A review of the regulation and governance of UK health research involving human participants, their tissue or their data.
A new pathway for the regulation and governance of health research
'A new pathway for the regulation and governance of health research' was published in January 2011. The report was prepared by a working group, chaired by Professor Sir Michael Rawlins FMedSci, convened in response to an invitation from Government to review the regulation and governance of UK health research involving human participants, their tissue or their data.The report proposes four key principles that should underpin the regulation and governance framework around health research in the UK, and makes recommendations to:
- Create a new Health Research Agency (HRA) to rationalise the regulation and governance of all health research.
- Include within the HRA a new National Research Governance Service to facilitate timely approval of research studies by NHS Trusts.
- Improve the UK environment for clinical trials.
- Provide access to patient data that protects individual interests and allows approved research to proceed effectively.
- Embed a culture that values research within the NHS.
In response to the review, the Government has announced steps to streamline the regulation and governance of health research as part of the Plan for Growth, which was published alongside the budget in March 2010. Key actions announced include:
- The creation of a new Health Research Regulatory Agency to streamline regulation and improving the cost effectiveness of clinical trials.
- The introduction of new incentives for efficiency in research initiation and delivery.
- A commitment to increasing the proportionality of the EU Clinical Trials Directive and its implementation.
In May 2012 it was announced in the Queen’s speech that the Government would bring forward draft legislation to establish the Health Research Authority on a stable and independent footing.
As part of follow-up activity in this area, the Academy contributed to three responses to the European Commission's concept paper on changes to the Clinical Trials Directive.
Professor Sir Michael Rawlins FMedSci, Emeritus Professor, University of Newcastle (Chair)
Professor Deborah Ashby OBE, Professor of Medical Statistics and Clinical Trials and Co-Director, Imperial Clinical Trials Unit, School of Public Health, Imperial College London
Dr Mary Baker MBE, President, European Federation of Neurological Associations
Professor Sir Rory Collins FMedSci, BHF Professor of Medicine & Epidemiology, Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford
Professor Janet Darbyshire CBE FMedSci, Emeritus Professor of Epidemiology, University College London
Professor Carol Dezateux CBE FMedSci, Professor of Paediatric Epidemiology and Director of MRC Centre of Epidemiology for Child Health, Institute for Child Health
Professor Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene and Tropical Medicine
Mr Mike Farrar CBE, Chief Executive of NHS North West
Professor Gary Ford, Jacobson Chair of Clinical Pharmacology, University of Newcastle
Dr David Gillen, Senior Director and Head of International Medical Affairs, Gilead Sciences
Professor Peter Johnson, Cancer Research UK’s Chief Clinician and, Chair of Medical Oncology, University of Southampton
Professor Shitij Kapur FMedSci, Vice Dean and Head of School, Institute of Psychiatry
Sir Ron Kerr, Chief Executive of Guy’s and St Thomas’ NHS Foundation Trust
Professor Jonathan Knowles, Vice Chairman, Caris Life Sciences
Professor Mike Parker, Professor of Bioethics and Director of the Ethox Centre, University of Oxford
Professor Genevra Richardson CBE FBA, Professor of Law, King’s College London
Mr Paddy Storrie, Deputy Head, St George’s VA School, Harpenden
Professor Patrick Vallance FMedSci, Senior Vice President, Drug Discovery, GlaxoSmithKline
Professor David Webb FMedSci, Christison Professor of Therapeutics and Clinical Pharmacology, University of Edinburgh
Observers joined the initial working group meetings to clarify factual points but were not present for discussion of the conclusions and recommendations of the study.
Mr Marc Taylor, Deputy Director of Research & Development, Head of Research & Development Systems and Governance, Department of Health
Dr David Griffiths-Johnson, Head of Innovation, Office for Life Sciences, Department for Business, Innovation & Skills
Professor Kent Woods FMedSci, Chief Executive, Medicines and Healthcare products Regulatory Agency; substituted by: Miss Margaret Jackman, Head of Strategy and European Medicines Policy, Medicines and Healthcare products Regulatory Agency
Dr Martyn Ward, Head of Clinical Trials Unit, Medicines and Healthcare products Regulatory Agency
Dr Robert Frost (Lead Secretariat), Policy Manager, Academy of Medical Sciences
Miss Emma Greenwood, Policy Researcher, Cancer Research UK
Dr Rachel Quinn, Director, Medical Science Policy, Academy of Medical Sciences
Dr Beth Thompson, Policy Officer, Wellcome Trust
Transforming the regulation and governance of health research
In February 2012, the Academy along with Cancer Research UK (CRUK) and the Wellcome Trust held a stakeholder meeting to review the impact of the Academy's report on the regulation and governance of health research in the year following its publication. Speakers covered issues such as the role of the new Health Research Authority, Clinical Trials Authorisation, research in the NHS and accessing data for research. A high-level panel, chaired by the President, reflected on priorities for the changing environment for health research and Earl Howe gave a keynote address. A report of the meeting 'Transforming the regulation and governance of health research' was published in May 2012.
Discussion with the Health Research Authority
On the 15 October 2014 Academy Fellows and guests met at the Academy of Medical Sciences to hear about the Health Research Authority’s (HRA) current work plan and provide feedback on the opportunities and challenges in the regulation and governance of health research. You can find the meeting note here.
Regulation and governance of health research - five years on
Five years on from the original working group report, significant changes had taken place in the environment including the establishment of the Health Research Authority (HRA) and preparations for the incoming EU Clinical Trials Regulation and the EU General Data Protection Regulation. Therefore the Academy, Cancer Research UK and the Wellcome Trust held a FORUM meeting on 1 November 2016 to explore progress five years on from the report, with a focus on three particular areas: HRA Approval; regulation of clinical trials; and data privacy and governance. The meeting report can be found here.
The HRA at ten: progress to date and future gazing
Ten years on from the establishment of the HRA, the Academy and the HRA convened experts from academia, industry, research charities, policy, funding and regulation, as well as public and patient representatives, to:
- Reflect on the progress made since the establishment of the HRA, identifying key successes, lessons learned and areas for improvement.
- Consider the research trends that will emerge over the coming decade and identify how the HRA can best meet the future needs of the research ecosystem and facilitate high-quality research and innovation while effectively protecting and promoting the interests of patients and the public.
The HRA’s Collaboration and Development Forum is a UK-wide group that supports the HRA with implementation of the unified approval process for the regulation and governance of health research in the UK, and helps to drive improvements to this process.
The Academy participates on this group, which enables us to feed into the processes around HRA Approval and the regulation and governance of health research more broadly. The Academy has also responded to HRA consultations such as providing input on its draft UK Policy Framework for health and social care (these responses can be found on the righthand side of this page).