workers and ensuring sufficient skilled health care workers in the health
service), so far as they are exercisable in or in relation to the LETB’s area.

(3) In carrying out its main function, an LETB must represent the interests of all
the persons who provide health services in the area for which the LETB is
5appointed.

(4) An LETB may co-operate with another LETB in the exercise of functions; and
two or more LETBs may exercise functions jointly.

(5) HEE may attend any meeting held by an LETB about a matter of concern to
HEE.

94 10LETBs: appointment etc.

(1) Where, on an application under this section, HEE is satisfied that the applicants
meet the criteria that HEE has set for the purpose (the “appointment criteria”),
HEE must appoint the applicants as members of an LETB for such area as HEE
considers appropriate.

(2) 15Where, on an application under this section, HEE is satisfied that the applicants
meet some (but not all) of the appointment criteria, it may nonetheless appoint
the applicants as the members of an LETB for such area and subject to such
conditions as HEE considers appropriate.

(3) The members of an LETB must include—

(a) 20persons who provide health services in the area for which the LETB is
appointed, and

(b) persons who have clinical expertise of a description specified in
regulations.

(4) The regulations may require a specified number of members to have that
25expertise.

(5) The following persons are also eligible to be appointed as members of an
LETB—

(a) persons who, in the area for which the LETB is appointed, provide
education or training for health care workers or for persons wishing to
30work as health care workers, and

(b) persons of such other description as HEE may decide.

(6) A member of HEE is not eligible for membership of an LETB.

(7) The appointment criteria must include criteria designed to ensure that a
majority of the members of an LETB are persons who provide health services
35in the area for which the LETB in question is appointed.

(8) If HEE is unable (for reasons beyond its control) to comply with any
requirement imposed by this section or regulations under this section to
appoint persons of a particular description as members of an LETB, HEE may
instead appoint employees of HEE (other than members of HEE).

(9) 40On appointing an LETB, HEE must appoint the chair of the LETB; but it may
not appoint as chair a person who—

(a) provides health services in the area for which the LETB is appointed, or

(b) in the area for which the LETB is appointed, provides education or
training for health care workers or for persons wishing to work as
45health care workers.

(10) HEE must notify applicants under subsection (1) or (2) of the decision on the
application and—

(a) in the case of an approval of such an application, the area for which the
LETB is appointed and the appointment under subsection (9);

(b) 5in the case of a rejection, the reasons for the rejection.

(11) HEE, having complied with subsection (10), must publish—

(a) the decision, and

(b) in the case of a rejection, the reasons for the rejection.

(12) The conditions on which a person is appointed as a member of an LETB must
10include a condition not to use information obtained in the capacity as such
otherwise than for the purposes of the LETB.

(13) Regulations may make further provision about—

(a) the membership of an LETB;

(b) the removal by HEE of members of an LETB;

(c) 15the suspension by HEE of members of an LETB.

(14) Schedule 6 (which includes provision about the area of an LETB, the
appointment criteria and the exercise of an LETB’s functions) has effect.

95 LETBs: co-operation by providers of health services

(1) Regulations must require specified commissioners of health services to include
20in the arrangements under the National Health Service Act 2006 for the
provision of such services terms to ensure that a provider of such services—

(a) co-operates with the LETB for each area in which it provides such
services, in such manner and to such extent as the LETB in question
may request, in planning the provision of, and in providing, education
25and training for health care workers;

(b) provides the LETB in question with such information as it may request;

(c) complies with such other obligations relating to education and training
for health care workers as may be specified.

(2) Duties imposed by regulations under subsection (1) on commissioners of
30health services are in addition to the duty imposed on such persons by section
1F(2) of the National Health Service Act 2006 (duty to secure that persons
providing health services co-operate with the Secretary of State in the
discharge of the duty as to education and training).

(3) Regulations may specify factors to which an LETB must, when proposing to
35make a request of the type mentioned in subsection (1)(a) or (b), have regard in
considering the reasonableness of making the request.

(4) A reference to a commissioner of health services is a reference to—

(a) the National Health Service Commissioning Board,

(b) a clinical commissioning group, or

(c) 40such other person as arranges for the provision of such services.

96 Education and training plans

(1) An LETB must publish for each financial year a document (called an
“education and training plan”) specifying how it proposes to exercise its main
function (see section 93(2)).

(2) The education and training plan of an LETB must specify how the LETB
proposes to—

(a) achieve the objectives and reflect the priorities set by the Secretary of
State for the purposes of section 90(1),

(b) 5achieve the objectives and reflect the priorities set by HEE for the
purposes of section 90(4)(a),

(c) achieve the outcomes set by the Secretary of State for the purposes of
section 90(2), and

(d) achieve the outcomes set by HEE for the purposes of section 90(4)(b).

