Publication

Notes from the Field: Jumpstarting the IRB Approval Process in Multicenter Studies
Health Services Research, Volume 42, Number 4, August 2007 , pp. 1773-1782(10) Blackwell Publishing.

Blustein, J., Regenstein, M., Seigel, B. & Billings, J.
08/01/2007

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.