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Human Subjects Division (HSD)


Document Details

Last Updated 05/31/2016
Version 1.60
Filesize 2.19 MB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Form
Use of HSD PDF Forms

HSD Forms are compatible with Adobe Reader, Version 10 and higher, though we recommend use of the most recent version. You may receive messages from Adobe to upgrade.

For Mac users: be sure to open the form in Adobe Reader or Acrobat.

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INSTRUCTIONS and NOTIFICATION: Emergency Use, Drug or Biologic


This document is used by physicians to:

  1. Determine and document whether the circumstances in which they hope to make emergency clinical use of an investigational drug or biologic meets the FDA requirements for emergency use;
  2. Guide them through the procedures required by the FDA and the UW for emergency use; and
  3. Notify the IRB of the emergency use with in 5 business days after the use.

Change Notes

  • Related to Ver. 1.60, noted 05/31/2016 @ 08:06pm
    Updated instructions for paper vs. Zipline applications.
    - sherrye
  • Related to Ver. 1.50, noted 12/29/2014 @ 09:23am
    Added clarifying instructions regarding submission to HSD.
    - sherrye
  • Related to Ver. 1.40, noted 10/17/2014 @ 09:33am
    Minor clairifications in instructions.
    - sherrye
  • Related to Ver. 1.30, noted 05/30/2014 @ 09:54am
    Added box for UW Department or Division
    - sherrye
  • Related to Ver. 1.20, noted 03/06/2014 @ 08:37am
    Corrected typos.
    - sherrye
  • Related to Ver. 1.10, noted 03/04/2014 @ 04:30pm
    Corrected phone number for HMC Investigational Drug Service.
    - sherrye
  • Related to Ver. 1.00, noted 02/28/2014 @ 09:00am
    Document newly added.
    - sherrye