IACUC Policy and Procedures for Research and Teaching Involving Live Vertebrate Animals

The Institutional Animal Care and Use Committee (IACUC) is appointed by the Provost of the College to ensure compliance with Federal regulations (Department of Agriculture 9 CFR parts 1 and 2; Public Health Service 99-158) concerning care and use of vertebrate animals in research and teaching activities. Any type of activity involving live vertebrate animals must be approved by IACUC prior to acquisition of animals or initiation of any research or laboratory exercise. Projects which may involve such activities include but are not limited to grant proposals, laboratory class exercises, thesis/dissertation research, and independent laboratory research.

For every project involving vertebrate animals, the principal investigator(s) is required to use the Protocol and Compliance Management online submission program.

Project Types

There are various types of projects involving the husbandry and experimental manipulation of vertebrate animals, all of which are subject to review and approval by IACUC. These include but are not limited to the following:

Grant Proposals
Prior to submitting a grant proposal for extramural or intramural funding, the investigator must use the Protocol and Compliance Management system to submit the online IACUC Project Evaluation Forms. For proposals submitted to NIH, NSF, and related agencies, present policy requires that the procedures in the project be under consideration by the IACUC and approved before any animals are acquired or work initiated. For agencies that have no explicit requirement for review and approval by the IACUC, it is the policy of the College that no animals may be acquired or animal use initiated before review and approval by the IACUC.

Independent faculty research
All independent faculty research with vertebrate animals, including pilot experiments conducted to obtain data necessary to the preparation of an extramural grant proposal require the approval of the experimental protocols and husbandry methods by the IACUC before being initiated.

Field/Biological Surveys
To ensure that the College remains informed of activities that may 1) involve animals on the State or Federal lists of threatened or endangered species, 2) require special permits for handling the animals, 3) bear appreciable risk to human health through contact with zoonoses, or 4) involve use of equipment and procedures that could be construed by some as inhumane, all field work involving vertebrate species in which the animal is harmed or disturbed, should be submitted to the IACUC. The IACUC accepts the protocols described in Guidelines for the Use of Fishes in Field Research (doc) (Hubbs et al., 2003) (pdf) and Guidelines for the Use of Live Amphibians and Reptiles in Field Research (Hutchinson, 1987) (pdf), Guidelines to the Use of Wild Birds in Research (The Ornithological Council, 1999), and Acceptable Field Methods in Mammalogy (Amer. Soc. Mammal., 1987) (pdf).

Class/Laboratory Research Exercises
Faculty members who supervise class associated research projects may submit a set of procedures for approval by the IACUC from which the student may select to address the research question identified. Procedures not included in those approved for the class instructor, and specific for the laboratory, will require submission of a modification request for protocol evaluation. Students should be aware that this will delay their research and may adversely affect their ability to complete the course in the prescribed time interval.

Graduate/Undergraduate Research Projects
All student protocols, including pilot or exploratory research, must be reviewed by the IACUC and approved before initiation of the work. Student submissions must be cosigned by their research advisor who will have ultimate responsibility for proper training in the care and handling of the animals and any specialized techniques used in the research.

General Animal Care and Use Protocols
The researcher responsible for general animal care and use in any facility must submit a protocol for these tasks (information may be added in narrative portion of the "Additional Information" page of the protocol submission form.) Included under this provision are procedures for animal display facilities, the turtle rehabilitation facility, rodent breeding programs, and other non-research facilities. These submissions must include a list of the species to be maintained and an estimate of the numbers of each animal bred or used annually. If animals maintained or produced under such an approval are transferred to a researcher for use in experiments, the investigator must have a valid IACUC approved project number(s) for use and maintenance of the transferred animals and must notify the IACUC of the species and number of animals transferred.

General Policies

Period of Approval
Projects and protocols are approved for the anticipated duration of the activity, up to a maximum period of three years, with a requirement for annual review. For research activities that extend beyond three years, a cloned submission of the previous protocol with updates/changes will be required after the first three years of the project to ensure new information available to the scientific community is fully considered in the design and performance of the research. Each renewal submission must include a current search for alternative methods.

