Federal Regulations Related to Human Subjects Research
There are a variety of federal regulations and state laws that apply to human subjects research. In addition, the Office of Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) have issued guidance documents and other materials that reflect their agency's current thinking. This page provides quick links to the most commonly accessed regulations and guidance documents.
2018 Final Rule
- Code of Federal Regulations (45 CFR 46) Protection of Human Subjects: The regulations that govern all research funded or supported by the federal government; also known as the Common Rule.
- Final Rule - Federal Policy for the Protections of Human Subjects:
- 45 CFR 164: The Privacy Rule (HIPAA)
- OHRP: OHRP's site contains resources and guidance germane to human subjects research and the regulatory process.
- OHRP FAQs about the 2018 Final Rule: OHRP has developed a list of common questions about the revised Common Rule with answers.
- OHRP 2018 Final Rule Decision Charts: These graphic charts are intended to aid those who need to decide if an activity is research involving human subjects that must be reviewed by the IRB and whether informed consent or the documentation of informed consent can be waived under the 2018 Final Rule.
Food and Drug Administration
- 21 CFR 50: Regulations for informed consent (Part 50), Financial Disclosure (Part 54), and for IRB committees (Part 56)
- 21 CFR 56: Regulations for IRB committees (Part 56)
- 21 CFR Subpart D: Subpart D additional safeguards for children in clinical investigations of FDA-regulated products under 21 CFR 50 and 56
- 21 CFR 312: Drug Regulations: IND Regulations including IND format, reporting requirements, sponsor responsibilities and investigator responsibilities
- 21 CFR 812: Device Regulations: IDE regulations including IDE content, format, reporting requirements, sponsor responsibilities and investigator responsibilities
- FDA Regulations Relating to Good Clinical Practice and Clinical Trials
Other Ethics Resources
- Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA).
- Belmont Report is one of the leading works concerning ethics and health care research. Its primary purpose is to protect subjects and participants in clinical trials or research studies.
- NIH Office of Science Policy is the primary policy adviser to the NIH Director on matters of significance to the agency, the research comminity, and the public.
- International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 131 countries and from many international organizations.