Address correspondence to Jan Blustein, M.D., Ph.D., Wagner Graduate School, New York University, Puck Building, 295 Lafayette Street, New York, NY 10012. Marsha Regenstein, Ph.D., and Bruce Siegel, M.D., M.P.H., are with the Department of Health Policy, George Washington University School of Public Health and Health Services, Washington, DC. John Billings, J.D., is with the Wagner Graduate School, New York University, New York, NY.
Notes from the Field: Jumpstarting the IRB Approval Process in Multicenter Studies
Version of Record online: 24 JAN 2007
Health Services Research
Volume 42, Issue 4, pages 1773–1782, August 2007
How to Cite
Blustein, J., Regenstein, M., Siegel, B. and Billings, J. (2007), Notes from the Field: Jumpstarting the IRB Approval Process in Multicenter Studies. Health Services Research, 42: 1773–1782. doi: 10.1111/j.1475-6773.2006.00687.x
- Issue online: 24 JAN 2007
- Version of Record online: 24 JAN 2007
- Institutional Review Board;
- ethics committees;
- multicenter studies;
- research ethics
Objective. To identify strategies that facilitate readiness for local Institutional Review Board (IRB) review, in multicenter studies.
Study Setting. Eleven acute care hospitals, as they applied to participate in a foundation-sponsored quality improvement collaborative.
Study Design. Case series.
Data Collection/Extraction. Participant observation, supplemented with review of written and oral communications.
Principal Findings. Applicant hospitals responded positively to efforts to engage them in early planning for the IRB review process. Strategies that were particularly effective were the provisions of application templates, a modular approach to study description, and reliance on conference calls to collectively engage prospective investigators, local IRB members, and the evaluation/national program office teams. Together, these strategies allowed early identification of problems, clarification of intent, and relatively timely completion of the local IRB review process, once hospitals were selected to participate in the learning collaborative.
Conclusions. Engaging potential collaborators in planning for IRB review may help expedite and facilitate review, without compromising the fairness of the grant-making process or the integrity of human subjects protection.