Consent in Clinical Trials; Changes in the Law

On 28 April 2026, the UK implemented significant reforms to its clinical trials framework. The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 amended the long‑standing 2004 Regulations, following extensive consultation and policy development led jointly by the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA).

The changes are designed to modernise the UK’s clinical trial environment, reduce administrative burden, and reinforce participant safety, while re‑establishing the UK as a competitive destination for commercial research. 

Of particular benefit is that the regulations offer sponsors of clinical trials that meet certain conditions the option to use simplified arrangements for seeking and evidencing informed consent. 

Conditions 

To make use of simplified consent arrangements, the clinical trial must qualify as a low‑intervention clinical trial. In broad terms, this requires that:

• the investigational medicinal product(s) are authorised for use in the UK;
• the product(s) are used in accordance with their marketing authorisation (or otherwise in a manner supported by established evidence and clinical practice);
• the trial reflects routine clinical practice, in that participants receive treatments they would ordinarily receive; and
• any additional diagnostic or monitoring procedures do not impose more than minimal additional risk or burden compared to normal clinical care.

Where a sponsor proposes to use simplified consent arrangements, the approach must be clearly justified and described in the trial protocol. 

Changes 

The changes move away from uniform, prescriptive consent processes toward a model reflecting participant risk. Sponsors have more flexibility in how information is provided but must justify their approach. 

The HRA has published guidance for these low‑intervention clinical trials (Simplified arrangements for seeking and evidencing consent in low intervention CTIMPs guidance - Health Research Authority) which has been adapted from their original guidance on the proportionate approaches to seeking and evidencing informed consent. 

The guidance is helpful as it provides several working scenarios of informed consent including:- 

“…The opportunity to participate will be introduced to potential participants at their pre-operative appointment. During that appointment potential participants will be shown a short video, set in one of the surgical units, presented on a touchscreen tablet. The video explains the nature of the research, it’s potential to generate new knowledge, and its potential impact for future NHS patients. It will cover the implications of taking part and the risks involved, so the participant can make an informed decision.

After watching the video, the potential participant then has an opportunity to ask any questions they may have with a member of the trial recruiting team. The potential participant then electronically signs the consent form by providing a digital signature via a touchscreen tablet”

And

“…GP surgeries will promote the study using posters that invite low-risk patients with asthma to speak to their GP about the research. As part of the research team, GPs will explain what the study is about, what it involves for the potential participant, its risks, it’s benefits for them and future NHS patients.

The consent conversation will cover the implications of taking part for participants and any risks involved so the participant can make an informed decision at the meeting. A member of the research team will be on hand to answer any questions the potential participant may have.

Unless requested by the potential participant there is no need for additional time to review this research opportunity”

Summary 

The law has not lowered the standard of informed consent, but it has transformed how that standard may be satisfied for low‑intervention clinical trials —moving from prescriptive formality to a flexible approach. 

For clinical trials that do not qualify as low‑intervention, the legal requirements for obtaining informed consent remain unchanged. 

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