IACUC Meet and Greet March 23 2022 12pm 1pm 1 Background 20 years of experience in animal research endeavors to include 5 major universities Charles River Laboratories and Jackson Laboratories ID: 930066
Download Presentation The PPT/PDF document "Office of Animal Welfare" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
Office of Animal WelfareIACUCMeet and GreetMarch 23, 202212p.m. - 1p.m.
1
Slide2Background20 years of experience in animal research endeavors to include 5 major universities, Charles River Laboratories and Jackson LaboratoriesRole
Supervise the activities of the Office of Animal Welfare
Fun factYoungest of 10 children
2
Tony Munn
Director, Office of Animal Welfare
Slide3Office of Animal Welfare Team MembersLauren Burhans, PhD - IACUC Administrator
Amanda Knutsen, RVT, RLATG -
Post Approval Monitor (PAM) AdministratorCourtney Cecil. RVT, RLAT -
Post Approval Monitor (PAM) AdministratorMary Herald -
IACUC Coordinator
Paula
Zaharko - Program Assistant
3
Slide4Poll QuestionThe United States passed the first national animal protections legislation in 1958: The Humane Slaughter Act.
In what year would you guess that the United Kingdom passed its first national law for the protection of animals?
1822
1876
1933
1967
4
Slide5Poll QuestionThe United States passed the first national animal protections legislation in 1958: The Humane Slaughter Act.
In what year would you guess that the United Kingdom passed its first national law for the protection of animals?
1822
1876
1933
1967
5
Slide6The ability to use animals in research is a public trustRegulatory oversight of the use of animals in research and teaching has been implemented in direct response to research use of animals that was deemed by the public to be unacceptable.Animal Welfare Act (1966): This was a response to the use of pets and shelter animals in medical research and testing without owner consent.
Health Research Extensions Act (1985): This was in response to researchers failing to maintain acceptable animal care practices for animals used in federally financed research.
6
Slide77The Public through the federal government is the largest sponsor of research involving animals
The Health Research Extension Act attached animal welfare to funding, and is highly effective because the public is the primary sponsor of research involving animals
Slide88Even with increased regulation and oversight, public opinion continues to trend towards a negative connotation of use
of
animals.
It now ranks as one of them most divisive issues in the United States.
Slide99
Any live or dead cat, dog, hamster, rabbit, nonhuman primate, guinea pig, and any other warm-blooded animal determined by the Secretary of Agriculture for research, pet use or exhibition.
Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes.
Includes non-vertebrate species that are integrated into the program of animal care
Includes animals not used in research or teaching but are integral to the program of animal care
The following animals are not covered: farm animals used for food or fiber (fur, hide, etc.); coldblooded species (amphibians and reptiles); horses not used for research purposes; fish; invertebrates (crustaceans, insects, etc.); or birds, rats of the genus Rattus, and mice of the genus Mus that are bred for use in research
Does not cover invertebrate animals
May cover invertebrates in certain situations
Slide1010
Agriculture
Biomedical
Research
Teaching
West Virginia University Program for Animal Care
Forestry/Natural Resources
(Field Work
/Teaching)
Production
Slide1111
Office of Animal Welfare
IACUC
Attending
Veterinarian
Office of Laboratory Animal Resources
Animal Care
Animal Welfare
Procedure consultation
USDA primary contact
Animal Facilities Liaison
IACUC administration
Post Approval Monitoring
IACUC communication
AAALAC contact
OLAW Contact for IO
Regulatory consultation
Reporting
Approval of work
Animal Use Policies
Special communications to researchers
Final Decision maker
Event and Complaint Investigation
Program and facility review
Institutional Official: Dr. Fred King, VP for Research
Agriculture staff
Slide12Institutional OfficialUltimate Responsibility for animal care and use programAppoints the members of the IACUC committeeResponsible for ensuring that the program for animal care has necessary resources to operate based on reports of the IACUC
Reporting progress and issues associated with the program for animal care including specific events that directly affect federally funded projects or that have the ability to affect federally funded projects
Has the inferred authority to suspend animal work due to positionCannot approve animal work, cannot re-initiate animal work suspended by the IACUC
12
Slide1313
Associated Groups
Slide14What if I do something wrong?The IACUC is not a punitive committee
Regulations require the committee to investigate all concerns, it's not personal.
The focus is on what happened and how can we prevent it from happening again not on assessing blame.The IACUC bases its decisions on what to report to the USDA and NIH based on the Animal Welfare Act and funding
Follow your protocol and the policies you agreed to
14
Slide15Working with the OfficeWe want to help, we don’t like red tape or speedbumps either.
