EXPANDED ACCESS TO TEST ARTICLES
Federal regulations allow for the expanded access to a test article (unapproved investigational drugs, biologics or devices) to treat a patient who does not have a comparable alternative therapy or has exhausted all options to treat their disease or condition. Prospective IRB review and approval is not required for emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. The LSUHSC-NO HRPP, however, does request prior notification of emergency use, if time permits, or for non-emergency or compassionate use using the procedures described below. Any subsequent use of the test article at the institution or affiliated sites is subject to IRB review.
Expanded Access Categories
Use of an Unapproved Drug or Biologic:
- Emergency Use for a Single Patient
- Non-Emergency Use for an Individual Patient
- Non-Emergency Use for an Intermediate-Size Patient Group
Use of an Unapproved Medical Device:
- Emergency Use for a Single Patient
- Compassionate Use for a Single Patient
All requests for expanded access should be submitted via Kuali; select Expanded Access to a Test Article as the protocol type.
Resources
