Regulations Governing Human Subjects Research

The following federal, state, and university regulations/guidelines affect how human subjects research may be conducted.

Federal Regulations:

• 45 CFR 46: Department of Health and Human Services Policy for Protection of Human Research Subjects
• 21 CFR 50: Food and Drug Administration Regulations for the Protection of Human Subjects
• 21 CFR 56: Food and Drug Administration Regulations Governing IRBs (Institutional Review Boards)
• Health Insurance Portability and Accountability Act (HIPAA)
• No Child Left Behind Act (NCLB)
• Family Educational Rights and Privacy Act (FERPA)
• Oregon Genetic Privacy Law

Federal Websites:

• Office for Human Research Protections (OHRP)
• Food and Drug Administration
• Office of Research Integrity

Historical Documents:

• The Belmont Report
• The Declaration of Helsinki
• The Nuremburg Code

Oregon State Laws/Regulations

• Oregon Public Records Law
• Oregon Genetic Privacy Laws [PDF]
• Oregon Identity Theft Protection Act

University of Oregon Policies/Guidelines 

• University of Oregon Public Records Procedure