The Health Research Authority (HRA) is implementing its plan to ensure UK clinical trials are registered in a publicly accessible database. From 30th September registration of the trial within 6 weeks of the first patient being recruited will be a condition of a favourable ethical opinion.
Failure to comply with this requirement will be a breach of good research practice and will be dealt with by research ethics committees in line with other breaches. The HRA developed these plans in response to a public consultation looking at how to improve transparency of research in the UK and to improve patient and public confidence in health research.
Janet Wisely, Chief Executive of HRA said: “We are fully committed to the principles of transparency in health research. Including a requirement for registration as a condition of the favourable ethical opinion is a significant step towards this”.
Tracey Brown, director of Sense About Science and co-founder of the AllTrials campaign: “The HRA has really led the way in its proposals to streamline registration compliance with the ethical approval process that all trials go through. The AllTrials campaign has a way to go. Despite the fact that hidden and unregistered trials are compromising patient care, and, rightly, causing public outrage, change is still being blocked and slowed by bodies who say it’s hard to do, complex and hard to police. Well the HRA’s proposals are clear and effective and give the lie to that. We know that other organisations and regulators around the world are being encouraged by the HRA’s resolute approach to transparency.”