At the end of the workshop, the participants will have an understanding of the history of research ethics, the principles that underlie the ethical conduct of research, and the application of those principles throughout the research process. Participants will also be exposed to guidelines for international research from the International Conference on Harmonisation. Finally, participants will review the informed consent process and its documentation, and receive pointers on writing appropriate informed consent forms. The course will cover history and ethics, regulations for investigators and informed consent. Portions of the workshop are interactive.
Substantial time is allotted for questions throughout the workshop.
Participants will receive a useful handout containing references to regulations and to helpful web sites, and copies of informed consent form templates. At the end, participants will receive a Certificate of Completion. Susan Fish PharmD, MPH is the Director of Regulatory Affairs of CareStat, Inc, Boston Mass, and an Associate Professor of Epidemiology and Biostatistics at the Boston University School of Public Health. She is a member of SAEM and former didactic subcommittee chair.