Tag Archives: European Commission

EARA sets out its guidance on improving Non-Technical Summaries for the general public

The European Animal Research Association (EARA) has submitted a guidance document on Non-Technical Summaries (NTS) to the EU Commission on how NTS can be made more understandable for the ordinary reader.

The details were presented by Javier Guillén, (pictured below) a member of the EARA working group that produced the guidance document, at the 14th FELASA Congress, held in Prague, Czech Republic, last week.

Javier told the Congress that as part of its strategy to improve openness and transparency on the use of animals in research in Europe, EARA has been working closely with the EU to help improve the information provided to the general public.

It is understood that the Commission will produce additional guidance on NTS for Member States using some of the EARA guidance document findings.

Every research project application, that intends to use animals, is required to include a publicly available NTS which includes a simple explanation of the project’s objectives, predicted harms, benefits and number and types of animals used. It must also demonstrate compliance with the 3Rs (replacement, reduction and refinement).

EARA Executive Director, Kirk Leech, said: “We are very pleased to hear that the Commission has found the EARA working group’s observations useful.

“NTS are a small part of the overall need to improve openness and transparency on animal research, but they could be a valuable resource, in particular, for the media and other influencers who communicate with the public directly, in explaining issues such as animal welfare and the benefits that biomedical research can bring for society.”

Every research project application, that intends to use animals, is required to include a publicly available NTS which includes a simple explanation of the project’s objectives, predicted harms, benefits and number and types of animals used. It must also demonstrate compliance with the 3Rs (replacement, reduction and refinement).

NTS are widely seen as a positive development in improving transparency on animal research to the public. However, it is widely agreed that there are a number of problems in the compilation, accuracy, standardisation and accessibility of NTS.

In November 2017, the EU Commission published its Review of Directive 2010/63/EU on the protection of animals used for scientific purposes. The Commission reported that there had been some progress on transparency, but suggested that further improvements were needed. In particular further work is needed on the publication of statistical information on animal use and on non-technical project summaries (NTS).

EARA identified clear opportunities to improve NTS for the general public and set up its working group in 2018. The working group brought together representatives from the user community, with a range of experts from backgrounds in animal welfare, communications and private and public biomedical research, including membership of institutional ethics committees and welfare organisations.

As an example of its guidance, the EARA working group suggested that, in the Adverse Effects section of the NTS, rather than saying what will be done to animals (e.g. ‘rats will be injected’), researchers should try to describe in everyday language what the animal’s experience is likely to be.

For example, ‘Rats will likely experience some discomfort, mild pain and bruising to the skin from being injected on four occasions’.

The members were Javier Guillén, (AAALAC International, chair), Michael Addelman (University of Manchester), Peter Janssen (FENS_CARE), Serban Morosan (GIRCOR) , Barney Reed (RSPCA) , Kirsty Reid (EFPIA) , Bob Tolliday (EARA) and Hanna-Marja Voipio (FELASA).


** The guidance is based on the current proposed template by the European Commission. Since a new version of this template is expected before the end of 2019, the Working Group may consider a future update of the guidance to make it fit better with the new template, although the opinion of the Working Group is that the main concepts of the presented guidance will be still valid.

For further information contact EARA Communications Manager, Bob Tolliday, btolliday@eara.eu on +44 (0)20 3675 1245 or +44 (0)7970 132801

EARA website study shows much more progress is needed to improve openness on animal research in Portugal

A study by the European Animal Research Association (EARA), of websites of biomedical research bodies in Portugal, assessing how they discuss research using animals, has found that the sector is still some way from an acceptable level of openness and transparency in animal research.

EARA assessed a total of 50 institutional websites in Portugal, during 2018, both public and private bodies, such as universities and pharmaceutical companies, and a rating system was developed to analyse the data. The main findings were that:

  • Just over a quarter (26%) of the institutions conducting animal research carry a recognisable statement on their websites explaining the use of animals in research/animal welfare.
  • However, around two thirds of websites assessed (62%) meet the criterion for providing ‘more information’, for instance by including the kind of animals used.
  • Just one in five (20%) of the websites can be considered to have prominent mentions of animal research – such as recognisable statements within three clicks of the homepage.

