Danila Maria I, Allison Jeroan J, Goins Karin Valentine, Chiriboga Germán, Fischer Melissa, Puliafico Melissa, Mudano Amy S, Rahn Elizabeth J, Merchant Jeanne, Lawrence Colleen E, Dunkel Leah, Israel Tiffany, Barton Bruce, Jenoure Fred, Alexander Tiffany, Cruz Danny, Douglas Marva, Sims Jacqueline, Richmond Al, Roberson Erik D, Chambless Carol, Harris Paul A, Saag Kenneth G, Lemon Stephenie C
Department of Medicine, Division of Clinical Immunology/Rheumatology, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.
University of Alabama at Birmingham Center for Clinical and Translational Science, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.
J Clin Transl Sci. 2021 Jun 14;5(1):e134. doi: 10.1017/cts.2021.797. eCollection 2021.
Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups.
We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components.
The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a "storytelling" intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process.
The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants.
种族和少数族裔群体成员参与研究存在多方面障碍，这些障碍源于历史上的社会不公，在参与者、研究团队和研究过程层面均有出现。知情同意程序是研究过程的关键组成部分，也是解决这些障碍的契机。本手稿描述了加强多样化入组转化研究（STRIDE）干预措施的开发过程，该干预措施旨在提高代表性不足群体个体的研究参与度。
我们采用社区参与的方法来开发一种综合的干预措施，该措施对文化和读写能力敏感，由多个部分组成，旨在解决知情同意过程中研究参与的障碍。这种方法包括让社区调查员参与干预措施开发活动，并利用社区参与工作室及其他方法获取社区成员对干预措施各部分的反馈。
STRIDE干预措施有三个组成部分：针对临床研究助理的基于模拟的培训项目，该项目强调在协助知情同意过程中的文化能力和沟通技巧；一个旨在提高与健康相关研究材料理解度和相关性的电子同意（eConsent）框架；以及一种“故事讲述”干预措施，即来自不同背景的先前研究参与者在同意过程中通过视频短片分享他们的经历。
社区参与的开发方法产生了一种多部分干预措施，该措施解决了已知的研究参与障碍，并可纳入研究的同意过程。一项正在进行的研究结果将确定其在增加研究参与者多样性方面的有效性。
