Regulatory Guidance
Federal regulations that relate to the protection of research participants are within the Code of Federal Regulations (CFR). CFR 21 and 45 pertain to IRBs and Subjects in clinical research. Below you will find links for the information above.
- Title 21 CFR Part 50 INFORMED CONSENT
- Title 21 CFR Part 56 IRBs
- Title 45 CFR Part 46 HUMAN SUBJECTS PROTECTION
Research subjects in California are required to read and sign the Experimental Subjects Bill of Rights. All subjects however, regardless of the state where the research is taking place, should have these same rights.
Experimental Subjects Bill of Rights.pdf
