MEMORANDUM OF UNDERSTANDING
RELATED TO THE USE OF DATA OBTAINED UNDER EMERGENCY USE
UNIVERSITY OF CALIFORNIA IRVINE - INSTITUTIONAL REVIEW BOARD
Emergency Use is defined under human subjects research regulations and policies as the utilization of a test
article (e.g., investigational drug, biologic or device) on a patient in a life-threatening situation for which no
standard acceptable treatment is available and insufficient time is available to obtain prospective IRB approval.
When permission is granted for Emergency Use, the patient is not considered to be a research subject, as the
Institutional Review Board has not approved the use. Furthermore, such care may not be claimed as research,
nor may the outcome of such care be included in any report of a research activity.
The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have advised
the University of California, Irvine (UCI) that data obtained under an Emergency Use protocol may be provided to
the manufacturer or supplier of the test article to the extent required under FDA regulations, provided the
manufacturer or supplier agree not to include the data in published or otherwise publicly-disseminated reports
of “research.” The University asks UCI faculty to obtain an authorized signature from the manufacturer or
supplier’s representative attesting to this understanding prior to the release of any data.
PLEASE COMPLETE THE FOLLOWING:
NAME OF TREATING PHYSICIAN:
NAME OF DRUG/BIOLOGIC/DEVICE:
NAME OF MANUFACTURER/SUPPLIER:
DATE OF USE OF TEST ARTICLE:
**TO BE SIGNED BY THE AUTHORIZED REPRESENTATIVE OF THE MANUFACTURER/SUPPLIER AND RETURNED TO
THE TREATING PHYSICIAN PRIOR TO THE RELEASE OF DATA DERIVED FROM EMERGENCY USE:
As an authorized representative of the manufacturer/supplier of the investigational test article(s) named above, I
have asked the treating physician to provide to me a copy of the data obtained from the above-noted Emergency
Use. I understand that this information is not research data and may not be included, alone or in compilation with
data obtained under research procedures approved by the Institutional Review Board, in any research report or
other publication of research. However, I understand it may be provided to the U.S. Food and Drug Administration
as required.
Signature:
Print Name:
Print Title:
Date: