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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. |
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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 |
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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 |
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