FDA issues final guidance in effort to protect clinical trial participants


US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD said in a statement that the final guidance “describes a consistent approach to written procedures implemented by the institutions and Institutional Review Boards responsible for the oversight of human subject research.”

The draft guidance was originally published in August 2016.

“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,”​ Gottlieb said in the press release.

The joint guidance titled – “Institutional Review Board (IRB) Written Procedures; Guidance for Institutions and IRBs”​ – was issued today by the US Food and Drug Administration in collaboration with the Office for Human Research Protections (OHRP).

The guidance outlines a written procedures checklist identifying FDA and HHS regulatory requirements for IRB written procedures, providing recommendations on the type of information to include.

According to the FDA, the checklist is designed “to prompt a thorough and more efficient evaluation of written procedures that are needed to help ensure the protection of human research subjects.” 



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