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The length of time you can expect from
submission to approval is dependent upon many factors, including the complexity of the application,
the number and nature of changes proposed (if amending a previously
approved protocol),
the ARC's meeting schedule, and whether the application is eligible for
review via Designated Member Review (see section entitled "The Review
Process" below).
Turnaround times for new and renewal
applications average approximately 6 weeks from submission to
approval. For renewal applications, investigators are strongly
encouraged to begin working on their applications as soon as possible
after receiving their first (90-day) expiration reminder notice.
Amendment and continuation
applications requesting significant changes (e.g., experimental
design, animal number or species/strain) average approximately 5 weeks
from submission to approval.
Amendment applications requesting
minor/administrative changes (e.g., personnel, locations, funding)
are generally approved within 7-10 days of submission, assuming no
outstanding issues such as personnel who have not completed all ARC
certification requirements or grant-protocol congruency issues (e.g.,
procedures described in the grant application that are not described in
the protocol).
Continuation applications
requesting no changes are generally ready for approval within 2 weeks of
submission. However, in an effort to not penalize investigators
who submit their applications early and who would otherwise lose a
substantial amount of time from their current approval period, these
applications are normally held for review until within 1 month of
expiration.
Investigators with an urgent funding
issue or who need ARC approval for experimental changes quickly should notify the Office
of Animal Research Oversight as soon as
possible.
Applications must be submitted to the ARC no later than the submission deadline. The ARC
usually convenes twice per month, and
the deadline for submission is generally 17 calendar days
prior to a meeting. (Meeting times and deadlines are
subject to change and will be promptly posted online
if any changes are necessary.)
For guidance in using the ARC's Research Application Tracking System (RATS),
please refer to the RATS
Desktop Guide,
Tutorial,
and
Frequently
Asked Questions.
If you are a new investigator and have not yet submitted a
protocol using RATS, a
sample protocol is available to help you become familiar with
the application format.
Questions?
Please contact the Office of Animal Research Oversight (OARO) at 310- 206-6308 or
oaro@research.ucla.edu
if you have any questions.
To determine your eligibility to serve as Principal
Investigator of a research protocol, please refer to UCLA
Policy 900 (Principal Investigator Eligibility) or contact OARO (310-206-6308). If the terms of Policy 900 are not met,
faculty sponsorship or principal investigatorship by a UCLA employee
with faculty appointment may be required.
Federal regulations require that the attending veterinarian or
his/her designee be consulted when planning studies that may cause
more than momentary of slight pain or distress to the animals.
Veterinarian consultation is also required when planning research or
procedural changes that may result in more than momentary or slight
pain or distress to animals. Please contact a DLAM
Veterinarian to schedule a consultation.
For most new, renewal, and continuation applications, as well as amendments with significant changes (e.g., experimental procedures, number of animals, method of euthanasia, animal species and/or strain, pain category), a Pre-Committee Review of your application prior to submission to the ARC is required. This
pre-review process is designed to address animal care issues and ensure
completeness of your application prior to Committee review.
Note!
A Pre-Committee Review is not required for the following types of applications:
- All applications requesting approval for experiments conducted entirely at another institution
- All applications requesting approval for
sharing
of animal tissues only
- Amendment applications requesting changes in Principal Investigator, Co-Investigator, personnel, funding, location, and/or protocol title only
Please
note that Pre-Committee Review must be completed and
subsequent modifications made to your application prior
to submission to the ARC. Early submission of your
application for Pre-Committee Review is therefore
strongly advised in order to meet the ARC submission
deadlines. If
recommended changes are not
incorporated into the application, the principal investigator
must provide explanations in the final application to be
submitted to the ARC. If Pre-Committee Review comments are not
incorporated or addressed in your application prior to submission to the
ARC, the protocol will not be reviewed by the Committee, and your
application will be returned to you.
To submit applications to for
Pre-Committee Review via RATS,
click on "Submit for Pre-Review" at the bottom of the menu.
Federal regulations allow for two types of review of animal use
protocols: Full Committee Review (FCR) and Designated Member
Review (DMR).Full Committee Review (FCR),
as its name suggests, involves review of an application at a convened
meeting with a quorum (majority of voting members) present. The
Committee has the authority to approve, require modifications to secure
approval, or withhold approval of an application. Any such decision is
based on a majority vote of the members present.
