|Enforcement official||Associate Vice President for Research |
Associate Director Research Compliance
|Classification||Board of Trustees-delegated Policy|
|Category||17. Research and Intellectual Property|
Statement of policy
Western Michigan University is committed to the highest standard of treatment and care of our animals* with the best possible care and thorough oversight by adhering to standards and regulations promulgated under the Animal Welfare Act, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the Guide for the Care and Use of Laboratory Animals; Guide for the Care and Use of Agricultural Animals in Research and Teaching; and other federal and state applicable regulations.
The Western Michigan University Institutional Animal Care and Use Committee (IACUC) oversees the animal care and use program at WMU. This policy establishes an Animal Care and Use Program (ACUP) to assure that the health and well-being of all animals being used for research, teaching and testing are a top priority. The privilege of using animals for instruction and research is considered with the utmost seriousness and investigators do not use animals for research unnecessarily. Prior to using animals for research, researchers must first search for alternatives, justify the use and seek approval for each and every research project involving animals. Careful consideration is given to the 3 Rs—reduction, replacement, and refinement by each investigator.
Western Michigan University recognizes the value in scientific and medical knowledge developed through animal research and the contribution this research has made that benefit both humans and animals (i.e., vaccine development, improved treatments for diseases, diagnostic tests, etc.) while acknowledging and respecting the views of others and being responsive and responsible in dealing with this subject.
*The term animal as used here includes any (nonhuman) vertebrate animal.
Summary of contents/major changes
Significant revisions to align with regulations.
1. Purpose of policy
This purpose of this policy is to assure all animals utilized by Western Michigan University researchers and instructors will receive proper care and humane treatment by conducting activities in accordance with all relevant federal, state and local laws, regulations, and guidelines governing the humane care of animals used in research, teaching, and testing activities. This policy outlines the principles that govern the humane conduct of animal-based activities and sets forth the means by which the University complies with applicable rules and regulations. This policy further stipulates the duties and responsibilities to ensure all animal facilities and programs are maintained at high ethical standards for animal care and use, and are operated in accordance with applicable legal requirements.
Mistreatment of any animal under Western Michigan University's care will not be tolerated.
2. Stakeholders most impacted by the policy
This policy applies to all personnel (employees, faculty, students, research staff, contractors, collaborators, other University affiliates) who use animals for research, teaching, or testing activities conducted under the auspices of Western Michigan University whether conducted on campus or at a satellite facility.
This policy applies to all situations which involve the use of animals for research, teaching and testing at Western Michigan University regardless of the particular college or university division in which the animals are used or the source of funding involved. This policy applies to all funded or unfunded activities using animals for research, teaching, or testing.
3. Key Definitions
3.1 Animal: Any live vertebrate (nonhuman) animal, or any other animal designated by applicable law, used or intended for use in basic or applied scientific investigations (e.g., traditional biomedical, agricultural, wildlife, or aquatic research), testing, the production of biological materials, or educational activities.
3.2 Animal Care and Use Program (ACUP): The animal care and use program refers to all the components that exist in support of the University’s activities involving animals. These components include the policies, procedures, standards, staffing, facilities, employees, researchers, equipment, animals, and practices put into place by the University to achieve the humane care and use of animals in the laboratory and throughout the University.
3.3 Attending Veterinarian (AV): The attending veterinarian is the individual with primary authority to execute the duties inherent in assuring the adequacy of veterinary care and overseeing other aspects of animal care and use, including quarantine, stabilization, clinical care and management, husbandry and disease surveillance.
3.4 Humane Care: Humane care means those actions taken to ensure that laboratory animals are treated according to high ethical and scientific standards.
3.5 Institutional Animal Care and Use Committee (IACUC): The IACUC is appointed by the President of the University or his or her designee, and derives its authority from the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the Animal Welfare Act and the Health Research Extension Act. The IACUC is qualified through the experience and expertise of its members to oversee the University’s animal program, facilities, and procedures in accordance with the applicable legal requirements.
