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Principal Investigator Responsibilities

Policy Based on Principal Investigator Meeting, March 18, 2003

Remarks from:

Tony Waldrop, Ph.D., Vice Chancellor for Research and Economic Development, Institutional Official
Tracy Heenan, D.V.M., Research Assistant Professor, Pathology; Director Office of Institutional Animal Care and Use
Dwight Bellinger, D.V.M., Ph.D., Professor of Pathology; Chief Veterinarian and Interim Director, DLAM
Lester Kwock, Ph.D., Professor of Radiology; Former Chair, Institutional Animal Care and Use Committee

Tony Waldrop, Ph.D., Vice Chancellor for Research and Economic Development, Institutional Official

UNC-Chapel Hill commitment to compliance and adherence with our Animal Welfare Assurance Statement.
1. University administration fully supports IACUC and DLAM and the humane care and use of research animals
2. Change in Institutional Official to reflect this support
Lower threshold for non-compliance with animal use application and federal and UNC-Chapel Hill policies and regulations.
1. Increased monitoring of research experiments utilizing animals by IACUC members, IACUC Compliance Coordinator, and DLAM staff
2. Increased reporting of non-compliance to Office of Laboratory Animal Welfare (OLAW) based on UNC-Chapel Hill stricter adherence to reportable categories. All of the following are reportable to the federal regulatory agency:
  1. failures to adhere to IACUC-approved protocols
  2. initiating animal work that has not been reviewed and approved by the IACUC
  3. deviations from approved Standard Operating Procedures (SOPs)
  4. conduct of animal-related activities by unauthorized or unqualified individuals
  5. ongoing, unresolved problems (e.g. overcrowding)
  6. shortcomings in the program of animal care and use that are not corrected in a timely manner, conditions (not authorized by the IACUC) that jeopardize the health and well-being of animals or cause their death
Examples of potential sanctions imposed for non-compliance with application or established policies
1. Continued non-compliance with mouse breeding policy resulting in overcrowding violations: impose fee for labor in addition to a penalty fee
2. Non-compliance with application or IACUC/DLAM policy
  1. contact department Chair and/or Dean
  2. invalidate data gathered without approved application
  3. inspection of "at-risk" laboratories and programs at least monthly to ensure compliance and presentation of an action plan to correct deficiencies
  4. increased frequency of application review (every year vs. every three years)
  5. suspension of animal use application
  6. reporting to OLAW
  7. others
IACUC Survey

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Tracy Heenan, D.V.M., Research Assistant Professor, Pathology; Director Office of Institutional Animal Care and Use

Principal Investigator is responsible for all aspects of an approved animal use application. The principal investigator must ensure the following:
1. Ensure adequate training of all personnel handling animals on project.
2. Ensure that personnel familiarize themselves with all aspects of the animal application.
3. Ensure that personnel adhere to IACUC and DLAM policies.
4. Ensure that personnel who speak English as a second language fully understand and adhere to the approved animal use application and to IACUC and DLAM policies.
5. Ensure that breeding colonies are monitored by research personnel daily and ensure compliance with established breeding policies. Genotyping must be done early.
6. IACUC is in the process of revising the Mouse Breeding Policy. Look for upcoming information from IACUC regarding changes in the policy. There will be required meetings for mouse breeders once policy is finalized.
7. Each investigator should establish and identify a lab coordinator to coordinate animal related activities of the laboratory and to train personnel in the laboratory in proper animal handling. (The laboratory coordinator may be the principal investigator.)
8. The laboratory coordinator will be required to attend formal training and will be certified by an IACUC or DLAM representative to ensure that "investigators and other personnel are appropriately qualified and experienced for conducting procedures on living animals."
9. After the coordinator is certified, the coordinator can then train other individuals in the laboratory. If the investigator changes the laboratory coordinator, he/she must inform the IACUC Office and the new coordinator must receive the necessary training.
10. Each investigator must establish a 24-hour contact name and phone number (or beeper) that DLAM can contact at anytime to ask animal health related questions. Notify DLAM and IACUC of the 24-hour contact name and number.
11. Conduct and document frequent monitoring of animals as deemed necessary by the IACUC in certain studies.
12. Report unanticipated adverse effects occurring in experimental animals to the IACUC. These are adverse effects that are not described in the animal use application.
13. Contact the IACUC Training and Compliance Coordinator when initiating any of the following: studies involving surgeries (survival and non-survival); behavioral studies involving aversive conditioning; studies involving animals in pain category E (unrelieved pain and/or distress); and studies with unanesthetized physical euthanasia (cervical dislocation and decapitation). Failure to contact the Coordinator prior to initiating studies is considered non-compliance and may result in sanctions.
14. Place rodent carcasses in animal coolers in sealed bags labeled with investigator name and application identification number.
15. Toe clipping is disallowed solely as a means of identification. In all cases use of the toe clip must be scientifically justified.
16. Recommend keeping records of animals euthanized.
17. Encourage investigators to provide a range of possibilities in the application. For example: provide a number of different acceptable methods of euthanasia or anesthesia; different methods of blood withdrawal, etc. Providing alternative methods may help reduce the number of amendments that need to be submitted.
18. How to Report Animal Mistreatment or Animal Use Application Noncompliance
Amendments to an approved animal use application
1. Investigator must submit in writing to the IACUC for review and approval any proposed changes to the approved procedures involving animals. Any changes to procedures described in the originally approved application (including changes in dosages, routes of administration, compounds, etc.) must be reviewed and approved by the IACUC prior to implementing.
2. The IACUC revised the current policy of limiting the number of amendments to three amendments over a three-year period. The IACUC will handle amendments on a case-by-case basis. All IACUC members will receive major amendments. Any member may request review of the amendment by the full IACUC. If the amendment significantly changes the content of the application, then the investigator will need to re-write the application to include the changes and the application will receive a full committee review.
Investigators maintaining "satellite" facilities
A satellite facility is a non-Division of Laboratory Animal Medicine (DLAM) facility in which animals are housed for greater than 12 hours and are cared for by the principal investigator.
1. Use DLAM computer-generated cage cards to identify animals.
2. Provide DLAM with a monthly animal census.
3. Contact DLAM veterinary personnel to report any animal health concerns.
4. Provide DLAM and IACUC with a 24-hour contact name and number.
5. Provide the IACUC with a key to your facility.

