View source for 3.4.1.1 Ethical evaluation and authorization process of animal use

== A. Background & Definitions ==

Depending on the country, animal use is documented in a “protocol” (e.g. USA), or in a “project” (e.g. European Union). Regardless of the name, for EQIPD purposes all animal use must be subjected to ethical evaluation and authorization before it commences. Evaluation and authorization can be merged and performed by the same body, or be independent processes performed by different bodies, which can be institutional, external, or the public competent authority (at regional or national government). In some countries the entire process can be performed by a single body (e.g. the Institutional Animal Care and Use Committee in USA), and in others by any combination of bodies at different level (e.g. institutional bodies for the evaluation and the government competent authority for the authorization, as in some European countries). When no regulations are in place, it is expected that the parent organisation establishes an internal process.



== B. Guidance & Expectations ==
The participation of the following bodies, either as part of the evaluation and/or authorization processes must be identified:
* Institutional body(ies) from the parent organisation involved
* External body(ies) involved
* Competent Authority (public, government)


'''PLEASE DO NOT FORGET'''
* To check the protocol/project form and ensure all requested information can be provided
* To complete the form with all necessary information to allow for an efficient and timely evaluation and authorization process, including enough elements to allow the evaluation body perform a harm-benefit analysis.
* In European Union establishments, include a non-technical summary, and consider the possibility of a future retrospective assessment.
* To submit the evaluation/authorization bodies the completed protocol/project form with enough time so the evaluation/authorization processes can be finalized before the planned time for animal use.


== C. Resources ==
* Template to describe information related to animal care and use (all items covered by Section 3.4.1) - 3.4.1 Animal care and use.docx
* PREPARE guidelines 2018 for planning animal research - [[PREPARE]]
* ARRIVE guidelines 2019 for reporting animal research - [[ARRIVE 2.0]]

Online and other available guidance:
* Directive 2010/63/EU (Articles 37-44) [https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0079:EN:PDF]
* Guide for the Care and Use of Laboratory Animals, NRC 2011 (pp. 24-33) [https://www.aaalac.org/resources/theguide.cfm]
* EU Consensus document on non-technical summaries: [http://ec.europa.eu/environment/chemicals/lab_animals/pdf/Recommendations%20for%20NTS.pdf]
* EU Consensus document on Project Evaluation and Retrospective Assessment [http://ec.europa.eu/environment/chemicals/lab_animals/pdf/Endorsed_PE-RA.pdf]
* EARA working group on Non-Technical Summaries: Guidance document to improve the language and understanding of NTS for the general public [http://eara.eu/wp-content/uploads/2019/06/NTS-Final.pdf]
* Current concepts of Harm–Benefit Analysis of Animal Experiments – Report from the AALAS–FELASA Working Group on Harm–Benefit Analysis – Part 1 [https://journals.sagepub.com/doi/full/10.1177/0023677216642398]
* Recommendations for Addressing Harm–Benefit Analysis and Implementation in Ethical Evaluation – Report from the AALAS–FELASA Working Group on Harm–Benefit Analysis – Part 2 [https://journals.sagepub.com/doi/full/10.1177/0023677216642397]
* For international collaborations, see different ethical review processes around the world: Guillen J (2017) Laboratory Animals: Regulations and Recommendations for the Care and Use of Animals in Research. Academic Press, Cambridge
* The Sex and Gender Equity in Research (SAGER) guidelines: rationale and recommended use [https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-016-0007-6]


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