3.6 Institutional Oﬃcial (IO): The President of the University appoints the institutional oﬃcial. The IACUC reports to the IO, who has the administrative and operational authority to commit institutional resources to ensure compliance with legal requirements which govern the University’s ACUP.
3.7 Principal Investigator: A principal investigator (PI) is the lead researcher/scientist for a particular well-defined science, or other academic project who takes direct responsibility for completion of a funded or unfunded project, directing the research, and reporting directly to IACUC, sponsor, or others as required.
4. Full policy details
The implementation of this policy is centered in the Office of the Vice President for Research and includes effective leadership in and collaboration among the three federally mandated components; the IO, AV, and the IACUC. The following outlines the roles, authorities, and responsibilities for the Animal Care and Use Program at Western Michigan University.
The IO for the university’s Animal Care and Use Program is appointed by the President of Western Michigan University. The IO bears the ultimate responsibility for the Program, although overall Program direction should be a shared responsibility among the IO, AV, and IACUC. The IO has the responsibility and authority for:
- 4.1.1. Resource planning and ensuring alignment of Program goals of quality animal care and use with the institution’s mission
- 4.1.2. Communicating the importance of animal welfare across Western Michigan University
- 4.1.3. Assuming the obligations of the Assurance for the Animal Care and Use Program on behalf of Western Michigan University
- 4.1.4. Supporting implementation of Program decisions and taking administrative actions to facilitate compliance
- 4.1.5. Allocating and distributing resources as necessary to ensure the Program’s overall effectiveness.
- 4.1.6. Appointing individuals to the IACUC and ensuring that these individuals are protected from coercion or undue influence while serving in this capacity
- 4.1.7. Appointing a Chair and Vice-Chair to provide leadership to the IACUC
- 4.1.8. Ensuring the Attending Veterinarian has the proper authority and resources to meet his/her responsibilities to the ACUP
- 4.1.9. Serving as a point of contact for OLAW, USDA, and other federal agencies sponsoring and overseeing animal use and providing required ACUP reports to these agencies
- 4.1.10. Communicating with and advising other senior administrative officials on ACUP issues as necessary
4.2. Institutional Animal Care and Use Committee
The IACUC has the responsibility for the assessment and oversight of the Institution’s Program components and facilities. The IACUC is comprised of at least 5 members 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.
To fulfill its oversight responsibilities, the IACUC has the responsibility and authority to:
- 4.2.1. Review and approve, require modifications to secure approval, or disapprove proposed animal use (protocol review) and significant changes to animal use. IACUC approval must be received before the use of animals for research, teaching, or testing can commence.
- 4.2.3. Conduct regular inspections of facilities and animal use area
- 4.2.4. Review the overall Program and assess animal care and use
- 4.2.5. Establish a mechanism for receipt and review of concerns involving the care and use of animals at the Institution
- 4.2.6. Evaluate ethical merit as it relates to the welfare and use of the animals
- 4.2.7. 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
- 4.2.8. Establish protocol and amendment review processes as described by federal regulations and guidance
- 4.2.9. Develop policies for the use of animals at Western Michigan University
- 4.2.10. Solicit input from stakeholders in the ACUP regarding ACUP operations
- 4.2.11. Make written recommendations to the IO regarding any aspect of the Program
- 4.2.12. Ensure that an occupational health and safety program is in place for individuals working with or regularly exposed to animals
- 4.2.13. Verify that IACUC activities are compliant with regulatory requirements and WMU policies (records retention and disposal)
Note: Proposals approved by the IACUC may be subject to further appropriate review and approval by officials of the Institution. However, no individual or official of the university may approve a project involving the use of animals for research, teaching, or testing (i.e., authorize it to proceed) that has not been reviewed and approved by the IACUC. The IACUC’s decision-making must be independent from coercion or undue influence.