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Dwight Bellinger, D.V.M., Ph.D., Professor of Pathology; Chief Veterinarian and Interim Director, DLAM

Research personnel must adhere to Division of Laboratory Animal Medicine policies:
1. Investigators are responsible for working with the DLAM staff to inform them about anticipated clinical signs in animals, anticipated phenotypes, and potential adverse effects resulting from experimental procedures, especially animals that may experience pain and distress. This will be accomplished by having summaries of the projects being conducted available to the DLAM staff and arranging for investigators and/or their staff to present their projects to the DLAM staff.
2. Ensure that research personnel utilizing DLAM facilities are familiar with and adhere to DLAM policies. This is especially important when working with research personnel who speak English as a second language. To help understand DLAM policy the DLAM will offer monthly training sessions for research personnel in each major animal facility. The DLAM has also expanded its web site which is now located at http://viper.med.unc.edu/DLAM. It can also be reached through the link at the IACUC web site.
3. Investigators must ensure proper use of cage cards and attention to animal health cards and "overcrowding" cage cards. Proper use of cards is essential to obtain accurate animal tracking and identification of animals; identify sick animals; and to identify overcrowded cages. Examples of improper use of cage cards include: reusing cards; using cards with expired application numbers; cages without cage cards; animals identified with the cage cards bearing an incorrect application number; inappropriate disposal of animal health cards and/or overcrowded cage cards. When animals that have been identified with an animal health card are euthanasia or used in an experiment, write the disposition of the animal on the card, date it and leave it on the changing table.
4. When the investigator's staff is responsible for feeding and watering of animals, the investigator must maintain a log to record feeding and watering of animals by research staff. The log must be dated and initialed daily to ensure adequate monitoring and care of animals and must be posted in the room where the animals are housed. Investigators should maintain copies for documentation.
5. Investigators must help maintain project rooms and not store dirty equipment in these areas when not in use.
6. Health and safety. The investigator must work closely with DLAM and Environment, Health and Safety to coordinate handling of carcasses and soiled bedding in projects involving hazardous agents. The bedding and carcasses are not normally disposed of as hazardous wastes; so any hazards should not be places in the regular waste.

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Lester Kwock, Ph.D., Professor of Radiology; Former Chair, Institutional Animal Care and Use Committee

Review of new and revised IACUC policies:
1. UNC-Chapel Hill IACUC Policy on Cage Population Densities for Breeding Mice
2. Rodent Toe Clip Policy
3. Carbon Dioxide Euthanasia Chamber Policy
4. Proper Disposal of Dead Rodents
5. Euthanasia Adult Rodents and Rodent Pups
6. Guidelines for the Euthanasia of Mouse and Rat Fetuses and Neonates
7. Rodent Tail Cut Method: Blood Collection (rats, mice)
8. Acceptable Methods of Rodent Blood Withdrawal
9. Rodent Tumor Burden Policy
10. Reviewing Requests for Exceptions to Regulations, Policies, and Nationally Accepted Standards
11. Certification of individual performing unanesthetized physical euthanasia