Some answers on the Health Research Authority..

Posted on September 14, 2011 by

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Answers to some questions Lord Willis posed about the government’s plans for the new Health Research Authority today.. They confirm the governments plans to establish the authority initially as a special health authority, but don’t give any more clues as to the timing of this other than it will be this year… so we can expect a statutory instrument to set it up soon.

They also confirm that no primary legislation will be necessary to undertake the activity they’ve announced to streamline processes in NHS foundation trusts – so these activities will get going without having to wait for primary legislation.

Interestingly, it’s not clear that this streamlining of NHS foundation trust approval and compliance processes will be led by the authority at all. The single health regulator envisioned by the academy of medical sciences would have led this work, but the distinction in this answer suggests that the government’s plan may not involve the authority leading on this.

Health: Medical Research

Questions

Asked by Lord Willis of Knaresborough

To ask Her Majesty’s Government what plans they have to streamline the compliance and approval processes for medical and health research; and when they intend to publish their proposals.[HL11730]

To ask Her Majesty’s Government whether primary legislation will be required to streamline the approval and compliance processes for NHS foundation trusts to take part in patient trials for medical and health related research; and, if not, how the Government will impose requirements on independent foundation trusts.[HL11731]

The Parliamentary Under-Secretary of State, Department of Health (Earl Howe): At a national level, the Government will create a health research regulatory agency to combine and streamline the approvals for health research which are at present scattered across many organisations. This will reduce the regulatory burden on research-active businesses, universities and the National Health Service, improve the timeliness of decisions about research projects and hence the cost-effectiveness of their delivery in the United Kingdom. This action has clear support from the Academy of Medical Sciences review of health research regulation and governance. As a first step, the Government will establish this year a special health authority with the National Research Ethics Service as its core. The new agency will work closely with the Medicines and Healthcare products Regulatory Agency to create a unified approval process and promote proportionate standards for compliance and inspection within a consistent national system of research governance.

At a local level, the Government will radically transform the incentives for efficiency in research initiation and delivery. In May, the Government launched through the National Institute of Health Research (NIHR) a framework of good practice and standard procedures called the NIHR Research Support Services to facilitate consistent local research management and greatly improve performance. NHS providers which adopt these standards will stop unnecessary duplication of checks. They will publish metrics regularly on their performance. They will have access to NIHR financial support for these activities. For clinical trials, the NIHR will from 2012 publish outcomes against public NIHR benchmarks, including an initial benchmark of 70 days or less from the time a provider receives a valid research protocol to the time when that provider recruits the first patient for that study. In future, NIHR funding to providers of NHS services will become conditional on meeting benchmarks, including the 70-day benchmark to recruit first patients for trials. The NIHR will make this a condition of new contracts from autumn 2011 and performance will affect funding from 2013.

The Government published their intentions in the Plan for Growth in March 2011, available from HM Treasury. None of them requires legislation expressly for NHS foundation trusts.

Background

The Academy of Medical Sciences reviewed the regulation of health research in the UK and recommended how this could be improved. Their recommendations included establishing a single regulator of health research. In the Plan for Growth published by the government alongside the 2011 budget, the government committed to setting this up as the Health Research Authority (HRA).

They have said that they plan to set this up as a special health authority in the first instance, introducing primary legislation in the next parliamentary session to make it an official independent body.

The Academy’s report also recommended other measures  to make the process of getting permission to do a research project easier, including streamlining the process of getting separate permissions from multiple NHS trusts.

We are currently waiting for the government to introduce a statutory instrument to parliament, which is needed to create a special health authority, and give us more detail on what the Health Research Authority is going to look like and their vision for how it will work.

The Academy’s recommendations to improve the system are widely supported and we’re concerned that the new Health Research Authority can deliver these.