The FDA’s Office of Good Clinical Practices (OGCP) is an important resource for clinical trial professionals who cannot find the answers they need in the agency’s multitude of regulations, guidances and policies.
OGCP answers questions submitted via email to email@example.com, interpreting the FDA’s position, offering advice on how to proceed and pointing out key documents and resources that provide more in-depth guidance. The following questions address IRB requirements for individual patient-expanded access.
Waiver of IRB Requirements for Individual Patient Expanded Access IND
Q: I have reviewed the recently updated FDA guidance documents, “Waiver of IRB Requirements for Drug and Biological Product Studies” and “Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers” as well as updated FDA Form 3926 and am seeking clarification related to FDA’s expectation for IRB review, or what is termed “concurrence”, in the guidance.
A6: Except for emergency expanded access use (see Q8) when there is not sufficient time to secure prospective IRB review, an investigator treating a patient with an investigational drug under expanded access is responsible for obtaining IRB review 11 and approval consistent with 21 CFR part 56 before treatment with the investigational drug may begin, regardless of whether the protocol is submitted in a new IND or to an existing IND (21 CFR 312.305(c)(4)). In the case of emergency expanded access use, FDA authorization is still required (§312.310(d)), but it is not necessary to wait for IRB approval to begin treatment.
Related to these documents, I had the following questions:
A: The IRB chairperson (or designated IRB member) would consider the same information that the full IRB would consider to determine whether to approve the treatment when reviewing and concurring for individual patient-expanded access use.
Informed consent is required for expanded access uses. Review of the informed consent would be part of the IRB review and concurrence process for individual patient-expanded access use.
Q: Just to further clarify the actual review pathway that is allowed, when the IRB chairperson (or designated IRB member) reviews an individual patient-expanded access use request, would the IRB chairperson document their review and concurrence as being done via expedited review (under 21 CFR 56 .110) or done via an “administrative” (non-IRB review) concurrence action?
Specifically, for those institutions that use electronic IRB systems to track and manage IRB reviews, we are trying to figure out if we must route these individual patient-expanded access use requests (when a waiver is requested) via an expedited review pathway or if they can have a separate administrative review pathway.
A: I think you are asking which regulatory IRB review pathway this type of review fits into, full board or expedited or if it would be in a different review pathway. Generally, review of individual patient-expanded access use by an IRB chairperson (or designated IRB member) would follow a different review pathway, that is, one in which the IRB chair or designee reviews the relevant documents (as determined by the IRB) and then his or her decision to concur or not (and/or any questions and responses) is documented.