Draft Care and Support Bill - Joint Committee on the Draft Care and Support Bill Contents

9  Health Research Authority


318.  The same powers that the Secretary of State used[252] to set up Health Education England had already been used on 22 September 2011 to set up the Health Research Authority (HRA) as a Special Health Authority.[253] Chapter 2 of Part 2 of the draft Bill will now formally constitute HRA as a non-departmental public body with its constitution and functions set out in statute, as Chapter 1 of Part 2 did for the HEE. This, the minister said, would ensure that it was independent of Government.[254]

319.  On behalf of the Wellcome Trust, one of the main global funders of medical research, Nicola Perrin, the Head of Policy, told us: "We have been very pleased to see the work it has done to establish itself. … it really has made an enormous difference as a research funder that they have come to us, engaged the research community and all their other stakeholders to ensure confidence and trust in what they are doing. We therefore welcome the alignment of responsibilities in the Bill; we think it is important that the HRA be established as an NDPB, which will give it both independence and stability to continue to do what it is doing already."[255] We agree; we too welcome the establishment of the HRA.

320.  The main functions of the HRA are set out in clause 67 as the co-ordination and standardisation of practice relating to the regulation of health and social care research; functions relating to research ethics committees; and functions relating to approvals for processing confidential information relating to patients. Russell Hamilton, the Director of Research and Development at the Department of Health, explained that it would have two parts to its objective: "The first will be to protect participants and potential participants in research, and it will do that mainly through its oversight of the research ethics committee system. Equally important is the second part of its objective, which is to promote the interests of those participating in research, particularly by facilitating the high quality of research."[256]

Promotion and coordination of research

321.  Among the functions of the current Special Health Authority are "such functions in connection with the facilitation and promotion of research … as the Secretary of State may direct".[257] Since it is the intention that the HRA should take on the functions of the Special Health Authority,[258] we would have expected to find the promotion of health and social care research listed in clause 67 as one of the primary functions and objectives of the HRA. The quality of such research in the United Kingdom is second to none, but if it is to thrive, it needs all the support it can get from the Government and from NDPBs. The protection of participants and of the general public are certainly very important, but there is no single body with the primary responsibility for promoting health and social care research, and it seems to us that the HRA would be well placed to carry out this task. Clause 67(2) should be amended to make the facilitation and promotion of health and social care research the first of the main objectives of the HRA.

322.  Clause 68 requires the HRA, the Secretary of State and seven other bodies to "cooperate with each other in the exercise of their respective functions relating to health or social care research with a view to coordinating and standardising practice relating to the regulation of such research". It seemed to us that there was considerable overlap between the responsibilities of some of these bodies. The field of embryo research is an obvious example. We asked officials from the Department of Health whether health research, which is defined by clause 67(3) as "research into matters relating to people's physical or mental health", included embryo research. They replied that this would be covered if it related to people's physical or mental health, but that it would continue to be strictly controlled by the HFEA, which required embryo research proposals to be approved by a research ethics committee before a licence would be issued.[259] We recommend in the following chapter that the HFEA should remain in being with its functions unaltered. It seems to us that the coordination of research will be easier if a single body has the responsibility for taking the lead, and that the HRA would be well placed for this. Where aspects of health and social care research are the responsibility of bodies other than the HRA, the duty of the HRA should include the coordination of that research with the research for which the HRA has responsibility.

323.  The Government should consider giving the HRA primary responsibility for coordinating and standardising the regulatory practice of all health and social care research carried out by the persons and bodies listed in clause 68(1) and by any others with similar responsibilities.

