Individual Financial Conflict of Interest in Research Committee

• The UConn Health Individual Financial Conflicts of Interest in Research Committee (Individual FCOIRC) is a faculty committee with responsibility for the identification and management of individual financial conflicts of interest as relates to the conduct of research at UConn Health.  The Individual FCOIRC includes broad representation of the UConn Health community.
• All UConn Health investigators are required to submit a financial disclosure electronically in the UConn Health InfoEd External Interests / FCOI & FCO system: https://uchealth.infoed.uconn.edu.
• The Individual FCOIRC meets regularly to review financial disclosures, identify individual financial conflicts of interest (FCOIs) in the conduct of research, and to assign appropriate management or mitigation plans for identified FCOIs.

Institutional Financial Conflict of Interest in Research Committee

• The UConn Health Institutional Financial Conflict of Interest in Research Committee (Institutional FCOIRC) identifies and manages institutional financial conflicts of interest in research as relates to: (1) the institution; and (2) Institutional/Covered Officials (IOs/COs) with: (a) authority or responsibility for research programs, research administration, or research funding, or (b) a position of authority (direct or indirect) over the conduct of research.  The Institutional FCOIRC includes broad representation of the campus community.
• All UConn Health IOs and COs identified on the list maintained by the Office of the Vice President for Research (OVPR) are required to submit a financial disclosure in the UConn Health InfoEd Financial Interests [FCOI] system.  Individuals who have more than one role at UConn Health (e.g., Investigator and IO) are only required to submit one disclosure in the UConn Health InfoEd Financial Interests [FCOI] system. The one disclosure covers the requirements of both Committees.
• The Institutional FCOIRC meets regularly to review financial disclosures, identify institutional financial conflicts of interest (FCOIs) in research, and to assign appropriate management or mitigation plans for identified FCOIs.

Listed below are various self-service how-to handouts, instructional sheets, guides, and job aides with step-by-step instructions on how to perform various functions within the UConn Health InfoEd Financial Interests [FCOI] system which covers financial interest disclosures for individuals, clinical practitioners, and institutional officials at UConn Health.

These materials are specific to UConn Health and should not be used by persons on the Storrs/Regional Campuses unless specifically instructed to do so by the FCOI staff.

How-to Guides for UConn Health Investigators

• Quick Reference Guide Updated
• Prepare and Submit an Individual Financial Disclosure Updated
• View Last Individual Financial Disclosure Updated
• Turning Off Pop-up Blocking on Various Web Browsers New

If you have questions about the requirements to submit an annual financial disclosure, please contact Dr. Gus Fernandez-Wolff (gfernandez@uchc.edu or 860.679.8125) or fcoi@uchc.edu.

For technical issues with InfoEd, please email era-support@UConn.edu or call 860.486.7944.

How-to Guides for Department Administrators, SPS staff, and FCOI staff – for UConn Health only

• Lookup the submission status of an Individual Financial Disclosure – for Department Administrators, SPS staff, and FCOI staff
• Add Personnel, Review COI Status and Send COI Email – for SPS staff
• Request a FCOI Review Needed Automatically through PT Module – for SPS staff

Painful Procedures used in Research Laboratory Animals

The IACUC has reviewed commonly performed procedures and has classified those procedures into pain categories.  This should be considered a starting point.

The IACUC actively reviews all commonly performed procedures and, for the purposes of understanding how these procedures can impact animal well-being, these procedures are assigned pain categories analogous to the definitions set forth by the USDA.  Because of the unique nature of science, each protocol is considered independently and the scope of potentially painful procedures are considered in the context of each protocol.  The specific pain category for any procedure may be changed by the IACUC as it best reflects the proposed work and expected well-being in that protocol.

