FDA eases IRB review of COVID-19 expanded access requests
Institutional review boards (IRBs) may establish procedures to have a single IRB member review individual patient expanded access requests for investigational drugs and biologic products to treat coronavirus disease (COVID-19), says new guidance from the US Food and Drug Administration (FDA).The guidance provides clarification for IRBs that may be seeing increased numbers of individual patient expanded access requests related to COVID-19 infection.
In light of the increased burden of expanded access requests, the guidance, which applies only to expanded access requests on behalf of individual patients, recommends that IRBs consider establishing a mechanism for individual members to review expanded access requests.
When completing FDA Form 3926 to request individual patient expanded access to an investigational drug for COVID-19, physicians may request a waiver from full IRB review. If this waiver is requested, the access request can receive single-member IRB review.
If the IRB opts for single-member review, the guidance suggests that the board develop procedures to identify what information is relevant for single-member review. Procedures should also denote a means for the member to indicate whether they concur or do not concur with the requested treatment.
During the public health crisis of the coronavirus pandemic, individual patient expanded access reviews should focus on weighing the risks and benefits of the requested investigational treatment for the individual patient, says the guidance. Therefore, the IRB must gather enough information to assure itself that patient risks have been minimized and the risks are “reasonable in relation to anticipated benefits.”
The guidance clarified that having a thorough patient history and treatment plan can be enough information for an IRB to make an assessment in an individual patient’s case: “In the context of an individual patient expanded access request, FDA does not expect that a protocol will be necessary to provide the IRB with sufficient information to determine if those criteria are satisfied.”
The patient history should include a detailed summary of previous therapies as well as comorbidities and other medications.
The treatment plan should include details of how the investigational drug will be administered, including criteria for discontinuation of treatment and how dosing will be modified in the case of adverse events.
Also, the plan should specify how the patient will be monitored for adverse events, clinical status, and treatment response. The IRB should also be provided with a summary of the known risks of the proposed investigational drug.
In its review, the IRB should consider the qualifications of the physician submitting the request. Informed consent should meet federal requirements, making clear to the patient or authorized representative that although the drug is being used for treatment, it is under investigation and therefore its use “involves research.”