4.3. Attending Veterinarian
The Attending Veterinarian is responsible for the health and well-being of all laboratory animals used at the institution. The AV is appointed by the IO and has expertise or training in laboratory animal medicine or in the use of the species at the institution. The AV is supported by additional veterinarians, as needed, with expertise in the species being used and has the responsibility and authority for:
- 4.3.1. Managing the program of veterinary care, environmental enrichment, and zoonotic disease prevention
- 4.3.2. Overseeing other aspects of animal care and use such as husbandry and housing to ensure that the ACUP complies with the regulations
- 4.3.3. Providing guidance and oversight to surgery programs and perioperative care and assisting the IACUC in determining that personnel performing surgical procedures are appropriately qualified and trained
- 4.3.4. Staying abreast of current regulatory requirements as it relates to the ACUP at Western Michigan University
- 4.3.5. Serving as the point of authority on regulatory interpretation for veterinary and animal husbandry regulations, and animal facility inspections for external agencies.
- 4.3.6. Communicating program issues including facility problems, regulatory updates and ACUP trends to the IACUC and the IO
- 4.3.7. Providing veterinary consultation during protocol development for procedures that may cause more than momentary or slight pain or distress to animals
- 4.3.8. Helping to ensure animals are not used for multiple major surgeries without IACUC approval.
- 4.3.9. Assisting institutional health officials to establish and monitor an occupational health program including biohazard control policies/procedures for ACUP activities and personnel
4.4. Principal Investigator Responsibilities
Primary responsibility for research with animals is vested in the PI who is conducting a study. This includes responsibility to comply with the laws, regulations, and institutional policies that regulate research. Others engaged in the conduct of the research such as co-investigators and research staff share this responsibility.
The following are eligible to serve as PI:
- Tenured/tenure track faculty
- Faculty specialists
- Full time professional staff on permanent appointment with WMU who have appropriate credentials (less than full time permanent appointment at the discretion of the WMU IACUC)
- Research Scientist (at the discretion of the WMU IACUC)
- Emeritus Faculty (with department appointment and at the discretion of the WMU IACUC).
Students may not serve as the principal investigator on an animal research study.
Part-time faculty, adjuncts, research associates, visiting professors, and visiting scholars are not eligible to serve as the principal investigator; however, they may serve as a Co-Investigator on an animal research study.
Investigators who utilize animals in their research, teaching and testing, have the following responsibilities:
- 4.4.1. Obtain IACUC approval prior to conducting animal use activities
- 4.4.2. Ensure that all personnel involved in animal use are listed on the applicable IACUC protocol prior to initiating work with animals
- 4.4.3. Ensure all personnel listed on the protocol have completed the IACUC required training prior to initiating work with animals.
- 4.4.4. Train all personnel in their laboratory and assure they are familiar with the conduct of activities as described in the IACUC protocol
- 4.4.5. Promote proper animal care and handling of animals in their studies
- 4.4.6. Ensure protocols are renewed prior to expiration of study when continuing beyond the one year approval date and resubmitting protocol if continuing research more than three years.
- 4.4.7. Submit all changes to the protocol to the IACUC for approval prior to implementation.
4.5. Office of Research Compliance
The Office of the Vice President for Research (OVPR) provides oversight for all animal research, teaching, and testing conducted at Western Michigan University. The Office of Research Compliance, an administrative unit of OVPR has responsibility for the development of overall research policies and operating procedures and for providing advice and assistance to college research administrators in the development of research programs within the colleges.
Research Compliance Office has the following responsibilities:
- 4.5.1. Receipt and screening of protocols submitted for IACUC review that involve the use of animals for teaching, testing, or research
- 4.5.2. Verifying that the principal investigator proposing the project is eligible to serve in the capacity of principal investigator and that all compliance-related requirements (e.g., COI disclosure, IACUC required training) have been met
- 4.5.3. Recommending full committee or designated member review of protocols to the IACUC Chair
- 4.5.4. Providing administrative support to the IACUC by keeping investigators and others informed of IACUC decisions and performing all other IACUC-related recordkeeping and administrative processing
- 4.5.5.Gathering and maintaining information related to exceptions to the Guide and AWA for inclusion in regulatory reports and advising IACUC on best practices related to regulatory requirements for IACUC administrative function.
