New website for Scientific Review Committee

The Scientific Review Committee (SRC) has a new website at research.unc.edu. The website contains helpful information for researchers as well as a new Interventional Protocol Template for non-NIH-FDA clinical trials (see bottom of that page).

The University of North Carolina at Chapel Hill has designated a Scientific Review Committee (SRC) to assess initial clinical research studies for scientific merit and integrity as a precursor to IRB review.

The SRC is comprised of senior clinical and translational research investigators and professional biostatisticians who, as a group, evaluate targeted research projects, which include those:

• That meet the regulatory and/or institutional greater than minimal risk criteria (Generally, a study that requires Full Board review at a convened IRB Committee Meeting meets the threshold for greater than minimal risk and review by the SRC)…

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• That have not previously undergone rigorous scientific review by a panel of experts assembled specifically to evaluate the project using criteria similar to the SRC. FDA or NIH Study Section review is not synonymous with SRC review and cannot be substituted as such…

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• That do not have a focus on cancer research nor recruit research subjects from UNC oncology clinics. Such studies are to be submitted for review by the UNC Protocol Review Committee…

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• Whose role is NOT SOLELY that of a participating study site in a multi-center, industry-sponsored study.

Scientific review at UNC-Chapel Hill requires submission of a comprehensive protocol written to accepted industry standards and incorporating all the elements that the SRC considers when reviewing proposed research for scientific merit (the value to be gained, e.g., how the new information will advance understanding in a particular line of scientific inquiry) and scientific integrity (the yielding of useful information, e.g., alignment between study design, sample size calculation, aim(s), recruitment method(s), outcome measures, study procedures, data collection/quality assurance, safety monitoring, and statistical analysis plan(s)).

For more information, visit research.unc.edu.