- Last updated:
- 01/19/2021
Additional Review by Non-IRB Committees
- Guidance Contact:
IU Human Research Protection Program (HRPP)
irb@iu.edu
IU Human Research Protection Program (HRPP)
irb@iu.edu
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.
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.
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:
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/.