IACUC Number: 201 Version Number: 2.0 Approval Date: November 20, 2014 Effective Date: November 20, 2014 Title: Education and Training of Animal Care and Use Personnel Purpose This policy provides a standard that the Princeton University Institutional Animal Care and Use Committee (IACUC) must use to ensure that a robust training program exists and that personnel working with or conducting procedures on laboratory animals are appropriately trained and qualified for the species and procedures listed on the IACUC approved procedures to which they are assigned. Regulatory Background The Animal Welfare Act (AWA), the Animal Welfare Regulations (AWR), the Guide for the Care and Use of Laboratory Animals (the Guide), and the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, all require that institutions provide training in order to ensure all staff working with laboratory animals are appropriately trained and qualified in the humane treatment of animals. The IACUC is responsible for ensuring training programs exist and that personnel conducting procedures on animals are trained and qualified when performing procedures including surgery, anesthesia and the assessment of pain and distress. Scope This policy applies to all personnel, including Principal Investigators (PIs), laboratory personnel, Laboratory Animal Resources (LAR) staff, and other animal users, at Princeton University, at Princeton University satellite facilities, or performing field research on a Princeton University IACUC approved animal use protocol. Responsibility Princeton University is responsible for providing either formal training programs or on the job training to administer an effective animal care program. The IACUC is responsible for ensuring that all personnel working with animals in research or teaching at Princeton University are proficient at working with the species and performing the procedures listed on an IACUC approved animal use protocol. The IACUC is also responsible for ensuring that a sufficient training program is in place at the institution, and performing regular reviews of the training program. o Research Integrity and Assurance (RIA) staff assists the IACUC by reviewing online training documentation for procedures and species as well as University Health Services medical surveillance have been completed. The Principal Investigator (PI) is primarily responsible to ensure that all personnel who will have contact with research animals are appropriately qualified, trained, and proficient at the procedures described in the IACUC protocol. Training and qualification must be available prior to starting any animal activity. The PI must provide written assurance to the IACUC that all Page 1 of 7
personnel listed on the IACUC protocol who will conduct procedures with research animals are appropriately trained and qualified to conduct the procedures described in the IACUC protocol, and submitted to and approved by the IACUC. Laboratory Animal Resources (LAR) is responsible for ensuring that all LAR Staff are adept at working with the species to which they are tasked and are trained to all policies and procedures relevant to the care of those animals. Laboratory personnel that are included on approved animal use protocols are responsible for seeking out additional training opportunities as needed, and are ethically obligated not to perform any procedures for which they are not trained. Definitions Qualified having complied with specific requirements. The IACUC is responsible for ensuring individuals are qualified. The following are examples of means to document qualification: A degree in life sciences, doctorate degree or other formal laboratory animal education, certified veterinary technician education, AALAS or other certification or licensure related to the animal field Providing a list of qualifications or assurance of qualifications on an IACUC protocol A resume/curriculum vitae (C.V.) Observations of applied skills Documentation of on the job or didactic or hands on training (e.g., computer based training modules or instructor led training) Note that some qualifications or previous experience may eliminate the need for additional training, although this must be considered on a case by case basis. Proficient competent or skilled with the species and for the procedures listed on an approved IACUC protocol. The PI is responsible for ensuring all personnel listed on his/her protocol are sufficiently trained and proficient at working with the species and performing the procedures listed on the protocol. Personnel must be supervised until they are considered proficient. I. Training Requirements for Working with Animals a. All researchers using animals must complete basic animal welfare compliance training before they may use animals in their research. This online training, managed through the AALAS Learning Library (ALL), covers awareness of animal welfare issues and includes a regulatory compliance overview for animal related research. b. Researchers conducting surgical procedures must have appropriate training to ensure that good surgical technique is practiced. Such training and qualifications should include but is not limited to: i. Aseptic technique: preparation of the surgeon, preparation of the surgical site, preparation of the surgical areas, tissue handling, and hemostasis. Page 2 of 7
II. III. ii. Proper use of instruments. iii. Proper use of suture materials and suture patterns. iv. Delivery, maintenance and assessment of a surgical plane of anesthesia. v. The use of analgesics, including the assessment of pain and distress. c. Researchers who are not qualified or who have not demonstrated adequate qualifications, experience, or proficiency may be included in an IACUC protocol provided that appropriate training is planned and completed prior to performing the procedure. The PI is responsible for assuring that all investigators are fully trained and qualified. IACUC Review of Personnel Qualifications & Post Approval Monitoring a. The IACUC, must assess the qualification of new PIs, and if necessary any supporting training documentation, against the requested study related work being proposed. To ensure the appropriate level of personnel trained and qualified are in place, an evaluation must take place during the IACUC review process of any new IACUC protocols, personnel amendments, and procedures or model amendment submissions. Additionally, the RIA Compliance Administrator reviews training records during the initial compliance review of the protocol. b. Training and qualifications specific to the animal species involved and to the kind of procedures to be performed must be ensured. Such qualifications should cover subject