Johns Hopkins Animal Care and Use: Committee Functions

Introduction
Federal regulations mandate that the Chief Executive Officer appoint an institutional animal care and use committee (IACUC). The IACUC is qualified through the experience and expertise of its membership to provide guidance and oversee the Johns Hopkins University’s animal care and use program and to maintain compliance with applicable laws, regulations and policies. The committee must have a chairman, a veterinarian with training and/or experience in laboratory animal science and medicine who has direct or delegated program responsibility, an experienced scientist, a non-scientist and an unaffiliated individual representing the public. The Institutional Official, the Vice Provost for Research, legally commits that Johns Hopkins University meets the requirements of the Animal Welfare Act (AWA) and Public Health Service (PHS) policy.

IACUC oversight functions

Semi-annual evaluation of the animal care program
Semi-annual inspection of facilities
Report to Institutional Official and the Office of Laboratory Animal Welfare (OLAW)
Advise on the animal care program, facilities and personnel training
Review animal use protocols
Review animal welfare concerns
Empowered to suspend animal activity in event of non-compliance

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Semiannual Program Reviews and Facility Inspections
The IACUC conducts thorough semiannual program review and animal facility inspections using the standards in the Guide for the Care and Use of Laboratory Animals (Guide).

Program review involves assessment of:

Institutional policies and responsibilities
IACUC membership and functions
IACUC record keeping and reporting procedures
Adequacy and appropriateness of the veterinary medical care program and study records
Training program for personnel
Occupational health and safety program.

Facility Inspection

Buildings, rooms, areas, enclosures and vehicles used for animal confinement, transport, maintenance, breeding, experiments and surgery.

Report program evaluation and facility inspection results including recommendations, plans and schedules for correcting minor or significant deficiencies to the Institutional Official.
Significant deficiencies are or may be a threat to animal health or safety.
Personnel Qualifications and Training
Principal Investigators must ensure that individuals listed in their animal use protocol are familiar with all procedures they will perform. Failure to provide evidence of acceptable level of competence in performing procedures is grounds for refusing to approve use of animals. The IACUC seminar series discusses various aspects of animal care and use at Johns Hopkins University. In addition, the IACUC maintains a collection of materials supporting animal care and use for investigator use. The Department of Comparative Medicine offers seminars and courses in laboratory animal biology, husbandry, diseases, facilities management and research techniques. Comparative Medicine library has a wide range of books, journals and audiovisual materials on different animal species available to investigators and personnel at Johns Hopkins University.

All individuals working with animals at Johns Hopkins University should be familiar with the handbook Use of Experimental Animals at Johns Hopkins University. This handbook describes the laboratory animal program within Johns Hopkins University, provides a list of contacts, dosages of commonly used drugs, anesthetics, analgesics and tranquilizers and a list of useful publications.

The NIH Office of Animal Care and Use and the Veterans Administration have excellent on-line training sites, which you are strongly encouraged to visit. Additional resources are available from the Animal Welfare Information Center (AWIC), the American Association for Laboratory Animal Science (AALAS), and the Institute for Laboratory Animal Research.

Animal Facilities and Husbandry
Johns Hopkins University animal facilities are maintained to promote animal well being, the quality of research, teaching or testing programs in which animals are used, and health and safety of personnel. Facilities are inspected daily by the veterinary staff on a rotating basis, every six months by the IACUC and unannounced by USDA Animal Care Inspectors.

We pay special emphasis to:

Daily observation and care of animals, including weekends and holidays.
Husbandry including food, water, bedding, sanitation, waste disposal and pest control.
Animal identification, genetic monitoring and animal health records.
Physical and social environment of the animals.
Facility location, components, construction, management and operation.
Veterinary Care
Our veterinary and animal care staff needs access to all animals for evaluation of their health and well being in order to provide quality care. We have a preventive medicine program in place to ensure freedom from and control of infectious disease. Our veterinarians provide emergency weekend and holiday care to treat diseases and injuries.

