Skip to main content
U.S. flag

An official website of the United States government

Here’s how you know

Dot gov

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

HTTPS

Secure .gov websites use HTTPS
A lock (LockA locked padlock) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

  • About HHS
  • Programs & Services
  • Grants & Contracts
  • Laws & Regulations
  • Radical Transparency
  • Big Wins
  • About OHRP
  • Regulations, Policy & Guidance
  • Education & Outreach
  • Compliance & Reporting
  • News & Events
  • Register IRBs & Obtain FWAs
  • SACHRP Committee
  • International
Breadcrumb
  1. HHS
  2. OHRP
  3. Education & Outreach
  4. Participating in Human Research and Clinical Trials
  5. Protecting Research Participants
  6. Principal Regulations
  • About Research Participation
    • Informational Videos
    • Questions to Ask
    • Protecting Research Volunteers
      • Why Have Regulations to Protect Research Participants?
      • What Regulations Protect Research Participants?
      • Who Oversees the Regulations to Protect Research Participants?
      • Is All Human Research Regulated?
      • Who is Responsible for Protecting Research Participants?
    • Additional Resources
    • Printable Information Materials
  • Upcoming Educational Events
  • Past Educational Events
  • Revised Common Rule
  • Human Research Protection Training
    • Human Research Protection Foundational Training
    • Participant-Centered Informed Consent Training
    • Considerations for Reviewing Human Subjects Research
    • OHRP Webinars
    • Mini-Tutorials
  • Videos
  • Exploratory Workshop
    • 2024 (Human Research with AI)
    • 2023 (Psychedelics Research)
    • 2022 (Payment for Participation)
    • 2021 (Third-Party Research Risks)
    • 2020 (Single IRB)
    • 2019 (Privacy and Data Research)
    • 2018 (Informed Consent)
  • Luminaries Lecture Series
  • Human Research Protection Program (HRPP) Resources
  • Educational Collaboration with OHRP
    • Research Community Forums (RCFs)
    • Educational Workshops
      • OHRP Co-Sponsored Workshops
    • Speaking Engagements
  • Education & Outreach Archived Materials

What Regulations Protect Research Participants?

Printable

The Common Rule

The Federal rules that protect people who participate in research were initially published by the Department of Health and Human Services (HHS).

The first section of the HHS rules (Subpart A) is called the Common Rule because it was simultaneously adopted by 15 Federal departments and agencies in 1991. The Common Rule was revised in 2017 to reflect how research has changed since 1991.

One key protection in the Common Rule is the requirement for appropriate review and approval of research by institutional review boards, or IRBs. IRBs are committees that make sure researchers follow the HHS rules and ethical guidelines as they carry out their studies.

The Common Rule generally requires that researchers get informed consent from those who participate in research. This includes giving them information they would need to make an informed decision about participation in language they would understand.


Additional Protections

In addition to the Common Rule, there are 4 other subparts in the HHS rules. Three of these (Subparts B, C, & D) provide additional protections for certain groups of research participants that could be considered vulnerable.

Content created by Office for Human Research Protections (OHRP)
Content last reviewed October 17, 2023
Back to top

Subscribe to Email Updates

Receive the latest updates from the Secretary and Press Releases.

Subscribe
  • Contact HHS
  • Careers
  • HHS FAQs
  • Nondiscrimination Notice
  • Press Room
  • HHS Archive
  • Accessibility Statement
  • Privacy Policy
  • Budget/Performance
  • Inspector General
  • Web Site Disclaimers
  • EEO/No Fear Act
  • FOIA
  • The White House
  • USA.gov
  • Vulnerability Disclosure Policy
HHS Logo

HHS Headquarters

200 Independence Avenue, S.W.
Washington, D.C. 20201
Toll Free Call Center: 1-877-696-6775​

Follow HHS

Follow Secretary Kennedy