Sign Here: How to Conduct Informed Consent with Deaf Individuals

在此签名：如何与聋人进行知情同意

基本信息

批准号：
10361565
负责人：
Melissa Lee Anderson
金额：
$ 21.05万
依托单位：
UNIV OF MASSACHUSETTS MED SCH WORCESTER
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-03-01 至 2024-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10361565
关键词：
American Sign Language Area Behavior Black race Clinical Clinical Research Clinical Treatment Collaborations Communication Communities Data Educational Intervention Enrollment Eugenics Feedback Feeling Film Focus Groups Health Care Research Health Personnel Healthcare Systems Hearing Individual Informed Consent Institution Intervention Language Latinx Length Linguistics Masks Measures Medical Minority Groups Modeling Motivation Nursing Students Outcome Participant Patients Performance Persons Procedures Process Production Professional Role Provider Randomized Randomized Controlled Trials Recording of previous events Research Research Ethics Research Personnel Research Training Resources Series Site Standardization Sterilization Suggestion Testing Therapeutic Training Training Activity Trust Underserved Population United States National Institutes of Health acceptability and feasibility base commune cultural competence deaf deafness design effectiveness testing efficacy evaluation efficacy outcomes feasibility testing formative assessment future implementation hard of hearing improved intervention delivery maltreatment medical schools member programs prototype recruit retention rate satisfaction simulation skills success systems research therapy development unethical

项目摘要

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.

项目概要/摘要美国聋人社区——使用美国手语的超过 500,000 人的少数群体 (ASL) – 是我国医疗保健系统中研究最充分、服务最缺乏的人群之一。造成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访问，例如以及对医学界的不信任感，例如临床研究人员。用英语口语或书面语招募、进行知情同意并收集数据，这些程序聋人 ASL 用户无法访问此外，医疗保健提供者和临床研究人员也遵循医学规定。 “治愈”或“修复”耳聋的模型，而大多数聋人并不想被修复，而是希望受到尊重作为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，知情同意程序已经被建议作为干预的关键领域因此，我们的团队开发了一个原型干预来培训。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该干预措施是通过麻省大学医学院两年的合作设计的。学校 (UMMS) 和当地聋人社区 – 社区论坛、焦点小组和干预开发团队包括聋人研究人员、电影制作人和外行人士。干预 – 一部 30 分钟的培训影片，标题为“在这里签名：如何对聋人研究进行知情同意” 参与者——尚未根据目标受众的关键意见进行细化（听力临床研究人员）；没有经过正式的功效评估；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，我们建议与主要利益相关者开展一系列焦点小组会议，以完善、扩展和最终确定“Sign Here”培训影片的两个不同版本——一个用于临床研究人员，一个用于医疗保健最终干预完成后，我们将进行两个同时进行的随机对照试验。试验（RCT）来测试两种培训干预措施的可行性、可接受性和初步效果40。研究人员和 40 名医疗保健提供者将被随机接收 (1) 版本的“在此处签名” 适合其专业角色的培训影片或 (2) “照常干预”条件（即标准 NIH 关于如何向聋哑人或听力障碍人士表达知情同意的指南）。结果将有可能验证具有直接价值的产品——两种易于获取、易于传播的产品培训电影，以促进聋人融入我们国家的医疗保健系统和临床研究成果还将为一项大型、多机构研究的设计提供信息，该研究将探讨 “Sign Here”培训干预措施在全国各地学术医学院的现实世界中的可扩展性。我们研究计划的长期目标是增加聋人参与的人数研究参与者，以及增加作为研究团队成员的聋人人数。