Making trial registration a condition of Research Ethics Committee approval and working with research funders and sponsors to set standards for access to data and human tissue are among proposals by the UK’s Health Research Authority (HRA) to ensure the publication of clinical and other health-research findings.
Set up in December 2011 to unify and streamline the UK’s research-approvals process while protecting and promoting the interests of patients and the public, the HRA is determined to play a leading role in the transparency debate.
The Authority’s chief executive, Janet Wisely, is addressing the issue in Parliament this week as an expert witness in the House of Commons Science and Technology Committee’s ongoing enquiry into clinical trials.
Out for consultation
The HRA, which has signed up to the AllTrials data-transparency campaign, already publishes summaries of research studies and the opinions of its Research Ethics Committees (RECs), it notes.
The Authority has now put out for consultation a set of proposals to take that commitment further, by leading and co-ordinating “activity in the UK to model and support success, create a culture of openness [and] challenge behaviours and opinions that present barriers to transparency”.
The HRA’s position paper, which is available for comment until 10 June 2013, reflects discussions at a stakeholder workshop hosted by the HRA on 25 April.
Delegates included representatives from industry, research-funding bodies and experts in public and patient engagement.
The HRA had previously consulted on the transparency issue through meetings with key stakeholders such as representatives of publishers, funding bodies and industry. It also took into account evidence from a survey of RECs.
Best possible use
“We believe this set of proposals … if implemented will increase public confidence by making the best possible use of their contribution to health research,” the HRA stated.
“Increasing transparency will avoid duplication, streamline research by improving efficiency, fundamentally improve patient safety and help to make the UK an even more attractive place in which to do good quality research.”
The HRA’s proposals include:
• Making the registration of clinical trials within an agreed timeframe a condition of REC approval from September 2013.
• Working with research funders and sponsors to set standards for the publication and dissemination of research outcomes.
• Developing mechanisms actively to review research-publication plans against the aforementioned standards and to include them specifically in the conditions for REC approval.
• Developing simple mechanisms to monitor compliance with REC-approved plans to publish research.
• Setting standards and issuing guidance on how people who have taken part in research can be informed appropriately of individual outcomes and study results.
• Working with regulators of the relevant professions to address misconduct in withholding research results.
• Working with publishers to dispel “the myths and perceptions about the difficulties in publishing results”.
“Change will only come through determined leadership and, with the commitment of our partners to increasing openness, we are now sharing our plans for promoting transparency in a robust and sustainable way,” Wisely commented.
The HRA has also been “mindful of our ambition to make it easier to do good-quality research in the UK and have set out sensible and proportionate measures that will increase transparency and increase confidence in health research in the UK”, she added.
Cross-constituency support
The Authority’s position paper drew cross-constituency support in the continuing debate around access to clinical-trial data.
AllTrials campaigner Dr Ben Goldacre said the Authority was “demonstrating clear leadership, with impressive and solid practical suggestions. I hope that all in medicine will give the HRA their wholehearted support”.
The proposals were also welcomed by Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry.
“We support the HRA’s aim to promote transparency in clinical research as a means of furthering public understanding of research,” Whitehead commented.
“We are also encouraged by the recognition that any initiatives developed in the UK should not be detrimental to our international standing as a leader in health research.”
A final version of the Authority’s position paper will be published after consideration by the HRA Board at their meeting on 28 June 2013.
