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Dialogue impacts health research regulations on informed consent and access to data

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The final report of the independent evaluation of the public dialogue on Recruiting Participants for Health Research was published in February 2016. The project was commissioned by the Health Research Authority (HRA) and supported by Sciencewise.

The dialogue was designed to inform the HRA as it developed a UK-wide Health Governance Framework to replace the existing separate policy documents in England, Wales, Scotland and Northern Ireland. The single new policy framework is designed to support good practice across the UK and will apply to research that is within the legislative and policy responsibility of any of the four UK Health Departments. The review of the framework coincided with forthcoming changes to the EU Clinical Trials Regulation which allows for greater proportionality to distinguish between high-risk and low-risk research.

The dialogue also focused on how patient data might be used to invite people to join research studies and who participants think should be allowed to access patient records in order to check eligibility.

The dialogue has already had significant impacts on HRA work and future plans:

•       In July 2015, the HRA issued a response report summarising all the feedback they had considered on the draft guidance on ‘Seeking Informed Consent for Simple and Efficient Trials in the NHS’, including the feedback from the the public dialogue workshops, and summarised the resulting HRA plans. The results of the public dialogue, and resulting HRA plans, are specifically covered in the report in relation to the use of information sheets, simplified consent processes, the deemed consent / opt out approach on randomised cluster trials at GP surgeries, and whether verbal consent should be sought and documented in medical notes to access the patient’s medical data for the purpose of research. Future guidance was planned on the use of short information sheets, which were also covered in the dialogue project.

•       In October 2015, the HRA developed guidance on two specific issues based on the input of the public and patient participants at the public dialogue workshops:

-       The first set of guidance focuses on proportionate consent for simple pragmatic clinical trials. The HRA plans to put out their revised guidance on proportionate consent to formal consultation early in 2016, and to finalise and launch the guidance in spring 2016.

Prior to the formal consultation process, the HRA held a major event in December 2015 in Oxford in order to raise the profile of this issue among key stakeholders. The HRA presented the dialogue results at this event, which was also attended by speakers who all contributed to the dialogue.

-       The second set of guidance focuses on how people are identified and recruited to take part in health research, which has implications in terms of access to patient records and shared data. The HRA has been developing draft guidance but this was delayed pending the completion of a wider Government review of consent on access to data; the guidance will therefore be completed following the publication of the report of that wider review.

•       Also in October 2015, the HRA issued a response report summarising all the feedback they had considered on the ‘Draft UK policy framework for health and social care research’ (the new Research Governance Framework). During 2015, the framework was revised, drawing on the dialogue results alongside a wide range of other research and consultation results.

In December 2015, a revised version of the policy framework – ‘UK Policy Framework for Health and Social Care Research’ was issued for public consultation between 18th December 2015 and 24th March 2016. The new framework sets out high level principles of good practice in the management and conduct of health and social care research in the UK, as well as the responsibilities that underpin high-quality ethical research. The new framework aims “to help make the UK an even better place to do research”. It is expected that the new framework will be completed and published in summer 2016.

The dialogue has also impacted on the HRA as an organisation:

•       A new public dialogue project on data sharing. HRA funding has been agreed for future public dialogue on data sharing for secondary research purposes and on the role of the Confidential Advisory Group (CAG) which gives approval on behalf of the Secretary of State for identifiable data to be shared without consent in circumstances where consent cannot be sought.

•       Feature in the HRA Annual Review. The importance of public engagement is reflected in the HRA annual review for 2014/15, which chose as the first highlight of the year "Listening to patients and the public”. The report goes on to describe “our work with patients and the public to lead on the new UK wide policy framework to replace the Research Governance Framework and … on proportionate consent in large pragmatic trials". This is a direct reference to this public dialogue project. The report features three of the participants in the public dialogues on the front cover, and includes descriptions of the dialogue from those three participants over three pages within the report.

•       Senior internal support. The evaluation report quotes the Chief Executive Officer of the HRA, who said:

“Much of the engagement in this field is more ‘tick box’ and we want to enhance patient and public involvement. We have a culture of finding different ways to engage with people - not just patients who have first-hand experience, but also the general public who might in the future.”

The dialogue also impacted researchers and others involved in the dialogue.

•       The evaluation provides evidence of impacts on the 24 specialists who took part in the dialogue workshops. These included a range of leading researchers from primary care, hospital and academic settings, three research nurses, two from the National Institute of Health and Social Care Research and one specialist linked to the Health and Social Care Information Centre; all had an interest in simplified consent, consent to approach models and information governance issues. The independent evaluation report quotes one specialist who “said that the results of the dialogue would validate their work, as the models used in the dialogue were based in their practice; and they hoped that this would then draw other research practitioners to them; to seek use of their approach and materials.”

•       The evaluation also provides evidence that other specialists commented in feedback forms that they had learnt about the “public’s viewpoints and knowledge of access to their records” and “how people new to the subject thought about these questions”, but also that they observed that dialogue “stimulated discussion very effectively.” Others said:

“Thank you - this will help inform our local practices too” Specialist, London

“Feel more able to understand public concerns about record access” Specialist, Liverpool

•       Members of the Oversight Group also confirmed that the dialogue results would be used and would influence their own work and organisations. For example:

“In Wales, we’ll use it [the report] to build on, especially around approaches to consent.”

“It could affect thoughts around the work - especially views on opt in/opt out perspectives.”

See related project page: HRA health research policy public dialogue: health research recruitment, data use and consent