Research relating to social care

324.  Despite its title, the HRA is as much responsible for the coordination and standardisation of practice relating to social care research as relating to health research. Nearly all that we read and heard about the HRA related to its health research functions, and we asked Dr Wisely, the Chief Executive, why the providers of social care were not in the list in clause 68(1) of the groups of people who are required to co-operate with HRA "in the exercise of their respective functions relating to health or social care research …". Her reply was that "if a study sits across the NHS and social care it will go to one of our Ethics Committees. There is a social care REC that looks at total social care studies that we are not responsible for."[260] Two bodies on this list appear to have responsibilities for social care research: the Health and Social Care Information Centre which, as its name implies, is in the business of providing information rather than advising on the regulation of research, and the Care Quality Commission, whose remit extends to regulation and improvement. It seems to us that the list of persons and bodies in clause 68(1) should specifically include the Social Care Research Ethics Committee.

Consent for consent

325.  One of the most intractable problems facing researchers who want to involve patients in clinical trials is the so­called consent for consent issue. As Nicola Perrin told us, "this is where in order to identify which patients are eligible to take part in a trial you may need access to identifiable information if you need to know their date of birth, post code, etc. Researchers do not have a legal basis on which to access that identifiable information, so you end up with a situation where either the clinical team has to identify the eligible participants—they do not have time; they understandably have a lot of other priorities—or alternatively to write to each person in the general practice and ask them if they would consent to their identifiable information being accessed by researchers. They would then be approached again if they were eligible for the trial to invite them to consent to take part."[261]

326.  The view of Sir John Tooke was that "patients by and large hugely benefit from involvement in clinical trials, whether they are in the active arm or not. … my experience in establishing registers of thousands of patients with diabetes, … is that I can count on the fingers of one hand the times patients, when adequately explained the purpose and controls, would not commit to that."[262]

327.  The HRA might well have a part to play in any solution to this problem. It has not however been suggested to us how these delicate issues of patient confidentiality might be resolved, nor whether this draft Bill would be an appropriate legislative vehicle. We understand that this an issue that the Caldicott Review[263] is looking at, and we think it preferable to leave this to them, in the hope that an early solution will be found in time for any necessary legislative amendment to be included in the Bill.


328.  Much of the most valuable health research of course involves patients, and the problem has always been to ensure transparency in this research, and full publication of the results, while still adequately preserving patient confidentiality. Much of the evidence we received on this part of the draft Bill related to this, and some of it suggested that this draft Bill provides an opportunity for the HRA to be given responsibility for this issue, with the specific objective of ensuring the fullest possible publication of research results.

329.  The Academy of Medical Sciences was one of those who thought that the HRA's new responsibilities for patient data and its links with associated stakeholders would assist it in contributing to the wider debate around transparency in the publication of research results. "We welcome the fact that the HRA has already announced plans to take steps to follow up the commitments that researchers make to research ethics committees relating to the publication of summary trial data. We are supportive of mechanisms to make clinical trial data available to inform research for the benefit of patients. This is subject to appropriate safeguards of confidentiality of participants (many mechanisms already exist to ensure this) and of course assuming that the research is scientifically sound. There are a number of issues around the publication of clinical trial data that need to be considered. These include the development of mechanisms to enable the release of data in a form that is both accessible and useful and avoids being misleading. We hope that the HRA will contribute to the debate about how these mechanisms should be developed."

330.  In their written evidence the Wellcome Trust said: "On the issue of transparency, we consider that transparency in the publication of research results is a vital part of the research pathway." Somewhat to our surprise, they continued "… we do not envisage an immediate role for the HRA with regard to research transparency …". However in her oral evidence Nicola Perrin told us: "We would add that although we certainly agree that transparency in research results is completely essential and we do see it as an intrinsic part of the HRA's role, our only concern would be that putting it on the face of the Bill should not be seen as the only solution. We cannot put it in the legislation and tick the box that transparency is now sorted because there are so many other stakeholders involved."[264]

