The Health Research Authority (HRA) has published a report on the legal, policy and ethical issues involved in using patient information to identify and contact individuals about participating in health and care research. The work follows recommendations from Lord O’Shaughnessy’s independent review of commercial clinical trials in the UK, which called for clearer arrangements to help patients hear about research opportunities in ways that are trusted and transparent. In response, the Department of Health and Social Care (DHSC) commissioned the HRA to establish a common approach to contacting patients about research. The report was developed on behalf of partners in the Recovery, Resilience and Growth (RRG) Programme, now part of the UK Clinical Research Delivery (UKCRD) programme. Programme partners will determine which recommendations to take forward and how to prioritise them. The HRA intends to publish detailed guidance to support implementation. It advises that changes to research studies should not be made until this guidance is available.

The Health Research Authority (HRA) has published its response to the High Court's decision refusing applications for permission to apply for judicial review and to stop the PATHWAYS Trial. The HRA states that the decision allows the trial, which forms part of a wider research programme aimed at understanding how the NHS can better support children and young people with gender incongruence, to proceed. The trial will examine the effects of puberty-suppressing medication on the physical, social and emotional wellbeing of participants. The HRA explains that the trial received a favourable opinion in November 2025 through the Combined Review process conducted jointly with the Medicines and Healthcare products Regulatory Agency (MHRA). Following concerns raised by the MHRA in February 2026, the trial sponsor, King's College London, amended the study protocol, which received a favourable opinion in June 2026.

The Health Research Authority (HRA) has responded to concerns after the government announced that data from UK Biobank had been advertised for sale online, saying it is investigating whether a serious breach has occurred in relation to existing Research Ethics Committee approval. It welcomed UK Biobank’s swift action to suspend access to the dataset, describing it as the world’s most comprehensive biomedical resource, containing de-personalised records of more than half a million volunteers. The HRA emphasised that trust in this national research resource depends on strong governance, proportionate safeguards and transparency, noting that access for researchers is granted by UK Biobank and subject to a rigorous vetting process under Research Ethics Committee and Confidentiality Advisory Group approval. Approval was granted in April 2021 and extended for six months beyond April 2026, and the HRA said it aims to balance enabling world-leading research with maintaining the highest possible standards of data security.

The Health Research Authority (HRA) has published updates to its Model Commercial Chief Investigator Agreement (mCCIA) and Model Confidential Disclosure Agreements (mCDAs). These model agreements are used in health and social care research throughout the UK and must be used from 28 April 2025. These amends form part of the HRA's UK Clinical Research Delivery programme which aims to develop and mandate an efficient and streamlined single UK standardised commercial contracting process to reduce unnecessary negotiation. The HRA now aims to update the model commercial site agreements for publication in May 2025.

The Health Research Authority (HRA) has released a draft Investigator Initiated Study Agreement, developed alongside devolved administrations, for use between non-commercial sponsors and commercial organisations. Typically when this research takes place it can take a long time to get an agreement because there is no standard contract available. The HRA produced this template agreement in response to Lord O'Shaughnessy's review of clinical trials identifying this issue and as part of the NHS Recovery Resilience and Growth programme to make it easier to set up clinical research in the NHS. The draft has been developed by the R&D Forum contracts group, who are NHS contract managers, with support from the UK Four Nations contracts leads and will be receiving comments on the draft model agreement until 9.00 am on 13 May 2024.

The NHS Health Research Authority (HRA) has published a new template for research sponsors on transparency wording under the United Kingdom’s General Data Protection Regulation, Assimilated Regulation (EU) 2016/679 (UK GDPR). The updated template aims to ensure research participants have the necessary information required to make an informed decision about the use of their data by sponsors. This new wording will be required to be used from 1 April 2025 for any new research applications submitted via the Integrated Research Application System.

The Health Research Authority (HRA), in collaboration with healthcare authorities in Scotland, Wales and Northern Ireland, has launched a toolkit to streamline and support the set-up of research across multiple UK nations. Designed for researchers conducting studies across more than one UK nation, the toolkit aims to assist in determining whether a study qualifies as research under the UK Policy Framework for Health and Social Care Research. Based on the Defining Research table from the Research Ethics Service, it provides guidance on navigating key national differences in legislation and processes.

The Health Research Authority (HRA) has published a report showing that 74% of health and social care studies received public involvement in 2023. The report reveals lower involvement rates in commercial research (53%) compared to non-commercial studies (89%). The HRA has reported that while the new Clinical Trials legislation, laid before parliament in late 2024, will not make public involvement a mandatory requirement, the government has expressed support for such involvement. The legislation follows a 2023 joint consultation with the Medicines and Healthcare products Regulatory Agency (MHRA) which showed strong backing for public involvement in trials. The HRA is now developing guidance for researchers based on the consultation feedback.

The Health Research Authority (HRA) has published its response to the World Medical Association’s consultation on revisions to the Declaration of Helsinki. The HRA has found majority of the proposed changes to the Declarations helpful in providing clarification and updating the text in line with changes in practice and legislation. On the other hand, it is criticised for its insufficient justification of the claims that the Declaration’s principles have primacy over all national and international laws and regulatory norms and standards. In addition, the HRA recommends that new wording should be given to clarify the process for making minor and substantial changes to research studies and the current document should be revised to ensure that Research Ethics Committees embrace diversity and inclusion.

The Health Research Authority (HRA) and devolved administrations have released a draft model Commercial Chief Investigator Agreement (mCCIA) for consultation. This new agreement aims to streamline the process of commercial organisations contracting Chief Investigators from NHS/HSC organisations for clinical trials of investigational medicinal products. The draft includes a standardised funding model with optional services and suggested rates. The HRA is seeking feedback by 30 November 2024.

The Health Research Authority (HRA) has published results from a survey conducted between November 2024 and January 2025. The survey conducted by the HRA explored public and stakeholder views on a proposal to simplify the process of obtaining and evidencing consent in low-risk clinical trials. Specifically, it examined whether recording verbal consent directly in a participant’s medical records rather than using a signed consent form would be acceptable. While 53% of researchers and 57% of research participants supported the idea, 76% of public respondents opposed it, citing concerns about the lack of physical evidence and potential for misunderstanding or coercion. Research Ethics Committee members were split, with many emphasizing the importance of trust and the formal nature of signed consent in ensuring informed participation.

The Health Research Authority (HRA) has implemented guidance updates to reflect the National Institute for Health and Care Research's (NIHR) transition from the Clinical Research Network (CRN) to the Research Delivery Network (RDN) in late 2024. The changes primarily involve updating references within HRA and Health and Care Research Wales Approval guidance documents and study support services information. While the terminology has been revised to reflect the new RDN structure, the HRA confirms there are no alterations to the practical steps required for applications. The RDN maintains its predecessor's role in supporting high-quality research delivery across England, with distinct support pathways remaining in place for commercial and non-commercial sponsors.