Use of animals in research

PTEN Research is committed to funding medical research that brings us closer to our goal of developing new and better treatments for PTEN hamartoma tumour syndrome (PHTS).

We believe there is an urgent need for research to improve the scientific understanding of the condition and to develop medicines that can improve the lives of people living with PHTS. We fund a broad spectrum of research, including laboratory studies to improve understanding of the mechanism of disease in PHTS, translational work to understand how these new results and insights apply to humans, clinical trials to assess the safety and efficacy of new treatments, as well as observational and data collection studies. Animal research forms a limited but vital part of this work.

Funding animal research is not a decision we take lightly. However, we recognise it as a necessary step on the path to discoveries that will improve the lives of people with PHTS, and we approach it with transparency and commitment to the highest animal welfare standards.

Almost every major breakthrough in human and veterinary medicine has involved animal research. For most new therapies, health authorities still expect animal safety data before a treatment can advance to human trials, although regulators are progressively recognising data from validated non-animal models where these are scientifically robust. Despite significant advances in alternative methods such as organ-based models (where special cells are grown in a laboratory to produce tissues that mimic the complexity of an organ) and computer simulations, there is not yet an alternative experimental model that can replicate the full complexity of the human body. For this reason, it is essential to use animals where no viable alternative option exists. We recognise that the field is moving rapidly: regulators and funders in the UK, USA and EU are actively working to expand the validated alternatives available to researchers, and PTEN Research supports and tracks this progress.

What do we mean by animal research?

Medical research uses animal models to mimic aspects of a human medical condition. Animal models are living, non-human animals: for example, rodents, worms, fruit flies or fish.

Using animal models provides essential insights into whole organism effects, optimal dosing, and long-term safety, enabling researchers to mimic human disease and test a treatment’s safety and possible activity before it enters human trials.

Policy statement

PTEN Research is committed to promoting the 3Rs - Replacement, Reduction and Refinement of animals in research in all projects it funds, and to meeting or exceeding the strictest regulatory standards in every project we fund.

What the 3Rs mean in practice for medical research:

  • Replace the use of animals with alternative research methods and where possible avoid the use of animals altogether.
  • Reduce the number of animals used.
  • Refine how animal-based experiments are carried out to minimise any suffering and to improve animal welfare.

Regulations and oversight in the UK and EU

Research teams in the United Kingdom must secure approval from both central Government (Home Office) and a local animal ethics committee before conducting animal research. As part of this approval process, each research project will be assessed on how it will apply the 3Rs.

The legal framework for animal research in the UK is the UK Animals (Scientific Procedures) Act 1986, which sets strict rules for when and how animals may be used. This was updated in 2013 to bring it in line with the European Directive 2010/63/EU, that explicitly balances animal welfare with the need for high-quality science. Since leaving the EU, the UK has retained these protections in full, carrying the rules over into domestic law so that protections for animals are maintained.

PTEN Research is fully committed to these principles and all of our research undertaken in the UK abides by rules set out by the Home Office. Under this system, animals can only be used when there is no alternative. But we believe organisations should go beyond any legal minimums, so we're proud and active signatories to the Concordat on Openness on Animal Research.

In November 2025, the UK Government published Replacing animals in science, a £75 million strategy to accelerate the development, validation and uptake of alternative methods to the use of animals in research. PTEN Research welcomes this commitment. We will continue to encourage all researchers we fund to use validated alternatives wherever they can robustly answer the scientific question at hand.

Research outside the UK and EU

When we fund research that involves animals outside of the UK and EU, we require that the highest local ethical and regulatory standards are upheld.

Implementation

PTEN Research takes every measure necessary to ensure that our policy on animal research is implemented effectively and that our promise to replace, reduce and refine the use of animals in research is upheld by our grant recipients.

Funding conditions: PTEN Research requires scientists we fund and work with to act strictly in accordance with all relevant laws and to comply with guidance documents. The research we fund is implemented by leading scientists in the field, who adhere to strict institutional and national regulations governing the use of animals in research. All applicants are required to acquire ethical approval for planned studies.

Grant application requirements: PTEN Research requires grant applicants to provide justification for their use of animals, including species and numbers. Where applicable, applicants are encouraged to use the National Centre for the Replacement, Refinement & Reduction of animals in Research’s (NC3R's) experimental design resources, including the online Experimental Design Assistant and the ARRIVE guidelines, to improve reproducibility and reporting of research involving animals.