Good clinical practice is essential training for the clinical research workforce that supports the integrity and rigor of clinical research during implementation. While good clinical practice has been a requirement for researchers undertaking drug, device, and biologic clinical trials, it is a relatively new requirement for NIH- funded researchers who undertake behavioral and social science (BSS) clinical trials. In recognition of a need for tailored good clinical practice training for BSS researchers, our team led the development of the Best Practices for Social and Behavioral Research Course. The course was developed in 2017 as part of an effort to increase competency-based research training and was quickly disseminated. It is now recognized as an acceptable training to fulfill the good clinical practice requirement for BSS researchers at the NIH. Since the course launch, there have been new regulatory changes and technical and scientific advances that require the course content to be updated. In addition, because BSS research studies typically involve communities and engagement of people with diverse and minority backgrounds, a community engagement module is proposed to provide fundamental training to support research processes considering these complexities. Lastly, accessibility of the current course to all people with disabilities needs to be fixed. To address these needs, the supplement project was designed to provide critical updates to the Best Practices in Social and Behavioral Research course. We have convened an expert study team and will engage an advisory board of stakeholders and course consultants representing groups of clinical research professionals and leaders in community-based organizations to ensure representation of many perspectives in all aspects of the project.
Our specific aims are to: 1) update the current Best Practices for Social and Behavioral Research Course to account for the latest regulatory requirements and scientific and technological advancements; 2) enable clinical research professionals to more readily partner with community-based stakeholders by developing a community- engagement module as part of the best practices training; and 3) evaluate the updated training course with users. This project is expected to yield a robust update to the Best Practices for Social and Behavioral Research Course which will be readily available through the array of dissemination outlets the current course utilizes.
The ability to effectively translate evidence from clinical research into practice settings and communities requires a trained research workforce that can design and implement high quality research with special attention to behavioral and social aspects that can contribute to translation barriers. Our team led development of the first-of-its-kind best practices training for research professionals who conduct behavioral and social science research and now seeks to provide a critical update to this best practices training online course. The result will be a robust training that will provide relevant up-to-date content for learners that can be readily disseminated to a growing workforce of research professionals through our established dissemination channels.
