Prior to Institutional Review Board (IRB) review, Indiana CTSI Scientific Review Committee (SRC) approval is required for new studies that meet the following criteria or when deemed necessary as an IRB provision for approval.
Investigators should send protocols to the Scientific Review Committee directly at email@example.com prior to IRB submission. The SRC will review new studies within two weeks. Human Subjects Office and IRB review will not occur until after SRC review and approval.
The instructions found in the IU IRB Protocol Template may facilitate protocol development aligned with the SRC review criteria. The Scientific Review Committee will review studies under the following review criteria:
If the Scientific Review Committee finds that each criterion is Present/Acceptable, the committee will approve. If any criteria are Absent or deemed Not Acceptable, the Scientific Review Committee will return comments to the Principal Investigator (PI) for revisions. The PI must address all Scientific Review Committee comments by making recommended revisions or providing further justification for resubmission to the committee. When resubmitting to the Scientific Review Committee, respond point-by-point to comments and revise the protocol using tracked changes. Once the committee approves the revised protocol, it will notify the PI, at which time the study can be submitted to the IRB for review.