Assessable learning outcomes for the EU Education and Training Framework core and Function A specific modules: Report of an ETPLAS WORKING Group.

Article 23(2) of the European Union Directive 2010/63/EU, which regulates welfare provisions for animals used for scientific purposes, requires that staff involved in the care and use of animals for scientific purposes be adequately educated and trained before they undertake any such work. However, the nature and extent of such training is not stipulated in the Directive. To facilitate Member States in fulfilling their education and training obligations, the European Commission developed a common Education and Training Framework, which was endorsed by the Member States Competent Authorities. An Education & Training Platform for Laboratory Animal Science (ETPLAS) Working Group was recently established to develop further guidance to the Learning Outcomes in the Framework, with the objective to clarify the levels of knowledge and understanding required by trainees, and to provide the criteria by which these Learning Outcomes should be assessed. Using the Framework document as a starting point, assessment criteria for the Learning Outcomes of the modules required for Function A persons (carrying out procedures on animals) for rats, mice and zebrafish were created with sufficient detail to enable trainees, providers and assessors to appreciate the level of knowledge, understanding and skills required to pass each module. Adoption and utilization of this document by training providers and accrediting or approving bodies will harmonize introductory education and training for those involved in the care and use of animals for scientific purposes within the European Union, promote mutual recognition of training within and between Member States and therefore free movement of personnel.

Are the Lives of Animals Well-spent in Laboratory Science Research? A Study of Orthopaedic Animal Studies in Turkey.

BACKGROUND: As in all fields of medicine, animal studies are widely performed in orthopaedics and have increased in number over time. However, it is not clear to what extent these studies provide a basis for future research or advancements in clinical science. Concerns about the reliability and translational ability of animal studies have been reported, and major orthopaedic journals and organizations are encouraging the reduction of unnecessary experiments on animals. QUESTION/PURPOSES: (1) What proportion of animal studies conducted for orthopaedic research in Turkey were never published? And of those that were published, how long did it take to publish? (2) What proportion of those studies were published in journals with an Impact Factor of 2 or more? (3) What proportion of those published papers were never cited or cited only once? (4) What was the contribution to science of an animal euthanized for orthopaedic research in Turkey? METHODS: We reviewed all oral and poster presentations at the Turkish National Congress of Orthopaedics and Traumatology from 2009 to 2017 (retrieved from the archives of Acta Orthopaedica et Traumatologica Turcica), as well as all postgraduate theses in orthopaedics from 1991 to 2017 (retrieved from the archives of the National Thesis Center of the Council of Higher Education) to identify all orthopaedic studies that involved animals. We searched the keywords "animal studies," "experimental studies," and "orthopaedics" in these archives. We defined animal research as orthopaedic studies based on animal models. From this search and using that definition, 252 studies were identified. Of those, 4% (9) were excluded as they were thesis studies with no abstract in the archives. Thus, a total of 243 animal studies performed in Turkey were included for analysis in this retrospective study. The abstracts of these studies were examined to determine the study model (such as bone fracture models, tendon healing models, cartilage models) and number of euthanized animals. Between 1991 and 2017, 9412 vertebrate animals were euthanized for these studies. We searched PubMed, Google Scholar, ResearchGate, and ORCID to determine whether these papers were subsequently published, in which journal, and how long after the initial presentation publication occurred. The Web of Science 2019 database was used to determine the Impact Factor of the journals, the total citation count of each study, and the mean annual citation for each study (citations per year). For purposes of this analysis, we divided journals into those with an Impact Factor of 2 or more, 4 or more, and those with an Impact Factor below 2. The mean annual citation per euthanized animal (citations per animal per year) was calculated to determine the contribution of a euthanized animal to science. RESULTS: A total of 42% (101 of 243) of the animal studies in Turkey were never published. For all published studies, the mean time to publication was 2.2 ± 2.6 years (95% CI 1.7 to 2.6). The proportion of studies published in orthopaedic journals with an Impact Factor of 2 or more was 14% (34 of 243). Among the 142 published papers, 38% (54) were either never cited or were cited only once, and the mean citations per year was 1.1 ± 1.7 (95% CI 0.7 to 1.3). The mean citations per animal/year among the 142 published studies was 0.03 ± 0.04 (95% CI 0.02 to 0.04). CONCLUSION: In the 243 theses and national congress presentations, 9412 animals were euthanized. Based on the low percentage of papers using animals that were euthanized and the very low proportion of studies published in higher-Impact Factor journals or garnering more than a single citation, in aggregate, little seems to have been gained from the loss of animal life. Future studies should try to replicate or refute our results in other countries. CLINICAL RELEVANCE: Orthopaedic researchers should try to reduce their use of unnecessary animal studies, for example, by reporting on the use of the "3Rs" (replacement, reduction, and refinement) in the development of an animal study design, as well as through following universal guidelines so that a study might have a clinical impact. Researchers should not conduct an animal study until they are convinced that the expected results are quite likely to deliver substantial benefit to people or to advance science in a meaningful way; although this seems intuitive, our results suggest that this may not be taking place. Ethics committees in Turkey should consider more detailed questioning before approving animal studies. If our results are replicated elsewhere, then a broader look at how these approvals are conducted should be performed.

