FDA issues final guidance in effort to protect clinical trial participants

By Melissa Fassbender

- Last updated on GMT

(Image: Getty/Visivasnc)
(Image: Getty/Visivasnc)
The FDA has published a final guidance today in its efforts to improve protection for participants in clinical trials and reduce regulatory burden.

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The draft guidance was originally published in August 2016.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.” 

IRB expert Tom Bechert, director of Huron Consulting Group, said the checklist at the core of the guidance, “is a helpful resource for any human research protection program seeking to continuously improve its policies and procedures.”

“It encourages institutions to provide greater operational detail to better describe ‘how’ various IRB administrative and review processes are performed,​” he told us.

How will the new guidance affect research organizations?

Bechert said it is important to note that the checklist has undergone significant revisions since the original draft guidance was released: “As such, human research protections professionals will need to familiarize (or re-familiarize) themselves with this final guidance to ensure that their policies and procedures address the operational details listed in the Written Procedures Checklist.”

AAHRPP-accredited institutions likely will have already addressed “the greater level of procedural detail”​ described in the guidance, Bechert added.

“On the other side of the spectrum, those organizations who maintain a very limited amount of policy and procedure content relying primarily on verbatim excerpts from existing regulations will likely find their existing materials to be insufficient relative to this guidance,”​ he explained.

“Such organizations should promptly develop plans to implement a more robust set of policies and procedures to better align themselves with FDA and OHRP’s current thinking as well as industry best-practice,” ​Bechert concluded.

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