Current through all regulations passed and filed through September 16, 2024
(A)
Policy
statement
The university of Toledo "UT"
acknowledges and accepts responsibility for the care and use of animals
involved in all research and educational activities conducted within the
institution. UT will comply with all applicable provisions of the animal
welfare act and animal welfare regulations. UT abides by the public health
service "PHS" policy and United States government principles for the
utilization and care of vertebrae animals used in testing, research, and
training. UT has established and will maintain a program for activities
involving animals in accordance with the guide for the care and use of
laboratory animals "the Guide." UT also conforms to other applicable federal,
state, and local statutes and regulations relating to animal care and
use.
(B)
Purpose of policy
This policy summarizes UT requirements
for conducting research or educational activities involving the use of
animals.
(C)
Scope
This policy applies to all UT faculty,
students, research participants and staff using animals in research or
educational activities.
(D)
Definitions:
(1)
Animal facility - any room or area where UT laboratory
animals are housed for more than twelve continuous hours. The UT institutional
animal care and use committee "IACUC" requires that the care of all animals
(warm- and cold-blooded vertebrates and higher invertebrates, such as squid,
octopus, lobsters, and crabs) housed in UT animal facilities must be approved
by and remain under the oversight of that committee.
(2)
Department of
laboratory animal resources "DLAR" - DLAR is the principal department
responsible for animal research facilities, animal husbandry, and veterinary
care of animal research subjects.
(3)
Institutional
animal care program - UT has a centralized animal care program, with one IACUC,
United States department of agriculture "USDA" research facility registration,
office of laboratory animal welfare "OLAW" assurance, and association for
assessment and accreditation of laboratory animal care international "AAALAC"
accreditation that covers all UT faculty animal research activities regardless
of UT campus/location. The office of research and sponsored programs
administers the animal care program.
(4)
IACUC - The
university of Toledo has one IACUC which oversees all animal research
activities on all UT campuses and offsite locations. The IACUC will be properly
constituted according to the animal welfare regulations with UT faculty, staff
and at least one unaffiliated and one non-scientist member. UT may also choose
to utilize the services of an external IACUC at its discretion.
(5)
OLAW - the office
within the national institutes of health responsible for the administration and
oversight of federal policy on the use of animals in research.
(6)
Satellite
facility - an animal facility as defined in this paragraph located outside of a
DLAR facility and managed by a UT department/investigator. These facilities
must be reviewed and approved in advance by the IACUC. DLAR will oversee the
animal care activities and provide veterinary care to all satellite facilities.
Satellite facilities are inspected by the IACUC semi-annually and are included
in the post-approval monitoring program.
(7)
UT-related
research and instructional activities - research and instructional activities
conducted by or under the direction of UT faculty, students, and other
employees in connection with their university responsibilities either on- or
off-campus (including other states or countries) and all research and
instructional activities involving animals which utilize UT
facilities.
(E)
Lines of authority and responsibility: The lines of
authority and responsibility for administering the program and ensuring
compliance are as follows:
(1)
Institutional official
The vice president for research serves
as the institutional official "IO" with authority to legally commit UT
resources to meet federal regulatory guidelines. This authority is delegated by
the president of the university. The IO is responsible for appointing members
to the IACUC. The IO is the signatory authority for the public health service
"PHS" assurance.
(2)
Attending veterinarian
The attending veterinarian "AV" is a
voting member of the IACUC and has authority to implement the regulatory
requirements of the Public Health Service and Animal Welfare Act. The AV
provides veterinary care and protocol consultation. The AV works closely with
the principal investigator for animal care issues, especially if unexpected
complications arise from experimental procedures. In the case of a pressing
health problem, if the investigator is not available, or if the investigator
and the AV cannot reach consensus on treatment, the AV has the authority to
treat the animal, remove it from the experiment, institute appropriate measures
to relieve pain or distress, or perform euthanasia if necessary.
(3)
Research compliance
The IACUC administrator is responsible
for maintaining regulatory records and reports, participates in inspections,
and performs post-approval monitoring of IACUC protocols.
(D)
Compliance
(1)
UT has established an IACUC, appointed by the
institutional official, to implement the policies for protection of animals
used in research and education.
(2)
UT has an animal
welfare assurance on file with the national institutes of health "NIH" OLAW
covering all research, research training, experimentation, and biological
testing and related activities involving live, vertebrate animals and higher
invertebrates, such as squid, octopus, lobster, and crabs, and includes the
duties and procedures of the IACUC.
(3)
PHS/NIH
regulations and the UT animal welfare assurance require that all UT-related
research and instructional protocols which involve the use of animal subjects
must be approved by and remain under the oversight of the IACUC. All UT-related
research and instructional activities as described in paragraph (D)(2) of this
rule, involving animal subjects must receive prior UT IACUC review and approval
before any project can begin. In the case of customized antibody production
using animals by an outside company, investigators must assure that the company
has an active IACUC and an NIH animal welfare assurance. The office of research
and sponsored programs has information on this process.