Researchers' attitudes to the 3Rs-An upturned hierarchy?

Animal use in biomedical research is generally justified by its potential benefits to the health of humans, or other animals, or the environment. However, ethical acceptability also requires scientists to limit harm to animals in their research. Training in laboratory animal science (LAS) helps scientists to do this by promoting best practice and the 3Rs. This study evaluated scientists' awareness and application of the 3Rs, and their approach to other ethical issues in animal research. It was based on an online survey of participants in LAS courses held in eight venues in four European countries: Portugal (Porto, Braga), Germany (Munich, Heidelberg), Switzerland (Basel, Lausanne, Zurich), and Denmark (Copenhagen). The survey questions were designed to assess general attitudes to animal use in biomedical research, Replacement alternatives, Reduction and Refinement conflicts, and harm-benefit analysis. The survey was conducted twice: immediately before the course ('BC', N = 310) and as a follow-up six months after the course ('AC', N = 127). While courses do appear to raise awareness of the 3Rs, they had no measurable effect on the existing low level of belief that animal experimentation can be fully replaced by non-animal methods. Most researchers acknowledged ethical issues with their work and reported that they discussed these with their peers. The level of an animal's welfare, and especially the prevention of pain, was regarded as the most pressing ethical issue, and as more important than the number of animals used or the use of animals as such. Refinement was considered more feasible than Replacement, as well as more urgent, and was also favoured over Reduction. Respondents in the survey reversed the 'hierarchy' of the 3Rs proposed by their architects, Russell and Burch, prioritizing Refinement over Reduction, and Reduction over Replacement. This ordering may conflict with the expectations of the public and regulators.

Developing a Collaborative Agenda for Humanities and Social Scientific Research on Laboratory Animal Science and Welfare.

Improving laboratory animal science and welfare requires both new scientific research and insights from research in the humanities and social sciences. Whilst scientific research provides evidence to replace, reduce and refine procedures involving laboratory animals (the '3Rs'), work in the humanities and social sciences can help understand the social, economic and cultural processes that enhance or impede humane ways of knowing and working with laboratory animals. However, communication across these disciplinary perspectives is currently limited, and they design research programmes, generate results, engage users, and seek to influence policy in different ways. To facilitate dialogue and future research at this interface, we convened an interdisciplinary group of 45 life scientists, social scientists, humanities scholars, non-governmental organisations and policy-makers to generate a collaborative research agenda. This drew on methods employed by other agenda-setting exercises in science policy, using a collaborative and deliberative approach for the identification of research priorities. Participants were recruited from across the community, invited to submit research questions and vote on their priorities. They then met at an interactive workshop in the UK, discussed all 136 questions submitted, and collectively defined the 30 most important issues for the group. The output is a collaborative future agenda for research in the humanities and social sciences on laboratory animal science and welfare. The questions indicate a demand for new research in the humanities and social sciences to inform emerging discussions and priorities on the governance and practice of laboratory animal research, including on issues around: international harmonisation, openness and public engagement, 'cultures of care', harm-benefit analysis and the future of the 3Rs. The process outlined below underlines the value of interdisciplinary exchange for improving communication across different research cultures and identifies ways of enhancing the effectiveness of future research at the interface between the humanities, social sciences, science and science policy.

