Ethical Principles, Federal & State Law
Conflict of Interest / Outside Activities Reporting
State Law
Federal Regulations and Guidance
SCRO Committee
National Academy of Sciences (NAS)
Human Research Protection Program and IRBs
Ethics
State Law
Federal Regulations and Guidance
Department of Health and Human Services
- DHHS Code of Federal Regulations
- 45 CFR Part 46 (Common Rule)
- 45 CFR Part 46, Subpart B (pregnant women, fetuses, neonates)
- 45 CFR Part 46, Subpart C (prisoners)
- 45 CFR Part 46, Subpart D (children)
- Office of Human Research Protections (OHRP)
- Office of Research Integrity
- Ethics and Research in the Community (for Community Researchers)
Family Educational Rights and Privacy Act (FERPA)
Food and Drug Administration (FDA)
- FDA Code of Federal Regulations
- 21 CFR Part 50 (Protection of Human Subjects)
- 21 CFR Part 56 (Institutional Review Boards)
- 21 CFR Part 312 (Investigational New Drug Application)
- 21 CFR Part 600 (Biological Products: General)
- 21 CFR Part 812 (Investigational Device Exemptions)
- Center for Biologics Evaluation and Research
- Center for Drug Evaluation and Research
- Center for Devices and Radiological Health
- FDA Good Clinical Practice Guidance
- FDA Information Sheets: Guidance for IRBs and Clinical Investigators
National Cancer Institute (NCI)
National Institutes of Health (NIH)
- Office of Human Subjects Research (OHSR)
- Certificate of Confidentiality Kiosk
- National Center for Research Resources
National Science Foundation (NSF)
- NSF Policy Office
- NSF Human Subjects Policy (application of Common Rule)
- NSF FAQs: Interpreting the Common Rule for Behavioral and Social Science Research
Other Resources
Council for International Organizations of Medical Sciences (CIOMS)
Glossary of Terms:
WHO: Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)