UNC holds town hall to discuss scientific review process

The Office of the Vice Chancellor for Research, The Office of Clinical Trials, The Office of Human Research Ethics presents:

Town Hall to Discuss Recent Changes to the Scientific Review Process at UNC

Do you have questions about the recent changes to the Scientific Review Process at UNC? Please join us for an interactive conversation about the most recent change.

Date: Tuesday, September 27, 2016
Time: 1:00 – 2:00pm
Location: MBRB G202

Come share your thoughts, voice your concerns and ask questions. All are welcome!

Scientific review of human subjects protocols is required as there is no acceptable risk to human subjects in the absence of valid scientific benefit. The regulatory rationale for requiring science merit reviews emanates from 45 CFR 46.111(a)(1) as follows:

• Risks to participants are minimized by using procedures consistent with sound research design and which do not unnecessarily expose participants to risk.
• Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.

For the past four years this review has been done by a subcommittee of the UNC IRB, the Scientific Review Subcommittee. To many this review was a part of the IRB review and resulted in IRB stipulations which had the potential to significantly delay the approval and start of a clinical trial. In an effort to increase efficiencies while remaining compliant with applicable regulations, the scientific review process has now been moved out of the IRB.

This new process is considered an institutional best practice. The requirement of submitting a formal protocol is another effort to implement a best practice by allowing investigators to submit a protocol to the Scientific Review Committee (SRC) while continuing to develop their informed consent document.

The formal protocol can be submitted to the SRC prior to IRB submission, the SRC meets weekly, therefore any protocol modifications should not result in a delay of 1 month that the IRB review currently requires if a study must be deferred due to scientific review stipulations. This new process will significantly accelerate the approval of investigator initiated studies.

The IRB application has been modified to assist you in determining if your protocol requires SRC review. Additional information is available on the Office of Clinical Trials (OCT) website research.unc.edu/offices/clinical-trials/scientific-review-committee.