New Requirements for Clinical Trials in the UK

24/09/2013

Trial Registration to be a Condition of the Favourable Research Ethics Committee Opinion from 30 September 2013

The UK Health Research Authority (HRA) is now implementing its plans for ensuring that UK trials are registered in a publicly accessible database.

 

From 30 September 2013 registration of clinical trials in a publicly accessible database will be a condition of the favourable ethical opinion.  This applies to England, Northern Ireland and Wales.

Scotland has a different system for registration of clinical trials and is not affected by the new rules.

The UK HRA has developed 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.

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. The current question A50-1 will continue to apply to all other studies, where plans for registration are asked for and the plans considered by the REC. For these four categories, the requirement will become mandatory and not, therefore, reviewed by the REC.

Implementation starts with the expectation by the HRA that all studies are to be registered before the first patient is recruited.

The sponsor and investigator will be in breach of the favourable ethical opinion if the study is not registered:

·       Within 6 weeks of the first patient recruitment or,

·       For medical device studies within the timeline determined by the current registration and publication decision trees.

The HRA will consult with the devices industry with an intention of bringing the requirements for devices studies in line with other clinical trials by March 2014.

Regarding documentation and reporting, the REC opinion letter will be updated from 30 September 2013 to state that for studies falling into the categories above that registration is a mandatory condition of the favourable ethical opinion in line with this guidance. Sponsors and investigators are not required to make a separate notification to the REC confirming the trial has been registered, but they should do so at the earliest opportunity - for example, if submitting an amendment or progress report. The HRA will be putting in place simple mechanisms to audit compliance and will publish registration rates.

For previously approved studies, the HRA expects current and previous studies to be registered and results to be put in the public domain.

The HRA recognises that other studies should be registered but that further consideration is required given the range of studies reviewed in the UK and the HRA needs to determine who should make the judgment for other studies. This will be considered alongside other HRA initiatives including the Ethics Officer pilot and HRA assessment and approval business case development. 

The HRA is putting in place plans to update the applicant and sponsor declaration on new studies, to declare that previous studies have been registered and published. The HRA expects to update the declaration in early 2014 as a further mechanism to ensure research transparency.

Source: NHS HRA Press Release 11 September 2013

Our team at Onorach would be happy to help you comply with the new requirements. If in any doubt or if you are planning a study in the UK, then please get in touch with us at info@onorach.com

Client Testimonial

Onorach adapted quickly to our requirements... ethical approval was dealt with quickly and effectively... with excellent communications maintained throughout. Onorach have been highly effective and I would not hesitate to use their services for future projects.
David Craig, Sales & Marketing Manager. Axis-Shield Diagnostics Ltd