HRA implements plans to make trial registration an ethical requirement | All Trials
abernard102@gmail.com 2013-09-14
Summary:
"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.'"