uconn health

Use of Expired Drugs and Biomaterials in Research Involving Animals

Purpose

The use of expired medical materials such as drugs, fluids, or sutures on animals is not considered to be acceptable veterinary practice and does not constitute adequate veterinary care as required by current animal care and use regulations.

Action

1. No expired drugs, fluid replacements, or surgical/medical materials used for analgesic or anesthetic purposes are allowed for use in animals utilized for research, testing, or teaching purposes.

2. All expired materials must be discarded on, or before, their expiration date.

3. Expired drugs or materials are not allowed for use in terminal procedures unless described and justified in the animal care and use protocol and approved by the IACUC.

Effective Dates:  December 2, 2021 through December 30, 2024

Retro-orbital Bleeding

Purpose

In order to comply with government regulations (PHS and USDA), AAALAC, The Guide for the Care and Use of Laboratory Animals, and standard veterinary care techniques, UConn Health’s Institutional Animal Care and Use Committee (IACUC) has implemented a policy concerning retro-orbital eye bleeding.

Action

1. All animals must be appropriately anesthetized prior to performing procedure.

2. Maximum blood collection volumes (mouse):

  • Weekly sampling (0.6% body weight):                             115μL (25g mouse)
  • Every other week sampling (0.8% body weight):          200μL (25g mouse)
  • Monthly sampling (no fluid replacement, 0.6%):          200μL (25g mouse)
  • Monthly sampling (with fluid replacement, 1.5%):       350μL (25g mouse)

3. Maximum blood collection volumes (rat):

  • Every other week sampling (1.5% body weight):           3.5 mL (250g rat)

4. Multiple retro-orbital plexus bleeding requires the use of alternate eyes each time the procedure is performed.

5. No bleeding may be performed from a damaged eye. In the event that both eyes are damaged, eye bleeding must cease.

6. Volumes greater than the maximum volumes listed above require scientific justification and prior approval by the IACUC.

7. Investigators should maintain familiarity with the Center for Comparative Medicine guidelines regarding retro-orbital plexus bleeding.

Effective Dates:  June 1, 2023 through June 30, 2026

This policy has been approved by a majority vote of the IACUC members

Death as an Endpoint

Purpose

In order to comply with federal regulations (USDA and PHS) and the Guide for the Care and Use of Laboratory Animals, 8th edition, 2011, the UConn Health’s Institutional Animal Care and Use Committee (IACUC) has established a policy on death as an endpoint in research projects.

Action

1. Studies should be terminated when animals begin to exhibit adverse clinical signs if this endpoint is compatible with meeting research objectives.

2. Protocols requiring death as an endpoint must contain the following:

  • Scientific rationale
  • Consideration of alternate endpoints
  • Number of animals used for this endpoint and why it is the minimum necessary
  • Plan describing the monitoring of these animals
  • What information is to be gained in the interval between moribundity and death

3. The use of death as an endpoint must be approved by the IACUC prior to the initiation of the research project.

4. Under no circumstances may the use of death as an endpoint be applied simply because it is an unambiguous and easy criterion to apply.

Effective Dates:  June 2, 2022 through June 30, 2025

Code of Ethics for the Care and Use of Animals

Purpose

In order to comply with government regulations (PHS and USDA) and the American Association for the Accreditation of Laboratory Animal Care (AAALAC) the UConn Health’s Institutional Animal Care and Use Committee (IACUC) has implemented a policy regarding a code of ethics for the care and use of animals.

Action

1. It is recognized that in many research protocols there is simply no alternative to the use of live animals. Despite this social imperative for animal experimentation, all investigators have an ethical obligation to explore ways in which animals can be partially or totally replaced by other biological or mathematical/computer systems. When a research question can be pursued using reasonably available non-animal or in vitro models and still result in sound scientific conclusions, the investigator should choose these alternatives.

2. When live animals are used in research or biological testing, there must be a reasonable expectation that such utilization will contribute to the enhancement of human or animal health, the advancement of knowledge, and/or the good of society. The relative value of the study is a particularly important consideration in potentially painful experiments where there is an ethical imperative that the benefits of the research clearly outweigh any pain, discomfort, and distress experienced by the animals.

3. Selection of an appropriate animal model is an important consideration, particularly at a time when alternative models for animal research are being emphasized. It is the investigator’s responsibility to select the optimal species for a particular project. In addition, the number of animals utilized in a protocol should be minimized consistent with sound scientific and statistical standards. It is also the investigator’s responsibility to consider the source of the animal and ensure that all animals used for experimental research are lawfully acquired.

4. When animals are used in a research project, the investigator has an ethical obligation to seek the least painful techniques feasible that will allow the protocol objective(s) to be pursued adequately. If a procedure has associated pain, discomfort, or distress, it is imperative that the investigator estimate the probably occurrence, magnitude, and duration of the pain, discomfort, or distress in order to adequately plan for the treatment of pain.

