The UK’s Health Research Authority (HRA) is pressing ahead with an action plan to promote transparency in research after securing “comprehensive” support for the proposals it put out for consultation last May.
The HRA says it will now, in consultation with stakeholders and partners, move forward to implement its proposals and generate “tangible outputs”.
The position paper issued by the Authority in May drew on discussions at a stakeholder workshop hosted by the HRA the previous month, where 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 Research Ethics Committees (RECs).
The resulting proposals included making trial registration a condition of REC approval and working with research funders and sponsors to set standards for access to data and human tissue.
The Authority, which has signed up to the AllTrials data-transparency campaign, already publishes summaries of research studies and the opinions of its Research Ethics Committees.
The HRA “believes fundamentally in providing important reassurances to the public on the issue of research transparency”, it noted. The Authority will now:
- Implement the registration of clinical trials as a formal condition of REC approval from September 2013.
- Work with partners to “understand what is meant by publication” and to ensure that when research is conducted, it is subsequently published “according to plans agreed with the REC at the time of approval”.
- Undertake an audit of completed research studies to get a better insight into publication rates in the UK.
- Look for additional ways to monitor compliance with publishing according to the agreed conditions of REC approval.
- Explore means by which researchers, sponsors and funders can “demonstrate good conduct”.
The HRA noted some “minor concerns” expressed through the consultation in relation to “potential sanctions that may ultimately be considered for the minority of researchers who fail to deliver upon their commitments to transparency”.
Given the overwhelming support for its transparency agenda, though, the authority expects that “the vast majority of researchers, sponsors and funders will embrace the plans to realise greater openness, responsible data-sharing, publication of all results and will address the issue of deliberate non-publication”.
Duty to enable
Welcoming the feedback on the HRA’s proposals, chief executive Janet Wisely said: “We have a duty to enable good quality ethical research, but we cannot achieve this by ourselves – it is incumbent on researchers, sponsors and funders to further the wider knowledge in their area of study, through the publication and dissemination of research findings, publishing all results, making data accessible to others and registering clinical trials”.
To do otherwise, Wisely added, was “a disservice to the public, the key partner in research whose interests we must work together to safeguard”.