Operating Policy and Procedure
HSC OP: 73.03, Animal Care and Use Program
PURPOSE: The purpose of this Health Sciences Center Operating Policy and Procedure (HSC OP) is to provide a framework for voluntary compliance with state and federal laws with regard to use of animals in research.
REVIEW: This HSC OP will be reviewed in June of each odd-numbered year by the Institutional Veterinarian and the IACUC Chair, with recommendations for revisions forwarded to the Senior Vice President for Research (SVPR) who serves as the Institutional Official.
POLICY/PROCEDURE:
1. Definitions.
a. Animal Care and Use Program. The Animal Care and Use Program (ACUP) is defined as the policies, procedures, standards, organizational structure, staffing, facilities, funding and practices put into place by an institution to achieve the humane care and use of animals throughout the institution. The ACUP comprises all activities conducted by and at an institution that have direct impact on the well-being of animals. This includes animal and veterinary care, policies and procedures, personnel and program management and oversight, occupational health and safety, the IACUC functions, and animal facility design and management.
b. Institutional Official (IO). The individual who, as a member of senior administration, bears ultimate responsibility for the Animal Care and Use Program (ACUP) and is responsible for resource planning and ensuring alignment of ACUP goals with the mission of the Institution. The IO signs the institution’s Public Health Service Assurance statement. The IO shall report to the President. The Senior Vice President for Research (SVPR) currently serves as the IO.
c. Institutional Animal Care and Use Committee (IACUC). The Institutional Animal Care and Use Committee or IACUC is established by the IO for the President for assessment and oversight of TTUHSC’s Animal Care and Use Program, components, and facilities. The Chair of the IACUC shall be designated by and report to the Institutional Official.
d. Institutional Attending Veterinarian (IVet). The Institutional Attending Veterinarian is the individual responsible for the health and well-being of all animals used in the TTUHSC Animal Care and Use Program. The IVet directly oversees all aspects of animal care and use to ensure compliance with Federal, State, and Local laws and regulations as well as contemporary Standards of Veterinary Care. The IVet also provides input on new animal facility design, renovations of existing animal facilities, and planning for institutional needs.
2. Compliance with laws and policies.
a. All activities must be in accordance with the Public Health Service (PHS) Assurance # D16-00032.
b. Applicable local, state, and federal laws. All TTUHSC activities involving animals must be in accordance with local, state, and federal laws and regulations applicable to the care and use of animals. These laws include, but are not limited to the Animal Welfare Act; federal regulations implementing the Animal Welfare Act; the Health Research Extension Act of 1985; the U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research and Training; the Public Health Services Policy on the Humane Care and Use of Laboratory Animals; and the provisions and principles set forth in the most recent editions of the Guide for Care and Use of Laboratory Animals.
c. Applicable TTUHSC policies and procedures. All TTUHSC activities involving animals must follow all applicable TTUHSC policies and procedures.
3. Obligations of the Administration and university members.
a. Administrative support. It is the responsibility of the President, the Institutional Official, the IACUC, the IVet, to support and protect the officially sanctioned use of animals in research, and teaching at the TTUHSC.
b. Administrative procedures. The President, in consultation with the Senior Vice President for Research (SVPR), the IACUC, and the IVet shall adopt appropriate administrative policies and procedures to implement this policy. The President, through the IO will ensure the IVet has sufficient authority to carry out assigned duties to include the authority to immediately halt any activity, in his or her professional opinion, that negatively effects animal health or welfare (Authority of the Institutional Attending Veterinarian).
c. TTUHSC personnel. University faculty, staff, students, visiting Professors, volunteers, and others involved in the care and use of animals shall:
i. Be appropriately qualified, trained, or supervised for conducting IACUC-approved procedures on animals;
ii. Receive and participate in adequate in-service training including the proper and humane care and use of laboratory animals;
iii. Abide by and carry out the decisions of the IACUC and the IVet.
iv. Permit IACUC personnel to inspect labs, records and data from ongoing activities to ensure regulatory compliance.
v. As appropriate, consider serving on related committees such as the IACUC, the IBC, the IRB and the LARC Advisory Committee.
