555.
14. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-2711.
15. See ref. 8, Emanuel et al. 2000, p. 2704,
16. citing the Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland: CIOMS, 1993.
17. See ref. 8, Emanuel et al. 2000.
18. See ref. 7, Marcus 2001, p. 553.
19. McWilliams R et al. Problematic variation in local institutional review of multi-center genetic epidemiology study. JAMA 2003;290: 360-366;
20. Burman W et al. The effects of local review on informed consent documents from multicenter clinical trials consortium. Controlled Clinical Trials. 2003;24:245-255; ref. 1, Freedman 1994.
21. See ref. 1, Freedman 1994.
22. See ref. 1, Levine 1986.
23. See ref. 1, Freedman 1994, p. 2.
24. See ref. 1, Freedman 1994, p. 2.
25. For a more general discussion of how "matters of institutional practice" should bear on our ethical deliberations, see Buchanan A. Justice, Legitimacy, and Self Determination. New York: Oxford University Press, 2004, pp. 22-29.
26. See ref. 1, Silverman et al. 2001; ref. 12, McWilliams et al. 2003.
27. Freedman claims that, in principle, statistical methods can account for "inter-institutional variability in subject selection" (see ref. 1, 1994, p. 2). Even if this were correct, it assumes that all internal amendments will be accurately disclosed to the sponsor.
28. See ref. 1, Freedman 1994.
29. See ref. 12, McWilliams et al. 2003.
30. Radshaw ME, Harris A, and Baum JD. Research ethics committee audit: Differences between committees. Journal of Medical Ethics 1996;22:78-82;
31. Gelder MG. A national committee for the ethics of research. Journal of Medical Ethics 1990;16:146-147.
32. http://www.ncicirb.org.
33. http://www.irbnet.org.