331.  We asked the Department of Health for a written statement of the Government's views. They sent us a note which said: "The Government is committed to transparency in the area of clinical trial data. From later this year, greater transparency and disclosure of trial results will be achieved by the work being carried out by the European Medicines Agency to make the summary results of interventional trials of medicinal products (other than phase 1 trials involving adults) in the European Union clinical trials register publicly available. There is also a strong focus on transparency in the proposed EU Clinical Trials Regulation being negotiated in the EU. In addition, the Government welcomes work being undertaken by the life sciences industry itself to develop schemes of voluntary publication of clinical trial data such as the initiative recently announced by GlaxoSmithKline (GSK). Issues of patient confidentiality must however be addressed appropriately to protect against the risks of releasing identifiable data. Under the Medicines for Human Use, (Clinical Trials) Regulations 2004 (Schedule 3, Part 1, paragraph (1)(o)), applications for an ethics committee opinion are required to include details of the arrangements for access to confidential data about the participants and the arrangements to protect their privacy, and any agreement on the policy for publication of the data produced by the trial. Ethics committees therefore consider the plans for both when giving their opinion in relation to clinical trials of medicinal products."

332.  Subsequently we put the question of transparency to the Minister, Dr Poulter. He did not agree in terms that there should be a duty to promote research transparency on the face of the draft Bill; he drew attention, as the Department had in its written evidence, to the voluntary participation of GlaxoSmithKline in the AllTrials campaign, and was concerned that a statutory duty of transparency might cause the big international pharmaceutical companies to take their research work overseas.[265] We believe these fears are unjustified, and that better cooperation with the Medicines and Healthcare Products Regulatory Agency (MHRA), the European Medicines Agency (EMEA) and the US Food and Drug Agency (FDA), would help ensure similar approaches to transparency.

333.  The view of the HRA itself was given by Dr Janet Wisley, its Chief Executive: "Currently applicants are asked when they apply to the Ethics Committee about their intention to register, publish, disseminate the findings of the research, make data available, make tissue available and how they would tell participants about the outcomes of the research. What we have not done before now is to look at compliance against those plans. …. From April we are going to start a simple check through the final report that we receive … to see whether or not people have published, made the data and the tissue available as they said they would to the Ethics Committee."[266] When asked whether it would be helpful to have an obligation to promote transparency in research on the face of the Bill, she replied: "My personal view is that it is absolutely fundamental to protecting the patients and the public in health research. I see it as a very important part of our role, so therefore if we can give more confidence to people that it is mentioned specifically then we would support that."[267]

334.  We continue to have concerns that, too often, researchers may be selective in the results they publish, giving more publicity to favourable results than to negative ones; that they publish summary results rather than full results; and that they use patient confidentiality as an excuse for any lack of transparency. We believe that the HRA and RECs have an important part to play in dealing with this situation.

335.  Clause 67(2) of the draft Bill must be amended so that promoting transparency in research and ensuring full publication of the results of research, consistently with preservation of patient confidentiality, becomes a statutory objective of the HRA.

336.  In its guidance to Research Ethics Committees, the HRA must place on them an obligation to include provisions on the publication of research when granting approval for the conduct of research, and an obligation to ensure that such provisions are complied with.

252   Section 28 of the National Health Service Act 2006. Back

253   The Health Research Authority (Establishment and Constitution) Order 2011, SI 2011/2323, which entered into force on 1 December 2011. See also the Healh Research Authority Regulations 2011, SI 2011/2341. Back

254   Dr Daniel Poulter MP, Parliamentary Under-Secretary of State, Department of Health, Q 353. Back

255   Q 284. Back

256   Q 29. Back

257   The Health Research Authority (Establishment and Constitution) Order 2011, SI 2011/2323, Article 3(1). Back

258   Clause 66, and the notes to it. Back

259   Supplementary written evidence of 15 February 2013. Back

260   Q 304. Back

261   Q 293. Back

262   Ibid. Back

263   Review by Dame Fiona Caldicott of the balance between protecting patients' confidential information against the need for sharing it to improve patient care.  Back

264   Q 291. Back

265   QQ 353-354. Back

266   Q 290. Back

267   Q 291. Back

previous page contents next page

© Parliamentary copyright 2013
Prepared 19 March 2013