Welcome! FASEB Webinar Series: Animal Research Regulations Part 1 - - PowerPoint PPT Presentation

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Welcome! FASEB Webinar Series: Animal Research Regulations Part 1 - - PowerPoint PPT Presentation

Feb 12, 2023 248 likes •802 views

Welcome! FASEB Webinar Series: Animal Research Regulations Part 1 Understanding Federal Oversight Mechanisms THE WEBINAR WILL BEGIN IN A FEW MINUTES Click the join link in your Confirmation email. If you dont have your link, go to

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Welcome!

www.faseb.org

FASEB Webinar Series: Animal Research Regulations

Part 1

Understanding Federal Oversight Mechanisms

THE WEBINAR WILL BEGIN IN A FEW MINUTES Click the join link in your Confirmation email. If you don’t have your link, go to https://www.gotomeeting.com/webinar/join-webinar and enter Webinar ID: 362-986-747 To use your telephone to hear the audio, call +1 (562) 247-8422 and enter Access Code: 766-330-264 If you experience trouble joining the webinar, please contact Customer Support at http://care.citrixonline.com/gotowebinar/join

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Part 1 – Animal Research Regulations

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Speakers

Patricia Brown, VMD, MS

Director, Office of Laboratory Animal Welfare Office of Extramural Research Office of the Director National Institutes of Health

Tanya Tims, DMV

Supervisory Veterinary Medical Officer, Animal and Plant Health Inspection Services - Animal Care, US Department of Agriculture

Alice Huang, PhD

Deputy for IACUC Guidance, Office of the Chief Veterinary Medical Officer, Department of Veterans Affairs

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To Ask A Question

Type your question in the white box and click “Send” (gray button)

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Animal Welfare Act (1966)

Institutional Animal Care and Use Committee (IACUC)

Animal Research Regulations

Health Research Extension Act (1985)

United States Department of Agriculture Animal and Plant Health Inspection Service (USDA APHIS) National Institutes of Health Office of Laboratory Animal Welfare (NIH OLAW)

Research with Animals

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Assuring Animal Welfare in Research Tanya Tims, DMV

Supervisory Veterinary Medical Officer, Animal and Plant Health Inspection Services (APHIS) - Animal Care

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Research Animal Oversight Entities

 USDA, OLAW and AAALAC  Considerable overlap:

  • Animal care and use committees (IACUC)
  • Attending veterinarian
  • Minimize pain and distress, Humane euthanasia
  • Sanitary, safe animal enclosures
  • Qualified personnel
  • Annual report; reporting of adverse events
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Differences

USDA OLAW AAALAC Certain warm-blooded animals All live vertebrate animals All vertebrates/invert All research facilities in US Receiving PHS funds

  • Vol. accreditation

International AWA and regulations PHS Policy and the “Guide” The “Guide” FOIA FOIA Confidential Unannounced annual on- site inspections Detailed written Assurance, some site visits Announced triennial

  • n- site visits

No OS&H regulations OS&H OS&H

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USDA APHIS Animal Care

Enforcement of the Animal Welfare Act

 Breeders  Dealers  Exhibitors  Research Facilities  Transporters and Handlers

Enforcement of the Horse Protection Act Emergency Response

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AC statistics

Fiscal Year 2019 Total Animal Care inspectors = 104 (66 are VMO’s) 920 registered research facilities (“R”) 160 registered Federal research facilities 1221 inspections conducted:

 91% full compliance  98% substantial compliance

www.faseb.org

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Animal Welfare Act

  • 1. To ensure that animals intended for use in research

facilities or for exhibition or for use as pets are provided humane care and treatment

  • 2. To assure the humane treatment of animals during

transportation in commerce, and….

  • 3. To protect the owners of animals from the theft of

their animals by preventing the sale or use of animals which have been stolen.

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The ‘Blue Book’

Code of Federal Regulations Title 9, Chapter 1, Subchapter A, Parts 1-4 Regulations and Standards

Provides for the humane care and treatment of “animals” in regulated activities.

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Research Activities defined

Research Teaching Testing Experimentation

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How did USDA get involved in the first place?

…pet theft and public outcry Prior to 1966, no federal law addressing laboratory animal welfare

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The Animal Welfare Act

The Laboratory Animal Welfare Act passed in 1966 Several amendments made over the years to include more than just laboratory animals…now known as the Animal Welfare Act. Among these changes was 1989 requirements of the IACUC

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Institutional Animal Care and Use Committee

Ensures activities are in accordance with the AWA R&S, unless there is an acceptable justification for departure in writing  Internal oversight body  Assesses the facility’s:

Program for humane care and use of animals

Proposed activities involving animals

Animal facilities

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So how does AC assure animal welfare at a research facility?

