Regulations

Applicable Regulation or Guidance

The U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) have regulations that contain provisions for ensuring that risks to subjects are minimized and reasonable in relation to the benefits, if any, expected to accrue to subjects and to the importance of the knowledge that may be expected to result from the research. The following links provide access to the specific federal regulations:

• The Common Rule at 45 CFR 46.111(a)(1) and FDA regulations at 21 CFR 56.111(a)(1)

The following links provide additional interpretive general guidance from the FDA and the DHHS:

• Guidance from the FDA
• Guidance from the DHHS Office for Human Research Protections