Ethical Issues in Behavioral Health Research

描述（由申请人提供）：该项目的长期目标是为全国的行为健康研究人员提供一个有效的、有理论基础的研究伦理课程，以满足他们的特殊需求。该课程将作为许多机构对研究人员要求的标准负责任的研究行为（RCR）指导的补充，RCR通常涵盖其他主题，如作者身份和动物的道德待遇。本课程的最终目的是使行为健康研究人员能够保护人类受试者，并最大限度地为参与者和消费者带来利益。由于数据表明，此类课程的最有效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，以便在全国各地的地方设施指导课程。为了确保最好的产品，我们招募了一个多元化的教师和顾问委员会，由国家认可的专家组成。参与者将在全国范围内招募，并将特别努力招募少数民族和代表性不足的参与者。具体目标1：编制课程材料（阅读材料、录像讲座和案例），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道德和监管问题的认识；(b)提高行为健康研究中伦理问题的敏感性或意识；(c)通过促进“分散”来改善道德判断，即集中注意道德情况的所有突出方面的能力；(d)透过鼓励对调查人员的价值观进行自我反思，并说明规例和相关专业守则所依据的价值观，以培养道德动机；(e)透过上述目标，增加信心，并教育调查人员了解可协助他们做正确事情的资源，从而促进道德行动。具体目标2：制定“培训培训师”计划，以帮助参与者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（阅读材料、视频讲座和案例）。然后，教师将使用我们项目网页上的实时视频流提供培训，其中包括聊天、实时语音通信和电子邮件等互动元素，对课程讲座和阅读进行问答，并讨论案例。具体目标3：评估和评估我们的项目。评估和评价将集中在三个方面。首先，课程是否符合第一个具体目标中所述的目标。讲师学员将在课程前后接受评估。第二，评估指导学员在其所在机构继续使用我们的课程的程度。第三，评估讲师参与者在课程结束后和一年后如何评估我们的课程。时间表：第一年将致力于实现具体目标1中阐述的目标。第二和第三年将致力于实现具体目标2和3中阐述的目标。圣路易斯大学卫生保健伦理中心和密苏里精神健康研究所致力于在第三年之后继续开设这门课程。

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.