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Comités de Ética

Introduction and background

Directive 2010/63/EU of the European Parliament and of the Council, and its transposition into Spanish law through Royal Decree 53/2013, establish the basic rules applicable to the protection of animals used for experimental and other scientific purposes, including teaching, through the application of the 3Rs principle set out by Russell and Burch (1959) to define the concept of “alternative methods to animal experimentation.”
 

- R for Replacement, meaning the substitution of vertebrates with any other method that uses non-sentient material. Non-sentient material is understood to include everything from computational models to in vitro assays using cell models, as well as studies involving less evolutionarily developed organisms such as microorganisms, plants, and certain invertebrates, which have a lower capacity to feel pain due, in some cases, to the absence of a nervous system and, in others, to the less complex development of their sensory systems.

- R for Reduction, by applying sequential strategies that minimize the number of vertebrates used, as well as implementing appropriate statistical design to ensure that only the number of animals necessary to obtain reliable and precise information is used, or by developing experimental strategies and approaches that allow more information to be obtained from the animals.

- R for Refinement, understood as any procedure that improves welfare and reduces the severity of harm caused to animals when replacement is not possible.

Objectives

The main objective of this Unit is to promote and enhance the application of the 3Rs in research carried out at ISCIII involving experimental animals listed in Annex I of Royal Decree 53/2013, as well as in the amendments included in the  Royal Decree 1386/2018. This entails a review of the current situation regarding animal research and alternative methods within the Institute, as well as the promotion of new methodologies that are scientifically valid and ethically viable from the perspective of the 3Rs philosophy.

For this purpose, different activities have  been identified:

a. Dissemination of information on the application of the 3Rs in ISCIII research
b. Education and Training
c. Promotion of the development and use of alternatives
d. Oversight and Ethical Considerations

Details of the proposal for the creation of the ISCIII 3Rs Unit can be found in the following document: 3Rs Unit Document

Composition

Alternative Methods at ISCIII

Relevant publications and projects

Training and Outreach

External links