We’ve established an advisory group to help us develop a set of principles for simplified arrangements for consent in low intervention clinical trials.
The group has been set up as part of our work on amended clinical trials regulations, which come into force on 28 April 2026.
Updated regulations will offer sponsors of clinical trials on existing medicines that meet certain criteria the option to use simplified arrangements for seeking and evidencing informed consent.
The types of clinical trials we are talking about in this work involve authorised medicines offered to the participant in the course of routine healthcare with no additional interventions or diagnostic procedures.
Creating principles for how these types of clinical trials can use simplified arrangements could help to:
- reflect a more proportionate approach to informed consent for low intervention clinical trials
- widen access to participation in these types of trials
- reduce the burden to research participants and researchers
Creating the advisory group
In 2022 a public consultation considered a set of proposals to update the UK legislation that underpins the regulation of clinical trials. The consultation included a proposal to simplify arrangements when seeking and evidencing informed consent in trials involving authorised medicines.
The majority of respondents agreed with the proposal and the UK government confirmed its commitment to the proposal as part of its response to the public consultation. The UK parliament approved this proposal into law in April 2025.
So, earlier this year, we ran a survey to get a better understanding of people’s views on simplifying the arrangements for seeking and evidencing consent.
We asked if people felt it would be acceptable for a doctor to record research participant’s consent in their medical records for eligible trials.
The results of the survey indicated the public were unsupportive of the proposal, however, findings did highlight possible opportunities to reduce burden and widen access. We recognised that we needed to hear more from our stakeholders to help us shape next steps.
With the advice and guidance of our Community Committee, we decided to establish a group that had the appropriate expertise, skills, and experience to support the development of a set of principles for simplified arrangements for consent that maintain people’s trust.
The principles will provide guidance for those looking to use simplified arrangements and will assist Research Ethics Committee (REC) members in evaluating the ethical considerations of using simplified arrangements.
The role of the advisory group and review network
The advisory group, which met for the first time this month, is made up of 12 members and includes HRA staff, members of RECs, legal experts, researchers and sponsors, and members of the public. Collectively, the group has expertise in informed consent, ethics, and UK legislation, as well as experience of managing and taking part in clinical trials.
Read more about the members and their experience.
Two members of the group are part of our Community Committee which has been integral to helping us think through how we develop this work and how we can involve the right people in the process.
The members will update the committee, which is part of our governance framework and advises the HRA Board, on progress as the principles are developed.
To make sure the principles reflect as wide a range of voices and experience as possible, the advisory group will be supported by a review network.
The network, which is made up of REC members, academics, members of the public, and a Community Committee member, will provide important feedback and insights over the coming months.
Developing the principles
The advisory group will meet 4 times up until early 2026 to discuss and develop the principles, with input from the review network throughout the process.
The final set of principles is expected to be developed by spring next year ahead of the amended regulations coming into effect.
Joanne Lloyd, public contributor and co-facilitator“It’s a pleasure to be co-facilitating this advisory group.
“I’ve been involved in a number of clinical trials as a research participant and understand first-hand how important the consent process is for people taking part in studies, and how it might impact their involvement.
“I’m particularly interested in how simplified consent arrangements can reduce the burden on participants while also safeguarding autonomy and public trust.
“I’m passionate about the role of communication in making research more inclusive, especially for underserved groups.
“Together, we’re committed to creating principles that are considered and impactful.”
Kirsty Edwards, HRA Policy Manager and co-facilitator“We are pleased to announce the establishment of a new advisory group dedicated to exploring simplified arrangements for consent in low intervention clinical trials.
“The advisory group will bring together a diverse range of expertise and perspectives to advise on a set of guiding principles. These principles aim to support the delivery of simplified arrangement for consent in important clinical trials, whilst maintaining public trust.”
Advisory Group members
Joanne Lloyd (Advisory group co-facilitator)
Joanne is a public contributor drawing upon extensive lived experience participating in clinical trials. She has a particular interest in how simplified consent arrangements can reduce burden while protecting autonomy and public trust, and how communication can enable greater inclusion of underserved groups. Joanne has experience contributing to a number of governance and ethics committees and national advisory groups. She is also Vice-Chair of the Consortium Public Advisory Group (CPAG) for the UKRI/Versus Arthritis–funded CRIISP programme.
Sarah-Jayne Ambler
Sarah-Jayne is a member of our Community Committee. She is a clinical research manager in midwifery at Medway NHS Foundation Trust. In her current role she has a focus on embedding research in to clinical care, harnessing all the benefits of research activity for service developers and is focused on ensuring all pregnant people have access to research opportunities. She is also a reproductive health research champion for Kent, Surrey and Sussex and is a member of the Central London REC.
