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 Assessment of Risks and Benefits

Dave Wendler PhD

NIH Clinical Center Dept of Bioethics

9:15-9:25 Discussion

9:25-10:10 Ethical Issues in the Use of Stored Tissue and Data

Sara Chandros Hull, Ph.D.

NHGRI and Dept of Bioethics

10:10-10:20 Discussion

10:20-10:35 Break

10:35- 11:30 Investigator Panel

Crystal Mackall MD (pediatrics)

Jorge Tavel MD (HIV/ international/ flu vaccine)