EARA | What are non-technical summaries?

Non-technical summaries (NTS), freely available to the general public in the EU, are intended to serve as a bridge between biomedical research, that requires the use of animals, and the general public. They are designed to provide clear and accessible explanations about how and why animals are used in specific research proposals and the potential outcomes that could benefit society.

What are NTS and why are they needed?

Non-Technical Summaries (NTS) are required by law in the European Union and are welcomed by researchers and institutions as a means to engage more openly with the public.

Historically, there has been a lack of information for the public about animal research and why it is still necessary to use and kill large numbers of animals in the pursuit of medical treatments and cures, and also a limited understanding about new approach methodologies, including non-animal methods of research that are now available.

Unsurprisingly, this has led to mistrust and ethical concerns about whether such loss can outweigh the benefit to society. This situation is also not helped by the factual misinformation supplied by many animal activist groups.

Every biomedical research project, that requires the use of animals, needs to go through an approval process in which the project proposal - detailing the animals that will be used - is formalised (see Box. How are NTS regulated).

CREDIT: Radboud University, The Netherlands

These research proposals are technical documents, written by an individual researcher, or research team, but an additional non-technical version - the NTS - also needs to be supplied. The main objective of the NTS is to explain in clear and accessible language how and why animals have to be used in the context of that specific research project and why the proposed species and number of animals, that will be used, is absolutely necessary for the project's objectives.

Each NTS should also explain how the researchers will use the latest scientifically approved methods of research that might help to replace or reduce the use of animals (the 3Rs) and, if not, they need to explain how the methods they are using will cause the least harm possible to those animals through the most effective current scientific techniques and animal welfare standards - this is known as refinement.

As a significant part of the research that uses animals is conducted by publicly-funded projects in public universities and research centres, NTS are also a transparent way for society as a whole to understand how and why public money is used in research using animals.

What are the main objectives of NTS? 

To engage and inform

Openness and transparency about research

Demystifying animal research

Providing useful feedback to researchers

Where can I find NTS from my own country?

Upon approval, every NTS is made publicly available, for example, through national databases or the EU database ALLURES, which includes the NTS from every EU Member State. This platform allows the public to search for summaries by country, research topic, or animal species used. For non-EU member countries, equivalent databases include national repositories, accessible via respective governmental or institutional websites. For Norway, the Norwegian Food Safety Authority oversees animal research, and information can be accessed on their Animal Research portal. In Switzerland, the Federal Food Safety and Veterinary Office (FSVO) provides information on animal experiments. The UK has a comprehensive database for non-technical summaries of project licences on the Home Office website.

What makes a good NTS?

Here’s how you will know whether you are reading a good NTS.

Avoiding scientific technical jargon: Has the researcher avoided scientific jargon, or unrecognisable terms and acronyms and, if they have used a technical term, have they properly explained what they mean to a general audience?
Use of clear language: Have short sentences and everyday language been used? EARA has produced a detailed guidance document that researchers can use to improve the wording of their NTS.
A focus on the experience of the animals: Has the researcher overlooked or not properly addressed any potential harms or pain that might be experienced by the animals or used language that downplays the severity of the procedures being performed?

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 was needed on the publication of statistical information on animal use and on non-technical project summaries (NTS).

In response, EARA brought together a working group of representatives from the biomedical 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.

In 2018, the working group submitted a guidance document on NTS to the EU Commission on how they could be made more understandable for the ordinary reader.

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).

Want to enhance your NTS? Check details about the EARA NTS writing workshops.

What is the structure of a NTS?

A NTS should start with a clear non-technical title, that is understandable to everyone and states the main aim of the project and which animals are used.

Example: Measuring the effects of potential childhood cancer treatments in mice

There should be a clear indication of the how long the project will take and highlight how long each animal will be used for.

Example: The entire project will last five years, with each animal used for periods between two and eight months

There should be keywords included without scientific jargon such as the species used, the disease or biological process being investigated, the purpose of the research, and the expected benefits.

Example: mice, cancer, treatment, childhood

If the animal species used will undergo genetic modifications to make it more suitable for the particular experiment, these should be mentioned and explained.
Example: Mice, some with a genetic modification that weakens their immune system.

An estimate of the maximum number of animals likely to be used in the project should be provided.
Example: A total number of 70 genetically-altered mice will be used for experimental procedures throughout the whole duration of the project, with 40 animals used for mild procedures, 20 animals for moderate procedures and 10 animals for severe procedures.

An explanation of the scientific objectives of the project and what it hopes to achieve, in terms of the knowledge gained.
This should focus on the expected results of the study and its direct contribution to that field of research.
Example: To evaluate the performance of a promising new drug in mice induced to have childhood cancer and its potential applicability in a clinical trial.

