1. Background Terms of Reference of the new DCU ANIMAL WELFARE BODY, 1.1 Legislation in the EU Approved by Research Committee in November 2016. Directive 2010/63/EU revising Directive 86/609/EEC on the protection of animals used for scientific purposes was adopted by the Council of the European Union on 22 September 2010. The Directive is firmly based on the principle of the Three Rs (3Rs), to replace, reduce and refine the use of animals used for scientific purposes. The scope of the 2010 Directive is wider and includes foetuses of mammalian species in their last trimester of development, and cephalopods, as well as animals used for the purposes of basic research, higher education and training. The Directive lays down minimum standards for housing and care, and it regulates the use of animals for scientific purposes through a systematic project evaluation requiring inter alia assessment of pain, suffering, distress and lasting harm caused to the animals. It requires regular risk based inspections and improves transparency through measures such as publication of non technical project summaries and retrospective assessment 1.2 Legislation in Ireland The EU Directive was transposed into Irish legislation by the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 (SI 543 of 2012). This legislation aims to improve the welfare of animals used for scientific purposes and to promote the principles of the 3Rs Replacement, Reduction and Refinement: Replacement refers to the use of scientifically satisfactory methods that do not require the use of animals, as an alternative to the use of live animals for scientific purposes. Where replacement is not possible, animal use must only be permitted where justified and where the expected benefits outweigh the potential adverse effects. Reduction measures must be applied so as to minimise the number of animals used in each research project, without compromising the objectives of the project. Refinement requires that that the breeding, accommodation and care of animals, and the methods used in scientific procedures, are refined to eliminate or reduce to the minimum any possible pain, suffering, distress or lasting harm to animals.
On 1st January 2013, the Department of Health and Children (DoHC) stopped being the Competent Authority for the licensing of studies that use animals for scientific research; responsibility was transferred to the Irish Medicines Board (IMB). In July 2014, the IMB was renamed the Health Products Regulatory Agency (HPRA). The HPRA is responsible for the implementation of the legislation, but the Department of Health continues to have responsibility for related policy and legislative developments. 1.3 DCU Policy on the Use of Animals for Scientific or Educational Purposes The DCU policy on the Use of Animals for Scientific or Educational Purposes was approved by University management on 20 th September 2016 and is available on the DCU University Policies web page. The University actively supports the implementation of the 3Rs. Replacement is encouraged through the active support of the development and uptake of alternatives to live animals in teaching and research. Reduction is achieved by the requirement for statistical justification of animal numbers requested in applications submitted both to the Animal Welfare Body (AWB) and to the DCU Research Ethics Committee (both of which are a prerequisite for the use of animals for scientific purposes) and by ensuring that only projects that are rigorously justified are approved. In addition, there is a requirement to maximise the amount of data emerging from animal studies by judicious experimental design. Refinement is brought about by ensuring that animal welfare is prioritised when designing studies, by providing excellent accommodation and care for the animals, and by ensuring high standards of training and education of researchers and animals care staff. 1.4 Transition from the dual role of old AWB and Bio Resource Advisory Group to new all encompassing Animal Welfare Body, November 2016 The Bio Resource Advisory Group (BRAG) was established to advise researchers who were considering using animals for scientific or educational purposes at Dublin City University (DCU). Establishment of the BRAG pre dated the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 (S.I. No. 543 of 2012)i (henceforth the Regulations ). Regulation 50(1) of the Regulations required DCU, as an Authorised Establishment, inter alia to set up a group known as the Animal Welfare Body (AWB). The AWB is required to carry out certain tasks, as laid down in Regulation 50(2). Therefore DCU set up the AWB in 2013 to comply with the EU legislation and Irish Regulations. The BRAG and the AWB coexisted for several years, although there was considerable overlap in their function and their membership. Following a review of the operation of both bodies, in October 2016 the BRAG and the AWB were merged, with the BRAG becoming, in effect, a sub committee of the AWB.
