Ethical and Regulatory Aspects of Clinical Research

Department of Clinical Bioethics

This course is designed to provide a historical context for research regulations and to help researchers and others working in human subject research gain insights and skills into the development of research protocols and their ethical implementation.

Objectives of the Course:

To learn the codes, declarations, and other documents that govern the ethical conduct of human subject research; review the critical elements of informed consent and their implementation in actual informed consent documents for clinical research; explore controversial issues relating to human subject research, including Phase I research, randomization, children in research, international research, etc; review the purpose if IRBs and provide IRB-like experience in reviewing research protocols; understand the experience of human subjects who have participated in research protocols.

8:30-8:40 Pre-test

8:40-9:20 Intro and Framework for the Ethics of Research with Human Subjects

Ezekiel Emanuel MD, PhD (Grady backup)

NIH Clinical Center Dept of Bioethics

9:20-9:30 Discussion

9:30- 10:15 History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest

Susan E. Lederer Ph.D.

University of Wisconsin

10:15- 10:25 Discussion