Currently, efforts to improve openness in Portugal are co-ordinated through a transparency agreement, which was launched last year by the Portuguese Society of Sciences in Laboratory Animals (SPCAL), in collaboration with EARA, and is signed by 16 institutions.

A total of 1,219 institutional websites within the EU[1] were assessed and the findings from the EARA Study of EU-based websites 2018 have now been presented to the EU Commission, which is currently examining the findings.

In comparison to Portugal, the percentage of institutions that displayed a statement on the use of animals in research in other countries was – France 32%, Germany 34%, Italy 39%, Spain 84% and UK 95%.

EARA Executive Director, Kirk Leech, said: “The biomedical sector in Portugal has made progress through its transparency agreement, but much more can be done. Institutions should  make greater use of all the opportunities to be more accessible and to be more transparent with the public.

“Our view is that the websites of the institutions that we assessed will play an increasingly important role in informing members of the public, media, decision-makers and regulators about the use of animals in research, their welfare and the benefits of biomedical science for humans and animals”

The website study has helped EARA identify areas of good practice on communications and openness in the life sciences sector and areas where improvement is needed. It will also help EARA provide guidance on best practice to all its member organisations and the sector as a whole across Europe and build on the advice already given to EARA members in the EARA Communications Handbook.

The study is therefore a tool that can then be used to encourage greater transparency in line with the recommendations made in Section 3 of the Review of Directive 2010/63/EU in November 2017.

Using the documentation and techniques developed in the course of this study, EARA intends in future years to revisit the websites involved and chart the improvement (or otherwise) of the institutional openness of the sector as a whole.

For further information contact EARA Communications Manager, Bob Tolliday, btolliday@eara.eu on +44 (0)20 3675 1245 or +44 (0)7970 132801

END


[1] A further 100 websites from non-EU countries were assessed.

EARA website study shows much more progress is needed to improve openness on animal research in Italy

A study by the European Animal Research Association (EARA), of websites of biomedical research bodies in Italy, assessing how they discuss research using animals, has found that the sector is still some way from an acceptable level of openness and transparency in animal research.

EARA assessed a total of 64 institutional websites in Italy during 2018, both public and private bodies, such as universities and pharmaceutical companies, and a rating system was developed to analyse the data. The main findings were that:

  • Around two in five (39%) of the institutions conducting animal research carry a recognisable statement on their websites explaining the use of animals in research/animal welfare.
  • However, more than two thirds of websites assessed (66%) meet the criterion for providing ‘more information’, for instance by including the kind of animals used.
  • Fewer than one in five (17%) of the websites can be considered to have prominent mentions of animal research – such as recognisable statements within three clicks of the homepage.

A total of 1,219 institutional websites within the EU[1] were assessed and the findings from the EARA Study of EU-based websites 2018 have now been presented to the EU Commission, which is currently examining the findings.

In comparison to Italy, the percentage of institutions that displayed a statement on the use of animals in research in other countries was – France 32%, Germany 34%, Spain 84% and UK 95%.

EARA Executive Director, Kirk Leech, said: “We believe the sector in Italy needs to make greater use of all opportunities to be more accessible and to be more transparent with the public. Whilst progress has been made by many institutions, much more could be done.

“Our view is that the websites of the institutions that we assessed will play an increasingly important role in informing members of the public, media, decision-makers and regulators about the use of animals in research, their welfare and the benefits of biomedical science for humans and animals”

The website study has helped EARA identify areas of good practice on communications and openness in the life sciences sector and areas where improvement is needed. It will also help EARA provide guidance on best practice to all its member organisations and the sector as a whole across Europe and build on the advice already given to EARA members in the EARA Communications Handbook.

The study is therefore a tool that can then be used to encourage greater transparency in line with the recommendations made in Section 3 of the Review of Directive 2010/63/EU in November 2017.

Using the documentation and techniques developed in the course of this study, EARA intends in future years to revisit the websites involved and chart the improvement (or otherwise) of the institutional openness of the sector as a whole.

For further information contact EARA Communications Manager, Bob Tolliday, btolliday@eara.eu on +44 (0)20 3675 1245 or +44 (0)7970 132801

END


[1] A further 100 websites from non-EU countries were assessed.

