How can we ensure animal experiments are replaced at every available opportunity using the current regulatory framework? 

One simple way is to strengthen the existing processes to ensure every opportunity to review, and challenge, animal research licence applications are utilised.  

The regulatory frameworks around animal research legislation provide several opportunities to assess animal research licence applications. If implemented fully, these checkpoints should ensure animal research doesn’t happen when there are non-animal approaches available, or the potential harm to animals is deemed unethical when weighed against the research outcomes’ potential benefits.  

In reality, we know that replacement is not properly addressed due to confusion around non-animal methods, how to search for them, where to look, and how to apply them. 

Ensuring replacement is a priority from the start

The responsibility is primarily on the researcher who will be the project licence holder to ensure the 3Rs have been correctly implemented. 

There are, however, systems in place to help ensure those requirements are met at the establishment and government level. 

When researchers apply for funding, their planned research will be reviewed. Whilst funders don’t fall under the frameworks of the Animals (Scientific Procedures) Act 1986 (ASPA), and so have no legal obligation to ensure replacement is properly considered, funders have a responsibility to ensure funding is spent ethically, has maximum impact and uses the most appropriate scientific methods and models. Funders therefore have an important roles as this is the first ‘checkpoint’ where animal use can be questioned, and replacement opportunities assessed.  

But is replacement the priority? 

A 2023 report highlighted that the review of replacement opportunities prior to animal research licences being issued is inadequate. We’re working hard to strengthen these frameworks and opportunities through our policy work and training to empower researchers and reviewers. Providing the right support to funding review panels, Animal Welfare Ethical Review Boards (AWERBs) and Home Office inspectors, will help them assess replacement opportunities more thoroughly and ensure replacements are more routinely identified. 

There are numerous checkpoints currently in place, as required by the legislation, but they’re failing to ensure researchers are addressing replacement thoroughly before opting to conduct a procedure on an animal.  

In the UK, there’s a requirement under ASPA for any establishment conducting regulated animal research to have an Animal Welfare and Ethical Review Body or AWERB. Among their tasks is the review of animal research project licence applications and provision of advice on animal welfare, the 3Rs and ethics. 

They are the first regulatory checkpoint before researchers apply for a licence from the Home Office. 

Despite their vital importance to ensuring replacement is properly implemented, AWERB positions are not paid and rely on volunteers.  

The RSPCA AWERB Directory contains useful resources for AWERB members. 

Animals in Science Regulation Unit

The Animals in Science Regulation Unit (ASRU) is the Home Office department which oversees the implementation of animal research regulation and practices in the UK. It’s made up of: 

• Inspectors 

• Licensing officers 

• Policy and admin group 

The Home Office inspectors review project licences in a similar way to the AWERBs. All Home Office inspectors are either veterinary or medical practitioners with biomedical research experience. 

The Animals in Science Regulation Unit produce a yearly report sharing the number of licences approved, but it no longer shares the number of applications that were rejected. 

All project licences require retrospective review after they are completed. 

We offer support to help implement Replacement at each ‘checkpoint’ in form of our Replacement Checklist.