Claire Williams is Chair of a Greater Manchester Research Ethics Committee, with over six years’ experience in research ethics. She is also Head of Pharmacovigilance and Regulatory Services at NorthWest EHealth and was involved in the pilot and development of the MHRA/HRA Inclusion and Diversity Plan guidance. Continue reading for her thoughts on the new clinical trials regulations for 2026…

What’s improved 

The continued move towards a more joined-up system, particularly through the combined review process, is positive. It should reduce duplication and make things more straightforward for sponsors. In practice though, it means we are increasingly seeing applications where everything needs to be right first time. There’s less opportunity for iteration, so the quality of initial submissions really matters. 

The shift to a more proportionate, risk-based approach also makes sense in principle. Aligning scrutiny with actual risk is the right direction of travel and long overdue. 

Transparency requirements, particularly around registration and sharing results including lay summaries, are also a clear positive. This aligns well with core ethical principles and reinforces accountability to participants. 

What’s changed 

There are also some more subtle but important shifts. The move away from referring to “subjects” reflects a more respectful approach to participants, and one that better aligns with how we think about people taking part in research. 

More broadly, the regulations recognise how much research has evolved, with more real-world, pragmatic and decentralised approaches now being supported within the framework. 

What concerns me 

Some of the changes are less comfortable from a Research Ethics Committee (REC) perspective. 

The move towards fewer REC members being required for quoracy may improve efficiency, but risks narrowing the breadth of perspectives in the room. Ethical review benefits from a mix of perspectives clinical, lay, and those with expertise in study design and that balance feels important to protect, particularly as this may place greater burden on those present. 

Similarly, the more limited scope for requests for further information reduces the opportunity for dialogue. While this supports faster decision-making, it may constrain the ability to fully explore areas of concern, particularly in more complex studies. 

There is also a broader risk that, taken together, these changes shift the balance too far towards efficiency at the expense of depth. 

What we need to protect 

As processes become more streamlined, the role of the REC becomes even more about judgement rather than process. 

Maintaining rigour, ensuring a range of perspectives, and keeping the participant voice central will be critical. The strength of the system has always been in the quality of ethical review, not just the speed of it. 

The challenge now is to embrace a more efficient model without losing what underpins public trust in research. 

Claire Williams, Head of Pharmacovigilance and Regulatory Services, NWEH.

FAQ’s  

What are the new UK clinical trial regulations and when did they come into force?  

The new regulations are The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. They update the UK framework for clinical trials of investigational medicinal products (CTIMPs) and apply across all four nations of the UK. 

They were signed into law in April 2025 and came into force on 28 April 2026, following a 12-month implementation period. 

https://www.legislation.gov.uk/uksi/2025/538/contents 

What do the regulations mean for trial transparency and results reporting? 

The regulations make research transparency a legal requirement. From 28 April 2026, clinical trials must be registered in a public registry before the first participant is recruited, or within 90 days of approval, whichever is sooner. 

Sponsors must also publish a summary of results within 12 months of trial completion and offer to share a lay summary with participants in a format they can understand.  

From a ethical perspective, this is positive because it strengthens accountability to participants and helps ensure that people who take part in research are not left wondering what happened to the study. 

How do the new regulations support diversity and inclusion in clinical trials? 

The regulations sit alongside wider Health Research Authority (HRA) and MHRA work to improve inclusion and diversity in research. The aim is to ensure clinical research includes people who are likely to be affected by the condition or intervention being studied, including groups that have historically been underserved or underrepresented.  

The HRA/MHRA Inclusion and Diversity Plan guidance asks researchers to consider who is affected by the disease or condition, whether the study population reflects those people, and whether any exclusions are justified. It also encourages consideration of whether data should be analysed by relevant groups, so that safety and effectiveness are better understood across the population. 

https://www.hra.nhs.uk/about-us/news-updates/new-inclusion-and-diversity-guidance-pilot/