5. In potentially painful procedures, the investigator must take all necessary steps to assess and monitor pain as well as discomfort and distress. In assessing pain, the investigator should use behavioral signs based on the normal behavior pattern of the species under study.

6. If a procedure will cause more than momentary slight pain or distress to the animal, the pain must be minimized both in intensity and duration through the administration of appropriate anesthetics, analgesics, and tranquilizers consistent with acceptable standards of veterinary medicine. It should be emphasized that the requirement for the alleviation/reduction of pain applies not only at the time the procedure is being conducted, but also following the procedure until such time when the pain is either alleviated or reduced to an acceptable tolerance level.

7. Potentially painful experiments should not be conducted on an awake animal under the influence of a paralytic or curarizing drug without the concomitant use of an appropriate anesthetic.

8. Research in which painful stimuli are used should be so designed as to provide a means of escape from that pain by the animals.

9. It is recognized that in certain research protocols, the administration of appropriate anesthetics and/or analgesics will compromise the scientific validity of the experiment. Such experiments must be justifiable in terms of scientific design and value, and the deletion of these drugs should be based on referenceable scientific fact or experimental data and not intuition. In addition, pain, discomfort, and distress levels should be carefully monitored. There is a limitation on the pain to which an experimental animal may be exposed. Investigators should choose the earliest possible end-point in order to minimize pain and discomfort. An animal that is observed to be in a state of severe pain that cannot be alleviated or reduced to an acceptable tolerance level should be immediately euthanized.

10. No animal should be subjected to multiple survival surgeries, except where they are inter-related and essential to the primary research objective.

11. Physical restraint procedures should be used on an awake animal only after alternative procedures have been considered and found to be inadequate. If a restraint will be utilized, the animal should be trained or conditioned to the restraining device, using positive reinforcement, prior to the beginning of the experiment. The restraining device should provide the minimum restraint consistent with the maximum security and comfort of the animal. In addition, the restraining device should provide the animal with the greatest possible opportunity to assume its normal postural adjustments. Awake animals should not be subjected to prolonged physical restraint.

12. It is the responsibility of the investigator to ensure that adequate post-surgical/procedural care is provided to all animals. This care must meet acceptable standards of veterinary medicine and be provided as long as necessary, including during non-duty hours.

13. Euthanasia is the act of inducing painless death. The proposed method of euthanasia must be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia (2013).  If an animal will not be subjected to euthanasia at the completion of a research protocol, it is the responsibility of the investigator to ensure that the final disposition of the animal is both humane and acceptable.

14. Procedures involving the use of animals should be performed by or under the immediate supervision of an individual with the appropriate training and experience relative to the procedures to be carried out on live animals.

Effective Dates:  June 2, 2022 through June 30, 2025

Cage Identification

Purpose

The Institutional Animal Care and Use Committee (IACUC) has implemented a policy stating that all animal care and use at the Health Center will comply with the recommendations set forth in the Guide for the Care and Use of Laboratory Animals, 8th edition, 2011. This policy will detail the requirements for cage identification.

Action

1. All animal cages must be appropriately labeled. It is the responsibility of the Principal Investigator (PI) to ensure that each cage is clearly identified with the following:

  • PI Name
  • Active Protocol Number
  • Species
  • Strain / Stock / Genetic Designation (either full name or a defined “nickname”[identified in the IACUC protocol(s)]) or GMO number
  • Sex
  • Date of Birth or Arrival Date / Age at Arrival

2. All cages housing animals exposed to or presenting a hazard must also be labeled with the Hazard Protocol Identification Number, the type of hazard associated with that cage (e.g., biohazard symbol or carcinogen / chemical hazard symbol / sticker), the specific hazard involved (e.g., infection with Leishmania spp.), the application date (when inoculated, exposed), and if appropriate, the clearance date.

Effective Dates: December 2, 2021 through December 30, 2024

Animal Holding in Investigator Laboratories

Purpose

In order to ensure a safe environment for both employees of the Health Center, and the laboratory animals, the Institutional Animal Care and Use Committee (IACUC) has implemented a policy regarding the holding of animals outside of the main Center for Comparative Medicine (CCM) animal facility in the Health Center.

Action

1. Animals must be transported from the animal housing room to the PI laboratory in clean, closed caging (either microisolator lids or soft bonnet type covers) where appropriate (e.g., rodent caging).  Please refer to the IACUC Policy on Animal Transport to and from PI Laboratories for full details on how animals are to be transported.

2. Animals may only be held in the PI laboratory for ≤12 hours if it is USDA-regulated species or ≤24 hours if it is any other species without prior IACUC approval. The housing of animals outside the above specified hours is discouraged and approved on a case-by-case basis requiring scientific and/or medical justification and prior approval by the IACUC.

