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Special topics of concern to the IACUC

Disaster Preparedness
Cage Population Densities for Mice
Monitoring to Assure that Animals Remain Pathogen Free
Reporting concerns
Restraint
Suspension and appeals of IACUC decisions
Use of Biohazards and recombinant DNA

These are areas the IACUC has questions about from time to time. Investigators whose protocols will involve research in these areas will find the information under each area useful.

Disaster Preparedness

Emergencies, accidents, and injuries can occur at any time, without warning. The ability to handle emergencies is a responsibility of each individual as well as a responsibility of UMBC. The better prepared you are, the more quickly you can take appropriate action and minimize confusion that may occur during an emergency (UMBC Emergency Response Plan, 2011).

The Guide for the Care and Use of Laboratory Animals as well as the Office of Laboratory Animal Welfare describe the requirements of disaster planning as well as offer resources for institutions such as UMBC to take into account the well-being of animals and personnel during unexpected events.

Facility personnel and animal users should be familiar with UMBC’s procedures in the event of emergencies. The disaster plan for animal facilities is found in the UMBC Emergency Response Plan, beginning on page 50. Additional campus resources can be found on the UMBC Environmental Safety and Health webpage as well as UMBC Human Resources site.

Collaborative Research

UMBC faculty members may arrange to carry out portions of research that involve the use of animals via an NIH-funded subcontract from an NIH-awardee (often a private company) that does not have an approved Animal Welfare Assurance on file with the NIH Office of Laboratory Animal Welfare (OLAW). In these situations, OLAW requires that the company apply for an “Inter Institutional Assurance,” under which UMBC will assure that the research will be carried out under the terms of our OLAW-approved Animal Welfare Assurance.  The ORPC will work with faculty to process Inter Institutional Assurance forms; these will require the review and signature from both the UMBC Institutional Official as well as the IACUC Chair. A sample form may be downloaded at http://grants.nih.gov/grants/olaw/sampledoc/interinstitutional_assurance.htm.
Pain review and management

All animals that undergo a painful procedure such as surgery and are likely to experience post procedural pain, should receive appropriate analgesic medication. The Principal Investigator in consultation with the Veterinarian should use their professional judgment to determine the need for analgesic medication.

Please consult UMB’s Program in Comparative Medicine resource guide to pain-distress management.

Cage Population Densities for Mice

Regulatory guidelines for housing laboratory mice indicate a need to clearly define maximum cage population densities. Determination of maximum cage densities in this Policy is based on the recommendations outlined in the “Guide” (Page 57 – 8th edition). In order to prevent or eliminate the possibility of overcrowding within cages, the UMBC IACUC has created this policy for use in laboratory mice facilities.

Population Density for Breeding Mice

  1. If the male is integral to successful rearing of offspring, the male may remain with a single female and her offspring.  A second female could also be present if there is to be only a single litter in this cage. Housing two (2) females with litters in the same cage as the male is not permitted.
  2. Up to two (2) females with litters not to exceed a total of 18 mice/cage (e.g. two females with a total of 16 offspring).  Each litter should be 4 or more days apart in age, otherwise they should be kept one litter per cage; this allows the placement of a limit on the total density of mice within 1 cage i.e. a younger litter is much lighter in weight than the older litter which is soon to be weaned. Conversely, we should only singly house 2 litters that are less than 14 days apart (to decrease the likelihood of a 14 day old mouse stepping on a 2-day old). Overall, the litters should range from 4-14 days apart.
  3. Weaning must occur on day 21 or when pups reach a weight of 8-12 grams unless the strain/line is specifically approved for later weaning by the IACUC. If weaning is to occur after 21 days, only 1 litter per cage may be maintained.
  4. This policy will be adhered to by investigators in preparing their animal use protocols, and throughout the period that animals are maintained under the protocol; any deviations from this policy must be approved by the IACUC..

Experimental (non-breeding) Mice

  1. No more than 5 mice (weanling to adults) may be housed in a cage at any time.
  2. Larger mouse strains (e.g. – MRL/MpJ and LG/J – adult body weights are substantially higher than other strains), whose body weight is in excess of 25 grams, should be housed at no more than 4 mice/cage.

