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HRA dialogue project leads to potential changes to consent for health research

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The final report of the Sciencewise-supported public dialogue by the Health Research Authority (HRA) on identifying and recruiting participants for health research was published on 21 July 2015.

The HRA announced the publication of the report stressing that the report had already had the following impacts:

"The findings have been used to inform the development of the HRA’s new UK wide Policy Framework which is replacing the Research Governance Framework and its associated operational guidance including:
•  specific guidance on the recruitment of participants
•  guidelines on simplified consent in large pragmatic trials in primary care."

On 22 July 2015, Simon Denegri, the Chair of the Oversight Group, posted a blog on the report in which he stresses the important role of the dialogue in simplifying the ways in which people get involved in health research. Part of the dialogue was designed to explore different ways that people could register their willingness to take part in research, and part was focused on how to simplify the consent process in clinical trials.

Simon Denegri says that this was the second public dialogue by the HRA supported by Sciencewise and goes on to say:

"This is a purely personal view but there seems to be a signal in this work that the public are open to a more flexible, proportionate and common-sense approach to consent in medical research. This is very important. My own direct experience of working on the 100k Genome Project and talking to patients is that what we institutionally define as necessary to ensure informed consent can have the reverse effect: obfuscation and misinterpretation. We are certainly not helping them and their families, and we are not helping ourselves by sticking rigidly to out-of-date practices.

I am very pleased that the exercise provides us with some evidence that the public have an appetite for seeing research nurses take on a bigger role in recruiting people to take part in research ... I think we are seeing a slow march towards a simplified consent model and, hopefully one day, dynamic or personalised consent."

On 21st July, the HRA also announced the report of their latest Year in Review for 2014/2015 in which the very first highlight is "Listening to patients and the public – read about our work with patients and the public to lead on the new UK wide policy framework to replace the Research Governance Framework and watch workshop videos on proportionate consent in large pragmatic trials".

This point relates directly to the Sciencewise-supported public dialogue above. The report itself features three of the participants in the public dialogues on the front cover. It also includes descriptions of the dialogue from these three participants over three pages, including the following comment from one public participant in the workshops:

"There were around 60 of us at the meeting with a good mix of attitudes and knowledge. ... What made exploring the issues useful was that we had complete transparency on the process - gaining that level of knowledge meant we could give feedback on how things should operate. The meeting I attended was completely open and frank about what happens - the benefit of that is that it enables debate that is honest and based on real life interactions."

This section of the report also shows that the project was supported and co-funded by Sciencewise, and provides a link to the Sciencewise website.

See related project page: HRA Patient and Public Views