Care and Use of Laboratory Animals
Date of Current Revision: February 2013
Primary Responsible Officer: Provost and Vice President for Academic Affairs
This policy provides the university community with procedures for the appropriate care and use of laboratory animals at the university.
The Board of Visitors has been authorized by the Commonwealth of Virginia to govern James Madison University. See Code of Virginia section 23-164.6; 23-9.2:3. The board has delegated the authority to manage the university to the president.
STATE OR FEDERAL STATUTE AND/OR REGULATION
In compliance with the Public Health Service (PHS) policy, "The chief executive officer shall appoint an Institutional Animal Care and Use Committee, qualified through the experience and expertise of its members to oversee the institution's animal program, facilities and procedures."
Any live, vertebrate animal used or intended for use in biological testing, experimentation, or instructional, research, research training or related purposes.
Any and all areas, buildings, enclosures, rooms or vehicles, including satellite facilities used for animal confinement, breeding, experiments inclusive of surgical manipulation, maintenance or transport. A satellite facility is any containment outside of a core facility or a centrally designated or managed area in which animals are housed for more than 24 hours.
Animal Welfare Act:
Title 9, Code of Federal Regulations (CFR), Chapter 1, Subchapter A, Parts 1 - 4. Public Law 89-544, 1966, as amended, (P.L. 91-579, P.L. 94-279 and P.L. 99-198) 7 U.S.C. 2131 etc. seq. Administered by the U.S. Department of Agriculture (USDA).
Animal Welfare Assurance or Assurance:
The documentation from an institution assuring institutional compliance with the PHS policy, Appendix B of the Guide.
Guide for the Care and Use of Laboratory Animals, Author: National Research Council. Publisher: National Academies Press, ISBN-10: 0-309-15400-6 2011 edition or succeeding revised editions.
Institutional Animal Care and Use Committee
An individual who has the authority to sign the university's Assurance, making a commitment on behalf of the university that the requirements of the Public Health Service policy will be met.
Public Health Service or PHS:
The Public Health Service includes the Alcohol, Drug Abuse and Mental Health Administration; the Centers for Disease Control; the Food and Drug Administration; the Health Resources and Services Administration; the National Institutes of Health; and the Office of the Assistant Secretary for Health, Department of Health and Human Services.
Standard Operating Procedures (SOPs):
A list of procedures that govern the operation of an animal care facility on campus to assure the health and welfare of all animals used in research, teaching or both.
According to the Assurance of Compliance with PHS Policy on the Humane Care and Use of Laboratory Animals, it is the responsibility of the university to provide direction and oversight for the use and care of live vertebrate animals in the conduct of scholarly research or other academic activities.
The policy applies to all student/faculty research and teaching whether funded from external or internal sources.
It is university policy that the care, housing, use and procurement of animals should conform to the National Research Council Guide for the Care and Use of Laboratory Animals or succeeding editions and other relevant federal policies and procedures.
6.1 Institutional Animal Care and Use Committee or IACUC
Membership or Composition - Described in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. http://grants.nih.gov/grants/olaw/references/phspol.htm See IACUC Membership Requirements at the following URL: http://grants.nih.gov/grants/olaw/tutorial/iacuc.htm
The IACUC will consist of not fewer than five members who shall include the following:
- A doctor of veterinary medicine with training in laboratory animal science and medicine, who has direct or delegated authority and responsibility for activities involving animals at the institution.
- A member whose primary concern is a nonscientific area
- A practicing scientist experienced in research involving the use and care of animals
- One individual not affiliated with the university other than as a member of this committee
6.2 Categories of Animal Use Subject to Review
The IACUC reviews all classroom and research projects involving the use of living non-human vertebrate animals to ensure the humane care and use of animals including, but not limited to the following:
- Classroom exercises, demonstrations and lab projects
- Faculty or staff research projects (including those that are funded)
- Graduate student projects
- Undergraduate student honor projects
- University-approved research by investigators not affiliated with the university who propose to involve university students, staff or faculty members as part of a proposed research project
6.3 Criteria Used for Review of Proposals
The JMU IACUC in its review of proposed animal use protocols involving animals will determine that the proposed activity meets the following requirements as spelled out in JMU's institutional assurance to the U.S. Public Health Service Office of Laboratory Animal Welfare:
- Procedures involving animals must be designed and performed with due consideration of their relevance to human or animal physical or mental health, the advancement of knowledge, or the good of society.
