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 Comprehensive Cancer Center (IUSCCC) Scientific Review Committee (SRC): required for prospective cancer-related research utilizing IUSCCC 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 biomedical studies that are reviewed by the convened IRB and have not undergone a peer-review process and for research that involves flexible expedited categories 400(b) and/or 700(b) and have not undergone a peer-review process; documentation of approval is required at time of IRB submission.

Additional information about the process and criteria used by the CTSI SRC can be found at: https://indianactsi.org/researchers/services-tools/regulatory-knowledge-and-support/scientific-review-committee/. 

• Ophthalmology Scientific Review: required for prospective Ophthalmology studies obtaining informed consent; documentation of approval required at time of IRB submission unless an exception has been granted.

Other additional review committees:

• Radiation Safety Committee: required for research involving radiation/radioactivity in addition to what is used for standard clinical treatment; review conducted concurrently with the IRB process; documentation of approval must be provided prior to final IRB approval
• VA Research & Development (R&D) Committee: required for VA research; review conducted after IRB approval has been granted
• Institutional Biosafety Committee (IBC): required for research involving recombinant or synthetic nucleic acid molecules; review conducted concurrently with the IRB process; documentation of approval must be provided prior to final IRB approval
• External IRBs or ethics committees:
  • When an external IRB is providing review, documentation of IRB approval is required at time of  submission for a Request to Rely
  • If required for transnational research, review may be conducted concurrently with the IRB process but it is strongly recommended that documentation of approval be provided at time of IRB submission. Documentation must be provided prior to IRB approval. The approval must cover the same protocol and consent versions reviewed by the IU IRB, including any IRB provisions.