Animal Care and Use Committee
Description
WFUHS Policies & Guidelines

Institutional Oversight of Animal Research
To review additional research policies, click here. (Section IV, WFUHS O&P Handbook)

DESCRIPTION

A. INTRODUCTION

The Animal Welfare Act (as amended in 1985) and NIH policy require an institutional committee to oversee the animal care and use program. This committee must be composed of at least five members and include an individual unaffiliated with the institution, a veterinarian with program responsibilities, a practicing scientist experienced in research involving animals and a nonscientist.

The Animal Care and Use Committee (ACUC) is the institutional committee for animal care and use issues at Wake Forest University (WFU). The ACUC has University-wide oversight responsibilities regarding adequacy of facilities, animal husbandry, health care and appropriate use of animals in educational programs and research. It is an important element of WFU's compliance with Federal and state regulations, and plays an essential role in advising WFU administration, the Animal Resources Program (ARP) and the Comparative Medicine Clinical Research Center (CMCRC) on matters related to the care and use of animals.

Members are appointed for rotating three-year terms by the Dean of the School of Medicine. Members of the University ACUC include practicing scientists, nonscientists, veterinarians and at least one lay person not affiliated with the University.

B. PROTOCOL REVIEW

In keeping with the regulations set forth in The Public Health Service Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions (1985, revised 1986) and the Animal Welfare Act, WFU policy requires all proposed activities using live vertebrate animals to be reviewed and approved by the ACUC.

1. Review Process
   Investigators must complete a standard ACUC protocol application form, which can be obtained from the Office of Research (x-4548). The review process is as follows:
   1. Applications are submitted to the Office of Research , Wake Forest University School of Medicine, in accordance with published monthly deadlines. The Office of Research refers submissions to the ACUC for review.
   2. An application excluding use of non-routine or harmful invasive procedures, prolonged restraint, multiple survival surgery, use of animals with a serious natural or experimental disease for an extended period of time or methods of euthanasia other than those recommended by the AVMA may be reviewed in an expedited manner prior to the next regularly scheduled meeting. This option is infrequently exercised. Such applications will be distributed to the full committee with a note indicating expedited review. Full committee review for these protocols may be requested by any ACUC member.
   3. All other applications are considered by the full committee at a convened meeting.
   4. The Committee convenes monthly to consider pending applications, review expedited actions taken and review progress of previously approved protocols if renewal beyond the initial one-year period is desired. Amendments or changes to previously approved protocols also are considered.
   5. The Committee votes on each application and a majority of members is needed for approval. One veterinarian and one member from a scientific discipline are necessary to achieve a quorum, which is defined as a majority of Committee members.
   6. No member may participate in the ACUC review or approval of an application or proposal in which the member may have a conflict of interest (e.g., is personally involved in the project); nor may a member who may have a conflict of interest contribute to the constitution of a quorum.
   7. As an alternative to convened meetings, each ACUC member may be provided with a list of applications and proposals to be reviewed. Sections of applications and proposals that relate to the care and use of animals are available to all ACUC members, and any member of the ACUC may on request obtain full Committee review of those sections and have the authority to approve, require modifications (to secure approval) or request full Committee review of those sections. If full Committee review is requested, approval of those sections may be granted only after review at a convened meeting of a quorum of the ACUC and with the approval vote of a majority.
   8. The ACUC may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold ap-proval of an application or proposal or vote with the ACUC.
   9. The ACUC notifies investigators in writing of its decision to approve or withhold approval of those sections of applica-tions or proposals related to the care and use of animals or of modifications required to secure ACUC approval. If the ACUC decides to withhold approval of an application or proposal, it must include in its written notification the reasons for its decision, and give the investigator an opportunity to respond in person or in writing. Applications are approved for three years.
   10. The ACUC conducts an annual continuing review of applications and proposals covered by this policy in the second and third years of the research proposal. Projects extending beyond this period must be resubmitted to the ACUC as a full protocol rather than a renewal request.
   11. Applications and proposals that have been approved by the ACUC may be subject to further appropriate review and approval by officials of the institution. However, those officials may not approve those sections of an application or proposal related to the care and use of animals if they have not been approved by the ACUC.
2. Activities Requiring Full Committee Review
   1. Use of Non-routine or Harmful Invasive Procedures

It is the policy of the WFU ACUC that protocols which involve non-routine or harmful invasive procedures such as major multiple survival surgery are not eligible for expedited review, and must always be reviewed by the full Committee. In most instances, multiple survival surgical procedures on a single animal are discouraged. However, under special circumstances, more than one major surgical procedure on a single animal may be permitted provided they are related components of a research or instructional project. Major surgery is defined as any surgery in which a major body cavity is opened.

