The University of Arizona

Regulations

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

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.