Human Subjects Protections:
Guidance Topics

Guidance Topics
  • DHHS Office of Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).
  • Code of Federal Regulations for research involving human subjects (45 CFR 46). Basic regulations governing the protection of human subjects in research supported or conducted by HHS. The regulations require basic protections to human subjects involved in both biomedical and behavioral research conducted or supported by HHS.  The statutory authority for the HHS regulations derives from 5 U.S.C. 301; 42 U.S.C. 300v-1(b); and 42 U.S.C. 289. 
  • Revisions to the Common Rule went into effect on January 21, 2019. All studies approved after that date will be required to comply with the new rule. The Revised Common Rule includes changes to categories of Exempt research, changes to Continuing Review requirements, and changes to Informed Consent content.  You can learn more in the What’s New in IRB Review Under the Revised Common Rule video.  
  • US FDA Information on research involving human subjects. The US Food and Drug Administration (US FDA)  is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. FDA regulations are published in title 21 of the CFR (21 CFR part 50, Protection of Human Subjects; 21 CFR part 56, Institutional Review Boards; 21 CFR part 312, Investigational New Drug Application; 21 CFR part 812, Investigational Device Exemptions). 
  • HIPAA Privacy Rule is the Federal protection for the privacy of personal health information. The Privacy Rule establishes a category of health information, defined as protected health information (PHI), which a covered entity may only use or disclose to others in certain circumstances and under certain conditions. In general, the Privacy Rule requires an individual to provide signed permission before a covered entity can use or disclose the individual’s PHI for research purposes. Under certain circumstances, however, the Privacy Rule permits a covered entity to use or disclose PHI for research without an individual’s Authorization. One way a covered entity can use or disclose PHI for research without an Authorization is by obtaining proper documentation of a waiver of the Authorization requirement by an Institutional Review Board (IRB).  
  • A Certificate of Confidentiality is issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. 
  • NIH Policy and Guidelines on the Inclusion of Children in Research is designed to increase the participation of children in research so that adequate data will be developed to support the treatment modalities for disorders and conditions that affect adults and may also affect children. 
  • NIH Guideline on the Inclusion of Women and Minorities in Research is designed to ensure participation of women and members of minority groups and their subpopulations in all NIH-supported biomedical and behavioral research projects involving human subjects.