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

使用适合文化和语言的研究最佳实践来培训 Promotoras/社区卫生工作者

• 批准号: 10311580
• 负责人: Sergio A. Aguilar-Gaxiola
• 金额: $ 22.53万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10311580
• 关键词: Address; Attention; Award; Behavior Therapy; Behavioral; Behavioral Research; Behavioral trial; Biological; Clinical Competence; Clinical Research; Clinical Trials; Communities; Community Health Aides; Competence; Computers; Conduct Clinical Trials; Course Content; Development; Devices; Disabled Persons; Documentation; E-learning; Ensure; Evaluation; Focus Groups; Funding; Good Clinical Practice; Institution; Intervention Studies; Knowledge; Learning Module; Linguistics; Methods; Minority; Participant; Perception; Pharmaceutical Preparations; Phase; Procedures; Process; Protocols documentation; Regulation; Relationship-Building; Reporting; Research; Research Personnel; Research Project Grants; Research Support; Research Training; Risk; Scientific Advances and Accomplishments; Series; Side; Specific qualifier value; Testing; Training; Translating; Translational Research; Translations; United States Food and Drug Administration; United States National Institutes of Health; Update; Visual impairment; base; behavioral study; behavioral/social science; clinical practice; common rule; community based research; community engaged research; community engagement; community involvement; course development; design; member; new technology; online course; practice setting; research study; research to practice; social; social science research; underserved community

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.

项目摘要 良好的临床实践是临床研究工作人员的基本培训， 临床研究在实施过程中的严谨性。虽然良好的临床实践一直是一个要求， 研究人员进行药物，设备和生物临床试验，这是一个相对较新的要求NIH- 资助从事行为和社会科学（BSS）临床试验的研究人员。为了满足 为BSS研究人员量身定制的良好临床实践培训，我们的团队领导了最好的 社会和行为研究课程的实践。该课程于2017年开发， 以增加基于能力的研究培训，并迅速得到传播。它现在被认为是一个 可接受的培训，以满足良好的临床实践要求的BSS研究人员在NIH。以来 课程推出后，出现了新的监管变化以及技术和科学进步， 课程内容有待更新。此外，由于BSS研究通常涉及社区， 为了让不同背景和少数族裔的人参与进来，提出了一个社区参与模块 提供基础培训，以支持考虑这些复杂性的研究过程。最后， 目前的课程对所有残疾人的可及性需要加以确定。为了满足这些需求， 一个补充项目的目的是提供关键的更新，以最佳做法，在社会和行为 研究课程。我们已经召集了一个专家研究小组，并将聘请一个利益攸关方咨询委员会 和课程顾问代表团体的临床研究专业人员和领导人在社区为基础的 组织，以确保在项目的各个方面代表许多观点。我们的具体目标是 1）更新当前的社会和行为研究课程的最佳实践，以考虑最新的 法规要求和科学技术进步; 2）使临床研究 专业人员更容易与社区利益相关者合作，建立一个社区- 参与模块作为最佳做法培训的一部分;以及3）评估更新的培训课程， 用户.该项目预计将产生一个强大的更新社会和行为的最佳做法， 研究课程，将通过一系列传播渠道随时提供 利用。