Care Bill [HL]

House of Lords

Session 2013 - 14
Internet Publications
Other Bills before Parliament

Care Bill [HL]

Care Bill [HL]
Part 3 — Health
Chapter 2 — Health Research Authority
96

(a)
to protect participants and potential participants in health or social care
research and the general public by encouraging research that is safe and
ethical, and
(b)
to promote the interests of those participants and potential participants
and the general public by facilitating the conduct of such research.
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(3)
The HRA must promote the co-ordination and standardisation of practice in
the United Kingdom relating to the regulation of health and social care
research; and it must, in doing so, seek to ensure that such regulation is
proportionate.
(4)
The HRA and each devolved authority must co-operate with each other in the
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exercise of their respective functions relating to the regulation of assessments
of the ethics of health and social care research, with a view to co-ordinating and
standardising practice in the United Kingdom relating to such regulation.
(5)
The HRA must—
(a)
keep under review matters relating to the ethics of health or social care
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research and matters relating to the regulation of such research, and
(b)
provide the Secretary of State with such advice about the matters
referred to in paragraph (a) as the Secretary of State requests.
(6)
The HRA must publish guidance on—
(a)
principles of good practice in the management and conduct of health
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and social care research;
(b)
requirements, whether imposed by enactments or otherwise, to which
persons conducting health or social care research are subject.
(7)
A local authority (within the meaning of Part 1), an NHS trust established
under section 25 of the National Health Service Act 2006 and an NHS
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foundation trust must each have regard to guidance under subsection (6).
(8)
The ways in which persons may co-operate with each other under subsection
(1) or (4) include, for example, by sharing information.
(9)
Section 290 of the Health and Social Care Act 2012 (duties for health and social
care authorities to co-operate), so far as applying to a person who is for the time
30
being within subsection (1), does not apply to functions of that person relating
to health or social care research.
(10)
Section 108(5) (exclusion of research into matters within devolved competence)
does not apply to the reference in subsection (1) or (4) to health and social care
research.
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Research ethics committees
110
The HRA’s policy on research ethics committees
(1)
The HRA must ensure that research ethics committees it recognises or
establishes under this Chapter provide an efficient and effective means of
assessing the ethics of health and social care research.
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(2)
A research ethics committee is a group of persons which assesses the ethics of
research involving individuals; and the ways in which health or social care
research might involve individuals include, for example—
(a)
by obtaining information from them;

Care Bill [HL]
Part 3 — Health
Chapter 2 — Health Research Authority
97

(b)
by obtaining bodily tissue or fluid from them;
(c)
by using information, tissue or fluid obtained from them on a previous
occasion;
(d)
by requiring them to undergo a test or other process (including
xenotransplantation).
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(3)
For the purposes of subsection (1), the HRA—
(a)
must publish a document (called “the REC policy document”) which
specifies the requirements which it expects research ethics committees
it recognises or establishes under this Chapter to comply with, and
(b)
must monitor their compliance with those requirements.
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(4)
The HRA may do such other things in relation to research ethics committees it
recognises or establishes under this Chapter as it considers appropriate; it may,
for example—
(a)
co-ordinate their work;
(b)
allocate work to them;
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(c)
develop and maintain training programmes designed to ensure that
their members and staff can carry out their work effectively;
(d)
provide them with advice and help (including help in the form of
financial assistance).
(5)
The requirements in the REC policy document may, for example, relate to—
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(a)
membership;
(b)
proceedings;
(c)
staff;
(d)
accommodation and facilities;
(e)
expenses;
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(f)
objectives and functions;
(g)
accountability;
(h)
procedures for challenging decisions.
(6)
The HRA must ensure that the requirements imposed on research ethics
committees in the REC policy document do not conflict with the requirements
30
imposed on them by the Medicines for Human Use (Clinical Trials)
Regulations 2004 (S.I. 2004/1031).
(7)
Before publishing the REC policy document, the HRA must consult—
(a)
the devolved authorities, and
(b)
such other persons as it considers appropriate.
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(8)
The HRA may revise the REC policy document and, where it does so, it must
publish the document as revised; subsection (7) applies to a revised policy
document in so far as the HRA considers the revisions significant.
(9)
The HRA must indemnify the members of each research ethics committee it
recognises or establishes under this Chapter against any liability to a third
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party for loss, damage or injury arising from the committee’s exercise of its
functions in assessing the ethics of health or social care research.
111
Approval of research
(1)
The HRA must publish guidance about—

