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An assessment of Institutional Review Board (IRB) stipulations can be used to improve the quality of clinical research protocols 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




  • Barry Eagel
  • Terry Mainprize


To enhance 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 Institutional Review Board (IRB). With the IRB priority on minimizing the risks to subjects, the Sponsor Clinical Safety Office (CSO) plays a critical role in these reviews. In a unique program to help ensure human subject protection, the CSO has performed an ongoing assessment of IRB stipulations from previously submitted protocols. During the period January 2010 to April 2012, 849 IRB stipulations from the initial review of 64 protocols were evaluated for stipulations that specified the safety language in the protocol. The results of this assessment have been applied to current protocol reviews and the development and revision of template safety language for Investigational New Drug (IND) protocols. Trends in the number and content of IRB stipulations were monitored during the assessment period. 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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