Informed Consent in Illiterate Subjects

说明（由申请人提供）：在发达国家，知情同意程序主要依赖于当地机构审查委员会（irb）批准的文件和参与者的签名，表明他们已经阅读并理解了文件。知情同意的两个基本目标是：第一，确保参与者得到充分和公平的信息；第二，确保自愿同意。不幸的是，在发展中国家，知情同意过程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，对西医的经验也有限。该提案的目标是制定知情同意策略，该策略对发展中国家文化程度有限或没有文化的人（他们对西医的经验有限）和对美国受过教育的人一样有效。这个问题与最广泛意义上的健康研究相关，因为在美国（新奥尔良，休斯顿，纽约，洛杉矶）也存在文化程度有限的人，他们对西医的经验有限。这项建议的具体目的是：1]制定策略，评估潜在参与者对研究方案的理解以及他们对知情同意过程的接受程度；[2]使用这些策略来比较参与者根据他们收到的信息（与巴马科语言研究所合作准备的录像带演示与传统的研究方案释义翻译）的理解，并比较接受新的同意程序（基于与研究代表和传统马里中介的讨论的口头同意，并用录像机记录）与传统的同意程序同意（基于“签名”，在参与者无法阅读的文件上放置“X”或拇指指纹）。如果成功，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，这种方法在文化水平和西医经验有限的城市内部环境中也有可能很有价值。通过摆脱目前对书面文件的依赖，这种方法提供了一个机会，重新关注知情同意的基本要素：参与者被充分和公平地告知，并自由地给予同意。由于知情同意依赖于书面文件，因此在发展中国家，由于文盲问题，知情同意常常失败。本建议使用录像带以视觉和方言呈现研究方案，并采用新的同意程序，该程序基于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。然后比较录像带演示与传统演示的有效性（工作人员对研究方案的意译翻译），以及接受新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）。

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).