Ensuring Informed Consent Delivery As A Process

确保知情同意交付作为一个过程

• 批准号: 6777908
• 负责人: Barton W. Palmer
• 金额: $ 10万
• 依托单位: VETERANS MEDICAL RESEARCH FDN/SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6777908
• 关键词: educational resource design /development; ethics; health science research support; human rights; informed consent; questionnaires; educational resource design /development; ethics; health science research support; human rights; informed consent; questionnaires

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.

该建议是根据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研究人员和研究人员的注意，以将同意作为一个过程，而不仅仅是形式的签名。有意义的同意不仅仅涉及向潜在的参与者签署的形式，而是涉及互动对话，在该对话中，相关材料被披露，研究者（或他/她的代表）确定参与者是否理解了基本信息，然后重新解释了不太理解的信息，以培养每个参与者的信息而不是让他或她是否能够使她能够使他或有意义地理解的方式培养一个有意义的信息，或者是有意义的。下面提出的活动旨在促进这种交互同意过程实际发生的可能性。具体目的包括开发5个项目问卷的算法和原型 促进在本提案中描述的两个设施中，在人类研究中提供知情同意的过程，并传播这些同意程序的使用。我们将在两个设施中的每个设施中确定5个主动协议。我们将审查这些协议（包括提交给本地IRB的同意书以及提交给当地IRB的任何其他材料），并基于五个“最重要的要素”以符合每个协议的同意，我们将为每个协议开发一份5项问卷，每个协议都将使用每个协议，然后将潜在的参与者真正理解基本元素并需要进一步的基本详细信息来确定潜在的参与者。我们还将召集社区焦点小组（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，他们的意见将用于修改我们的同意算法和问卷，以更好地近似社区价值和标准。根据在初始协议中使用这些方法的经验，我们将修改调查表和方法，以提高有效性和有效性。借助这一经验，我们将举办两个60分钟的研讨会（每个设施），以分发为所有研究人员在两个设施中的每个研究人员开发的程序。