IACUC POLICY IACUC Training Requirements

Transcription

1 IACUC POLICY IACUC Training Requirements I. Purpose: To describe the requirements, procedures and documentation of training related to conducting animal research at the University of Pennsylvania. This document applies to any individual working in animal research. II. Background: The Animal Welfare Act, as described in the Animal Welfare Regulations, (9 CFR Ch. 1, 2.32) and the Public Health Service (PHS) Policy require that the Institutional Animal Care and Use Committee (IACUC) ensure that personnel conducting animal research are qualified and properly trained. The National Institutes of Health (NIH)/Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture (USDA) provide limited guidance on how a training program is implemented, but is clear that a training program and documentation of training are necessary for all members of the animal program. III. Ensuring and documenting training: The IACUC ensures appropriate training by providing species- and procedure-specific training through the training staff of University Laboratory Animal Resources (ULAR), through consultants and Penn Community members with special expertise, and, for ULAR Veterinarian staff, through professional education and training. ULAR oversees non-ular trainers through the Certified Training Program. Training for research staff and principle investigators is documented through an online Learning Management System (Knowledge Link), within specific protocols, and in supporting ULAR training databases, if needed. The IACUC ensures training by crosschecking protocol personnel with their training in Knowledge Link. IV. Identifying training needs, developing training, and the role of the TSC: Decisions on training are made via consensus by the IACUC Training Subcommittee (TSC). These include identifying training requirements, determining who needs to be trained (assignment), and how training is implemented. In addition to the voting members, the TSC includes personnel involved with training from the Office of Animal Welfare (OAW) and ULAR. Changes in requirements and procedures often necessitate changes in training; the TSC acts in active consultation with other subcommittees as part of the overall implementation of new policies and regulations. The TSC especially works in consultation with the Compliance Subcommittee and Compliance Liaisons in order to respond to compliance issues that can be addressed by the design, implementation, and assignment of training or by retraining. Because regulations, best practices, and the needs of researchers and the institution are constantly changing, the TSC continually oversees the development and implementation of new and updated training. V. Requirements for IACUC approval of protocols/amendments/continuing reviews: To ensure that the research community understands the regulations and guidelines (federal and institutional) that govern animal research, as well as receives training in general species-specific care and basic procedures, the IACUC at the University of Pennsylvania has adopted the following training requirements. Appendix C summarizes basic required trainings by role as listed on the protocol. Completion of these trainings and any applicable procedure-specific trainings (see section VI) is required before the protocol can be approved. Approval of amendments requires all personnel to be current on Penn Profiler, while personnel being added need to complete all required training, and personnel associated with amended procedures need to complete any procedure-specific trainings. Approval of Continuing Reviews requires all personnel to be current on Penn Profiler and, for those APPROVED 3/11/2015

2 IACUC POLICY IACUC Training Requirements personnel working with macaques, the Occupational Health and Safety: Macaque Users Orientation module. A. Penn Profiler: A required online survey used to assign job-specific training for all University employees, including animal users. Penn Profiler includes a series of occupational health and animal use risk assessment questions. Based on the answers, Penn Profiler will assign required training. This course is automatically assigned to all University employees, or otherwise can be manually assigned by OAW or ULAR personnel. Required Frequency: Every year B. Regulations and the IACUC Curriculum: This web-based training consists of six modules and provides a basic understanding of the roles of the IACUC and presents the United States governmental agencies and laws that regulate animal research. It discusses the basic parts of the protocol form as well as policies regarding specific animal use procedures that are commonly performed at Penn. The course can be found in the Knowledge Link catalog. Required Frequency: Every 3 years C. Species-Specific Training Curricula: Most curricula consist of a web-based training pre-requisite and a species-specific hands-on training session. Content is developed and provided by the ULAR Training Division. The courses provide a basic understanding of handling and common biomethodologies related to a particular species. This training does not substitute for protocolspecific training in specific procedures. Individuals must work with and receive training from their PI and/or other laboratory personnel to become proficient in protocol-specific procedures. Depending on the role(s) of the individual on the protocol, as described in the qualification section, they may be required to take all or some of the species-specific curriculum prior to being approved to work on the IACUC protocol. The courses can be found in the Knowledge Link catalog the online courses and a sign-up option for a scheduled offering of the hands-on portion. Required Frequency: One time requirement for each species D. Occupational Health and Safety: Animal Users Orientation: This web-based training covers the general occupational health and safety risks when working with or near laboratory animals, including non-human primates (excluding macaque species). The course covers zoonoses, allergens, personal protective equipment, chemicals, ergonomics, sharps, occupational health risks, Tuberculosis testing, and contact information. The course can be found in the Knowledge Link catalog. Required Frequency: Every 3 years E. Occupational Health and Safety: Macaque Users Orientation: This is a web-based training for those who will be working with the macaque species of non-human primates. This course will cover general and specific information including zoonoses, allergens, personal protective equipment, chemicals, ergonomics, sharps, occupational health risks, contact information, and pertinent information regarding the Herpes B virus and Tuberculosis. The course can be found in the Knowledge Link catalog. Required Frequency: Every year VI. Training for specific procedures (dependent upon protocol procedures):

