How do I submit a non-emergency expanded access request for an unapproved drug, biologic, or device to the IRB?
There are five different types of non-emergency use expanded access:
- Individual patient expanded access use of an investigational drug
Individual patient drug expanded access requests should be submitted to the IRB as a new study. If the study team checked “Request for Authorization to Use Alternative IRB Review Procedures” on FDA Form 3926 (field 10.b.) or has a separate waiver request included with FDA Form 1571 for the purpose of obtaining concurrence from an IRB Chair or designee, this information should be included in the application. Instead of uploading a protocol, the submission should include the following:
- A thorough patient history and treatment plan, included in the Form FDA 3926 or in a separate document that includes:
- The proposed daily dose, route, and frequency of administration of planned treatment; duration of planned treatment; criteria for discontinuation of treatment; and planned dose modifications for adverse events;
- The planned monitoring for adverse events, response to treatment, and changes in clinical status, as well as proposed modifications to the treatment plan to mitigate risks to the patient if appropriate;
- The key details of the patient’s history, including diagnosis and summary of prior therapy (including response to such therapy); the reason for request, including an explanation of why the patient lacks other therapeutic options; and information regarding a patient’s relevant clinical characteristics (such as comorbid conditions and concomitant medications) that is necessary to assess the potential for increased risks of the drug; and
- A summary of known risks of the drug
Use TEMPLATE: Emergency Use Consent Document (HRP-506) to prepare your consent document. A Continuing Review application must be submitted to the IRB at least annually, and any modifications or new information should be reported accordingly.
- Compassionate Use (Individual patient/small group access) of a device
Requests for compassionate use of a device should be submitted to the IRB as a new study. See WORKSHEET: Compassionate Use of an Unapproved Medical Device (HRP-325) for the regulatory criteria allowing such a use and make sure these are followed. The FDA does not consider the compassionate use of an unapproved device to be a clinical investigation, however, it is expected that informed consent be obtained. Use TEMPLATE: Emergency Use Consent Document (HRP-506) to prepare your consent document.
Instead of uploading a protocol, the submission should include CHECKLIST: Compassionate Use Request for Investigational Devices (HRP-1201), which includes the treating clinician providing a summary of the conditions constituting the compassionate use, other relevant details of the case, approval from the device manufacturer, device/product manual, FDA authorization, and any other relevant information (i.e., patient-facing materials, etc.). Continuing review is not required for compassionate use; however, if any problems occur as a result of device use, these should be discussed in the follow-up report and reported to the IRB as soon as possible. - Intermediate-size patient population access to the use of a drug
- Expanded access for widespread use of a drug
- Treatment use of a device
Requests for any of these three (3) types of expanded access use (i.e., numbers 3, 4, and 5 above) should be submitted to the IRB as a new study. Submissions should include the protocol, consent form, and other pertinent information (i.e., Investigator’s Brochure, device/product manual, patient-facing materials, etc.). Use TEMPLATE: Biomedical Consent Document (HRP-592) to prepare your consent document. A Continuing Review application must be submitted to the IRB at least annually, and any modifications or new information should be reported accordingly.