Singly Housed Mouse

Mice should not be housed alone unless IACUC approved or due to medical reasons as assessed by the veterinarian.

Separation of Mice in Overcrowded Cages

It is incumbent the animal care staff and the Principal Investigator (PI) and their respective staff to follow population guidelines.  Cages that are identified by the animal care staff as overcrowded will require separation within 48 hours of discovery.  Cages that are out of compliance are marked by placing an action card on the cage instructing research staff to correct the problem. Animal care staff will monitor cage density as part of their routine duties and will attempt to notify researchers and/or their designated contact person via email, by phone, or in person if overcrowded cages are discovered. on the day the problem is identified to allow the lab member the opportunity to correct the problem within 2 days, unless it is an issue that warrants immediate action. If after 2 days the cage(s) are still in need of separating, animal care staff will separate the animals and notify the attending veterinarian and IACUC Chair. Animal care staff may separate immediately, or change the cage of any animals when animal welfare concerns exist. Non-compliance to this policy and “The Guide” may require a report to the Office of Laboratory Animal Welfare (OLAW).

Monitoring to Assure that Animals Remain Pathogen Free

The IACUC requires the placement of sentinel animals in housing areas to assure that the colony remains free of specific pathogens. The Attending Veterinarian manages the university-wide rodent sentinel and quarantine program, and consults with all research faculty members prior to IACUC review and approval of their proposed use of animals. Such animals are periodical euthanized and tested for disease; you may need to build this into both your protocol and project budget. There should be a minimum of 2 animals placed in each room.

Sentinel animals in UMBC’s rodent housing facilities are regularly sent for serology multiplex tests for the presence of a number of pathogens. When the sentinel serology indicates animals are positive for any of the pathogens, at least one animal from each cage of the positive racks in the affected animal rooms will be tested by UMBC Comparative Medicine for follow-up serology. Principal investigators will be notified of the follow-up serology results when they become available.

In the case where follow-up serology results are positive, users of the animal facilities should be aware of the following:

  1. The room(s) are now considered “dirty” and the positive rack(s) will also be marked. Work must be conducted by working from “clean” to “dirty” animals. When working in the “dirty” rooms, animals on the positive rack must be handled last.
  2. Animals in the positive cages identified on follow-up serology may be euthanized within the animal facility. These animals are not to be moved out of their rooms. Contact the Attending Veterinarian before euthanizing any animals.
  3. The Attending Veterinarian should be contacted immediately if users have animals in the affected room(s) which are immuno-compromised.
  4. If ANY animals are moved from these rooms into another room, onto another rack, to another investigator, and/or facility, immediately contact Attending Veterinarian as these animals pose a possible health threat to the animals of other investigators within the facility. Moved animals must be tested.
  5. Special or additional measures and precautions may be required when accessing the affected rooms (e.g. use of gloves, booties or lab coats)

Fish Embryo Use

Larval forms of fish and amphibians have vertebrae and are covered by PHS policy. The IACUC requires submission of an animal use protocol for research and teaching projects utilizing fish and amphibian embryos.

 Avian Embryo Use

Avian embryos are not considered live animals by U.S. regulatory agencies and many universities do not regulate their use in research. Nonetheless, there is a consensus in the scientific community that avian embryos greater than one half of the way to hatching can experience pain. If avian embryos hatch, intentionally or unintentionally, they are live vertebrate animals and are regulated by the IACUC. The IACUC requires submission of an animal use protocol for research and teaching projects utilizing pre-hatched avian embryos 10.5 days or older.

Adverse Events

Reports of adverse events, which are events that occur consistent with routine care or expected outcomes that results in an unexpected morbidity or mortality in animals that was not described in the animal use protocol, should be reported at the time of the problem or event and summarized in the Annual Report, including an explanation of how these events/problems were resolved.

