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result(s) for
"Directive 2010/63/EU"
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Animal Welfare Aspects in Planning and Conducting Experiments on Rodent Models of Subarachnoid Hemorrhage
2023
Subarachnoid hemorrhage is an acute life-threatening cerebrovascular disease with high socio-economic impact. The most frequent cause, the rupture of an intracerebral aneurysm, is accompanied by abrupt changes in intracerebral pressure, cerebral perfusion pressure and, consequently, cerebral blood flow. As aneurysms rupture spontaneously, monitoring of these parameters in patients is only possible with a time delay, upon hospitalization. To study alterations in cerebral perfusion immediately upon ictus, animal models are mandatory. This article addresses the points necessarily to be included in an animal project proposal according to EU directive 2010/63/EU for the protection of animals used for scientific purposes and herewith offers an insight into animal welfare aspects of using rodent models for the investigation of cerebral perfusion after subarachnoid hemorrhage. It compares surgeries, model characteristics, advantages, and drawbacks of the most-frequently used rodent models—the endovascular perforation model and the prechiasmatic and single or double cisterna magna injection model. The topics of discussing anesthesia, advice on peri- and postanesthetic handling of animals, assessing the severity of suffering the animals undergo during the procedure according to EU directive 2010/63/EU and weighing the use of these in vivo models for experimental research ethically are also presented. In conclusion, rodent models of subarachnoid hemorrhage display pathophysiological characteristics, including changes of cerebral perfusion similar to the clinical situation, rendering the models suited to study the sequelae of the bleeding. A current problem is low standardization of the models, wherefore reporting according to the ARRIVE guidelines is highly recommended.
Graphical Abstract
Animal welfare aspects of rodent models of subarachnoid hemorrhage. Rodent models for investigation of cerebral perfusion after subarachnoid hemorrhage are compared regarding surgeries and model characteristics, and 3R measures are suggested. Anesthesia is discussed, and advice given on peri- and postanesthetic handling. Severity of suffering according to 2010/63/EU is assessed and use of these in vivo models weighed ethically.
Journal Article
Animal-Friendly Affinity Reagents: Replacing the Needless in the Haystack
by
Hendriksen, C.F.M.
,
Gray, A.C.
,
Borrebaeck, C.A.K.
in
AFAs
,
Affinity
,
alternatives to animals
2016
The multibillion-dollar global antibody industry produces an indispensable resource but that is generated using millions of animals. Despite the irrefutable maturation and availability of animal-friendly affinity reagents (AFAs) employing naïve B lymphocyte or synthetic recombinant technologies expressed by phage display, animal immunisation is still authorised for antibody production. Remarkably, replacement opportunities have been overlooked, despite the enormous potential reduction in animal use. Directive 2010/63/EU requires that animals are not used where alternatives exist. To ensure its implementation, we have engaged in discussions with the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) and the Directorate General for Environment to carve out an EU-led replacement strategy. Measures must be imposed to avoid outsourcing, regulate commercial production, and ensure that antibody producers are fully supported.
Millions of animals are used for the routine production of antibodies for research, monitoring, diagnostics, and therapeutics, although the true magnitude of use is unknown.
The EU Directive on the protection of animals used for scientific purposes (2010/63/EU) requires that animals are not be used for scientific purposes where a non-animal alternative exists.
Animal-friendly affinity reagents (AFAs) from non-immunised sources and produced by phage display are mature and available to replace animal immunisation methods for antibody production.
In line with Directive 2010/63/EU, an EU-wide replacement programme must now take precedence. In this Opinion article, we outline recommended actions that must be prioritised.
Journal Article
Approved Ambiguities: An Analysis of Applications for the Ethical Review of Animal Research in Sweden—Focusing on Harm, Benefit, and the 3Rs
by
Lindsjö, Johan
,
Jörgensen, Svea
,
Weber, Elin M.
in
Agriculture
,
Animal and Dairy Science
,
animal ethics
2025
This study examines regulatory requirements concerning the ethical review of animal research in Sweden, in particular legal obligations placed on applicants, and to some extent on Animal Ethics Committees (AECs). It focuses on what information applying researchers are required to provide, to what extent submitted applications reflect the fulfilment of these requirements, and how the AECs handle the information they receive. The study emphasizes areas of concern critical for an ethical evaluation. By examining a selection of submitted applications, the study has found information about harm, benefit, and the 3Rs is often insufficient or occasionally altogether missing, thus hindering the AECs’ performance of a harm–benefit analysis (HBA) and an assessment of how the applying researcher has considered the 3Rs in their project. The authors underscore the necessity for applying researchers to include detailed, relevant, complete, and accurate information to facilitate a thorough ethical review. To facilitate a shift towards a more thorough project evaluation, the authors suggest nine action points to improve the ethical review process for the sake of applicants, evaluators (AECs), and the animals used in research. This approach will also help enhance research quality, promote transparency, and build public trust in the ethical review process.