3 IACUC POLICY IACUC Training Requirements A. Aseptic Technique Online Training: This is a web-based training that provides an overview of the requirements of survival and non-survival surgical procedures and proper aseptic technique for both USDA- (e.g., sheep, dogs, pigs, cats) and non-usda- (e.g., mice and rats) regulated species. This course is required for all individuals associated with a survival or non-survival surgical procedure. The course can be found in the Knowledge Link catalog. Required Frequency: Every 3 years B. Physical Methods of Euthanasia Training: This is an instructor-led training which provides an overview of the techniques and issues surrounding physical methods of euthanasia of conscious animals (cervical dislocation and decapitation without anesthesia). This is required for all personnel associated with procedures listing these methods of euthanasia. Individuals need to contact ular-tr@pobox.upenn.edu to arrange the training session. Required Frequency: One time requirement for each method & species C. CO 2 Euthanasia Principles and Procedures: This web-based training provides an overview of the requirements for the gradual-fill method and equipment required to minimize pain and distress associated with CO 2 inhalation. The training, titled CO 2 Euthanasia in Rodents, focuses on the use of CO 2 for euthanasia in rodents, but the same principles and equipment apply to other species (i.e., birds). This training is required for all personnel associated with a euthanasia procedure that lists CO 2 as the primary or confirmatory method of euthanasia. The course can be found in the Knowledge Link catalog. Required Frequency: One time requirement D. Laboratory and Biological Safety at Penn Curriculum: This training was developed and is provided by Environmental Health and Radiation Safety (EHRS). Completion of these courses is required for all personnel working in research laboratories to ensure adequate understanding of the hazards in the laboratory setting. Introduction to Laboratory and Biological Safety is instructor-led and presented monthly. Check the EHRS website or Knowledge Link for dates. This training must be updated annually by taking the web-based course, Laboratory Safety Annual Update. The course can be found in the Knowledge Link catalog. Required Frequency: Every year E. Radiation Safety Training: These courses are assigned by Penn Profiler or EHRS and are provided by EHRS. Training specific to the type of radiation being used is required for laboratory staff who use radioactive material, x-ray machines, or who have access to irradiators. Radiation Safety training requirements and training history are available through Knowledge Link, but courses are located on the EHRS website. Required Frequency: Every year VII. Additional training items: These additional training items are available within Knowledge Link and are not required for approval of ARIES submissions, but they may need to be completed prior to performing specific activities. Some of these trainings are assigned by Penn Profiler. A. Diversity Brown Bag Professional and Respectful Workplace Training: This training was developed by members of the office of the Vice Provost for Research, the School of Medicine, the School of Veterinary Medicine, ULAR, Human Resources, and the office of Affirmative

