Development of a Course for Graduate Students on the Ethics In Biostatistical Practice

• Activity Number: 55
• Type: Invited
• Date/Time: Sunday, August 4, 2013 : 4:00 PM to 5:50 PM
• Sponsor: Committee on Professional Ethics
• Author(s): Howard Cabral*+
• Companies: Boston University School of Public Health

Abstract

Biostatisticians are involved in aspects of research and evaluation from concept development to design to analysis and dissemination. They bring unique skills to these endeavors and are placed in positions of responsibility that require the application of ethical guidelines in many situations. This presentation will describe the development of a 10-hour course in the ethical practice of biostatistics for graduate students in biostatistics at both the Master's and doctorate level at Boston University. The course mainly covers topics in the conduct of clinical research that include the responsible conduct of research, certification for the conduct of research on human subjects, legal responsibilities for data management plans, and issues around conflict of interest. Students review documents of governmental guidelines and regulations, published papers in the literature on these topics, and consider case studies developed at our institution, by the ASA working group on ethics in statistical practice, and by the working group of the Biostatistics, Epidemiology, and Research Design Key Function Committee of the Clinical and Translational Science Institutes (CTSI) of NIH.