Welcome to Animal and Veterinary Services OLA HAWAII Boot Camp 2018 Sylvia kondo, dvm, avs manager & university veterinarian Office of vice president for research and innovation www.Hawaii.edu/research

Objectives 1. (What) Background Information 2. (How) Getting Started Working with Vertebrate Animals 3. (Who) Can Provide Assistance to You Office of vice president for research and innovation www.Hawaii.edu/research

Background Information - AVS AVS helps oversees the University of Hawaii Animal Care and Use Program 1) providing veterinary oversight for the use of vertebrate animals for research, teaching, and management activities and 2) ensuring the individuals are adequately trained. Office of vice president for research and innovation www.Hawaii.edu/research

Background Information - AVS AVS also operates the vivariums at Mānoa and Kaka‘ako. In July 2016, JABSOM and UH Cancer Center animal care programs received accreditation by the Association for Assessment and Accreditation for Laboratory Animal Care, International (AAALAC). Office of vice president for research and innovation www.Hawaii.edu/research

Background Information Federal Regulations U. S. DHHS Public Health Service Health Research Extension Act of 1985 Office of vice president for research and innovation www.Hawaii.edu/research

Background Information Federal Regulations United States Department of Agriculture Food Security Act1985 One month after passing the Health Research Extension Act of 1985 The Animal Welfare Act was amended In the Food Security Act Office of vice president for research and innovation www.Hawaii.edu/research

Background Information Federal Regulations The UH must maintain an Assurance of Animal Welfare with the Public Health Service (PHS) that it will conform with the PHS Policy on Humane Care and Use of Laboratory Animals. This allows the UH to receive federal funds for vertebrate animal research, teaching, testing. The UH must be registered with the USDA, who conduct periodic inspections of the animal facilities to ensure compliance with the Animal Welfare standards, if they use AWA covered species. Office of vice president for research and innovation www.Hawaii.edu/research

Background Information Federal Regulations It is mandated by the the federal regulations that each institution appoint an Institutional Animal Care and Use Committee (IACUC) to oversee and evaluate the institution’s animal programs, procedures, and facilities. Office of vice president for research and innovation www.Hawaii.edu/research

Background Information Federal Regulations All vertebrate animal activity must be reviewed and approved by the IACUC prior to start of work. Any revisions to an existing protocol must also receive prior approval. Once a year, the UH IACUC reviews annual renewals of the protocol The UH IACUC uses the Topaz® protocol software. Office of vice president for research and innovation www.Hawaii.edu/research

Background Information Federal Regulations The IACUC conducts semi-annual inspections of research facilities and evaluates the institution’s program of humane animal care and use. Office of vice president for research and innovation www.Hawaii.edu/research

Background Information Federal Regulations The IACUC reviews and investigates concerns involving care and use of animals at the institution. They are authorized to suspend previously approved animal activities. Office of vice president for research and innovation www.Hawaii.edu/research

Background Information Federal Regulations Significant problems with animal care must be reported. One method of reporting deficiencies is known as the Whistle Blower Policy. These deficiencies can be confidentially reported without fear of discrimination or reprisal. See UH IACUC Policy 7 Reporting Concerns of Animal Misuse or Abuse. Office of vice president for research and innovation www.Hawaii.edu/research

Background Information Federal Regulations Failure of the University of Hawaii to comply with Federal regulations can result in suspension or loss of contracts and grants involving vertebrate animals, citations and monetary fines, closure of facilities, and negative publicity to the institution. Office of vice president for research and innovation www.Hawaii.edu/research

Getting Started 1. Complete on-line CITI Training What modules are required by UH IACUC? Visit UH IACUC policy 13 Requirement for Personnel Training https://drive.google.com/file/d/0B8s- CpRof36BRW9KcXRnWTdRbWM/edit For CITI on-line registration and modules visit https://about.citiprogram.org/en/homepage/ Office of vice president for research and innovation www.Hawaii.edu/research

Getting Started 2. Individuals complete protocol-specific training prior to working independently on protocol activities Demonstration of proficiency for hands on procedures Standard Operating procedures for chemical and/or potential biological hazards used in animals Office of vice president for research and innovation www.Hawaii.edu/research

Getting Started 3. Individuals requesting access into the vivariums and who work with research animals on an IACUC protocol and/or routinely exposed to animals, animal waste, or animal tissues must enroll in the Occupational Health and Safety Program (OHSP). Office of vice president for research and innovation www.Hawaii.edu/research

Getting Started 3. How to enroll in Occupational Health and Safety Program a. Complete  OHSP Education Contact lasofc@hawaii.edu to access training b. Complete Health History Questionnaire to be reviewed by a Health Professional Visit http://www.hawaii.edu/researchcompliance/occupational- health-and-safety-manuals Office of vice president for research and innovation www.Hawaii.edu/research