EARA website study shows the Spanish biomedical sector must continue to improve openness on animal research

A study by the European Animal Research Association (EARA), of websites of biomedical research bodies in Spain, assessing how they discuss research using animals, has found that the sector needs to continue to make progress towards an acceptable level of openness and transparency in animal research.

EARA assessed a total of 189 institutional websites in Spain, during 2018, both public and private bodies, such as universities and pharmaceutical companies, and a rating system was developed to analyse the data. The main findings were that:

  • A large majority of institutions (84%) conducting animal research carry a recognisable statement on their websites explaining the use of animals in research/animal welfare.
  • However, just under two in five of the websites assessed (38%) meet the criterion for providing ‘more information’, for instance by including the kind of animals used.
  • Fewer than one in five (18%) of the websites can be considered to have prominent mentions of animal research – such as recognisable statements within three clicks of the homepage.

Currently, efforts to improve openness in Spain are co-ordinated through the Transparency Agreement on Animal Research in Spain (‘Acuerdo de transparencia sobre el uso de animales en experimentación científica en España’) which was launched by the Spanish Confederation of Scientific Societies (COSCE), with the collaboration of EARA, and has been adhered to by more than 130 institutions.

A total of 1,219 institutional websites within the EU[1] were assessed and the findings from the EARA Study of EU-based websites 2018 have now been presented to the EU Commission, which is currently examining the findings.

In comparison to Spain, the percentage of institutions that displayed a statement on the use of animals in research in other countries was – France 32%, Germany 34%, Italy 39% and UK 95%.

EARA Executive Director, Kirk Leech, said: “The biomedical sector in Spain has made good progress through the transparency agreement, but much more can be done. Institutions should make greater use of all the opportunities to be more accessible and to be more transparent with the public.

“Our view is that the websites of the institutions that we assessed will play an increasingly important role in informing members of the public, media, decision-makers and regulators about the use of animals in research, their welfare and the benefits of biomedical science for humans and animals”

The website study has helped EARA identify areas of good practice on communications and openness in the life sciences sector and areas where improvement is needed. It will also help EARA provide guidance on best practice to all its member organisations and the sector as a whole across Europe and build on the advice already given to EARA members in the EARA Communications Handbook.

The study is therefore a tool that can then be used to encourage greater transparency in line with the recommendations made in Section 3 of the Review of Directive 2010/63/EU in November 2017.

Using the documentation and techniques developed in the course of this study, EARA intends in future years to revisit the websites involved and chart the improvement (or otherwise) of the institutional openness of the sector as a whole.


[1] A further 100 websites from non-EU countries were assessed.

Much more progress needed to improve openness on animal research in EU – EARA website study

A study by the European Animal Research Association (EARA), of more than a 1,000 websites across the EU, assessing how the biomedical sector talks about research using animals, has found that ‘the sector is still some way from an acceptable level of openness and transparency in animal research’.

The findings from the EARA Study of EU-based websites 2018 have now been presented to the EU Commission, which is currently examining the findings.

A total of 1,219 institutional websites within the EU were assessed, both public and private bodies, including universities and pharmaceutical companies, during 2018 and a rating system was developed to analyse the data which found that:

• Just under half (44%) of the institutions conducting animal research carry a recognisable statement on their websites explaining the use of animals in research/animal welfare.

• Just over half the websites assessed (53%) meet the criterion for providing ‘more information’, for instance by including the kind of animals used.

• Well under a third (28%) of the websites can be considered to have prominent mentions of animal research – such as recognisable statements within three clicks of the homepage.

• Only just over a third (36%) of the websites assessed carry any imagery related to animal research.

• Around half the websites (49%) assessed featured some kind of case study on the animal research they support, fund or conduct.

• Fewer than a quarter (23%) of the websites in the sector provide ‘Extensive Information’ online, for instance, Frequently Asked Questions (FAQs) or press releases.

Comparing some of the countries in the study, showed variations across the EU. The percentage of institutions that displayed a statement on the use of animals in research was – France 32%, Germany 34%, Italy 39%, Netherlands 15%, Spain 84%, and UK 95%.

EARA Executive Director, Kirk Leech, said: “We believe the sector needs to make greater use of all opportunities to be more accessible and to be more transparent with the public. Whilst progress has been made by many institutions, much more could be done.”

