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FOA一致，EDICT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重要伦理挑战：长期使用长知情同意书及其对潜在参与者理解研究的不利影响。有大量证据表明，潜在的研究参与者并不完全理解知情同意书中披露的信息。同意书的篇幅很长是一个促成因素。EDICT将识别关键利益相关者认为的知情同意书中包含的相关和无关信息;将此信息纳入行为和临床研究的简短知情同意书模板的开发中;然后使用随机对照设计，与两项实际HIV预防试验网络（HPTN）研究中的标准知情同意书相比，评估来自模板的简短知情同意书。具体而言，EDICT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）研究者和研究协调员，以及5）HPTN社区工作组和当地社区咨询委员会的成员--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2阶段，访谈数据将用于创建简短的知情同意书模板。模板中包含的最终语言将在HPTN代表、监督机构代表和研究伦理专家的会议上确定，然后与潜在参与者进行认知预测试。在第3阶段，我们将使用两组随机对照设计，与实际行为和临床HPTN研究中分配标准知情同意书的受试者相比，评估分配使用模板开发的简短知情同意书的受试者的受试者理解、受试者满意度和知情同意质量。虽然之前已经证明，与较长的同意书相比，较短的同意书在实现参与者理解方面同样有效或更好，但它们尚未在III期随机试验或EDICT中提出的涉及大于最小风险的研究中进行测试，并且较长的同意书仍然普遍使用。因此，EDICT将提供所需的数据，为关于同意文件的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.