Ethical Issues in Behavioral Health Research

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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.