In these uncertain times, a single regulator for research is one of the safer bets you might place.
The UK's Department of Health has signalled its own preference for such a body in its review of Arm's Length Bodies. The Academy of Medical Science is gathering opinions as part of its independent inquiry into medical research regulation. It is perhaps more a question of 'when' and 'how' rather than 'if' such a body will be created.
Many patients represented by the Association of Medical Research Charities (AMRC)'s member charities will welcome the advent of a single regulator if it means research involving them is safe but easier and quicker to accomplish. They will know already the regulatory difficulties that researchers and funders can face in getting work off the ground. They will have helped voice this frustration in parliament and the media.
As for the wider public, I suspect they will be largely ignorant of its work but trusting in its existence. As in other areas - such as animal research - they will view it as an important factor contributing to their view that things are being done in the right way, but not the only one.
My hope is that a single regulator would be adventurous in its outlook as it thinks about this relationship. As custodian of the public's trust it will be well-placed to play a significant if not pivotal role in strengthening the partnership between researchers, patients and the public. But it must set about this task from the very beginning. And it must be integral to the way it talks, breathes and behaves as a body.
Fortunately it has many precedents and models to learn from in the shape of the Human Tissue Authority (HTA), Human Fertilisation and Embryology Authority (HFEA), National Institute for Health and Clinical Excellence (NICE) and others. This week I was sent a workshop report from the UK Biobank Ethics and Governance Council on involving publics in biobank research and governance looking at a range of ideas from citizens' inquiries to citizens' panels. The ideas are out there. The real question is whether it will be brave enough to adopt, adapt and innovate.
As I talk to patients and charities, it is interesting to me that the vast majority are drawing a very strong distinction between the single regulator involving patients and the public in its work, and it having a role in public engagement.
On the former, there is an almost unanimous desire to see mechanisms put in place which involve patients and the public and that are aimed at ensuring good governance, accountability and transparency. Yet they are lukewarm, at best, on the idea that single regulator should venture into the realms of public engagement. Too often have they seen it used as a well-intentioned smokescreen for developing a more business-like relationship with patient groups, patients and the public.
The bottom line is medical research is increasingly a shared endeavour between researchers and patients. If a single regulator can reflect this in the way it works, then we will have reason to trust it.
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