Strategies to Support Cooperation of Multiple Organizations’ Institutional Review Boards (IRBs)
The Agency for Healthcare Research and Quality (AHRQ) PBRN Resource Center hosted a webinar on Wednesday, September 10 from 12:30 – 2:00 p.m. ET, on various types of Institutional Review Board (IRB) cooperation that can be pursued to support practice-based research. The presenters defined and described processes for ceding review to a lead IRB, serving as the IRB of record and participating in reliant IRB review. The presenters also gave examples of how practice-based research networks have successfully implemented these processes.
Please Note: CME credits were approved for those who attended the live event of this webinar only. If you have any questions about obtaining CME credit for this webinar, please contact the PBRN Resource Center at PBRN@ahrq.hhs.gov.
Critical Reference Material:
- IRBShare: a joint IRB review model for multisite studies.
- Blustein J, Regenstein M, Siegel B, Billings J. Notes from the field: Jumpstarting the IRB approval process in multicenter studies. Health Serv Res. 2007;42(4):1773-1782.
- Check DK, Weinfurt KP, Dombeck CB, Kramer JM, Flynn KE. Use of central institutional review boards for multicenter clinical trials in the United States: A review of the literature. Clin Trials. 2013;10:560-567.
- Cola PA, Reider C, Strasser JE. Ohio CTSAs Implement a Reliant IRB Model for Investigator-Initiated Multicenter Clinical Trials. Clin Transl Sci., Jun 2013; 6(3): 176–178.
- Finch SA, Barkin SL, Wasserman RC, Dhepyasuwan N, Slora EJ, Sege RD. Effects of local institutional review board review on participation in national practice-based research network studies. Arch Pediatr Adolesc Med. 2009;163(12):1130-1134.
- Graham DG, Pace W, Kappus J, Holcomb S, Galliher JM, Duclos CW, Bonham AJ. Institutional Review Board Approval of Practice-based Research Network Patient Safety Studies. In: Henriksen K, Battles JB, Marks ES, et al., editors. Advances in Patient Safety: From Research to Implementation (Volume 3: Implementation Issues). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb.
- Green LA, Lowery JC, Kowalski CP, Wyszewianski L. Impact of institutional review board practice variation on observational health services research. Health Serv Res. 2006;41(1):214-230.
- Greene SM, Braff J, Nelson A, Reid RJ. The process is the product: a new model for multisite IRB review of data-only studies. IRB: Ethics & Human Research, 2010;32(3):1-6.
- Klitzman R. How local IRBs view central IRBs in the US. BMC Med Ethics. 2011;12:1-14.
- Koski G, Aungst J, Kupersmith J, Getz K, Rimoin D. Cooperative research ethics review boards: A win-win solution? IRB. 2005;27(3):1-7.
- Kulynych J, Heffernan KG. Community research partnerships: Underappreciated challenges, unrealized opportunities. JAMA. 2013;309(6):555-556.
- Marsolo K. Approaches to facilitate institutional review board approval of multicenter research studies. Med Care, July 2012;50 Suppl:S77-81.
- McWilliams R, Hebden CW, Gilpin AM. Concept paper: A virtual centralized IRB system. Account Res. 2006;13:25-45.
- Montello M, Mooney M, Denicoff A, Adler J, Goldberg J, Abrams J. National Cancer Institute-sponsored cooperative groups: changing process to speed progress. Clin Lymphoma Myeloma. 2009;9(3):194-196.
- National Cancer Institute. National Cancer Institute central institutional review board initiative. 2014. Accessed 4/3/2014 at https://ncicirb.org.
- U.S. HHS and FDA. Regulatory information: Cooperative research-information sheet. 2011. Accessed 1/29/2014 at http://www.fda.gov/RegulatoryInformation/Guidances/ucm126422.htm.
- Wolf LE, Croughan M, Lo B. The challenges of IRB review and human subjects protections in practice-based research. Med Care. 2002;40(6):521-529.
- Wolf LE, Walden JF, Lo B. Human subjects issues and IRB review in practice-based research. Ann Fam Med. 2005;3(Suppl):S30-S37.
- Presentation slides (PDF - 1.64 MB)