EDICT: Effective Delivery of Informed Consent Trial

描述（由申请人提供）：拟议的研究- EDICT（有效交付知情同意试验）-直接响应资助机会公告（FOA） PA-11-180，生物医学，社会和行为研究中的伦理问题研究。与《自由信息法》一致，《知情同意书》解决了与美国国立卫生研究院（NIH）资助的临床和行为研究相关的一个重要伦理挑战：长期使用长篇知情同意书及其对潜在参与者对研究的理解的不利影响。有大量证据表明，潜在的研究参与者并不完全理解同意书中披露的信息。同意书的长度是一个促成因素。EDICT将识别关键利益相关者认为的同意书中包含的相关和无关信息；将这些信息纳入行为和临床研究的简短同意书模板的开发中；然后使用随机对照设计，将从模板中获得的简短同意书与两项HIV预防试验网络（HPTN）研究中的标准同意书进行比较。具体来说，《法令》将分三个阶段进行。在第一阶段，将与主要研究利益相关者进行访谈——1)参与者，2)东道国研究伦理委员会成员，3)监督机构成员，4)调查人员和研究协调员，以及5)HPTN社区工作组和当地社区咨询委员会成员——以确定知情同意书中被认为与潜在研究参与者决策相关或无关的组成部分。在第二阶段，访谈数据将用于创建简短的知情同意模板。将纳入模板的最终语言将在HPTN代表、监督机构代表和研究伦理专家的会议上确定，然后对潜在参与者进行认知预测试。在第3阶段，我们将采用两组随机对照设计，评估参与者的理解能力、参与者满意度和知情同意的质量。在实际的行为和临床HPTN研究中，被分配到使用模板制定的短同意书的参与者与被分配到标准同意书的参与者进行比较。虽然与较长的同意书相比，较短的同意书先前已被证明在获得参与者理解方面同样有效或更好，但它们尚未在III期随机试验的背景下进行测试，也未在像EDICT所建议的风险大于最小的研究中进行测试，并且较长的同意书仍然普遍使用。因此，该项研究将提供必要的数据，为关于知情同意文件长度及其对知情同意质量的影响的长期政策辩论提供信息。

DESCRIPTION (provided by applicant): The proposed research - EDICT (Effective Delivery of Informed Consent Trial) - directly responds to the funding opportunity announcement (FOA) PA-11-180, Research on Ethical Issues in Biomedical, Social and Behavioral Research. Consistent with the FOA, EDICT addresses an important ethical challenge related to the conduct of clinical and behavioral research funded by National Institutes of Health (NIH): the persistent use of long informed consent forms and their adverse impact on potential participants' comprehension of the research. There is substantial evidence that potential research participants do not fully understand information disclosed in consent forms. The long length of consent forms is a contributing factor. EDICT will identify pertinent and extraneous information included in consent forms as perceived by key stakeholders; incorporate this information in the development of short consent form templates for both behavioral and clinical research; and then evaluate the short consent forms derived from the templates, compared to standard consent forms within two actual HIV Prevention Trials Network (HPTN) studies, using a randomized controlled design. Specifically, EDICT will proceed in three stages. In Stage 1, interviews will be conducted with key research stakeholders -- 1) participants, 2) members of host-country research ethics committees, 3) members of oversight bodies, 4) investigators and study coordinators, and 5) members of the HPTN Community Working Group and local Community Advisory Boards -- to identify components of informed consent forms that are perceived to be either pertinent or extraneous to potential research participant decision making. In Stage 2, interview data will be used to create short informed consent templates. The final language to be incorporated in the templates will be determined during a meeting of HPTN representatives, representatives from oversight bodies, and experts in research ethics, and then cognitively pre-tested with potential participants. In Stage 3, using a two-arm randomized controlled design, we will evaluate participant comprehension, participant satisfaction, and quality of informed consent among participants assigned to the short consent form developed using the template compared to participants assigned the standard consent form in actual behavioral and clinical HPTN studies. While short consent forms have been previously shown to be as effective or better at achieving participant understanding compared to longer forms, they have not been tested in the context of Phase III randomized trials or in research that involves greater than minimal risk as proposed in EDICT, and longer consent forms are still commonly used. EDICT will therefore provide data needed to inform long-term policy debates regarding the length of consent documents and their effect on the quality of informed consent.