Inspections

Oversee the function of the IACUC

  • Protocol review
  • Required records
  • Veterinary Care requirements
  • Personnel

Inspect facilities and animals

Animal handling

Review animal acquisitions

Education

Mock Inspections/Courtesy visits

IACUC training

Follow up on Non-compliances

Required Reporting

Annual report

Protocol Suspensions

Significant deficiencies not corrected

MMOPs

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AC Inspections

  • Based on the AWA Regulations
  • Inspections are unannounced
  • Frequency of Inspection based on Risk
  • Required by law to inspect RFs at least once/year
  • Photographs
  • Document non-compliances
  • Exit interview
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We Inspect:

Animals Facilities (animal rooms, surgical suites, cage wash, food storage) Transport and primary enclosures Husbandry and care practices Talk with employees (Investigators, Technicians, Caretakers)

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AC Inspections

  • All required IACUC documents
  • Protocols
  • All practices Involving Pain and Distress
  • SOPs
  • Dog Exercise Plan
  • Primate Enrichment Plan
  • Program of Veterinary Care
  • Animal room records
  • Personnel training requirements
  • Staffing to provide required animal care
  • Procurement of animals
  • Tracking of animals and numbers

We review:

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Animal Care Mission

To provide leadership in establishing standards of humane care and treatment of animals, and to achieve compliance with those standards through inspections, education and cooperative efforts.

AC

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www.faseb.org

Sources of Information

Animal Care Ft. Collins Office: 970-494-7478 Animal Care Riverdale Office: 301-851-3751 Animal Care Website:

www.aphis.usda.gov/animal_welfare/index.shtml

  • Animal Welfare Act and Regulations (“Blue Book”,2017)
  • Animal Welfare Inspection Guide: Chapter 7

APHIS stakeholder registry (to receive notices and updates):

https://public.govdelivery.com/accounts/USDAAPHIS/ subscriber/new

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Research Involving…Animals

Patricia Brown, VMD, MS, DACLAM Director, Office of Laboratory Animal Welfare National Institutes of Health

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Understanding the Dual Nature of NIH

NIH supports institutions & people (Extramural Research)

  • >2,500 institutions
  • >400,000 scientists & research

personnel

  • Approx. 70,000 applications and 40,000

awards annually

  • Approx. 80% of the NIH budget

NIH is an institution

(Intramural Research)

  • Approx. 6,000 scientists
  • Approx. 10%
  • f NIH’s budget

Extramural Research Grants by Institution

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25

National Institutes of Health

National Institute

  • n Alcohol Abuse

and Alcoholism National Institute

  • f Arthritis and

Musculoskeletal and Skin Diseases National Cancer Institute National Institute

  • n Aging

National Institute

  • f Child Health

and Human Development National Institute

  • f Allergy and

Infectious Diseases National Institute

  • f Diabetes and

Digestive and Kidney Diseases National Institute

  • f Dental and

Craniofacial Research National Institute

  • n Drug Abuse

National Institute

  • f Environmental

Health Sciences National Institute on Deafness and Other Communication Disorders National Eye Institute National Human Genome Research Institute National Heart, Lung, and Blood Institute National Institute

  • f Mental Health

National Institute

  • f Neurological

Disorders and Stroke National Institute

  • f General

Medical Sciences National Institute

  • f Nursing Research

National Library

  • f Medicine

National Center for Complementary and Integrative Health Fogarty International Center National Center for Advancing Translational Sciences National Institute

  • f Biomedical

Imaging and Bioengineering NIH Clinical Center Center for Information Technology Center for Scientific Review National Institute

  • n Minority Health

and Health Disparities

Office of the Director

No funding authority

Office of Extramural Research

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OLAW Mission

To ensure the humane care and use of animals in Public Health Service-supported research, testing, and training involving animals and thereby contribute to the quality

  • f research

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Authorizing Legislation - Public Law 99-158 Health Research Extension Act of 1985

  • NIH Director to establish guidelines for

research funded by NIH and PHS agencies

  • Animal Welfare Assurance agreement
  • Institutional Animal Care and Use

Committee (IACUC) with oversight authority

  • Institutional opportunity to correct

deficiencies

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Key Elements of the PHS Policy

  • All vertebrate animals
  • Animal Welfare Assurance
  • Institutional Animal Care and

Use Committee

  • Self-regulation by institution
  • Requirements for:
  • Record keeping
  • Reporting

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OLAW Responsibilities

  • Oversee implementation of PHS Policy
  • Provide interpretation and guidance
  • Negotiate Animal Welfare Assurances
  • Evaluate compliance
  • Institutional self reporting
  • Third party allegations
  • Educational activities

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PHS Policy

Animal defined as: “any live vertebrate animal used or intended for use in research, research training, experimentation,

  • r biological testing or for

related purposes.”