- Animals selected for a procedure must be of an appropriate species and quality, and the number of animals used must be the minimum required to obtain valid results. Alternate approaches such as mathematical models, computer simulation and in vitro biological systems should be considered whenever possible.
- Consistent with sound research design, procedures with animals must avoid or minimize discomfort, distress and pain to the animals.
- Procedures that may cause more than momentary or slight pain or distress to the animals must be performed with appropriate analgesia, anesthesia or sedation; animals to undergo surgery or other painful procedures must always be properly anesthetized. Any variation from this requirement must be justified for scientific reasons in writing and must be reviewed and approved by the IACUC.
- Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved must be painlessly sacrificed at the end of the procedure or, if appropriate, during the procedure.
- Multiple major surgical procedures on the same animal are discouraged and may be justified only when the procedures are related components of a research protocol. Such multiple surgical procedures require written justification and IACUC approval; approval will not be granted on the basis of cost savings alone.
- The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding and non-medical care of animals will be directed by a scientist trained and experienced in the proper care, handling and use of the species being maintained or studied.
- Medical care for animals will be available and provided as necessary by a qualified veterinarian.
- Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
- All animals must be held in IACU-inspected and -approved facilities. Surgical procedures must be performed only in facilities that have been approved by the IACUC for that purpose.
- Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association Panel on Euthanasia. Any variation from this requirement must be justified for scientific reasons in writing and must be reviewed and approved by the IACUC.
6.4 Procedures for Submitting Proposed Animal Use Protocols to the IACUC
- Submit an electronic copy and forward one signed original of the completed protocol package - Attachment A (including the description of the methodology involving animals and abstract) to the Office of Sponsored Programs for review, approval and distribution. The electronic version can be submitted at: http://www.jmu.edu/sponsprog/iacucsubmit.html or e-mailed to firstname.lastname@example.org.
- Protocols will not be accepted for review unless the hard copy of the protocol cover page provided to the Office of Sponsored Programs contains signatures of the instructor or principal investigator, each co-investigator named and the appropriate director or unit head.
- Protocols to be reviewed should be received by the IACUC not less than 30 days prior to the date approval is required.
- IACUC approval must be received before starting the project.
- On approval, commencement and expiration dates will be assigned for the project, and a copy of the Action of the Board Form will be returned to the principal investigator or instructor.
Post-Approval IACUC Procedures
- Application approval will be valid for a maximum of three years.
- The principal investigator or instructor will contact the IACUC chairperson annually to verify the status of the project.
- If no significant change in the protocol has occurred, approval may be extended for a year.
- Amendments will be filed for minor and major changes during the approval year.
- Any significant change in the protocol requires a new application and approval.
- Approval will be canceled for discontinued projects.
- Significant departure from the original protocol requires prior approval from the IACUC.
6.5 Statement of Concern/Complaint Concerns about animal abuse or infractions of animal care and user regulations, use the following chain of command to report the situation:
Should circumstances exist that prevent the use or implementation of this chain of command, concerns may be directed to the IACUC chairperson or a member of IACUC. Concerned parties may file a report to research compliance at http://www.jmu.edu/sponsprog/research_compliance_reports.html.
In grievous matters, the university, after verification of the report and the situation, will take appropriate actions to ensure the humane care and use of animals and will report the matter to the appropriate authorities. No committee member, facility employee, laboratory personnel or student shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standard in accordance with Misconduct in Research and other Scholarly Work, Policy No. 2205.
6.6. All animal care facilities (vivaria) will follow the SOPs that apply to their particular species. These SOPs are posted on the IACUC website at http://www.jmu.edu/sponsprog/iacuc_sops.html.
6.7 This policy will be posted inside the vivarium for use by any person reporting an animal care and use issue.
7.1 The IACUC reviews research applications proposing the use of vertebrate animals to ensure that the described care and use of animals are in compliance with federal rules and regulations and university policy. The IACUC is responsible for the following:
- Reviewing the institution's program for the humane care and use of animals at least once every six months using the Guide as a basis for evaluation.
- Inspecting all of the institution's animal facilities at least once every six months using the Guide as a basis for evaluation.
- Preparing reports of IACUC evaluations as set forth in the PHS policy and submitting the reports to the provost/institutional official.
