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UH
Requirements For Vertebrate Animal Use I. Overview
of Federal Mandates Federal mandates,
primarily the United States Department of Agriculture (USDA) Animal
Welfare Act (AWA) of 1966 and the 1985 amendments to the AWA, and the
Public Health Service (PHS) Policy on Humane Care and Use of Laboratory
Animals, referred to also as the National Institutes of Health (NIH)
Policy, require an institutional animal-use oversight committee. The
committee is referred to as the "Institutional Animal Care and
Use Committee" or more commonly known as the IACUC. This committee
is further required by this University and is campus policy. Failure to comply
with federal standards and codes may result in civil or criminal prosecution
and the suspension of animal research activities at the entire institution.
Furthermore, an institution's failure to comply with federal laws, regulations,
codes, and policies that govern animal use may lead to severe consequences,
one of which is the termination of federally funded support for projects. Vertebrate animal
use must be reviewed and approved by the UH IACUC prior to the use occurring.
Committee review is required regardless of animal use site, funding
source, species, or animal number. An approved protocol must be procured
by all University faculty, staff, or students using vertebrate animals
in research, teaching or testing. There are some situations were a protocol
is not required. Inquiries in these matters are to be directed to the
Institutional Animal Care & Use Committee, c/o Regulatory Compliance
Officer and Executive Secretary (telephone 956-4446/facsimile 956-4448). II. Information
Required For Protocol Applications The applicant is required to furnish a non-technical description of the research/teaching/training activity, a justification for the use of animal, description of all of the procedures to be performed on the animals, and precautions taken to assure humane care and treatment of animal subjects. Information is required on providing the species of animals proposed, numbers of the animals, animal holding facilities, use of anesthetics/analgesics/paralytic agents, methods of restraint, survival/non-survival surgery procedures, the methods of euthanasia and the final disposition of animal subjects. Thorough preparation
of the protocol application facilitates the review process and reduces
the chance of delay in initiating projects and in the review of applications.
The animal use protocol applicants are advised to write the applications
in non-technical terms as scientist and non-scientist alike will review
the submittal. III. The IACUC
Review Process: The protocol review
process normally takes at least 4-5 weeks. Problems associated with
the application (e.g., additional information required, controversial
topics, etc.) may cause the review and approval process to be delayed. Protocol applications
must be received by IACUC Regulatory Compliance Officer & Executive
Secretary no later than the second Wednesday of each month. All applications
will be reviewed by a quorum at regularly scheduled IACUC business meetings
held on the third Thursday of each month. No exceptions will be made
for late submittals. If an application is not received by the second
Wednesday deadline for that month, the application will be deferred
to the next review cycle. At the convened meeting,
the committee reviews new applications, renewed protocols, and revisions
to previously approved applications, as well as discuss remaining or
additional issues related to proposed animal use. Following the meeting,
investigators/applicants are notified of the status of their applications
in writing, generally, within 3-5 working days. A protocol approval
is valid for a maximum of one year from the date of the meeting at which
it was approved. Multiple year protocol applications must be renewed
by the applicant and reviewed by the committee annually. IV. Extramural
Funding Agencies: Be advised that the National Institutes of Health (NIH) and the National Science Foundation (NSF) require verification of animal use approval within 60 days after the receipt date for which a grant proposal is submitted. If verification of institutional animal use approval is not received by the extramural funding agency deadline(s), the grant application will be considered incomplete and deferred to the next review cycle. Many other funding agencies follow the policies of the NIH and NSF which allow a 60-day grace period for receipt of the verification of institutional approved animal use. Whenever possible, an animal use protocol application should be sent to the IACUC for consideration before an application for extramural funding is submitted to an agency. |