Research published in BMC Medical Ethics  has found that NHS research ethics committees (RECs) could monitor bias in clinical trial publication and outcome reporting. RECs review all applications for NHS research conducted in the UK and determine whether the research is ethical. There are currently more than 60 RECs across the UK that each year review around 6,000 research applications.

Researchers working at the ‘Hampshire A’ research ethics committee reviewed 116 studies completed between January 2010 and December 2011. They reviewed study application forms to compare original primary and secondary outcomes (what the study was set up and designed to investigate) with the outcomes that were actually published in academic journals.

The research found that only 37/116 studies were published in an academic journal (32%), and over half (57%) of published studies had primary or secondary outcomes which differed from those in the original trial application form.

All UK NHS research must go through ethical approval, which means that RECs have unique access to the data on which studies are conducted and what the studies are designed to explore. The results demonstrate that it would be possible for RECs to monitor publication and outcome reporting bias for UK research.

Dr Simon Kolstoe, chair of the Hampshire A REC and principal investigator of this study said:

“Most of us volunteer to sit on research ethics committees because we care about research and want to see it carried out to high ethical standards. Thanks to the Health Research Authority (HRA) the UK ethics system is already well ahead of many other countries, but at the moment one failing is the ability to monitor or influence what researchers are doing with data after their studies finish. By combining a simple literature search with data already held by the HRA, we have shown that the HRA is in a powerful position to determine whether researchers are publishing the work they originally committed to carry out. Gathering this data routinely and for all ethics committees would provide the HRA with the knowledge required to effectively prevent reporting bias in the majority of human medical research conducted in the UK.”

Dr Ben Goldacre, author and co-founder of AllTrials said:

“This evidence uses some of the best data we have on trials conducted in the UK, and it sets out in unambiguous black and white the appalling scale of the problem we face. Despite all the false reassurances of the past decade, trialists continue to withhold the results of clinical trials as a matter of routine.

This cannot be acceptable: the UK government and research regulators need to urgently step up and address this issue. We need routinely collected data, presented in full public view, on all trials conducted, their completion date, and whether they have made their results available or not. We need to name and shame the researchers, universities, companies and treatments where results are being withheld. It is only through this kind of individual accountability that we will see progress.

The HRA already has all the infrastructure necessary to achieve this basic level of transparency and accountability. I hope they will now see fit to close the loop, by collecting and sharing this information, urgently. They are the ethics regulator: what is happening is unethical, and they can fix it, at extremely low cost.”