Care Bill (HL Bill 1)

CHAPTER 2 Health Research Authority

Establishment

96 The Health Research Authority

(1) There is to be a body corporate called the Health Research Authority (referred
5to in this Act as “the HRA”).

(2) Schedule 7 (which includes provision about the HRA’s constitution, the
exercise of its functions and its financial and reporting duties) has effect.

(3) The Special Health Authority called the Health Research Authority is
abolished; and, in consequence of that, the following are revoked—

(a) 10the Health Research Authority (Establishment and Constitution) Order
2011 (S.I. 2011/2323S.I. 2011/2323), and

(b) the Health Research Authority Regulations 2011 (S.I. 2011/2341S.I. 2011/2341).

(4) The Secretary of State may by order provide for the transfer of property, rights
and liabilities from that Special Health Authority to the HRA; for further
15provision about an order under this section, see section 105.

General functions

97 The HRA’s functions

(1) The main functions of the HRA are—

(a) functions relating to the co-ordination and standardisation of practice
20relating to the regulation of health and social care research (see section
98);

(b) functions relating to research ethics committees (see sections 99 to 102);

(c) functions as a member of the United Kingdom Ethics Committee
Authority (see section 103 and the Medicines for Human Use (Clinical
25Trials) Regulations 2004 (S.I. 2004/1031S.I. 2004/1031));

(d) functions relating to approvals for processing confidential information
relating to patients (see section 104 and the Health Service (Control of
Patient Information) Regulations 2002 (S.I. 2002/1438S.I. 2002/1438)).

(2) The main objective of the HRA in exercising its functions is—

(a) 30to 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.

(3) 35Health research is research into matters relating to people’s physical or mental
health; but a reference to health research does not include a reference to
anything authorised under the Animals (Scientific Procedures) Act 1986.

(4) Social care research is research into matters relating to personal care or other
practical assistance for individuals in need of care or assistance because of age,
40physical or mental illness, disability, pregnancy, childbirth, dependence on

alcohol or drugs or other similar circumstances; and “illness” has the meaning
given by section 275(1) of the National Health Service Act 2006.

(5) A reference to health or social care research does not include a reference to
research into matters which are within the legislative competence of a
5devolved legislature.

(6) A reference to research that is ethical is a reference to research that conforms to
generally accepted ethical standards.

(7) The Secretary of State may by order amend subsection (1) in consequence of—

(a) functions being given to the HRA,

(b) 10functions being taken away from the HRA, or

(c) changes to the description of functions that the HRA has for the time
being.

Regulatory practice

98 Co-ordinating and promoting regulatory practice etc.

(1) 15The HRA and each of the following must co-operate with each other in the
exercise of their respective functions relating to health or social care research,
with a view to co-ordinating and standardising practice relating to the
regulation of such research—

(a) the Secretary of State;

(b) 20the licensing authority for the purposes of the Medicines Act 1968;

(c) the Health and Social Care Information Centre;

(d) the Chief Medical Officer of the Department of Health;

(e) the Human Fertilisation and Embryology Authority;

(f) the Human Tissue Authority;

(g) 25the Care Quality Commission;

(h) the Administration of Radioactive Substances Advisory Committee;

(i) such person, or a person of such description, as regulations may
specify.

(2) In performing the duty under subsection (1), a person must have regard to the
30need—

(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
35and the general public by facilitating the conduct of such research.

(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) 40The HRA and each devolved authority must co-operate with each other in the
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
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) 5The HRA must publish guidance on—

(a) principles of good practice in the management and conduct of health
and social care research;

(b) requirements, whether imposed by enactments or otherwise, to which
persons conducting health or social care research are subject.

(7) 10A 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
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) 15Section 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
being within subsection (1), does not apply to functions of that person relating
to health or social care research.

(10) Section 97(5) (exclusion of research into matters within devolved competence)
20does not apply to the reference in subsection (1) or (4) to health and social care
research.

Research ethics committees

99 The HRA’s policy on research ethics committees

(1) The HRA must ensure that research ethics committees it recognises or
25establishes under this Chapter provide an efficient and effective means of
assessing the ethics of health and social care research.

(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) 30by obtaining information from them;

(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
35xenotransplantation).

(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) 40must monitor their compliance with those requirements.

(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;

(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
5financial assistance).

