Guidance on IRB Written Procedures Finalized

The US Food and Drug Administration (FDA) and Department of Health and Human Services’ (HHS) Office for Human Research Protections on Thursday finalized guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow. 

IRBs are bodies established to approve and oversee studies involving human research subjects in order to ensure that participants are adequately protected. 

The guidance finalizes a draft version from in 2016 and is being issued as part of a requirement under the 21st Century Cures Act for HHS and FDA to harmonize their human subject protection regulations. 

Specifically, the guidance provides IRBs with a 55-item checklist to follow to ensure that the written procedures they develop meet the regulatory requirements for the studies they oversee. 

Under federal regulations, IRBs are required to follow written procedures for various functions, including conducting reviews of research, determining which projects require more frequent review and reporting issues that occur during research to the appropriate agency officials. 

But the regulations do not specify the content and format written procedures must follow, so it is up to individual IRBs to develop and maintain their own set of written procedures. 

“Our efforts to make the regulatory requirements and guidance for human subject research more consistent present an opportunity to both enhance the protection of human research subjects and reduce the regulatory burden on the research community by creating efficiencies and strengthening standards in the clinical trial enterprise,” said FDA Commissioner Scott Gottlieb.

FDA, Guidance