For IRBs and Physicians
Our Partners in Expanded Access
WCG Foundation (WCGF) is committed to helping desperately ill patients who want the chance to try experimental medicines. These patients have exhausted all treatment options and are not able to participate in a clinical trial or wait for existing trials to be complete.
As a last resort, patients can turn to pharmaceutical companies and the Food and Drug Administration (FDA) for approval to participate in an expanded access (compassionate use) program. These programs allow patients to try experimental medicines under a single patient request, provided patients receive permission from the drug sponsor, FDA, and an institutional review board (IRB). The process can be cumbersome and frustrating for patients and families who are all too aware that time is running out.
To help patients and to support the critical role of IRBs, WCGF works hand in hand with IRBs to reduce the procedural obstacles that desperately ill patients can face. WCGF serves as a resource to IRBs, providing information about FDA requirements and suggestions on how to streamline the IRB review process for expanded access. We also offer assistance to physicians who are applying for expanded access for their patients.
Below is a list of organizations whose IRBs are working with WCGF to streamline IRB review procedures. Since organizations continue to sign on, please check back frequently for the most recent list.
- University of Colorado Denver
- University of Pennsylvania
- University of Southern California
- UT Health, University of Texas Health Science Center at Houston
- Vanderbilt University Medical Center
In addition, WIRB, an independent IRB, has agreed to help support expanded access by providing IRB reviews free of charge in cases where the physician is not affiliated with an organization that has its own IRB.
We encourage all IRBs to join WCGF in transforming the review process so that every patient request for expanded access is approved quickly. Together, we can make a difficult time a little easier for desperately ill patients and their families.
For more information, including assistance with your IRB procedures, please contact WCGF at firstname.lastname@example.org or call 404.386.8982.
- Streamlining IRB Procedures
- Responsibilities of a Sponsor-Investigator (Treating Physician)
- FDA Guidance: Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers (October 2017)
- FDA Form 3926 (*Right-click and select “save link” to save the file to your computer)
- FDA website