UKRIO research integrity webinar: clinical trials

 2:00 pm – 4:00 pm, Wednesday 14 October 2020

Overview 

The next webinar in the series of monthly sessions from the UK Research Integrity Office will focus on clinical trials.

In 2019, the House of Commons Science and Technology Select Committee asked more than forty UK universities to ensure they were complying with clinical trials transparency requirements.  UKRIO agrees with the Committee that ‘selective non-publication of the results of research distorts the published evidence base and is a threat to research integrity.’ 

UKRIO has promoted and supported transparency in research through our practical advisory service, our education and training, and the other services we provide to the research community. A key standard in our Code of Practice for Research is that ‘researchers have a duty to publish the findings of all clinical research involving human participants.’ 

In this webinar, the speakers will address the complex issues surrounding transparent and timely reporting of results from clinical trials.

Speakers

Patricia Burns will discuss how the University of Dundee approached the challenge of improving clinical trials transparency and reporting, including publishing results on public databases. Sharing her experiences and lessons learnt, she will describe the changing landscape of research in Dundee. Moving from the original rush of activity to upload results to evidence compliance, to the less frenetic but no less challenging situation of today, where the involvement of patients and public is building trust and creating a more transparent environment across all areas.

Dr Birgit Whitman will talk about clinical trial registration and reporting of results. HEIs are committed to transparency and public accountability and it is central to their mission to generate new knowledge through research. Despite best efforts, legacy issues can hinder the 100% upload of results. Expert support for investigators is essential to navigate the current registry requirements.

Marc Taylor will draw on experience with the registration and reporting of clinical trials to invite discussion of the oversight of health research in British universities. What conclusions should we draw from British academics' preference for registration with ClinicalTrials.gov, and their poor record in reporting results? How should we view the many coronavirus studies reporting preliminary results on Medrxiv, and the very few reporting verified results to registries in the World Health Organization network? In the aftermath of the pandemic, will the governance of health research in British universities fit them to be world-beating?  

Slides from presentations will be circulated to attendees afterwards and made available on UKRIO's website.

If you need advice relating to a particular research project, publication, problem, or allegation of misconduct, please contact UKRIO direct, so we can give you the right level of support: https://ukrio.org/get-advice-from-ukrio/

Programme  

Speaker Biographies

Patricia Burns, Senior Clinical Research Governance Manager, University of Dundee and NHS Tayside

Patricia Burns is the Senior Clinical Research Governance Manager for University of Dundee and NHS Tayside. Having worked in respiratory research for over a decade she moved to Research Governance in 2014, bringing to the role a wealth of experience in drug studies she ensures standards that enhance research integrity across Tayside.

Dr Birgit Whitman, Head of Research Governance & Integrity, University of Birmingham

Dr. Birgit Whitman is currently Head of Research Governance & Integrity for the University of Birmingham. Prior to this appointment, she worked for 11 years as Head of Research Governance at the University of Bristol, after 20 years in the NHS as a Research Assistant in Surgery, NHS R&D Manager and Trust Innovation Lead. She completed her PhD in the Wellcome Unit for the History of Medicine at Glasgow University, looking at Breast Cancer treatment and patient narratives.

Birgit has worked for the Leonard Cheshire Foundation (an international Foundation that has the aim of changing attitudes towards disability) and has completed a degree in History and Women's studies.

Marc Taylor, Vice-Chair, UK Research Integrity Office and Chair of ISRCTN

Marc Taylor is Vice-Chair of the UK Research Integrity Office, as well as being a Trustee of the organisation and a Member of its Advisory Board. He is also Chair of ISRCTN, which owns the ISRCTN register of clinical trials. He is a member of the Confidentiality Advisory Group at the Health Research Authority, and a member of the HRA’s Audit and Risk Committee. He is a Trustee of the York Blind and Partially Sighted Society.

Marc was until 2011 Head of R&D Systems and Governance in the Department of Health’s Research and Development Directorate. He was the lead official for research governance, including national policy on the NHS Research Ethics Committee system and the UK Ethics Committee Authority. He was also the lead official for policy on information systems to support the National Institute for Health Research.

In 2003 to 2005, he was head of Research Policy and Governance. In 1999 to 2003, he was head of NHS R&D Policy, including the central management of the national NHS R&D Budget. Before joining the Research & Development Directorate, Marc held posts in the Finance Directorate of the Department of Health, and in NHS Estates, an executive agency of the Department. In 1976 to 1991, he worked in the Foreign and Commonwealth Office and the Department for International Development.

James Parry, Chief Executive, UK Research Integrity Office 

James is the Chief Executive of the UK Research Integrity Office. Joining UKRIO in 2006, he took up his current role in 2008, overseeing UKRIO's transition to a registered charity supported by more that 100 research organisations.

He directs UKRIO’s work programme and leads its advisory service, responding to queries and concerns about research practice from researchers and the public. He developed UKRIO’s core guidance publications, such as its Code of Practice for Research, which are used by many leading research organisations.

James works with UKRIO’s subscribers and the wider UK research community to provide them with tailored support on research practice. He regularly speaks on how to sustain and enhance research integrity; audiences have included the Royal Society, the Nuffield Council on Bioethics, the Irish National Forum on Research Integrity, the UK Research Integrity Forum and the World Conference on Research Integrity.

James has collaborated in numerous initiatives to support research integrity. He has worked with the Royal Society and other bodies on initiatives to effect positive change to research culture, assisted with the revision of the UK Concordat to Support Research Integrity, revised policies and systems for research integrity and governance at many universities, and regularly delivers training and discussion sessions at UK research organisations.

Prior to joining UKRIO, James worked as an archaeologist and a university administrator.

Future UKRIO events: For further information on future events in the webinar series, or other UKRIO events and training, please visit our website.

UKRIO welcomes suggestions for topics which we could explore in our webinar series. If you have any suggestions or comments, please contact us.

Disclaimer: the views presented are not necessarily those of the UK Research Integrity Office.