matters including species specific behavior, the assessment of pain and distress, animal handling, animal restraint, dosing methodology, tissue collection methodology and any surgical procedures or other special procedure being performed on animals as described in the IACUC protocol. Online species specific care and use and procedure modules will be assigned using the AALAS Learning Library. c. Those involved in animal care and use should be evaluated by a subject matter expert, such as an LAR veterinarian or RIA member. The frequency of evaluation may vary based on the complexity of the work and/or species. Individuals conducting postapproval monitoring may assist in assessing qualifications and proficiency. IACUC Review of Training Program a. The animal research training program is a collaborative effort between the IACUC, LAR, and EH&S, and must be reviewed regularly by the IACUC. b. Training program content must include: i. Humane methods of animal maintenance (e.g., housing, husbandry, handling) and experimentation of various species (e.g., animal restraint, research procedures, use of anesthesia, pre and post operative care, aseptic surgical techniques, euthanasia); ii. Recognition of normative species specific normal appearances and behaviors. Recognition of species specific pan or distress behaviors; iii. Concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress; Page 3 of 7
iv. Proper use of anesthetics, analgesics, and tranquilizers for any species used by the facility; v. Methods for reporting deficiencies in animal care and treatment as reported by any employee of the facility; and vi. Utilization of services available to provide information on: 1. Appropriate methods of animal care and use; 2. Alternatives to the use of live animals in research; 3. Prevention of unintended and unnecessary duplication of research involving animals; and 4. The intent and requirements of the Animal Welfare Act and the Guide. c. Additional training should cover: i. Ethical use of animals in research; ii. Use of hazardous agents, including chemical, biological and radiation; iii. Occupational health and safety including, where appropriate, zoonotic diseases, laboratory animal allergy, and a respiratory protection program; and iv. IACUC responsibilities and function. d. Opportunities for continuing education should be available to research and animal care personnel and IACUC members to ensure standards of research and veterinary practices are utilized. e. A mechanism (e.g., documentation) should be in place to demonstrate training has been provided and individuals are qualified. In an effort to satisfy the various training requirements captured in this policy, the outline below provides the specific required training for IACUC members, faculty, students, and research staff working with laboratory animals. The following applies to all Princeton University Animal Users: Access to the animal facility will not be given to any employee without prior completion of the following steps: 1. All personnel must successfully complete the EHS web based training for animal workers. http://web.princeton.edu/sites/ehs/biosafety/animalworker/intro.htm 2. All personnel must complete required courses in the AALAS Learning Library (ALL) or attend equivalent training sessions. To enroll in AALAS Learning Library: a. The information on the required course and how to register with the ALL can be found at: http://www.princeton.edu/ria/animal research protectio/training/ b. Follow the instructions under Enroll in AALAS Learning Library. 3. Once in ALL, click on the Animal Care and Use Courses tab on the right and take the courses as outlined below. Page 4 of 7
All personnel must take the "Princeton University All Personnel" track which contains, "Working with the IACUC: Working with the IACUC". Based on the work being performed and the species being used, personnel are also required to take the following: If you work with: Mice Then take this training: Princeton University Mouse Users Introduction to Mice Rats Princeton University Rat Users Working with the Laboratory Rat Non human Primates Princeton University Non Human Primate Introduction to Nonhuman Primates Health Risks and Safety Procedures for Working with Nonhuman Primates Video: Working Safely with Nonhuman Primates Amphibians Princeton University Amphibian Users Introduction to Amphibians Xenopus Princeton University Xenopus Users Working with Laboratory Xenopus Fish Princeton University Fish Users Working with Laboratory Zebrafish Rodent Colonies Princeton University Rodent Colony Management Mouse Breeding Colony Management Rodent Surgery Princeton University Rodent Surgery Pain Recognition and Alleviation in Laboratory Animals Inhalation Anesthesia Systems for Rodents Aseptic Technique for Rodent Survival Surgery Page 5 of 7
Field Research Wildlife Research Introduction to Wildlife All personnel must complete medical review with Employee Health Services to be enrolled in the University occupational health program, including TB testing and proof of measles vaccination or titer for people who are going to work with primates. 4. After completing steps 1 3, bring: a. A copy of the completed Employee Health Form signed by Health Staff. b. Verification of test completion of the species specific AALAS Learning Library Princeton University Track. c. Princeton University ID number d. To the animal facility tour and orientation. This is the most important step in the process of obtaining access to your animal research room(s). Contact Susie Chow at siuchow@princeton.edu to schedule an orientation. 5. After these steps are completed, LAR will grant ID card access to the appropriate facility and research areas. Renewal training: The IACUC will determine a schedule for renewal of training. All persons listed on an animal protocol must renew their medical surveillance and clearance through Employee Health Services. The schedule for renewal is determined by Employee Health Services. References 1 Animal Welfare Act & Animal Welfare Regulations (9 CFR, Part 2, Subpart C, Section 2.31(d) (1) (viii)) and (9 CFR, Part 2, Subpart C, Section 2.32). 2 The Guide for the Care and Use of Laboratory Animals; 8th Edition; National Research Council. The National Academies Press, Washington, D.C., 2011. 3 Office of Laboratory Animal Welfare. National Institutes of Health. Institutional Animal Care and Use Guidebook, 2nd ed., Bethesda, MD, 2002 4 The IACUC Handbook; 2nd Edition; CRC Press Taylor & Francis Group, Boca Raton, FL 33487 2742; 21:2 Version History Version Number Revision Date Revisions 2.0 November 17, 2014 Rewrite. Page 6 of 7
1.0 January 20, 2011 Created by J. Schantz and K. Rogers Page 7 of 7