- Reviewing concerns involving the care and use of animals at the institution.
- Making written recommendations to the provost/institutional official regarding any aspect of the institution's animal program, facilities or personnel training.
The provost/institutional official will apprise the appropriate university offices of the committee's recommendations and concerns. In addition, the provost/institutional official will provide the Office of Facilities Planning with an up-to-date list of approved animal facilities and a separate list of facilities where vertebrate animal research is currently taking place.
- Reviewing and approve, require modifications (to secure approval or withhold approval) of those activities related to the care and use of animals as set forth in the PHS policy.
- Reviewing and approving, require modifications in (to secure approval or withhold approval) proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS policy.
- Notifying investigators and the university in writing of its decision to approve or withhold approval of those activities related to the care and use of animals or of modifications required to secure IACUC approval as set forth in the PHS policy.
- Authorizing the suspension of an activity involving animals as set forth in the PHS policy.
- Overseeing lawful procurement of vertebrate animals.
- Reviewing and approving all new, continuing or revised protocols involving use of animals in university-supported and/or externally funded research or instructional activities.
- Overseeing adherence to the SOPs.
7.2 The principal investigator or instructor is responsible for the following:
- Submitting a properly executed application for Use of Animals in Research and Teaching for each project to the Office of Sponsored Programs, the administrative arm for IACUC. The protocol will be distributed for review and approval to the IACUC. No work may commence until IACUC approval has been obtained.
- Ensuring that all animals are obtained lawfully.
- Ensuring that arrangements are made for obtaining any special permits necessary for the acquisition of certain exotic, wild and restricted species.
- Ensuring that personnel are adequately trained in the care, handling and restraining of all animals used in relevant experimental procedures.
- Establishing proper procedures in their laboratory or study area for all aspects of animal care and use such as anesthesia, postoperative care, preoperative care, sampling techniques and euthanasia, as well as disposing of animal carcasses and waste. The principal investigator or instructor is not responsible for the physical removal of animal carcasses and waste. However, the principal investigator or instructor is responsible for implementing procedures for preparation of wastes according to the Guide for collection and disposal. Waste disposal will be collected and disposed of in a safe and sanitary manner under the auspices of the Environmental Health Coordinator.
- Ensuring that instructions to laboratory personnel are implemented, including the health-care program.
- Ensuring that aseptic surgery is performed in a facility designed in accordance with the recommendations in the Guide for the Care and Use of Laboratory Animals 2011 or succeeding editions).
- Ensuring that procedures are in compliance with all campus policies, including regulations concerning the use of agents such as radionuclides, biohazardous agents, etc., as well as those involving the use of vertebrate animals. Experimentation with such agents may require registration with or approval by other campus committees or offices.
- Laboratory animals are not allowed outside the approved laboratory facility for more than 12 hours.
- Major amendments to protocol require IACUC review.
- Examples of major amendments include:
- Change in purpose or specific aim of study
- Change of principal investigator
- Change of species
- Addition of species
- 10% or more increase in animal numbers over the number approved on the initial protocol and any subsequent committee reviewed amendments
- Addition of a survival surgery
- Addition of a painful procedure
- Unanticipated marked increase in clinical signs or proportion of animal deaths
- Addition or change of anesthetic or analgesic agent or a change in dosage
- Examples of major amendments include:
- Minor amendments are processed through the IACUC office as administrative changes.
- Minor amendments include:
- Changes to contact information of the PI or study personnel
- Changes to training updates of the PI or study personnel
- Addition or deletion of study personnel
- Addition of faculty collaborator
- Addition of another strain of the same species
- Change of sex in the animal to be used
- <10% increase in animal numbers over the number approved on the initial protocol and any subsequent committee reviewed amendments
- Addition of sample collection times (if not exceeding standard limits - with veterinary consult as needed)
- Additional non-invasive sampling (if not exceeding standard limits - with veterinary consult as needed)
- Reducing or eliminating previously approved water or feed restrictions
- Addition of or change in dosage of an experimental drug in the same class as one previously approved
- Addition or deletion of animal usage location
- Minor amendments include:
Sanctions will be commensurate with the severity and/or frequency of the offense and may include termination of employment.
The authority to interpret this policy rests with the president and is generally delegated to the Provost and Senior Vice President for Academic Affairs.
Approved by the President: November 2002
Previous Version: November 2002