Role of the Animal Welfare Body The Animal Welfare Body has the following mixture of statutory and non statutory functions: 1. To review and inspect all aspects of DCU animal care and use, including all animal facilities and animal care records, review animal use protocols, and review and investigate complaints about animal use. The purpose of these reviews and investigations is to provide a mechanism that ensures compliance with all regulations and policies and allows for interaction between the AWB and institutional staff members; 2. To advise the staff dealing with animals on matters related to the welfare of animals, in relation to their acquisition, accommodation, care and use; 3. To advise the staff on the application of the requirement of replacement, reduction and refinement, and keep it informed of technical and scientific developments concerning the application of that requirement; 4. To establish and review internal operational processes as regards monitoring, reporting and follow up in relation to the welfare of animals housed or used in the establishment; 5. To follow the development and outcome of projects, taking into account the effect on the animals used, and identify and advise as regards elements that further contribute to replacement, reduction and refinement; 6. To advise on rehoming schemes, including the appropriate socialization of the animals to be rehomed; 7. To facilitate, where appropriate, the establishment of programmes for the sharing of organs and tissues of animals killed; 8. To aid users in the preparation of an application to the DCU Research Ethics Committee (REC) and to advise the REC on the ethical approval of that application (including the granting of conditional approval, if appropriate); 9. Where an application for a Project Authorisation must then be made to the HPRA, to aid and advise users in the preparation of that submission and to provide support and advice throughout the review process, until the application has been granted or refused by the HPRA, and 10. To keep up to date with the legislation and developments related to the use of animals for scientific purposes, and to advise the university senior management when required. The tasks in items 2 to 7 in the above list are statutory duties, laid down by Regulation 50(2) of the Regulations. AWB Authority and Reporting
The AWB reports to the University Research Committee via the Compliance Officer appointed under Regulation 44. The AWB must be in regular communication with the Compliance Officer via the Animal Care and Welfare Officer (appointed under Regulation 45) to ensure that any serious issues or decisions that have implications for animal welfare or budgetary implications are immediately brought to his/her attention. The AWB is an advisory body of the DCU Research Ethics Committee (REC) and proposals that have been endorsed by the AWB are sent to the REC for final Ethical Approval. No proposal involving the use of animals may be sent to the REC without the pre approval of the AWB. Some of the AWB members may also be members of the REC, which facilitates communication between these two bodies. All personnel carrying out research work on live animals, whether on DCU premises or elsewhere, must do so in accordance with protocols which have been approved by the AWB and the REC. In addition to the ethical requirement for protocol approval, persons intending to carry out regulated procedures on live animals for scientific or educational purposes must hold the appropriate authorisation(s) issued by the HPRA. An application to the HPRA for a project authorisation may not be made unless and until the applicant has received approval from the REC. An application to the HPRA for an individual authorisation does not require ethical approval from the REC. The holder of any authorisation issued by the HPRA must comply with any condition attached to that authorisation. No work on live animals may be carried out unless and until the Training Officer appointed under Regulation 46 is satisfied as to the competence of the individual concerned. AWB Competencies AWB Review of Research Proposals involving the use of animals The AWB reviews all research proposals involving the use of animals, and makes a recommendation to the REC, and the proposal must receive ethical approval from the REC, before any research may begin (and any project that proposes the use of live animals will also require appropriate authorisation(s) from the HPRA). The AWB may recommend approval of a proposal, may require modifications to a proposal in order to secure a positive recommendation, may recommend conditional approval, or may recommend rejection of any proposal that it receives. Researchers should submit the
application on the relevant form 1, for consideration of the AWB before submitting an application to the REC. Review of the Animal Care Program The AWB must ensure the humane care and use of animals in the university. Hence, the AWB must ensure the following: a) That appropriately approved protocols and standard operating procedures are available to users working with animals. b) That all appropriate records as advised by the HPRA are of the highest standards and are regularly maintained. c) That corrective action is speedily implemented to address any identified deficiencies. Facility Inspections Facility inspections must be carried out at least nine times per annum by the Designated Veterinarian (DV) appointed under Regulation 48. A report noting any deficiencies must be then submitted by the DV to the AWB, including suggestions for corrective action where appropriate. Significant deficiencies, i.e. those that pose an immediate threat to the health or welfare of the animals, must be corrected within the shortest possible time frame. Membership The membership of the DCU AWB is as follows: Designated Veterinarian Animal Care and Welfare Officer, as required by Regulation 50(1)(a) Training Officer Animal Technical Officer Academic/Researcher representative(s) (more than one may be appointed, and at least one member of the AWB must be a scientific member, as required by Regulation 50(1)(a)) Biostatistician(s) (at least one) One of the above members will be appointed as the Chairperson. Although the membership of the AWB is at the discretion of the University (subject to Regulation 50(1)(a)), the HPRA requires that a balance be maintained between animal 1 Application for Approval of a Project Involving Animals, where the project also requires a project authorisation from the HPRA, together with a draft of the application to the HPRA for a project authorisation, or Application for Approval of a Project Involving Animals, where the project does not require a project authorisation from the HPRA
welfare representatives and researchers. In particular, the composition of the AWB must not allow for researchers always to be able to outvote animal welfare representatives on the AWB. i SI 543 of 2012 is available online at http://www.irishstatutebook.ie/eli/2012/si/543/made/en/print Amendments to the SI are listed at http://www.irishstatutebook.ie/eli/isbc/si2012_501 550.html, which can be reached from a button on the home page of SI 543.