Ethical considerations associated with conducting clinical research will be explored in this workshop intended for medical writers, editors, and researchers with some experience reviewing, analyzing, and communicating data-regulated therapeutic development activities. The workshop will consist of short presentations on relevant ethical issues with respect to therapeutic (drug, device, vaccine) clinical trials, and group discussions on major ethical considerations of some case studies. Topics include the importance of ethics in good clinical practice (GCP), the informed consent process and the challenges that may arise in developing countries, the infrastructure of ethics committees, and data safety monitoring committees. Throughout, the workshop will focus on the central ethical issue in clinical study conduct: to ensure subject safety and well-being.

Optional Pre-Course Review Materials will be distributed prior to the tutorial/workshop.

NOTE: This workshop, Ethics of Communicating Regulated Drug Development Activities, is required to complete the AMWA Regulatory and Research specialty certificate.

This tutorial is being offered in collaboration with the American Medical Writers Association (AMWA).

For more information on this tutorial please click here.