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;长期目标是教育和促进研究者和研究人员将知情同意作为一个过程，而不仅仅是在表格上签名。有意义的同意不仅仅是交给潜在参与者一份表格让他们签名，而是涉及一种互动对话，在这种对话中，相关材料被披露，研究者说，（或其代表）确认参与者是否理解了基本信息，然后再--以一种促进每个参与者对该信息的最终理解的方式解释不太理解的信息，以便他或她可以做出有意义的选择是否参与该协议。下文提议的活动旨在促进这种互动的同意过程实际发生的可能性。具体目标包括开发一种算法和5项问卷的原型， 促进对参与研究提供知情同意的过程，并在本提案所述的两个机构推广在人类研究中使用这些同意程序。我们将在两个设施中的每一个确定5个活动协议。我们将审查这些方案（包括知情同意书和提交给当地IRB的任何其他材料），并根据同意每个方案的五个“最基本要素”，我们将为每个方案制定一份5项问卷，然后每个方案的PI将使用该问卷来确定潜在参与者是否真正理解基本要素和/或需要进一步解释基本细节。我们还将召集社区焦点小组（包括高功能研究参与者或家庭成员）来审查这些材料，程序，他们的意见将用于修改我们的同意算法和问卷调查，以更好地接近社区的价值观和标准。基于在初始方案中使用这些方法的经验，我们将修改问卷和方法，使其更加有效和高效。有了这些经验，我们将举行两个60分钟的研讨会（每个设施一个），以传播开发的程序，供两个设施的所有研究人员更广泛地使用。

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.