IACUC Orientation Part 1.6 PI Responsibilities and IACUC Training Requirements
The Principal Investigator is responsible for all aspects of an approved animal use application including but not limited to the following:
(training requirements start with LAC section on p 2 below)
Principal Investigator (PI) has overall responsibility of laboratory personnel handling animals in lab and in DCM facilities
- Establish a culture of compliance; zero tolerance for non-compliance with established policies, standard operating procedures, regulations
- PIs must abide by the application certification statements
- PIs and all animal handlers must read the applications and amendments after approval and be familiar with all animal procedures
- Establish a 24-hour contact number so that DCM can contact lab personnel at any time to ask animal health related questions
Ensure adequate training of personnel handling animals on the project
- Establish a Lab Animal Coordinator to train and certify lab personnel and to coordinate activities of the laboratory
- Ensure that all animal handlers are familiar with animal care and use responsibilities, regulations, and policies
- Ensure that personnel who speak English as a second language fully understand and adhere to the protocol and IACUC and DCM policies
- Get renewals and applications to IACUC on time
- Application submissions are due by the 15th of the month prior to the expiration date (i.e., a full 6 weeks prior to expiration).
- OACU suggests that PI’s send continuation applications a month early if possible to avoid situations where there are animals in-house on an expired application
Ensure that research personnel adhere to procedures described within approved animal use applications, IACUC policies, and DCM policies
- Review new and revised IACUC policies with research staff, for example:
- Proper CO2 Euthanasia
- Amendments required for new procedures and personnel
- Mouse Cage Density Policy
- Proper procedures in DCM facility
- Proper transport of animal
- Rodent Carcass disposal
- No sharing of DCM facility access cards
- Ensure proper documentation: The USDA and PHS policies require proper documentation of animal care and use to assess compliance with research protocols and clinical care procedures. Dates of all observations, treatments, and procedures must be recorded. Dates and times (including AM/PM) of all time-sensitive observations or treatments (post-operative evaluations, pain medication) must be recorded. Extent of records vary based on the nature of the procedure; however, at a minimum, records of the procedure must consist of: Animal ID, date of procedure, type of procedure, anesthetics/analgesics used (dose, route, time), anesthesia chart (vital signs – e.g. pulse rate, heart rate), drugs given (dose, time), general procedures (e.g. intubation, beginning and end of surgery, etc.). Any deviations from the procedure as approved in the protocol due to emergency need must be documented, explained, and reported to the Office of Animal Care and Use. All records must be available for review at any time by IACUC and external regulatory officials.
- Conduct and document appropriate monitoring of animals as deemed necessary by the IACUC
- Report to the IACUC unanticipated adverse effects occurring in experimental animals
The investigator is required to contact the IACUC Training and Compliance Team to schedule a procedural observation when first 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)
- Studies with unanesthetized physical euthanasia (cervical dislocation and decapitation)
- Use of paralytic agents
Contacting the IACUC Compliance Team for these types of studies is a requirement when using animals on this campus. A Compliance Coordinator must observe the procedure and assess whether individuals conducting the procedure are qualified. The Investigator’s failure to contact a Compliance Coordinator prior to initiating these procedures may be considered non-compliant and may result in sanctions.
The Laboratory Animal Coordinator Certification Program
Investigators should fully support the UNC-Chapel Hill Laboratory Animal Coordinator Certification program. Investigators should support and provide the necessary resources and authority to their designated Laboratory Animal Coordinators (LAC). In addition, PIs must be fully aware of responsibilities vested in LAC’s and should receive LAC didactic training.
Each Investigator with active animal applications must appoint a Laboratory Animal Coordinator and notify the IACUC. The LAC is a trained and certified member of the research team who is responsible for coordinating animal activities in the laboratory and for training and certifying other members of the laboratory in proper animal handling. The LAC should be a permanent employee rather than a student. The LAC must be trained and certified by the IACUC, not another LAC. The Principal Investigator may serve as the Laboratory Animal Coordinator.
Laboratory Animal Coordinator Training
a) Laboratory Animal Coordinator Lecture – Every LAC must take the on-line orientation and attend a lecture outlining the responsibilities of a Lab Animal Coordinator. Contact OACU for registration at 919-966-5569. A member of the Training and Compliance Team will give the lecture on a monthly basis.
b) Species Specific Animal Handling – If the laboratory performs its own animal procedures (rather than arranging for DCM to perform the animal handling), the laboratory must have an IACUC-certified LAC certified in basic animal handling. The LAC must be capable of training lab members in the basic techniques. Alternatively the lab may opt to have each individual in the lab who handles animals attend the appropriate IACUC basic animal handling training class(es). A LAC cannot be certified by another LAC.
If DCM performs all of your animal procedures, it may not be necessary for the LAC and/or laboratory members to have species specific training. Please consult with OACU on a case-by-case basis.
NLAC—voluntary membership to the Network of Laboratory Animal Coordinators. For more information go to the NLAC website. The Network of Laboratory Animal Coordinators (NLAC) is an organization composed of LAC’s from all over campus. NLAC’s goal is to enhance communication between animal research laboratory personnel, IACUC, and DCM. NLAC activities support the University’s mission to expand the body of knowledge and teach individuals involved in all levels of animal research by providing a forum for the open exchange of ideas and an information network for policies, procedures, and regulations.
