Notice Number: NOT-OD-12-148
Key Dates
Release Date: September 10, 2012
NOT-OD-21-161 - Request for Information (RFI) on Clarifying the Reporting Requirements for Departures from the Guide for the Care and Use of Laboratory Animals
NOT-OD-12-020: Adoption and Implementation of the Guide for the Care and Use of Laboratory Animals: Eighth EditionIssued by
National Institutes of Health (NIH)
Purpose
This Notice provides guidance to Public Health Service (PHS) grantee institutions on review and reporting requirements for departures from the Eighth Edition of the Guide for the Care and Use of Laboratory Animals (Guide).
Background
The NIH Office of Laboratory Animal Welfare (OLAW) oversees PHS-funded animal activities according to the PHS Policy on Humane Care and Use of Laboratory Animals (Policy). The Institutional Animal Care and Use Committee (IACUC) is responsible for oversight of the animal care and use program and its components as described in the PHS Policy and the Guide.
The PHS Policy IV.B.3. requires that the IACUC shall prepare reports of their semiannual program reviews and animal facility inspections and submit the reports to the Institutional Official (IO). The reports must contain a description of the nature and extent of the institution's adherence to the Guide and the PHS Policy and must identify specifically any departures from the provisions of the Guide and the PHS Policy, and must state the reasons for each departure. IACUC approval of departures from the Guide must be based on scientific, veterinary medical, or animal welfare issues. PHS Policy IV.F.3. requires Assured institutions to report noncompliant unapproved departures from the Guide to OLAW.
Since 1996, NIH had required Assured institutions to base their programs of animal care and use on the Seventh Edition of the Guide. On December 2, 2011, NIH announced that Assured institutions would be expected to implement the Eighth Edition of the Guide in 2012. The Eighth Edition of the Guide emphasizes the use of performance standards, providing flexibility that empowers institutions to continue to improve and advance the humane care and use of vertebrate animals in research, research training and biological testing.
Reporting requirements
Institutions are advised to read the Eighth Edition of the Guide carefully; it establishes exceptions in specific situations. These exceptions are not departures from the Guide and are not required to be reported to the IO. Additionally, guidance in the Eighth Edition of the Guide is stated in terms of standards that must be met, standards that should be met, and standards that may be met.
OLAW defines a must statement as a minimum standard required of all Assured institutions. Deviation from these standards with IACUC approval is a departure from the Guide and must be reported in the semiannual report. Deviation from a must statement without IACUC approval is a noncompliance that must be reported to OLAW through the IO.
Reporting requirements for should statements in the Guide vary:
- Should statements often involve performance standards. Well-established performance standards are not departures from the Guide and need not be reported in the semiannual report to the IO.
- Deviation from a should statement with IACUC approval is a departure from the Guide and must be reported in the semiannual report to the IO.
- Deviation from a should statement without IACUC approval is a noncompliance that must be reported to OLAW through the IO.
May statements in the Guide are suggestions that institutions can choose to implement if suitable for their program and deviations are not included in the semiannual report to the IO.
IACUC approval of departures from the Guide must be based on scientific, veterinary medical, or animal welfare issues. For additional information and examples of departures refer to OLAW FAQ C7.
Inquiries
For questions or further information, contact:
Office of Laboratory Animal Welfare
Office of Extramural Research
National Institutes of Health
RKL1, Suite 360
6705 Rockledge Drive
Bethesda, MD 20892-7982
Phone: 301-496-7163
Fax: 301-915-9481
Email: olaw@od.nih.gov
Web: http://olaw.nih.gov/
and Human Services (HHS)
