Data access and consent to use health systems data in clinical trials

Data access and consent to use health systems data in clinical trials Green Paper for consultation | October 2025 Green paper: Data access and consent to use health data in clinical trials Page 2 | 19 Green Paper v1.0 dated 21 October 2025 | DOI: 10.5281/zenodo.17406642 Contents Contents ............................................................................................................................................................ 2 Executive Summary ....................................................................................................................................... 3 Overview ........................................................................................................................................................ 5 Issue 1: Fragmentation and Complexity .................................................................................................... 7 Issue 2: Variation in requirements for consent to use health data ........................................................... 8 Issue 3: Limited capacity of data custodians to process data access applications.................................... 8 Issue 4: Retroactive application of new standards and legal frameworks ................................................ 8 Issue 5: Lack of trial participant voices ...................................................................................................... 9 Recommendations from the Forum .............................................................................................................. 9 Recommendation 1: A centralised data access approval system ............................................................. 9 Recommendation 2: An overarching, objective standard to assess the adequacy of consent to the release of health data .............................................................................................................................. 10 Recommendation 3: A precedent set review pathway for common datasets and specific trial uses .... 12 Enabling effective implementation ............................................................................................................. 13 Conclusion ................................................................................................................................................... 13 Next steps .................................................................................................................................................... 14 Working group members and contributors ................................................................................................. 15 References ................................................................................................................................................... 16 Appendices .................................................................................................................................................. 19 Green paper: Data access and consent to use health data in clinical trials Page 3 | 19 Executive Summary Lay Summary: Making Health Research Easier and Safer This Green Paper outlines how health systems data (HSD) - information related to a person’s health, care, and medical history - can be used to improve the efficiency and effectiveness of clinical trials. Clinical trials are essential studies that test new treatments, and using HSD can help researchers identify, recruit, and follow up with participants more effectively. This approach has the potential to lead to better treatments and improved health outcomes. However, most clinical trials do not currently use HSD, largely due to difficulties in accessing the data. These challenges arise because the process for getting access to data is complicated and not the same across the UK. Different organisations follow different rules, and some organisations do not have enough staff or time to manage all the requests. As a Working Group of the Clinical Trials Stakeholder Prioritisation Forum, part of the HDR UK Transforming Data for Trials programme, we have examined these issues and proposed specific recommendations to streamline data access while ensuring the safe and ethical use of patient information. Key proposals include the establishment of a central national data service to oversee and coordinate data access approvals, and the development of a standardised framework for assessing participant consent to use and access their HSD. These measures aim to reduce delays, improve consistency, and support researchers in navigating legal and regulatory requirements. Several problems were identified: the current system involves too many steps and differing rules, leading to confusion and inefficiency; there is variation in how consent is interpreted, which can delay approvals; data access teams are often under-resourced; new legal standards are sometimes unfairly applied to older studies; and trial participants are frequently excluded from decisions about how their data is used. These issues not only hinder research progress but also risk undermining public trust. To address these challenges, the working group recommends (1) creating a centralised approval system; (2) establishing clear and objective standards for consent; and (3) introducing pre-approved pathways for commonly used datasets. These changes would simplify the process for researchers and reduce administrative burden. Importantly, the Green Paper emphasises the need for meaningful public engagement, including the involvement of citizen panels and shared patient and public forums, to ensure that the voices of trial participants and the wider public are heard and respected. Green paper: Data access and consent to use health data in clinical trials Page 4 | 19 In summary, improving access to health systems data in clinical trials requires coordinated reform, clear guidance, and