 

Reporting Concerns Regarding Animal Care

UMBC believes the responsible use of laboratory animals in research and instruction, and is committed to protecting the welfare of these animals. It is the responsibility of the UMBC IACUC to investigate all concerns regarding the care, treatment and use of animals for research or teaching on either campus or off campus if the concern involves faculty. Often, the preferred first course of action is to discuss the issue and resolve it on site with the individuals present. Please follow information at this link: Research compliance feedback and reporting research concerns

Such concerns may be written or verbal and no matter how initially raised, will be directed to the IACUC for preliminary evaluation of merit. Confidentiality of the individual raising the concern will be preserved to the extent necessary to conduct the review. The “Institution” will take steps to prevent any retaliatory action.  The “Animal Welfare Act” protects the rights of individuals reporting animal welfare concerns and prohibits discrimination or reprisal for reporting violations of regulations or standards.

All reports are treated seriously and are investigated. If the IACUC finds merit in the concern, it will be passed on to the IO. If the IO agrees with the IACUC assessment, he/she will take administrative action to effect an immediate correction, if this is feasible. If immediate action is not feasible, the IO will notify the OLAW and initiate a process to evaluate the concern and to effect appropriate and sufficient action to correct it.  The IO will take appropriate steps during the review to prevent any retaliation and to protect, to the extent practicable under University policies, the positions and reputations of the persons who made the complaint.

Prolonged Restraint

Brief physical restraint of animals for examination, collection of samples, and a variety of other clinical and experimental manipulations can be accomplished manually or with devices such as restraint stocks or squeeze cages.  It is important that such devices be suitable in size and design for the animal being held and operated properly to minimize stress and avoid injury to the animal.

Prolonged restraint of any animal should be avoided unless essential to research objectives.  Less restrictive systems, such as the tether system or the pole and collar system, should be used when compatible with research objectives.  The following are important guidelines for the use of restraint equipment:

Animals to be placed in restraint equipment should be conditioned to such equipment prior to initiation of the research

The period of restraint should be the minimum required to accomplish the research objectives.  The IACUC must approve prolonged restraint for any reason

Attention must be paid to the possible development of lesions or illnesses associated with restraint, including contusions, decubital ulcers, dependent edema, and weight loss.  If these or other problems occur, veterinary care must be provided to treat the animal, which if necessary must be temporarily or permanently removed from the restraint device.

Suspensions and Appeals of IACUC Decisions

The IACUC is authorized to suspend an activity involving animals as set forth in “PHS Policy” at IV.C.6. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present. The IO, in consultation with the IACUC, shall review the reasons for suspension, take appropriate corrective action, and report that action with full explanation to OLAW.  A decision by the IACUC to suspend an activity may be appealed.

If approval of a proposal is denied by the IACUC because there are serious questions about the care and use of animals, the principal investigator or course instructor can request an appearance before IACUC to answer the questions raised by the Committee. The investigator or instructor may demonstrate, or be asked to demonstrate to the IACUC, the procedures to be used in the research.

If the first appeal to the Committee does not resolve matters to IACUC’s satisfaction, the investigator or instructor may, after consultation with the Vice President for Research, request a second meeting with the IACUC. At this meeting the investigator or instructor may present expert witnesses from UMBC or elsewhere to testify to the adequacy or necessity of the animal care and use outlined in the proposal. The decision of the Committee following this meeting will be final.

Experiments Involving Biohazards/recombinant DNA

No hazardous agents (infectious, oncogenic, radioactive or chemical) may be used in any animal facility without being cleared by the IACUC.  The use of radioactive materials requires additional approval by UMBC radiation safety office.  If special caging and care are required, Veterinary Resources (VR) must be contacted well in advance (prior to submitting an animal protocol is recommended). The VR faculty and facilities personnel of VR are available for consultation and advice on matters relevant to animal housing, care and use when biohazard agents are proposed.

The use of recombinant DNA or transgenic animals will also require review and approval from the UMBC Institutional Biosafety Committee (IBC). Investigators are reminded that approvals form both the IACUC and the IBC are required before initiating and conducting such research with animals.

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