The BRC and UCLH/UCL Joint Research Office asks that all UCLH and UCL researchers make sure they follow Health Research Authority guidance on registering their studies on a publicly-accessible database.
A recent HRA audit found that many investigators and study sponsors were unaware of the requirements, even though failing to register a study is considered a serious breach of Research Ethics Committee requirements.
In 2013, the HRA made it a condition of a trial receiving a ‘favourable opinion’ from an HRA Research Ethics Committee that a trial is registered publicly. Here, ‘trial’ refers to:
- Clinical Trials of an Investigational Medicinal Product (CTIMPs)
- Combined trials of an investigational medicinal product and an investigational medical device
- Clinical investigations or other studies of medical devices
- Other clinical trials to study novel interventions or randomised clinical trials to compare interventions in clinical practice.
Any database on either the World Health Organisation’s list or the International Committee of Medical Journal Editors’ list is acceptable to register on.
For the purposes of commercial sensitivity, registration of Phase 1 trials can be deferred.
The HRA audit (which excluded CTIMP studies as there is a legal requirement for these studies to be registered) found that fewer than 40% of studies are publicly registered. The HRA is expected to produce a strategy for improving this figure.
In the meantime, it will be considering withholding approval for future studies from investigators who do not register studies, as well as referring investigators to their universities.
The House of Commons Science and Technology Committee urged the HRA to take action against investigators who do not register trials on publicly-available databases in its recent report, Research Integrity: Clinical Trials Transparency.
