Ask the Experts
Question:
Why do IRBs require sponsors to confirm the FDA’s IND number as a condition of IRB approval? I cannot find this requirement in the FDA regulations.
– Director, Regulatory Affairs, Pharma
Response:
You are correct that there is no FDA regulatory requirement for the IRB to have a IND number to approve a study. However, WCG IRB is accredited by the Association for the Accreditation of Human Research Protection Programs. In order to maintain accreditation, an IRB must meet standards that may exceed the regulatory requirements. One of the accreditation standards is for an IRB to confirm that the drug has an IND number or is exempt from the IND requirements prior to IRB approval of the study.
From a practical perspective, this accreditation standard and IRB requirement may prevent researchers from starting studies before the FDA has issued an IND number.
CLICK HERE to navigate to ELEMENT I.7.A.: When research involves investigational or unlicensed test articles, the organization confirms that the test articles have appropriate regulatory approval or meet exemptions for such approval.
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