Emmanuel Ax
Emmanuel is a public contributor who brings significant lived experience as a parent of a child who has been involved in a clinical trial and as a carer to a family member. He has engaged in a number of public involvement and engagement activities spanning topics such as mental health, stroke and cancer. Emmanuel has a particular interest in ensuring information and the informed consent process is clear and easy to understand, both for participants, parents and carers.
Dr Simon Baudouin
Simon is a member of our REC community. He is a retired intensive care doctor and previous chair of the Faculty of Intensive Care Medicine (FICM) Professional Standards committee. Simon has experience as a REC member reviewing trials which seek to simplify participant information and consent. He also has experience as a Chief Investigator of a National Institute of Health Research (NIHR) multi-centre study of rehabilitation after critical illness.
Dr Catherine Blewett
Catherine is the Senior Development Manager in the co-ordination and standardisation team working with stakeholders in the health research regulation field to standardise practice across the UK. She is currently overseeing the revision and implementation of the UK clinical trials regulations for the HRA. Catherine’s PhD thesis established enabling regulatory approaches to the use of surplus tissue samples for secondary research purposes.
Dr Simon Kolstoe
Simon is a member of our Community Committee. He is an Associate Professor of Bioethics, and the University Ethics Advisor at the University of Portsmouth. His work looks at the role of ethics committees and governance structures in promoting research integrity. Simon currently chairs ethics committees for the HRA, UK Health Security Agency (UKHSA) and UK Ministry of Defence. He also works with the UK Research Integrity Office (UKRIO) leading workshops and training in research ethics.
Dr Katy Peters
Katy is an Associate Professor in Medical Law and Ethics with the Surrey Law School at the University of Surrey. Katy’s PhD research explored the intersection between vulnerability, capacity and autonomy in clinical negligence litigation. She has a particular interest in the law relating to capacity, consent, participation and litigation support. She a member of our REC community as Alternate Vice Chair for Bloomsbury REC and also a council member for the Medico-Legal Society.
Sarah Phillips
Sarah is a member of our REC community. She is the Human Research Governance Lead at the Quadram Institute and has experience as a Principal Investigator on two human studies during the COVID-19 pandemic. During these she adapted and simplified consent pathways to enable project continuation under unprecedented conditions, whilst safeguarding participant rights and comprehension. Sarah is committed to developing proportionate, practical consent processes that uphold ethical standards.
Dr Clare Relton
Clare is a Senior Lecturer in Clinical and Public Health Trials at Queen Mary University London. Clare’s PhD research explored how pragmatic intervention trials can generate evidence of practical use to patients and clinicians. She has a special interest in exploring ways to ensure that the informed consent and recruitment processes are practical, ethical and efficient.
Alex Ruck Keene KC (Hon)
Alex is an experienced barrister, writer and educator. His practice at 39 Essex Chambers is focused on mental capacity, mental health and healthcare ethics law, and he has appeared in cases involving these issues in both the Supreme Court and the European Court of Human Rights. Alex was appointed an Honorary QC (now KC) in March 2022 for his contribution to mental health and capacity law outside the courtroom. He is also a member of the BMA Medical Ethics Committee.
Dr Victoria Shepherd
Victoria is a Principal Research Fellow and registered nurse based in the Centre for Trials Research at Cardiff University. She has a special interest in improving the inclusion of under-served populations with a particular focus on populations and settings where informed consent can be challenging, including the use of proxy and 'deferred consent' models. Victoria is also part of our REC community as member of Wales REC 1.
Dr Rebeka Sultana
Rebeka is a public contributor who brings significant lived experience from her involvement in patient and public involvement and engagement in health research. She has a background in pharmacy and quality assurance, and brings the viewpoint of a parent carer. Rebeka has a particular interest in research inclusion, having worked with diverse communities and vulnerable groups, and feels inclusion and diversity in research is crucial to ensuring treatment and care are tailored to everyone’s needs.
Supporting staff
Dr Kirsty Edwards (Advisory group co-facilitator)
Kirsty is a Policy Manager within the policy and engagement team at the HRA leading the work on simplified arrangements for consent. In recent years she has contributed to a range of policy initiatives, including work on mental capacity in longitudinal research. With a background in the charity sector and experience as a social researcher, Kirsty is deeply committed to ensuring that the voices of patients and research participants are central to shaping public policy.
Clive Collett
Clive is the Head of Policy and Engagement at the HRA. He has over 25 years of experience of research regulation and research ethics committees within the NHS. He has been closely involved in the update to the UK’s clinical trials regulations, including the introduction of the new research transparency requirements. He is also a lay member of the Ministry of Defence Research Ethics Committee (MODREC).
Mia Crispin
Mia is a Policy and Partnerships Officer at the HRA. She has worked at the HRA for 4 years across the approvals team, learning and development team and now the policy and engagement team. Mia will be supporting the advisory group; including preparing agendas, providing pre-reading and taking minutes. Mia is available as a point of contact, alongside Kirsty and the public involvement team.
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