Murphy Susan L, Guetterman Timothy C, Haro Elizabeth K, Shakour Sana
University of Michigan, Ann Arbor, USA.
University of California, Santa Cruz, USA.
J Empir Res Hum Res Ethics. 2025 Feb-Apr;20(1-2):29-37. doi: 10.1177/15562646241302396. Epub 2024 Dec 18.
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.
与药物和器械研究相比，行为与社会科学研究（BSSR）的监管较为宽松。在我们大学，内部质量保证活动表明，与其他研究相比，BSSR研究存在更多但类似的问题。然而，大多数机构资源都是为支持药物和器械研究而量身定制的，在促进严谨的BSSR研究开展的有效策略方面存在证据空白。两个校园单位合作开展了一项两阶段研究。首先，我们根据BSSR研究审计数据对合规问题进行了特征描述。其次，我们对行为研究人员和其他人进行了访谈，以讨论合规问题的促成因素和潜在的缓解策略。通过主题分析，我们确定了可以在个人、研究团队和大学系统层面解决的问题。研究结果概述了减少合规问题的潜在策略。
