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Patrick Stone

FDA Compliance

Should the FDA Get Tougher on Investigational Review Boards?

Why not to abandon the last line of defense for patient safety?

Published: Thursday, June 4, 2015 - 16:34

The FDA says that investigational review boards (IRBs) aren’t required to collect a statement of investigator assurance from studies they preside over.

This is troubling. My first question: How are IRBs going to assure that clinical investigators will abide by requisite 21 code of federal regulations (CFR) and the sponsor-approved protocol? How will IRBs ensure that the protocol they are approving is authorized by the FDA for human clinical trials?

Clinicaltrials.gov is a great repository and can be a big help here, but only if the IRBs use it and it’s updated in a timely manner. In my days as an FDA inspector (back in 1998), we were trained that IRBs are the FDA’s eyes and ears because the FDA isn’t going to get to very many clinical investigator audits. Fewer than one percent of clinical trials ongoing domestically are reviewed by the agency.

That’s why I’m a little worried. Why would the FDA abandon a last line of defense for patient safety? I’m not sure why the agency takes this position, but luckily for patients, most IRBs do hold clinical investigators accountable for all HHS requirements (FDA and OHRP) and even conduct quality audits for a small percentage of the clinical trials they preside over. If 21 CFR is the bare minimum requirement for compliance, wouldn’t additional IRB oversight be a big boost to compliance if the FDA isn’t able to review a much higher percentage of the domestic ongoing clinical trials?

There’s another area of concern: A 2013 FDA guidance states that only sponsors and clinical investigators need to keep track of financial disclosure documents. Financial disclosure should be reviewed by IRBs, especially institutional IRBs that can easily verify if conflicts of interest exist for clinical investigators under their review.

But let’s save that topic for the next time.

First published May 11, 2015, on the AssurX blog.

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About The Author

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Patrick Stone

Patrick Stone works toward a future where disease cures and prevention are the main goal of all new test articles. Stone is president and lead consultant at TradeStone QA LLC, which serves the global public by protecting the supply and quality of healthcare products before entering the market place. Stone specializes in Institutional Review Board (IRB) compliance and quality assurance audits; computer system validation and 21 CFR Part 11 compliance; LIMS/data management system compliance; and 21 CFR, GCP, cGMP, and ICH compliance. Stone is the author of Bubble Gum Badge—An FDA His-Story (Xlibris Corp., 2011). You can follow Stone on Twitter.