Sign Here: How to Conduct Informed Consent with Deaf Individuals

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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.