Pain Category B (breeding and housing)

• Breeding only
• Housing only

Pain Category C (momentary pain or distress)

• Alert animals (behavioral observation or brief restraint)
• Anesthetize and release for non-invasive procedures (e.g., imaging, bandage change)
• Change in environmental parameters (e.g., diet, light cycle, room temperature if within thermoneutral zone)
• Chemical carcinogen use (e.g., BrdU)
• Euthanasia with or without tissue/organ harvest
• Food restriction that results in weight loss of <20% of normal age-matched controls
• Gavage
• Irradiation (sublethal or with reconstitution)
• Non-surgical collection of body fluids (blood, urine, etc.) unless otherwise categorized
• Radioisotope use
• Simple injections (IP, IV, SubQ, etc.)
• Tail biopsy for genotyping prior to or at weaning
• Use as a parasitic host

Pain Category D (more than momentary pain or distress for which appropriate anesthetic, analgesic, or tranquilizing drugs will be used)

• Antibody production:  polyclonal (non-ascites, no footpad injections)
• Burns
• Diagnostic procedures  (e.g, laparoscopy, needle biopsy)
• Electric shock with escape
• Introduction of illness (including the administration of toxins, microbiological agents, clincal transgenic phenotypes) with pain relief
• Lavage
• Non-survival surgery
• Physical trauma
• Survival surgery
• Tail biopsy for genotyping on post-weaning animals
• Toxic substances use (e.g., streptozotocin, MPTP, cisplatin, doxycyline)
• Transgenic mouse production (embryo manipulations to produce novel strains, etc.)
• Tumor induction or implantation without metastasis
• Exposure of skin to UV light to induce sunburn with pain relief
• Exposure of blood vessels for catheterization
• Exsanguination or transcardial perfusion under anesthesia

Pain Category E (more than momentary pain or distress for which appropriate anesthetic, analgesic, or tranquilizing agents are not used)

• Antibody production:  ascites
• Death as an Endpoint or lethal dose studies
• Euthanasia by procedures not approved by AVMA Guidelines
• Exposure to extreme environmental temperatures
• Food restriction that results in weight loss of >20% of normal age-matched controls
• Footpad injections (antibody production or microorganism)
• Forced exercise
• Genetically engineered animals with phenotype that causes pain or distress that will not or cannot be alleviated
• Housing outside thermoneutral zone
• Induction of arthritis with prolonged pain and discomfort
• Induction of illness (including the administration of toxins, LPS, microbiological agents without pain relief)
• Noxious stimuli from which there is no escape, including electric shock
• Ocular or skin irritancy tests
• Pain study
• Paralysis
• Total body irradiation (lethal or without reconstitution)
• Tumor production or implantation with metastasis
• Unusual or prolonged restraint (e.g., pie chamber, chair – 30 minutes or more in a conscious animal)
• Use of housing outside thermoneutral zone
• Water deprivation beyond that which is necessary for ordinary pre-surgical preparation
• Withholding of post-operative analgesia for any surgical procedure for which analgesia is typically given

Purpose:

Prolonged restraint of conscious animals can be stressful and has the potential to physically harm the animal; however, prolonged restraint may be necessary in order for research objectives to be met.  In order to ensure that physical restraint of conscious animals for prolonged periods is scientifically justified and performed in a manner that is humane as possible, UConn Health’s Institutional Animal Care and Use Committee (IACUC) has implemented the following guidelines for prolonged physical restraint of animals used for experimental purposes.

Action:

