Poor regulation of research can cause direct harm to patients, suggests a new research study led by the University of Dundee.
The international study led by Dr Jonathan Mendel from the University has called for greater transparency in ethics committee processes.
The report, which saw input from researchers across the UK and Australia, has been published in the British Medical Journal (BMJ).
Investigating the process of ethical approval and the information given to patients with rheumatoid arthritis in clinical trials, the study suggests that by making documentation freely available, it will allow ethical decisions to be independently reviewed, publicly discussed, and learnt from.
It further suggests that systematic review of evidence could allow for more effective scrutiny by Research Ethics Committees prior to publication.
Dr Mendel, a Lecturer in Human Geography whose research covers social aspects of trials amongst other areas, said, "We have shown that ethics processes around trials can lead to problematic decisions, which risk having significant impact on trial participants.
"Ethics processes are important to society, and should be open to public scrutiny. This is vital, both to minimise avoidable participant harms and to maintain public trust."
Dr Ben Goldacre from the University of Oxford, said, "Transparency for clinical trials is now firmly on the agenda with campaigns such as AllTrials. But transparency requires more than trial results. We can only be confident that patients' interests are being protected if all consent forms and ethics deliberations are publicly available."
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Jonathan Mendel et al. Problems with ethical approval and how to fix them: lessons from three trials in rheumatoid arthritis, BMJ (2016). DOI: 10.1136/bmj.i4626