Institutional Animal Care and Use Committee

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Animal Welfare Program Institutional Animal Care and Use

T O A N I M A L W E L F A R E A N D B I O S A F E T Y P

1 Animal Welfare Program Institutional Animal Care and Use Committee IACUC JOHN A. BURNS SCHOOL OF MEDICINE & UH CANCER CENTER RESEARCH COMPLIANCE WEEK OCTOBER 20, 2016 C A R Y N H A S H I M O T O A N I M A L W E L F A R E A N D B I O S A F E T Y P R O G R A M S O F F I C E O F R E S E A R C H C O M P L I A N C E 1

2 Learning Objectives for IACUC Presentation What is the IACUC? When. is IACUC involved? Who is the IACUC? How does IACUC work? Protocol Requirement Training Requirement Increase Protocol Approval Probability Suggestions for Preventing Delays or Non-approval Where is the UH IACUC found? Know Your Animal Welfare Compliance Professionals IACUC Guidance Documents 2

3 What is the IACUC? According to Federal Regulation. Institutions that use live vertebrate animals for research, instruction, training, or testing are required to establish a selfregulating entity (the IACUC) to provide oversight and continuously evaluate all aspects of the institution s animal care and use program. 3

4 When is IACUC involved? Federal Requirements COVERED SPECIES The Animal Welfare Act (AWA), plus amendments administered by the USDA Animal Plant Health Inspection Service. Excludes birds, rats of the genus Rattus, mice of the genus Mus, bred for use in research, and farm animals used in agricultural research. 4

When is IACUC involved? Federal Requirements NIH FUNDING Health Research Extension Act (Public Health Act) administered by the Office of Laboratory Animal Welfare (OLAW) of NIH.

5 When is IACUC involved? Federal Requirements NIH FUNDING Health Research Extension Act (Public Health Act) administered by the Office of Laboratory Animal Welfare (OLAW) of NIH. Animal use activities supported by Public Health Service (PHS) funding at an institution with an Animal Welfare Assurance that commits the institution to comply with the PHS Policy regardless of funding source. Applies to all vertebrate animal species. NSF funding (2016) 5

6 When is IACUC involved? Other Entities Requiring IACUC..ACCREDITATION Institution receives support from an agency that requires compliance with PHS Policy (e.g., National Science Foundation). Institutions that are or desire to be AAALAC accredited. 6

7 Who is the IACUC? Committee Composition Veterinarians with institutional program responsibilities Scientist members with animal research experience Non-scientist members Individuals not affiliated with institution Minimum of five members UH IACUC has 15 active members in addition to 6 alternates. 7

8 How. does IACUC work? Duties and Responsibilities Every six months conduct Institutional Humane Care and Use Program Review. Every six months inspect all animal facilities, studies areas, including satellite locations where animals are housed or used. Prepare reports of committee evaluations for the Institutional Official (IO). Develop and implement institutional policies and procedures as recommended to the IO with regard to the institution s animal care and use program, facilities or personnel training. 8

9 How. does IACUC work? Duties and Responsibilities Review and investigate legitimate concerns involving the care and use of animals resulting from public complaints or reports from facility personnel or employees. Investigate serious or continuing noncompliance. The matter must be reported to OLAW and/or USDA-APHIS, the funding agency, and accrediting organization (AAALAC). Corrective action is required, with possibility of activity suspension. IACUC Protocol Application. Prior to animal activities. Review proposed use, require modifications (if necessary) for approval or withhold approval. Protocol must be approved in full prior to initiating animal use activity. 9

IACUC Protocol Requirement PHS Policy In order to approve research projects or propose significant changes in ongoing research projects, the IACUC shall conduct a review of those components related

10 IACUC Protocol Requirement PHS Policy In order to approve research projects or propose significant changes in ongoing research projects, the IACUC shall conduct a review of those components related to the care and use of animals, and determine that the proposed research projects are in accordance with this Policy. In making this determination, the IACUC shall confirm that the research project will be conducted in accordance with the Animal Welfare Act.that the research project is consistent with the Guide (Guide for the Care and Use of Laboratory Animals), unless acceptable justification for a departure is presented. The IACUC shall conduct continuing review of each previously approved, ongoing activity covered by this policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with IV.C at least once every three years. Full Renewal = de novo Review 10

IACUC Protocol Requirement TOPAZ Protocol Management Web-based Software www.hawaii.