2. Prolonged Restraint

The WFU ACUC policy states that protocols which involve prolonged restraint are not eligible for expedited review and must always be reviewed by the full Committee. Standard tethering systems for rats and monkeys that allow full mobility within cage space are not considered prolonged restraint by the ACUC. This decision is based on years of experience with these techniques in several laboratories within the institution.

3. Use of Animals With a Serious Natural or Experimental
   Disease Maintained for an Extended Time

It is the policy of the WFU ACUC that protocols which involve the long-term maintenance of animals with serious debilitating diseases must always be reviewed by the full Committee. An example of such a protocol is one including maintenance of animals with naturally occurring or experimentally induced paralysis.

4. Methods of Euthanasia Other Than Those Approved by the AVMA

The ACUC currently approves all methods of euthanasia that are in agreement with the 1993 AVMA Panel on Euthanasia recommendations. Exceptions to these recommendations are reviewed individually by the ACUC and approved when deemed acceptable. This requires scientific justi-fication by the investigator and may require observation of the proposed method by ACUC members. (See ACUC policy on decapitation and cervical dislocation.)

3. Special Considerations
   1. Lay Language

Federal law requires that certain portions of ACUC protocols be written in terms that a lay person can understand. The ACUC requests that investigators pay special attention to this requirement. Protocols that are not written in lay language, as determined by the ACUC lay representative(s), will be returned to the investigator for rewriting.

2. Anesthesia and Analgesia

Appropriate anesthesia and analgesia are essential in animal experiments involving painful or invasive procedures. The ACUC recommends that investigators review appropriate sections of the Animal Resources Program manual and, if necessary, consult with the Department of Comparative Medicine's veterinary staff on matters pertaining to anesthesia and analgesia in animals before submitting a protocol for ACUC approval. Prior consideration often eliminates the need for protocol revision and thus expedites the review process.

3. Experimentation Involving Hazardous Agents

All animal studies involving the use of hazardous agents (living microorganisms, toxic chemicals and carcinogens or radioisotopes) must be approved by the appropriate committee(s) (i.e., Biosafety or Radiation Safety) before the ACUC can approve an animal protocol.

1. Experiments Using Chemicals, Carcinogens and Pathogenic Organisms

Animal studies involving the use of toxic chemicals, carcinogens and pathogenic organisms must be approved by the Biosafety Committee before approval by the ACUC can be obtained and studies initiated. Applications for Biosafety Committee approval (Memorandum of Understanding) may be obtained from the Office of Research (x-4548).

2. Experiments Using Radioisotopes

Animal studies involving the use of radioisotopes must be approved by the Radiation Safety Committee before approval by the ACUC can be obtained and studies initiated. Applications for such studies may be obtained from Environmental Health and Safety (x-4578).

4. Satellite Animal Housing Facilities

The policy of the WFU ACUC states that animals must be housed within an ARP-operated animal facility. An exception to housing animals within the central animal facilities is made on the basis of scientific requirements of a particular research project, and can be made only by the ACUC. Requests for such an exception must be submitted in writing to the ACUC and must specifically address the scientific justification for not housing the animals in the central facilities as well as each of the other points listed in the Policy on Housing Laboratory Animals. Permission must be granted by the ACUC before animals are housed anywhere outside the central facilities. ARP personnel are available for consultation concerning the laws and regulations that pertain to satellite facilities as well as those that address the husbandry and veterinary care of animals housed within them.

5. Satellite Surgery Facilities

Federal laws and guidelines govern survival surgery in all species of animals. In order to ensure institutional compliance with these regulations, it is the policy of the ACUC that all survival surgery be performed only in ACUC-approved facilities. Investigators must apply to the ACUC for approval of a satellite surgical facility. ARP personnel are available for consultation concerning the laws and regulations that pertain to rodent and nonrodent survival surgical facilities.

C. ACUC POLICIES

The ACUC has adopted policies that address specific animal care and use issues. Investigators using animals in research and teaching activities are urged to review these policies before completing ACUC protocol forms. The full text of these policies is available from the research office.

D. ADDITIONAL ACUC RESPONSIBILITIES

1. Review the institution's program for humane care and use of animals
2. Inspect, at least semi-annually, all of the institution's animal facilities, including satellite facilities
3. Review concerns involving the care and use of animals at the institution
4. Make written recommendations to the Executive Vice-President for Health Affairs and Dean regarding the institution's animal program, facilities or personnel training
5. Review and approve, require modifications in (to secure approval), withhold approval or propose significant changes regarding the use of animals in ongoing activi-ties.
6. The ACUC may suspend a previously approved activity if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide or the institution's Memorandum of Understanding. The ACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the ACUC and with the vote of a majority of the quorum. If the ACUC suspends an activity involving animals, the institutional official in consultation with the ACUC shall review the reasons for suspension, take appropriate corrective action and report that action with a full explanation to the Office for Protection from Research Risks, other NIH offices or other agencies as required.