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.

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