1. Physical restraint is use of manual or mechanical means to limit some or all of animals normal movement for the purpose of examination, collection of samples, drug administration, therapy or experimental manipulation.
2. Prolonged restraint will be defined as a period of physical restraint for 30 minutes or more of a conscious animal.
3. The Guide for the Care and Use of Laboratory Animals states that prolonged restraint must meet the following conditions:
   • Restraint devices should not be considered a normal method of housing or used for convenience;
   • Alternatives to physical restraint should be considered;
   • The period of restraint must be the minimum time necessary to achieve the research goals;
   • Animals to be placed in restraint devices should be given training (with positive reinforcement) to adapt to the equipment and personnel;
   • Animals that do no adapt to the restraint methodology should be removed from the study;
   • Provision should be made for observation of the animal at appropriate intervals, as determined by the IACUC;
   • Veterinary care must be provided if lesions or illnesses associated with the restraint are observed; and
   • The purpose of the restraint device and its duration should be clearly explained to personnel involved with the study and personnel must be properly trained.
4. Complete descriptions of the use of the restraint device needs to be detailed in the non-surgical procedures section of the protocol.  Details regarding the justification for use, the acclimation of the animals to the restraint device, and the veterinary care plan (if required) is to be detailed in the Protocol Checklist section of the protocol; the “Prolonged Restraint” checkbox must be checked and all questions completed.
5. If there are any indications that animals are not adapting to the prolonged restraint being used, or if there are any injuries to the animals, the Attending Veterinarian (AV) must be consulted.  The AV may terminate the restraint procedures at any time if there are any signs of complications that may compromise the animals’ health.
6. Prolonged physical restraint of non-acclimated animals can only be approved by the IACUC if it is required to achieve scientific objectives (e.g., to induce stress); this may warrant the study to be classified as pain category “E”.

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

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

IACUC Policy on Vaporizer Calibration and Maintenance

Purpose:

Anesthesia machines and vaporizers must be in good working conditions to reduce anesthetic gas leaks, to ensure the best performance of scavenging equipment, and to provide the appropriate percentage of anesthetic delivery.  Personnel must be trained in the proper use of anesthetic machines and vaporizers prior to operations; CCM should be contacted to arrange for training.  Vaporizer scavenging must also be evaluated; EH&S should be contacted to arrange for an evaluation.

Action:            

1. Accuracy of anesthetic agent ouput from a precision vaporizer must be verified annually or any time the vaporizer has not been in service for more than a year.  If the verified deliver is ± 15% out of calibration of the target value, the unit must be serviced by qualified personnel or company.
2. CCM will maintain a list of vaporizers for a yearly calibration and arrange for the calibration to be performed. The CCM Vet staff will send an initial e-mail, followed by remainder notification to all users regarding the scheduled time/date of calibration. It is the responsibility of the PI to pay for this service. If the PI couldn’t avail that scheduled time for calibration; then they have to schedule on their own.
3. Isoflurane vaporizers may not be used with any other inhalant anesthetic.
4. The vaporizer must be maintained in an upright position to indicate liquid levels accurately.
5. Use compressed O₂ USP (99.99% Pure), supplied by Carrier gas.
6. If charcoal canisters are used for scavenging, record the amount of time in use or the canister weight after each use (initial weight of canister should be written on the canister). Follow manufacturer’s recommendations for the use of the canister regarding when it requires replacement.  Canisters typically must be discarded after either 12 hours of use or a 50g increase in weight.  When removing canisters from scavenging, please take them or enclose them in a secondary container.  Canisters must be picked up by EH&S for disposal.
7. If the vaporizer is used in a chemical fume hood so that the released gas outlets to the inside of the hood, there is no requirement for a charcoal filter to be used.

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

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

IACUC Policy on Veterinary Consultation Regarding the Use of Animals on which Pain Category D and/or E Procedures are to be Performed

Purpose:  Regulations require that procedures that may cause more than momentary or slight distress to animals will involve, in the planning state, consultation with the Attending Veterinarian (AV) or their designee.  This policy is implemented to ensure compliance with the federal mandate when a Principal Investigator (PI) is using animals in a procedure classified as pain category D and/or E.

Action:

1. The PI, or their designee, shall consult with the AV during writing, and prior to submitting, an IACUC protocol.
2. The AV shall complete a protocol review worksheet when consulting with the PI.
3. The worksheet, and future modifications to it, shall require approval by the IACUC.
4. The completed worksheet shall be co-signed by both the AV and the PI after the consultation process is completed.
5. A copy of the worksheet will be given to the PI.
6. An electronic copy of the worksheet shall be uploaded (electronically attached) to any protocol submission falling under this policy.  The worksheet shall be appended in section 4.2.1.7- “Mandatory Veterinary Consultation for Pain/Distress Categories D and E”.
7. Any protocol submitted without a completed consultation worksheet will be returned to the PI without review.

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

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