The public might just be on the verge of getting the sort of health research regulator they need and deserve.
Yesterday the Health Research Authority (HRA) published its plans for promoting transparency around publication of health research findings. Of particular note from a public and patient perspective is its proposal to:
‘set standards and issue guidance for how those that have participated in research are appropriately informed of individual outcomes and study results at the end.’
The HRAs move follows months of debate on the issue of transparency. A House of Commons Science and Technology Select Committee appearance beckons for them tomorrow morning (as it does me). Its plan marks the end of the beginning in the campaign for greater openness spearheaded by AllTrials. It is important that we support HRA as it tackles the implementation of its recommendations.
I hope people will take time to study Appendix 6 of the document released by HRA yesterday. This contains a summary of the public dialogue exercise it has carried out over the last few months. It shows that the public and patients care about publication of research findings. In fact, they care a lot. As one participant is quoted as saying:
‘Research should all be published: because that would be the right ethical thing to do.’
And they have a great deal to say on how best to report the results of research studies to participants in an accessible and sensitive manner.
Yesterday I met a colleague who was telling me how the European Medicines Agency (EMA) has completely fouled up its own process for dealing with the transparency issue. You may recall that it set up six working groups to look at different issues and made an ‘open call’ for group members. But, as I understand it, EMA put so many parameters on who the groups’ ‘public’ members should be, that it defeated the purpose of having them. What with this and the recent European Court judgement in favour of two pharma companies; one can only muse on the irony that the forces of opaqueness should find new friends in those places they have roundly criticised for many years for holding back progress.
Anyway, three cheers for the HRA. At last a regulator that doesn’t mumble or bumble but is clear about the future.
Simon Denegri's Lay Review 
Yes it’s the interpretation of ‘appropriately’ that needs care. Patients tell me all the time they want to be routinely informed, not have to do anything extra to ‘request the information’ – yet last week a researcher told me that had been their intention and they had to change it to ‘on request’ to get ethical approval.
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