All protocols are submitted to the Committee for the Scientific Review of Protocols (CSRP) prior to review by the Institutional Review Board (IRB). The CSRP, through an internal and external peer review process, assesses scientific quality and appropriateness of the study to the goals and mission of the NIMH IRP. All clinical protocols must be reviewed and approved by the CSRP prior to IRB review, which focuses on human subject protections.
A guide to preparing and conducting a clinical research study called Protomechanics, is available at the website: http://www.cc.nih.gov/ccc/protomechanics/ . The Office of Human Subjects Research (OHSR) guidelines for writing research protocols and informed consent documents are found in the http://ohsr.od.nih.gov/ .
The PTMS (Protocol Tracking and Management System) website (http://cims.ninds.nih.gov ) provides templates for both protocol and consent submissions and details all the required elements for all submissions. All new protocols must be started and submitted using PTMS. All NIMH intramural protocols are stored in PTMS, and all continuing reviews, amendments and other changes must be processed using this electronic submission software. The PTMS website can be accessed via the IRB website or through the following address http://cims.ninds.nih.gov which permits off campus access.
The CSRP meets monthly. Please contact Jeanne Radcliffe (301-594-7732) with any questions about this process.
Karen Berman, James Blair, Chris Baker, Francis McMahon, Judy Rapoport, Peter Schmidt, Carlos Zarate, Maryland Pao, Jean Radcliffe(recorder), and Susan Amara.