4 IACUC POLICY IACUC Training Requirements Action. This course is intended to promote respect and understanding in the workplace. The course can be found in the Knowledge Link catalog. Required Frequency: One time requirement B. Animal Facility Orientation: This instructor-led training is developed and provided by ULAR Facility Management. Before gaining key access to an animal facility, new personnel must complete an Animal Facility Orientation for each of the facilities to which they need access. This orientation includes a facility tour. During the tour, they will be shown different areas of the facility and learn the general policies for working in animal facilities and specific policies for that particular facility. For registration, see the facility orientation courses located in the Knowledge Link catalog. The courses are listed individually by facility name. Required Frequency: Once per facility prior to obtaining facility access C. Animal Cage Change Station and Biosafety Cabinet Training: This web-based training was developed by the ULAR Training Division and Facility Management. This course will introduce mouse and rat users to the proper use of the change stations that are located in many of the colony rooms. Proper use of these units is important in helping to decrease the spread of disease (e.g., pinworms, and Mouse Hepatitis Virus [MHV]) through the facility. The course can be found in the Knowledge Link catalog. Required Frequency: One time requirement D. Polaris 4.0 Training Curriculum: This web-based training was developed by ULAR to describe how to place animal orders, view billing statements, and request cage cards, as well as obtain other procurement items. Training is required for laboratory staff and departmental business administrators prior to gaining access to Polaris. Training is not required for PIs with view-only access. You must request access from the ULAR business office prior to enrolling in the training. Detailed information can be found on the ULAR Polaris web site. Required Frequency: One time training prior to gaining access to Polaris E. Procedures for Non-Animal Users Entering ULAR Facilities: This course is for faculty, staff, and students who do not work directly with animals or for ULAR but may need to enter animal facilities (e.g., Physical Plant employees, outside contractors, and compliance or safety staff). This course may be online or instructor-led, includes an overview of animal research and occupational health and safety, and describes procedures for entering an animal facility. This course has online and instructor-led options available in Knowledge Link. Required Frequency: One time requirement (FRES employees every 2 years or as per EHRS requirement) VIII. Special training conditions: There are specific research applications (see A: Privately Owned Animal Protocol POAP, B: Offsite Application, and C: Satellite Housing Application) with training requirements that differ from Form A research protocol requirements. There are also specific training conditions for unique scenarios (see D-H) where variations to training requirements exist. Please refer to attachment C for details of training requirements for specific ARIES personnel roles. A. POAP personnel should only include VHUP employees that are integrally involved in the research project. They need to complete Penn Profiler, Regulations and the IACUC Curriculum, applicable Occupational Health and Safety training, and procedure-specific trainings; they are

5 IACUC POLICY IACUC Training Requirements exempt from species-specific training but will be required to complete species-specific webbased training, if available. Personnel performing their routine job duties (e.g., anesthetist, veterinary technician, radiologist, or surgeon) should not be listed on the protocol as personnel as these are routine hospital services. B. Offsite Applications (for work being performed at a non-penn location using Penn funds, such as academic collaborations, subcontracted work, and custom antibody production) personnel all need to complete Penn Profiler and the Regulations and the IACUC Curriculum, excluding BAs, who do not need to be current with any training unless they are also listed as the protocol contact. Additionally, personnel working with animals at the offsite location will also need to complete any applicable species-specific curriculum and occupational health and safety courses. C. Satellite Housing Application personnel are responsible for daily monitoring of animals and their environment when housed in satellite housing locations. Personnel are required to complete Managing Satellite Housing, Regulations and the IACUC Curriculum, applicable species-specific curriculum, and Penn Profiler prior to approval and gaining access to SHEPHERD to make daily observation recordings. D. Veterinarians and Certified Veterinary Technicians (CVTs) with expertise in the species that they will be working with (credentials approved by ULAR Training) may be exempt from the instructor-led portion of the training, depending on the species proposed to be used. They may, however, be required to take the web-based training. E. Individuals that can document years of experience working with a particular species, but who are not veterinarians or CVTs may not be required to take the instructor-led training; however they still need to complete either a web-based training or a modified training for the species which they propose to use. This ensures the individual is aware of federal, local, and University regulations/policies regarding that specific species. The documentation of experience will be reviewed on a case-by-case basis and exemptions must be approved by ULAR Training. Examples include: 1. PIs and/or research personnel who will be working directly with the animals on the protocol will be required to take at least the web-based training. 2. Outside (non-penn) consultants who are participating in teaching a special technique or procedure involving any laboratory animal will be evaluated on a case-by-case basis. 3. Individuals who started working at Penn prior to 2002 and are still using the same species are exempt from taking the instructor-led training. They are still required to take the web-based training if the course is available. If they begin to use a new species they will be required to take all applicable training(s). F. PIs, Co-PIs, and collaborators with the Scientific Advisor role are not be required to take the species-specific hands-on instructor-led training; however, they still need to complete Penn Profiler, Regulations and the IACUC Curriculum, and either a web-based training or a modified training for the species on the protocol. This ensures the individual is aware of federal, local, and University regulations/policies regarding that specific species G. Individuals, not in the Scientific Advisor role, working on a protocol but NOT handing animals, will be required to complete Penn Profiler, Occupational Health and Safety: Macaque