3. Animals must be held in a laboratory room that has been listed on the PI’s approved Animal Care and Use Protocol. In addition, if animals are to be kept unsupervised in the PI laboratory, the doors to the laboratory must be kept closed and locked. If animals are held in the laboratory for >12 hours for a USDA-regulated species or >24 hours for a non-regulated species, a log showing daily checks, temperature, and humidity must be maintained. CCM will provide the template for required daily animal checks. Further:

  • Light must be maintained 12:12 light/dark cycle;
  • The cage card must contain all the required information;
  • Feed, bedding, water bottle, and cages can be obtained from the CCM animal facility and should be changed weekly. Husbandry practices should be followed as if they are housed in the animal facility;
  • Dirty bedding should be disposed of in closed biohazard trash bags;
  • The animal may not be returned to the animal facility without prior permission; and
  • The facility must be available for CCM animal care/IACUC staff at all times.

4. Animals involved in experiments that use hazardous materials or organisms which are required to be housed in the PI laboratory are to be removed from CCM facilities, transported to, and held in the PI laboratory in accordance with additional specific instructions in the safety protocol governing the hazardous work approved by the Biological Safety Officer and the IACUC.

5. Animal caging (with or without animals) may NOT be placed, unsupervised, in the hallways.

6. Any laboratory in which animals are held without IACUC approval will forfeit the privilege of bringing animals into the laboratory for 3 months.  All procedures must be performed in the animal facility for that period of time on all animals.

Effective Dates:  June 1, 2023 through June 30, 2026

This policy has been approved by a majority vote of the IACUC members.

Animal Training and OHS Requirements

Purpose

The Animal Welfare Act, Animal Welfare Regulations, and PHS Policy require institutions to provide training for all personnel engaged in animal research to include, but not limited to: Principal Investigators (including those that do not work directly with animals), research associates, post-doctorate fellows, students, animal facility personnel, and IACUC members.

PHS Policy requires institutions to have an occupational health surveillance (OHS) program and that all animal users participate in the program.

The Institutional Animal Care and Use Committee (IACUC) is charged with ensuring that all personnel who use animals are adequately trained and enrolled in the OHS program.

Action

1. All new personnel who require animal use training must contact register for a class to attend at a 3-hour core lecture series on vertebrate animal use.  Registering for a class is done on the web at IACUC initial trainingNew personnel may not register for training unless they have a UCH network account.

2. Continuing training will be accomplished by PowerPoint slides through SharePoint.  New training slides will be published in SharePoint each year.  Details on how to access training is maintained on the IACUC website at IACUC online renewal training.

3. Additional training in specific procedures may be required and will be scheduled through the Center for Comparative Medicine (CCM). All individuals using animals are required to maintain documentation of procedural training on the Animal training record form.

4.OHS enrollment is required of all individuals who use laboratory animals.  Enrollment is done on-line through the SharePoint system.  Personnel must have a UCH network account in order to enroll in, or renew, OHS enrollment.  The Mandatory Annual Certificate of Enrollment form is found on the web.

5. The IACUC office will be responsible for notifying all personnel who require continuing training and informing personnel on what on-line course(s) must be completed and the date by which the training must be completed.  The IACUC office will be responsible for notifying all personnel who require OHS enrollment and re-enrollment and the date by which the OHS enrollment must be completed.

6. The IACUC office will be responsible for documenting all initial and on-line training activities of animal users at UConn Health.  The IACUC office will be responsible for notifying all personnel who require OHS enrollment and re-enrollment.

7. No person shall attempt to work with animals until they have completed the required training and OHS enrollment. Failure to obtain approved training and failure to maintain OHS enrollment constitutes non-compliance with this policy.

8. Protocol associates who do not complete the required training and/or OHS enrollment by the due date will be administratively removed from the protocol(s) and have their access privileges to CCM facilities withdrawn.  A reinstatement of protocol associates will require a modification to be submitted to the IACUC.  An affected protocol associate must re-request facility access from CCM in order to have facility access reinstated.

9. Principal Investigators who do not complete the required training and/or OHS enrollment by the due date will have their protocols withdrawn.  Protocols may be reactivated by the IACUC when requirements have been completed.

This policy has been approved by a majority vote of the IACUC members

Effective Dates:   December 7, 2023 through December 31, 2026

Annual Reviews and Expired Animal Protocols

Purpose

In order to comply with both NIH-PHS government regulations that cover all vertebrate animals and USDA government regulations that cover most warm-blooded vertebrate animals, the UConn Health’s Institutional Animal Care and Use Committee (IACUC) has implemented a policy regarding the expiration of protocols and the requirements for annual review.

