1. © 2009 Cengage Learning. All Rights Reserved. Clinical Research

2. © 2009 Cengage Learning. All Rights Reserved. Regulation of Research on Human Subjects  History Nuremberg Code: adopted by U.N. 1948 Declaration of Helsinki: adopted by World Medical Association in 1964 Belmont Report: adopted by U.S. in 1979

3. © 2009 Cengage Learning. All Rights Reserved. Regulation of Research on Human Subjects contd.  Sources of U.S. Law “Common Rule” at 45 C.F.R. § 46  Applies to all biomedical and behavioral research conducted by federal departments/agencies Food, Drug, and Cosmetic Act  Requires that drugs must be safe before marketing

4. © 2009 Cengage Learning. All Rights Reserved. Informed Consent Elements of discussion between principal investigator (PI) and prospective subject:  Disclosure of relevant information to prospective subjects  Indication that subjects comprehend information  Voluntary agreement to participate in study  Must be written

5. © 2009 Cengage Learning. All Rights Reserved. Institutional Review Boards  Conducts review of clinical research  Protects rights and welfare of subjects  Approves research protocols

6. © 2009 Cengage Learning. All Rights Reserved. Agency Oversight  Dept. of Health and Human Services U.S. Public Health Service  National Institute of Health  Office of Human Subjects Research Office of Human Research Protection  Food and Drug Administration