Valid Consent/Refusal: A Core Competency for Research

描述(由申请人提供)：研究伦理课程通常讲授获得潜在志愿者有效同意的理由和要求；IRB要求调查人员描述他们将如何获得同意并将其记录在案。然而，有效的同意是一个过程；同意的做法需要的不仅仅是对其理由的了解，也不是文件中应该包括的内容。传统的基于内容的方法未能教会那些招募研究参与者的人如何获得同意，调查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、实施和评估一门旨在提高调查人员获得同意的知识和技能的课程。该课程基于成人学习的原则，使用类似的方法教授临床同意的经验，以及由PI进行的需求评估。本课程以书面和说教材料开始，内容包括同意的理由和组成部分、评估能力的组成部分和程序、替代决策的原则和做法、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。其次，在不同的情景下(例如，能力有问题，需要口译员)，一小群学习者进行角色扮演，评估能力，披露冲突，并获得同意。最后，当学习者要求“病人”参与研究并披露利益冲突时，他们要展示自己的技能。模拟患者指导员(SPI)的培训是扮演患者的角色，使用核对表评估学员完成任务的能力，并向学员提供反馈。在n&gt；310名学员中，对这门课程的随机对照评估将比较知识获得、自我效能和结果预期。对同一学习者(n&gt；310)进行的第二次随机对照评估使用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，以衡量对课程的满意度和有效性。2002年，该机构有1000多名依赖人类志愿者的教职员工调查人员，学习人数很多。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。在美国和加拿大许多有SPI项目的大学，也很容易实现SPI的复制，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.