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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:

  1. numbers of lines analysed and the procedures undertaken
  2. adverse effects of procedures and their control
  3. lines with particular welfare issues and pre- and post-phenotyping care undertaken
  4. lines where humane endpoints were established and reached