3-71 Animal Subject Research

• Effective date of this revision: August 31, 2023
• Contact for more information: Office of Research Compliance,  Institutional Animal Care and Use Committee

I. BACKGROUND

Central Michigan University (CMU) has provided a formal guarantee to the Public Health Service, Office of Laboratory Animal Welfare that it will adhere to mandated procedures to assure all regulations are followed for appropriate care and use of all animals involved in research, research training, and biological testing activities (PHS Animal Welfare Assurance D16-00580). CMU is also registered with the USDA and complies with the Animal Welfare Act and Health Research Extension Act for using animal subjects.   This policy will be executed by the CMU Animal Care and Use Program (ACUP) for vertebrate animals. 

The ACUP encompasses the research, testing and teaching activities conducted by and at the Institution that have a direct impact on the well-being of animals, including animal and veterinary care, policies and procedures, personnel and program management and oversight, occupational health and safety, Institutional Animal Care and Use Committee (IACUC) functions, and animal facility design and management. The ACUP is further detailed in the PHS Animal Welfare Assurance and ACUP Description. 

In order to comply with the regulations for the care and use of animals in research, CMU has established an IACUC to review all research involving the use of vertebrate animals and to implement institutional policy regarding such research. The IACUC is responsible for oversight of the ACUP as described in the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) and the Guide for the Care and Use of Laboratory Animals. The IACUC, composed of faculty and staff from a variety of disciplines plus community members, is directly responsible to the Vice President for Research and Innovation as the Institutional Official (IO).

II. PURPOSE 

It is the policy of CMU to promote the proper care and use of animals in activities conducted on behalf of the university by adhering to the Guide for the Care and Use of Laboratory Animals (Guide); Animal Welfare Act and Regulations (AWARs); PHS Policy; Guide for the Care and Use of Agricultural Animals in Research and Teaching (Ag. Guide); and other applicable regulations. 

III. DEFINITIONS 

Animal: For the purposes of this policy, animals are defined as all vertebrate animals. 

Institutional Official: The IO for the ACUP is the Vice President for Research and Innovation. The IO will have overall responsibility under this Policy for CMU’s IACUC/ACUP. 

IV. POLICY

All research involving the use of animals conducted by CMU faculty, staff or students, or sponsored in part or in whole by CMU, must be reviewed and approved prior to the start of research, and conducted in full compliance with IACUC policies and procedures.

It is the responsibility of the principal investigator to ensure that appropriate ethical principles are adhered to in the conduct of research involving animal subjects. The principal investigator is responsible for the ethical treatment, and prevention of negligent treatment, of animal subjects by collaborators, assistants, students, or employees, who are assisting with the research. 

V. PROCEDURES 

A. Program Management Responsibility and Authority 

Effective leadership in and collaboration among the three federally mandated components, IO, Attending Veterinarian (AV), and the IACUC, requires communication of activities between these components as well as other support units in the ACUP as necessary to ensure efficient ACUP operation. 

B. Institutional Official

The IO has the responsibility and authority for: 

1. Compliance with all CMU policies and all applicable regulations related to the ACUP
2. The signatory authority for the PHS Assurance to the Office of Laboratory Animal Welfare
3. Allocating the necessary resources needed to ensure the overall effectiveness of the ACUP The IO has the authority to delegate these duties as needed.

The IO bears the ultimate responsibility for the ACUP, although overall program direction should be a shared responsibility among the IO, AV, and IACUC. 

C. Institutional Animal Care and Use Committee

To conduct its responsibility effectively, CMU maintains an IACUC to review research protocols involving animal subjects and to provide oversight of the ACUP and its components. 

The IACUC is an autonomous body composed of a minimum of five members appointed by the IO that meet specific criteria described in federal regulations, including an individual with scientific experience, a veterinarian with designated program responsibilities, a non-scientist and a non-affiliated individual representing community interests. (AWARs, PHS Policy) 

The IACUC’s decision-making must be independent from coercion or undue influence. No officials of the institution may approve animal subjects use (i.e., authorize it to proceed) that has not been approved by the IACUC. Research involving animal subjects may not commence until all institutional approvals are obtained (e.g., space and research support confirmation with animal facility management). 

The IACUC has the responsibility and authority to: 

1. Review and approve, require modifications to secure approval, or disapprove all proposed animal use (protocol review) and significant changes to animal use, to include the ethical merit of animal welfare.
2. Suspend or terminate approval of activities not being conducted in accordance with the IACUC’s requirements or that has been associated with unexpected serious harm to animals.
3. Review the ACUP and conduct facility inspections semiannually and report all review results to the IO.
   
4. Conduct post approval monitoring, at minimum annually, to confirm congruence of research activities to the approved IACUC protocol and federal regulations and guidelines that govern research.
5. Make written recommendations to the IO regarding any aspect of the ACUP.

D. Attending Veterinarian

The AV is responsible for the health and well-being of all laboratory animals used at CMU. The AV is appointed by the IO. The AV is supported by a clinical veterinarian with expertise in the species being used. The AV is responsible for:

1. In conjunction with the IACUC, overseeing all aspects of the ACUP to include the husbandry and housing of animals to ensure that the ACUP complies with all CMU policies, and other regulations and guidelines (e.g., Guide and PHS Policy).
2. Communicating program issues including facility problems, regulatory updates, and ACUP trends to the IACUC and the IO.
3. Providing veterinary consultation during protocol development to include procedures that may cause more than momentary or slight pain or distress to animals.

E. Principal Investigator Responsibilities 

Principal Investigators who utilize animals in their research or teaching have the following responsibilities:

1. Ensure that all personnel involved in animal use are listed on applicable IACUC protocols prior to initiating work with animals.
2. All personnel in their laboratory are trained in and familiar with the conduct of activities as described in the IACUC protocol.
3. Promote proper animal care and handling of animals in their studies.

VI. OTHER

The IACUC has jurisdiction over all animal subject research conducted under the auspices of CMU, regardless of funding source or performance site. Research conducted under the auspices of CMU includes research:

1. Conducted at CMU.
2. Conducted by or under the direction of any CMU employee or agent (including students) in connection with their institutional responsibilities.
3. Conducted by or under the direction of any CMU employee or agent (including students) using any property or facility of CMU.
4. Involving the use of any CMU non-public information.

CMU may review any research protocol and reserves the right to terminate the implementation of a research protocol that has been approved by the IACUC, if in the opinion of CMU said research protocol would place its animal subjects, university, or community at undue risk. CMU may not, however, approve the implementation of any research protocol that has been rejected by the IACUC, nor may CMU override the decision of the IACUC to withhold approval for a research protocol.

The IO, IACUC, and AV adopts policies and procedures to implement this Policy. These shall serve as the governing procedures for the conduct and review of all CMU’s animal subject research.

Central Michigan University reserves the right to make exceptions to, modify or eliminate this policy and or its content. This document supersedes all previous policies, procedures or guidelines relative to this subject.