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Additional Review by non-IRB committees
Additional Review by Non-IRB Committees
- Guidance Contact:
IU Human Research Protection Program (HRPP)
Some human subjects research studies require additional approval
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.
In an effort to enhance efficiency and provide more flexible and tailored scientific review, the IRB and CTSI partnered in October 2016 to pilot a revised scientific review process. In the revised process, scientific merit of research proposals was transferred from the IRB’s initial review to a separately convened committee under the oversight of the CTSI. The pilot project narrowly focused on studies most commonly identified by the IRB as requiring scientific changes – greater than minimal risk investigator-initiated studies that had not undergone external scientific review, for example, by a funding agency. At the conclusion of the pilot project, quantitative and qualitative data was reviewed. While the rate of IRB tabling of these studies decreased, the overall turnaround time did not improve as a result of the external scientific review process. Institutional leadership determined the partnership to be beneficial and recommended its continuation with certain modifications to improve efficiency and transparency.
In March 2018, the CTSI Scientific Review Committee (SRC) process was modified as follows:
- The scope was slightly narrowed to require CTSI SRC review only for greater than minimal risk biomedical studies that had not undergone a peer review process;
- Researchers were instructed that SRC review should be completed prior to submission to the IRB. Specifically, researchers should initiate the scientific review process as soon as the protocol is finalized – the SRC does not need the additional information needed by the IRB such as the consent, recruitment materials, or the IRB application forms.
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; document 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.