Clinical Research

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

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

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

Institutional Review Boards

Conducts review of clinical research Protects rights and welfare of subjects Approves research protocols

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