Evaluated self-assessments

At the HTA, we have used different inspection models over the years although our core approach has been a site-based inspection, typically with two inspecting staff. 

Our keenness to make improvements - not least in response to the COVID pandemic restrictions - led to us develop assessment methodologies that were less reliant on being physically present on site. The reframing of our approach  encouraged us to think even harder about proportionality and responsibility for compliance, taking risk into account. 

The Virtual Regulatory Assessment (VRA) - which is a model we developed and implemented during the pandemic - has been our least intensive form of inspection, for the lowest risk establishments. In the research sector, we have used these as our default assessment methodology and they are almost always single-person inspections, which has allowed us to do more inspections and therefore have greater coverage.

It should also be noted that at any point - either during inspection planning or as a result of what we uncover -  we can add in a site visit component so this becomes a 'hybrid' inspection.

Alternatively, we may choose to do a more ‘traditional’ site visit inspection from the outset. The HTA has also used 'themed' inspections in certain sectors, where the compliance against selected standards is not assessed.

For our lower risk establishments, we were keen to trial an even more proportionate regulatory tool without reinventing the existing process infrastructure.

We have called these ‘Evaluated self-assessments’ (ESAs). There are risks and caveats in a self-assessment approach but also opportunities. We think that more regular contact with a larger number of establishments will help to keep compliance with our standards as an active and ongoing consideration.

We followed a ‘test-and-learn’ approach in developing ESAs, based on these principles:

• To utilise existing operational processes and products, either identically or with minimal modification
• For ESAs to be a complementary addition to our existing range of regulatory tools 
• For ESAs to be recognisably lighter touch and distinct in approach, being less resource-intensive for internal and external users
• To have clear escalation points and outcomes, which integrate with existing approaches
• To be proportionate to anticipated risks while recognising possible limitations
• To reinforce that responsibility for compliance is with those undertaking regulated activities.

ESAs have been piloted in our lower risk establishments in the research sector.  All these establishments had undergone a previous inspection and a full premises assessment, either as part of a licence assessment or a post-licensing inspection.

The pilot ESAs worked well, with no establishments contacting us for clarification. Establishments have submitted responses promptly, suggesting the form is clear and straightforward to complete. The forms have also provided sufficient information for Regulation Managers to evaluate.

Feedback from DIs involved in the pilots has confirmed the information provided was clear and helpful, with positive feedback on the process.

Taking internal and external feedback into account, we are satisfied that the new ESA approach has proven to be successful and suitable addition to our regulatory oversight toolkit. In terms of resource, we expect that they will continue to prove less resource-intensive than VRAs.

ESAs have worked well for lower risk research sector establishments, the relatively low risks of self-assessment being offset by the benefits of improved regulatory oversight and compliance awareness. In terms of our inspection planning for this business year, we have committed to 30 ESAs in the research sector, which is additional to 20 other research inspections.

ESAs have the potential to support more frequent regulatory oversight of establishments, informing risk evaluation within the sector. They should not be considered equivalent to a more intensive inspection - and establishments should not only undergo ESAs - but they are a useful addition to the programme of regulatory oversight for appropriate licensed establishments.

ESAs, as currently modelled, may not be suitable for establishments that require more intensive regulatory oversight, for example due to their individual risk profile or the complexity of the sectoral standards that apply to them. However, a self-assessment approach could be considered as a possible option between more intensive inspections.

We will continue to monitor feedback for any emerging issues and, in due course, we will be able to compare outcomes between different types of assessments.