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Centralized Institutional Review Board (IRB) Review
Central (single) IRB review of multi-site research has been under discussion for years—the 2011 Advance Notice of Proposed Rulemaking (ANPRM) served to bring this discussion to the fore. Centralized IRB Review is a full-day program that will provide attendees with the opportunity to learn about the single IRB review process, the different types of centralized IRBs, the logistics involved in setting up and working with a centralized IRB process, and the presumed advantages and disadvantages of a single review structure. The program will conclude with a panel discussion of the overall challenges of a single review process, and the potential costs and/or savings a single review process may entail for local IRBs, institutions, principal investigators, and central IRBs.
Interested in learning more about the program? View the agenda, or register now.
Program Faculty Confirmed to Date
P. Pearl O’Rourke, MD
P. Pearl O’Rourke, MD, is the director of human research affairs at Partners HealthCare Systems in Boston, and an associate professor of pediatrics at Harvard Medical School. As the director of human research affairs, she is responsible for the systems that support the regulatory and ethical oversight of human subjects research and the responsible conduct of research. Dr. O’Rourke is a past chair of PRIM&R’s Board of Directors, and has been a speaker at a number of PRIM&R meetings, addressing topics such as privacy, human embryonic stem cells, and the reporting of serious adverse events. She is also chair of Partners Healthcare System’s newly formed ESCRO committee. Dr. O’Rourke has worked as a pediatric critical care physician at Children's Hospital, Boston and at Children's Hospital, University of Washington in Seattle, where she was the director of the pediatric intensive care unit. Additionally, in Seattle, she served many years as a member of the IRB. Dr. O’Rourke has also been involved in international medical care, serving in China and Indonesia with Project HOPE. In 1995-1996, she did a Robert Wood Johnson Health Policy fellowship and worked for Senator Edward Kennedy (Democrat-MA) as a member of the labor committee staff. Following this fellowship, she became the deputy director of the Office of Science Policy in the Office of the Director at the National Institutes of Health where she worked on issues such as privacy, gene therapy (transfer) embryonic stem cells, and genetic discrimination.
Questions?
Please contact us via email or telephone at 617.423.4112, ext. 131. Thank you!