One of the key roles of the HRA is to co-ordinate and standardise the processes that researchers and sponsors need to follow when designing and conducting research in the UK.
This makes sure there is consistency across the health and social care research sector and makes it easier and faster for high-quality studies to be set-up and delivered.
On 28 April 2026, amended clinical trials regulations will come into force for clinical trials of investigational medicinal products (CTIMPs). These types of trials assess the safety or efficacy of medicinal products. The updated regulations are legal changes to how CTIMPs are run in the UK.
Other types of health and social care research, including clinical trials that do not involve investigational medicines, are not part of the amended regulations.
These types of studies are referred to as ‘non-CTIMPs’. They include:
- clinical trials that test the safety and effectiveness of patient interventions such as medical devices, surgical techniques, public health measures and behavioural therapies research
- other types of health and social care research that are not clinical trials, for example interviews or focus groups with healthcare users
The HRA, working in partnership with other UK organisations that support research, is introducing changes to how non-CTIMPs are processed and managed to align with the updated clinical trials regulations.
The changes will promote consistency across health and social care research in the UK and will streamline the applications process.
This will make it simpler for sponsors and researchers to obtain regulatory approval.
What is changing?
‘Amendment’ terminology
The term ‘amendment’ to describe changes to approved studies will be replaced with ‘modification’ .
Modifications will be categorised as ‘substantial modifications’, ‘modification of an important detail’ or ‘minor modifications’.
Approvals timelines
We’re updating our approvals timelines for non-CTIMP applications and modifications so they’re in line with CTIMP timelines.
Research transparency
We’re making some changes to the transparency timelines for non-CTIMP studies to align our research transparency policy with the amended regulations.
This includes changes to registration timelines and deferral periods.
When are the changes happening?
The changes we’re introducing to non-CTIMPs will apply across all 4 nations of the UK (England, Wales, Scotland and Northern Ireland) from 28 April 2026.
This is in line with amended clinical trials regulations which come into force on the same date.
Guidance to help you prepare
We’re encouraging sponsors, researchers and anyone involved in carrying out non-CTIMP studies to start preparing for the changes and to update their policies, processes and procedures.
We’ve published guidance to explain the new requirements and to help researchers and sponsors get ready.
The guidance outlines the following changes:
- overview of the changes
- update to ‘amendment’ terminology for non-CTIMPs
- the approvals process for non-CTIMPs
- the approvals process for non-CTIMP modifications (amendments)
- research transparency requirements for non-CTIMP clinical trials
The guidance covers the Research Ethics Committee review process. It does not detail any other review processes that non-CTIMPs may need, such as HRA and Health and Care Research Wales (HCRW) Approval.
If you have any questions about the guidance or the changes to non-CTIMPs, please email the HRA’s engagement team.
Clinical trials regulations
For more information about legal changes to CTIMPs, head to our Clinical trials regulations reform webpage.
You can also sign up to our Clinical Trials update for the latest news and information on the upcoming changes to the regulations.