NLAC offers the following benefits:
- NLAC quarterly educational seminars
- NLAC listserv firstname.lastname@example.org (a means for LAC’s to share information, animals, supplies)
- NLAC steering committee email@example.com (a group of LAC’s and DCM and IACUC representatives that coordinate NLAC activities and seminars)
- NLAC web site http://research.unc.edu/nlac/
Laboratory Personnel Who Use Live Vertebrate Animals
The Investigator must ensure the adequacy of training and the level of experience of all animal handlers in the laboratory. The Investigator must ensure that all individuals in their laboratory who handle animals either have the necessary certification or will receive the training necessary to conduct procedures according to federal regulations and IACUC policy. The training may be conducted by an IACUC Training Coordinator, Laboratory Animal Coordinator, or DCM technicians and veterinarians. All animal handlers must be listed on the appropriate Animal Care Application. Completion of the on-line orientation does not add personnel to an Animal Care Application. This must be done when the application is submitted or later as an amendment.
Orientation, Training, Certification and Addition of Personnel Listed on the Animal Use Application
There are three steps to be completed by every person working with live vertebrate animals at the University of North Carolina at Chapel Hill: Completion of the IACUC Online Orientation; hands-on training and certification; and addition of new personnel to the Animal Care Application. There are also special considerations for personnel who are designated as Laboratory Animal Coordinators and personnel who need access to DCM facilities. The following outline briefly describes each of these steps and special considerations.
I. IACUC Orientation–before handling animals, the individual must complete IACUC Online Orientation. Orientation is located online inside the individual’s research profile. Get there via http://acap.research.unc.edu/iacuc_reg. Orientation consists of :
a) IACUC Online Orientation—overview of IACUC function and program of animal care at UNC-Chapel Hill. Completion of all quizzes is required.
b) DCM Online Orientation—overview of DCM function and animal care program. Completion of quizzes is required.
c) Animal Handler Form – accessible from within the Research Profile. Form completion required for any individual who handles live vertebrate animals. Form submission adds employee into the University Employee Occupational Health Clinic (UEOHC) secure database. The UEOHC treats animal handlers in the event of an animal bite or development of animal related allergies.
d) Research Profile–accessible only from within the lab personnel registration site. Provides demographic and orientation completion status information.
II. Personnel Addition – All personnel who handle animals must be added to any Animal Use Applications with which they are involved.
a) Personnel Added to Animal Use Application–-go to ACAP to initiate an amendment. Amendment required to add all new personnel to animal use applications. The system will direct user either to complete amendment online or to a link to the older paper amendment form for applications submitted prior to ACAP. Please note that the Personnel Added to Animal Use Application Form is no longer in use; all personnel additions are processed as amendments.
b) Notify OACU via email at firstname.lastname@example.org when personnel leave or transfer to another lab.
III. Hands-on and Species Specific Animal Handling Training (IACUC Online Orientation is a prerequisite for such classes)
All personnel must receive hands-on training for basic animal handling and techniques through at least one of the following methods.
a) Training by Certified Laboratory Animal Coordinator – Laboratory Animal Coordinators (LAC) may train personnel in animal handling. The LAC must enter training information on-line http://acap.research.unc.edu/iacuc_reg. The on-line Animal Care and Use Training database can only be edited by a certified LAC. Once you have entered your ONYEN or SOMID click on Lab Coordinator Certification Submission. Please contact OACU if you need help using the system.
b) IACUC Rodent Labs and Lectures – OACU Training and Compliance offers rodent handling labs and lectures (listed below). Information on class dates and on-line registration is provided on the IACUC website (http://research.unc.edu/iacuc/) or by calling OACU, 919-966-5569. Follow the Wet Labs and Hands-on Training link.
- Aseptic Techniques – required for LAC’s of labs that perform survival surgeries. The LAC may train their personnel or have the OACU certify individuals in this class.
- Mouse Techniques – includes various basic techniques such as handling, identification, blood withdrawal, and injections.
- Rat Techniques – includes various basic techniques such as handling, identification, blood withdrawal, and injections.
- Mandatory Mouse Breeding Policy Lecture – includes information about the current mouse cage density policy. Mandatory for all mouse breeders (PI, LAC and personnel breeding mice).
- Basic Mouse Breeding Colony Management – introduction to colony management including mouse biology, breeding schemes and trouble shooting. Voluntary course offered quarterly.
c) Division of Comparative Medicine (DCM) Training – DCM will provide training for all other vertebrate species:
a. Other mammalian or avian species – Contact DCM at 919-843-7992 for more information
b. Other vertebrates (amphibian, aquatic) – Contact Julia Whitaker, DVM, email@example.com or 919-843-7992
Part 1.6 PI Responsibilities — Page 4 of 5 — IACUC Online Orientation — February 27, 2007
d) OACU Training and Compliance Coordinator One-on-One Training – performed on a limited basis. Contact OACU at 919-966-5569.
e) Physical Euthanasia Training/Certification – each laboratory member who performs unanesthetized physical euthanasia (cervical dislocation or decapitation) must be trained and certified by an OACU Training and Compliance Coordinator. This certification cannot be performed by the LAC.
IV. DCM Facility Access
a) IACUC and DCM Online Orientation Required – DCM will not allow facility access until IACUC and DCM Online Orientation is completed.
b) ID Badge Required – All personnel must wear a photo ID badge while in an animal facility. DCM can provide information on obtaining a badge (919-843-7992). Many DCM facilities also use these badges as key card access.
c) Animal Facility Orientation – Contact the facility manager or supervisor for a tour. Contact DCM for more information at 919-843-7992.
In summary, the following must be completed before an animal handler can work with animals:
- Complete IACUC and DCM Online Orientation and Staff Registration
- Complete Research Animal Handler and Animal Caretaker Form
- Laboratory Animal Coordinators – complete Laboratory Animal Coordinator Certification Course
- Other Animal Handlers must be certified by OACU or by their certified LAC, DCM veterinary technicians, or DCM veterinarians.