Office for the Protection from Research Risks OPRR

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National Institutes of HealthOffice of
Extramural ResearchOffice of Laboratory Animal
Welfare

• Denis Doyle
• Director, Division of Assurances
• [phone]
• dd14y_at_nih.gov

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OLAW Electronic Access

• E-mail olaw_at_od.nih.gov
• Web Site http//grants.nih.gov/grants/olaw/olaw.h
  tm

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OLAW Responsibilities

• Administration and implementation of PHS Policy
  on Humane Care and Use of Laboratory Animals
• Educational programs
• Negotiation of assurances
• Evaluation of compliance

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Authorizing Legislation and Implementing Policy

• Health Research Extension Act of 1985, Public
  Law 99-158 "Animals In ResearchNovember 20,
  1985
• Public Health Service Policy on Humane Care and
  Use of Laboratory Animals Revised September,
  1986 Reprinted March, 1996

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• Institute of Laboratory Animal ResourcesCommissio
  n on Life SciencesNational Research Council1996
• The PHS Policy requires institutions to use the
  Guide as a basis for developing and implementing
  an institutional program for activities involving
  vertebrate animals

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http//grants.nih.gov/grants/olaw/tutorial/index.h
tm
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Key Elements of PHS Policy

• Enforced self-regulation
• Animal welfare assurance
• Oversight by IACUC
• Recordkeeping requirements
• Reporting requirements

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Enforced Self-Regulation

• Performance standards
• Flexible
• Self-monitoring
• Self-correcting
• Self-reporting

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Assurances

• What is an Animal Welfare Assurance?
• Documentation of institutional commitment
• Description of institutional programs and
  procedures
• Principal method of compliance oversight

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Assurances

• Types of Assurances
• Full
• Interinstitutional
• International

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Assurances

• Information to be included in the assurance
• Applicability
• Lines of authority and responsibility
• IACUC membership
• Procedures used to implement the Policy
• Veterinary care program
• Personnel qualifications
• Occupational health program
• Training
• Facilities and species
• Institutional accreditation status

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IACUC Membership Requirements

• At least five members
• Veterinarian with program authority
• Scientist experienced in animal research
• Non-scientist
• Individual unaffiliated with the institution

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Responsibility of the IACUC

• Review applications and proposals
• Semiannual program and facility evaluation with
  report to IO
• Review concerns
• Advise IO
• Suspend PHS-supported activities if necessary

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Important Considerations in IACUC Review

• Procedures
• Analgesia and anesthesia
• Euthanasia
• Environmental conditions
• Veterinary medical care
• Personnel qualifications
• Alternatives

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Recordkeeping Requirements

• Animal welfare assurance
• Minutes of IACUC meetings
• Records of IACUC review of protocols
• Semiannual IACUC reports, including minority
  views
• Annual IACUC report, including minority views
• Accrediting body determinations

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Semiannual IACUC Reports

• Describe adherence to the Guide
• Identify departure from Guide and provide reasons
• Develop plan and schedule for correcting
  deficiencies
• Submit report recommendations to IO

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Annual Reporting Requirements

• Program or facility changes
• IACUC membership changes
• Dates of semiannual IACUC evaluations
• Dissenting views
• Gain or loss of AAALAC accreditation

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Responsibilities of the Principal Investigator

• Correct completion of the PHS 6246-1 or 6246-3
  form
• Have the animal work reviewed by the IACUC
• Address the five points in the vertebrate animal
  section
• Comply with institutional policies and procedures

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Vertebrate Animal Section

• Description of proposed use of animals
• Justification of use, species and numbers
• Veterinary care
• Procedures to minimize pain and distress
• Method of euthanasia

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Form PHS 6246-1

• Department of Health and Human Services
• Public Health Service
• Small Business Innovation Research Program
• Phase I Grant Application
• Follow instructions carefully

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5.Vertebrate Animals

• No
• Yes
• 5a. If yes IACUC approval date
• 5b. Animal Welfare Assurance no.

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OLAW Site Visits

• Division of Assurances
• random, routine, use private peer
  consultants
• examine adequacy and accuracy of Assurance
  document as actually applied
• confirm that self regulating system is working
  based on personal visit

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Site Visit Emphasis

• Institutional support for entire program
• Functioning of IACUC
• Lines of authority
• lines of communication from vet and IACUC chair
  to Institutional Official
• Documentation
• minutes, SOPs, health records, semiannual
  reports, protocols

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Site Visit

• Animal facilities, procedure areas, support space
• Meet with IACUC, Veterinarian, Institutional
  Official
• Review training, occupational health, USDA reports