Informed Consent in Illiterate Subjects

文盲受试者的知情同意

• 批准号: 7471777
• 负责人: Donald John Krogstad
• 金额: $ 20.73万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-12 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7471777
• 关键词: Achievement; Address; Adult; Antimalarials; Belief; Caring; Collaborations; Consent; Consent Forms; Developed Countries; Developing Countries; Development; Documentation; Elements; Ensure; Environment; Ethicists; Focus Groups; Future; Goals; Health; Individual; Informed Consent; Institutes; International; Interview; Language; Link; Los Angeles; Mali; Medical; Medicine; New York; Oral; Participant; Patients; Pattern; Persons; Phase II Clinical Trials; Phase III Clinical Trials; Population; Procedures; Process; Protocols documentation; Public Health; Reading; Reliance; Research; Research Ethics Committees; Sample Size; Site; Study Section; Study Subject; Terminology; Testing; Translating; Translations; Videotape; World Health Organization; Writing; base; compare effectiveness; experience; illiteracy; illiterate; inner city; interest; literacy; literate; member; novel; volunteer

DESCRIPTION (provided by applicant): In developed countries, the informed consent process depends primarily on documents approved by local Institutional Review Boards (IRBs) and on the participants' signatures, to indicate they have read and understood the document. The two essential goals of informed consent are first, to ensure that participants are fully and fairly informed, and second, to ensure that consent is given freely. Unfortunately, the informed consent process often fails to achieve these goals in developing countries because the participants have limited or no literacy and limited experience with western medicine. The goal of this proposal is to develop informed consent strategies which are as effective for persons in developing countries with limited or no literacy (who have limited experience with western medicine) as they are for educated individuals in the U.S. This issue is relevant to health research in the broadest sense, because individuals with limited literacy who have limited experience with western medicine are also present in the U.S. (New Orleans, Houston, New York, Los Angeles). The specific aims of this proposal are to: 1] develop strategies to assess the understanding of a study protocol by potential participants and their acceptance of the informed consent process, and 2] use those strategies to compare the understanding of participants based on the information they have received (videotape presentation prepared in collaboration with the Institute of Languages in Bamako vs. the conventional paraphrased translation of the study protocol) and to compare the acceptance of a new consent procedure (oral consent based on discussion with a study representative and a traditional Malian intermediary that is documented with a video recorder) to the conventional consent (based on "signing," placing an "X" or a thumbprint on a document the participant cannot read). If successful, this proposal will permit the development of similar strategies at other overseas and domestic sites - based on key informant interviews and focus groups to ensure that the strategies selected are consistent with local cultural beliefs and patterns. Thus, this approach also has the potential to be valuable in inner city environments where limited literacy and limited experience with western medicine are common. By departing from the current reliance on written documentation, this approach offers an opportunity to refocus on the essential elements of informed consent: that the participants be fully and fairly informed, and that consent be given freely. PUBLIC HEALTH RELEVANCE Because informed consent depends on written documents, it often fails because of illiteracy in developing countries. This proposal uses a videotape to present the study protocol visually and in dialect, and a new consent procedure based on recording the consent transaction between the subject, study representative and traditional Malian intermediary with a video camera. It then compares the effectiveness of the videotape presentation to the conventional presentation (paraphrased translation of the study protocol by a staff member) and the acceptance of the new consent procedure to the acceptance of the conventional consent procedure (placing an "X" or a thumbprint on the consent document).

描述（由申请人提供）：在发达国家，知情同意过程主要取决于当地机构审查委员会（IRB）批准的文件和参与者的签名，以表明他们已阅读并理解该文件。知情同意的两个基本目标是：第一，确保参与者充分和公平地知情;第二，确保自由地表示同意。不幸的是，在发展中国家，知情同意程序往往无法实现这些目标，因为参与者的文化程度有限或根本没有文化，对西方医学的经验也有限。本提案的目标是制定知情同意战略，这些战略对发展中国家文化水平有限或没有文化的人同样有效（对西医经验有限），因为他们是为受过教育的个人在uidoss.这个问题是相关的健康研究在最广泛的意义上，因为在美国（新奥尔良、休斯顿、纽约、洛杉矶）也存在着对西方医学经验有限的文化程度有限的人。这项建议的具体目标是：1]制定策略，以评估潜在参与者对研究方案的理解及其对知情同意过程的接受程度，和2]使用这些策略来比较参与者基于他们所获得的信息的理解（与巴马科语言研究所合作制作的录像带介绍与研究方案的传统释义翻译）并比较对新的同意程序（基于与研究代表和传统马里中间人讨论的口头同意，并使用录像机记录）与传统同意（基于“签名”，在参与者无法阅读的文件上放置“X”或拇指指纹）的接受程度。如果成功的话，这一建议将允许在其他海外和国内地点制定类似的战略----基于关键的信息提供者访谈和焦点小组，以确保所选择的战略符合当地的文化信仰和模式。因此，这种方法也有可能是有价值的内城环境中，有限的识字和有限的经验与西方医学是常见的。这种方法摆脱了目前对书面文件的依赖，提供了一个机会，可以重新关注知情同意的基本要素：参与者充分和公平地知情，自由地表示同意。 由于知情同意取决于书面文件，在发展中国家，由于文盲，它经常失败。该提案使用录像带以视觉方式和方言呈现研究方案，并使用摄像机记录受试者、研究代表和传统马里中介之间的同意交易，以此为基础制定新的同意程序。然后比较录像带演示与传统演示（工作人员对研究方案的释义翻译）的有效性，以及接受新的同意程序与接受传统同意程序（在同意文件上放置“X”或拇指指纹）的有效性。