2023/24 review: A risk-based approach

Developing our regulatory toolkit

We developed VRAs during the Covid-19 pandemic to ensure we could continue to monitor the compliance of our licensed establishments, without needing to conduct on-site inspections. We have continued to use VRAs as an effective assessment method for lower-risk establishments and sectors, enabling us to assess more establishments.

Given the success of VRAs and their routine use within the research sector, we developed another regulatory tool that results in similar benefits using a lighter touch – ‘evaluated self-assessments’ (ESAs). These require lower-risk establishments to carry out an assessment against our framework and report the details within a defined timeframe. We subsequently analyse the return alongside the regulatory history of the establishment and take steps to escalate areas of non-compliance, as necessary.

Following a pilot programme, ESAs have been added to our regulatory toolkit. They help us have routine contact with establishments in a proportionate way and help establishments actively maintain compliance with our standards. ESAs also reinforce the message that responsibility for compliance lies with those undertaking regulatory activities. 

Alongside developing a new regulatory method and working to reach an ambitious inspection target, we also conducted a review of our inspection regime. This involved looking at how we inspect establishments: from assessing the risks that a sector presents through to inspection and post-inspection follow-up. It also considered how we could improve the use of technology and data to support a more risk-based approach. 

The review suggested models and options that could benefit how we regulate – for example, by improving how we evidence and assess compliance and strengthening the post-inspection process. These suggested areas for improvement will be tested and shaped in the coming business year, in line with our strategic priority to further enhance our approach to regulation.

Taking steps to be an efficient regulator

During 2023/24, we looked at the risks facing our sectors to help determine the best use of our regulatory tools and identify where additional efforts may be needed.

For the first time since the Covid-19 pandemic, we asked licensed establishments across our six sectors to complete a data collection exercise. The exercise sought to inform how we profile risks, as well as how we use data and intel to take a risk-based and differentiated approach to inspection. The results helped us to gain insight on the key risks at an establishment and sector level. For example, within the anatomy and research sectors, the data has been used to prioritise and plan the allocation of inspections.

Last year, we began developing a regulatory insight model to transform how we use data to regulate. The model will use information from our sectors and beyond to identify key risk areas and routinely identify emerging themes and trends across our licensed establishments and sectors. This will support our regulatory oversight and use of finite resources. 

To help develop the model, we collaborated with an external consultant to map the data used to inform indicators, determine where there is potential to streamline and automate the data that we compile, and encourage data reporting to ensure that the model works. This work will continue into 2024/25 as we seek to build and test a prototype model.