6 IACUC POLICY IACUC Training Requirements Users/Animal Users Orientation (whichever is applicable based upon the species within the protocol), and Regulations and the IACUC prior to approval of the protocol submission. Their role on the Personnel tab within the ARIES protocol should be Technical personnel, their skills and qualifications for their specific tasks must be listed, and they will need to be escorted into the ULAR animal facility (they will not be given facility access). Examples include: 1. MRI technician 2. Perfusionist 3. Other equipment operators that will not touch the animals H. Individuals working in Facility Real Estate Services (FRES) and/or Tradespeople who may enter Penn Animal Facilities are required to complete Penn Profiler, attend or review the Procedures for Non-Animal Users Entering ULAR Facilities course, and follow the ULAR Visitor s Policy. IX. Trainees: Trainees are individuals who are participating in a training course which is covered by an IACUC-approved training protocol. Persons serving as trainers for training protocols need to be listed as personnel on the protocol and complete all required training. Trainees, Penn students or employees, or participants from other institutions may not need to be listed as personnel on these training protocol(s) but will be required to complete the following (A and B are provided by ULAR Training): A. A participant sign-in sheet provided by the ULAR Training Division. B. Regulations and the IACUC A modified training has been developed by the ULAR Training Division specifically for training protocols. This training can be presented by a certified trainer (see section XI), before or during the training session. Each trainee will need to sign off that they completed and understand the training. C. Species-Specific Curriculum Due to the nature of most training protocols, the Species-Specific Curriculum may not be required. The protocol will be reviewed and, if warranted, the IACUC may require that trainees take the web-based and/or instructor-led training before participating in the training course. X. LARC program: The Laboratory Animal Research Coordinator certification (LARC) program is voluntary and open to all permanent staff members working in laboratories at Penn to provide expertise in animal care, regulations, and training. The LARC benefits the PI, research laboratory, and animal program by facilitating smoother research protocol application, more efficient review/approval, and decreased risk of non-compliance issues. This program is offered at no cost and is managed by OAW with significant contributions from ULAR, EHRS, and the IACUC. Completion of the following are required to complete the program. If sessions cannot be attended or made up during the given cycle, the LARC may attend the needed sessions during the following cycle. A. Didactic Sessions (9 topics) Small group sessions will be held each month, with each covering a different topic. B. Hands-On Sessions (3 Total) Sessions will be held each month in January, April, and May. These sessions include a more in-depth ULAR orientation and vivarium walkthrough, training on how to train, and preparation for site visits.