Bioética de la investigación preclínica en las ciencias biomédicas / Bioethics of preclinical research in biomedical sciences

Introducción: la oposición a la utilización de animales en la investigación biomédica se apoya en diversos argumentos científicos y éticos.Objetivo: realizar una revisión bibliográfica sobre la bioética de la investigación preclínica en las ciencias biomédicas.Procedimientos empleados en la recogida de la información: la búsqueda en Internet abarcó artículos publicados fundamentalmente en los últimos 5 años. Se evaluaron revistas internacionales de impacto de la Web of Sciencies relacionadas con el tema (38 revistas). Se consultaron las bases de datos de sistemas referativos, como MEDLINE, PubMed y SciELO con la utilización de descriptores como animal research ethical, animal welfare, animal ethics committee, animal pain, alternatives to laboratory animals y sus y sus equivalentes en español. Se incluyeron artículos en idioma inglés, portugués y español. Se obtuvio 141 artículos, pero el estudio limitó solo a 53, porque enfocaban esta temática de manera más integral.Análisis e integración de la información: al analizar el comportamiento de los artículos respecto a su representatividad en las diferentes revistas científicas donde fueron publicados, 5,9 por ciento de ellos correspondieron a la revista Alternatives to laboratory animals: ATLA e igual porcentaje a la Cambridge quarterly of healthcare ethics. Los restantes artículos estuvieron distribuidos de manera uniforme entre las otras revistas.Conclusiones: el conocimiento y cumplimiento de los principios bioéticos que rigen la conducta de los seres humanos, su relación con el medio ambiente y las ramas del conocimiento, permite brindar un abordaje generalizador y un enfrentamiento abarcador a aspectos significativos de la investigación con animales(AU)

Introduction: opposition to the use of animals in biomedical research is based on a variety of scientific and ethical arguments.Objective: carry out a bibliographic review about the bioethics of preclinical research in biomedical sciences.Data collection procedures: an online search was conducted for papers preferably published in the last five years. An evaluation was performed of international high impact journals from the Web of Sciences which dealt with the subject (38 journals). Databases from reference systems such as MEDLINE, PubMed and SciELO were consulted with the aid of search terms like animal research ethical, animal welfare, animal ethics committee, animal pain, alternatives to laboratory animals and their Spanish counterparts. The papers included were in English, Portuguese or Spanish. Of the 141 papers obtained, the reviewers selected the 53 which approached the study topic in a more comprehensive manner.Analysis and integration of information: an analysis of the representativeness of papers in the scientific journals where they were published showed that 5.9 percent corresponded to the journal Alternatives to Laboratory Animals: ATLA, and an equal percentage to the journal Cambridge Quarterly of Healthcare Ethics. The remaining papers were evenly distributed among the other journals.Conclusions: awareness of and compliance with the bioethical principles governing the behavior of human beings and their relationship to the environment and fields of knowledge, enable a generalizing approach to and comprehensive management of significant aspects of animal research(AU)

Bioética de la investigación preclínica en las ciencias biomédicas / Bioethics of preclinical research in biomedical sciences

