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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.

项目总结/文摘