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Consent for simple trials: consultation

Last updated on 19 Jun 2017

This HRA consultation has closed and is displayed for reference only.

In October 2014 the HRA sought comments on proposed guidance on seeking consent in a proportionate manner from patients to take part in large-scale simple and efficient research trials within the NHS.

Decisions taken by healthcare professionals regarding the appropriate treatment for a patient are sometimes taken in the absence of sufficient evidence as to which of the available treatments is the most effective. There is growing concern that failure to address these uncertainties could have resulted in, and could continue to allow doctors to prescribe treatments without clear evidence on comparative efficacy and lead to wasted NHS resources. Furthermore, not informing patients that treatments are being offered without convincing evidence potentially could undermine their trust in the NHS.

It is therefore important to systematically evaluate the suitability of some medicines and treatments in order to better inform evidence-based prescribing within the NHS. This is in line with the Secretary of State for Health’s statutory duty to promote “(a) research on matters relevant to the health service, and (b) the use in the health service of evidence obtained from research”.

In order to effectively evaluate the large number of treatments available on the NHS to find out which of them is best for a specific condition, it has been proposed that simple, large scale, real-world trials should be conducted. These could involve using the records of significant numbers of patients, without affecting their care or treatment.  These large scale, pragmatic trials can take place now, but the procedures involved in relation to consent and information giving do not differentiate between high-risk studies of novel compounds and these low-risk studies of commonly used treatments.  This can lead to poor recruitment in some studies

Given that the amount of clinical information which is already known about already commonly used treatments, it might be possible to apply a simplified consent process to such pragmatic studies on the basis of lower risk.

The consultation

In order to inform the development of HRA guidance representing an agreed ethical framework for seeking consent in such trials that is proportionate to the low risks involved, a call for comments opened on Monday 6 October, with a deadline of 5pm on 28 November 2014.

The report covers:

  • the background to the report
  • a summary of responses to the report
  • specific responses by question
  • the next steps

The responses, in conjunction with feedback obtained from parallel public dialogue workshops, will inform the development of future HRA guidance concerning  seeking consent in a proportionate manner, not just in simple and efficient trials, but also other types of research.

This project was part of our work to develop a new policy framework for research in the NHS. 

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