Ensuring Informed Consent Delivery As A Process

本提案是根据RFA-OD-03-007(“人类受试者研究增强计划”[HSREP])提交的；其长期目标是教育和促进研究人员将知情同意作为一个过程，而不仅仅是作为表格上的签名。有意义的同意涉及的不仅仅是将表格交给潜在参与者签署，而是涉及一次互动对话，在对话中披露相关材料，调查员(或其代表)确定参与者是否理解基本信息，然后以促进每个参与者最终理解该信息的方式重新解释不太了解的信息，以便他或她能够就是否参加该议定书作出有意义的选择。以下提议的活动旨在促进实际发生这种互动同意过程的可能性。具体目标包括开发5项问卷的算法和原型，以 促进对参与研究提供知情同意的进程，并在本提案所述的两个设施传播这些同意程序在人类研究中的使用。我们将在两个设施中分别确定5个有效的方案。我们将审阅这些协议(包括同意表格及任何其他提交给当地IRB的材料)，并根据同意每个协议的五个“最基本元素”，为每个协议制定一份由5个项目组成的问卷，每个协议的主管随后将使用该问卷来确定潜在参与者是否真正了解基本元素和/或需要进一步解释基本细节。我们也会召集社区焦点小组(包括高功能的研究参与者或家庭成员)来审查这些材料和程序，他们的意见将被用来修改我们的同意算法和问卷，以更接近社区的价值观和标准。根据在初始方案中使用这些方法的经验，我们将对问卷和方法进行修改，使其更加有效和高效。有了这种经验，我们将举办两次60分钟的研讨会(每个设施一个)，以传播为两个设施的所有研究人员更广泛使用而制定的程序。

This proposal is submitted in response to RFA-OD-03-007 ("Human Subjects Research Enhancements Program" [HSREP]); the long-term goals are to educate and foster the attention of investigators and research staff to informed consent as a process, rather than merely as a signature on a form. Meaningful consent involves more than handing potential participants a form to sign, but rather involves an interactive dialogue in which relevant material is disclosed, the investigator (or his/her representative) ascertains whether the participant comprehended the essential information, and then re-explains poorly understood information in a way that fosters each participant's eventual understanding of that information so that he or she can make a meaningful choice about whether or not to participate in that protocol. The activities proposed below are intended to foster the likelihood that such an interactive consent process actually occurs. Specific aims include developing an algorithm and prototypes of 5-item questionnaires to facilitate the process of providing informed consent to research participation, and to disseminate use of these consent procedures in human research at the two facilities described in this proposal. We will identify 5 active protocols at each of the two facilities. We will review these protocols (including the consent forms and any other materials submitted to the local IRB), and based on the five "most essential elements" for consent to each protocol, we will develop a 5-item questionnaire for each protocol that the PIs of each will then use to ascertain whether potential participants actually understand the essential elements and/or require further explanation of essential details. We will also convene community focus groups (including high functioning research participants or family members) to review these materials and !procedures, and their input will be used to revise our consent algorithm and questionnaires to better approximate community values and standards. Based on the experience using these methods in the initial protocols, we will revise the questionnaires and methods to make the more effective and efficient. With this experience, we will then hold two 60 minute seminars (one at each facility) to disseminate the procedures developed for wider use by all researchers at each of the two facilities.