The UK Parliament and Northern Ireland Assembly approved changes to the law governing the regulation of clinical trials involving investigational medicinal products (CTIMPs) across England, Wales, Scotland, and Northern Ireland.
In parallel, the Health Research Authority, has introduced new expectations on how non-CTIMPs (i.e. clinical trials testing medical devices, public health measures, behavioural therapies or any other types of health and social care research), need to be managed to support transparency, patient safety and research integrity.
An overview of the main changes is summarised below:
- Terminology is now aligned with international standards and clarifies the level of review required for each type of modification: ’amendment’ has been replaced with ‘modification’, categorised as ‘substantial’, ‘important detail’, or ‘minor'; trial site’ will be referred to as ‘trial location’ and ‘subject’ as ‘participant’
- Registration of non-CTIMPs remains a condition of a REC’s favourable opinion but for clinical trials involving medicines will be a legal requirement. A study will need to be registered before the first participant is recruited or within 90 days of approval (whichever is earlier). Registration databases: ISRCTN (preferred) or ClinicalTrials.gov
- Timeframes for the approval process have been clarified ; streamlining NHS staff studies IRAS Help - Preparing & submitting applications - NHS staff as research participants) and revised approval process for modifications (amendments), updating the modification amendment tool.
- Roles for Research Ethics Committees (RECs) are clarified, with streamlined review pathways and adjustments to the quorum rules
- New provisions allow simplified consent procedures for low-risk trials, to reduce barriers to participation while maintaining informed decision-making
- Pharmacovigilance reporting obligations are updated to align with international standards. Sponsors will need to follow enhanced procedures for reporting adverse events, ensuring timely identification and response to safety signals across all clinical trials.
- Updated model agreements for use with participating NHS organisations.
More details can be found on the HRA website: Guidance on changes to the clinical trials regulations - Health Research Authority and University webpage Obtaining Sponsorship from the University of Bath - guidance.
A webinar was held on 12 March jointly presented by HRA and MHRA which covered the key changes in the updated regulations, the transitional arrangements and guidance. A recording of this webinar is available via the HRA website.
For details how these changes impact clinical trials of investigational medicinal products (CTIMPs) please refer to the HRA website. Additionally, the MHRA Clinical Trials Hub contains guidance, news, and other useful information.
Future changes:
- A new digital service, Plan and Manage Health and Care Research, will be introduced in 2027 to streamline applications and processes replacing IRAS.
Information will be provided when released by the HRA. To be kept up to date with clinical trials news from the HRA please sign up to receive updates.
Content updated: 15 April 2026