2nd Edition 2002 arena/olaw institutional Animal Care and Use Committee Guidebook


Program of Education and Training for New IACUC Members



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Program of Education and Training for New IACUC Members



ORIENTATION MODULE

(Suggested time – approximately 2 hours)



Suggested Topics




Objectives





  1. To introduce members to the role of the IACUC and its evolution

  2. To provide the basic information necessary for IACUC members to discharge their responsibilities

  3. To provide a forum for response to, and discussion of, members' concerns and questions


Conducted by
The IACUC staff, the IACUC Chair or designee, veterinary staff, or consultants. Training can be provided by one or more of these individuals.
Syllabus:


  1. The IACUC --- its evolution and responsibilities

    1. Genesis and chronology

    2. U.S. Government Principles

1.3. Benefits and pitfalls of IACUCs

    1. Criteria for membership

    2. Authority of the IACUC

    3. The unique role of the IACUC within the organization




  1. Operation and procedures

    1. Proposal (protocol) submission

    2. Proposal review

2.2.1. Process

2.2.2. IACUC review criteria

2.2.3. Review by quorum


      1. Review by designated reviewers

      2. Post-meeting process.

    1. Monitoring of approved protocols

      1. Periodic review (continuing review)

      2. Protocol changes (amendments)

    1. Records

    2. Semiannual reviews

      1. Animal care and use program

      2. Institutional animal facilities

    1. Handling animal welfare concerns

    2. Roles, responsibilities, relationships

      1. IACUC

      2. IACUC Program office

      3. Veterinarian

      4. Animal Care Program (e.g., Department of Comparative Medicine or Laboratory Animal Resources)

      5. Institutional Official (IO)

      6. Office of Laboratory Animal Welfare (OLAW), NIH

      7. Animal and Plant Health Inspection Service (APHIS), USDA

      8. Project sponsor/grantor

      9. Community


Suggested Resource Materials





  • Public Health Service Policy on Humane Care and Use of Laboratory Animals. NIH. Reprinted 2000.

  • Health Research Extension Act, P.L.99-158.

  • Animal Welfare Act - P.L. 89-544 as amended by P.L. 94-279, P.L. 99-198, P.L. 91-579 and P.L. 101-624.

  • Animal Welfare Regulations. 9 CFR.

  • Institutional Administrator's Guide for Animal Care and Use. NIH. 1988.

  • Guide for the Care and Use of Laboratory Animals. NRC. 1996.

  • ARENA/OLAW Institutional Animal Care and Use Committee Guidebook. 2002.

  • Institutional IACUC Policies and Procedures Manual.

For additional suggestions see the Core Module in the National Research Council’s Education and Training in the Care and Use of Laboratory Animals – A Guide for Developing Institutional Programs, pages 11 through 15.


Program of Education and Training for IACUC Members
Recommended Continuing Education Module
(Varying amounts of time---can be incorporated in each IACUC meeting and/or designated or ad hoc meetings)

Suggested Topics



Objectives


  1. To increase members' knowledge, understanding and awareness

2. To keep members current on:

    1. Laws (federal, state, local)

    2. Regulations (proposed, promulgated/issued)

    3. Directives

    4. Guidelines

    5. Developments and trends

    6. Institutional policies

3. To address issues, concerns and questions raised by IACUC members, institutional staff, and the community.
Conducted by
The IACUC Staff, the Chair or designee, veterinary staff, or consultants.
Syllabus
Agenda based on:


  1. Questions and concerns brought to the attention of the IACUC

  2. Official directives

  3. Publications

  4. Notices of, and reports from, conferences, seminars, etc.

  5. Animal facility staff and/or veterinarian’s observations and recommendations

  6. Facility inspections and program evaluations

  7. Problem situations



Suggested Resources: See Appendix A.





A.5. Legal Concerns


The functions and activities of IACUCs are based on two federal laws: the Health Research Extension Act of 1985 (P.L.99-158) (HREA) and the 1985 amendments to the Animal Welfare Act (AWA), the Improved Standards for Laboratory Animals Act of 1985 (P.L. 99-198). In addition, other federal rules may pertain to IACUCs, such as the Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Good Laboratory Practice (GLP) regulations and the Endangered Species Act (ESA). Committee members need to be aware of the legal obligations of their institutions, the responsibilities of the IACUC in relation to these institutional commitments, and the regulatory requirements for which they may be personally accountable.


Many states have statutes and regulations in place relevant to laboratory animals as well. Institutional Officials (IOs) and IACUC administrators should ensure that procedures are in place to enable IACUCs to be cogni-zant of and compliant with state and local laws and regulations that may affect their institution’s animal care and use program. A useful reference is the National Association for Biomedical Research (NABR) publication, State Laws Concerning the Use of Animals in Research.
Institutions are responsible for informing IACUC members of their re-sponsibilities, providing training relative to their role on the IACUC, and ensuring that members have the information necessary to fulfill their duties as IACUC members:


  • IACUC members should be provided with documents such as the PHS Assurance with the Office of Laboratory Animal Welfare, NIH (OLAW), the PHS Policy, the Guide and the Animal Welfare Regulations (AWRs). Committee members should be aware of their institutional registration with the U.S. Department of Agriculture (USDA) and reports of inspections and other interactions with Animal and Plant Health Inspection Service (APHIS).




  • IACUC members should be free to request through the IACUC Chair or IO, guidance from the institution’s legal counsel with regard to Committee actions.




  • IACUC members should be provided with information regarding their obligation to treat material as privileged or confidential, especially

prior to final Committee action, or agency funding. In the case of trade secrets or patent applications, such information is protected by law (7USC 2157, Section 27).




  • IACUC members should understand that their signatures are legally binding on official IACUC reports such as the six-month program review and facilities inspection report.





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