active public involvement. By making the process more transparent, consistent, and inclusive, we can accelerate health research while safeguarding individual rights and building public confidence in the use of health data. Scientific Summary Efficient and timely access to HSD is a major barrier to their wider use in clinical trials. Access is complex and fragmented for a number of reasons. In the UK, health data is a special category of personal data, and statutory and common law frameworks govern its use. There are different national jurisdictions along with a multiplicity of data assets and data custodians, with different (and sometimes changing) requirements for data access. In December 2024, we formed a Working Group from the Clinical Trials Stakeholder Prioritisation Forum, part of the HDR UK Transforming Data for Trials programme, to address data access issues raised during our Forum meetings. The aims were: 1) to describe specific data access issues that affect clinical trials in the UK, e.g. assessment of trial consent procedures, and 2) to make recommendations to improve standardisation of consent assessment and streamline data access approval processes for clinical trials and consented cohorts. The Forum comprises stakeholders from public and patient organisations, data custodians, clinical trialists and researchers, regulators, funders, and enabling networks such as UKCRC Registered Clinical Trials Units Network. We collated views and experiences of stakeholders on the topic of UK data access that were shared during breakout discussions of the two Forum meetings in April 2024 and September 2024, and we identified common themes. We then formed recommendations through Forum and Working Group discussions to address pertinent issues. The five common issues identified were: 1) Fragmentation and complexity across the current data access approval systems; 2) variation in requirements for participant consent for data access; 3) limited capacity of data custodians to process data access applications; 4) retroactive application of new standards and legal frameworks; and 5) a lack of trial participant voices. We discussed three approaches that could address most of these issues and incorporate patient and public voices throughout. Our recommendations to streamline data access in the UK are: 1) standardise procedures to assess the adequacy of trial participant consent to link and use HSD; 2) create a centralised data access approval system as recommended by the Sudlow Review (the newly formed Health Data Green paper: Data access and consent to use health data in clinical trials Page 5 | 19 Research Service); and 3) develop a precedent set review pathway for common datasets and specific trial uses. We present these approaches and suggested implementation. We welcome and encourage comments and contributions to help further this work. We are also interested to hear suggestions as to how best to implement the recommendations presented here and what barriers need to be addressed. A survey has been created alongside this paper to establish level of agreement with the recommendations and capture feedback on implementation challenges. This survey will remain open until 19 December 2025 (inclusive). Overview Purpose To describe specific issues around data access that affect clinical trials in the UK, in particular the assessment of the trial consent procedures, and to constructively suggest ways to improve standardisation of consent assessment and streamline data access approval processes for the wider UK trials community. This paper proposes changes to solve some of the issues raised. It does not provide a framework for data access or detailed plans or processes but seeks to share collective experiences and recommendations for improvement. Introduction/background The recently published Sudlow Review clearly describes the potential benefits and opportunities of using health data safely and securely to improve health and wellbeing, and save lives.[1] It highlights the advances made by the RECOVERY trial to quickly answer key questions about treating severe COVID-19 through the judicious use of health data to obtain trial outcomes.[1, 2] Clinical trials are the most reliable method to assess new pharmacological, behavioural, and policy interventions, but they are resourceintensive, and can take a long time to complete. Health data has the potential to increase the efficiency of clinical trials by assisting identification, recruitment and follow-up of participants, leading to better treatments and health improvement.[3] The main barrier to using health systems data in research, particularly in clinical trials, is efficient and timely data access,[1, 3-7] and the legal and administrative requirements to allow sharing of personal data, Green paper: Data access and consent to use health data in clinical trials Page 6 | 19 including the assessment of whether the trial consent procedures are acceptable in relation to the release of health data. Clinical trials have been strictly regulated for decades, to protect participants and to ensure scientific rigour and integrity, and trial teams regularly securely manage personal data about trial participants in accordance with regulatory requirements.[8] In most trials, participants have provided written informed consent to allow the use of their routinely collected health data and in most cases giving explicit consent for release of health data about them to the trial team, so there are expectations that such data are accessed and utilised for the trial. However, despite the advances made during the COVID-19 pandemic in the use of linked health data, delays in data access still severely impact timely delivery of clinical trials and their potential benefits.[1] The UK health data landscape is complex for a number of reasons. Health data is a special category of personal data, and there are statutory and common law frameworks to govern such data; the UK General Data Protection Regulation (GDPR; implemented within the Data Protection Act 2018 [DPA]) and the common law duty of confidentiality.