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Compliance In Focus
Posted by John Lehmann on Thu, Sep 12, 2013

FDA Issues Guidance for IRBs

On August 27th, the FDA issued its final guidance for institutional review boards (IRBs).  TheFDA Issues Guidance for IRBs goals of this guidance are to strengthen human subject protection during clinical trials and increase the efficiency of the IRB review process.

In the final guidance, the FDA clarifies that IRBs, sponsors and clinical investigators are all responsible for ensuring that research complies with applicable laws and regulations and that risks to subjects are minimized.  FDA also updated the guidance to confirm that its recommendations may be fulfilled by any IRB, whether independent or institutional, local  or central.

The reaction to the new guidance has been mixed.  In an August 28th article,  BIOtechNOW supported the guidance stating “Promoting the use of centralized IRBs is a key priority of BIO’s Clinical Trials Modernization Initiative, which was created to help bring innovative new medicines to patients more efficiently, while protecting and enhancing patient safety.”

The Association of Clinical Research Organizations (ACRO) and the Society for Clinical Research Sites (SCRS) have submitted comments that are similar.   They both feel the guidance “does not recognize the established process and responsibilities carried out and held by sponsors, CROs, and IRBs in relation to each of their current roles in qualification of investigators and sites.”

ACRO and SCRS believe the guidance will create more confusion by not distinguishing between investigator-initiated and commercially sponsored research.

So the verdict on the guidance is still out.  What are your thoughts on the FDA guidance?  Please share below.

Photo Credit: Porter Yates

Centralized vs. OnSite Monitoring

Topics: Guidance, Institutional Review Boards, ACRO, SCRS, FDA


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