web
You’re offline. This is a read only version of the page.
close
Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
Print Article: KA-04411

What are requirements for Human Subjects Research?

Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.

Human Subjects Regulations Decision Charts
Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan
Guidance on NIH Office of Extramural Research (OER) on-line tutorial Protecting Human Research Participants (PHRP)
Office for Human Research Protections (OHRP)