The Health Research Authority has formed The Research Transparency Strategy Group in response to the House of Commons Science and Technology Committee Report on clinical trials transparency, part of its inquiry on research integrity.
The report, published in October 2018, challenged the HRA to drive improvements in research transparency and recommended that a detailed strategy be created to outline how this will be done. We have accepted this recommendation, and work on our strategy development has begun.
To ensure that our strategy is robust, impactful and realistic, we are developing it with input from the research community via the new Research Transparency Strategy Group. The group includes sponsors, campaigners, funders and patients. Professor Andrew George, a Non-Executive Director on the HRA Board, is the Chair. The knowledge and expertise of the group will shape a strategy that achieves compliance with transparency requirements and inspires public confidence in research. The group has published its terms of reference.
The full list of members is:
Professor Andrew George (@ProfAGeorge)
Andrew George is an immunologist who has spent his academic career at Imperial College London developing approaches for the immunotherapy of cancer and preventing transplant rejection. He has also been Chair of a Research Ethics Committee (REC) for 10 years, and Chair of the National Research Ethics Advisors’ Panel for seven, for which he was awarded an MBE. He has been Deputy Vice Chancellor at Brunel University London, and is currently interim Chair of Imperial College Health Partners. He is also a coach and consultant.
Marise Bucukoglu (@EdinburghACCORD)
Marise Bucukoglu is Head of Research Governance in the College of Medicine, University of Edinburgh. Since graduating from Edinburgh with a degree in Pharmacology, Marise has worked in clinical research for over 20 years in both the pharmaceutical industry and academic sector. In her current role, Marise and her team provide support and guidance to Edinburgh based researchers and devote much of their time to promoting good practice and high standards of research integrity across the University’s clinical research community.
Professor David Edwards
David Edwards is Professor of Paediatrics and Neonatal Medicine, Kings College London, Head of the Department of Perinatal Imaging and Health, and Director of the Kings College Centre for the Developing Brain.
He became a Member of the Royal College of Physicians in 1986 and a Fellow in 1993, a Fellow of the Royal College of Paediatrics and Child Health in 1998, a Fellow of the Academy of Medical Sciences in 2002, and a Fellow of the Royal College of Radiologists in 2016.
David holds current grant funding from the MRC, EPSRC, Wellcome Trust and other bodies. He leads the Developing Human Connectome Project, a €15 million programme funded by the European Research Council to map the development of structural and functional connectivity in the fetal and newborn brain.
Dr Cham Herath (@dcherath)
Cham Herath is an infectious disease trained physician with over 16 years’ experience in the pharmaceutical industry and over 20 years in the healthcare sector overall. He has worked at Roche Pharmaceuticals, Gilead Sciences, Chiesi and is currently the Medical Director for AstraZeneca UK.
The clinical disciplines through his career in industry have covered HIV medicine, Viral Hepatitis and Hepatology, Cardiology, Respiratory, transplant medicine, oncology (solid tumours and haem-oncology), neonatology and rare diseases, including the launch of the world’s first licensed stem cell and gene replacement therapy.
Dr Simon Kolstoe
Simon Kolstoe completed a PhD in biochemistry before working in drug discovery for 10 years, initially at UCL Medical School and then at the University of Portsmouth, latterly funded by a BBSRC new investigator award.
During this time, Simon developed an interest in research ethics. He is now Ethics Advisor and Senior Lecturer in Research Ethics at the University of Portsmouth, and has experience chairing NHS and Ministry of Defence Research Ethics Committees.
Simon's current research interests include reporting bias, ethics committee consistency, the development of institutional (both academic and government) policies that promote research integrity, and how the paradigms of research ethics may need to be re-examined in light of the possibilities of big data.
Síle Lane is head of international campaigns and policy at Sense about Science, the independent charity that campaigns around open discussion of research and evidence in public life. Sense about Science runs the AllTrials campaign, the global movement of nearly 100,000 people and hundreds of organisations calling for all clinical trials to be registered and results from them reported. AllTrials has put the issue of clinical trial transparency onto agendas at the highest levels, persuaded governments, research funders, universities and companies to adopt new policies, and developed tools to allow everyone to hold these institutions to account.
Dr Julie McCarroll (@JFJMcC and @publichealthni)
Julie McCarroll is Programme Manager in HSC R&D Division of the Public Health Agency in Northern Ireland. HSC R&D Division is responsible for administering the health and social care R&D budget for the Department of Health in Northern Ireland, as well as leading on the research governance agenda.
Julie holds a BSc in Microbiology and a PhD in Molecular Biology from Queen’s University Belfast. After holding a number of roles in the pharmaceutical industry, Julie took up her current post of Programme Manager in 2013. In addition to a range of project and infrastructure funding initiatives, she is also responsible for aspects of research integrity, governance, and working with industry. She represents the Division on a number of groups, including the NIHR Non-Commercial Costing and Attribution Group, the DoH (NI)’s Strategy for AMR and HAI Group, and the Ensuring Value in Research Funders’ Forum.
Alex Newberry is Head of Research Governance and Research Informatics for Health & Social Care Research & Development Division, Welsh Government. Alex has responsibility for a range of research policy agendas including research ethics and approvals, public involvement and engagement, data-driven research and the HealthWise Wales research cohort.
Professor Sir Stephen O'Rahilly
Stephen O'Rahilly is Professor of Clinical Biochemistry and Medicine, and Director of the MRC Metabolic Diseases Unit at the University of Cambridge. His research investigates the fundamental mechanisms of metabolic disorders such as obesity and Type 2 diabetes, and how knowledge of disease pathogenesis can be translated into improvements in diagnosis and therapy.
Dr Marina Parry (@marina_parry)
Marina Parry is a Senior Research Fellow in the Attard Lab at University College London where she is performing genomic analysis of prostate cancer samples from patients enrolled in the STAMPEDE clinical trial. Prior to this she worked as a postdoc at the CRUK Manchester Institute (2014-2017) and the University of Southampton (2012-2014). In addition to her research role, Marina is an ardent science communicator and is passionate about improving the culture of scientific research and the place of science in society.
Derek Stewart is a former teacher who was treated for throat cancer in 1995. He is a passionate advocate for patient and public involvement of all aspects of health and care research. In this capacity he has been involved with many research projects and chaired groups and boards. He is currently working part-time with the NIHR Biomedical Research Centre in Nottingham to help shape the engagement and involvement of the wider community.
As Head of Policy and Public Affairs at the Association of Medical Research Charities (AMRC), Nisha leads on AMRC's policy priorities to ensure the sector has the best possible environment for health and medical research charities. Nisha has over a decade's experience in healthcare public affairs and policy. During her career she has worked in the policy team at the Labour Party; in Parliament; for two public affairs consultancies and most recently in government affairs for Novartis Pharmaceuticals.
Dr Matt Westmore (@matt_westmore)
Matt Westmore is the Operations Director for the National Institute of Health Research Evaluation, Trials and Studies Coordinating Centre (NETSCC). Matt leads on Adding Value in Research, a cross-NIHR programme of work aimed at increasing transparency, improving research integrity and reducing avoidable waste, with the ultimate aim of maximising the impact of research for the tangible and intangible costs involved. Matt is also a co-convener of Ensuring Value in Research, an international forum of funders who are interested in sharing best practice under this agenda.
The Research Transparency Strategy Group will meet during the first half of 2019 to help the HRA create a draft strategy that can be put out to consultation. This strategy will then receive input from partners, existing groups such as the Transparency Forum and the wider research community. After the consultation period, the HRA will finalise the strategy and deliver it to the Science and Technology Committee by December 2019, as requested.