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Committee for the Scientific Review of Protocols (CSRP)

The NIH intramural program requires scientific review of all new clinical protocols prior to review by the NIH Institutional Review Board (IRB). Standard elements for scientific review of protocols are guided by the Policy for Scientific Review of Clinical Protocols Utilizing the NIH Intramural Program where submission requirements and review criteria can be found. At NIMH, the Committee for the Scientific Review of Protocols (CSRP) is responsible for this process.

All protocols and significant amendments must undergo scientific review and approval by the CSRP before they are submitted for IRB review. The CSRP meets monthly and for each submission reviews the protocol, science review application, study application, and key study personnel (KSP) form. These forms can be found on the iRIS website. NIMH protocol navigators are available to assist investigators with the completion of these forms.

The IRB requires that protocols and consent forms be written according to the IRB protocol template. Use of the template ensures that all elements required by regulations will be in the protocol and consent forms. Templates can be found on the IRBO website in the section labeled templates and forms.

Minutes from the CSRP meetings are sent via email to the study PI and processed through the iRIS system. After the PI has addressed any stipulations from the CSRP they are notified of final CSRP approval. Then, the protocol advances to the Chief Scientific Officer and Scientific Director of the NIH Clinical Center for approval. This must occur before a new protocol can be submitted to the IRB.

Please contact the CSRP coordinator Jeanne Radcliffe with questions about this process.

Committee Members:
Carlos Zarate, MD (CSRP chair); Karen Berman, MD; Chris Baker, PhD; Monique Ernst, MD; Sun Jung Kang, PhD; Ellen Leibenluft, MD; Francis McMahon, MD; and Peter Schmidt, MD.