Reviewing Institutional Review Board (IRB) stipulations can enhance the protocol review process/application. Clinical Research Directorate/CMRP, SAIC-Frederick, Inc., NCI-Frederick, Frederick, MD 21702

Thursday, October 11, 2012 — Poster Session IV
2:00 p.m. – 4:00 p.m.	Natcher Conference Center, Building 45	NIAID	RSCHSUPP-10

Authors

• T. Mainprize
• S. Simpson
• D. Moore
• B. Baseler

Abstract

The implementation of new protocols/consents is often delayed by the need to respond to Institutional Review Board (IRB) stipulations. For investigators, this barrier to clinical research can be difficult to overcome and is best avoided by the initial submission of carefully reviewed and well crafted documents. With the objective of enhancing the clinical research enterprise, draft protocols/consents written by intramural investigators at the National Institute of Allergy and Infectious Diseases (NIAID) are first reviewed for regulatory concerns by the Regulatory Compliance and Human Subjects Protection Branch/Program (RCHSPB/P), before they are submitted to the IRB. In a unique program, designed to maximize the quality of the documents, RCHSPP reviewers perform an ongoing assessment of IRB stipulations from previously submitted protocols for IRB language preferences to apply in their future protocol reviews. During the period 2010-12, 430 IRB stipulations from 16 RCHSPP reviewed protocols/consents were evaluated. With the expectation that the application of lessons learned from previous IRB stipulations would result in higher quality protocol reviews, the trend in the number of IRB stipulations/protocol was monitored during the time stipulations were assessed. Funded by NCI-Contract No. HHSN261200800001E This research was support [in part] by the National Institute of Allergy and Infectious Diseases.

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