Requests for Protocol Modification
Changes to a protocol must be submitted to the IACUC, using the Protocol and Compliance Management system, and approved before implementation of any modification to a protocol. Included under this policy are changes in personnel. The purpose of these reviews is to ensure the College remains in compliance with the Animal Welfare Act including the provision of necessary training of personnel.

Annual Reviews
Should projects extend longer than one year from the date of initial approval, materials must be submitted to the IACUC for annual review through the Protocol and Compliance Management system before the anniversary date to allow processing time. These reviews may be approved administratively without committee review, and should not contain any substantive modifications.

OLAW FAQ's:  vital information for researchers (Last Update 12/1/11)

OLAW GUIDANCE ON ANIMAL CARE

Specific Policies

The Three R's
The IACUC endorses the application of the 3 R's concept to the minimization of pain and distress in animals. The 3 R's are: Reduction, Replacement, and Refinement. Reduction refers to reducing the number of test animals to the minimum consistent with the production of reliable information. Replacement (also known as alternative methods) refers to the substitution of alternative living or non-living models for certain research (substitution of invertebrate species for vertebrate species or use of in vitro methods in place of in vivo methods.). Refinement refers to any means used to decrease the incidence or severity of pain and distress in research animals. All three elements of the concept must be addressed in protocol submissions to the IACUC.

Multiple survival surgeries
Multiple survival surgeries on individual animals require explicit approval by IACUC. In general, multiple survival surgeries are discouraged, but may be performed when necessary to complete a particular experiment and with appropriate safeguards.

Identification of Animals
All animal housing must be tagged with the protocol number, to include the current annual review date and investigator's name, under which the activity is being maintained. Those animals that have been subjected to surgical treatments should be identified. Breeding animals should be identified appropriately to track lineage.

Policy regarding ascites production
Monoclonal antibodies are commonly produced from an ascites tumor induced in a mammal such as a mouse. The deliberate induction of a tumor, which in itself produces pain in the animal host, and various procedures often used to harvest repeatedly the antibody are considered to be inhumane. If there are no alternative techniques for the production of antibodies, use of this technique can clearly be justified by a sufficient expression of need alone. Although alternative in vitro techniques have been developed, there is presently no clear consensus concerning the balance of advantages and disadvantages of in vitro versus in vivo methods. Therefore, at this time, it is reasonable to continue the use of ascites tumors to produce monoclonal antibodies provided there is ample scientific justification to warrant this use of animals. Until such time as there is a consensus concerning in vitro techniques, it shall be the policy of the IACUC that:

Investigators who propose the production of monoclonal antibodies through ascites production are required to justify use of this technique over any of the available in vitro techniques or purchase of the monoclonal antibodies from a "core facility" such as that at The Johns Hopkins University where in vitro techniques are used. With proper scientific justification, the committee will continue to approve, on a case by case basis, protocols that include monoclonal antibody production from mouse ascites.

Training
All personnel working with live vertebrates must receive sufficient training in all procedures in which they will participate to ensure that animals are properly cared for and maintained. View the Federal Compliance On-Line Training Programs for the care and use of laboratory animals. New faculty, staff, and students are required to complete the Humane Care and Use of Laboratory Animals and Occupational Health and Safety modules, along with any other applicable species or technique modules before beginning work with animals. Student and staff training will be supplemented by the principal investigator who is responsible for maintaining his/her own training level. The Adjunct and Associate Adjunct Veterinarians will provide training, as needed, to any investigator who wishes to engage in surgical techniques with which they are unfamiliar. It is the principal investigator's responsibility to maintain training records for themselves and any other participants working under their approved protocol. Training records must be provided for inspection by any oversight authority including the IACUC.