7 IACUC POLICY IACUC Training Requirements C. Attend 4 IACUC meetings. D. Additional Materials Additional materials to be completed include a pre- and post-course survey, various AAALAS Learning Library Modules, and a review of the Guide for the Care and Use of Laboratory Animals and associated review questions. XI. Certified Trainers: ULAR Training Division may approve certain individuals to be certified trainers for their particular laboratory or a particular species. Requests for a certified trainer to provide training for personnel in another lab, without being added as personnel to the applicable protocols, should be sent to ULAR Training for review and approval. At any time, the IACUC or ULAR Training Manager may remove an individual s status as a certified trainer. The following is a description of the procedures, expectations, and conditions for achieving and maintaining certified trainer status: A. Certified trainers and ULAR Training and Veterinary staff may use PI animals for training purposes without being added as personnel to the protocol. If the certified trainer will only be training on procedures for which they are certified (details of additional procedures will be documented by ULAR Training and maintained within Knowledge Link), they do not need to be added as approved personnel to protocols. If they will be training procedures that have not been documented as part of their certification, they need to be added as approved personnel to the protocol. B. The individual must complete the ULAR Species-Specific Curriculum for the species that they will be using. C. The individual must receive Certified Trainer training from a member of the ULAR Training Division. This includes a review of content and responsibilities, as well as a live trainer observation session, where a ULAR trainer observes the certified trainer teach course content. As part of the certified trainer approval process, a certified training checklist is completed and signed by both the new certified trainer and the ULAR Trainer. When the observational training session has been completed and the status of the certified trainer is approved, their name will be added to a database indicating what species/procedure(s) the individual is approved to train, and with which PI(s) they are working. ULAR training division maintains the database with this information for reference. D. Individuals will be entered into Knowledge Link as a certified trainer (e.g., Species-specific hands-on training-rabbit-certified trainer) by ULAR Training. E. As a certified trainer, the individual may only train in the basic care, handling, and specific procedures listed on their documented checklist (see attachment D) for the given species and procedures. When providing the equivalent of basic hands-on training, they are required to discuss all of the same items ULAR Training Division would discuss during the equivalent instructor-led course provided by ULAR. These items are listed on the species-specific training checklists. The ULAR Trainer will provide certified trainers with any documents they will need for training. F. Trainees may not participate in specific protocol procedures until they have been trained AND added to the protocol. It is therefore recommended that hands-on training for trainees be independent of scheduled research procedures. If it is necessary that training sessions are to be

8 IACUC POLICY IACUC Training Requirements combined with pre-operative procedures (e.g., animal handling, catheter placement, or intubation) the participant can only participate in the trainings outlined by the ULAR Training Division and cannot do any subsequent protocol-related work or documentation until the IACUC has approved their addition to the protocol. Until approval is obtained, the trainee can only participate in the species-specific hands-on training and basic anesthesia training as described. G. The species-specific checklist for new trainees needs to be completed and signed by the certified trainer. The checklist can either be faxed to the ULAR Training Division ( ) or ed to to be documented in the Knowledge Link training database. H. There may only be one certified trainer per laboratory, per species. Exceptions are acceptable if laboratories are collaborating. I. All certified trainers are required to attend an annual meeting to review their responsibilities and be informed of any updates to regulations and guidelines. J. The ULAR Training Division will perform yearly reviews of certified trainers to ensure teaching methods, delivery, and training processes are met. XII. ULAR Clinical Staff Technical Services: ULAR Veterinarians and Veterinary Technicians may assist research staff with research procedures without being specifically named as personnel on the IACUC-approved protocol procedure. As an example, the ULAR clinical staff may assist research investigators in the provision of anesthesia and analgesia delivery to animals as described within the protocol. The ULAR Associate Director for Clinical Care and Training or the Veterinary Technician Manager will ensure the clinical staff performing the protocol procedure are appropriately qualified and trained for the given species and technical support to be provided prior to them assisting the research staff. XIII. Work with Tissue By-products: All Penn individuals working with tissue by-products from animal species are required to take Penn Profiler, which will assign appropriate occupational health instruction. If working with non-human primate macaque species tissues only, individuals will be required to also take the Occupational Health and Safety: Macaque Users Orientation annually. For all other species tissues, Occupational Health and Safety: Animal Users Orientation will be required every 3 years. XIV. Documentation: A. Documentation of training is mainly provided through the Penn Knowledge Link System. If documentation of training cannot be found in Knowledge Link, Training Record Binders, or on the ULAR server, but the individual can provide a training certificate proving that the course was completed, this information should be conveyed to the ULAR Training Division to ensure that the information is uploaded into the system. B. All training for FRES and trades people will be documented in the Penn Knowledge Link database or the ULAR training database and per the ULAR visitor s policy (if applicable.)