Care Bill [HL]
Part 3 — Health
Chapter 2 — Health Research Authority
98

(a)
the cases in which, in its opinion, good practice requires a person
proposing to conduct health or social care research that involves
individuals to obtain the approval of a research ethics committee
recognised or established by the HRA under this Chapter, and
(b)
the cases in which an enactment requires a person proposing to
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conduct research of that kind to obtain that approval.
(2)
Before publishing guidance under subsection (1), the HRA must—
(a)
consult the devolved authorities and such other persons as the HRA
considers appropriate, and
(b)
obtain the approval of the Secretary of State.
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(3)
The HRA may revise guidance under subsection (1) and, where it does so, it
must publish the guidance as revised; subsection (2) applies to revised
guidance in so far as the HRA considers the revisions significant.
(4)
Schedule 8 (which amends various references to research ethics committees in
secondary legislation) has effect.
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112
Recognition by the HRA
(1)
The HRA may, on an application made by or on behalf of a group of persons,
recognise the group as a research ethics committee which is capable of—
(a)
approving research of the kind referred to in section 111(1), and
(b)
giving such other approvals as enactments require.
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(2)
The HRA may not recognise a group under this section unless it is satisfied
that—
(a)
the group will, if recognised, comply with the requirements set out in
the REC policy document, and
(b)
there is or will be a demand for such a group.
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(3)
In deciding whether to recognise a group under this section, the HRA must
have regard to whether the group is recognised as a research ethics committee
by or on behalf of a devolved authority.
(4)
The HRA may do anything (including providing financial assistance) to help a
group wishing to be recognised under this section to reach a position from
30
which it should be able to make an application for recognition under this
section that is likely to succeed.
(5)
The HRA may revoke a recognition under this section if it is satisfied that—
(a)
the group to which the recognition applies is not complying with the
requirements specified in the REC policy document,
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(b)
the group is not (or is not properly) carrying out its function of
assessing the ethical aspects of research, or
(c)
revocation is necessary or desirable for some other reason.
(6)
A group in existence immediately before the commencement of section 107,
and established or recognised by or on behalf of the old Health Research
40
Authority, or by or on behalf of the Secretary of State, as a research ethics
committee which assesses health or social care research is to be regarded as
recognised by the HRA under this section.

Care Bill [HL]
Part 3 — Health
Chapter 2 — Health Research Authority
99

(7)
The reference in subsection (6) to the old Health Research Authority is a
reference to the Special Health Authority called the Health Research Authority
(and abolished by section 107).
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Establishment by the HRA
(1)
The HRA may establish research ethics committees which have the following
5
functions—
(a)
approving research of the kind referred to in section 111(1);
(b)
giving such other approvals as enactments require.
(2)
The HRA must ensure that a research ethics committee established under this
section complies with the requirements set out in the REC policy document.
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(3)
The HRA may abolish a research ethics committee established under this
section.
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Membership of the United Kingdom Ethics Committee Authority
In regulation 5 of the Medicines for Human Use (Clinical Trials) Regulations
2004 (S.I. 2004/1031) (United Kingdom Ethics Committee Authority)—
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(a)
in paragraphs (1), (2) and (3), for “the Secretary of State for Health”, in
each place it appears, substitute “the Health Research Authority”, and
(b)
in paragraph (2), for “the Secretary of State” substitute “the Health
Research Authority”.
Patient information
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115
Approval for processing confidential patient information
(1)
The Health Service (Control of Patient Information) Regulations 2002 (S.I.
2002/1438) are amended as follows.
(2)
In regulation 5 (the title to which becomes “Approval for processing
information”)—
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(a)
the existing text becomes paragraph (1), and
(b)
in sub-paragraph (a) of that paragraph, for “both the Secretary of State
and a research ethics committee” substitute “the Health Research
Authority”.
(3)
After paragraph (1) of that regulation insert—
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“(2)
The Health Research Authority may not give an approval under
paragraph (1)(a) unless a research ethics committee has approved the
medical research concerned.”
(4)
After paragraph (2) of that regulation insert—
“(3)
The Health Research Authority shall put in place and operate a system
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for reviewing decisions it makes under paragraph (1)(a).”
(5)
In regulation 6 (registration requirements in relation to information), in
paragraph (1)—
(a)
before “the Secretary of State” insert “the Health Research Authority
or”, and
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Care Bill [HL]
Part 3 — Health
Chapter 3 — Chapters 1 and 2: supplementary
100

(b)
before “he” insert “it or”.
(6)
In paragraph (2)(d) of that regulation, before “the Secretary of State” insert “the
Health Research Authority or (as the case may be)”.
(7)
In paragraph (3) of that regulation, for the words from the beginning to “in the
register” substitute “The Health Research Authority shall retain the particulars
5
of each entry it records in the register, and the Secretary of State shall retain the
particulars of each entry he records in the register,”.
(8)
For paragraph (4) of that regulation substitute—
“(4)
The Health Research Authority shall, in such manner and to such
extent as it considers appropriate, publish entries it records in the
10
register; and the Secretary of State shall, in such manner and to such
extent as he considers appropriate, publish entries he records in the
register.”
Chapter 3
Chapters 1 and 2: supplementary
15
Miscellaneous
116
Transfer orders
(1)
An order under section 94 (establishment of Health Education England) or
section 107 (establishment of the Health Research Authority) (a “transfer
order”) may make provision for rights and liabilities relating to an individual’s
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contract of employment.
(2)
A transfer order may, in particular, make provision the same as or similar to
provision in the Transfer of Undertakings (Protection of Employment)
Regulations 2006 (S.I. 2006/246).
(3)
A transfer order may provide for the transfer of property, rights or liabilities—
25
(a)
whether or not they would otherwise be capable of being transferred;
(b)
irrespective of any requirement for consent that would otherwise
apply.
(4)
A transfer order may create rights, or impose liabilities, in relation to property,
rights or liabilities transferred.
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(5)
A transfer order may provide for things done by or in relation to the transferor
for the purposes of or in connection with anything transferred to be—
(a)
treated as done by or in relation to the transferee or its employees;
(b)
continued by or in relation to the transferee or its employees.
(6)
A transfer order may in particular make provision about continuation of legal
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proceedings.