Federal regulations require consultation with a veterinarian during planning of an animal activity. Pre-surgical planning, training, monitoring, and post-surgical care consultations are available (410-955-3273). Our assurance requires the practice of relief from pain and timely euthanasia. All drugs must be stored and maintained appropriately. Controlled drugs and supporting records must be stored securely according to Drug Enforcement Agency requirements. Expired drugs must be clearly labeled, separated from in date drugs and discarded.

The attending veterinarian has the authority to implement the veterinary care program, and to oversee the adequacy of all other aspects of animal care and use including but not limited to animal husbandry, nutrition, sanitation practices, zoonoses control and hazard containment. Animal Resources (410-955-3713) ensures that appropriate animal husbandry facilities, personnel, equipment and services are available. They have also developed guidelines for animal procurement and transportation.

Occupational Health and Safety
Johns Hopkins University is concerned about the safety and welfare of its faculty, staff and students. We are committed to alerting individuals to potential work-related health risks and counseling them on methods to avoid workplace hazards through a comprehensive occupational health and safety program.

Principal investigators are responsible for ensuring that all individuals working under their supervision have a safe working environment and are educated of the potential hazards associated with their jobs. Individuals who have direct contact with animals, living tissues, body fluids, wastes or living quarters are required to participate in the Animal Exposure Surveillance Program.

Individuals working with laboratory animals are exposed to hazards and potential risk of developing allergy to laboratory animals, physical and/or chemical injury, exposure to biological agents that can be transmitted between animals and humans (zoonotic agents). People with impaired immune function may be at increased risk from hazards associated with animal care and use. Moreover, a large number of workplace chemicals, physical and biologic agents can damage the reproductive systems of both male and female workers, resulting in infertility, spontaneous abortion, developmental impairment or death in an embryo, fetus or child. UC Davis has an excellent description of the risks associated with use of animals. Occupational Health and Safety in the Care and Use of Research Animals (1997), Institute of Laboratory Animal Research, National Research Council and Biosafety in Microbiological and Biomedical Laboratories provide extensive information and references. Hazardous materials require approval by the Health, Safety and Environment (410-955-5918) before use in animal facilities. Investigators using hazardous materials are required to advise the Facility Manager and animal caretakers of the use of these materials in animals and the appropriate precautions to be taken during the care of these animals.

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Addressing Animal Welfare Concerns
The IACUC has a mandate to evaluate concerns, raised by anyone, regarding the care and use of animals at Johns Hopkins. If you suspect mistreatment of animals or noncompliance please contact the IACUC or the Training and Compliance Administrator at 443-287-3742 or 443-287-3738. All such complaints will be treated in strict confidence by the IACUC. The AWA protects the rights of individuals reporting such acts and prohibits discrimination against or reprisal for reporting violations of regulations or standards under the AWA. Concerns may also be reported through 1-877-WE-COMPLY (1-877-932-6675).

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Reports the IACUC is required to provide
The IACUC in fulfilling its oversight role is required to:

Provide a written report of the animal protocol review to the investigator.
Report findings of the semi-annual program review and evaluation including plans and schedules for correction to the Institutional Official.
Annual reports of the animal care and use program including status of compliance with regulations to regulatory agencies. Serious noncompliance and suspension of animal activity require prompt reporting.
Make recommendations to the Institutional Official regarding any aspect of the facility's animal use program, facilities, training program and occupational health program.
Maintain minutes of IACUC meetings, including records of attendance, protocol reviews, activities of the Committee, Committee deliberations, a copy of approved institutional assurance to the public health service and records of accrediting body determination.
Submit results of investigation of animal welfare concerns to the Institutional Official.
Reports should include any minority views filed by IACUC members.