9 IACUC POLICY IACUC Training Requirements C. Guests and other trainees who are not Penn affiliates, but have completed IACUC required training, may have their training documented in the training database located on the ULAR server. D. Temporary guests may request Guest Access to complete IACUC training requirements by contacting their business administrator. This will provide temporary (1 year) access to Knowledge Link trainings. Users will need to send their full name and birth date. Records will be accessible by Knowledge Link administrators. E. Visitors not being added onto an IACUC protocol who are entering animal facilities must follow the IACUC visitor policy, ULAR s visitor policy, and EHRS visitor requirements. F. An existing reciprocity agreement is in place between CHOP and Penn. Information regarding this agreement is attached. G. An existing agreement is in place between the Wistar Institute and Penn for Penn employees performing animal work supported by Penn funds at the Wistar Institute. Information regarding this agreement is attached. This training will not be documented within Knowledge Link, but will be maintained by the Wistar Institute and verified by OAW at the time of initial approval and subsequent 3-year approvals of the associated Offsite Application. H. If an individual would like to apply for exemption from instructor-led training, the PI on the protocol will need to the following documentation to ULAR Training Division: recent curriculum vitae (CV) for the individual and a brief description outlining what procedures they will perform and how they are qualified to do them. I. PIs of training protocols (see section IX) will submit the completed paperwork establishing completed training of Trainees participating under the training protocol to ULAR Training See attachment E. XV. Attachments: A. CHOP-Penn Training Reciprocity Agreement (please see version on ULAR website) B. Wistar-Penn Training Agreement for work performed at the Wistar Institute by Penn employees listed on an Offsite Application (please see version on ULAR website) C. Training Required Role/Position D. Training Checklist E. Regulations and the IACUC Modified for Trainees & Sign-in Sheet F. Certified Trainer Checklist

10 Animal Care and Use Program Training Requirements Core Training Requirements for IACUC Approval PIs/Co-PIs using animals: Scientist Role PIs/Co-PIs acting only in an advisory role: Scientific Advisor Role Research staff handling animals : Laboratory Manager, Research technician/stu dent and Scientist Roles Administrative staff and BAs: Administrative Manager, and BA Roles Technical staff who work close to animals (MRI tech, etc.): Technical Personnel Role Vets or veterinary techs with speciesspecific experience: Veterinary Staff Role *Animal tissue, egg or embryo users (Not listed on protocolbut training is required) Regulations and the IACUC Curriculum 6 modules X X X X (approx. 60 mins.) Species-Specific Web-based Training (Pre-requisite) X X X X (approx mins.) Species-Specific Hands-on Training X X (approx. 2.5 hrs.) Occupational Health and Safety: Animal Users Orientation, or X X X X X Occupational Health and Safety: Macaque Users Orientation (approx. 20 mins.) Penn Profiler X X X X X X X (approx.. 15 mins.) *Note: Depending on the user role selected within ARIES, additional training is required for the PI and Co-PI as well as personnel associated with procedures using zebrafish 7 days of age and older or tadpoles at any age. Procedural Training Requirements for IACUC Approval (only need to be completed if performing these functions as part of the IACUC protocol) - Aseptic Technique Online Training - Physical Methods of Euthanasia Training - CO2 Euthanasia in Rodents: Principles and Procedures - Laboratory and Biological Safety at Penn Curriculum (if applicable) - Radiation Safety Training (if applicable) Additional Training Requirements not required for IACUC Approval --Diversity Brown Bag Professional and Respectful Workplace Training (required for all) - Animal Facility Orientation (if applicable) - Animal Cage Station and Biosafety Cabinet Training (if applicable) - Polaris 4.0 Training Curriculum (if applicable)

11 Checklist for Species-Specific Hands-On Training Mouse Name: Date: Penn ID Number: Name of instructor(s): Task Completed Not Completed Discussed Comments Species-Specific Information Zoonoses/Laboratory Animal Allergies Physical / Mechanical Restraint Sex Determination Oral Gavage (Demonstration) Facial Vein Blood Collection (Demo) Identification Methods (Ear punch & ear tag; Discussion: micro-tattooing & microchipping) Intraperitoneal (IP) Injection Chemical Restraint (Anesthesia: Injectable vs. Inhalation) IACUC Guideline 11 & Recordkeeping Assessing Depth of Anesthesia Subcutaneous (SQ) Injection Intravenous (IV) Injection Retro-Orbital Blood Collection Cardiac Puncture Euthanasia prolonged exposure to CO2 OLAW Requirement (Confirmation of Death) Cervical Dislocation Additional Comments: Instructor s Signature: ULAR Training Division, ular-tr@pobox.upenn.edu 5/1/14

