Ethical Issues in Behavioral Health Research

描述(由申请者提供)：该项目的长期目标是为全国的行为健康研究人员提供一门有效的、理论上有基础的研究伦理课程，以满足他们的特殊需求。开发这门课程是为了补充许多机构要求调查人员的标准负责任研究行为(RCR)指导，这些指导通常涵盖其他主题，如作者身份和动物的道德待遇。本课程的最终目标是使行为健康研究人员能够保护人类受试者，并使参与者和消费者获得最大利益。由于数据表明，此类课程最有效的形式需要大量的时间投入和小组案例讨论，因此该项目的首要目标是培训和认证教师，以便在全国各地的当地设施指导课程。为了确保尽可能提供最好的产品，我们招募了一个由国家公认的专家组成的多元化的教职员工和咨询委员会。参与者将在全国范围内招募，并将特别努力招募少数族裔和代表性不足的参与者。具体目标1：编写课程材料(读物、讲座录像和案例)，以帮助教师实现以下教育目标：(A)增加对行为健康研究中的伦理和监管问题的知识；(B)提高行为健康研究中的伦理敏感性或对伦理问题的认识；(C)通过培养“分散”--关注道德状况的所有显著方面的能力--改善道德判断；(D)通过促进对调查员价值观的自我反思和说明条例和相关职业守则所依据的价值观，培养道德动机；以及(E)通过上述目标促进道德行动，增加信心，并教育调查人员了解可帮助他们做正确事情的资源。具体目标2：制定“培训培训者”计划，帮助学员在当地机构使用我们的课程材料。我们将为学员提供所有课程材料(阅读资料、视频讲座和案例)。然后，教师将使用我们计划网页上的实时视频流媒体提供培训，其中包括聊天、实时语音通信和电子邮件等互动元素，以进行关于课程讲座和阅读材料的问答环节，并讨论案例。具体目标3：评估和评估我们的计划。评估和评估将集中在三件事上。首先，课程是否达到了第一个具体目标中规定的目标。讲师-实习生将在课程前后接受评估。第二，评估受训教师在其本国机构继续使用我们的计划的程度。第三，评估讲师和学员在课程结束后和一年后对我们课程的评价。时间表：第一年将致力于实现L特定目标中阐明的目标。第二年和第三年将致力于实现特定目标第二和第三年中阐明的目标。圣路易斯大学卫生保健伦理中心和密苏里州心理健康研究所致力于将课程持续到第三年。

DESCRIPTION (provided by applicant): The long-term goal of this project is to provide behavioral health researchers throughout the nation with access to an effective, theoretically grounded, course in research ethics tailored to meet their special needs. The course would be developed to complement the standard responsible conduct of research (RCR) instruction that many institutions require of investigators, which typically cover additional topics such as authorship and the ethical treatment of animals. The ultimate aim of this course is to equip behavioral health researchers to protect human subjects and to maximize benefit to participants and consumers. Because data suggests that the most effective format for such courses requires a significant time commitment and small group case discussions, this project aims above all to train and certify instructors to direct the course at local facilities nationwide. In order to ensure the best product possible, we have recruited a diverse faculty and advisory board consisting of nationally recognized experts. Participants will be recruited nationwide, and special efforts will be made to recruit minority and underrepresented participants. Specific Aim 1: To develop course materials (readings, video-taped lectures and cases) that will assist instructors in meeting the following educational objectives: (a) to increase knowledge of ethical and regulatory issues in behavioral health research; (b) to heighten ethical sensitivity or awareness of ethical issues in behavioral health research; (c) to improve moral judgment by fostering "decentration" - the ability to focus on all salient aspects of a moral situation; (d) to foster moral motivation by promoting self reflection on investigator's values and illustrating the values that underlie the regulations and relevant professional codes; and (e) to facilitate ethical action through the above objectives, by increasing confidence, and by educating investigators about resources that can assist them in doing what is right. Specific Aim 2: To develop a 'training the trainer' program to assist participants in using our course materials at their local institutions. We will provide participants with all course materials (readings, video lectures, and cases). Faculty will then provide training using live video-streaming from our program web page with interactive elements including chat, real-time voice communication, and email to conduct question and answer sessions on the course lectures and readings and to discuss cases. Specific Aim 3: To assess and evaluate our program. Assessment and evaluation will focus on three things. First, whether the course meets the objectives stated in the first specific aim. Instructor-trainees will be assessed before and after the course. Second, to assess the extent to which the instructor-trainees go on to use our program at their home institutions. Third, to assess how the instructor-participants would evaluate our program both immediately following completion of the course and one year hence. Timeline: Year 1 will be devoted to meeting the goals articulated in specific aim l. Years 2 and 3 will be devoted to meeting the goals articulated in specific aims 2 and 3. The Center for Health Care Ethics at Saint Louis University and the Missouri Institute of Mental Health are committed to sustaining the course beyond year 3.