4. Institutional Official.
a. Appointment of the Institutional Official. The President shall appoint the SVPR as the Institutional Official to oversee all aspects of TTUHSC's animal care and use program.
b. Authorities of the Institutional Official. The President shall delegate the authorities necessary to carry out the responsibilities identified in subdivision c. to the Institutional Official.
c. Responsibilities of the Institutional Official. The Institutional Official shall:
i. Ensure that the IACUC, IVet, and the LARC have sufficient financial, administrative, and other such resources to execute an Animal Care and Use Program that meets current industry standards of animal care and facility maintenance.
ii. Assist the IACUC and IVet in planning for the needs of the TTUHSC to fulfill its research and teaching mission.
iii. Ensure compliance with applicable laws and policies identified in Section 2;
iv. Appoint IACUC Chair and other committee members;
v. Develop in consultation with IACUC and the Institutional Veterinarian administrative policies and procedures for review and possible adoption by the President which are necessary to implement this policy;
vi. Implement this policy with the assistance of the President, the IACUC, and the IVet through the Laboratory Animal Resource Center (voluntary compliance);
vii. Perform all necessary regulatory reporting requirements;
viii. Report to the appropriate federal governmental and TTUHSC officials any serious or continuing noncompliance with the laws and policies identified in Section 2 and any corrective action taken;
ix. May subject protocols that have been approved by the IACUC to further review or denial, but may not approve an activity that has not been approved by the IACUC;
x. Commit TTUHSC to meet the requirements of the PHS policy and the Animal Welfare Act;
xi. Ensure that the institution has an Attending Veterinarian who provides adequate veterinary care to its animals in compliance with federal, state, and local laws, policies and guidelines.
5. Animal Care and Use Committee.
a. Establishment of Animal Care and Use Committee. The President, through the Institutional Official shall establish and maintain an Institutional Animal Care and Use Committee. All campuses will function under PHS Assurance #D16-00032.
b. Membership. In accordance with Federal guidelines, the IACUC shall consist of at least five members with diverse backgrounds and expertise, one of whom comes from a community external to TTUHSC. The other members of the IACUC consist of at least a Veterinarian experienced with laboratory animals, a practicing scientist experienced in research involving animals, and a member whose primary concerns are in a nonscientific area. Administrative support for the IACUC shall be provided by Research Integrity Office staff.
c. Responsibilities. The IACUC shall:
i. Review and approve all proposed activities involving animals prior to the start of the activity;
ii. Conduct post-approval monitoring of ongoing activities involving animals.
iii. Conduct semi-annual inspections of facilities where animals are being housed and utilized;
iv. Provide a mechanism for anonymous reporting of animal welfare concerns and investigate all complaints of welfare concerns and protocol noncompliance;
v. Report any serious or continuing noncompliance with federal, state, or TTUHSC laws, policies, or procedures to the Institutional Official; and
vi. Report any corrective actions taken in response to noncompliance to the Institutional Official.
d. Determinations. The IACUC shall review and approve, require modifications in, or withhold approval of all TTUHSC activities involving animals in accordance with TTUHSC policy, local, state, and federal regulation and guidelines.
e. Authorities. The IACUC has the authority to:
i. Inspect all facilities utilized for the care and use of animals;
ii. Review and evaluate TTUHSC's Animal Care and Use Program;
iii. Obtain records and other relevant information related to the use of animals;
iv. Take any actions, including suspending an activity, that are in its judgment necessary to ensure compliance with applicable Local, Federal, State laws, or TTUHSC policies and procedures.
f. Principles of animal research. In performing its duties, the IACUC shall adhere to the following recognized principles:
i. Procedures involving animals will be designed and performed with due consideration of their relevance to:
1. Human or animal health
2. The advancement of knowledge, or
3. The good of society; and
ii. The proper use of animals requires the avoidance or elimination of pain and the minimization of discomfort and distress which requires sound research design.
6. Institutional Attending Veterinarian (IVet).
a. The President shall, through the SVPR designate an Institutional Veterinarian to establish and maintain a specific program to provide Veterinary services and research support through the Laboratory Animal Resources Center as defined in subdivision c.
b. Responsibilities: The Institutional Veterinarian has direct responsibility for the health and well-being of all animals used in teaching and research at TTUHSC. The IVet shall serve as the primary Attending Veterinary Clinician. The Institutional Attending Veterinarian or his designee shall serve on the IACUC and work closely with the IACUC Chair to meet programmatic goals.
c. The Laboratory Animal Resources Centers (LARC) will be directed and supervised by the Institutional Attending Veterinarian. The IVet has the authority to stop animal use, if in his/her professional opinion, sufficient animal welfare concerns exist.
d. The LARC shall provide the following services:
i. Husbandry programs including animal procurement/transportation, species-specific housing, biosecurity, and vivarium space management.
ii. Veterinary Medical services including disease detection, prevention, and treatment; consultation and assistance in anesthesia, analgesia, surgery, post-operative care, protocol-related health issues, euthanasia.
iii. Training for faculty, staff, and students in appropriate animal handling, procedural and surgical technique, and reproductive biology/breeding as needed.
iv. Expert consultation on the selection, care, and use of animals used in TTUHSC research.
v. Expert consultation on facility planning for the space and equipment needs of TTUHSC based on number and type species maintained and expected growth thereof.
vi. Consultation with Safety Services regarding animal and employee safety and Occupational Health as needed to consistently comply with all required regulations and to maintain desired accreditations.