- 4.5.6. Notifying investigators of expired/terminated/suspended protocols and facilitating corrective actions (e.g., protocol renewal, closure)
- 4.5.7. Serves as the point of authority on IACUC protocol review processes
- 4.5.8. Facilitating post-approval monitoring, USDA inspections, and Semiannual Inspections
- 4.5.9. Assisting in the IACUC’s investigation of ACUP findings or concerns
- 4.5.10. Preparing regulatory reports and agency notifications (e.g., noncompliance) per IACUC direction to appropriate institutional officials, OLAW, and other federal agencies as required
- 4.5.11. Maintaining IACUC records per the university’s “WMU Record Retention Guide” and arranging for inspection or provision of records as legally required
- 4.5.12. Providing administrative support to the Institutional Biosafety Committee (IBC), which is an ancillary component of the ACUP
- 4.5.13. Developing overall research policies, operating procedures, and guidance
- 4.5.14. Providing advice and assistance to researchers and research administrators in the development of research programs and protocols
- 4.5.15. Partnering with IACUC, researchers, and administrators to provide educational opportunities to assure the university is compliant with federal, state, and local laws and regulations and university policies governing animal care and use
- 4.5.16. Ensuring, with assistance from the animal facility manager, a Disaster Plan is in place and responsible personnel are familiar with the plan
4.6. Research Facility Manager:
Dedicated animal housing facilities support the ACUP by providing resources to facilitate research, teaching, and testing. The Research Facility Manager has the following responsibilities:
- 4.6.1. Developing and implementing training for institutional staff in the care and use of animals at Western Michigan University
- 4.6.2. Verifying the number of animals approved and used on IACUC approved protocols is accurate, and providing this information in regulatory reports
- 4.6.3. Facilitating transfer of animals from expired or terminated protocol to another approved protocol, as applicable
- 4.6.4. Managing the daily care of animals and operating the university’s animal housing facilities in compliance with regulatory requirements
- 4.6.5. Notifying the IACUC if facility conditions fall outside the regulatory requirements and animal health may be impacted
- 4.6.6. Notifying the AV staff when veterinary care is needed
- 4.6.7. Providing enrichment and social housing to all animals unless exempted by the principal investigator and protocol.
- 4.6.8. Ensuring that husbandry personnel comply with the requirements for protocol personnel in terms of training requirements and occupation health and safety risk assessments
- 4.6.9. Assessing the performance of environmental monitoring systems if present on a regular basis to ensure functionality
4.7. Occupational Health and Safety Program (OHSP)
The WMU Administration, the WMU Office of the Vice President for Research with the support of Environmental Health and Safety, shall establish safety policies, and procedures for work with animals. Providing a safe working environment for employees is the responsibility of all university administrators, supervisors and staff. The Office of Laboratory Animal Welfare also states that the safety of the staff is the responsibility of the Institutional Animal Care and Use Committee.
The OHSP program is jointly administered by the Office of the Vice President for Research (OVPR), Environmental Health and Safety (EHS), and Sindecuse Health Center.
- 4.7.1. OVPR is responsible for:
- 18.104.22.168. Training researchers using the facility as part of the animal care and use training.
- 22.214.171.124. Providing information on zoonotic diseases to which employees may be exposed
- 126.96.36.199. Autoclaving contaminated animals and animal waste
- 188.8.131.52. Arranging for pick up and disposal of animals and animal waste
- 4.7.2. EHS is responsible for:
- 184.108.40.206. Evaluating the occupational risk for animal users as needed
- 220.127.116.11. Conducting Hazard Assessment reviews for all Principal Investigator’s using hazardous agents as part of an IACUC protocol
- 18.104.22.168. Developing hazard information forms to be posted at the lab, housing or procedure space for the duration of the hazard
- 4.7.3. Sindecuse Health Services is responsible for:
- 22.214.171.124. Evaluating employees whose exposure or history presents a potential occupational risk
- 126.96.36.199. Providing ongoing care and assessments to personnel according to the “Health & Safety Program for Animal Handlers.”
4.8. Training Requirement for Use of Animals in Research or Teaching
All WMU personnel (faculty, staff and students) who use animals in their research or teaching are required to complete the IACUC training program. Researchers must also complete any specific courses relevant to their research prior to the start of the project.