Getting Started 4. If you are the Principal Investigator on a protocol Contact an AVS veterinarian when developing protocols that may involve more than momentary pain or distress. Request Veterinary Care for your protocol activity by completing IACUC Policy 15 Form, found at http://www.hawaii.edu/researchcompliance/veterinary-care Office of vice president for research and innovation www.Hawaii.edu/research

Getting Started 5. Complete classroom training required by the Biosafety Program and/or the Environmental Health and Safety Office. Ensure that any permits for importing biological commodities are in place (long lead times). Office of vice president for research and innovation www.Hawaii.edu/research

Getting Started 6. Complete and submit online Topaz IACUC Protocol form Visit http://www.hawaii.edu/researchcompliance/forms Office of vice president for research and innovation www.Hawaii.edu/research

Getting Started IACUC protocol Write concisely and at a 12th grade high school lay language. Avoid cutting and pasting your grant application Address harm-benefit statement for protocols involving more than momentary pain or distress Provide a simple chronological sequence of events in experimental design Office of vice president for research and innovation www.Hawaii.edu/research

Getting Started IACUC protocol Useful links to SOPs and UH IACUC policies to assist you as your write your protocol Visit https://www.hawaii.edu/researchcompliance/iacuc-policies-and- guidelines Useful link for literature data base searches for alternatives http://libguides.jabsom.hawaii.edu/iacuc Office of vice president for research and innovation www.Hawaii.edu/research

Getting Started IACUC protocol 3 Rʻs Replacement Refinement Reduction Statistical tests Previous literature Office of vice president for research and innovation www.Hawaii.edu/research

Getting Started IACUC protocol Reducing regulatory burden on making some revisions outside of full committee review to a previously approved protocol: Significant Changes to Previously Approved Protocol https://drive.google.com/file/d/0B8s- CpRof36BUmIwZW1oZnoyRjg/edit Designated Member Review Office of vice president for research and innovation www.Hawaii.edu/research

Getting Started IACUC protocol IACUC Policy 45 for procedures involving research, testing, or instruction conducted with live vertebrate animals and collaborating research institutions and organizations.  https://www.hawaii.edu/researchcompliance/news/new-policy- animal-use-activities-collaborating-institutions-and- organizations Office of vice president for research and innovation www.Hawaii.edu/research

Who Can Assist Me? AVS staff AVS Veterinary Staff (developing IACUC proposals, assistance on protocols, veterinary supply orders, training and documentation of compentencies for procedures using animals) Dr. Michael Wong, Staff Veterinarian, wongmich@hawaii.edu AVS Veterinary Assistant Dr. Sylvia Kondo, University Veterinarian, sylviak@hawaii.edu Office of vice president for research and innovation www.Hawaii.edu/research

Who Can Assist Me? AVS staff Ms. Diana Talerico, Operations Supervisor, dtaleric@hawaii.edu (rodent orders, rodent exports and imports, Occupational Health and Safety education, general vivarium questions/concerns, estimates) Jeff Hall, (vivarium access requests and orientations) Ms. Karen Okamura, Fiscal Administrator, kokik@hawaii.edu (animal orders, estimates, fiscal and billing questions) Office of vice president for research and innovation www.Hawaii.edu/research

Who Can Assist Me? Animal Welfare Compliance Office Ms. Denise Yee, IACUC Coordinator and Compliance Officer, deniseye@hawaii.edu Ms. Caryn Hashimoto, Post-Approval Specialist and Compliance Officer, carynh@hawaii.edu Mr. Norman Magno, Manager and Compliance Officer, Executive Secretary UH IACUC, Animal Welfare Program nmagno@hawaii.edu Office of vice president for research and innovation www.Hawaii.edu/research

Who Can Assist Me? Biosafety Program (use of biological commodities in animals and in the laboratory) Mr. Hubert Olipares, Biosafety Officer, Audits and Inspection Specialist, olipares@hawaii.edu Mr. Steve Case, Education Coordinator, stevec@hawaii.edu Ms. Caryn Hashimoto, IBC Coordinator, carynh@hawaii.edu Mr. Norman Magno, Manager and Compliance Officer, Biosafety Program, nmagno@hawaii.edu Office of vice president for research and innovation www.Hawaii.edu/research

Who Can Assist Me? Environmental Health and Safety Office (Use of chemicals and physical hazards in animals and in the laboratory) Mr. Hans O. Nielson, Occupational Health and Safety Program Manager, hansn@Hawaii.edu Ms. Lisa Johns, JABSOM EHSO, ljohns@hawaii.edu Ms. Janet Meeks, JABSOM EHSO, meeksj@hawaii.edu Mr. Matt Hiramoto, UH Cancer Center EHSO, MHiramoto@cc.hawaii.edu Office of vice president for research and innovation www.Hawaii.edu/research

Thank you for your time and attention For more information on AVS please visit https://www.hawaii.edu/researchcompliance/animal-resource- center-services Office of vice president for research and innovation www.Hawaii.edu/research