Valid Consent/Refusal: A Core Competency for Research

描述（由申请人提供）：研究伦理课程通常教授获得潜在志愿者有效同意的基本原理和要求；IRB要求调查人员描述他们将如何获得并记录同意。然而，有效的同意是一个过程；同意的实践需要的不仅仅是对其基本原理的了解，或者应该包括在文件中的内容。传统的基于内容的方法无法教会那些招募研究参与者的人如何获得同意，研究人员也需要知道如何识别和披露利益冲突。我们的目标是制定、实施和评估一门课程，旨在提高调查人员获得同意的知识和技能。该课程基于成人学习的原则，使用类似方法进行临床同意教学的经验，以及PI的需求评估。课程以书面和教学材料开始，内容包括同意的基本原理和组成部分，能力评估的组成部分和过程，替代决策的原则和实践，利益冲突的类型和例子，以及如何“做”同意，包括如何披露利益冲突。接下来，小组学习者进行角色扮演，在不同的场景下评估能力、披露冲突和获得同意（例如，有问题的能力、需要翻译）。最后，学习者在要求“病人”参与研究并披露利益冲突时展示技能。模拟病人指导员（spi）被训练成扮演病人的角色，使用检查表评估学习者完成任务的能力，并向学习者提供反馈。一项随机对照的课程评估将在10310名学员中比较知识收获、自我效能和结果预期。第二次随机对照评估使用SPI作为评估工具，对课程的非SPI组成部分的相同学习者（n b> 310）进行评估。所有参与者（n=500/年，为期3年）完成问卷调查，测量课程的满意度和有用性。2002年，有超过1000名教师调查者依靠人类志愿者，因此该机构的学习者数量很大。我们计划从第三年开始向其他机构的研究人员提供这门课程。在美国和加拿大的许多拥有SPI项目的大学中，SPI的复制也很容易完成，我们将在学术出版物中传播评估结果。

DESCRIPTION (provided by applicant): Curricula in research ethics typically teach the rationale and requirements for acquiring valid consent from potential volunteers; IRB's require investigators to describe how they will obtain and document consent. Valid consent, however, is a process; the practice of consent requires more than knowledge of its rationale, or what should be included in documents. Traditional content-based methods fail to teach those who recruit research participants how to obtain consent, and investigators also need to know how to recognize and disclose conflicts of interest. We aim to develop, implement and evaluate a course designed to improve knowledge and skills of investigators for obtaining consent. The course is based on principles of adult learning, experience teaching clinical consent using similar methods, and needs assessments by the PI. The course begins with written and didactic material on the rationale and components of consent, the components of and process for evaluating competence, principles and practices for surrogate decision making, types of and examples of conflicts of interest, and how to "do" consent, including how to disclose conflicts of interest. Next, small groups of learners' role-play evaluating competence, disclosing conflicts and obtaining consent in differing scenarios (e.g., questionable competence, need for interpreter). Finally, learners demonstrate skills as they ask a "patient" to participate in research and disclose a conflict of interest. Simulated patient instructors (SPIs) are trained to play the part of the patient, assess the learner's ability to complete the task using a checklist, and provide feedback to the learner. A randomized controlled evaluation of the course in n>310 learners will compare knowledge gains, self-efficacy and outcome expectations. A second randomized controlled evaluation on the same learners (n>310) of the non-SPI components of the course uses the SPI as an evaluation tool. All participants (n=500/year for 3 years) complete questionnaires measuring satisfaction with and usefulness of the course. With over 1000 faculty investigators who relied on human volunteers in 2002, the population of learners at this institution is large. We plan to offer the course to researchers from other institutions beginning in the third year. Replication of the SPI is also easily accomplished at the many universities in the U.S. and Canada that have SPI programs, and we will disseminate evaluation findings in scholarly publications.