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Guide to ethics committees assessment of project applications under scientific animal protection legislation changes tracked
It also describes the evidence to be provided to the HPRA and included as supporting documentation as outlined in the ‘Guide to Project Applications under Scientific Animal Protection Legislation’., This is seen to be in the best interests of animal HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-3.1 5/16 welfare and in to improve the overall efficiency of the process., The HPRA is open to the integration of the ethics committee with the animal welfare body, or to other governance HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-3.1 6/16 arrangements such that both bodies work closely together for the benefit of animal welfare and are informed of each other’s decisions (as relevant)., Refer to the ‘Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection Legislation’ for information on submitting amendment applications., HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-3.1 12/16 6.2 Assessment of the potential benefits being realised The HPRA notes that the criteria in section 6.1 might not be demonstrable in every case., Guide to ethics committees assessment of project applications under scientific animal protection legislation changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0116-guide-to-ethics-committees-assessment-of-project-applications-under-scientific-animal-protection-legislation-pdf-v4-changes-tracked6c6b4233-7ce4-41cf-8da5-7ac8b52ac9c1.pdf?sfvrsn=7cdc59d_4Application for an individual authorisation under scientific animal protection legislation
Application for an Individual Authorisation under Scientific Animal Protection Legislation For details on completing this application form, please see the HPRA ‘Guide to New, Amendment, Renewal and Reactivation Applications for Individuals under Scientific Animal Protection Legislation’., Have you completed a relevant approved or accredited scientific animal training course?, Select the species of animal(s) for which authorisation is sought using the table below., Where the species of animal does not clearly fit into the general categories provided, please specify the species in the relevant column., Application for an individual authorisation under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0344-application-for-an-individual-authorisation-under-scientific-animal-protection-legislationv18.docx?sfvrsn=e33b8ac5_7Training requirements and courses | Scientific animal protection
Guide to training education and competency requirements under scientific animal protection legislation PDF : 244 KB | 01/04/2025 Note that the HPRA itself does not offer training., Training requirements and courses | Scientific animal protection
https://www.hpra.ie/regulation/scientific-animal-protection/training-requirements-and-coursesApplication for authorisation of breeder,supplier,users under scientific animal protection legislation
Application for Authorisation of Breeder/Supplier/Users under Scientific Animal Protection Legislation Section A: breeder/supplier/user establishment Details APPLICANT DETAILS (I.E., establishments with no locations If the application is for a user establishment that does not have any animal facilities, the establishment location fields should not be completed., Title & Name Role in animal welfare body Section D: Site Master file Submit a completed site master file with this application form, providing the information outlined in the ‘Guide to Preparation of a Site Master File for Breeder/Supplier/Users under Scientific Animal Protection Legislation’ (available at www.hpra.ie)., oany restrictions on the extent to which an animal can satisfy its physiological and ethological needs are kept to a minimum., othe welfare and care of animals is appropriately overseen and that the animal welfare body is appropriately informed and consulted., Application for authorisation of breeder,supplier,users under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0345-application-for-authorisation-of-breeder-supplier-users-under-scientific-animal-protection-legislation-v7.docx?sfvrsn=7f2e86d1_6Guide to use of animals for educational purposes under scientific animal protection legislation
Guide to Use of Animals for Educational Purposes under Scientific Animal Protection Legislation HPRA Guide to Use of Animals for Educational Purposes under Scientific Animal Protection Legislation AUT-G0117-5 2/6 1 SCOPE Directive 2010/63/EU (the Directive) and S.I., No. 324 of 2020 (hereafter referred to as the Regulations) establish measures for the protection of animals used for scientific or educational purposes., HPRA Guide to Use of Animals for Educational Purposes under Scientific Animal Protection Legislation AUT-G0117-5 4/6 4.1 Use of animals in education of agricultural, veterinary, life sciences or medical students The use of animals in education of third or fourth level students may be divided into the following categories: 4.1.1 Use of live animals for animal handling training Use of animals for training in proper animal handling does not fall under the scope of the legislation where such use does not ‘cause the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice’., Further information is provided in the Guide to project applications under Scientific Animal Protection Legislation. 4.1.3 Use of cadavers for dissection labs Animal cadavers are frequently used to train undergraduates in anatomy and physiology., HPRA Guide to Use of Animals for Educational Purposes under Scientific Animal Protection Legislation AUT-G0117-5 6/6 Training in animal handling skills does not require a project authorisation, but any procedures that are carried out as part of vocational training on live animals will require a breeder/supplier/user authorisation, project authorisation and individual authorisations for trainers and trainees., Guide to use of animals for educational purposes under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0117-guide-to-use-of-animals-for-educational-purposes-under-scientific-animal-protection-legislation-v5.pdf?sfvrsn=aefd9942_6Guide to practices outside the scope of scientific animal protection legislation