The study has helped EARA identify areas of good practice on communications and openness in the life sciences sector and areas where improvement is needed. It will also help EARA provide guidance on best practice to all its member organisations and the sector as a whole across Europe and build on the advice already given to EARA members in the EARA Communications Handbook.

EARA anticipates that institutional websites will play an increasingly important role in informing members of the public, media, decision-makers and regulators about the use of animals in research and the contribution of animal research to biomedical science. The website study is therefore a tool that can then be used to encourage greater transparency in line with the recommendations made in Section 3 of the Review of Directive 2010/63/EU in November 2017.

Using the documentation and techniques developed in the course of this study, EARA intends in future years to revisit the websites involved and chart the improvement (or otherwise) of the institutional openness of the sector as a whole.

For further information contact EARA Communications Manager, Bob Tolliday, btolliday@eara.eu on +44 (0)20 3675 1245 or +44 (0)7970 132801

END

Notes to editors

About EARA

The European Animal Research Association (EARA) is an organisation that communicates and advocates on biomedical research using animals and provides accurate, evidence-based information. It also takes responsibility for the choice and sustainability in the global transport of animals for medical research. It has more than 60 partner organisations, including private and public research bodies, universities, regional and national biomedical associations and suppliers, across 14 European countries.

EARA’s vision is to enhance the understanding and recognition of research involving animals across Europe, allowing for a more constructive dialogue with all stakeholders and a more efficient climate for research in Europe.

The benefits of animal research
Most of the medicines we have come from animal research. Often science doesn’t need to use animals, but for many key questions they are crucial. They will help millions with conditions such as cystic fibrosis, Alzheimer’s disease, spinal cord damage and parasitic infections like malaria. There are three main reasons why animals are used in research:

• To advance scientific understanding,
• To develop solutions to medical problems,
• To test medicines and vaccines in order to protect the safety of people, animals and the environment.

Animals are used when there is a need to find out what happens in the whole living body, which is far more complex than the sum of its parts. It is very difficult, and in most cases simply not yet possible, to develop non-animal methods to replace the use of living animals.

Supporting excellent biomedical science in Europe

The first FEAM European Biomedical Policy Forum annual lecture took place in Brussels, in March, dedicated to the topic Biomedical and health research: developing a vision for Europe.

The Forum is an initiative from the Federation of European Academies of Medicine (FEAM) and aims to bring together representatives from academia, research charities, industry, European and national trade associations and professional bodies, regulators, public health bodies, and patient and consumers groups. Among the topics discussed were: thematic priorities for future research; linkage with the UN Sustainable Development Goals (SDGs); research missions; current gaps in support; and how to improve coordination and consolidation of research programmes across Europe.

This  is  an  important  time  for  European  health  policy  and  for  sustaining  biomedical  research  and innovation. The forthcoming EU Framework Programme for Research and Innovation, FP9, provides a critical opportunity for stakeholders across the biomedical and health sectors to discuss their research vision and priorities for Europe, linkage with global goals, and defining approaches to closing gaps in support and to promoting coordination of effort. Continue reading

Scientists in Europe must take more responsibility for openness, says EARA executive director

Openness and transparency surrounding the use of animals in research is ‘still an Achilles Heel’ for the biomedical sector, a roundtable hosted by the Federation of European Academies of Medicine (FEAM) last week has heard.

Speaking at the meeting, EARA Executive Director, Kirk Leech, said: “The zeitgeist is openness and transparency for the biomedical sector, but this is still an Achilles Heel for many European institutions.” Continue reading

European scientific community welcomes EU review of the Directive for the protection of animals used for research

PRESS RELEASE

LONDON, UK – 10 November, 2017

The European scientific community supports the view of the EU Commission, that the Directive on the protection of animals used in biomedical research is bringing significant benefits in animal welfare and a sound foundation for future best practice in the sector.

The European Animal Research Association (EARA), which represents more than 60 organisations across Europe in the biomedical research sector, has welcomed the Commission report, published today. The report reviews the requirements of Directive 2010/63/EU – all uses of live animals for research or education and testing must be carried out in compliance with the Directive.