The IACUC makes available a library of materials that may be used for self-training and updating knowledge. Available to each investigator is the Assurance Statement of the College, IACUC policies, the Guide for the Care and Use of Laboratory Animals (OLAW, PHS), the USDA regulations (Subchapter A), Guidelines for the Use of Fishes in Field Research (Hubbs et al., 2003) (doc) , Guidelines for the Use of Live Amphibians and Reptiles in Field Research (Hutchinson, 1987) (pdf), Acceptable Field Methods in Mammalogy (Amer. Soc. Mammal., 1987), and Guidelines to the Use of Wild Birds in Research (The Ornithological Council, 1999). Additionally, a list of useful references and training materials will be made available from the committee; a partial bibliography of pertinent information, a list of IACUC Members with contact information, and other materials deemed as appropriate to assist investigators in meeting the requirements under the Animal Welfare Act.

Special Activities
In some cases, it is necessary to maintain unique conditions as a part of a research protocol, e.g., photo-periods, radiation treatments, immuno-suppression. If such a laboratory area is not properly identified, and entry is made inappropriately, responsibility shall rest with the investigator not the inspecting authority.

Administrative Procedures
The IACUC considers OHS issues when conducting protocol reviews. The Committee specifically considers potential risk from infectious agents, recombinant-DNA molecules that are not exempt from federal guidelines, hazardous chemicals, radiation, and the use of animals that present unique hazards. The W&M Protocol Compliance and Management system allows protocol submissions to multiple committees if necessary.

Facility Design and Operation
Facilities Maintenance staff follow a regular program of maintenance of equipment. Staff and researchers are required to report potentially harmful conditions promptly to facilities maintenance staff and to their supervisor. Training of staff and researchers includes instruction regarding potentially harmful conditions. New or replacement equipment is planned and selected with consideration of ergonomic principles and safety issues. Planning for new space uses professionals with experience and training in designing laboratory animal facilities. Engineering controls being considered for future space, currently in planning stages, include fume hoods, biological safety cabinets, isolation cages, and directional air flow. The facilities inspections carried out by the IACUC consider OHS operational issues.

Exposure Control Methods
General:  Chemical fume hoods are used for control of chemical hazards, and safety cabinets are used as appropriate for storage of hazardous chemicals. Biological safety cabinets are used for the protection of personnel from aerosols produced by experimental procedures involving etiological agents. Researchers, students, and staff are instructed to use protective equipment to protect against airborne dust and animal dander, in particular. Barriers are used when working with some animals. Cage filter tops are used to minimize exposure to some animals. When additional hazards are identified by researchers, staff, or the IACUC, additional precautions may be recommended or required.

Work Practices:  Access to work areas is restricted to staff, researchers, and students working under approved protocols. Workers are provided with preliminary training materials with an established animal care OHS guide, and must pass an exam on the material. Workers are instructed to reduce exposure by: (1) direct and indirect contact by appropriate hand washing, decontamination of surfaces, and use of protective equipment, including gloves, gowns, and eye protection, and good personal hygiene; (2) reducing percutaneous exposures from sharp objects; (3) reducing exposure by ingestion by not eating, drinking, or smoking in animal holding areas and protecting the mouth from contamination; and (4) reducing exposure by inhalation by using fume hoods, HEPA filters in vacuum equipment, and careful handling of liquids.

Housekeeping:  Employees and researchers are instructed to minimize clutter and to follow good housekeeping standards, with regular cleaning scheduled according to the research and animals being held. Dust suppression methods are used to minimize dust exposure.

Waste Disposal:  All waste from experiments is disposed of at a permitted facility. The College's Environment, Health, and Safety Office coordinates the waste transport and disposal. Please see: Request for Hazardous Waste Disposal Form (doc).

Restraint of Animals:  Species-specific safe techniques are used to restrain animals, including appropriate protective gloving against rodent bites. Primates, dogs, cats, and other mid sized to large laboratory animals are not used in our facilities, and thus physical restraint of potentially dangerous animals is not routinely required. The IACUC considers restraint issues in review of protocols, and can recommend or require appropriate restraint methods.

