Can you provide an IRB approval before FDA’s review of the IND?

Question:

Can you provide an IRB approval before FDA’s review of the IND?
—Director, Clinical Operations, Biopharmaceutical Sponsor

Response:

For an Investigational New Drug (IND), an IRB may approve a protocol prior to the end of FDA’s 30-day review window for the IND. However, no study-related activities may begin until approval has been granted by all regulatory authorities. WCG IRB may issue a conditional approval pending receipt by the IRB of the IND number – not just on the end of the FDA’s 30-day waiting period.

If the protocol is being submitted to an open IND (and the IND is not on clinical hold), the sponsor may choose to start the study after IRB approval without waiting 30 days for the FDA review of the amendment¹. It’s up to the sponsor to decide whether they want to start the study without waiting out the FDA review window. The risk to the sponsor is that if the FDA does come back with comments, the sponsor would have to stop the study and secure approval from the IRB and the FDA before proceeding.

One way to minimize this risk of a clinical hold would be to seek advice from the FDA prior to submitting the amendment to the FDA and the IRB. Or, if the study is a very standard design (i.e., a food effect study with a design frequently used), the sponsor may decide to take the risk of proceeding once the protocol is approved by the IRB without waiting for the 30-day review window to elapse.