9 Health Research Authority
Background
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.
Transparency
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
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