Valid Consent/Refusal: A Core Competency for Research

有效同意/拒绝：研究的核心能力

• 批准号: 6938607
• 负责人: SUSAN Dorr GOOLD
• 金额: $ 47.06万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-18 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6938607
• 关键词: Valid; Consent; Refusal; Core; Competency

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.

描述（由申请人提供）：研究伦理学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；同意的做法需要的不仅仅是了解其基本原理或文件中应包含的内容。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原则、使用类似方法教授临床同意的经验以及 PI 的需求评估。该课程从书面和教学材料开始，内容涉及同意的基本原理和组成部分、评估能力的组成部分和过程、代理决策的原则和实践、利益冲突的类型和示例，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，评估不同场景下的能力、披露冲突并获得同意（例如，能力可疑、需要口译员）。最后，学习者在要求“患者”参与研究并披露利益冲突时展示技能。模拟患者指导员 (SPI) 经过培训，可以扮演患者的角色，使用清单评估学习者完成任务的能力，并向学习者提供反馈。对 n> 310 名学习者进行的课程随机对照评估将比较知识增益、自我效能和结果期望。对课程非 SPI 部分的相同学习者 (n>310) 进行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 人/年，持续 3 年）均完成了问卷调查，衡量课程的满意度和有用性。 2002 年，该机构拥有 1000 多名依靠人类志愿者的研究人员，因此该机构的学习者人数众多。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。在美国和加拿大许多设有 SPI 项目的大学也可以轻松复制 SPI，我们将在学术出版物中传播评估结果。