Ask us! we love questions. We are often amazed at the way live animals are used in the university’s mission and the uniqueness that comes with every question.
We understand last minute requests and will do everything we can within the rules to get you what you need in the time you need. We have and will continue to add flexibility in our procedures where the opportunity presents itself
We are stakeholder focused and intend to provide superior service.
15
Slide16Lauren Burhans, Ph.D.IACUC Administrator
Background
Ph.D. in Neuroscience (Univ. of Illinois)
14 years as research staff at WVU
3+ years in the WVU Office of Animal Welfare
Role
Manage IACUC protocol and amendment submissions:
Pre-Review
IACUC Review Approval
Protocol-Grant Congruency
Fun fact
Recipe tester for America’s Test Kitchen
16
Slide17Work FlowProtocol and Amendment Submissions
17
PI submits to
OAW office
Pre-Review
Review
Determination
DMR
FCR
VVC
Admin
IACUC
Review
CITI Training
Requires
Modification
Not
Approved
OHQ
DMR
FCR
DMR/FCR
Approved
Slide18Protocol Review TypesFull Committee Review (FCR):
Submission is reviewed and voted upon in monthly meeting with a quorum of members present.
Designated Member Review (DMR): Submission is reviewed and decided upon using a subcommittee of one or more members appointed by the Chair directly or via designated authority.
18
DMR
FCR
DMR
FCR
Slide19Poll QuestionPHS Policy on the Humane Care and Use of Laboratory Animals and the Animal Welfare Regulations define the responsibilities of the IACUC regarding the review and approval of proposed significant changes to animal activities.
Which one of these changes to an approved IACUC protocol would be considered significant and
require IACUC review?
Increasing animal numbers
Change in Principal Investigator
Adding an NIH funding source
Adding personnel conducting surgery
Change in blood collection method
19
Slide20Poll QuestionPHS Policy on the Humane Care and Use of Laboratory Animals and the Animal Welfare Regulations define the responsibilities of the IACUC regarding the review and approval of proposed significant changes to animal activities.
Which one of these changes to an approved IACUC protocol would be considered significant and
require IACUC review?
Increasing animal numbers
Change in Principal Investigator
Adding an NIH funding source
Adding personnel conducting surgery
Change in blood collection method
20
Slide21Amendment Review TypesFCR or DMR
Veterinary Verification and Consultation (VVC):
Mainly used to verify details associated with already approved methods, based on an approved IACUC guidance or policy. Examples: changes in veterinary drugs, AVMA approved euthanasia methods, blood collection.
Administrative:
Changes in contact information, funding, personnel, correction of typographical errors, increase in animal numbers (no changes to procedures or drugs)
21
DMR
FCR
VVC
Admin
DMR
FCR
DMR/FCR
Slide22Review OutcomeApproval
Work cannot begin until a written
approval is in placeRequires Modifications to Secure Approval
Revisions need to be made to the protocol (IACUC Revisions Request)
Not Approved
22
IACUC
Review
Requires
Modification
Not
Approved
Approved
Slide23Due DatesFCR protocols and amendments: 15
th
of the month to ensure review at the next IACUC meeting
DMR protocols and amendments: Rolling review, no specific due dates
3
yr
renewals: 2 months in advance of expiration date to avoid lapse in approval
23
Slide24RESOURCES
OAW website main page:
https://animal.research.wvu.edu/
Protocol forms and instructions:
https://animal.research.wvu.edu/protocols
IACUC Policies-Guidelines-SOPs:
https://animal.research.wvu.edu/policies-and-guidelines
Training:
https://animal.research.wvu.edu/training
24
Slide25Amanda Knutsen, RVT, RLATgPost Approval Monitor (PAM)
Administrator
Background
I have been in the veterinary medicine/research fields for over 20 years. I worked at a local veterinary hospital before accepting a position in Office of Laboratory Animal Resources (OLAR) in 2005. I moved over to the Office of Animal Welfare (OAW) in 2018.
Role
Assist the IACUC with their PAM responsibilities and work with research staff in any area that is needed. I am here to help!
Fun fact
I currently have a feral kitten (affectionately named Mr. Murder Mittens) living in my bathroom. I also share my house with 3 other cats (not feral), a beagle that barks too much, 2 kids and a husband.
25
Slide26Poll QuestionAfter the Animal Welfare Act (AWA) was passed in 1966, Congress assigned the US Department of Agriculture – Animal and Plant Health Inspection Service (USDA-APHIS) the responsibility of enforcing it. The AWA covers many species of animals used for research, testing, experimentation, or exhibition purposes.