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13 Welcome to Regulations and the IACUC- Modified- Trainees This training module is presented by University Laboratory Animal Resources (ULAR). Some of the information presented in this module is courtesy of researchtraining.org. University Laboratory Animal Resources Training Division School of Veterinary Medicine or

14 Regulations and the IACUC- Modified- Trainees Completion of this training will satisfy the Regulations and the IACUC Requirement for visiting trainees using animals at the University of Pennsylvania for research or teaching. A copy of the accompanying sign-in sheet must be faxed or scanned/ ed to ULAR Training no later than the day of the training event. For questions, please contact: ULAR Training Division Ular-tr@pobox.upenn.edu Fax: Phone:

15 Overview of the Course The goal of this course is to cover important information about using animals for research, teaching or testing. 1. Information on laws that protect animals used for research or teaching. 2. Occupational health and safety information. 3. Recordkeeping requirements. 4. A reminder to respect animals.

16 Regulations Protecting Animals Animal Welfare Act (AWA) Enforced by the United States Department of Agriculture (USDA). Inspections occur at least once a year and are unannounced. Protects any live or deceased dog, cat, non-human primate, guinea pig, hamster, rabbit, sheep, cows, or other warm blooded animal; except mice (from genus- Mus), rats (from genus- Rattus), birds, farm animals used for food or fiber, and horses not used in research.

17 Regulations Protecting Animals Public Health Service Policy (PHS Policy) Enforced by the Office of Laboratory Animal Welfare (OLAW). Protects all vertebrae animals. Requires adherence to the following documents: The Guide for the Care and Use of Laboratory Animals. The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching or simply, the Ag Guide.

18 The University of Pennsylvania s Institutional Animal Care and Use Committee (IACUC)

19 IACUC Functions The Institutional Animal Care and Use Committee (IACUC) is required by the Animal Welfare Act (AWA) of 1985 and PHS Policy. The IACUC ensures institutional compliance with the Guide for Care and Use of Laboratory Animals, AWA, Ag Guide, PHS Policy, and AAALAC position statements, if accredited. All projects using animals for research and teaching must be reviewed and approved by the Committee.

20 IACUC Functions (continued) Review and approve all proposed animal research and teaching activities. Request modifications during protocol review for approval of research or teaching activities. Review the animal care and use program every six months and its compliance with regulations. Inspect the animal facilities every six months for deviations from the Guide and federal regulations.

21 IACUC Functions (continued) Ensure an Occupational Health and Safety program is in place. Develop institutional guidelines and policies. Suspend research or teaching activities that deviate from federal regulations or institutional policies. Review animal welfare concerns.

22 IACUC Functions (continued) Ensure training in the following areas: Humane practice of animal care and biomethodology Minimization or elimination of pain and distress Utilization of alternative search strategies Protocol writing and review process

23 Occupational Health and Safety at the University of Pennsylvania

24 Occupational Health and Safety Everyone should be aware of specific risks for the species you will be working with: Injuries Zoonoses Laboratory Animal Allergies

25 Occupational Health and Safety- Injury Injuries A few requirements in regards to safety to help prevent injury: - Do not wear sandals or opened-toed shoes when working with animals. - Do not re-cap needles. This will avoid potential needle stick injury to the needle handler. Needles, syringes, and any other sharp item should be immediately placed in a sharps container after use. - Be cautious of recently mopped floors or areas that could potentially be wet to minimize the chance of a slip and fall injury. Note to trainer: address any other potential injuries that may be present in the training environment.

26 Occupational Health and Safety - Zoonoses Zoonotic agents are those that are transmitted from animals to humans. Species-specific fact sheets cover zoonotic diseases. Read the attached fact sheet related to the species with which you will be working. These charts list the following: Pathogen - agent that causes disease Transmission - route for infection Animal disease - clinical signs in animals Human disease* - clinical symptoms in people Note to trainer: Please distribute appropriate zoonotic fact sheet to trainees.

