I: Background and Purpose
The UCR IACUC oversees
and evaluates all aspects of animal care and use. All animal
research at UCR requires an IACUC-approved animal use protocol (AUP)
that has been reviewed by the IACUC to ensure
that the criteria
described in the PHS Policy1, the Animal Welfare
Regulations (AWRs) 2,
and the Guide for the Care and Use of
Laboratory Animals (Guide)3 are met. In its review of proposals,
the IACUC’s primary responsibility is to ensure animal welfare, while
facilitating compliance with applicable laws, regulations, and policies
consistent with the performance of appropriate and productive scientific
endeavors.
This policy describes the submission and review process
for new protocols, 3-year reviews, and amendments (revisions) to existing
protocols.
II: Related policies
529-225: Custom Antibody Production Using Animals at Off-Campus Facilities
529-271: Authority of the Attending
Veterinarian
Definitions
Term
|
Definition
|
Amendment
|
Any
change to an IACUC approved protocol
|
AUP
|
Animal Use
Protocol
|
FCR
|
Full
Committee Review
|
DMR
|
Designated Member Review
|
AA
|
Administrative Approval
|
VVC
|
Veterinary Verification and
Consultation
|
1.
All vertebrate
animal use in research or teaching at UC Riverside must be included in an
approved AUP, including the use of animals
in field research, breeding programs, or use of animals in the classroom or
non-classroom instruction. Purely observational studies (animals and their environment are neither manipulated nor intentionally disturbed by the researcher or
at the request of the researcher) do not require review or approval.
2.
Protocols are automatically reviewed by Full Committee Review
(FCR) when the protocol
or amendment involves any of the following criteria:
a. Pain category E procedures (unrelieved pain or
distress).
b.
Procedures that introduce a new, higher-level pain category.
c.
Major survival surgery
or addition of a survival
procedure to a previously non- survival protocol.
d.
Prolonged and unusual
physical restraint of unanesthetized animals
(a restraint that lasts longer than 15 minutes should be considered
“prolonged restraint.” However, the
length of time that could lead to distress in an animal will vary depending on
the species, type of restraint used, activities performed on the animal, etc.).
e.
Fluid/food regulation (fasting prior to surgery or other procedures
that require a period of < 24 hours
without access to food or water is not considered fluid/food regulation.)
g.
Request for an exception to any UCR IACUC
Policy or the Guide for the Care and Use of Laboratory Animals (NRC,
2011).
h.
Use of a neuromuscular blocking agent.
3.
Any change to a protocol
must be submitted
as an amendment to an AUP. Amendments are processed by Full Committee Review (FCR), Designated Member
Review (DMR), Veterinary Verification and Consultation (VVC), or administrative
approval (AA), depending on the nature of the proposed revision. All review
procedures are described in Section V.
4.
No member may participate in the IACUC review or approval of an
activity in which that member has
a conflicting interest (e.g., is personally involved in the activity) except to
provide information requested by the IACUC, nor will a member who has a
conflicting interest contribute to the constitution of a quorum,
in accordance with federal regulations.
5.
An IACUC quorum
is a majority of the total number
of voting members
of the IACUC. A majority
vote of the quorum present at a convened meeting is required to conduct AUP
reviews and IACUC business. No proposed changes may be implemented until the
amendment is approved by the IACUC.
IV: Submission and Pre-review
All AUPs are submitted
electronically to the IACUC Office using Kuali. Approval of an AUP is for
three
years.
After
which,
a
renewal
is
submitted.
All
three-year
renewals
and
new
AUPs
must
undergo a pre-review. The pre-review is performed by the Campus Veterinarian
(CV) and members of the IACUC Office. During the pre-review, comments are made,
and modifications
may
be
requested.
Once
addressed,
the
pre-review
is
completed,
and
the
protocol
is
prepared
for IACUC review.
Amendments to AUPs do not require
a pre-review unless:
1. the changes require the AUP to be reviewed
by FCR as outlined in section III.2
2. addition of another animal species
3. addition of a procedure
that may increase
pain and distress
as determined by the CV
Hazard Review
Use of hazardous agents
(controlled substances, infectious agents, carcinogens, toxic
chemicals, noxious gases including volatile anesthetics, radioisotope
materials, tumor cells, and tissues, sera, or other biologics that may contain
infectious agents) in laboratory animals will be reviewed by the appropriate
Environmental Health and Safety (EH&S) officer. This review can occur
during the pre-review or IACUC review stage.
V: Protocol Review Process
There are only two valid methods
of IACUC review allowed by PHS Policy and the Animal Welfare Regulations: (1) full-committee review (FCR) by a convened
quorum of the members of the IACUC, or (2) designated member
review (DMR) by one or more members.
FCR takes
place at a convened meeting
with at least
a quorum of the members
present. For each AUP, the IACUC has the authority to
approve, require modifications (to secure approval), withhold approval, or
defer until a future meeting. Determination of the outcome is by a simple
majority of the members present.
DMR may only be utilized
after all members have been provided the opportunity to call for full-
committee review. The IACUC members have three (3) business days to review a
submitted AUP to call for FCR. If any member requests
FCR, that method
must be used. If not, the IACUC Chair appoints one or more qualified
IACUC members to serve as the designated reviewer(s). Designated review may result in
approval, a requirement for modifications (to secure approval), or referral to
the full committee for review. Designated review may not result in withholding
of approval. If modifications to the protocol are required in order to secure
approval, the AUP is returned to the PI to incorporate those modifications into the protocol
and resubmit for review by the DMR.
