Sign Here: How to Conduct Informed Consent with Deaf Individuals

项目总结/摘要 美国聋人社区-使用美国手语的50多万人的少数群体 (ASL)- 是我们国家医疗保健系统中最缺乏研究和服务的人群之一。 这种代表性不足的原因包括在医疗保健和研究环境中缺乏语言， 以及对医学界的不信任感。例如，临床研究人员经常 招募，进行知情同意，并收集口头或书面英语数据， 聋人手语用户无法访问。此外，医疗保健提供者和临床研究人员遵循医疗 “治愈”或“修复”耳聋的模式，而大多数聋人不希望被修复，而是希望得到尊重 作为一个文化和语言上的少数群体。 为了开始纠正临床研究中的不信任和代表性不足，知情同意过程已经 被认为是一个重要的干预领域。因此，我们的团队开发了一种原型干预， 研究人员在知情期间与聋人研究参与者进行有能力和敏感的互动 同意过程。这项干预措施是通过马萨诸塞大学医疗中心和马萨诸塞大学医疗中心之间为期两年的合作设计的。 学校（UMMS）和当地聋人社区-社区论坛，焦点小组和干预措施 开发团队包括聋人研究人员，电影制片人和外行。由此产生的原型 干预-一个30分钟的培训电影，题为在这里签名：如何与聋人研究进行知情同意 参与者-尚未根据目标受众的关键输入进行细化（听力临床 研究人员）;没有正式评估疗效;也没有适应听力的需要 医疗保健提供者和医学/护理学生。 因此，我们建议与主要持份者举行一系列焦点小组会议，以完善、扩大和 最终确定两个不同版本的Sign Here培训影片-一个用于临床研究人员，一个用于医疗保健 提供商在最终干预完成后，我们将进行两个并行的试点随机对照研究。 随机对照试验（RCT），以测试两种培训干预措施的可行性，可接受性和初步疗效。40 研究人员和40名医疗保健提供者将随机接受（1）在此签名的版本 为他们的专业角色定制的训练影片或（2）“常规干预”条件（即，标准NIH 关于如何向聋人或听力障碍者传达知情同意的指导）。 结果将可能验证具有即时价值的产品--两个高度可及、易于传播的 培训电影，以促进聋人在我们国家的医疗保健系统和临床 研究的努力。结果还将为一项大型多机构研究的设计提供信息，该研究将探索 在全国的学术医学院中，Sign Here培训干预措施的现实世界可扩展性。 我们研究计划的长期目标是增加聋人的数量， 研究参与者，以及增加聋人作为研究团队成员的人数。

PROJECT SUMMARY/ABSTRACT The U.S. Deaf community – a minority group of more than 500,000 people who use American Sign Language (ASL) – is one of the most understudied and underserved populations within our nation’s healthcare system. Reasons for this underrepresentation include lack of language access in healthcare and research settings, as well as communal feelings of mistrust toward the medical community. For example, clinical researchers often recruit, conduct informed consent, and collect data in spoken or written English, procedures that are inaccessible to Deaf ASL users. Additionally, healthcare providers and clinical researchers follow a medical model to “cure” or “fix” deafness, whereas most Deaf people do not want to be fixed, but rather to be respected as a cultural and linguistic minority group. To begin to rectify mistrust and underrepresentation in clinical research, the informed consent process has been suggested as a key area of intervention. As such, our team developed a prototype intervention to train research personnel to competently and sensitively interact with Deaf research participants during the informed consent process. The intervention was designed through a two-year collaboration between UMass Medical School (UMMS) and the local Deaf community – community forums, focus groups, and an intervention development team inclusive of Deaf researchers, filmmakers, and laypeople. The resulting prototype intervention – a 30-minute training film titled Sign Here: How to Conduct Informed Consent with Deaf Research Participants – has not yet been refined based on critical input from the target audience (hearing clinical research personnel); not been formally evaluated for efficacy; nor adapted to meet the needs of hearing healthcare providers and medical/nursing students. We, therefore, propose to conduct a series of focus groups with key stakeholders to refine, expand, and finalize two distinct versions of the Sign Here training film – one for clinical researchers and one for healthcare providers. After the final interventions are complete, we will conduct two concurrent pilot randomized controlled trials (RCTs) to test the feasibility, acceptability, and preliminary efficacy of the two training interventions. 40 research personnel and 40 healthcare providers will be randomized to receive (1) the version of the Sign Here training film tailored to their professional role or (2) an “intervention as usual” condition (i.e., standard NIH guidance on how to communicate informed consent to Deaf or hard-of-hearing individuals). Results will potentially validate products of immediate value – two highly-accessible, easy-to-disseminate training films to promote the inclusion of Deaf individuals in our nation’s healthcare system and clinical research endeavors. Results will also inform the design of a large, multi-institution study that will explore the real-world scalability of the Sign Here training interventions in academic medical schools across the nation. The long-term objectives of our research program are to increase the number of Deaf people engaged as research participants, as well as increase the number of Deaf people engaged as research team members.