(5) The requirements in the REC policy document may, for example, relate to—

(a) membership;

(b) proceedings;

(c) staff;

(d) 10accommodation and facilities;

(e) expenses;

(f) objectives and functions;

(g) accountability;

(h) procedures for challenging decisions.

(6) 15The HRA must ensure that the requirements imposed on research ethics
committees in the REC policy document do not conflict with the requirements
imposed on them by the Medicines for Human Use (Clinical Trials)
Regulations 2004 (S.I. 2004/1031S.I. 2004/1031).

(7) Before publishing the REC policy document, the HRA must consult—

(a) 20the devolved authorities, and

(b) such other persons as it considers appropriate.

(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) 25The HRA must indemnify the members of each research ethics committee it
recognises or establishes under this Chapter against any liability to a third
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.

100 Approval of research

(1) 30The HRA must publish guidance about—

(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) 35the cases in which an enactment requires a person proposing to
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) 40obtain the approval of the Secretary of State.

(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
45secondary legislation) has effect.

101 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 100(1), and

(b) 5giving such other approvals as enactments require.

(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) 10there is or will be a demand for such a group.

(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
15group wishing to be recognised under this section to reach a position from
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
20requirements specified in the REC policy document,

(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 96, and
25established or recognised by or on behalf of the old Health Research 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.

(7) The reference in subsection (6) to the old Health Research Authority is a
30reference to the Special Health Authority called the Health Research Authority
(and abolished by section 96).

102 Establishment by the HRA

(1) The HRA may establish research ethics committees which have the following
functions—

(a) 35approving research of the kind referred to in section 100(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.

(3) The HRA may abolish a research ethics committee established under this
40section.

103 Membership of the United Kingdom Ethics Committee Authority

In regulation 5 of the Medicines for Human Use (Clinical Trials) Regulations
2004 (S.I. 2004/1031S.I. 2004/1031) (United Kingdom Ethics Committee Authority)—

(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”.

5Patient information

104 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
10information”)—

(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) 15After paragraph (1) of that regulation insert—

“(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) 20The Health Research Authority shall put in place and operate a system
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
25or”, and

(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
30register” substitute “The Health Research Authority shall retain the particulars
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
35extent as it considers appropriate, publish entries it records in the
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 Miscellaneous and General

Miscellaneous

105 Transfer orders

(1) An order under section 83 (establishment of Health Education England) or
5section 96 (establishment of the Health Research Authority) (a “transfer order”)
may make provision for rights and liabilities relating to an individual’s
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)
10Regulations 2006 (S.I. 2006/246S.I. 2006/246).

(3) A transfer order may provide for the transfer of property, rights or liabilities—

(a) whether or not they would otherwise be capable of being transferred;

(b) irrespective of any requirement for consent that would otherwise
apply.

(4) 15A transfer order may create rights, or impose liabilities, in relation to property,
rights or liabilities transferred.

(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) 20continued by or in relation to the transferee or its employees.

(6) A transfer order may in particular make provision about continuation of legal
proceedings.

General

106 Part 3: interpretation and supplementary provision

(1) 25For the purposes of this Part, an expression in the first column of the following
table is defined or otherwise explained by the provision of this Act specified in
the second column.

(2) A power under this Part to give a direction—

(a) includes a power to vary or revoke the direction by a subsequent
direction, and

(b) must be exercised by giving the direction in question in writing.

(3) 15The amendments made by sections 103 and 104 and Schedule 8 to provisions
of subordinate legislation do not affect the power to make further subordinate
legislation amending or revoking the amended provisions.

Part 4 General

107 20Power to make consequential provision

(1) The Secretary of State may by order make provision in consequence of a
provision of this Act.

(2) An order under this section may amend, repeal, revoke or otherwise modify an
enactment.

(3) 25The power conferred by this section is not restricted by any other provision of
this Act.

(4) A saving or a transitional or transitory provision in an order under this section
by virtue of section 109(7) may, in particular, modify the application of a
provision made by the order pending the commencement of—

(a) 30another provision of the order,

(b) a provision of this Act, or

(c) any other enactment.

(5) Before making an order under this section that contains provision which is
within the legislative competence of a devolved legislature, the Secretary of
35State must consult the relevant devolved authority.

(6) A reference to an enactment includes a reference to an enactment passed or
made after the passing of this Act.