DMR after FCR: In cases where an AUP has undergone review at a Full Committee meeting, but the IACUC requires
modifications in order to approve,
OLAW has provided
the following guidance, with
which the USDA concurs:
All IACUC members agree in writing
in advance that the quorum
of members present
at the FCR meeting may decide by unanimous vote to use DMR after FCR
when modifications are needed to secure approval. However, any member of the
IACUC may, at any time, request to see the revised protocol or amendment and/or
request FCR for the protocol or amendment.
·
“In advance” means that this policy
must be approved
by the IACUC prior to the first meeting at which it is used.
·
“In writing” means that the
policy and procedures must be written down and
documented in the IACUC’s permanent
records (e.g., IACUC meeting minutes)
as having been established by
unanimous agreement of all Committee members. Members are not required to
physically sign the policy.
·
New IACUC members will be trained
in the process, but do not have to endorse
the Policy for it to remain in effect.
3-Year (triennial) Review:
Per PHS Policy, a complete de novo review
of each current IACUC protocol is required once every three years. Notices are sent to investigators
regarding an upcoming expiration. Notices clearly convey to investigators that
federal regulations do not allow protocol extension. At the triennial review, PIs of ongoing projects
are required to submit
a renewal to their AUP. No vertebrate animal activities are allowed beyond
expiration unless an AUP renewal has been reviewed and
approved.
VI:
Amendments to AUPs
Any modification to a protocol must
be submitted by the PI electronically as an amendment/revision to the AUP. The proposed
changes may not be implemented until the
amendment/revision is approved by the IACUC.
Modifications to an approved
AUP will be processed by FCR, DMR, Veterinary Verification and Consultation (VVC), or administrative approval, depending on
the nature of the proposed revision. The IACUC Office will review the proposed
revision and classify it as “significant” or “minor” based on the following
criteria:
1.
Significant changes that must be approved
by one of the valid IACUC approval
methods (DMR or FCR), include changes:
a.
from non-survival to survival surgery;
b.
resulting in greater pain, distress, or degree of
invasiveness;
c.
in housing and or use of animals at a location
that is not part of the animal program overseen by the IACUC;
d.
in species;
e.
in study objectives;
f.
in Principal Investigator (PI); and
g.
that impact personnel safety.
2.
Certain significant changes may be handled administratively according to IACUC-
reviewed and -approved policies in consultation with a veterinarian authorized
by the IACUC (VVC). Consultation with the veterinarian must be documented. The veterinarian may refer any
request to the IACUC for review for any reason and must refer any request that does not meet the parameters
of the IACUC-reviewed and -approved policies. VVC may be used for:
a. Changes to anesthesia, analgesia, or sedation.
b.
Addition or replacement of a euthanasia method that is acceptable (or
conditionally acceptable when those conditions are met) according to the AVMA Guidelines for theEuthanasia of
Animals.
c. Addition of medication related
to veterinary health
(e.g., antibiotics).
3.
A significant change
that may be handled administratively without additional consultation or notification,
according to this IACUC-reviewed and -approved policy, is an increase of not
more than 10% in previously approved animal numbers.
4.
Minor changes that may be handled administratively without IACUC-approved policies, consultations, or
notifications include:
a.
Correction of typographical errors.
b.
Correction of grammar.
c.
Contact information updates.
d.
Change in personnel other than the PI (there
will be an administrative review to
ensure that all such personnel are appropriately identified, adequately trained
and qualified, enrolled in occupational health and safety programs, and meet
other criteria as required by the IACUC).
e.
Addition/change of a funding
source.
f.
Removal of a proposed experiment from a protocol.
g.
Addition of a housing or procedure room that has been previously approved by the IACUC;
h.
Addition of a genetic strain
that does not have clinical
manifestations that require veterinary oversight or special
husbandry procedures.
VII: Protocol
and amendment withdrawals
Protocols and amendments will be considered withdrawn by the PI when:
•
The PI requests the withdrawal of the AUP or amendment in writing.
•
One year after the last response from the PI.
•
Amendments will be considered withdrawn when the associated AUP expires.
VIII: References
1.
Public Health Service, Policy on Humane Care and Use of Laboratory
Animals, Office of Laboratory Animal Welfare,
National Institutes of Health, U.S. Department of Health and Human Services, Bethesda, MD.
2.
Animal Welfare Act Regulations 9 CFR §2.31
3.
National Research
Council. 2011. Guide for the Care and Use of Laboratory Animals: Eighth Edition. Washington, DC
4.
The National Academies Press AVMA Guidelines for the Euthanasia of Animals (most current edition).
5.
NIH Guide Notice
NOT-OD-14-126 (https://grants.nih.gov/grants/guide/notice-files/not-od-14-126.html)
6.
OLAW Webpage Significant Changes (https://olaw.nih.gov/guidance/significant-changes.htm)
7.
Frequently Asked Questions (FAQs) on PHS Policy, http://grants.nih.gov/grants/olaw/faqs.htm#641, Protocol Review,
FAQ D19, “May an
IACUC use designated member review (DMR) to review an animal study protocol
subsequent to full committee review (FCR) when modifications are needed to
secure approval?”
Approved: 12/16/2019; 9/20/2021; Reviewed: 7/10/23; Revised:
05/12/2025