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New guidance being developed following public dialogue on health research

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Following the public dialogue project carried out with Sciencewise support at the end of 2014, the Health Research Authority (HRA) has been revising their Policy Framework for Health and Social Care Research prior to a formal consultation, following an informal call for comments earlier in the year. In addition the HRA has recently been developing guidance on two specific issues based on the input of the public and patient participants at the public dialogue:

•       The first set of guidance focuses on proportionate consent for simple pragmatic clinical trials. The HRA will be putting out their revised guidance on proportionate consent to formal consultation early next year. It is expected that the guidance will be finalised and launched in spring 2016.

Prior to the formal consultation process, and in order to raise the profile of this issue among key stakeholders, the HRA is holding an event on 3rd December 2015 at Oxford Town Hall. Speakers will include Ben Goldacre, Iain Chalmers and Tjeerd van Staa (who all contributed to the dialogue). The HRA will be presenting the dialogue results at this event.

•        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 The HRA has been developing draft guidance but this is currently on hold pending the completion of a Government review of consent led by Dame Fiona Caldicott. The findings of the review may impact on the drafting of the guidance, which will therefore be completed following the publication of the review report.

The HRA dialogue report was published in June 2015 (see www.sciencewise-erc.org.uk/cms/assets/Uploads/HRA-IRPHR-Dialogue-Report-Final-June-24-3.pdf); the evaluation report is expected to be published soon.

See related project page: HRA health research policy public dialogue