Academy proposes a new way to regulate medical research in the UK

Posted on January 11, 2011 by

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Over the past year, the Academy of Medical Sciences has been reviewing the regulation and governance of medical research in the UK at the request of the government. Today they are reporting on what they’ve found, proposing a new, simplified and streamlined system of regulation which would make it easier and more attractive to do health research in the UK. Their recommendations include a single Health Research Agency to deal with all aspects of regulating research in one place and initiatives to put research right at the heart of the NHS. The government has stated that they intend to make changes to the regulation of medical research in the UK, these recommendations will inform how they now start to do this.

Background

In March 2010, aware of concerns that the complex and bureaucratic regulatory environment is stifling health research in the UK, the government announced a review of the regulation and governance of medical research in the UK with a view to making recommendations to improve this. Professor Sir Mike Rawlins agreed to lead the review which would be undertaken by the Academy of Medical Sciences. In July 2010, the coalition government published a health white paper and alongside this a review of all the arm’s length bodies associated with the NHS which included proposals to change the way medical research is regulated in the UK (see previous post here). The government announced that the detail of how they will do this will be guided by the recommendations this review makes.

What has happened now?

The review A new pathway for the regulation and governance of health research has been published. You can download all the documents here. The Academy’s press release gives a nice quick summary of where this report fits and what it covers.

What does the report say?

The report itself is very detailed, going into all the ins and outs of exactly how the regulation of research operates in the UK at the moment, identifying what does and doesn’t work. But it comes to some very clear conclusions and recommendations. These are all summarised very succinctly on page 2-6. Plus on page 6 there’s a great guide to where you can find what in the rest of the report.

The report kicks off by exploring what principles should underpin how we go about regulating medical research in the UK. It identifies four:

1 Safeguard the wellbeing of research participants

2 Facilitate high-quality health research to the public benefit

3 Be proportionate, efficient and coordinated

4 maintain and build confidence in the conduct and value of health research through independence, transparency, accountability and consistency

(see chapter 2 for detail on the thinking behind these)

The report identifies the key problems with the current regulatory system that are slowing things down:

  • Delays and duplication in obtaining research permissions from NHS Trusts
  • Complexity and inconsistency across the regulatory pathway
  • A lack of proportionality in the regulation of clinical trials
  • Inappropriate constraints on access to patient data
  • A healthcare culture that fails to full support the value and benefits of health research

And then it makes a series of recommendations which together make up a detailed vision of a new regulatory and governance pathway:

You can read a summary of how this pathway will look – complete with a great diagram summarising how research would move through it – and all 17 recommendations together in chapter 10, but the key themes are:

Putting research at the core of the NHS. There are a number of recommendations aimed at embedding a culture that values research within the NHS. These include working with medical research charities and AMRC to inform people about the role and benefits of health research alongside lots of incentives and levers to encourage those working in the NHS to recognise and promote research. (chapter 3 goes into the detail around this)

Creating a new Health Research Agency. An arm’s length body which will oversee the regulation and governance of health research, effectively becoming a one-stop shop for health research regulation. It will do this by acting as a national research governance service able to conduct all NHS research governance checks just once to cut out all the unnecessary duplication and inconsistencies that occur at the moment across different NHS trusts. (more on how this would work in chapter 4) And it will bring together all the functions of multiple research regulators to act as a single system for approvals; the National Research Ethics Service will be part of it (see chapter 8). Some research regulation is devolved; the proposed new Health Research Agency will aim to work alongside these systems so they can interact seamlessly. There are some recommendations for changes to the regulation of human tissue; recommending that, for proportionality, plasma, serum, urine, faeces and saliva should no longer come under the Human Tissue Act (see chapter 7 for detail).

Changing the regulation of clinical trials. Work to ensure the European Clinical Trials Directive – which is recognised as having negative impacts across Europe and is currently under review by the EU commission – is revised to improve and simplify the situation in the UK. And, as this will take a while, immediately for the MHRA (which regulates clinical trials of medicines) to put in place some changes which should improve the process of regulation of clinical trials. Eventually the MHRA should work closely with the new Health Research Agency. (More detail on all this in chapter 5)

Putting in place mechanisms that will make it possible for patient data to be used for medical research. Progress on improving the use of patient data for medical research has been slow. The report urges the government to implement the recommendations made in the 2008 Data Sharing review. The legislative framework around the use of patient data is very complex. The UK Data Protection Act is already under review and Europe is planning to review the EU Data Directive; the report recommends this is a good opportunity to clarify some of the legislation in this area. The review also recommends that work should go forward to develop a system allowing researchers to work with healthcare providers to identify potential patients to be contacted about research studies in which they might wish to participate (an opportunity enshrined in the NHS Constitution, the handbook accompanying this says: “The NHS will do all it can to ensure that patients, from every part of England, are made aware of research that is of particular relevance to them. The NHS is therefore putting in place procedures to ensure that patients are notified of opportunities to join in relevant ethically approved research and will be free to choose whether they wish to do so”) (all the detail is in chapter 6)

What next?

Now these recommendations have been made to government, they will be in a position to start finalising the detail of their plans to change the regulation and governance of medical research. We are expecting a health and social care bill to be published shortly which will put in place a lot of the changes proposed in the government’s health white paper, however these changes to regulation are not expected to be included in this bill; the government mentioned in its response to the consultations on their health white paper that these changes would be dealt with elsewhere. (see previous post here)

Mike Rawlins in his comments accompanying the report launch has suggested that work get under way to put these recommendations into action as soon as possible, even before legislation is in place:

It is vital that the HRA is established as soon as possible. To achieve its goals it will have to be a genuine single regulator and not a mere façade hiding the continuation of many separate existing bodies. We recommend that it is established as soon as possible to start making necessary changes to start making necessary changes right away and then confirmed in primary legislation in due course.

What is AMRC doing?

AMRC and our members have been involved throughout the review process, feeding in information, evidence and working with INVOLVE to explore patients’ views on medical research and how it should be governed and regulated.

Simon Denegri, AMRC Chief Executive, has welcomed the report:

The Academy’s report does not only chart a way forward for improving the current regulatory system for conducting clinical trials.  Its recommendations also presents us with an opportunity to make health research a truly public endeavour with the full engagement of the NHS, its staff and, above all, patients.  It is the active support of patients which is central to the successful conduct of health research and we are pleased that the Academy has listened to their views during the course of its review. AMRC and its 125 member charities welcome the report and urge the Government to move swiftly to take forward its proposals.

And reflected in a lot more detail on the content of the report, its reception and what it means for medical research charities and the people they support as the government takes this forward on his blog here.

There is lots of coverage today. For more detail check out BBC Online and Nature.

Also, the Guardian have a big feature on the Human Fertilisation and Embryology Authority, one of the arm’s length bodies proposed to become part of the new single research regulator.

UPDATE: also, check out my guest blog on the Society of Biology’s fab blogspot

Posted in: Policy