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

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

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 5, 2024 through December 31, 2027

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.

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 training.  New 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

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

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

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 200 grams to be the total mouse mass to be grouped (no more ethan 5 mice) per cage. Post weaned mice are defined as no longer suckling or greater than 21 days old.

2. Monogam Breeding (one male to one female)- The IACUC recommends one male to one female in a permanent breeding arrangement.  Birthdates must be noted on such cages and the 21 day weaning time limit must be observed.

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.

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 200 grams including the males and the non-pregnant females.

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:  February 27, 2025 through June 30, 2025

Purpose

In order to comply with government regulations and to make the modification approval process as simple as possible for the Principal Investigators (PI), the IACUC has established a policy on modification review and approval.

Action

Any change to a protocol requires the PI to submit a modified protocol through InfoEd.  This is sent to the IACUC office and the IACUC Administrator reviews the modification for processing.  The IACUC Administrator is responsible for determining if a modification is major (significant) or minor; however, the ultimate decision, should there be any questions, will lie with the IACUC Chair.

Table one below lists examples of modifications that would be considered minor or major (significant).  Table two below lists examples of modifications to be reviewed by various review methods.

IF THE MODIFICATION IS MINOR: Review of the submitted modification will be reviewed administratively for approval by an appropriate member of the IACUC.  If there are any questions regarding the assignment of an appropriate member, the IACUC Chair will review the modification.  No other review by the IACUC is required.

IF THE MODIFICATION IS MAJOR: The modification will be reviewed by the IACUC according to federally recognized review processes:  Full Committee Review (FCR), Designated Member Review (DMR), or Veterinary Verification and Consultation (VVC).  The IACUC Administrator is responsible for determining a review type; however, the ultimate decision, should there be any questions, will lie with the IACUC Chair.

Full Committee Review:  If the IACUC Administrator determines that the significant modification requires a full committee review, it will be processed as such.  The modification will be assigned appropriate reviewer(s) and will be reviewed by the full committee at a regularly convened meeting.

Designated Member Review:  If the IACUC Administrator determines that the significant modification meets the criteria for a DMR review, it will be processed as such:

1. Notification of the submission of the modification will be sent to the entire committee so that each member may make a determination of whether or not they wish to call for a full committee review of the modification.  The IACUC Administrator will generally allow a few days for this review; however, exceptional circumstances may warrant a shorter review time period.
2. The modification will remain on the agenda covering the request period for documentation purposes.
3. It is the responsibility of the IACUC member(s) assigned to review the modification to do so by the assigned due date.
4. The modification does not get reviewed at a regularly convened IACUC meeting.

Veterinary Verification and Consultation Review:  If the IACUC Administrator determines that the significant modification meets the criteria for a VVC review, it will be processed as such:

1. The modification request will be sent to the Attending Veterinarian (AV) for approval.  Certain circumstances may warrant that the request also be reviewed by safety personnel (if there is an addition of the use of a hazardous chemical or biological agent).
2. The modification will remain on the agenda covering the request period for documentation purposes.
3. It is the responsibility of the AV assigned to review the modification to do so by the assigned due date.
4. The modification does not get reviewed at a regularly convened IACUC meeting.

The initial determination of modification requests to be minor or major (significant) and the review type (FCR, DMR, or VVC) will be performed by the IACUC Administrator.  Should there be any questions regarding whether or not a modification is considered to be minor or major (significant), it will be decided by the IACUC Chair.  Should there be any questions on the assignment of a review process for major (significant) changes, it will be decided by the IACUC Chair.

TABLE ONE:  Examples of Major (Significant) vs. Minor Modifications

Major- Requires IACUC Review	Minor- Handled Administratively
Change in purpose or aim of a study	Addition of qualified personnel (other than PI)
Change in Principal Investigator	Addition or deletion of funding sources
100% or greater increase in rodent animal numbers	Addition or deletion of room locations
25% or greater increase in non-rodent animal numbers	<100% increase in rodent animal numbers
Addition of survival surgery	<25% increase in non-rodent animal numbers
Addition of painful procedure	Need to repeat an experiment
Housing of animals in a location that is not part of the animal program overseen by the IACUC	Addition of animal strains, including transgenic or gene targeted lines
Any changes that have the potential to impact personnel safety
Changes in experimental procedures
Addition of experimental procedures
Addition of species

TABLE TWO:  Major Modifications- Criteria for FCR/MDR/VVC Reviews

Full Committee (FCR)	Designated Member (DMR)	Veterinarian (VVC)
Addition of major survival surgery	Chage in purpose or specific aim of a study	Changes to anesthesia and analgesia
Addition of painful procedures	Change in Principal Investigator	Addition of non-invasive sample collections
Death as an Endpoint	Housing of animals in a location that is not part of the animal program overseen by the IACUC	Euthanasia to any AVMA-approved method
Any exceptions to regulations or standards	Any changes that have the potential to impact personnel safety	Addition of sample collection times
Addition of a new USDA-regulated species	Addition of new non-USDA-regulated species
	Addition of minor survival surgery

 

Effective Dates:  December 5, 2024 through December 31, 2027

 

Purpose

The Institutional Animal Care and Use Committee IACUC) recognizes that ensuring compliance with approved animal care and use protocols is an important aspect of a laboratory animal program. The purpose of a post approval monitoring (PAM) program is to work with investigators to facilitate their animal research and to be proactive in identifying potential problems in their compliance with active IACUC protocols. The PAM program at UConn Health will operate under the acronym PAWS: Post-Approval Animal Welfare Support.

Action

1. All PAM will be under the supervision of the IACUC and will be performed by a designated Compliance Liaison Officer (CLO) accompanied by one voting member of the animal Care Committee.  A minimum of 12 reviews will be performed per year.

2. All active animal care and use protocols are eligible for PAM review. Criteria which may increase the frequency of PAM protocol review include:

• Animal use in pain categories D or E
• Significant personnel changes
• Significant increases in protocol activity
• The use of biohazards and/or carcinogens
• The use of physical restraint
• The use of food and/or water restrictions

3. A summary of the findings of PAM reviews during a given month will be reported to the IACUC at its monthly meeting.

4. The PAM program consists of the following areas:

• Semi-annual inspections;
• Unannounced drug inspection visits;
• Observation of procedures:
• Records review;
• Housing room inspections;
• Review of new protocols with investigative staff prior to first use; and
• Any aditional activity deemed to be appropriate by the IACUC and/or IACUC staff.

5. The PI and the senior research staff for the reviewed protocol are required to be present during a PAM review to facilitate the review; this likely depends upon the activity being reviewed.

6. Issues that pose a significant threat to animal welfare will be referred immediately to the attending veterinarian for resolution and also to the IACUC for further investigation.

7. A written report of the monitoring results, including suggested corrective actions, will be brought to a meerting for review by the IACUC.

8. The PI will have 28 calendar days from the IACUC meeting date of the discussion of the initial PAM review to respond to any identified deficiencies and recommended corrective actions. Investigators who disagree with PAM review results, recommendations, or corrective actions can appeal their concerns to the IACUC.

9. The IACUC chair (or designee) will review and approve the PI’s responses. If the PI’s responses are not acceptable, the IACUC chair (or designee) will seek further revisions and the PI will have 14 additional days to respond.

10. If the PI does not respond to the inspection findings of the PAM activity conducted within the appropriate time frame as outlined above, the ACC will then decide on how to proceed.

Effective Dates:   June 6, 2024 thru June 30, 2027