Designated Member Review (DMR): The DMR process is somewhat
more complicated. Briefly, a list of applications eligible for DMR is
distributed to all ARC members, and any member can call for FCR of any
application. If no member requests FCR, the Chair designates one or
more reviewers who have the authority to approve the application or
require modifications to secure approval. The Designated Reviewer does
not have the authority to withhold approval of an application;
any protocol with serious concerns must be presented to the Full
Committee for further discussion.
The DMR process is intended to allow the Committee to devote more
time during convened meetings to protocols warranting greater
discussion, such as proposals involving more invasive or more painful
procedures. Protocols that involve minimal potential for pain/distress
(e.g., euthanasia of animals for tissue harvest only) or that do not
involve substantial modifications (e.g., continuation applications with
no significant changes) are more likely to be reviewed through DMR.
However, review through DMR is no less thorough than review through FCR.
Committee members are notified of applications eligible for DMR once
per week. While this process can often allow a quicker turnaround time
than review via FCR, DMR is not the same as the "expedited
review" process permitted for review of certain human research
proposals. It is also important to note that assignment to DMR does not
guarantee that an application will not be referred to FCR.
Administrative Review: Amendment applications to existing
protocols that involve certain changes not considered significant (e.g.,
addition of a new funding source, changes in personnel, use of a new
vivarium housing location) can be reviewed administratively. Typically,
the turnaround time for applications undergoing administrative review
ranges from a few days to a week.
As always, please contact the Office of Animal Research Oversight (x66308) with your
questions or concerns about the review process, as well as appropriate
timelines for processing applications prior to grant deadlines or lapse
in ARC approval.
ARC policy mandates
that all personnel having direct contact with live
vertebrate animals must obtain ARC certification prior to
initiating work with laboratory animals.
-
UCLA
Medical History Questionnaire Form (MHQ)
The UCLA Medical History
Questionnaire for Investigators, Technicians, Students
and All Others Exposed to Laboratory Animals must be
completed by all investigators and personnel who are
listed in an ARC protocol. In accordance with University
Policy, completion of this form is mandatory for all
personnel having contact with research animals or animal tissues and all
personnel who have a security key card or key to enter
the vivarium. Please note that the MHQ must be
submitted on an ANNUAL basis.
Forms can be completed online at the above address. If you have
questions regarding the form, please contact OHF at (310) 825-6771.
In
lieu of submitting the Medical History Questionnaire (MHQ) form,
visitors may complete the MHQ Waiver
Form provided they: 1) are not UCLA faculty, staff or students and
2) will only have transient contact with animals or animal or human
tissue for a period of time not to exceed 3 days. All others
must complete the MHQ.
The
NIH
Guidelines for Research Involving Recombinant DNA Molecules requires
that all transgenic rodents used, housed, or constructed at UCLA be
registered with the UCLA Institutional Biosafety Committee (IBC).
Please
complete Appendix
D - Registration of Transgenic Animals and return it to:
Biosafety
Officer Rowelle Enriquez
Office of Environment, Health, and Safety (EH&S)
501 Westwood Plaza, 4th Floor
160508
These
applications will be reviewed by the Biosafety Officer and the IBC Chair
to determine if a full IBC review is required. Upon IBC approval,
a letter of approval will be issued to the principal investigator
indicating the biosafety level of containment required for housing and
handling the transgenic rodents.
The
VA/UCLA Memorandum of Understanding Regarding Care and Use of Laboratory
Animal Subjects describes the procedures for review of
UCLA-sponsored research studies conducted at the VA Greater Los Angeles
Heatlhcare System (VAGLAHS), and VA-sponsored research studies conducted
at UCLA.
Developed
by the National Institute of Allergy and Infectious Diseases (NIAID),
in conjunction with the NIH Office of Laboratory Animal Welfare (OLAW), this tutorial provides a step by step guide to the preparation of an application and covers such topics as considering alternatives, obtaining assurances and Institutional Animal Care and Use Committee (IACUC) approval, Just-In-Time processes, NIH review of animal subjects
applications, grant awards, IACUC monitoring of awards, and reporting requirements.
Although designed specifically for NIAID applicants, the information is
relevant to any investigator submitting an application to the NIH for an activity involving animals.
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