Clinical Research Review Committee

The Clinical Research Review Committee (CRRC) meets on an ad hoc basis and helps investigators to prepare comprehensive clinical research protocols for submission to the Institutional Review Board (IRB). The CRRC pre-reviews protocols to ensure that 1) federal requirements are met for the informed consent of patients, 2) scientific merit is satisfied, and 3) the protocol contributes to the protection of the health and welfare of human subjects. Fourteen individuals make up the CRRC: physicians, research nurses, research associates, a biostatistician, an attorney, a pharmacist, a medical writer, and a lay individual. The committee functions under the leadership of Cary N. Mariash, MD, Medical Director of the Methodist Research Institute.

The CRRC also focuses on the statistical plan of the proposed study, ensures that the correct information is provided on the necessary IRB forms (Summary Safeguard, Statement, Documentation of Review and Approval [DRA], HIPAA & Recruitment Checklist, etc.), and offers comments/edits regarding the informed consent.

Following the CRRC’s review, the committee’s comments, suggestions and edits are immediately forwarded to the principal investigator and research coordinator. This expediency provides adequate time for the investigator to address any issues raised by the CRRC before the deadline for submission of the final protocol to the IRB Office in the IU Office of Research Administration. Using the CRRC service does not lengthen the time to submission for IRB review.

The CRRC serves only in an advisory capacity to the investigator; however, over the past 26 years, members of the IRB have placed great value in the comments and suggestions proffered by the committee. The CRRC does not hold approval or veto authority over any submitted protocol. The function of the CRRC is to assist the investigator in providing the IRB with a more comprehensive protocol and one that will attain approval in less time.


Lisa Conway