4.9. Radioactive Materials
All animal-related research with radioactive material must be conducted in accordance with the University’s Radiation Safety Policy and procedures and under the auspices of the Radiation Safety Officer (RSO).
At a minimum, all faculty, staff, students, employees and collaborating researchers who want to work with radioactive material or radiation-producing machines must complete radiation safety training. To arrange training, contact the Radiation Safety Officer.
All animal-related research with hazardous microbial agents and/or their products must be conducted in accordance with the University’s’ Microbiological Safety and Security Policy and procedures and under the auspices of the Biosafety Officer (BSO).
All research involving recombinant or synthetic DNA must be conducted in according with the University’s Recombinant or Synthetic DNA Biosafety Policy and procedures under the auspices of the Institutional Biosafety Committee (IBC).
4.11. Animal Care and Use Program will consist of:
- 4.11.1. Procedures, guidelines, and practices to ensure all WMU research is conducted in compliance with laws and regulations governing the use of animals in research, teaching and testing and University policies.
- 4.11.2. Documentation necessary to demonstrate compliance with the use of animals in research, teaching and testing laws and regulations.
- 4.11.3. Defined process(es) for the timely review of submitted requests for the use of animals in research, teaching and testing.
- 4.11.4. Process for post approval monitoring to assure research, teaching and testing is being conducted as approved by the IACUC.
- 4.11.5. A process for record keeping and auditing (internal and external).
4.12. Animal Facility:
- 4.12.1. Animal Facility Access: Access shall be limited to principal investigators with protocols that are currently approved, authorized personnel named in IACUC approved protocols, members of the IACUC and others such as maintenance and custodial personnel as approved by the IACUC. Access requires a valid, Western Michigan University photograph identification card. The authorization of personnel will be reviewed as deemed necessary by the facility manager, associate vice president for research, associate director research compliance and/or the Department of Public Safety. A principal investigator desiring to add or remove personnel must submit a written amendment to the IACUC requesting changes to an approved protocol. The post approval change request must be reviewed and approved by the IACUC prior to implementation. Upon approval of the change, the facility manager will be notified and access granted.
- 4.12.2. Visitors: All visitors to the facility must be approved by the Office of the Vice President for Research, the IACUC, or the facility manager. Minors are not permitted in the facility.
5. Accountability and Consequences of Non-Compliance
It is the responsibility of faculty and administrators to be aware of and comply with the regulations and laws relative to their work, students assisting them in their work or research, agreements and collaborations with others, who may use animals for research, teaching, or testing.
Potential violations of federal, state, or local laws and regulations or the Western Michigan University animal policy will be considered by the IACUC. Actions will be taken according to the nature, severity, duration, and repetitiveness of the offense. Violations of this policy may result in disciplinary actions in accordance with the University policies, applicable collective bargaining agreements, and other relevant policies.
The IACUC has the authority to suspend or terminate a research, teaching, or testing activity if it determines that the activity cannot be brought into compliance with existing laws or policies. Disciplinary action may include loss of privileges in the use of animals in research, teaching, or testing activities. Deficiencies in animal care and use could result in mandatory reporting to the governing federal agency.
Additional consequences for non-compliance include possible individual disciplinary procedures for failure to follow applicable University policies and requirements.
5.1. This policy shall be reviewed no less than every three years.
5.2. Reasons to review/revise earlier include changes in regulations or program requirements.
6. Additional Information
7. Related procedures and guidelines
Animal Welfare Assurance
Institutional Care ans Use committee Standard Operating Procedures
Occupation Health & Safety Program for Animal Handlers
Protocol submission forms can be found on the OVPR webpage at http://www.wmich.edu/research/forms
|Effective date of current version||May 7, 2019|
|Date first adopted||November 17, 1987|
|Revision history|| |
Friday, January 1, 1988 - 10:37 Revised
|Proposed date of next review||May 1, 2022|
|Certified by|| |
Terri Goss Kinzy, Vice President of Research
|At the direction of|| |
Terri Goss Kinzy, Vice President of Research