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Protocol Review
Federal regulations require an approved animal use protocol before any animal activity can be initiated. The Johns Hopkins University IACUC reviews animal use protocols regardless of where the study is done. Individuals using tissues or sera do not need a protocol unless access to the tissues or sera result in the death or manipulation of an animal. The IACUC reviews proposed research projects or proposed significant changes in ongoing research projects. Significant changes include objectives of a study, from non-survival to survival surgery, invasiveness of a procedure or discomfort to an animal, species or approximate number of animals used, principal investigator, anesthetic agent(s), the use or withholding of analgesics and method of euthanasia. Ongoing protocols are reviewed at least once every year. IACUC review is performed to determine that animal activities are or will be carried in accordance with the AWA, PHS policy, the Guide and the Johns Hopkins University’s assurance, unless acceptable justification for a departure is presented. Performing activities involving animals without an approved animal use protocol is a violation of Federal Law and University Policy, and may result in criminal and civil penalties.

Animal use protocol forms submitted for IACUC approval must be filled out appropriately to avoid delay of approval. Protocols must be written such that the general public can understand the information.

The IACUC has the authority to approve, require modifications before approval or disapprove proposed activity. The decision of the IACUC will be communicated to the investigator in writing. Appeals of IACUC decision can only be made to the IACUC. Once approved the information contained in the protocol submission may become available to the public under the Freedom of Information Act.

To secure approval and to comply with Federal regulations the principal investigator the protocols should completely address the following issues:

Relevance of the proposed study to human or animal health, the advancement of knowledge or the good of the society
Why animals are needed in the study.
Adequacy of the species, quality and quantity of animals requested for study.
Proper husbandry and veterinary care for the animals.
Ways to minimize pain and distress including alternatives to potentially painful and distressful procedures.
Complete description of all procedures to be performed, including use of aseptic techniques during surgery, pre and post-operative monitoring and pain relief.
Humane endpoints and appropriate euthanasia.
Training, qualifications and experience of all individuals involved in the study.
Consideration for safety of individuals and animals involved in the study.
Statement that the study does not unnecessarily duplicate previous studies.

Applications and proposals approved by the IACUC may be subject to further review and approval by officials at Johns Hopkins University. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC. Once the protocol is approved, the principal investigator is contractually responsible for ensuring only activities that were approved are carried out and that the protocol is current and active while activities are taking place. It is a violation of Federal regulations to carry out activities that are not approved or maintain animals following expiration of a previously approved protocol. Such a violation can result in severe sanctions for the university and the investigator.

Major survival surgery
AWA regulations require that survival surgeries be performed using aseptic techniques; and in non-rodent species the procedure must be done in a dedicated surgical facility. Investigators performing survival surgery must identify where this will take place. Individuals performing these procedures must be appropriately trained to perform them. Survival surgery can either be major or minor.

Major survival surgery penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic functions. Minor survival surgery does not expose a major body cavity and causes little or no physical impairment. Federal regulations permit only one major survival surgery, except when scientifically justified and approved by the IACUC, required as a routine veterinary procedure to protect the health or well being of the animal as determined by the attending veterinarian or approved by the Administrator of the Animal and Plant Health Inspection Service (USDA). Animals surviving a major surgical procedure should be identified to prevent them from undergoing a second major survival procedure.

Food and fluid restriction
For studies requiring food and/or fluid restriction, at least the minimum quantity of food and fluid necessary for development of young animals and maintaining long term well being of all animals should be available. Such restrictions should be scientifically justified, include a program to monitor physiologic and behavioral indices and criteria for temporary or permanent removal from the study.

Pain and distress
Painful procedure in animals means any procedure resulting pain in excess of that caused by injections or other minor procedures. Currently there is no definition for distress, however, USDA has proposed the following working definition: ‘A state in which an animal can not escape from, or adapt to, the external or internal stressors or conditions it experiences, resulting in negative effects upon its well-being.’

The AWA and the United States Government Principles for the Utilization and Care of Vertebrate Animals in Testing, Research, and Teaching prohibit the use of paralytic agents during surgery or other painful procedures in un-anesthetized animals.

Animals exhibiting signs of pain, discomfort, or distress such as decreased appetite and/or activity level, adverse reactions to touching inoculated areas, open sores or necrotic skin lesions, abscesses, lameness, conjunctivitis, corneal edema, and photophobia are expected to receive appropriate relief unless written scientific justification is provided in the animal activity proposal and approved by the IACUC.

