2. Lasting Ethical Implication in Research: The Tuskegee Experience Sapana Panday Widener University

3. History of Bioethics Commissions 1996-2001 1974–78 1978-83 1994-95 The Advisory Committee on Human Radiation Experiments The National Commission for the Protection of Human Subjects of Biomedical Behavioral Research 2001–09

4. The Belmont Report The Belmont report is a statement of basic ethical principles and guidelines surrounding the conduct of research with human subjects. The report was published in the Federal Register, and reprints provided upon request. This was to ensure that it was readily available to scientists, members of Institutional Review Boards, and Federal employees. ohsr.od.nih.gov/guidelines/belmont.html

5. Boundaries between Practice and Research The distinction between practice and research is blurred especially when they occur together. ▫ Practice: interventions that are designed solely to enhance the well-being of an individual patient and that has a reasonable expectation of success. ▫ Research: an activity designed to test an hypothesis, with the potential to generate generalizable knowledge. Practice and research may be carried on together when trying to evaluate the safety and efficacy of a therapy. ohsr.od.nih.gov/guidelines/belmont.html

6. Basic Ethical Principles ohsr.od.nih.gov/guidelines/belmont.html

7. Applications ohsr.od.nih.gov/guidelines/belmont.html

8. Common Rule ori.hhs.gov/education/products/ucla/chapter2/page04b.htm

9. “…it became the standard declaration of ethical principles for research not only in the United States, but in most of the rest of the world.” Robert J. Levine, MD Professor of Medicine Yale University Co-Author, Belmont Report