Emergency Treatment Notification

Emergency Treatment Notification (ETN) is handled jointly by either the FHCRC IRB or the University of Washington's Human Subjects Division, depending on the activity.

1. The FHCRC IRB is responsible for Emergency Treatment Notification (ETN) involving:
   • Investigational Device and Conventional Agents used in Novel Ways for Adult Research Patients in a life threatening situation
   • Pediatric (Seattle Children's) Transplant Patients
   [download ETN form] Updated March 20, 2013

2. The University of Washington Human Subjects Division (UWHSD) is responsible for Emergency Treatment Notification for:
   • Adult patients at the University of Washington Medical Center (UWMC);
   • Adult patients at the Seattle Cancer Care Alliance (SCCA) Out Patient Division.
   The UWHSD will handle all ETNs for the above two scenarios because the UWMC Investigational Drug Service (IDS) Pharmacy is the pharmacy of record for ordering, dispensing and accounting for FDA regulated investigational agents at these locations.

   For further information, please visit the University of Washington's Human Subjects webpage at http://www.washington.edu/research/hsd/hsdman3.html#III-e

Specific procedures are described in the IRB policy/procedure on Emergency Treatment Notification (Policy 2.4). [pdf]

Note: Whenever emergency care is initiated without prior IRB review and approval, the patient may not be considered to be a research subject. Such emergency care may not be claimed as research, nor may the outcome of such care be included in any report of a research activity. It is also the policy of the FHCRC IRB that whenever emergency use of a test article is initiated without prior IRB review and approval, it is considered research and the patient is considered to be a research subject.  For more information, please see http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc91-01.htm.