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，理论上的接地，研究伦理课程，以满足他们的特殊需求。该课程将被开发，以补充许多机构要求研究人员的标准责任研究行为（RCR）指令，其中通常涵盖其他主题，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，并使参与者和消费者的利益最大化。由于数据表明，此类课程的最有效形式需要投入大量时间和小组案例讨论，因此该项目的首要目标是培训和认证教员，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，我们已经招募了一个多元化的教师和咨询委员会，由国家认可的专家组成。将在全国范围内征聘参加者，并将特别努力征聘少数族裔和代表人数不足的参加者。具体目标1：开发课程材料（阅读材料、录像讲座和案例），这将有助于教师达到以下教育目标：（a）增加行为健康研究中伦理和监管问题的知识;（B）提高行为健康研究中伦理问题的敏感性或意识;（c）通过培养“分散”能力-即关注道德状况的所有突出方面的能力-来提高道德判断力;（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专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、增强信心和教育调查人员了解可帮助他们做正确事情的资源，促进道德行动。具体目标2：制定一个“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，教师将提供培训，使用实时视频流从我们的程序网页与互动元素，包括聊天，实时语音通信，和电子邮件进行问答课程讲座和阅读，并讨论情况。具体目标3：评估和评价我们的计划。评估和评价将侧重于三件事。第一，课程是否符合第一个具体目标中规定的目标。将在课程之前和之后对教员学员进行评估。第二，评估在何种程度上，培训生继续使用我们的计划在他们的家乡机构。第三，评估参与者在完成课程后立即和一年后如何评价我们的课程。时间轴：第一年将致力于实现具体目标1所述的各项目标。第二年和第三年将致力于实现具体目标2和3所述的目标。圣刘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该课程维持到3年级以后。

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.