The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: An Innovative Approach to Multisite IRB Review and Oversight

Clinical and Translational Science

Volumn 8, Issue 1, 2015, Pages 57-66

  Winkler, Sabune J ^a   Witte, Elizabeth ^a   Bierer, Barbara E ^a,b  

^a HARVARD MEDICAL SCHOOL   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

Bioethics; Cede review; Cooperative agreement; Institutional review boards; IRB authorization agreement; Master IRB agreements; Multicenter clinical trials; Reliance agreement; Reliance agreement models; Research ethics

Indexed keywords

ARTICLE; CATALYST; CONTINUING EDUCATION; HUMAN; INSURANCE; LAW; PRIORITY JOURNAL; REGULATORY MECHANISM; RESEARCH ETHICS; RESEARCH SUBJECT; COOPERATION; MEDICAL SCHOOL; MULTICENTER STUDY (TOPIC); ORGANIZATION; PROFESSIONAL STANDARD; SOCIAL CONTROL; THEORETICAL MODEL;

COOPERATIVE BEHAVIOR; ETHICS COMMITTEES, RESEARCH; HUMANS; MODELS, THEORETICAL; MULTICENTER STUDIES AS TOPIC; ORGANIZATIONAL INNOVATION; SCHOOLS, MEDICAL; SOCIAL CONTROL, FORMAL;

EID: 84922639294     PISSN: 17528054     EISSN: 17528062     Source Type: Journal    
DOI: 10.1111/cts.12202     Document Type: Article

References (8)

1. Menikoff J. The paradoxical problem with multiple-IRB review. N Engl J Med 2010; 363(17): 1591-1593.
2. Emanuel EJ, Wood A, Fleischman A, Bowen A, Getz KA, Grady C, Levine C, Hammerschimdt DE, Faden R, Eckenwiler L, et al. Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Inter Med. 2004;141(4): 282-291.
3. Pritchard IA. How do IRB members make decisions? A review and research agenda. J Empir Res Hum Res Ethics 2011; 6(2): 31-46.
4. Stark L: Behind Closed Doors: IRBs and the Making of Ethical Research. Chicago: University of Chicago Press; 2012.
5. Drezner MK, Cobb N: Efficiency of the IRB review process at CTSA-sites. Presented at CTSA Clinical Research Management Workshop; 2012. https://ctsacentral.org/sites/default/files/documents/2_drezner.pdf. Accessed August 11, 2014.
6. Silberman G, Kahn K: Burdens on research imposed by Institutional Review Boards: the state of the evidence and its implication for regulatory reform. Milbank Quarter. 2011; 89(4): 599-627.
7. See U.S. Department of Health and Human Services Office of Human Research Protections Quality Assessment Program. http://www.hhs.gov/ohrp/education/qip, Accessed April 15, 2014.
8. See Collaborative Institutional Training Initiative (CITI Program) at the University of Miami. https://www.citiprogram.org, Accessed April 15, 2014.