Action

1. All protocols expire approximately 35 months from the approval date.

2. All protocols require a new submission approximately every 35 months of the work continues.

5. Email notifications via InfoEd are sent to the PI four (4) months prior to the protocol expiration date stating that the protocol is expiring and a new application will be due two (2) months prior to the expiration date.

6. All protocols will be terminated on the expiration date; extensions are not allowed under federal regulations or our PHS Assurance.  If a new replacement protocol has not been approved, all experimental animal use must cease.  Breeding pairs covered under the expired protocol must be separated.

7. A “stop census” in InfoEd must be performed on the day the protocol expires and animals must be transferred to another active protocol (e.g., the PI’s renewal protocol or the CCM holding protocol). The transferred animals will be counted against the renewal or holding protocol.

Effective Dates:      December 7, 2023 through December 31, 2026

Food Placement for Impaired Rodents

Purpose

The Guide for the Care and Use of Laboratory Animals states that animals should be fed palatable, non-contaminated, and nutritionally adequate food daily or according to their particular requirements unless the protocol in which they are being used requires otherwise. In addition, the Guide states that feeders should be designed and placed to allow easy access to food and to minimize contamination with urine and feces. Placement of rodent chow in an appropriate feeder may not be in the animal’s best interest if that animal is unable to reach the food hopper. In this situation, the IACUC recognizes that placement of rodent chow on the floor of the cages of sick or injured animals will ensure that animals will be able to access the food.

Action

1. An appropriate amount of rodent chow or powdered food in a Petri dish should be placed in the cage of animals that cannot reach the food hopper or have an impairment which affects their ability to chew rodent chow.

2. The cage should be identified as being a cage where food is being placed on the floor of the cage because of an impaired animal.

3. Food should be changed minimum weekly, or as needed, so as to minimize potential contamination with the animals’ urine and feces.

4. Food should be placed on the floor of the cage for the least amount of time necessary to ensure adequate nutrition of the impaired animal.

Effective Dates:      December 1, 2022 through December 31, 2025

Cage Density and Weaning Activity for Mice

Purpose

In order to comply with government regulations (PHS and USDA), the American Association for Accreditation of Laboratory Animal Care (AAALAC), and The Guide for the Care and Use of Laboratory Animals, 8th edition, (NRC, 2011) the UConn Health’s Institutional Animal Care and Use Committee (IACUC) has implemented a  policy concerning cage densities and weaning activities for mice.

Action

1. The IACUC allows a housing maximum of 125 grams to be the total mouse mass to be grouped per standard 67 sq. in. cage. Post weaned mice are defined as no longer suckling or greater than 21 days old. An exception to this 125 gram rule is granted for large or obese mice (e.g., NOD) where two mice are permitted per cage even if the combined weight exceeds 125 grams by the ACC. The benefits of social housing takes preference over body mass but such cages must be flagged with the 125 gram exception sticker.

2. Monogam Breeding (one male to one female)- The IACUC recommends one male to one female in a permanent breeding arrangement as the optimal use of the 67 sq. in. cage size available in CCM. In this arrangement, cage densities may temporarily exceed the 125 gram combined mouse mass for large parents/litters such as out-bred strains of mice (e.g., CD-1 mice). However, birthdates must be noted on such cages, the 21 day weaning time limit must be observed, and such cages must be flagged with the 125 gram exception sticker if the weight limit is exceeded.

3. Bigam Breeding (one male to two females)- The IACUC recognizes the necessity for difficult breeders (need for cross fostering and utilizing post partum estrus) to be set up in a bigam breeding arrangement with a permanent presence of the male with two females. Such cages must be within the 125 gram maximum mouse mass limit at the time of breeding unit set-up. Pups less than 9 grams may stay past the 21 day weaning deadline, but no more than 10 pups from maximum two litters are allowed per cage at any given time by the IACUC. Cages exceeding the maximum 125 gram total mouse mass must be flagged with the 125 gram exception sticker.

4. Multigam Breeding (one male to more than two females)- Harem breeding is permitted provided the total mouse mass at the time of breeding cage set up is less than 125 grams including the males and the non-pregnant females. Due to pregnancies, the total mouse mass may temporarily exceed the 125 gram rule; however, females must be separated prior to parturition even if this means that the post partum estrus will be missed. Cages exceeding the maximum 125 gram total mouse mass must be flagged with the 125 gram exception sticker.

5. Investigators and research staff should maintain familiarity with this density policy and CCM’s flagging system. CCM staff will flag, with a pink sticker, cages with pregnant females. On the same sticker, CCM staff will record the date of birth (DOB) and the date of weaning (Wean). Once the date of weaning is reached, CCM staff will post a “PLEASE WEAN” sticker as a last reminder. After that, CCM staff will wean without further notice if a cage is in violation of this cage density policy.

Effective Dates:  June 2, 2022 through June 30, 2025