11 IACUC Protocol Requirement TOPAZ Protocol Management Web-based Software New Projects = Full Protocol Form Significant Revisions for experimental procedures (adding surgery or painful procedures), scope and objectives of study, and Principal Investigator = Full Protocol Form Three-Year Renewals (de novo) = Full Protocol Form includes progress report. Annual Renewals = Short Form General Revisions or Amendment for new study personnel, change in animal numbers, most changes in experimental procedures = Short Form 11

IACUC Training Requirement Animal Welfare Act, PHS Policy, and AAALAC Animal Welfare Regulations, PHS Policy, and AAALAC standards require personnel involved in the care and use of animals to be

12 IACUC Training Requirement Animal Welfare Act, PHS Policy, and AAALAC Animal Welfare Regulations, PHS Policy, and AAALAC standards require personnel involved in the care and use of animals to be adequately educated and trained, and/or qualified in basic principles of laboratory animal sciences to ensure high quality sciences and animal well-being. Personnel caring and using animals should be appropriately trained, and the institution should provide formal or on-the-job opportunities to train and/or provide education to facilitate effective implementation of the training program emphasizing the humane care and use of animals. 12

IACUC Training Requirement CITI General Animal Welfare Online Training www.citiprogram.

13 IACUC Training Requirement CITI General Animal Welfare Online Training Personnel who will be participating in a UH IACUC protocol must complete the CITI course, Investigators, Staff, and Students (UH) prior to working with animals or entering an animal facility. Refresher CITI course, Refresher Course for Investigators Conducting Research with Laboratory Animals Refresher Course must be completed every three years. 13

IACUC Training Requirement CITI Species-Specific Online Training Courses Mice Working with Mice in Research Rats Working with Rats in Research Settings Mice and

14 IACUC Training Requirement CITI Species-Specific Online Training Courses Mice Working with Mice in Research Rats Working with Rats in Research Settings Mice and Rats Reducing Pain and Distress in Laboratory Mice and Rats CITI Aseptic Survival Surgery Online Course Regardless of species Aseptic Surgery 14

IACUC Training Requirement Protocol-specific Instruction The Principal Investigator is responsible for providing education on specific procedures as described on the IACUC approved protocol along

15 IACUC Training Requirement Protocol-specific Instruction The Principal Investigator is responsible for providing education on specific procedures as described on the IACUC approved protocol along with other education that promotes best practices and operator safety. Instruction and learning opportunities must be documented. Records must be available for IACUC and Veterinary Staff to review. Protocol-specific training examples are, but not limited to euthanasia procedures, survival surgery, ear tagging or notching, and genotyping. 15

16 Increase Protocol Approval Probability Suggestions for Preventing Delays or Non-approval Complete training requirements prior to IACUC review. Refrain from using scientific jargon in protocol. Use language a 12 th grade educated person can understand. Do not incorporate grant proposal scientific language in protocol. Whenever possible simplify. Use flowcharts and schematics to present complicated procedures. Involve the Attending Veterinarian s Office in planning of protocol prior to IACUC review. Experimental procedures, administration of pharmaceutical agents, anesthetics, analgesia, euthanasia, and final disposition of research subjects. IACUC Policy

17 Increase Protocol Approval Probability Suggestions for Preventing Delays or Non-approval Submit protocol amendments for all changes, including the addition of new personnel. o Amendment is not effective until committee approves. o Failure to secure approval prior to implementation of modification is a noncompliance. Be mindful of protocol expiration dates. o Renew protocols before they expire. o At least two reminders are forwarded to the investigator months/weeks prior to expiration date. o Continued work on expired protocols is a noncompliance. Fulfill other research compliance requirements concurrently. 17

18 Increase Protocol Approval Probability Suggestions for Preventing Delays or Non-approval IACUC meets every month of the year. o Protocol application submission dates and monthly committee meeting dates are posted 4 months prior to the new year. Year 2017 is already posted. During the committee process, provide requested information, and respond by correction schedules and resubmission timelines. o Failure to adhere to guidance may delay final review and possible approval of your protocol by a month. o JABSOM/Cancer Center faculty utilize AVS, an AAALAC accredited program. Protocol information and personnel training descriptions must be answered in the manner acceptable to the AAALAC standards. When unsure, contact the ORC Animal Welfare Program professionals before proceeding. 18

19 Where is the UH IACUC found? Office of the Vice President for Research and Innovation Office of Research Compliance (ORC) Animal Welfare Program Physical Address: (effective October 31, 2016) 2425 Campus Road Sinclair 10 Honolulu, HI Website Address:

20 Know Your Animal Welfare Program Professionals Denise Dr. TOPAZ Yee, CPIA Assistant Compliance Officer, IACUC Coordinator Phone: Caryn Hashimoto Assistant Compliance Officer, PAM Specialist Phone:

21 Know Your Animal Welfare Program Professionals 21

htm Animal Welfare Act (Animal Welfare Regulations) https://www.nal.usda.

22 IACUC Guidance Documents Resources Public Health Service Policy on Humane Care and Use of Laboratory Animals Animal Welfare Act (Animal Welfare Regulations) Guide for the Care and Use of Laboratory Animals Hey, we don t make these things up! 22

Institutional Biosafety Committee

Biosafety Program Institutional Biosafety Committee IBC JOHN A. BURNS SCHOOL OF MEDICINE & UH CANCER CENTER RESEARCH COMPLIANCE WEEK OCTOBER 20, 2016 H U B E R T O L I P A R E S A N I M A L W E L F A R