TRAINING IN CLINICAL RESEARCH ETHICS

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DESCRIPTION: Candidate: This career development award will allow the candidate to shift his focus as a biomedical scientist toward an independent career in the field of research ethics. The proposed research program provides an ideal framework for his career development goals to acquire expertise in ethical theory, human subject research ethics and policy, and survey methodology. Career development activities will consist of guided reading and discussion with the mentor, auditing of selected courses, and participation in national courses, meetings, and workshops. Environment: The career development and research goals are necessarily multi-disciplinary and multi-institutional. The candidate's mentor, Dr. Lawrence Schneiderman, can contribute approximately 25 years of experience in ethical theory, social research, and biomedical ethics. The candidate's home institution also provides a highly supportive administration as well as faculty and programs with expertise and interest in ethics, clinical research, and social research methods. This will be supplemented by consultants from the Universities of Minnesota, Pittsburgh, and Washington. Research: The need to address research ethics, and specifically clinical research ethics, is driven by several recent trends. The lines between clinical practice and research are increasingly unclear, new technologies are raising difficult questions not previously imagined, and reported violations of the ethical, legal, and social principles governing research with human subjects continue to increase. Formal instruction in research ethics seems an obvious solution and is increasingly required. Unfortunately, empirical data have provided little or no support for the presumed benefits of this training. Therefore, the central hypothesis to be tested is that: Research ethics training has a positive impact on ethical decisionmaking. Specific Aims: Aim #1: Define characteristics of existing training programs that might have an impact on the skills and knowledge necessary for ethical decisionmaking. Aim #2: Conduct pilot assessment of the roles of the different training methods in producing acute and long-term changes in ethical decisionmaking skills and knowledge. Aim #3: Assess acute and long-term effects of ethics training at a wide range of institutions representative of the following dimensions: large, medium, and small; public and private; and historically black and minority colleges and universities. Completion of the proposed aims will provide: valuable new information about the effectiveness of training in research ethics; a foundation for the candidate's independent career in applied research ethics; and the experience and knowledge necessary for the candidate to be a resource to his institution and the research community.