Introducción: la oposición a la utilización de animales en la investigación biomédica se apoya en diversos argumentos científicos y éticos. Objetivo: realizar una revisión bibliográfica sobre la bioética de la investigación preclínica en las ciencias biomédicas. Procedimientos empleados en la recogida de la información: la búsqueda en Internet abarcó artículos publicados fundamentalmente en los últimos 5 años. Se evaluaron revistas internacionales de impacto de la Web of Sciencies relacionadas con el tema (38 revistas). Se consultaron las bases de datos de sistemas referativos, como MEDLINE, PubMed y SciELO con la utilización de descriptores como animal research ethical, animal welfare, animal ethics committee, animal pain, alternatives to laboratory animals y sus y sus equivalentes en español. Se incluyeron artículos en idioma inglés, portugués y español. Se obtuvio 141 artículos, pero el estudio limitó solo a 53, porque enfocaban esta temática de manera más integral. Análisis e integración de la información: al analizar el comportamiento de los artículos respecto a su representatividad en las diferentes revistas científicas donde fueron publicados, 5,9 por ciento de ellos correspondieron a la revista Alternatives to laboratory animals: ATLA e igual porcentaje a la Cambridge quarterly of healthcare ethics. Los restantes artículos estuvieron distribuidos de manera uniforme entre las otras revistas. Conclusiones: el conocimiento y cumplimiento de los principios bioéticos que rigen la conducta de los seres humanos, su relación con el medio ambiente y las ramas del conocimiento, permite brindar un abordaje generalizador y un enfrentamiento abarcador a aspectos significativos de la investigación con animales(AU)

Introduction: opposition to the use of animals in biomedical research is based on a variety of scientific and ethical arguments. Objective: carry out a bibliographic review about the bioethics of preclinical research in biomedical sciences. Data collection procedures: an online search was conducted for papers preferably published in the last five years. An evaluation was performed of international high impact journals from the Web of Sciences which dealt with the subject (38 journals). Databases from reference systems such as MEDLINE, PubMed and SciELO were consulted with the aid of search terms like animal research ethical, animal welfare, animal ethics committee, animal pain, alternatives to laboratory animals and their Spanish counterparts. The papers included were in English, Portuguese or Spanish. Of the 141 papers obtained, the reviewers selected the 53 which approached the study topic in a more comprehensive manner. Analysis and integration of information: an analysis of the representativeness of papers in the scientific journals where they were published showed that 5.9 percent corresponded to the journal Alternatives to Laboratory Animals: ATLA, and an equal percentage to the journal Cambridge Quarterly of Healthcare Ethics. The remaining papers were evenly distributed among the other journals. Conclusions: awareness of and compliance with the bioethical principles governing the behavior of human beings and their relationship to the environment and fields of knowledge, enable a generalizing approach to and comprehensive management of significant aspects of animal research(AU)

Report of the Federation of European Laboratory Animal Science Associations Working Group on animal identification.

The primary aim of this report is to assist scientists in selecting more reliable/suitable identification (ID) methods for their studies. This is especially true for genetically altered (GA) animals where individual identification is strictly necessary to link samples, research design and genotype. The aim of this Federation of European Laboratory Animal Science Associations working group was to provide an update of the methods used to identify rodents in different situations and to assess their implications for animal welfare. ID procedures are an indispensable prerequisite for conducting good science but the degree of invasiveness differs between the different methods; therefore, one needs to make a good ethical evaluation of the method chosen. Based on the scientific literature the advantages and disadvantages of various methods have been presented comprehensively and this report is intended as a practical guide for researchers. New upcoming methods have been included next to the traditional techniques. Ideally, an ID method should provide reliable identification, be technically easy to apply and not inflict adverse effects on animals while taking into account the type of research. There is no gold standard method because each situation is unique; however, more studies are needed to better evaluate ID systems and the desirable introduction of new and modern approaches will need to be assessed by detailed scientific evaluation.

FELASA guidelines and recommendations.

The Federation of European Laboratory Animal Science Associations (FELASA) has been releasing guidelines and recommendations on several laboratory animal science disciplines for more than 15 y. The Working Groups producing these documents comprise specialists in each of the addressed topics, are nominated by the FELASA constituent associations, and are elected by the FELASA Board of Management. The FELASA guidelines and recommendations are not regulatory but rather are proposals based on scientific knowledge and the state of the art of laboratory animal science activities. Because they are supported by laboratory animal science associations that represent the vast majority of European professionals, these guidelines and recommendations have influenced the development of various regulatory requirements in Europe, including those related to education and training, routine laboratory animal activities, and animal health monitoring. Some reports fill existing gaps in the European legal framework or complement it. The Working Groups occasionally collaborate with other European organizations, thus enhancing the professional input and effect of the documents produced. The recently established AALAS-FELASA Liaison Body may result in future international cooperation that benefits laboratory animal science and welfare in a global context.