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THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)

HOW TO APPLY FOR IACUC PROTOCOL APPROVAL

WHO CAN AUTHORIZE WHAT TYPES OF MODIFICATIONS?
(rev. December 2007, February 2005, June 2003)

Notes:
Email questions to iacuc@ucsf.edu
Modifications to the protocol may not be implemented until reviewed and approved by the IACUC.

UCSF-IACUC had adopted formalized procedures, known as “Designated Reviewer”, approved by the USDA and PHS. This process allows for review of proposed activities (protocols) by less than a full Committee.

Modifications

Modifications are classified as one of the following two categories:

Minor Modifications (MI): apply to changes such as a change in the PI, study title or location, and minor procedural changes. The designated reviewers described below will review these modification requests.

Major Modifications (MA): in general, these apply to studies involving regulated species and/or category E, as well as major procedural changes in non-USDA regulated species or change or addition of any species to a study. The IACUC membership will be notified of any such modification being reviewed by a “designated reviewer” and they may ask for a full IACUC review.

An investigator requesting major changes to the experimental procedures will be asked to incorporate the changes into a complete application.

The following is intended to establish a clear line of authority as to who can authorize what modifications; the following are considered as the designated reviewers for modifications listed, however, the IACUC Chair may assign specific requests to any member of the IACUC:
i Laboratory housing (MI): Designated Reviewer Subcommittee
ii . Change in therapeutic medication (anesthetics, analgesics, antibiotics, etc.) (MI): LARC veterinarians
iii. Increase in number of animals:
  a. Non-USDA regulated species (MI): LARC veterinarian or IACUC Chair/Vice Chair
  b. USDA regulated species (MA): Depending on the extent of changes requested, Full Committee or Designated Reviewer
iv. Addition of new species (MA): USDA Regulated species: Full Committee; non-USDA regulated species: Designated Reviewer Subcommittee
v. Change in experimental procedure (MA or MI): Depending on the extent of changes requested, Full Committee or Designated Reviewer
vi. Change in monitoring frequency:
  a. Changes with no animal welfare impact (e.g. frequency of recording, addition of a new parameter) (MI): Designated Reviewer
  b. Changes with potential animal welfare impact (e.g. discontinuation of monitoring) (MA): Full Committee or Designated Reviewer
vii. Closure of a protocol (MI): IACUC professional staff in collaboration with LARC director regarding disposition of remaining animals
viii. Transfer of a protocol to another PI (MI): IACUC Chair. [Requires a formal confirmation from PI (or the Department Chair if the PI has left the university) and the receiving PI requesting the change. This requires closure of old protocol, transfer to the new PI with new number, transfer of animals, (if any) and corresponding records to the new PI.
ix. Other: Full IACUC or designated reviewer, depending on extent of change
 

Administrative Changes

Name additions (MI): IACUC professional staff (conditional upon successful completion of required training)
•. Name deletions (MI): IACUC professional staff
Reduction in number of animals (MI): IACUC professional staff