While we were in parliament talking to parliamentarians about data yesterday, the government published the draft care and support bill. This includes some interesting plans with impacts for health research.
It contains clauses to establish the Health Research Authority (HRA) as a non-departmental public body regulating health research across the UK (at the moment it is operating as a special health authority and only has authority over the health service in England).
It also contains clauses to establish Health Education England. One of the issues we raised during debate of the Health & Social Care Act 2012 last year was the central role of education and training in supporting everyone in the NHS workforce to get involved in research and take up the results of research to improve patient care. We pushed for Health Education England to be established as soon as possible to strategically coordinate all health education and training across England.
And it amends the Public Bodies Act 2011 to allow for the abolition of the Human Tissue Authority and Human Fertilisation and Embryology Authority. There is a consultation open at the moment to decide their future which we will be responding to – all the detail in this blog.
A committee of peers and MPs will discuss the draft bill later this year, suggesting how it might be improved. Ahead of this, we’ll be looking through the draft bill in detail and highlighting what looks good and bad from our perspective.
Which clauses are you talking about?
You can download the bill here.
Chapter 2, clauses 66 -74 and schedule 7 establish the Health Research Authority and its functions as a non-departmental public body.
There is a factsheet explaining what the draft bill plans to do.
We’ll be looking at these clauses in detail with an eye to ensuring:
- Patient and public involvement is built into the system – getting this right is central to public confidence in the regulation of health research
- What powers the HRA has to streamline the regulation of health research. Obtaining all the necessary local NHS R&D permissions is recognised as a big barrier to research projects getting off the ground, but the HRA is not planned to take control of these permissions. Instead a 70-day target has been introduced and NIHR research funding is contingent on it being achieved. We are concerned over how effective this target will be in practice in streamlining R&D permissions, and how this target will be coordinated with the streamlining work of the HRA.
- How the HRA will be able to support and develop a culture of research across the NHS.
- The HRA’s role in regulating access to identifiable patient data for research. Currently the Secretary of State for Health is responsible for approving exceptional research projects which need to access identifiable data without consent. This responsibility is planned to transfer to the HRA by April 2013. Clause 74 of the draft bill addresses this and we are concerned to ensure this regulatory role finds the right balance of protecting patient confidentiality and allowing valuable research to go ahead. The HRA with its central purpose to protect and promote the interests of patients and the public in health research is well placed to lead this. The Caldicott review is currently looking at these issues in detail and we gave evidence to them on Tuesday – more here.
The clauses establishing Health Education England are in Chapter 1, clauses 54 to 65 and Schedule 5.
Health Education England was set up as a special health authority in June. It is just getting up and running and is not planned to properly take on its coordinating role for education and training until April 2013. These draft clauses will establish Health Education England as a non-departmental public body. They also establish how it will work with existing Local Education and Training Boards.
There is a factsheet explaining the plans.
We’ll be looking at this closely to ensure the HEE will take steps to ensure the NHS workforce gets the education and training they need to engage with research. This includes continuing to foster effective partnerships between academia and the NHS to deliver research and innovation, and creating a system that offers greater mobility for individuals to move between academic and clinical practice so that they can take knowledge and research with them to play a role in delivering first class patient care.
What next?
The draft bill will be discussed by a committee of peers and MPs later this year who will suggest how it might be improved. The government is likely aiming to introduce the actual, revised bill in the next session. The current session of parliament will probably finish around May time so we’ll be looking out for this in the next Queen’s speech.
The committee will take evidence so we will be able to feed into their scrutiny of the draft bill, both raising any concerns we have and making suggestions for how it could be improved.
Mark Ryan-Daly
July 12, 2012
Yet again a rather negative view taken towards NHS R&D. I think it is time AMRC recognised the work by NIHR CRN and the CLRNs in streamlining R&D and the NHS permissions process. It has changed greatly since 2007/08 and will continue to improve. However, it will only improve with the positive cooperation of AMRC. Particularly in recognising the changes and that they (and the charities they represent) have a role to play.
While work is being done to improve timelines – a target of 30 days for NHS R&D and the MHRA, the target for ethical review is still at 60 days which seems strange.
Until the Department of Health revise the Research Governance Framework, NHS permissions will lie with the NHS organisations themselves.
beckypurvis
July 16, 2012
Hi Mark,
Again you are absolutely right – there is some great work underway to streamline the process of getting multiple NHS R&D permissions and getting research projects off the ground faster – and some real success. But this is not happening everywhere and everyone needs to be involved in streamlining the process, not just the NHS but the funders – including medical research charities – as well. This is why we are concerned that the 70-day target by itself may not be enough and are seeking reassurance that other steps will be taken alongside this to support everyone involved to speed up the process, and to monitor and evaluate success so we can identify what is working and what we still need to do to get this right.
The Academy of Medical Sciences, whose recommendations led to the creation of the Health Research Authority, suggested that the authority should control the NHS R&D permissions process. There are no plans for the Authority to take over this role, but as a central coordinating body it may be able to play a valuable role in supporting and coordinating all the individuals involved.
It would be great to hear more about the success stories and where you feel there are still problems as you have first-hand experience of all this – perhaps I can tempt you into writing us a guest blog?
Becky