Identifying Strategies for Strengthening Behavioral and Social Science Research Study Conduct

Abstract

Behavioral and social science research (BSSR) studies are less stringently regulated compared to drug and device studies. At our university, internal quality assurance activities revealed BSSR studies have more, but similar, issues compared to other studies. However, most institutional resources are tailored to support drug and device research, leaving an evidence gap regarding effective strategies for fostering rigorous BSSR study conduct. Two campus units partnered to undertake a two-phase study. First, we characterized compliance issues based on BSSR study audit data. Second, we conducted interviews with behavioral researchers and others to discuss contributors to compliance issues and potential mitigating strategies. Through thematic analysis, we identified problems at that can be addressed at individual, study team, and university systems levels. Study results outline potential strategies to reduce compliance issues.