Expanded access, sometimes called “compassionate use,” is the use of an investigational medical product (one not approved by FDA) outside of a clinical trial.

The University of Wisconsin-Madison IRB is committed to using expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices.

Wherever possible, a patient’s use of an investigational medical product as part of a clinical trial is preferable because clinical trials can generate data that may lead to the approval of products and, consequently, to wider availability. However, when a patient cannot be enrolled in a clinical trial (e.g., the patient is not eligible or there are no ongoing clinical trials), the patient may be able to receive the product, when appropriate, through expanded access.