FDA Expanded Access Informed Consent Template

Mar 29, 2017 12:00 pm

This template should be used when creating an FDA Expanded Access informed consent document. This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use.

For more information on specific guidance, please see the following:

For assistance with obtaining FDA and IRBMED approval to use an Expanded Access investigational medical product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing UM-Expanded-Access-Request@med.umich.edu


Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: bpsea@umich.edu
Last Updated: April 13, 2020 1:00 PM