Research Compliance Services is currently revising and further developing its policies and procedures. As policies and procedures are finalized, they will be posted here. Policies on which RCS is seeking feedback from the campus community may also be posted here in the future. Please contact us for any questions regarding future postings.
The following federal, state, and university regulations and guidelines inform RCS policy and 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)
Federal Websites:
- Office for Human Research Protections (OHRP)
- Food and Drug Administration
- Office of Research Integrity
- National Institutes of Health (NIH) Grants & Funding: Policy & Compliance
International Regulations, Laws and Organizations:
- International Compilation of Human Research Standards
- GDPR - European Union General Data Protection Regulation
- ICH - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
- World Health Organization (WHO) Listing of Clinical Trials Registries
Oregon State Laws/Regulations:
University of Oregon Policies/Guidelines:
- University of Oregon Office of Public Records
- Qualtrics - UO Site licensed survey software and data collection tool
Ethical Codes and Research Standards:
If you have questions, please contact Research Compliance Services.