Any human, animal or environmental health benefits expected to arise from the study.
This should emphasise the long-term, hoped-for results, rather than exaggerating or speculating about the immediate effects of the specific research in terms of treatments or cures.
Example: Understanding how a tumour’s blood supply develops, with the goal of assisting in the development of a drug to stop the tumour from growing.

Any harms that may happen (adverse effects) to the animals, as a consequence of the experiments.
This should be acknowledged honestly and terms such as ‘mild’, ‘moderate’, or ‘severe’ should be applied to describe the effects of the procedures (such as injections or surgery) on the animals used and these effects should be described from the animals’ point of view.
Example: Around half of the mice will gradually lose muscle strength in their limbs and so will find it harder to move around. In the most extreme case, expected to be experienced by only a few of the mice, they may completely lose the use of one or more limbs.

The principles of Replacement, Reduction, and Refinement (known commonly as the 3Rs of animal research) need to be addressed and the researcher needs to explain if any of the principles are being applied and if not, why not.

Replacement
If any animals are being replaced by other complementary scientific methods being used in the research, this should be stated. If not, the project should explain why a whole organism has to be used – such as for analysis of specific organ interactions, or for observation of the responses of the immune system – rather than using non-animal methods which are currently not able to replicate a whole organism
Example: The genetically modified mice chosen for this study may develop similar, or comparable tumours to those found in children. We will study if new treatments have an effect on those tumours and for that reason, we will study the recovery and behaviour of the mice. To study how blood vessels grow in this particular cancer tissue, we need to use animals. Cell cultures or organs-on-chips cannot yet replicate this whole process.

Reduction
The researchers should describe all the measures being taken to ensure that the minimum number of animals are used, such as thorough experiment planning and reliable statistical justifications for the numbers used (known as sample size) and a carefully detailed plan for every step of the experiment.
Example: Calculations and specific statistical tests have been used to determine the minimum number of animals needed to study the disease in both of the mice models used, adjusted for each one separately.

Refinement
The scientists need to explain what actions they are taking to minimise any harms to the animals and should also highlight the best practices in routine animal care and experimental procedures.
This should include detail, such as the housing that the animals will be kept in and how the animal will be looked after following any procedures, such as additional surgery to reduce any pain or stress.
Example: We manage sick animals on a daily basis and provide them with soft bedding, which the mice find comfortable and which reduces sores on their feet. We make it easier for them to eat by providing infant formula mixed with food used for weaning mice plus supplements. We also house sick mice together in smaller numbers which allows them to move around the cage more easily due to their reduced mobility.

Retrospective NTS assessments

Once an experiment has finished, certain projects require the research team to complete a Retrospective Assessment (RAR) form, which is a review of what actually happened at the end of a research study compared to the initial objectives and predictions. These assessments help to determine if the research objectives were met and if the welfare of the animals was adequately considered or predicted. This can identify any unexpected outcomes, or adverse effects, that were observed during the study and give valuable insights for future research planning.

According to EU Directive 2010/63, retrospective assessments are mandatory for those projects that:

Include procedures classified as ‘severe’ in terms of the level of pain, suffering, distress, or lasting harm inflicted on the animals.
Use monkeys (non-human primates), as these animals have a higher level of protection under animal welfare regulations. Projects that involve their use will need to be reviewed to assess if their use was justified and the number of animals used was accurate.
Projects flagged as requiring an RAR: Some projects are only authorised on the basis that a retrospective assessment is also required. This could be because it has been requested by country-specific competent authorities based on ethical, scientific, or animal welfare concerns.

How are NTS regulated?

Non-technical summaries (NTS) are regulated within the European Union by Directive 2010/63/EU on the protection of animals used for scientific purposes.

This Directive provides a legal framework for the use of animals in research, testing, and education, emphasising ethical considerations and the principles of the 3Rs of laboratory animals’ welfare: Reduction, Refinement, and Replacement. Before any proposed research project involving animals can begin, it must undergo an approval process to assess if the benefit to human health of the knowledge gained from the research outweighs the severity of procedures and harm done to the animals – known as a harm-benefit analysis – and also to evaluate any ethical implications and animal welfare considerations.

The approval process is overseen by the relevant national body, supervised by the government, that is responsible for the implementation of the EU Directive (competent authorities) as well as Animal Welfare Bodies (AWBs) that are appointed by every institution that conducts scientific research using animals. In European countries outside the EU, such as the UK and Switzerland, similar regulatory frameworks exist to ensure animal welfare in research. For instance, the UK follows the Animals Scientific Procedures Act 1986, and Switzerland has stringent laws under the Federal Act on Animal Protection.

Working document on NTS from the European Commission.