108 Power to make transitional etc. provision

(1) The Secretary of State may by order make transitional, transitory or saving
provision in connection with the commencement of a provision of this Act.

(2) An order under this section may modify the application of a provision of this
5Act pending the commencement of—

(a) another provision of this Act, or

(b) any other enactment (including one passed or made after the passing of
this Act).

109 Regulations and orders

(1) 10A power or duty to make regulations under this Act is exercisable by the
Secretary of State.

(2) Regulations and orders under this Act must be made by statutory instrument.

(3) Subject to subsections (4) and (5), a statutory instrument containing regulations
or an order under this Act is subject to annulment in pursuance of a resolution
15of either House of Parliament.

(4) A statutory instrument which contains (whether alone or with other provision)
any of the following may not be made unless a draft of the instrument has been
laid before, and approved by a resolution of, each House of Parliament—

(a) regulations under section 13(7) (the eligibility criteria);

(b) 20regulations under section 15(4) (the cap on care costs) other than those
made in discharge of the duty under section 16(1);

(c) the first regulations under section 15(8) (the amount attributable to an
adult’s daily living costs);

(d) regulations under section 35(9) (deferred payment agreements and
25loans: protection of security) which include provision that amends or
repeals a provision of an Act of Parliament;

(e) an order under section 72(9) (delegation of local authority functions);

(f) regulations under section 81 (offence of supplying etc false or
misleading information);

(g) 30an order under section 107 (consequential provision) which includes
provision that amends or repeals a provision of an Act of Parliament;

(h) regulations under paragraph 17 of Schedule 7 (fees chargeable by the
HRA).

(5) Subsection (3) does not apply to—

(a) 35an order under section 83 (transfer order to new HEE);

(b) an order under section 96 (transfer order to new HRA);

(c) an order under section 108 (transitional etc. provision);

(d) an order under section 111 (commencement).

(6) A power to make regulations or an order under this Act—

(a) 40may be exercised for all cases to which the power applies, for those
cases subject to specified exceptions, or for any specified cases or
descriptions of case,

(b) may be exercised so as to make, for the cases for which it is exercised—

(i) the full provision to which the power applies or any less
45provision (whether by way of exception or otherwise);

(ii) the same provision for all cases for which the power is
exercised, or different provision for different cases or different
descriptions of case, or different provision as respects the same
case or description of case for different purposes of this Act;

(iii) 5any such provision either unconditionally or subject to
specified conditions, and

(c) may, in particular, make different provision for different areas.

(7) A power to make regulations or an order under this Act (other than the power
to make an order under section 108 or 111) includes —

(a) 10power to make incidental, supplementary, consequential, saving,
transitional or transitory provision, and

(b) power to provide for a person to exercise a discretion in dealing with a
matter.

(8) Before making regulations under section 49(10) (meaning of references to
15business failure), the Secretary of State must consult the Welsh Ministers.

110 General interpretation

In this Act—

• “devolved authority” means the Scottish Ministers, the Welsh Ministers
  or the Department for Health, Social Services and Public Safety in
  20Northern Ireland,

• “devolved legislature” means the Scottish Parliament, the National
  Assembly for Wales or the Northern Ireland Assembly,

• “enactment” includes—

  (a)

  an enactment contained in subordinate legislation (within the
  25meaning of the Interpretation Act 1978), and

  (b)

  an enactment contained in, or in an instrument made under, an
  Act of the Scottish Parliament, an Act or Measure of the
  National Assembly for Wales or Northern Ireland legislation,

• “financial year” means a period of 12 months ending with 31 March (but
  30see also the definition of that expression in paragraph 3 of Schedule 2,
  paragraph 19 of Schedule 5 and paragraph 18 of Schedule 7), and

• “the health service” means the comprehensive health service in England
  continued under section 1(1) of the National Health Service Act 2006.

111 Commencement

(1) 35The provisions of Parts 1 to 3 come into force on such day as the Secretary of
State may by order appoint.

(2) The provisions of this Part come into force on the day on which this Act is
passed.

(3) Before making an order under this section bringing section 48 (provider
40failure: temporary duty in cross-border cases) into force, so far as it applies to
accommodation in Wales, the Secretary of State must obtain the consent of the
Welsh Ministers.

(4) Different days may be appointed under subsection (1) for different purposes
(including different areas).