Abstract
Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Scientific Review Committees (SRCs) were proposed to facilitate this assessment by the Clinical and Translational Science Award (CTSA) SRC Consensus Group. This study assessed SRC feasibility and impact at CTSA-affiliated academic health centers (AHCs). SRC implementation at 10 AHCs was assessed pre/post-intervention using quantitative and qualitative methods. Pre-intervention, four AHCs had no SRC, and six had at least one SRC needing modifications to better align with Consensus Group recommendations. Facilitators of successful SRC implementation included broad-based communication, an external motivator, senior-level support, and committed SRC reviewers. Barriers included limited resources and staffing, variable local mandates, limited SRC authority, lack of anticipated benefit, and operational challenges. Research protocol quality did not differ significantly between study periods, but respondents suggested positive effects. During intervention, median total review duration did not lengthen for the 40% of protocols approved within 3weeks. For the 60% under review after 3weeks, review was lengthened primarily due to longer IRB review for SRC-reviewed protocols. Site interviews recommended designing locally effective SRC processes, building buy-in by communication or by mandate, allowing time for planning and sharing best practices, and connecting SRC and IRB procedures. The CTSA SRC Consensus Group recommendations appear feasible. Although not conclusive in this relatively short initial implementation, sites perceived positive impact by SRCs on study quality. Optimal benefit will require local or federal mandate for implementation, adapting processes to local contexts, and employing SRC stipulations.
Highlights
Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs)
Ten sites participated during both study periods, spanning three types of extant Scientific Review Committees (SRCs) processes: four sites did not have SRC processes, four had a single SRC process conducted by a centralized group or by individual departments, and two sites had multiple extant SRC processes that participated in the study (n = 7 and n = 15)
The 26 extant SRC processes at baseline were relatively well aligned with the prioritized criteria (Fig. 1)
Summary
Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Research review should take into consideration a study’s scientific quality and operational feasibility to ensure that a protocol can be completed and will achieve its objectives so that the fewest number of participants are exposed to risk to answer the study question, and that the study question is worthwhile to answer [5,6].
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