Cleaning Cages:  Removing animals of some species from cages is carried out in escape-proof chambers as necessary. Workers are instructed to use protective clothing and equipment for protection during cage changes. Additional precautions are required for handling of some waste materials.

Personal Protective Equipment:  Staff are instructed to use gowns, masks, and eye protection by safety glasses or goggles during work with cleaning, disinfecting, cage changing, and potentially hazardous agents.

Education and Training
Researchers, staff and students are required to complete an OHS safety module that includes instruction on safe working habits. Further instruction is provided by written guidelines specific to particular research units. Employees are instructed about hazards from potential allergens, and on ways to minimize exposure to allergens. These include documents on zoonoses specific to rodents or birds (e.g., Hantavirus, Lyme disease, West Nile Virus) or to specific hazards (e.g., Pfisteria).  Employees working on animals are in regular and direct contact with scientists carrying out the projects, and scientists play an active part of the education and training process. Finally, key employees receive additional instruction in helping to train and monitor other workers and students.  Documentation of education and training exercises and materials should occur regularly, overseen by an institutional health and safety officer.

Occupational health-care services
The College contracts with an occupational medicine specialist for services. The College complies with OSHA standards for training, fitting, and pulmonary examinations wherever necessary.

Equipment Performance
Fume hoods are tested annually by the EH&S Office to ensure that they meet standards. Biosafety cabinets are tested and certified annually by a third party testing company. Air filters are changed regularly as determined by their stated useful life. Water handling units and water filters for fish and amphibians are checked daily, and cleaned and maintained on weekly and monthly schedules. Areas with potentially hazardous cleaning or other materials are tested and monitored according to needs for the materials being used. Sterilizing devices are maintained regularly to ensure continued ability to perform adequately. Checks are performed to ensure proper sterilization temperatures are reached during each sterilization activity as well as monthly.

Information Management
Information on employees and researchers exposed to potential risks is available from research protocols and duty assignments. Occupational Health and Safety training records for staff and researchers are maintained in a computer data base. Material safety data sheets are filed for materials used in research and cleaning and are available through the web to W&M users. Accident and injury records are maintained centrally by the University for any job-related injury. Accident and injury records are reviewed by the DH&S Office for follow-up as necessary.

Emergency Procedures
Emergency situations are responded to by the supervisors of facilities following established guidelines. Prior to predicted emergencies such as hurricanes or snow storms, additional checks are made of back-up systems, and specific sets of duties for the post-event period are assigned to researchers and staff. Specifications are established for acceptable conditions for animal care work or research. Animals and systems are arranged to maximize protection from the emergency.  A telephone tree is established for personnel back-up and for reporting on completion of duties. The telephone tree moves up through notification of the supervisor and campus emergency responders (via Campus Police), department chair, IACUC chair, and outward to individual researchers and technicians. The specific individuals called depend upon the nature and extent of the emergency. If any individual is not reachable by phone, contacts are made at the higher level. Back-up procedures are agreed upon for safe performance of duties if phone service fails. Emergency veterinary services are planned for, and temporary animal housing space checked. Potential hazards are indicated by prominent labels on doors.  In unexpected emergencies, supervisors of each facility take responsibility following established procedures to maintain facilities and animals, with back-up provided by researchers or staff. An automated system monitors temperatures and power near especially sensitive facilities, and automatically cycles through a telephone number tree of responders until receiving a manual acknowledgment. Both the William and Mary Police Department and Facilities Management have animal facilities ranked as vital for frequent checks and reporting to supervisors. Finally, the Chair of the IACUC or his/her designate checks with supervisors, staff, the Police Department, and Facilities Management to stay informed on the condition of facilities during or after an emergency. Following an emergency, the adequacy of the protection and response is evaluated, and changes instituted as necessary.

