Publication of research findings
The publication of research findings is an important issue for all those involved in the conduct of research, including clinical research nurses, and those who might benefit from the results of that research. The Health Research Authority (HRA) held a stakeholder workshop in April at which there was general agreement on the need for greater transparency around the publication of clinical and other healthcare research findings. This has been debated at length and a recent campaign by www.alltrials.net brought this issue to the public’s attention and has now received in excess of 51,000 signatures. Ben Goldacre’s popular book ‘Bad Pharma’ also highlighted the consequences of poor, inadequate or non-reporting of research findings for science and, most importantly, for patients.
Today (13 May 2013) the HRA has issued a Press Release in which it makes a number of proposals for how they would like to promote transparency around the publication of health research findings, including:
- To make the registration of clinical trials within an agreed timeframe a condition of REC approval from September 2013.
- To work with research funders and sponsors to set standards for the publication and dissemination of research outcomes.
- To develop mechanisms to actively review plans for publication against these standards and include them specifically within the condition of the REC approval.
- To develop simple mechanisms to monitor compliance with REC approved plans to publish.
- To set standards and issue guidance for how those that have participated in research are appropriately informed of individual outcomes and study results at the end.
- To work with regulators of professions to address the misconduct of withholding results.
- Work with publishers to dispel the myths and perceptions about the difficulties in publishing results.
When researchers make an application for ethical approval using the Integrated Research Application System (IRAS) they are required to describe their plans for disseminating their findings. Any researcher who does not propose a reasonable approach to publishing will be challenged on this and most research ethics committees (RECs) now consider it unethical not to have a publication strategy. The researcher will also be asked how they plan to share the findings with their research participants, when it is appropriate to do so. Regardless of the responses to these questions, many research projects currently end and the reviewing REC often does not have the capacity or the authority to ensure that researchers have complied with the agreed publication strategy. It will be easier for RECs and other regulators to deal with this if a) it is a requirement that all research projects are registered on accessible databases and if b) there is a process in place to ensure that researchers publish as agreed. It will be interesting to see what the consequence of not publishing might be and who will enforce this.
To read the full Press Release or to find more information visit the HRA website (www.hra.nhs.uk). If you would like to comment on these proposals you should e-mail Tom Smith (firstname.lastname@example.org) before 10 June. It is important that this consultation includes input from all those involved in clinical research. Clinical research nurses play a central role in the conduct of research and should also make a contribution to this important debate.← Getting unstuck and taking control of your life and career with CHOICE The quality of informed consent in clinical trials →