UK trial rules tightened up
pharmafile | September 11, 2013 | News story | Research and Development, Sales and Marketing | all trials, hra, transparency
Anyone wanting to conduct clinical trials in the UK will have to register their research in order to receive a ‘favourable ethical opinion’ before they can begin, according to new rules to be introduced at the end of the month.
The Health Research Authority (HRA), whose remit is to protect and promote the interests of patients and the public in health research, is bringing in the plan from 30 September to ensure that UK trials are put onto a public database.
It means that from next month all studies should be registered before the first patient is recruited: if this is not done within six weeks of that first recruitment, the sponsor and investigator will fall foul of the new rules.
This new breach of good research practice will be added to the list of those managed by Research Ethics Committees in the trial process.
The HRA is to consult with the medical devices sector with a view to imposing similar restrictions on it by March next year.
“We are fully committed to the principles of transparency in health research,” said HRA chief executive Janet Wisely. “Including a requirement for registration as a condition of the favourable ethical opinion is a significant step towards this.”
It will be possible for those setting up trials to query the need for registration but the HRA, created in December 2011 as a Special Health Authority, warns that it “does not…expect exceptions to be made”.
The new ruling forms an interesting part of pharma’s current transparency debate – not least because it does not only cover future research: the HRA says it “expects current and previous studies to be registered and results to be put in the public domain”.
The HRA took on the activities of the National Research Ethics Service, thus bringing together services previously provided by the National Patient Safety Agency and some functions of the Strategic Health Authorities.
Adam Hill
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