UT-related research involving animal
subjects that occurs solely at another institution may not require prior UT
IACUC review and approval, but does require a formal memorandum of
understanding "MOU" between the institutions that addresses responsibilities
for animal care and use, ownership, and IACUC review and oversight. UT IACUC
review requirements are determined on a case-by-case basis.
(E)
Processes and procedures
The office of research and sponsored
programs is responsible for developing and maintaining processes and procedures
to implement this policy and for operating the UT animal care program in
accordance with all applicable federal regulations, in consultation with the
IACUC and DLAR.
(1)
The responsible party (a/k/a IACUC protocol principal
investigator) for UT-related research and instructional protocols submitted to
the IACUC for approval must be a salaried UT faculty member. The IACUC protocol
principal investigator must be in a position to provide direct, personal,
day-to-day oversight of activities and personnel associated with the IACUC
protocol. Any exceptions to the above criteria regarding the eligibility of an
individual to serve as the PI of an IACUC protocol must be approved by the vice
president for research.
(2)
The PI or a co-investigator on any research grant,
agreement or contract requiring IACUC approval must be the PI on the IACUC
protocol(s) supporting the work described in the research grant, agreement or
contract. In the case of a fellowship, the faculty sponsor/mentor for the
trainee applicant must be the PI on the regulatory protocol(s) supporting the
work described in the application, and the trainee applicant must be among the
authorized personnel on the same regulatory protocol(s).
(3)
The IACUC is
responsible to ensure that all animal activity for extramurally funded research
awards are congruent with active and approved IACUC protocol(s) and are
consistent with PHS policy on humane care and use of laboratory animals
(IV.C.l.) and OLAW animal welfare assurance. All procedures described in
extramural funding proposals must be approved in or amended to IACUC protocols
before any "just in time" documentation will be released or animal research
activities allowed. The PI is solely responsible for ensuring that all
procedures are approved at the appropriate time for all proposal applications.
The IACUC will only assess IACUC protocol congruency with proposed research
plans when notice of award is received or "just in time" documentation is
requested.
(4)
Prior approval must be granted by the IACUC for all
modifications to previously approved activities and addition of personnel.
Significant changes must be reviewed and approved by the IACUC. Significant
modifications, as identified by OLAW include but are not limited to changes: in
usage of potentially hazardous materials; in the objectives of a study;
proposal switch from non-survival to survival surgery; in the degree of
invasiveness of a procedure or discomfort to an animal; in species or in the
approximate number of animals used; in principal investigator involved in
animal procedures; and in anesthetic agent(s), the use or withholding of
analgesics, and methods of euthanasia. Additional factors may involve changes
in the duration, frequency, or number of procedures performed on an
animal.
(5)
Only laboratory personnel who have been approved by the
IACUC to work on a specific protocol may handle and perform the experimental
procedures on the animals covered by the protocol. All personnel who have
contact with animals are required to complete training and instruction
regarding humane animal research as required by the IACUC. Information on
training is provided by the DLAR.
(6)
All personnel
with expected animal contact are required to be enrolled in the occupational
health program for animal users as defined by the UT department of
environmental health and radiation safety.
(7)
Research animals
must be obtained from an appropriate source, such as commercial breeding
facilities or another university/institution. Obtaining animals from any other
source must be approved in advance by the IACUC. All animal orders must be
processed through DLAR in order to verify that there is an approved IACUC
protocol and reconcile inventory of the total number of approved animals with
the approved protocol. The UT office of technology transfer administers
material transfer agreements.
(8)
Any animal that
has been housed in UT animal care facilities cannot be guaranteed to be free of
any hazardous conditions or agents. Therefore, to assure protection of others
from such unknown conditions, the adoption or transfer of any such animal to
any private individual or non-research organization is not permitted without
prior documented approval of the IACUC.
(9)
In advance of
housing any animal at UT treated with hazardous substances, the PI must provide
written notification to UT DLAR that includes the name, dose, and dates during
which precautions must be taken for hazardous substances. All animals treated
with hazardous substances must be housed appropriately and signage with the
name of the substance (abbreviations are unacceptable) and the type of hazard
(e.g., carcinogen) must be posted.
(F)
Resources/references
Animal welfare act - 1966 animal
welfare act "AWA" and its amendments, codified at
7 U.S.C.
2131, et. seq. and C.F.R. title
9
https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa_awa/ct_awa_progra
m_information
https://www.aphis.usda.gov/animal_welfare/downloads/AC_BlueBook_AWA_FINAL_2017_508comp.pdf
Health research extension act of 1985
https://olaw.nih.gov/policies-laws/hrea-1985.htm
Public health service "PHS" policy on
humane care and use of laboratory animals (policy)
https://olaw.nih.gov/policies-laws/phs-policy.htm
National institutes of health "NIH"
office of laboratory animal welfare "OLAW"
http://grants1.nih.gov/grants/olaw/olaw.htm
U.S. government principles
https://olaw.nih.gov/policies-laws/gov-principles.htm