Which of the following rodents is NOT covered by the AWA, and therefore, not covered by the USDA-APHIS?
Wild mouse (genus Peromyscus)
Lab mouse (genus Mus musculus)
Chinchilla (genus Chinchilla)
None of the above are covered
All the above are covered
26
Slide27Poll QuestionAfter the Animal Welfare Act (AWA) was passed in 1966, Congress assigned the US Department of Agriculture – Animal and Plant Health Inspection Service (USDA-APHIS) the responsibility of enforcing it. The AWA covers many species of animals used for research, testing, experimentation, or exhibition purposes.
Which of the following rodents is NOT covered by the AWA, and therefore, not covered by the USDA-APHIS?
Wild mouse (genus Peromyscus)
Lab mouse (genus Mus musculus)
Chinchilla (genus Chinchilla)
None of the above are covered
All the above are covered
27
Slide28Where do our rules come from?Federal Regulations:National Institutes of Health (NIH)
Office of Laboratory Animal Welfare (OLAW)
USDA- APHIS Animal Welfare Act (AWA) and Animal Welfare Regulations (AWR)
US Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (2015)
28
Slide29Other valuable resources: The National Research Council of the National Academies “Guide for the Care and Use of Laboratory Animals” (8th
ed.)
AKA “The Guide”Federation of Animal Science Societies (FASS) “Guide for the Care and Use of Agricultural Animals in Research and Teaching” (4th ed.)
AKA “The Ag Guide”American Veterinary Medical Association (AVMA) ”Guidelines for the Euthanasia of Animals” (2020 ed)
29
Slide30What is Post Approval Monitoring? According to the 8th Ed. Of the Guide for the Care and
Use of Laboratory Animals:
Post Approval Monitoring, also known as PAM, is a term that is used to cover all types of monitoring after the IACUC’s initial approval.
This can include inspections, observation of procedures and animals in the facility, and review of records.
30
“Continuing IACUC oversight of animal activities is required by federal laws, regulations and policies.”
Slide31Who is responsible for PAM at WVU?The IACUC, animal care and veterinary staff, and the OAW staff are all able to perform PAM activities.
The OAW has 2 dedicated PAM administrators, myself and Courtney Cecil. We are both Registered Veterinary Technicians and are former members of the OLAR veterinary staff.
31
Slide32So, what do we actually do?We review approved protocols based on certain criteria (Category E, USDA, surgery)and may reach out for a meeting with you and your laboratory staff.
Ideally, we would like to be able to meet with or visit all PIs and staff during the life of the protocol (every 3 years).
We may observe procedures listed on your protocol, if possible.
We may review records (e.g., training or surgery)
32
Slide33We also:Assist the IACUC with inspections Facility inspections and areas where surgeries are performed are inspected once every 6 months.
Laboratory inspections are done on a routine basis.
In the future, we would ideally like to see these spaces inspected once every 3 years, or more often if needed. AAALAC site visit preparation
As an accredited facility, AAALAC visits us every 3 years.Prior to the site visit, we will hold informational sessions and try to visit all animal use areas to make sure documentation and signage is up to date.
We are here to help! Just send us an email or give us a call.
33
Slide34ResourcesOAW website https://animal.research.wvu.edu
OLAR website
https://hsc.wvu.edu/olar/
Links to the following can be found under the Policies and Guideline tab on the OAW website (Federal Guidelines):
Guide for the Care and Use of Laboratory Animals (8
th
ed.)Guide for the Care and Use of Agricultural Animals in Research and Teaching (4
th
ed.)
AVMA Guidelines for the Euthanasia of Animals (2020 ed)
USDA Animal Welfare Act and Animal Welfare Regulations
PHS Policy
Office of Laboratory Animal Welfare (OLAW)
34
Slide35RO Meet & Greet SessionsRemaining sessions are on Wednesdays from 12 -1pmRegistration Link: https://wvu.qualtrics.com/jfe/form/SV_5iPkWQ50ocYxeQeResearch AdministrationRecording: https://youtu.be/1V-M2Il4XCkOffice of Sponsored ProgramsRecording: https://youtu.be/kw9iRTy-iQg
Office of Human Research ProtectionsRecording: https://youtu.be/hO-Rca33lcE Office of Animal Welfare/IACUCRecording: https://youtu.be/Wm3rsEGPY70
Conflict of Interest / Responsible Conduct of Research March 30th Export Control Office, Office of Tech Transfer, High Performance Computing
April 6th
Shared Research Facilities
April 20th 35
Slide36Thank you!
We appreciate your participation in the event.
Please let us know how we can help you. 36