Question:

What is the IRB’s responsibility for the review of updated Investigator Brochures?

– IRB assistant director at a large health system

Response: 

Investigator Brochures (IB) can be intimidating documents for an IRB. However, many revisions are technical updates or revisions to previous data based on pre-clinical and clinical research that has been collected since the earlier version of the IB was published that may not require review by the convened IRB.

There are several strategies IRBs can take to streamline the review process and determine the level of review. The IRB can ask the sponsor to provide a summary of the changes to the IB or a copy of the revised IB with changes tracked.  With either a summary of changes or a tracked revision, IRB staff can assess whether the new information requires review by the convened IRB as a possible unanticipated problem involving risks to subjects or others. 

IRBs can also ask sponsors whether the revised information in an IB requires a modification to the protocol or the informed consent document. If the sponsor confirms that the revised IB has no impact on the protocol or the informed consent document, then it is unlikely that the IB revision represents new information that requires review by the convened IRB.

It is unusual for a sponsor to use an IB revision as the vehicle for communicating important risk updates to the IRB. Changes in risk information that require a protocol modification or an update to informed consent materials are rarely withheld until an IB is updated. Sponsors will typically communicate information of immediate impact through a mechanism such as a Dear Investigator Letter or other specific communication, with that information being incorporated into the next planned update to the IB. 

An IRB’s review of an updated IB that represents an unanticipated problem posing risks to subjects or others is no different from any other submission type. The review should include member(s) with sufficient knowledge of the specific scientific discipline relevant to the submission.  If the new information in the updated IB is beyond the level of expertise of the members, the IRB may use a consultant to assist in the review.