The Health Research Authority - the planned new single regulator of health research across the UK – came into a being as a special health authority on Thursday. It had its first board meeting and has published a plan of action for its initial four months of operation. The Lords are also set to discuss what the fully established new authority will eventually look like and how it will effectively act to streamline the regulation of research in the UK on Monday afternoon.
The Academy of Medical Sciences recommended in their review of the regulation and governance of health research in the UK which was published in January 2011 that a single regulator of health research be set up, to streamline regulation and make the process more straightforward and easier to navigate.
In the Plan for Growth which published alongside the 2011 budget in March, the government committed to establishing a Health Research Authority to act as this single regulator and to take a number of other steps to streamline the regulatory process.
They planned to establish the Health Research Authority as a special health authority in the first instance, bringing in primary legislation to establish it as proper non-departmental public body with authority across the UK in time. To do this, they introduced a statutory instrument which would set up the Health Research Authority on 1 December. This was discussed in the House of Lords in November but was not opposed and so the Health Research Authority came into existence on 1 December 2011.
What is it’s plan of action?
This lays out how the HRA is going to get up and running. This is how it will work within it’s current remit as a new home for the National Research Ethics Service (NRES)- it doesn’t plan for how it is going to take on further regulatory powers the government is planning to transfer to it in time – such as the regulation of patient data, the research regulatating functions of the hfea etc. – although it does say it will work closely with the department of health as this is taken forward.
This plan lays out its purpose
The purpose of the HRA is to protect and promote the interests of patients and the public in health research.
And outlines the details of how it will be managed and governed. It goes on to explain which functions it is taking over an how it will take them forward (the integrated research administration system (IRAS), the national research ethics service (NRES)) and list the organisations it will collaborate with.
This plan does include an undertaking to develop a comprehensive plan to effectively involve patients and the public in the HRA’s work:
3.3 Patient and public involvement
The HRA will develop and implement a comprehensive plan for effective patient and public involvement. The HRA and DH have approached INVOLVE and the Association of Research Medical Charities (ARMC) for advice and support in developing this strategy and early discussions have taken place. The HRA will confirm plans for effective patient and public involvement before April 2012.
AMRC and INVOLVE originally fed into the Academy’s review which recommended the HRA be established having held a workshop asking what patients thought about the regulation and governance of research exploring how they feel about their data being used for research, how they want to be involved in research when they are being treated by the NHS etc – charities with their strong links with patients are natural partners in helping the HRA to do this well.
The House of Lords are currently scrutinising the Health & Social Care Bill clause by clause. The Health Research Authority is not part of this bill but peers have tabled a new clause proposing that it should be to give them an opportunity to question some of the government’s plans for the authority’s remit and how they expect it to operate. They are particular interested to know more about:
- exactly which regulatory responsibilities will the HRA take on – what power will it have over streamlining the process of multiple trusts each giving permission for a research proposal to go ahead (currently an area where a lot of delays creep in) Will it take over the research regulation function of the Human Tissue Authority and Human Fertilisation and Embryology Authority? Will it take over the regulation of the use of patient data for research?
- When it will be established as a proper non-departmental public body in primary legislation? Until this happens, the authority will not have jurisdiction across the whole of the UK. Earl Howe has indicated that legislative proposals will be published for pre-legislative scrutiny in the next session of parliament with the intention to introduce a bill to establish the NDPB properly later in the session.
There’s more detail of some of the questions the Lords have in my summary of the discussion of the statutory instrument a few weeks ago. This is likely to come up for discussion next Monday, 5 December.
In the meantime, the Health Research Authority had it’s first board meeting on Thursday and is getting up and running.