Training Promotoras/Community Health Workers using Culturally and Linguistically-Appropriate Research Best Practices

项目摘要 良好的临床实践是对临床研究人员的基本培训，支持诚信和 实施过程中临床研究的严格性。虽然良好的临床实践一直是对 从事药物、器械和生物临床试验的研究人员，这是对NIH- 资助从事行为和社会科学(BSS)临床试验的研究人员。认识到一种需要 对于为BSS研究人员量身定做的良好临床实践培训，我们的团队领导开发了Best 社会与行为研究实践课程。该课程于2017年开发，作为一项努力的一部分 增加基于能力的研究培训，并迅速传播。它现在被认为是一种 可接受的培训，以满足美国国立卫生研究院对血瘀证研究人员的良好临床实践要求。自.以来 课程推出后，出现了新的法规变化和技术和科学进步，需要 要更新的课程内容。此外，由于BSS研究通常涉及社区和 为了让具有不同和少数族裔背景的人参与进来，建议建立一个社区参与模块 考虑到这些复杂性，提供基础培训以支持研究过程。最后， 需要确定当前课程对所有残疾人的可及性。为了满足这些需求， 补充项目旨在为社会和行为方面的最佳做法提供关键更新 研究课程。我们已经召集了一个专家研究小组，并将聘请一个利益相关者咨询委员会 和课程顾问，代表以社区为基础的临床研究专业人员和领导者团体 各组织应确保在项目的所有方面都能代表许多观点。我们的具体目标是 到：1)更新当前的社会和行为研究最佳实践课程，以考虑到最新的 法规要求和科技进步；2)使临床研究成为可能 专业人士通过开发社区更容易地与基于社区的利益相关者合作- 将参与模块作为最佳做法培训的一部分；以及3)评估更新后的培训课程 用户。该项目预计将对社会和行为最佳做法进行强有力的更新 将通过一系列传播渠道随时提供的研究课程 利用。

Project Summary 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.