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；长期目标是教育和培养调查人员和研究人员将知情同意视为一个过程，而不仅仅是在表格上签名。有意义的同意不仅仅是给潜在的参与者一张表格让他们签字，而是包括一个互动的对话，在这个对话中，相关的材料被披露，研究者（或他/她的代表）确定参与者是否理解了必要的信息，然后重新解释不理解的信息，以一种促进每个参与者最终理解这些信息的方式，这样他或她就可以做出是否参与该协议的有意义的选择。下面提议的活动旨在促进这种互动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

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.