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Animal Welfare (WP5)
Aims and Overview
We
will establish procedures for the assessment and oversight of animal welfare as
an intrinsic part of the EUMODIC programme. This will involve standardised
procedures across the consortium for determining levels of suffering, applying
appropriate welfare requirements and determining humane endpoints.
Determination
of welfare is intrinsically linked to phenotype outcome; welfare is contingent
on phenotype and is assessed as part of the overall phenotypic analysis.
Determination of phenotype will feed into the level of assessment of suffering
and the application of appropriate husbandry and welfare requirements. EUMODIC
provides a key opportunity for the assessment of new approaches to determining
and describing welfare status in genetically modified animals and acquiring
additional evidence on the welfare benefits of enriching the cage environment.
Workplan
Establishment of a welfare advisory
committee
A welfare advisory committee will be established to
oversee welfare aspects of the project.
This will be composed of 6 representatives from institutes who are
involved with animal welfare locally (GSF,
MRC, ICS, Sanger, CNR and EMBL). It may
also include local representatives from local ethical committees, if
they have an interest or are required for the business of the committee. In addition, we will have two representatives
from the secondary phenotyping centers. The
committee will report to the Project Management Committee. There will also be a representative on the
Scientific Advisory Board who will oversee animal welfare issues. The committee will meet yearly at the annual
project meeting. They will also meet
mid-year either by conference call or in person.
EUMODIC will
follow both EU and national regulations
All breeding and experiments will be performed
according to the recommendations in European Union Directive 86/609/EEC that
covers the protection of animals used for experimental and scientific
purposes. National regulations will be
followed and local ethical review panels and licences will be obtained as
detailed in section 10 (ethical issues) below. The Project Office will ensure
that all appropriate legislation and licencing documents are obtained and
passed to the European Commission.
EUMODIC
investigations will be based on a cost-benefit analysis seeking to minimise the
numbers of animals used and apply appropriate welfare improvements and human
endpoints
Each of the 650 lines in EUMODIC are chosen on the
basis that knowledge of the function of the gene investigated is important for
understanding both biological and disease systems. As investigation of each
mutant proceeds the benefits of investigating gene function are weighed against
the costs involved and, if necessary, appropriate husbandry conditions and
humane endpoints will be instituted (see below).
Numbers of animals used will be kept to a minimum. The
numbers of males and females tests in each of the EMPReSSslim pipelines is
based on a careful assessment of the minimal number of animals required to
obtain statistically valid phenotype data.
In addition to the 500 viable lines that will be subjected to primary
phenotyping, a number of lines will be included in secondary phenotyping. Numbers of lines entering each test in each
secondary phenotyping workpackage are given in the tables in Appendix A at the
end of this document. Regular (6 monthly) reports on the number of lines
entering primary and secondary phenotyping will be collated and sent to the
Project Management Committee, SAB and European Commission (see workpackages 1
& 2 for milestones and deliverables on this).
EUMODIC will
institute SOPs for animal welfare across the consortium
An SOP for animal welfare will be established that
will be applied across the consortium bringing uniformly high standards to the
application of best practice in assessment and care of welfare. The SOP will
include:
- Animal
welfare sheets, including:
- Observations
of neonatal and juvenile development
- Observations
of visible adult abnormalities
- Guidelines
on the establishment of appropriate husbandry conditions to maximise
welfare based on cage-side observations and phenotypic assessment (see
below)
- Guidelines
on humane endpoints taking into account information from animal welfare
sheets and other phenotypic observations undertaken as part of
EMPReSSslim.
EMPReSSslim in itself provides an enormous amount of
information on welfare by the documentation of phenotypes for various body
systems. As information on phenotype is gathered it will be possible to make a
more informed assessment of whether and what humane endpoints need to be
instituted.
EUMODIC will
disseminate information on welfare for mutant lines investigated
We will bring to the attention of the wider community
any welfare problems associated with individual mutant lines. All data on
phenotypes will be published through the EuroPhenome database. However, we will
also record adverse effects based on records of visual observations from the
animal welfare sheets or based on the phenotype data collected as part of
EMPReSSslim. In addition, where appropriate we will document and disseminate
measures to maximise welfare and minimise suffering of mutant lines.
EUMODIC will
prepare an annual report detailing welfare issues and progress with instituting
welfare improvements
An annual report will be written on welfare issues,
detailing:
- numbers of
lines analysed and the procedures undertaken
- adverse
effects of procedures and their control
- lines with
particular welfare issues and pre- and post-phenotyping care undertaken
- lines
where humane endpoints were established and reached
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