11 September 2013
FOR IMMEDIATE RELEASE
The HRA is now implementing its plans for ensuring that UK trials are registered in a publicly accessible database.
The HRA has a commitment to promote transparency in research, and has worked in consultation to develop plans to implement a set of practical and proportionate measures to improve transparency of research in the UK and to improve patient and public confidence in health research. It is now implementing the proposal to make trial registration a condition of the favourable ethical opinion. Janet Wisely, Chief Executive of HRA, commented: “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.”
From 30 September 2013 registration of clinical trials in a publicly accessible database will be a condition of the favourable ethical opinion. Failure to register will therefore be a breach of good research practice and managed through standard operating procedures for RECs (Research Ethics Committees) in line with other breaches.
The studies for which registration is mandated will initially be determined by the IRAS filter question. It will include the first four categories on the Integrated Research Application System (IRAS) filter question number 2, namely:
Clinical trial of an investigational medicinal product
Clinical investigation or other study of a medical device
Combined trial of an investigational medicinal product and an investigational medical device
Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice