OAR: Office of Animal Resources-Homepage-MU-Columbia

CHAPTER 1 - Ethics and Public Perception of Animal Care and Use	CHAPTER 7 - Animal Housing and Care
CHAPTER 2 - Replacement, Reduction of Animal Care and Use	CHAPTER 8 - Handling Common Laboratory Species
CHAPTER 3 - Policies and Regulations	CHAPTER 9 - Research Animal Diagnostic and Investigative Laboratory
CHAPTER 4 - Animal Welfare Act	CHAPTER 10 - Control of Animal Pain and Distress
CHAPTER 5 - University of Missouri-Columbia Animal Care and Use Committee	CHAPTER 11 - Surgery and Postoperative Care
CHAPTER 6 - Sources of Information	CHAPTER 12 - Animal Euthanasia

Prepared by the Office of Animal Resources

University of Missouri-Columbia

Mu-Animal Care & Use Committee

- - Semiannual Evaluation of Animal Programs & Facilities

- - Recommendations to the Institutional Official

- - ACUC Review of Animal Care & Use Protocols

- - Protocol Review Criteria

- - Review of Concerns

- - Activities Not in Accordance With the MU Assurance

MU-Animal Care and Use Committee

Each institution falling under the PHS Policy or the Animal Welfare Act regulations is required to have an Institutional Animal Care and Use Committee (IACUC) of a prescribed composition, and to assign the IACUC specific responsibilities. The University of Missouri Animal Care and Use Committee (ACUC) meets the prescribed membership requirements and is charged with a specified set of responsibilities, which include:

Semi-annual reviews of animal care and use programs;
Semi-annual inspections of animal care and use facilities;
Preparations of reports of the animal care and use program and facilities evaluations;
Making recommendations to the Institutional Official regarding any aspect of the MU animal program, facilities or personnel training;
Reviewing and approving, requiring modifications in (to secure approval), or withholding approval, of proposed and ongoing protocols involving the care and use of animals;
Recommending suspension of activities involving animals that are not in compliance with standards, and
Reviewing concerns involving the care and use of animals at MU. The ACUC functions to support the efforts of investigators by:
1. Assuring investigators, granting agencies and the public of a sincere and methodical review of humane aspects of animal care and use, a process which may allay concerns and increase support;
2. Facilitating the involvement of veterinarians and other scientists in the application of new experimental animal procedures and in solving problems;
3. Contributing to the maintenance of quality animal care programs and facilities, and
4. Advising MU on animal related legislation and standards, and public concern.
5. OAR providing staff support to the ACUC.

Semiannual evaluation of laboratory animal programs and facilities.

Semiannual evaluation of programs and facilities are accomplished by the ACUC as follows: The ACUC conducts its evaluation by reviewing the description provided and by conducting a site visit to each animal resource.

The report of the ACUC semiannual evaluation includes: 1) a description of the nature and extent of adherence to the Guide, PHS Policy, MU policy, or other applicable standards; 2) a description of and statement of reasons for departures from these standards; 3) a list of significant deficiencies and minor deficiencies, and 4) a plan and schedule for correcting each deficiency.

All ACUC members review the report and have an opportunity to add minority opinions. The report is submitted to the Institutional Official (Vice Provost for Research).

The committee schedules its inspections with the to ensure that they will be present to guide the site visit and answer questions about the programs and facilities. The directors should provide the ACUC with information about deficiencies and unit preferences on plans and schedules for corrective action.

Recommendations to the Institutional Official

All of the ACUC’s reports and minutes of its meetings are forwarded to the Vice Provost for Research who is MU’s “Institutional Official.”. These documents generally contain recommendations. In addition, recommendations regarding any aspect of the MU animal program, facilities or personnel training may be forwarded by the ACUC at any time.

ACUC Review of Animal Care and Use Protocols

For each application and proposal containing protocols involving the care and use of vertebrate animals, the Principal Investigator (PI) is required to submit an Animal Care and Use Protocol Review Form, which is submitted directly to the ACUC, M144 Medical Sciences Bldg. Protocols for the care and use of animals are reviewed by the ACUC before submission of proposals to external agencies for funding. Exceptions are handled on a case-by-case basis with the approval of the Vice Provost for Research.

In the Review Form, it is the PI’s responsibility to provide accurate and sufficient information to permit the committee’s review for humane care, treatment, and use of animals. Use of reference documents is not encouraged, but the importance of a lay summary is encouraged.

The Review Form is assigned a reference number for identification and is entered into a computerized protocol review data base for record-keeping purposes. A veterinarian reviews information concerning use of anesthetics, analgesics, and tranquilizers, surgical procedures and facilities, pre- and post-surgical care, animal health issues, euthanasia, etc. The Review Form and the veterinarian’s comments on veterinary issues are then forwarded to the coordinator of the ACUC, who in turn forwards them to a qualified ACUC member to review (primary reviewer). The primary reviewer returns the Review Form to the coordinator recommending either approval, defer for clarification, modification to secure approval, or withholding of approval.

If the primary reviewer recommends approval of an animal care and use protocol that is likely to produce no pain or distress, or only minor and transient pain or distress, the process is completed without convened committee review by the ACUC chairman’s signature on the Animal Care and Use Protocol Review Certification.

If the primary reviewer recommends deferring the review pending clarification by the PI, the Review Form and questions that need to be answered for clarification are returned to the PI. The Review Form with clarification is processed in the same manner as an original submission.

In the event that a primary reviewer recommends modification of a protocol or withholding approval of a protocol, the ACUC coordinator notifies the PI of the reason(s) for the recommendation and the date on which the protocol will be reviewed by the convened ACUC. The PI has the option to have the unaltered protocol reviewed by the convened committee, to submit amendments or modifications to the protocol prior to the committee’s review, and/or to meet with the ACUC to discuss the protocol.

Prior to the monthly meeting of the ACUC, a listing of all protocols to be reviewed that month is provided to each member along with the brief description on page 1 of the Review Form. Member desiring review of a specific protocol notifies the coordinator in advance of the next scheduled committee meeting, and it is placed on the agenda. Also reviewed by the convened ACUC are protocols for which the primary reviewer recommends requiring modification (to secure approval), or withholding approval, and all animal care and use protocols categorized as likely to involve more than minor and transient pain or distress. This includes experiments in categories D and E. (See Table 1.)

Upon the ACUC approval, the PI and the Office of Grants and Contracts (if asked for) are sent a signed copy of the Animal Care and Use Protocol Review Certification. If, after review, the committee’s decision is to require modification to secure approval or to withhold approval, the PI is notified of the decision and the reason(s) behind it by copy of the Animal Care and Use Protocol Review Certification.

Approval of a protocol is valid for one year from the date of ACUC approval, provided that there are no significant changes in animal care and use.

If there are significant changes in animal care and use, the PI should submit a letter in which the nature of the changes in animal care and use are clearly stated.

Ongoing activities involving animals will be reviewed every one years. OAR will advise the ACUC chairman of the activities due for one-year review. The chairman then requests that the PI submit an updated Review Form. If the P1 indicates, by memo, that there are no significant changes, no other information is required. The ACUC chairman will forward the old Review Form and an updated one, or a memo indicating no significant changes, to a primary reviewer.

Table 1

CATEGORIES OF BIOMEDICAL EXPERIMENTS BASED ON INCREASING ETHICAL CONCERNS NON-HUMAN SPECIES
Category	Examples & Comments
Category A Experiments involving either no living materials or use of plants, bacteria, protozoa or invertebrate animal species.	Biochemical, botanical, bacteriological, microbiological, or invertebrate animal studies, tissue cultures, studies on tissues obtained from autopsy or from slaughterhouse, studies on embryonated eggs. Invertebrate animals have nervous systems and respond to noxious stimuli, and therefore must also be treated animal humanely.
Category B Experiments on vertebrate animal species that are expected to produce Little or no discomfort.	Mere holding of animals captive for experimental purposes; simple procedures such as injections of relatively harmless substances and blood sampling physical examinations; experiments on completely anesthetized animals which do not regain consciousness; food/water deprivation for short periods (a few hours); standard methods of euthanasia that induce rapid unconsciousness, such as anesthetic overdose or decapitation preceded by sedation or Light anesthesia.
Category C Experiments that involve some minor stress or pain (short-duration pain) to animal species.	Exposure of blood vessels or immolation of chronic catheters with anesthesia; behavioral experiments an awake animals that involve short- term stressful vertebrate restraint; immunization employing Freund's adjuvant; noxious stimuli from Which escape is possible; surgical procedures under anesthesia that may result in some minor post-surgical discomfort. Category C procedures incur additional concern in proportion to the degree and duration of unavoidable stress or discomfort.
Category D Experiments that involve significant but unavoidable stress or pain to vertebrate species.	Deliberate induction of behavioral stress in order to test its effect; major surgical procedures under anesthesia that result in significant post-operative discomfort; induction of an anatomical or physiological deficit that will result in pain or distress; application of noxious stimuli from which escape is impossible; prolonged periods (up to several hours or more) of physical restraint; maternal deprivation with substitution of punitive surrogates; induction of aggressive behavior Leading to self -mutilation or intra-species aggression; procedures that produce pain in which anesthetics are not used, such as toxicity testing with death as an end point; production of radiation sickness, certain Injections, and stress and shock research that would result in pain approaching the pain tolerance threshold, I.e. the point at which intense emotional reactions occur. Category D experiments present explicit responsibility an the investigator to explore alternative designs to ensure that animal distress is minimized or eliminated.
Category E Procedures that involve severe pain near, at, or above the pain tolerance threshold of unanesthetized conscious animals.	Use of muscle relaxants or paralytic drugs such as succinyl choline or other inflicting curariform drugs used alone for surgical restraint without the use of anesthetics; severe burn or trauma Infliction on unanesthetized animals; attempts to induce psychotic-Like behavior; killing by use of microwave ovens designed for domestic kitchens or by strychnine; inescapably severe stress or terminal stress. Category E experiments are considered highly questionable or unacceptable irrespective of the significance of anticipated results. Many of these procedures are specifically prohibited in national policies and therefore may result in withdrawal of federal funds and/or institutional USDA registration.

From: “Consensus Recommendations on Effective AnimaL Care and Use Committees, Laboratory Animal Science Special Issue, January 1987.

If there are significant changes, a Review Form must be completed and provide a completely updated animal care and use protocol description which will be reviewed as in a new submission.

In signing a Review Form the PI makes a commitment to notify the ACUC of any significant changes regarding the use of animals in ongoing activities. Examples of significant changes include changes to higher species, larger numbers of animals, and more painful procedures. Notification may be accomplished by sending a memo stating the reference number of the approved protocol and a description of the significant changes through the OAR to the Chairperson, ACUC; or by submitting an updated Review Form. Changes are reviewed in the same manner as new submissions.

Protocol Review Criteria

The ACUC has adopted the protocol review criteria of the PHS Policy because they are sufficiently inclusive to assure compliance with requirements of other agencies, as well as UM policy. The ACUC review confirms that the care and use of animals will be in accordance with applicable standards unless acceptable justification for a departure is presented and approved. Specifically, the ACUC determines that the proposed animal care and use meets the following requirements:

Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound experimental design;
Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the non-use of such agents is justified for scientific reasons, in writing, by the investigator;
Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly killed at the end of the procedure or, if appropriate, during the procedure;
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 the animals will be directed by a veterinarian or other 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;
Methods of euthanasia used will be consistent with the most recent recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator.

Investigators and course directors should be aware that all protocols involving vertebrate animals must be reviewed before they are initiated. It should also be noted that providing the appropriate information requested in the Animal Care and Use Protocol Review Form, and including justification for withholding anesthetics, analgesics, and tranquilizers and the use of euthanasia methods other than those recommended, will expedite the review process. It is the responsibility of the PI to ensure that every animal involved in experimentation is covered by and traceable to an approved protocol.

Review of Concerns

Concerns involving the care and use of animals in animal resources should be given to the chairman, ACUC. The chairman will investigate, or appoint another committee member(s) to investigate and determine if there is valid cause for concern. If there is not, the chairman will so notify the individual(s) involved and will file a report on the findings of the investigation in the ACUC records. If a valid cause for concern is determined, the chairman will attempt to resolve it through discussions with the individual(s) involved and file a report on the concern and its resolution in the committee records. If a satisfactory resolution cannot be achieved, the concern will be considered by the ACUC which will recommend a resolution to the Vice Provost for Research.

Activities Not in Accordance with the MU Assurance

Upon notification that an activity involving animals is not being conducted in accordance with applicable University policies, provisions of the Animal Welfare Act, the Guide, the MU Assurance, or the PHS policy, the chairman of the ACUC will conduct an investigation of the matter. If the activity is found to be not in accord with the documents referenced, the chairman will convene a meeting of the ACUC to consider the matter. The person or persons involved will be invited to present justification for the departure from standards to the convened ACUC. The objective of the discussions will be to resolve the issue and make modifications that will allow activities to continue in an acceptable manner.

If a majority of a quorum of the convened ACUC votes for suspension of an activity the chairman will send a written recommendation to the Vice Provost for Research. The Vice Provost for Research, in consultation with the ACUC, shall review the reasons for suspension, take appropriate corrective action and, in accordance with the PHS policy, report that action with a full explanation to OPRR.