Journal Article
Researchers and Their Experimental Models: A Pilot Survey in the Context of the European Union Health and Life Science Research
by
Straccia, Marco
,
Del Pace, Lorenzo
,
Viviani, Laura
in
animal experimentation
,
Animal welfare
,
Biomedical research
2022
A significant debate is ongoing on the effectiveness of animal experimentation, due to the increasing reports of failure in the translation of results from preclinical animal experiments to human patients. Scientific, ethical, social and economic considerations linked to the use of animals raise concerns in a variety of societal contributors (regulators, policy makers, non-governmental organisations, industry, etc.). The aim of this study was to record researchers’ voices about their vision on this science evolution, to reconstruct as truthful as possible an image of the reality of health and life science research, by using a key instrument in the hands of the researcher: the experimental models. Hence, we surveyed European-based health and life sciences researchers, to reconstruct and decipher the varying orientations and opinions of this community over these large transformations. In the interest of advancing the public debate and more accurately guide the policy of research, it is important that policy makers, society, scientists and all stakeholders (1) mature as comprehensive as possible an understanding of the researchers’ perspectives on the selection and establishment of the experimental models, and (2) that researchers publicly share the research community opinions regarding the external factors influencing their professional work. Our results highlighted a general homogeneity of answers from the 117 respondents. However, some discrepancies on specific key issues and topics were registered in the subgroups. These recorded divergent views might prove useful to policy makers and regulators to calibrate their agenda and shape the future of the European health and life science research. Overall, the results of this pilot study highlight the need of a continuous, open and broad discussion between researchers and science policy stakeholders.
Journal Article
The impact of Directive 2010/63/EU on cephalopod research
by
Andrews, Paul
,
Galligioni, Viola
,
Ponte, Giovanna
in
Aquaculture
,
Biomedical and Life Sciences
,
Biomedicine
2015
Here we discuss several impacts of some of the changes that have occurred since the implementation of Directive 2010/63/EU and of other regulations and directives on the scientific research involving cephalopods. Changes that correspond to a significant turning point of policies require responses from all those involved in research with cephalopods (including aspects of aquaculture research) as well as those responsible for their daily care and welfare.
Journal Article
Cephalopod biology and care, a COST FA1301 (CephsInAction) training school: anaesthesia and scientific procedures
2017
Cephalopods are the sole invertebrates included in the list of regulated species following the Directive 2010/63/EU. According to the Directive, achieving competence through adequate training is a requisite for people having a role in the different functions (article 23) as such carrying out procedures on animals, designing procedures and projects, taking care of animals, killing animals. Cephalopod Biology and Care Training Program is specifically designed to comply with the requirements of the “working document on the development of a common education and training framework to fulfil the requirements under the Directive 2010/63/EU”. The training event occurred at the ICM-CSIC in Barcelona (Spain) where people coming from Europe, America and Asia were instructed on how to cope with regulations for the use of cephalopod molluscs for scientific purposes. The training encompasses discussion on the guidelines for the use and care of animals and their welfare with particular reference to procedures that may be of interest for neuroscience. Intensive discussion has been carried out during the training sessions with focus on behavioural studies and paradigms, welfare assessment, levels of severity of scientific procedures, animal care, handling, transport, individual identification and marking, substance administration, anaesthesia, analgesia and humane killing.
Journal Article
In vivo Work
by
Lewis, David I.
in
computer models of organs or tissues
,
European Union adopted Directive 2010/63/EU
,
harm/benefit analysis
2011
This chapter contains sections titled:
Introduction
Animal welfare legislation
The principles of the 3Rs
Alternatives to the use of animals in the development of new medicines
Animal models of disease
Experimental design
Recognition of pain, suffering or ill health in animals used for research
Ethical review of in vivo studies
Harm/benefit analysis
The arguments for and against animal experimentation
How you can achieve your potential in in vivo work
References
Additional resources
Book Chapter
Experimental liver fibrosis research: update on animal models, legal issues and translational aspects
by
Streetz, Konrad
,
Weiskirchen, Ralf
,
Tolba, René
in
Animal experimentation
,
Biomarkers
,
Cell Biology
2013
Liver fibrosis
is defined as excessive extracellular matrix deposition and is based on complex interactions between matrix-producing hepatic stellate cells and an abundance of liver-resident and infiltrating cells. Investigation of these processes requires
in vitro
and
in vivo
experimental work in animals. However, the use of animals in translational research will be increasingly challenged, at least in countries of the European Union, because of the adoption of new animal welfare rules in 2013. These rules will create an urgent need for optimized standard operating procedures regarding animal experimentation and improved international communication in the liver fibrosis community. This review gives an update on current animal models, techniques and underlying pathomechanisms with the aim of fostering a critical discussion of the limitations and potential of up-to-date animal experimentation. We discuss potential complications in experimental liver fibrosis and provide examples of how the findings of studies in which these models are used can be translated to human disease and therapy. In this review, we want to motivate the international community to design more standardized animal models which might help to address the legally requested replacement, refinement and reduction of animals in fibrosis research.
Journal Article
Long-Term Experiences of Basic Education in Laboratory Animal Science
2025
Adequate education in laboratory animal science and subsequently the attendance of relevant courses are mandatory prerequisites for animal experimentation. The course content for different stakeholders is stipulated by European and national regulations. If all of this content is covered, accreditation by competent bodies is possible and recommended. Here, we present our experiences with an EU-Function A/C/D accredited course (practical training with mice and rats) and an introductory seminar for undergraduate students, which have been running for more than ten years. All courses were organized in-house and were very relevant to the students and their needs but were also very labor intensive. The courses were systematically (and retrospectively) evaluated, showing a high degree of satisfaction and a great acquisition of knowledge, and the organizer was able to re-adjust the courses as needed over the years. Tests demonstrated the students’ progress and highlighted some parts of the lessons that were difficult to convey, such as those on legal regulations, housing and feeding, transport, GM animals, breeding, and the classification of severity. Dummies were proven to be very helpful at the beginning of the training but could not fully replace training with live animals. On-site lectures were favored over online sources, which were needed due to the pandemic. High standards in education are mandatory, and the accreditation process allows for the transferal of certificates to other institutions.
Journal Article