The University of Rochester's Clinical and Translational Science Institute

描述（由申请人提供）：使用美国手语（ASL）的聋人包括未充分研究的语言和文化少数群体。沟通和社会文化障碍在很大程度上将聋人手语使用者排除在健康监测和研究活动之外。为了促进与聋人和健康有关的知识基础，我们需要方便和有效的知情同意程序，以便将聋人ASL用户纳入健康研究。 标准的书面英语知情同意书的障碍包括许多成年人的英语阅读能力低，因为出生或幼儿期失聪。许多成年聋人出生后/幼儿期也有有限的机会获得周围的信息，如无意中听到的谈话和广播。由此产生的有限的“信息基金”，加上低英语识字率，使书面英语同意书对大多数人无效 聋哑美国手语使用者。本研究将探讨三种不同的方式与聋人成人ASL用户的知情同意沟通，并比较其有效性的理解，愿意从事研究（同意后），和信任的措施。这三种模式是：（1）书面英语，（2）将相同的书面英语知情同意材料直接翻译成美国手语，并以一人使用美国手语的电影形式呈现，以及（3）对相同的书面英语知情同意材料进行对话改编，在电影中呈现为几个聋人之间的对话，他们的对话内容涉及书面英语知情同意源文件和潜在基金中的信息，信息差距。这项研究的结果将为聋人ASL使用者和其他语言少数群体的知情同意研究提供信息，并为聋人ASL使用者更多地参与健康研究铺平道路。这项研究开始响应“健康人2020”的号召，扩大有关残疾人健康决定因素的知识库。这项拟议的研究将采取一种用于聋人健康教育材料的方法，并将其应用于提供研究同意信息的过程。这里评估的基于视频的同意方式对其他群体的同意/赞同有影响，包括其他语言少数群体和识字率低的群体，包括幼儿。

DESCRIPTION (provided by applicant): Deaf people who use American Sign Language (ASL) comprise understudied language and cultural minority groups. Communication and sociocultural barriers largely exclude deaf ASL users from health surveillance and research activities. To advance the knowledge-base related to deaf people and health, we need accessible and effective informed consent processes in order to include deaf ASL users in health research. Barriers to standard written English informed consent include the low English reading ability of many adults deaf since birth or early childhood. Many adults deaf since birth/early childhood also have limited access to ambient information, such as from overheard conversation and radio. The resulting limited "fund of information," coupled with low English literacy, renders written English consent forms ineffective for most deaf ASL users. This study will examine three distinct modalities of informed consent communication with deaf adult ASL users and compare their effectiveness using measures of comprehension, willingness to engage in research (post-consent), and trust. The three modalities are: (1) Written English, (2) direct Translation of the same written English consent material into ASL, presented on film featuring one person using ASL, and (3) Dialogic Adaptation of the same written English consent material, presented on film as a dialogue amongst several deaf individuals where the content of their conversation addresses the information from the written English informed consent source document and potential fund of information gaps. Findings from this research will inform research on informed consent with deaf ASL users and other language minority populations, and will pave the way for increased participation of deaf ASL users in health research. This research begins to address the Healthy People 2020 call to expand the knowledge base about determinants of health for people with disabilities. This proposed research will take an approach used with health education materials meant for deaf audiences and apply it to the process of delivering research consent information. The video-based consent modalities evaluated here have implications for consent/assent with other groups, including other language minority groups and those with low literacy, including young children.