In particular, the EU recognised that measures to improve transparency to the general public on the performance of research establishments in the areas of animal use and welfare are starting to have an effect. Requirements to publish non-technical summaries of the objectives and benefits of research projects, as well as annual statistical data, are also seen to have greatly improved openness in Member States. Continue reading

Recommendations on the report of the European Commission Scientific Conference ‘Non-Animal Approaches – The Way Forward’

The European Commission published in April 2017 the report of the conference ‘Non-Animal Approaches – The way forward’ that they organised in Brussels on 6 and 7 December 2016. The Conference’s presentations and video recordings can be viewed on DG Environment website.

The conference was announced in the Commission’s response to the Europeans Citizens Initiative ‘Stop Vivisection’ as one of four actions that should contribute towards the goal of, ultimately, phasing out animal testing.

The key recommendations outlined in the report are extracted here for simplicity:

Recommendations Session 1 – Animal Testing Today
There is a need for on-going investment in public and private funding in non-animal alternatives. However, consideration is required to ensure the proposed research is appropriate, addresses areas of need, and is of high quality with appropriate statistical design. To achieve these goals, the following are required:
1. A thorough gap analysis of where alternatives are still lacking and how to improve the current alternatives to be fit for purpose
2. The investigation of more “human” testing e.g. using human cell-based systems
3. Consideration of whether there should be a more stringent scientific peer review of methodology before starting any project using animals or developing alternatives
4. A need for systematic use of ARRIVE, and other relevant guidelines to stimulate a culture of scientific excellence.
5. Improvements in study design and data analysis for all animal experimentation as well as for non-animal studies.
6. More standardisation, e.g. in design, analyses, statistics and publication
7. The need to publish negative results systematically – start with all publicly funded studies using animals

Recommendations Session 2 – Biomedical Research: Strengths and Limitations of Non-Animal Alternatives
1. There is a need for a continued and organised research agenda within Europe to co-ordinate the short-term and longer-term uptake of alternatives based around in silico and in vitro approaches in the short term and human-on-chip and microphysiological approaches in the longer term. Some more strategic top-down or central steering of this research agenda might be beneficial.
2. Fundamental biological research, from sequencing of human genomes to tissue and organ level biology, should not be discontinued as this will support the better development of the next generation of alternatives to animal testing.
3. Effort is required to speed up and possibly simplify the process of validation (also covered in a later session) leading to acceptance of alternatives and therefore greater uptake.
4. Greater resources should be made available for data sharing, including consideration of greater access to confidential data – or knowledge being made available from it. Resources such as patient DNA databases should be created for research purposes.
5. Education and training of all researchers using animals is mandatory in the EU, enforcement of compliance is necessary to ensure respect for animals and their correct, ethical use.

Recommendations Session 3 – Regulatory Testing: Strengths and Limitations of Non-Animal Alternatives
1. New approaches for the validation of complex alternatives need to be developed now, i.e. moving away from the one-to-one replacement paradigm, to ensure acceptance and uptake.
2. Regulators should lead the way whilst working closely with industry and other stakeholders.
3. The process should start with a common problem definition.
4. Work is required on defining, understanding and agreement on acceptable risk to human safety on using non-animal data – as a result regulation may need to be adapted.
5. Progress in the area of acceptance of alternatives must be collaborative at a number of levels and will require resources to achieve this:
a. International collaboration e.g. EU, US, Japan etc.
b. Stakeholders e.g. regulators, industry, developers etc.
6. Dates and targets for the phasing out of animal tests, where possible, should be considered. Although not all panellists considered that helpful.
7. Additional barriers to the acceptance of alternatives, beyond those already known, should be identified and strategies to remove them be defined.
8. There should be support for internationally led case studies to evaluate and demonstrate the acceptance of new alternative approaches. In this context, it could be helpful to carefully map out uncertainties of current animals tests.
9. An in vitro Mode of Action-based classification system like today’s GHS will be required.