27 Occupational Health and Safety- Allergies People can develop allergies to many animal species after having contact with them. Persons who develop allergy symptoms should seek medical counseling and may have to discontinue working with that species in the future. Some common clinical signs of allergies in order of mild to severe are: Reddening of the skin with or without itching Rhinitis, rhinorrhea, sneezing, allergic conjunctivitis Wheal formation, local or general rash Local to generalized swelling of soft tissue Bronchoconstriction/Asthma Shock/Anaphylaxis Please see a physician if you experience any of these symptoms.

28 Occupational Health and Safety PPE Personal Protective Equipment- PPE PPE can prevent or delay the development of allergies and provide additional safety. It is recommended that you wear gloves when handling animals or animal products. Wear a disposable dust mask when working closely around animals when possible. Wear dedicated clothing and shoes to prevent allergens or zoonotic agents being transferred to personal clothing. Always wash your hands after working with the animals.

29 Occupational Medicine Contact Main Campus Philadelphia, PA Routine Care: Hospital of the University of Pennsylvania Penn Tower, 4 th Floor 1 Convention Ave., Philadelphia, PA Hours: 9:00 AM 5:00 PM Emergency Care: Hospital of the University of Pennsylvania Ground Floor Ravdin 3400 Spruce Street, Philadelphia, PA hours

30 Important Information about Animals used in Research or Teaching

31 Recordkeeping for Animals If it is not documented, it did not happen. In order to document that we are following the laws that protect the animals, all procedures must be documented. Some of the requirements of these laws include: - providing adequate veterinary care, - performing procedures as approved on animal care and use protocols, - minimizing pain and distress in laboratory animals, - and documenting and confirming death of the animal.

32 Recordkeeping for Animals You must keep records for everything that you do with the animals. For research studies or surgeries a template can be used- just leave a space for the animal s identification number, protocol number, and date, as well as a space for any deviations. For anesthesia Record time of any drug administration. Record parameters monitored (temp, heart rate, respiratory rate). Or, parameters as described in the approved IACUC protocol.

33 Recordkeeping for Animals For USDA covered species, records must be kept for three years after the death or other final disposition of the animal. All records should be centrally located and must available for inspection. For teaching situations -the person in charge of the teaching protocol is responsible for keeping the records.

34 Remember to Respect the Animals Remember: Animals are part of the research and/or teaching team. All animals deserve to be treated humanely. Animal welfare issues can be reported anonymously to the IACUC. Understand that attitudes and emotions related to working with laboratory animals vary between people. A good rule to follow is: If it causes pain and distress in us, assume it will in other species. It is a privilege to work with the animals, not a right.

35 Summary of the Course Laws protect animals used in research, teaching and testing. Penn s IACUC is committed to ensuring that we are compliant with the laws so that we can continue to do the work that we do. Be aware of Occupational Health and Safety concerns for the species you are working with. Recordkeeping is required in order to document the work that we are doing with the animals and to document that the animals are being used humanely and in accordance with the laws that protect them. All animals deserve to be treated humanely. Animal welfare issues can be reported anonymously to the IACUC.

36 Websites for Reference ORA - ULAR - OLAW - USDA -

37 Checklist for Certified Trainers Name: Date: Penn ID Number: Principal Investigator (s): Species: Session 1 Training Review and Processes Completed Not Completed Comments Initial Documentation: Online and Hands on Review of Responsibilities: Training delivery Documenting Ethics Revoke/Privileges Training Details: Occupational Health and Safety Laboratory Animal Allergies Zoonoses Cost of Caring Record Keeping guidelines Species Specific Information ULAR Training contact information Checklist Additional comments: CT agrees to comply with all essential training details and policies. CT approval is pending until ULAR observes training. Certified Trainer Signature: Session 1 Completion: YES / NO Instructor s Signature: Session 2 Training Observation Completed Not Completed Comments Review: Delivery Materials Techniques/Procedures Confirm ULAR training Processes Session 2 Completion: YES / NO Date of Observation: Instructor s Initials: ULAR Training Division, ular-tr@pobox.upenn.edu