CHANGES TO THE LICENCING AUTHORITY FOR VERTEBRATE ANIMAL RESEARCH
On 1st January 2013 the process for getting ethical approval and licences for research involving vertebrate animals has changed. The Health Products Regulatory Authority (formerly the Irish Medicines Board (IMB) has now become the competent authority responsible for ensuring compliance in Ireland for animal welfare and in particular for compliance with the new EU directive 2010/63/EU and SI No 543 2012. All organisations, individuals and projects involving vertebrate animals will now require separate authorisations to carry out that research. Each organisation is required to set up an Animal Welfare Body who will be responsible within the organisation for animal welfare as well as ensuring compliance with the new regulations.
You should contact the Animal Welfare Body at Maynooth University ([email protected]), who will assist you in completing the required HPRA documentation.
PLEASE NOTE: Research that is carried out under existing licences is not required to be authorised and the licence is valid until it's end date.
CHANGES TO ETHICAL APPROVAL PROCESS AT NUI MAYNOOTH
If you are applying for ethical approval for research that is not covered by an existing licence you MUST first apply for your INDIVIDUAL authorisation from the Health Products Regulatory Authority . Once you have received your individual authorisation you may then apply for ethical approval to Maynooth University.
Approval will be given for specific animals and procedures as well as for a discrete period of time, after which you may apply for a renewal should it be justifiable and deemed necessary. Ethical approval is required by the HPRA in order to submit a project authorisation application. In order to align with the information that is required by the HPRA, there are significant changes to the documentation for submitting a protocol for ethical approval at Maynooth University.
- Please submit this Administration form - Vertebrate Animals and a completed HPRA application form (link available within the admin form) for a project authorisation for ethical review of a research project involving the use of Vertebrate Animals with all supporting documentation to the Maynooth University Research Support Office Ethics Commmittee Secretariat: [email protected]
- Please submit this Administration Form - Amendments or Renewals involving the use of Vertebrate Animals and a completed HPRA application form (link available within the admin form) for amendments or renewals to an approved research project involving the use of Vertebrate Animals with all supporting documentation to to the Maynooth University Research Support Office Ethics Commmittee Secretariat: [email protected]
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