[9-10] There are different common law mechanisms within UK national jurisdictions which further complicates data access. Other factors include multiplicity of data assets, fragmentation across regions, nations and healthcare settings, and the risk-averse approach of some data custodians, along with differing and changing requirements which may not be transparent. The complexity of how health data is accessed and used in clinical trials is shown in Figure 1 as an example. The Sudlow Review describes these issues, highlights specific examples and makes recommendations to facilitate safe and better use of health data.[1] Learnings from the Forum and wider community During the April 2024 meeting of the Forum, the following three priority areas were identified: • Standardising the procedures used to assess consent to link and use health data and streamlining the approval process while ensuring compliance with regulatory requirements. • Improving the incorporation of patients and the public voices in streamlined decision making. • Building capacity and expertise within trials teams. The first area was discussed more fully in the September 2024 meeting to explore issues that trialists face and make recommendations that could support the streamlining of processes. These are summarised below. Green paper: Data access and consent to use health data in clinical trials Page 7 | 19 Issue 1: Fragmentation and Complexity A key challenge is the fragmentation and complexity of the current data access approval systems for clinical trials. [3-6] This is a concern particularly for large UK-wide trials that require health data from multiple custodians and healthcare settings for recruitment or to obtain key outcomes. Delays occur due to the need for approvals from different data access committees, which creates huge administrative burden and slows the progress of important research.[4-6] Data sharing agreements have taken as long as 24 months to Figure 1: An example of data flows in a clinical trial using trial-specific and health systems data. Under UK GDPR, identifiable personal information is flowed from the Healthcare provider (research sites) to the Sponsor (into a restricted part of its secure data environment), which is shared with the Data Custodian organisation for data linkage. Linked pseudonymised data are securely transferred to the Sponsor to analyse with trial data within the Sponsor’s secure data environment. CRFs: Case report forms; UK GDPR: UK General Data Protection Regulation implemented within the Data Protection Act 2018; GP: General Practice; NHS: National Health Service. *Section 251 support is where section 251 of the NHS Act 2006 (England & Wales) is applied to allow disclosure of data without breaching the common law duty of confidentiality. Equivalent legislation in Northern Ireland to section 251 is the Health and Social Care (Control of Data Processing) Act 2016. The Scottish equivalent is overseen by the Public Benefit and Privacy Panel for Health and Social Care. UK GDPR legal bases from Articles 6 & 9 with Common Law Duty of Confidentiality or Section 251 support or equivalents* Sponsor: Secure Data Environment Sponsor: Secure Data Environment (restricted access) Sponsor: Trial Database Healthcare Provider (local sites) Electronic patient record system (GP or Hospital) Trial data placed in CRFs with non-identifiable information Process & manage pseudonymised data and combine with trial data Data Custodian/Provider Data custodian links personal identifiers (e.g. NHS/CHI number, date of birth) to health data Identifiable information removed to create pseudonymised data extracts Trial data placed in CRFs with identifiable information (e.g. NHS/CHI number, date of birth) Identifiable personal information For data linkage (e.g. NHS/CHI number, date of birth) Trial database Encrypted data shared in line with data sharing agreement via Secure Electronic File Transfer Statistical analysis(trial findings) Green paper: Data access and consent to use health data in clinical trials Page 8 | 19 obtain, and often with a further delay for data receipt; this is unacceptable for timely analyses and reporting of trial results.[4-6] Similar inefficiencies existed in the past when individual local ethics committees provided separate ethical opinions for trials. Reformation of the ethics review process since 1997 to a centralised system has significantly improved efficiency, and a similar approach could be beneficial for data access approvals. Issue 2: Variation in requirements for consent to use health data There is variation in requirements between data custodians and their data access committees, particularly in the assessment of the adequacy of consent for linkage with health systems data.[3-6] Under UK GDPR (article 12; DPA 2018 section 44), information provided to trial participants must describe the legal basis and purpose of data processing to meet their reasonable expectations of how their data will be used and managed.[9, 10] However, differing interpretations of trial information and consent materials by data custodians can lead to delays in approving projects, while also undermining the trust that participants place in both trial researchers and institutions. It also undermines the research ethics committee who review and approve these materials for ethical use by the trial team. Risk aversion can result in “default no” decisions on whether consent procedures are adequate to meet the common law and other legal requirements. This adds further administrative burden to trial teams who then need to seek permission to access data without participant consent from bodies such as the Confidentiality Advisory Group of the Health Research Authority in England and Wales and Public Benefit and Privacy Panels in Scotland and Northern Ireland.