Guide to Practices outside the Scope of Scientific Animal Protection Legislation HPRA Guide to Practices Outside the Scope of Scientific Animal Protection Legislation AUT-G0119-4 2/9 1 INTRODUCTION This guide is intended to clarify when studies or practices involving animals may fall outside the legislation governing the protection of animals used for scientific purposes i.e., The EU Commission advice is that the conduct of pre-clinical trials falls within the scope of scientific animal protection legislation and requires HPRA project authorisation., Additionally, confirmation of dose studies carried out under laboratory conditions or in artificially diseased or infected animals also falls within the scope of scientific animal protection legislation., HPRA Guide to Practices Outside the Scope of Scientific Animal Protection Legislation AUT-G0119-4 7/9 3.2.1 Section A, Applicant Details Information and contact details for the applicant should be provided here., For the purposes of this guide, the HPRA concludes that the following trials, studies or practices fall within the scope of scientific animal protection legislation: HPRA Guide to Practices Outside the Scope of Scientific Animal Protection Legislation AUT-G0119-4 9/9 - Practices likely to cause the animal a level of pain, suffering, distress or lasting harm equivalent to or higher than that caused by the introduction of a needle according to Good Veterinary Practice, Guide to practices outside the scope of scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0119-guide-to-practices-outside-the-scope-of-scientific-animal-protection-legislation-pdf-v4.pdf?sfvrsn=64ebed45_6Guide to ethics committees assessment of project applications under scientific animal protection legislation
It also describes the evidence to be provided to the HPRA and included as supporting documentation as outlined in the ‘Guide to Project Applications under Scientific Animal Protection Legislation’., This is seen to be in the best interests of animal welfare and to improve the HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-4 4/12 overall efficiency of the process., HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-4 9/12 6.2 Assessment of the potential benefits being realised The HPRA notes that the criteria in section 6.1 might not be demonstrable in every case., HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-4 11/12 Whether the ethical reviews take place face-to-face or virtually, a record (i.e. minutes) must be taken., HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-4 12/12 The proper conduct of a harm-benefit analysis can be quite complex with no specific mathematical formula available to deliver a decision., Guide to ethics committees assessment of project applications under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0116-guide-to-ethics-committees-assessment-of-project-applications-under-scientific-animal-protection-legislation-pdf-v4.pdf?sfvrsn=6dace401_7Application for transfer of a project authorisation under scientific animal protection legislation
Application for Transfer of a Project Authorisation under Scientific Animal Protection Legislation For details of the requirements, see the ‘Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation’., I hereby confirm that in the event of the transfer being granted, FORMTEXT will furnish to FORMTEXT : -all records and documentation including records and documentation in support of the original application for project FORMTEXT , -all records and documentation in support of any previous and ongoing amendments to the project authorisation, all animal records in relation to the project, and all correspondence with the Health Products Regulatory Authority concerning the project; and -all items (including but not limited to samples) of whatsoever nature required to be held by the holder of the project authorisation FORMTEXT ., Application for transfer of a project authorisation under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0453-application-for-transfer-of-a-project-authorisation-under-scientific-animal-protection-legislation-v3.docx?sfvrsn=8f617b98_6Application for reactivation of an individual authorisation under scientific animal protection legislation
Application for Reactivation of an Individual Authorisation under Scientific Animal Protection Legislation For details on completing this application form, please see the HPRA ‘Guide to New, Amendment, Renewal and Reactivation Applications for Individuals under Scientific Animal Protection Legislation’., A new ‘Application for an individual authorisation under Scientific Animal Protection Legislation’ must be submitted in this case., Application for reactivation of an individual authorisation under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0865-application-for-reactivation-of-an-individual-authorisation-under-scientific-animal-protection-legislation-v1.docx?sfvrsn=636b06b8_9Guide to preparation of a SMF for breeder supplier users under scientific animal protection legislation changes tracked
The guidance is an addition to the HPRA ‘Guide to Applications for Breeder/Supplier/Users under Scientific Animal Protection Legislation’., HPRA Guide to Preparation of a Site Master File for Breeder/Supplier/Users under Scientific Animal Protection Legislation AUT-G0099-5.1 5/13 3 FORMAT OF SITE MASTER FILE The SMF should contain adequate information in an easily-readable format when printed., HPRA Guide to Preparation of a Site Master File for Breeder/Supplier/Users under Scientific Animal Protection Legislation AUT-G0099-5.1 10/13 How the animal welfare bodyAWB performs the tasks required of it in Regulation 50 should be outlined., The HPRA ‘Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation’ HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation includes guidance on what is expected from an ethics committee. 4.12 Animal health and welfare system The system for monitoring the health and welfare of animals at the breeder/supplier/user establishment should be outlined., HPRA Guide to Preparation of a Site Master File for Breeder/Supplier/Users under Scientific Animal Protection Legislation AUT-G0099-5.1 12/13 It should be indicated how any bio-security measures in place, including rodent, fly and pest control, are implemented., Guide to preparation of a SMF for breeder supplier users under scientific animal protection legislation changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0099-guide-to-preparation-of-a-smf-for-breeder-supplier-users-under-scientific-animal-protection-legislation-v5-changes-tracked77c10b2697826eee9b55ff00008c97d0.pdf?sfvrsn=ca4c1fb_4