Program Evaluation
Program evaluation takes place at the request of the senior official of the University.  Members of the evaluation group are appointed by the senior official of the institution. Appointees include members of each major activity in the occupational health and safety program. Chairpersons of relevant committees participate as requested, and managers of the environmental health and safety group serve as resources for the group. Evaluations measure effectiveness of the program to reduce occupational risks to an acceptable minimum. Three major elements are reviewed: the institution’s injury and illness experience, its regulatory-compliance performance, and the results of efforts to promote occupational health and safety through involvement of participants in the occupational health and safety program. Data sources include material taken from injury or illness records, exposure monitoring (if performed for any purpose), training records, minutes and reports of institutional health and safety committees, actions and minutes of the IACUC, and results of inspections conducted by the IACUC or regulatory agencies.

References
Occupational Health and Safety in the Care and Use of Research Animals, (1997), Institute for Laboratory Animal Research (ILAR). Website:  http://books.nap.edu/books/0309052998/html/106.html.

Facility Inspections

There are three types of facility inspections performed during the course of each year. Each type of inspection has a specific purpose.

1) APHIS Veterinarian Inspection. The USDA APHIS Veterinarian makes one or more unannounced inspections during the course of each year. The purpose of the inspections is to verify that the IACUC is properly overseeing the use of animals in research and teaching. The IACUC may be cited during the course of such inspections because of deficiencies observed in the laboratory facilities or for various aspects of committee operation, especially record-keeping. Investigators may be contacted during this visit by the IACUC Office to ensure that someone is present in each laboratory during such visits. Whenever possible, the IACUC Chair will be present during part or all of these visits. Following receipt of the inspector's report, the IACUC Chair will notify appropriate investigators of any citations requiring corrective action by an investigator and include a time limit for such correction. Failure to correct a deficiency can lead to IACUC withdrawal of authorization to continue work so as to protect the College and other investigators from being denied the authority to conduct research by the federal regulatory agencies.

2) Announced IACUC Inspections. The IACUC will make announced semiannual inspections following its semiannual meetings. These inspections will occur on the Williamsburg campus on the day of the meeting, or within one week of the date of the meeting, as appropriate. The VIMS campus inspections will be conducted on the same day, or within one week of that day (unless notice is given in advance changing this schedule). Inspections at each facility, conducted in accordance with The Guide, involve the veterinarian and at least one member of the committee (preferably the Chair), who is not a member of the facility staff or the PI.

3) At least two times per year, the Adjunct Veterinarian or his/her associate and the IACUC Chair or his/her designee will perform unannounced inspections of all facilities. The purpose of these inspections is to confirm that appropriate veterinary care is being provided to all animals; that proper sanitation, feeding, housing, etc. are being provided; and that approved protocols are being followed. The inspections are intended to be supportive of investigators, not punitive, by providing an independent evaluation of animal conditions leading to corrective action when appropriate.

Semi-Annual Meetings

The IACUC will hold semiannual meetings in the spring and fall in accordance with the Assurance Statement of the College and the Animal Welfare Act and associated regulations.

Reports of Animal Abuse

Any member of the college community who has specific concerns about the handling of animals in a particular protocol has the right, and the obligation, to submit their concern in writing to the Institutional Officer, the Chair of the IACUC, the Adjunct Veterinarian, or other Committee members. The College also makes available a phone number to call should the individual choose to remain anonymous. By calling 757-871-9581, calls to this number cannot be linked to a specific extension if the call originates from a campus phone.

Upon notification of a concern, the IACUC Chair along with the Adjunct Veterinarian, will initiate an investigation of the situation. They will report the allegation and their initial findings to the members of the Committee at a specially called meeting. The investigator involved will be invited to attend the meeting to present his/her view of the issue. The committee will then enter into a closed session to resolve the validity of any allegation and to determine the appropriate action. Such action may include a resolution that the allegation is unfounded, a change in protocol to eliminate the cause of concern, or in extreme cases, termination of a protocol. Results of the deliberation will be provided to the investigator and to the person making the initial allegation. In accordance with the Animal Welfare Act and the Assurance Statement of the College, all such proceedings will be reported in full to the responsible federal agencies.