How independent are IRBs?

IRB Ethics and Human Research

Volumn 30, Issue 3, 2008, Pages 15-19

  Macklin, Ruth ^a  

^a ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONFLICT OF INTEREST; PROFESSIONAL PRACTICE; PROFESSIONAL STANDARD; REVIEW;

CONFLICT OF INTEREST; ETHICS COMMITTEES, RESEARCH; PROFESSIONAL AUTONOMY;

EID: 50249121111     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (24)

1. th WMA General Assembly, Venice, Italy, October 1983; 41st WMA General Assembly, Hong Kong, September 1989; 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996; and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000.
2. Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland: CIOMS, 1001, at p. 24.
3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guidelines for Good Clinical Practice. 1996, paragraph 3.2.4.
4. Marshall PA. Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-Poor Settings, 2007. TDR/SDR/SEB/ST/07, Special Topics No. 5, World Health Organization, Geneva, Switzerland, at 15.
5. National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants. Bethesda, Md.: National Bioethics Advisory Commission, 1001, at p. 28.
6. See ref. 5, National Bioethics Advisory Commission 2001, p. ii.
7. http://www.wirb.com/.
8. http://www.brany.com.
9. Koski G, Aungst J, Kupersmith J, et al. Cooperative research ethics review boards: A win-win solution? IRB: Ethics & Human Research 2005;27(3):1-7, at 3.
10. Department of Health and Human Services. Protection of Human Subjects. 45 CFR 46, at 46.102.
11. See ref. 10, Department of Health and Human Services at 46.107 (e), IRB Membership.
12. http://www.wirb.com/shell.php?content=content/about_history.
13. Elliott C, Lemmens T. Ethics for sale: For-profit ethical review, coming to a clinical trial near you. Slate, December 13, 2005, http://www.slate.com/id/2132187/.
14. http://www.branyirb.com/irb_resources.shtml.
15. See ref. 14, http://www.brany.eom/services.shtml#ibc.
16. See ref. 13, Elliott and Lemmens 2005, p. 1.
17. See ref. 13, Elliott and Lemmens 2005.
18. See ref. 13, Elliott and Lemmens 2005.
19. Emanuel E. Testimony delivered September 12, 2002, at the sixth meeting of the President's Council on Bioethics, transcript available at http://www.bioethics.gov/transcripts/sepo2/session2.html.
20. Lemmens T, Elliott C. Should society allow research ethics boards to be run as for-profit enterprises? Commercial IRBs have a fundamental conflict of interest. PLoS Medicine 2006, available at http://medicine.plosjournals. org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0030309&ct= 1.
21. Department of Health and Human Services. Food and Drug Administration. Institutional review boards: Requiring sponsors and investigators to inform institutional review boards of any prior institutional review board reviews; withdrawal. Federal Register 2006;71(10):2493-2494.
22. See ref. 5, National Bioethics Advisory Commission 2001, p. 64.
23. http://www.biomedirb.com.
24. http://www.xenirb.net/.