Deaf ACCESS: Adapting Consent through Community Engagement and State-of-the-art Simulation

项目摘要/摘要 美国聋人社区--由50万人组成的使用美国手语的少数群体--是 在生物医学研究中最未被研究的人群。其中一个原因是经常使用研究 聋人无法使用的方法(例如，随机数字拨号电话调查)。另一个 理性是研究人员和聋人在观点上的主要区别。研究人员经常将目标 来“治愈”或“修复”听力损失。然而，聋人并不认为自己需要“修复”，而是认为 具有共同经历、历史、艺术和文学的丰富文化的成员。这些障碍促成了 由于长期以来在研究界对聋人的虐待，导致他们对研究人员不信任 以及不愿参与生物医学研究。 作为对这些问题的回应，我们将引导聋人接触：通过社区参与调整同意 和最先进的模拟技术。作为我们研究团队的一部分，我们与聋人社区成员合作，我们 将修改知情同意程序，使他们更适合聋人，然后使用医学模拟来 培训研究助理如何适当地招募和招募聋人研究参与者。我们的目标是：(1) 确定聋人参与生物医学研究的障碍和促进者，重点是 知情同意程序，通过在Deaf举办四个聋人社区论坛和三个焦点小组 社区文化机构；(2)根据从目标1吸取的经验教训，在#年制定培训干预措施 哪些聋人社区成员教研究助理提供符合文化背景的知情同意 使用美国手语翻译；以及(3)测试干预的可行性和接受性 在与五名听力研究助理进行基于模拟的培训期间，这五名助理目前正在进行 获得加州大学马萨诸塞州医学院的同意(且之前没有与聋人打交道的经验)。 这些目标是基于我们之前的先导研究，基于模拟的社区参与研究 干预《知情同意议定书》的测试和培训，其中纳入了文化和语言 利用非洲裔美国人和拉丁裔人的专业知识将称职的方法纳入知情同意程序 社区成员。我们非常适合实现这些目标，作为一个致力于 社区参与的多方向学习和分享的过程。我们的结果将支持更大规模的试验 此外，还将制作具有很大分发和推广潜力的培训产品。这部作品 将为一项可持续的研究计划奠定基础，该计划将改变我们接触和接触聋人的方式 社区，增加聋人参与生物医学研究和研究的人数 鼓励更多的聋人积极投身于研究领域。

PROJECT SUMMARY/ABSTRACT The U.S. Deaf community – a minority group of 500,000 people who use American Sign Language – is one of the most understudied populations in biomedical research. One reason is the frequent use of research methods that are not accessible to Deaf people (for example, random-digit-dial telephone surveys). Another reason is the major difference in points-of-view between researchers and Deaf people. Researchers often aim to “cure” or “fix” hearing loss. Deaf people, however, do not view themselves as needing to be “fixed,” but as members of a rich culture with shared experience, history, art, and literature. These barriers have contributed to a long history of mistreatment of Deaf people in the research world, resulting in their mistrust of researchers and reluctance to participate in biomedical research studies. In response to these issues, we will lead Deaf ACCESS: Adapting Consent through Community Engagement and State-of-the-art Simulation. Collaborating with Deaf community members as part of our research team, we will adapt informed consent procedures to make them more Deaf-friendly, and then use medical simulation to train research assistants how to appropriately recruit and enroll Deaf research participants. We aim to: (1) identify the barriers and facilitators to Deaf people’s engagement in biomedical research, with an emphasis on the informed consent process, by holding four Deaf community forums and three focus groups at Deaf community cultural institutions; (2) develop a training intervention based on lessons learned from Aim 1, in which Deaf community members teach research assistants to deliver culturally appropriate informed consent using an American Sign Language interpreter; and (3) test the feasibility and acceptance of the intervention during simulation-based training sessions with five hearing research assistants who currently conduct informed consent at UMass Medical School (and who have no prior experience working with Deaf individuals). These aims are based on our previous pilot research, Simulation-based Community-engaged Research Intervention for Informed Consent Protocol Testing and Training, which incorporated culturally and linguistically competent methods into the informed consent process using the expertise of African-American and Latino community members. We are ideally suited to achieve these aims as a diverse research team committed to a community-engaged process of multi-directional learning and sharing. Our results will support a larger trial of Deaf ACCESS and will produce training products with much potential for distribution and replication. This work will lay the foundation for a sustainable program of research that shifts how we approach and engage the Deaf community, increasing the number of Deaf people who participate in biomedical research studies and encouraging more Deaf people to become actively engaged in the research world.