Ontario cancer research ethics board: Lessons learned from developing a multicenter regional institutional review board

Journal of Clinical Oncology

Volumn 26, Issue 9, 2008, Pages 1479-1482

  Saginur, Raphael ^a   Dent, Susan F ^a   Schwartz, Lisa ^a   Heslegrave, Ronald ^a   Stacey, Sid ^a   Manzo, Janet ^a  

^a MCMASTER UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CANADA; CANCER RESEARCH; CLINICAL PROTOCOL; MEDICAL DECISION MAKING; MEDICAL ETHICS; MEDICAL SOCIETY; PRIORITY JOURNAL; QUALITY CONTROL; RESPONSIBILITY; CANCER CENTER; CLINICAL TRIAL; ETHICS; HEALTH CARE ORGANIZATION; HUMAN; MULTICENTER STUDY; ORGANIZATION AND MANAGEMENT; PROFESSIONAL STANDARD; RESEARCH ETHICS; STATISTICS; UNITED STATES;

CANADA; CANCER CARE FACILITIES; CLINICAL TRIALS AS TOPIC; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMANS; MULTICENTER STUDIES AS TOPIC; NATIONAL CANCER INSTITUTE (U.S.); ONTARIO; UNITED STATES;

EID: 41149177476     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2007.12.6441     Document Type: Article

References (24)

1. Office of the Inspector General. Institutional Review Boards: A Time for Reform. http://oig.hhs.gov/oei/reports/oei-01-97-00193.pdf
2. National Institutes of Health, Office for Human Research Protections, Department of Health and Human Services, Association of American Medical Colleges, American Society of Clinical Oncology: Alternative Models of IRB Review: Workshop Summary Report. http://www.hhs.gov/ohrp/sachrp/documents/ AltModIRB.pdf
3. Emanuel EJ, et al: Oversight of Human Participants Research: Identifying Problems to Evaluate Reform Proposals. Ann Intern Med 141:282-291, 2004
4. Food and Drug Administration. Guidance for Industry: Using a centralized irb review process in multicenter clinical trials, March 2006. http://www.fda.gov/cber/gdlns/irbclintrial.pdf
5. Government of Ontario. About Ontario: Ontario Ministry of finance census highlights 2005. http://www.gov.on.ca/mbs/english/about/geography2.html
6. Enzle ME, Schmaltz, R: Ethics Review of Multi-Centre Clinical Trials in Canada. Health Law Rev 13:51-57, 2005
7. Gold JL, Dewa CS: Institutional Review Boards and Multisite Studies in Health Services Research: Is There a Better Way? Health Serv Res 40:1:291-308, 2005
8. Redshaw ME, Harris A, Baum JD: Research Ethics Committee Audit: Differences between committees. J Med Ethics 22:78-82, 1996
9. Stair TO, Reed CR, Radeos MS, Koski G, et al: Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial. Acad Emerg Med 8:636-641, 2001
10. McWilliams R, Hoover-Fong J, Hamosh A, Beck S, et al: Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study. JAMA 290:360-366, 2003
11. Burman WJ, Reves RR, Cohn DL, Schooley RT: Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards. Ann Intern Med 134:152-157, 2001
12. Burman W, Breese P, Weis S, Bock N, Bernardo J, Vernon A, and the Tuberculosis Trials Consortium: The effects of local review on informed consent documents from a multicenter clinical trials consortium. Control Clin Trials 24:245-255, 2003
13. Schneider EC, Epstein AM, Malin JL, Kahn KL, Emanuel EJ: Developing a System to Assess the Quality of Cancer Care: ASCO's National Initiative on Cancer Care Quality. J Clin Oncol 22:2985-2991, 2004
14. Wood A, Grady C, Emanuel EJ: Regional ethics organizations for protection of human research participants. Nat Med 10:1283-1288, 2004
15. American Society of Clinical Oncology Policy Statement: Oversight of Clinical Research. J Clin Oncol 21:2377-2386, 2003
16. US Department of Human Health Services, Office for Human Research Protections. IRB knowledge of local research context, August 27, 1998 (updated July 21, 2000). http://www.hhs.gov/ohrp/humansubjects/guidance/local.htm
17. Tri-Council Policy Statement. Ethical Conduct for Research Involving Humans, August 1998 (2000, 2002, 2005 amendments). http://www.pre.ethics.gc.ca/ english/pdf/TCPS%20October%202005_E.pdf
18. US Food and Drug Administration. Code of Federal Regulations Title Part 56. Institutional Review Boards Subpart C: IRB Functions and Operations 56.114 - Cooperative Research, revised April 1, 2006. http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56&showFR=1&subpartNode= 21:1.0.1.1.21.3
19. US Food and Drug Administration. Code of Federal Regulations Title 45 Part 46. Protection of Human Subjects 46.114: Cooperative Research, revised June 23, 2005. http://www.nihtraining.com/ohsrsite/guidelines/45cfr46.html#46.114
20. Vanderbilt Clinical Trials Center Home Page. Clinical Trials Center. http://www.mc.vanderbilt.edu/ctc/macro.html
21. Biomedical Research Alliance of New York: BRANY IRB. http://www.branyirb. com
22. National Cancer Institute: The Central Institutional Review Board Initiative. http://www.ncicirb.org
23. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001. http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01. pdf
24. Christian MC, Goldberg JL, Killen J, Abrams JS, et al: A Central Institutional Review Board for Multi-Institutional Trials. N Engl J Med 346:1405-1408, 2002