Some human subjects research studies may require review by and approval from regulatory offices or committees other than the IRB. Depending on the type of review, IRB approval may be withheld until approval has been obtained.
Scientific Merit Review as part of the IRB Process
In order to approve human subjects research, both federal regulations and IU HRPP Policy require the IRB to confirm that risks to subjects are reasonable in relation to any anticipated benefits, considering both benefits to subjects and the importance of the knowledge that may reasonably result from the research. A consideration of the scientific merit of the proposed research is a core component of making this risk-benefit determination. As risks increase, so does the intensity and importance of the scientific merit review. It is important to note that review of a study’s scientific merit is neither a new requirement nor a new process, and has historically always been a part of the IRB review process.
At IU, the following Scientific Review Committees exist:
- IU Simon Cancer Center (IUSCC) Scientific Review Committee (SRC): required for prospective cancer-related research utilizing IUSCC patients or resources; documentation of approval required at time of IRB submission unless an exception has been granted
- Indiana CTSI Scientific Review Committee (SRC): required for greater than minimal risk biomedical studies that have not undergone a peer-review process; documentation of approval required at time of IRB submission unless an exception has been granted.