The UK’s Health Research Authority (HRA) is making good on its plans to require pre-registration of clinical trials as a condition of study approval by Research Ethics Committees (RECs).
From 30 September 2013, registration of clinical trials in a publicly accessible database will be a prerequisite for a favourable ethics opinion.
Failure to register will be treated as a breach of good research practice and managed through standard operating procedures for RECs in line with other breaches, the HRA warned.
The Authority, which has signed up to the AllTrials campaign on disseminating clinical-trial data, confirmed in July that it would be insisting on trial registration as part of a broader action plan to promote transparency in research.
These proposals, which the HRA said were backed comprehensively by its health-research partners, drew on discussions at a stakeholder workshop hosted by the Authority the previous month, as well as previous meetings with key stakeholders and evidence from a survey of Research Ethics Committees.
Studies for which registration is mandatory will initially be determined by a filter question in the Integrated Research Application System (IRAS) used for applications to National Health Service Research Ethics Committees since April 2009.
This process will include the first four categories on the 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.
The current question A50-1 in IRAS will continue to apply to all other studies – i.e., asking for study registration plans, which will then be considered by the REC.
For the four categories cited above, mandatory registration means this element will not be reviewed by the Research Ethics Committee.
The HRA expects all relevant studies to be registered before the first patient is recruited. Both the sponsor and investigator will be regarded as breaching good research practice if the study is not registered:
- Within six weeks of the first patient being recruited; or
- For medical device studies, within the timeline determined by the current decision trees for registration and publication.
The HRA will consult with the medical devices industry, with a view to bringing the requirements for devices studies into line with other clinical trials by March 2014.
Opinion letters issued by RECs will be updated from 30 September 2013 to state that, for studies falling into the categories set out above, registration will be a mandatory condition of favourable ethics opinion.
Trial sponsors and investigators are not required to make a separate notification to the REC confirming that a study has been registered, but they are asked to do so “at the earliest opportunity” – for example, when submitting an amendment or a progress report.
The HRA will be put in place “simple” mechanisms to audit compliance with the new requirement and will publish registration rates.
The Authority expects both current and previous studies to be registered, and results from this research to be “put in the public domain”.
The HRA says it recognises other types of studies should be registered but believes that “further consideration is required given the range of studies reviewed in the UK”.
Moreover, the Authority needs to determine “who should make the judgement” for other studies.
The HRA is working on plans to update early next year the applicant and sponsor declaration on new studies, to indicate that previous studies have been registered and published.