May 11, 2015
Patrick Stone, President, TradeStoneQA
The FDA says IRBs (Investigational Review Boards) are not required to collect a statement of investigator assurance from studies they preside over.
This is troubling. My first question would be how are IRBs going to assure clinical investigators will abide by requisite 21 code of federal regulations (CFR) and the sponsor approved protocol? How will IRB’s ensure that the protocol they are approving is authorized by FDA for human clinical trials?
Clinicaltrials.gov
is a great repository and can be a big help here, but only if it used by the IRB’s and updated in a timely manner. In my day as an FDA inspector [1998] we were trained that IRB’s are FDA’s eyes and ear’s because FDA is not 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 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 & 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 FDA is not 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 IRB’s 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!
Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.
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