Valid Consent/Refusal: A Core Competency for Research

描述（由申请人提供）：研究伦理学课程通常会教授从潜在志愿者那里获得有效同意的理由和要求; IRB要求研究者描述他们将如何获得和记录同意。然而，有效的同意是一个过程;同意的做法需要的不仅仅是了解其理由或文件中应包括什么。传统的基于内容的方法无法教会招募研究参与者如何获得同意，研究人员还需要知道如何识别和披露利益冲突。我们的目标是开发，实施和评估旨在提高知识和技能的研究人员获得同意的课程。该课程是基于成人学习的原则，使用类似的方法教学临床同意的经验，以及PI的需求评估。该课程开始于书面和教学材料的理由和同意的组成部分，评估能力的组成部分和过程，代理决策的原则和实践，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，小组学习者的角色扮演评估能力，披露冲突，并在不同的情况下获得同意（例如，能力有问题，需要口译员）。最后，学习者展示技能，因为他们要求“病人”参与研究，并披露利益冲突。模拟患者指导员（SPI）接受培训，扮演患者的角色，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。在n>310名学习者中对课程进行随机对照评估，比较知识获得，自我效能和结果期望。第二次随机对照评估相同的学习者（n>310）的非SPI组件的课程使用SPI作为评估工具。所有参与者（n=500/年，为期3年）完成问卷调查，测量满意度和有用的课程。在2002年，有超过1000名教师研究人员依靠人类志愿者，这个机构的学习者人数很大。我们计划从第三年开始向其他机构的研究人员提供该课程。在美国和加拿大的许多大学中，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.