[45] Issue 3: Limited capacity of data custodians to process data access applications Some data custodians have very limited capacity to process data access requests.[5] Under-resourcing of data access teams and high staff turnover lead to significant delays in obtaining approvals. Issue 4: Retroactive application of new standards and legal frameworks Changes to existing standards for data access or legal frameworks (such as UK GDPR in 2018) has led to retroactive review of existing applications and sometimes previously approved access requests.[5] This is a particular issue for trials with longer term follow-up where consent was taken many years previously. Applying new frameworks to past decisions can erode the trust that participants have placed in trials, particularly if prior research is retroactively deemed non-compliant with new standards. This could severely damage relationships between trial researchers, data custodians, and trial participants, as it could call into question the validity of previously conducted research. Green paper: Data access and consent to use health data in clinical trials Page 9 | 19 Issue 5: Lack of trial participant voices The lack of trial participant involvement in data approval processes is seen as a missed opportunity. While participants are directly affected by how their data is used and have exposed themselves to the potential risks in a trial, they are often excluded from high-level decisions. This exclusion can lead to decisions that do not adequately reflect the concerns or priorities of trial participants, further eroding trust in the system. Recommendations from the Forum Several solutions were proposed to streamline the data access approval process, including standardisation of the assessment of trial consent to access health data. Recommendation 1: A centralised data access approval system The creation of a central body to oversee health data access approvals for clinical trials would address widespread delays and inconsistencies across the current system. Trialists often face complex, fragmented approval processes involving multiple custodians and different requirements. These inefficiencies slow the delivery of research and create unnecessary administrative burden, especially for UK cross-border trials.[1] Fragmented data access can also introduce bias from missing outcome data, which can lead to underor over-estimation of treatment effects. The recent announcement of the National Health Data Research Service (HDRS) offers a well-timed opportunity to embed our recommendation within its future development.[11] The HDRS has strong potential to enhance timely data access for trials, which supports research delivery and efficiency, and promotes trial participation to a broader range of participants. While legal variation across the UK makes full centralisation challenging and complex, coordination between nations should be prioritised to support consistency where possible. The remit of this new service and its relationship to existing structures, such as the Health Research Authority, must be clearly defined. A single body could act as a point of contact for researchers, supporting navigation of legal and regulatory steps across organisations such as the Health Research Authority, Research Ethics Committees, and the Medicines and Healthcare products Regulatory Agency. It should assess requests in line with public benefit, provide guidance on the suitability of research organisations, and coordinate a standardised application process.[11] A nationally recognised application form, similar to the IRAS system, would improve Green paper: Data access and consent to use health data in clinical trials Page 16 | 19 References 1. Sudlow CLM. Uniting the UK’s Health Data: A Huge Opportunity for Society. Zenodo 2024. doi: 10.5281/zenodo.13353747 [accessed 30 November 2024]. 2. RECOVERY Collaborative Group, Horby P, Lim WS, et al. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med 2021;384(8):693-704. doi: 10.1056/NEJMoa2021436. 3. Sydes MR, Barbachano Y, Bowman L, et al. 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Access to routinely collected health data for clinical trials – review of successful data requests to UK registries. Trials 2020;21:398. doi: 10.1186/s13063-020-043298. Green paper: Data access and consent to use health data in clinical trials Page 18 | 19 22. Thompson J, Bobou M, Roberts K, et al. The reporting of Health Systems Data use in primary results publications of clinical trials: A systematic review. Research Square 2025. doi: 10.21203/rs.3.rs5959412/v1. 23. Toader AM, Gamble CL, Dodd S, Williamson PR. The use of healthcare systems data for RCTs. Trials 2024;25:95. doi: 10.1186/s13063-023-07846-4. Green paper: Data access and consent to use health data in clinical trials Page 19 | 19 Appendices Appendix 1: Monitoring precedent set pathways A proposed approach to monitor and adapt precedent set pathways is by periodic review publications of data utility comparison studies (DUCkS) and data-enabled trials (Sydes et al., 2024). DUCkS are used to assess whether health systems data can replace trial-specific data collection methods in clinical trials. For example, DUCkS may provide evidence that a specific health dataset is accurate and contemporaneous for a particular trial outcome or event. If there is sufficient evidence to provide confidence in using this health dataset, then clinical trialists may design their trials to use it. Data access could be streamlined by including the dataset and its particular trial use within the precedent set pathway. Periodic review of data-enabled trial publications in bibliographic database and in grey literature (e.g. ClinicalTrials.gov and EU Clinical Trials Register) will also identify frequently used health system datasets and their trial uses.[21, 22] Search terms will include “routine data”, “rand*”, “trial”, “RCT”, “randomised controlled trial”, etc.