Recommendations Session 4 – Reporting on European Commission Actions 1 – 3
1. The European Commission should continue its role to monitor compliance with Directive 2010/63/EU and to increase the vision of using alternatives to animals wherever possible.
2. Consideration could be given as to how the Three Rs could further be promoted through Directive 2010/63/EU e.g. through the use of dedicated information officers.
3. Access to knowledge sources should be reviewed and improved, for instance by their quality assurance and the provision of an (internet) one-stop-shop to access all resources using an improved search engine.
4. Support should be provided for dissemination events, such as conferences and workshops, to increase outreach especially for non-scientists.
5. Consideration should be given to require publication of Three Rs methods where possible.
6. Assistance should be provided to compile and publish negative data where possible, interoperable databases of information are one approach that should be investigated.
7. A funding strategy to promote knowledge sources for the Three Rs and access to them should be developed, including commitments from the European Commission and private industry.

Recommendations Session 5 – Responsible Research
1. The European Commission should continue (and increase) funding of research in alternatives in specific areas that will stimulate their uptake and implementation.
2. All EU agencies such as ECHA, EMA and EFSA and initiatives such as EPAA and IMI should further encourage the uptake of alternatives and the implementation of the Three Rs principles.
3. Science must make efforts to understand and remove all elements of bias from the experimental design and reporting of results.
4. The use of tools such as the NC3Rs Experimental Design Assistant should be mandatory in the design of experiments and be required by grants funding agencies.
5. The implementation of the NC3Rs ARRIVE guidelines should be mandatory in grant proposals as well as publication of results, starting with all publicly funded research using animals.
6. Greater efforts should be made to ensure results are openly available e.g. using data repositories such as European Open Science Could, allowing access to all results including negative results, and enabling free and easy data reuse; especially results derived from publicly funded research using animals.
7. Journal editorial policies should more fully embrace the Three Rs principles ensuring the ARRIVE guidelines have been respected.
8. The peer-review process should be assessed as to whether it is fit for purpose with regard to transparency and implementation / review of the Three Rs.
9. The assessment of research impact should be revised to remove the emphasis from highly significant “headline” results to ensuring quality and relevance.
10. 2020 should be designated the “Year of Systematic Review”.
11. Each Member State should be encouraged to have a Science Media Centre, such as that in the UK, which helps the general press with the correct reporting of research outcomes.

Recommendations Session 6 – The Future: The Way Forward
1. Harmonisation of all new methodologies is required; there is good progress for metabolomics as one example which should be supported.
2. There is a need for a large-scale evaluation of metabolomics to demonstrate its utility to identify mechanisms of action relating to chemical safety for a number of species.
3. Support is required to complete the development of technologies such “human-on-a-chip”, in readiness for industry adoption and validation.
4. There is a need to widen the Adverse Outcomes Pathway type approach to areas outside regulatory toxicity e.g. in disease modelling.
5. Human tissue should be made more readily available and this should be addressed at EU level.
6. All new technologies require some form of validation to demonstrate their fitness of purpose. Further efforts in developing validation schemes and strategies may be required.
7. iPS and related technologies should be developed to address specific organ level effects and disease treatments.
8. Further understanding of the limitations of the new technologies is necessary, especially how to scale up cellular based techniques to in vivo.
9. Patient groups should be informed about the new technologies, their advantages and risks.
10. Efforts to show how to combine all new technologies e.g. for drug safety are required which may need a new way of thinking both about the technology itself and the means of combining information.
11. There is a continued need for education and training in all aspects of animal-free science and the Three Rs; this is required at all levels from school and university students to established researchers in academic, industrial and contract laboratories. Proper and full dissemination of knowledge will be key to this. This will require the promotion of the new techniques and approaches and raising awareness of resources through well-designed internet resources and, preferably, a single search engine from which all information can be accessed. There is also a need to inform and educate the public more effectively including through Scientific Conferences and to maintain an open and constructive dialogue between stakeholders.

The European Animal Research Association (EARA)
June 2017

Scientists’ engagement in animal research policy-making – Lab Animal Europe column

The November issue of Lab Animal Europe magazine features an Outreach article written by Emma Martinez, EARA Communications and Policy Officer. In this article, also published in Lab Animal (US), Emma discusses how the European Citizens’ Initiative ‘Stop vivisection’ and the review of Directive 2010/63/EU converge on the European Commission scientific conference ‘Non-Animal Approaches – The Way Forward’ and the need for scientific engagement. Continue reading