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What
is a "Master" Animal Use Protocol (AUP)?
A "Master" AUP describes all uses of live vertebrate animals proposed
by an individual Principal Investigator for a one-year
period. For investigators with multiple research projects, the Master AUP presents
a cumulative description of all proposed animal species, numbers and procedures
to be used during the next 12 months. The Master Protocol must be fully approved
by the ACUC before acquisition, housing or use of animals.
In the past,
Principal Investigators usually submitted an AUP for each of their animal
research projects. The advantage of the Master AUP is that only one protocol
form must be prepared, reviewed and approved each year for investigators
involved in multiple projects. Once a Master Protocol is approved, proposed
changes (such as modifications in ongoing procedures) can be added to it
by submitting a revised protocol. Finally, under the Master Protocol system,
each investigator is assigned a single AUP number that can be used when ordering
animals and certifying new grant applications. The term AUP will
mean a document that describes all proposed uses of animal for a 12-month
period.
All forms and
instructions are available here.
Who must
submit an AUP?
Each Principal Investigator who uses live vertebrate animals in research must
submit an AUP. For continuing projects, the AUP must be updated and reviewed
annually. Only individuals with Principal Investigator status at UC Berkeley
may submit an AUP.
Must an
AUP include off-campus projects?
Field projects that are strictly observational (i.e., involve no direct handling
of animals and no significant disruptions of their environments) need not be
included in the AUP. All other off-campus projects, including those in other
countries, must be described in the AUP.
What is
the approval period for an AUP?
AUPs ordinarily are approved for a one-year period. Although annual submission
of an AUP for ongoing projects is the responsibility of the investigator, the
ACUC will send a courtesy renewal reminder 1 month prior to protocol expiration.
If the project will continue with no changes, renewal may be requested by checking
the "no change" box and returning the renewal forms to the ACUC.
Changes in personnel and/or anticipated animal housing needs can be accommodated
by noting the changes on the renewal form. [Note: “No change renewals”
may only be submitted twice. The third annual renewal requires that the protocol
be rewritten and resubmitted as if it were a new protocol.] If changes in
animal species, numbers, or procedures are proposed, a revised AUP must be
submitted to the ACUC for review.
How can
I modify an approved AUP?
Once an AUP has been approved, changes in animal species, numbers, procedures,
or the location of an activity may require submission of a revised
AUP, with
the changes shown in colored, bold, or underlined text on the original AUP.
Minor changes (such as the addition of a related species or procedure) can
usually be administratively approved within 1-2 weeks of receipt. Significant
changes must be reviewed by the full membership of the ACUC at the next regularly
scheduled meeting. Call or email the ACUC office for guidance on making changes
to your approved AUP.
What is
the timetable for reviewing and approving an AUP or an addendum?
The ACUC meets 10 times a year. AUPs or revisions received at least 6
weeks before a meeting can usually be included in the agenda for that meeting,
unless preliminary screening indicates that the ACUC requires significant
further
information. Consequently, the time required to review an AUP or addendum normally
ranges from 6-8 weeks, depending on the timing of the submission and whether
there is a need for additional information. Information about upcoming meeting
dates and applicable submission deadlines can be found here.
Whom can
I contact for advice about preparing an AUP?
For help in preparing an AUP, or for advice about the laws, regulations and
policies that may affect your proposed use of animals, contact the ACUC at
642-8855. For assistance in planning specific animal care or use procedures
(e.g., use
of anesthetics or analgesics, surgical procedures, special animal care requirements,
transportation, etc.), contact OLAC veterinary
staff at 642-9232.
How do
I arrange to acquire animals?
Live vertebrate animals cannot be purchased or otherwise acquired without
an approved AUP. All arrangements for the acquisition and transportation
of live vertebrates from any source must be made through OLAC,
including acquisition of animals from another investigator or institution,
and transportation of animals between campus facilities. Plans to acquire,
transport, and house animals in the field will be reviewed and approved
by OLAC as part of the regular AUP review process. If wild animals are
to be used, arrangements for any necessary quarantine must be made through
OLAC before animals are obtained. The investigator also is responsible
for determining if permits (such as U.S. Fish and Wildlife or California
Fish and Game) are required, and all applicable permits must be obtained
before animals are acquired. If the animals are illegal to possess in
the state of California ("detrimental species"), the permits
must be applied for through OLAC. All other permits, such as importation
and collection permits, are the responsibility of the investigator to
obtain, but OLAC may be contacted for advice or assistance in procuring
them. For further information about the acquisition of animals, call OLAC
at 2-9232.
How is
animal housing space assigned?
Animals cannot be housed without an approved AUP. However, approval of an AUP
does not guarantee that animal housing space will be available for the proposed
project. OLAC is responsible for
the management of animal housing space on campus, and assigns space when it
is available. If appropriate and adequate space is not available, the request
for space is forwarded to the Committee on Animal Research Space Assignment
(CARSA), which reviews and recommends plans for accommodating space requests.
CARSA is composed of academic senate members who are animal users and non-animal
users, the Director of OLAC, the Chair of the ACUC, and the Assistant Vice Chancellor
for Research. CARSA is advisory to the Vice Chancellor for Research, who has
authority to make animal research space assignments.
Will my
AUP be available to the public?
Under State law and campus policy, an AUP is available on written request to
members of the public once it has been approved by the ACUC. However, you may
request, under item 13 of the Protocol Form, that portions of your AUP be exempt
from public disclosure if you believe that they describe unpublished techniques,
procedures or data for which you may seek a copyright or patent, or the disclosure
of which would place your research at a competitive disadvantage. Requests for
exemption from public disclosure will be reviewed on a case-by-case basis by
University counsel in consultation with the investigator.
What about
potential conflicts of interest?
Since most of the scientists serving on the ACUC are Berkeley faculty members
who are engaged in animal research funded by competitively awarded research
grants, it is possible for potential conflicts of interest to arise during the
AUP review process. If you feel you have a potential conflict of interest with
a member of the ACUC (e.g., are a competitor for extramural research awards),
you may request in writing that this Committee member be excluded from review
of your AUP. When such a request is made, the identified Committee member will
not have access to your AUP or funding application, and will leave the room
when these are discussed and voted upon by the remaining members of the Committee.
The names of current Committee members can be obtained by calling the ACUC.
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