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.

8:30-9:15 Ethical issues in research with children

Robert Nelson MD PhD

FDA

9:15-9:25 Discussion

9:25- 10:10 Research Involving Persons at Risk for Impaired Decision-Making

Don Rosenstein, M.D.

University of North Carolina Medical Center

10:10- 10:20 Discussion

10:20- 10:35 Break

10:35- 11:30 Informed Consent

Christine Grady RN PhD

NIH Clinical Center Department of Bioethics

For more information, visit
http://www.bioethics.nih.gov