Regulations and UO Policy [1]
Research Compliance Services is currently revising and further developing its policies and procedures. As policy/procedure is finalized, it 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 [2] for any questions regarding future postings.
The following federal, state, and university regulations/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 [3]
- 21 CFR 50: Food and Drug Administration Regulations for the Protection of Human Subjects [4]
- 21 CFR 56: Food and Drug Administration Regulations Governing IRBs (Institutional Review Boards) [5]
- Health Insurance Portability and Accountability Act (HIPAA) [6]
- No Child Left Behind Act (NCLB) [7]
- Family Educational Rights and Privacy Act (FERPA) [8]
Federal Websites:
- Office for Human Research Protections (OHRP) [9]
- Food and Drug Administration [10]
- Office of Research Integrity [12]
- National Institutes of Health (NIH) Grants & Funding: Policy & Compliance [13]
International Regulations, Laws and Organizations:
- International Compilation of Human Research Standards [16]
- GDPR - European Union General Data Protection Regulation [17]
- ICH - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [19]
- World Health Organization (WHO) Listing of Clinical Trials Registries [20]
Oregon State Laws/Regulations:
- Oregon Public Records Law [21]
- Oregon Genetic Privacy Law [22]
- Oregon Identity Theft Protection Act [23]
University of Oregon Policies/Guidelines:
- University of Oregon Office of Public Records [24]
- Qualtrics - UO Site licensed survey software and data collection tool [25]
Ethical Codes and Research Standards:
- The Belmont Report [26]
- The Declaration of Helsinki [27]
-
The Nuremburg Code [28]