Applying to an Institutional Review Board for an Expanded Access Program

Expanded Access Programs (EAPs), also known as Managed Access Programs, help sick patients gain access to drugs that are not available through traditional access routes. These can be drugs that are still in development, in either phase II or phase III clinical trial, or drugs that are approved but are only commercially available in certain countries.

In the US, EAPs are carefully regulated by the US Food and Drug Administration (FDA). Although the FDA supports expanded access, and approves almost 99% of the applications that it reviews, the agency does require a patient’s physician to complete a number of steps before the patient can begin receiving treatment through an EAP.

When a patient is trying to access a drug that is still in development, one of these required steps involves applying to an Institutional Review Board (IRB). An IRB is made up of a group of appropriately selected individuals who are charged with reviewing any proposed research in the US which involves human subjects. Their job is to ensure that the rights and health and wellbeing of participants are protected.

Because the use of an investigational drug could potentially put patients’ health and wellbeing at risk, the FDA requires a physician to send an informed consent document to the his/her local IRB. This document should clearly show that the patient(s) involved in the EAP understands the potential known risks associated with taking the drug, and is aware that there may also be significant unknown risks involved with taking any unapproved medication. It must indicate that the patient(s) has been sufficiently informed by his/her physician and is willing to accept these risks.

After reviewing the document, the IRB can do one of three things;

  • Choose to accept the proposed EAP
  • Tentatively approve the program as long as revisions are made and a new report indicating the changes is submitted
  • Disapprove the EAP

Without IRB approval, an EAP cannot legally be conducted, so it is important for a physician to find an IRB and provide it with the appropriate materials. IRBs are usually associated with healthcare institutions, like hospitals, or with research institutions, like universities, but there are independent IRBs available as well.

The FDA does have special allowances for emergency situations, where a patient requires access to a drug almost immediately. In these special cases, the FDA can approve an EAP without IRB approval, as long as the IRB is notified within five working days of the patient starting treatment.