Regulations and Guidance
OHRP
- Office for Human Research Protections
- Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, with Revisions (SACHRP)
- FAQs, Terms and Recommendations on Informed Consent and Research Use of Biospecimens (SACHRP)
- Human Subjects Regulations Decision Charts
- Human Research Questions & Answers (OHRP)
- Institutional Review Board Written Procedures: Guidance for Institutions and IRBs (2025) | HHS.gov
- International Compilation of Human Research Standards (2016 edition)
- OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals (2020) | HHS.gov
- Revision of the Common Rule | HHS.gov
- Protection of Human Subjects: 45 CFR 46
FDA
- Food and Drug Administration
- Frequently Asked Questions Regarding Protection of Human Subjects of Research
- eCFR :: 21 CFR Part 56 -- Institutional Review Boards
- eCFR :: 21 CFR Part 312 -- Investigational New Drug Application
- eCFR :: 21 CFR Part 812 -- Investigational Device Exemptions
Ethical Principles & Codes
- Belmont Report
- Nuremberg Code | History, Date, & 10 Points | Britannica
- Declaration of Helsinki – WMA – The World Medical Association