From 28 April 2026, the HRA will introduce changes for non-clinical trials of investigational medicinal products (CTIMP) studies to align with the new clinical trials regulations. While non-CTIMPs are not subject to the new clinical trials regulations, the HRA will implement changes to adopt aligned terminology and processes, including aligning approvals timelines with CTIMPs and updating research transparency requirements. The changes will apply UK-wide and are intended to promote consistency and proportionality across health and social care research.

The Health Research Authority (HRA) has published a blog outlining new legal research transparency requirements under forthcoming UK clinical trials regulations, together with transitional arrangements for ongoing studies. The changes, which come into force on 28 April 2026, introduce mandatory obligations on sponsors to register trials, publish results and provide summaries to participants, with enforcement powers available to the Medicines and Healthcare products Regulatory Agency (MHRA). Sponsors will be required to register each clinical trial in a public registry before the first participant provides consent or within 90 days of approval, publish a summary of results in the same registry within 12 months of the global end of the trial and offer a lay summary of results to participants or other ‘relevant persons’ within the same period. The HRA states these measures are intended to promote openness in clinical trials and support public trust and participation. The blog also outlines transitional arrangements. Where a trial ends before 28 April 2026, the new requirements will not apply, although existing obligations, including Research Ethics Committee requirements to register trials within six weeks of recruiting the first participant, will continue. Where a trial has been submitted or approved before that date but ends on or after it, it must be registered before first participant consent or within 90 days of 28 April 2026, whichever is earlier, and a summary of results must be published in the same registry. There is no legal requirement in such cases to provide a lay summary, although this is encouraged. All trials submitted on or after 28 April 2026 will be subject to the amended regulations. From that date, failure to comply with registration or results publication requirements will constitute an offence. The MHRA may take enforcement action, including infringement notices and potential prosecution and may refuse to approve trials where sponsors have failed to comply with transparency requirements in other studies.

The Health Research Authority (HRA) has introduced comprehensive updates to clinical trials regulations, effective 28 April 2026, that now apply to clinical trials of investigational medicinal products (CTIMPs) and include associated policy changes for non-CTIMP studies. This review of the UK’s clinical research regulatory framework has been developed in collaboration with health departments across all four nations of the UK.

The Health Research Authority (HRA) has published a report to share its findings of the People-Centred Clinical Project from 2023 and has issued recommendations on how to improve clinical research for participants. The findings suggest that the barriers to people-centred clinical research are accessibility, care, value and recognition, funding and resources, capacity, engagement etc. To tackle this, the HRA proposes 19 improvement goals through conditions like possibility, trust, purpose and a people-centred research culture. Recommendations within these conditions include improving accessibility, cost and convenience to participants, communication and feedback, mindset and attitude of researchers, system capacity across the clinical research system and engagement for research.

The Health Research Authority (HRA) has launched a pilot inviting feedback on a draft information governance (IG) guide. The guide aims to reduce uncertainty and duplication in the study set-up process by clarifying how IG is assessed centrally when NHS and HSC research studies are submitted for HRA approval and what local IG checks may still be required by participating NHS organisations. It consolidates the IG information that sponsors are already required to provide under section 5.1 of the UK Study-Wide Governance Criteria, including: (1) what good IG looks like at sponsor level; (2) how this can be clearly and proportionately evidenced in IRAS; (3) what is reviewed and assured nationally; (4) what participating organisations can rely on without repeating checks and (5) when limited local checks may still be necessary. It focuses on research approval processes specific to England but is underpinned by UK-wide information governance principles, including data protection, confidentiality and accountability. The HRA is seeking feedback from sponsors, sites and stakeholders across the UK on how these principles operate in practice to inform future iterations of the guide and potential UK-wide adoption. As part of the pilot, it is also inviting feedback on a proposed approach to documenting processor arrangements. The pilot will run until 30 April 2026.

The Health Research Authority (HRA) has launched a new three-year strategy, to support the UK government’s health and economic growth missions. The strategy aims to make the UK the easiest place to conduct trusted health and social care research by enhancing digital infrastructure, embedding productivity, reducing regulatory burden, and building public trust. It aligns with the 10 Year Health Plan’s ambitions to accelerate clinical trials, increase research access, and improve NHS sustainability.

The Health Research Authority (HRA) has updated its Research Ethics Committee’s (REC) process for progress and safety reports. For the process for studies approved by RECs across the UK, the requirement to submit annual progress reports has been removed. However, annual reviews must still be submitted to the Confidentiality Advisory Group, and an end-of-study declaration and final study report will have to be submitted to the REC. Changes have also been made to how Suspected Unexpected Serious Adverse Reactions (SUSARS) and annual safety reports are acknowledged. The changes were applied to research approved by RECs in England and Wales from 1 June 2024 and came into effect in Scotland and Northern Ireland on 1 August 2024.

The Health Research Authority (HRA) has detailed its regulatory oversight role for the new £600m Health Data Research Service announced by the government on 7 April 2025. The service, jointly funded with the Wellcome Trust, will provide centralised access to NHS data for medical research from late 2026. HRA confirmed its Research Ethics Committees and Confidentiality Advisory Group will continue reviewing data access applications, with 99% of current applications processed within 60-day targets. The framework includes mandatory technical assurance processes and standardised commercial contracting to reduce study setup times to 150 days by March 2026.

The Health Research Authority (HRA) has released its key focus for 2024 to boost transparency in research and clinical trials, following a public attitudes survey it commissioned in 2023. The HRA will focus on three main areas, which include registration of clinical trials, publication of results and communicating study outcomes to participants. Compliance with registering trials hovered at just below 90% between 2018–2021. The HRA plans to increase this to 100% and is planning to publish a list of all trials with their registration reference number beginning with trials approved in 2022. The key focus forms part of the HRA's 2023–2025 strategy.

The Health Research Authority (HRA) has proposed changes to simplify the informed consent process for low-risk clinical trials in the UK. The HRA defines low-risk clinical trials as those comparing pre-approved medicines, involving no additional treatment or diagnostic procedures. Under the proposal, consent would be documented in medical records rather than through written forms, while maintaining the legal requirement for informed consent and the right to withdraw. The HRA is seeking public and professional feedback on these changes through a survey closing on 10 January 2025, to inform future Clinical Trials regulations and HRA guidance.

The Health Research Authority (HRA) has published a plan for 2026–28 setting out how it intends to support the use of AI in health and social care research while maintaining appropriate safeguards. The plan focuses on three priorities: (1) clarifying when AI development, evaluation and implementation activities constitute research and require review, (2) clarifying when health information may be accessed using AI-enabled and data-driven approaches to identify and contact potential research participants and (3) ensuring that the review of AI-enabled and data-driven research is informed, rigorous and consistent. According to the HRA, these measures are intended to make it simpler and faster to conduct AI-enabled research, support inclusive participation in research and help maintain public confidence that regulation is keeping pace with developments in the field.

The Health Research Authority (HRA) has published a list of clinical trials which received a favourable opinion from a Research Ethics Committee (REC) in 2022 to improve research transparency and make information from health and social care research publicly available. This initiative is part of the ‘Make it Public’ campaign aimed at increasing transparency in health research. Information about these trials was already available in the research summaries database, but the list provides a quick reference to all those which received a REC favourable opinion, along with their registration numbers. There are a total of 1545 trials.