Foundations of American Bioethics: the Belmont Report and the Common Rule

Megan Allyse, Ph.D, Science and Society initiative, IGSP. The Belmont Report and the Common Rule are the ethical and regulatory foundation of human subjects research in the US and a mandatory guide for all federally funded research with human subjects and human samples. In this session, we will review the contents of these important ethical documents and apply them to a hypothetical research protocol. The goal will be to explore the implications of the rise of research ethics regulation in the US and to better understand the infrastructure of ethical research with human subjects.

Readings:

• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979
• Code of Federal Regulations TITLE 45: PUBLIC WELFARE, Department of Health and Human Services, PART 46 PROTECTION OF HUMAN SUBJECTS