IMPROVING THE CONSENT PROCESS FOR LOW LITERACY PARENTS

改善文化程度低的家长的同意程序

• 批准号: 2889471
• 负责人: FRANCES A. CAMPBELL
• 金额: $ 21.68万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-26 至 2002-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2889471
• 关键词: African American; caucasian American; clinical research; comprehension; educationally disadvantaged; health care service evaluation; health science research analysis /evaluation; human subject; information dissemination; informed consent; interactive multimedia; low socioeconomic status; reading disorder; videotape /videodisc

DESCRIPTION (Adapted from the Investigator's Abstract): Consent forms serve to guarantee that human beings participating in research are fully informed of their rights and of the procedures, risks, and benefits of any studies they agree to join. One significant problem accruing to the process of obtaining informed consent concerns the presentation of the necessary information. To ensure that complete information is conveyed, many consent forms are long and couched in technical language. Such complex language may not be suitable for target populations where literacy levels are low. Much of the research aimed at improving participant comprehension has focused on the readability of the consent forms. Such research does not, however, consider whether printed material is simply inadequate as a means of communication for individuals who have difficulty reading. Little research has examined the use of alternative media as a means of increasing accessibility of consent material for low-literacy populations. Because the poor and children of the poor are at especially high risk for a variety of health, educational, and social ills, it is particularly important that they be represented in studies addressing problems to which they are vulnerable. For this reason, research to learn how to increase the degree to which low-income parents understand the purposes of research involving their children and the effectiveness of the recruitment and consent process is particularly important. The research proposed herein is designed to (a) examine the readability and comprehensibility of currently employed consent forms, and (b) examine the media through which information is communicated to low-literacy subjects, represented by the parents of Head Start children. This will include the development of materials in alternative media (such as videotape enhancement, and interactive multimedia presentations) and testing subjects' comprehension of information presented, and their willingness to consent to their children's participation in research as a function of these various media.

描述（改编自研究者摘要）：知情同意书 保证参与研究的人充分知情 他们的权利以及任何研究的程序、风险和获益 他们同意加入。 一个重要的问题是， 获得知情同意涉及必要的 信息. 为了确保传达完整的信息，许多人同意 表格很长，用技术语言表达。 这种复杂的语言可能 不适合识字水平低的目标人群。 多 的研究，旨在提高参与者的理解集中在 同意书的可读性。 然而，这样的研究并没有， 考虑印刷材料是否只是不足以作为一种手段， 为阅读有困难的人提供沟通。 点研究 研究了使用替代媒体作为增加 识字率低的人口获得同意材料。 因为 穷人和穷人的孩子特别容易患上各种疾病， 健康，教育和社会弊病，特别重要的是，他们 在针对他们易受影响的问题的研究中派代表参加。 因此，研究如何提高 低收入父母了解研究的目的， 儿童以及招募和同意程序的有效性， 尤其重要。 本文提出的研究旨在（a） 检查当前使用的同意书的可读性和可理解性 形式，以及（B）检查信息传播的媒介 低文化程度的科目，由家长代表的开端儿童。 这将包括在替代媒体（如 录像带增强和交互式多媒体演示）和测试 受试者对所呈现信息的理解，以及他们愿意 同意他们的孩子参与研究作为这些功能 各种媒体。