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PHS Policy Standards for Animal Care and Use

AVMA Guidelines for the Euthanasia of Animals: 2020 Edition (Formerly Report of the AVMA Panel on Euthanasia

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Federally supported scientists are accountable from the time they first plan their research to the time the research is completed to protect the welfare of the animals used in the research.

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NIH Core Message http://grants.nih.gov/grants/policy/air/NIH_ensure_welfare.htm

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US Government Principle II

“Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge,

  • r the good of society."

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US Government Principle III

“The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.”

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US Government Principle IV

“Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.”

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US Government Principle V

“Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.”

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Post-Award Responsibilities

  • Obtain IACUC approval prior to using

animals or making significant changes

  • Ensure research is conducted according

to the approved protocol

  • Comply with institutional policies and

procedures

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More Post-Award Responsibilities

  • Address significant changes to the use of

animals in progress reports to NIH

  • Obtain prior permission from NIH for the

use of animals involving a change in scope, including changes in performance site

  • NIH Grants Policy, Section 8.1.2.5

Change in Scope

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Post-Award Miss-steps

  • Conducting research in the absence of

IACUC approval

  • Implementing a significant change without

IACUC approval

  • Such noncompliance must be reported by the

IACUC through the Institutional Official to:

  • OLAW
  • the funding component(s) supporting the award
  • Where charges have been made for unauthorized

animal activities, appropriate adjustments must be made to remove those charges

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NIH-supported research is a partnership

  • Collaborative relationship exists between

funding agency and awardee institution

  • The partners share a mutual need to

assure compliance

  • Each partner has responsibilities and
  • bligations as stewards of public funds
  • Institutional self-governance is the

foundation of PHS Policy

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Thank You

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Thank you

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How Does VA Integrate the Requirements of USDA and OLAW?

Alice Huang, PhD Deputy for IACUC Guidance Office of the Chief Veterinary Medical Officer Veterans Health Administration Department of Veterans Affairs

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www.faseb.org

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www.faseb.org

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www.faseb.org

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www.faseb.org

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VA-Specific Requirements

www.faseb.org

Why does VA impose further requirements?

Because of VA’s structure as an

  • rganization of 70+ separate

research programs

Setting agency-wide standards Promoting agency-wide coordination and harmonization

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Setting Agency-Wide Standards AAALAC Accreditation R&D Committee Protocol Review Requirements

 2 Reviewers  Secondary Review

Collaborations

 CVMO approval to accept IACUC approval of Collaborating

Institution

 VA representation on IACUCs

Office of Research Oversight

www.faseb.org

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www.faseb.org

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Coordination and Harmonization

Working with others outside of VA

 FOIA requests  Congressional inquiries  New legislation  CURES Act  FDP

Depends on CVMO being well-informed

 Semiannual reports  Alerts about matters of potential public interest  Reports to oversight entities www.faseb.org

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www.faseb.org

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To Ask A Question

Type your question in the white box and click “Send” (gray button)

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www.faseb.org

Other Questions?

Naomi E. Charalambakis, PhD Senior Science Policy Analyst Office of Public Affairs Federation of American Societies for Experimental Biology (FASEB) ncharalambakis@faseb.org

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COVID-19 Resources

www.faseb.org

  • USDA Animal and Plant

Health Inspection Service (APHIS) Frequently Asked Questions – https://www.usda.gov/coro navirus

  • COVID-19 and VA Animal

Care and Use Programs – Frequently Asked Questions – https://www.research.va.g

  • v/programs/animal_resea

rch/animal-care-FAQ- COV-19.docx

  • Recorded Webinar:

“Pandemic Contingency Planning and Its Impact

  • n Animal Care”
  • OLAW Guidance in

Preparing for the Coronavirus Disease 2019 Outbreak

  • Flexibilities for Assured

Institutions for Activities

  • f IACUCs (NOT-OD-20-

088) NIH-wide:

  • Coronavirus Disease

2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding [updating in real time]