Alternatives
The AWA requires the principal investigator to consider alternatives to procedures that may cause pain or distress to animals and to provide a written narrative of the methods used and sources consulted to determine the availability of alternatives. Alternatives should address replacement, reduction and refinement (3Rs) without compromising research results. Consider alternatives during planning of the animal use proposal. If a bona fide alternative method is identified, the written narrative should justify why this alternative was not used. The narrative enables IACUC to assess that a reasonable and good faith effort was made to determine availability of alternatives or alternative methods. The following sources provide a wealth of information on alternatives to pain and distress: ALTWEB, the Johns Hopkins Center for Alternatives to Animal Testing (CAAT), AWIC (an information service of the National Agricultural Library), University of California Center for Animal Alternatives, NORINA, FRAME, and Statistical Tools.

Records
Records must be current, legible and comprehensive in order to demonstrate delivery of adequate care and convey necessary information to all parties involved in animal care. Records should include at least:

Identity of the animal
Procedures performed on the animal including dates
Descriptions of illness, injury, distress, and/or behavioral abnormalities and resolution of the problem
Dates, details and results of all medically related observations, examinations, tests, and procedures
Dates and details of treatments, including name, dose, route, frequency and duration of treatment with drugs or medications
Treatments should include diagnosis and prognosis (when appropriate), type, frequency and duration of treatment, criteria and/or schedule for re-examination by a veterinarian as well as the veterinarian's recommendations concerning activity level or restrictions of the animals.
All records shall be maintained for at least three years. In any case records, shall be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be accessible for inspection by authorized OLAW, PHS or other Federal representatives. Records should be available to veterinary staff to enable appropriate clinical decisions.

Monoclonal Antibody Production
The consensus adopted by the NIH is that production of ascites potentially produces pain and distress and that in vitro production methods should be the default. Ascites production should be a last resort when in vitro methods have failed (Monoclonal Antibody Production, National Research Council). Check the Antibody Resource Page before you contemplate making your own. The Cell Culture Laboratory, Genetic Resources Core Facility is an excellent in house resource for production of monoclonal antibodies in vitro. Faculty members from Comparative Medicine are available for consultation and collaboration in Monoclonal antibody production.

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Suspension of Animal Activities
The IACUC is empowered to suspend a project if it finds violations of the AWA, PHS Policy, the Guide or Johns Hopkins University's Assurance in accordance with established Federal procedures. The Institutional Official is required to take appropriate corrective action, and report the action and the circumstances surrounding the suspension to OLAW and the relevant funding agency. USDA will be notified if the suspension is the result of a violation of the AWA or involves a species covered by the AWA. Suspensions can only be revoked at a convened meeting of the IACUC with a quorum of the voting members after all conditions of the suspension have been fulfilled. Reinstatement of animal activity after a suspension may necessitate submitting a bran new protocol or an extensively revised protocol.

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Post Protocol Approval Responsibilities of the Investigator

Abiding by all the protocol terms
Training for personnel involved in their projects
Ensuring personnel involved in their projects participate in the Occupational Health program
Providing a safe working environment
Record keeping
Completion of the F6 section of your grant proposal
Applications and proposals for awards submitted to PHS that has a component involving use of animals should contain the following information:
Identification of species and approximate number of animals to be used.
Rationale for involving animals.
Appropriateness of the species and numbers to be used.
A complete description of the proposed use of the animals.
Methods to limit discomfort and injury to what is unavoidable in the conduct of scientifically valuable research, including route, dose, frequency and duration of analgesic, anesthetic and tranquilizing drugs that will be used.
A description of any euthanasia method to be used.
Approved animal use protocol number.
IACUC approval of an animal use protocol is no longer required prior to peer review of competing applications due to introduction of “Just-in-Time” procedures by the PHS for animal-based research. Instead verification of IACUC approval is required prior to award of funds. At that time, the IACUC will determine whether the procedures described in the grant application are covered by one or more approved protocols before providing verification to the PHS funding agency.

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