Scientific Review Committee

The Scientific Review Committee (SRC) ensures that the scientific question being asked within a protocol is relevant and that the design of the protocol is appropriate to answer that question.

The SRC review will primarily focus on the elements of good scientific study design. Proposals will be evaluated for the following criteria:

• clarity of the research question,
• appropriateness and efficiency of design,
• rigor and feasibility of methods,
• qualifications and expertise of the research team,
• scholarship and pertinence of background material and rationale,
• adequacy of sample size and relevance of controls,
• and the validity of the statistical analysis plan.

In addition, the Committee may desire to comment on the proposal’s scientific relevance or compelling ethical or patient safety issues. The SRC will submit a summary of their evaluation to the IRB and report their final recommendation as (1) recommend approval without revision, (2) recommend approval pending acceptable revision, or (3) recommend rejection. Recommendations will be based on consensus. The Scientific Review Committee may call upon a consultant if additional expertise is needed to conduct a review. The opinion of the consultant will be taken into consideration when developing the final report. The fact that a consultant was utilized will be noted in the letter to the IRB.

The IRB requires scientific review for all studies reviewed by the convened board that have not already undergone review by another body. The IRB also reserves the right to send any study to the Scientific Review Committee for evaluation. The Scientific Review Committee will generally meet the week before the scheduled IRB meeting to discuss the research protocol.

A member will not review any protocol in which s/he has an interest in the study. If needed, the IRB may call upon the Scientific Advisory Committee of the General Clinical Research Center for assistance.