- Department of Health and Human Services (DHHS)/Office for Human Research Protections (OHRP)
Website: http://www.hhs.gov/ohrp/
Regulations: DHHS: 45 CFR Part 46 DHHS— Protection of Human Subjects
Guidance: http://www.hhs.gov/ohrp/policy/index.html#topics
- Food and Drug Administration (FDA)
Website: http://www.fda.gov/
Regulations:- FDA: 21 CFR Part 50 FDA– Protection of Human Subjects
- FDA: 21 CFR Part 54 FDA– Financial Disclosure by Investigators
- FDA: 21 CFR Part 56 FDA– Institutional Review Boards
- FDA: 21 CFR Part 312 FDA– Investigational New Drug Application
- FDA: 21 CFR Part 812 FDA– Investigational Device Exemptions
- US Department of Education (FERPA—Family Educational Rights and Privacy Act; for research use/access/disclosure of student records)
Website: https://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html
Regulation: https://studentprivacy.ed.gov/node/548/
- Office of Civil Rights (HIPAA-Health Insurance Portability and Accountability Act; for research use/access/disclosure of identifiable health information)
Website: http://www.hhs.gov/ocr/hipaa/
Regulation: 45 CFR 160 and Subparts A and E of 45 CFR 164