(3) 10In preparing its education and training plan, an LETB must have regard to—

(a) the priorities that the providers of health services whom the LETB
represents have in relation to the provision in the LETB’s area of health
services and of education and training for health care workers or
persons wishing to become health care workers,

(b) 15the priorities that commissioners of health services in the LETB’s area
have in relation to those matters,

(c) any assessment of relevant needs relating to the LETB’s area prepared
under section 116 of the Local Government and Public Involvement in
Health Act 2007,

(d) 20any joint health and wellbeing strategy relating to the LETB’s area
prepared under section 116A of that Act, and

(e) the LETB’s objectives in the longer term in relation to the exercise of the
LETB’s main function.

(4) In preparing its education and training plan, an LETB must involve—

(a) 25the providers of health services whom the LETB represents,

(b) the commissioners of health services in the LETB’s area,

(c) the Health and Wellbeing Board for that area,

(d) such persons as HEE may direct the LETB to involve, and

(e) such other persons as the LETB considers appropriate.

(5) 30Before publishing its education and training plan (or an amended education
and training plan), an LETB must obtain approval of the plan (or the amended
plan) from HEE.

(6) Before giving an approval under subsection (5), HEE may direct the LETB
concerned to amend the education and training plan (or the amended
35education and training plan) as HEE specifies.

(7) But, in the case of an LETB which meets all the appointment criteria, the only
amendments which HEE may direct to be made under subsection (6) are those
HEE considers necessary in order to ensure that the LETB achieves the
outcomes set by HEE for the purposes of section 90(4)(b).

(8) 40Where HEE exercises the power under subsection (6), it must publish—

(a) the amendments in question, and

(b) its reasons for directing them to be made.

(9) HEE may give LETBs directions about—

(a) what to include in their education and training plans;

(b) 45how to present them.

(10) An LETB may perform the duty under subsection (1) by preparing two or more
documents which, taken together, specify how it proposes to exercise its main
function.

97 Commissioning education and training

(1) 5Each LETB must for each financial year arrange for the provision of education
and training in accordance with its education and training plan for that year.

(2) Where HEE considers that it would be better for the arrangements for the
provision of certain education and training to be made on a national basis, it—

(a) may arrange for the provision of that education and training
10accordingly, or

(b) may direct one or more LETBs to do so on its behalf.

(3) Before exercising a power under subsection (2), HEE must involve LETBs in
making its decision.

(4) HEE must for each financial year allocate to each LETB the amount that HEE
15considers appropriate to enable the LETB to comply with this section.

(5) In doing so, HEE must take into account any duty to which the LETB is subject
under section 98(9) (requirement to make payments by reference to an
approved tariff price or a price varied under a specified procedure).

(6) An LETB may arrange for another person to help it to exercise the function
20under subsection (1) or (where it is directed to do so under subsection (2)(b))
the function under subsection (2)(a) (and such functions as are exercisable for
the purposes of or in connection with the exercise of the function concerned).

(7) Each LETB—

(a) must keep under review the quality of the education and training the
25provision of which it arranges, and

(b) must report its findings to such persons as it considers may be
interested by them.

(8) An LETB must produce such reports on the exercise of the function under
subsection (1) (including on the quality of the education and training the
30provision of which it arranges) as HEE may require.

Tariffs

98 Tariffs

(1) The Secretary of State may specify a tariff setting approved prices in respect of
education and training.

(2) 35The approved prices may be different for different descriptions of education
and training (and may in particular be different for different areas).

(3) A tariff specified under subsection (1) must be published.

(4) If a tariff is specified under subsection (1), the Secretary of State may also
specify a procedure for varying the approved prices in particular cases or
40descriptions of cases.

(5) If the Secretary of State does so, the procedure—

(a) must be published, and

(b) must require a price as varied under the procedure to be published.

(6) A published tariff or variation procedure may be revised or revoked by the
Secretary of State.

(7) 5If a tariff or variation procedure is revised, the Secretary of State must publish
it as revised.

(8) If it is revoked, the Secretary of State must publish a statement to that effect.

(9) Where a tariff sets an approved price for a particular description of education
or training, payments made by an LETB or HEE in respect of the provision of
10that description of education or training must be made—

(a) by reference to the approved price, or

(b) where the approved price has been varied in accordance with a
variation procedure that has effect in relation to it, by reference to the
price as varied.

CHAPTER 2 15Health Research Authority

Establishment

99 The Health Research Authority

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

(2) 20Schedule 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) the Health Research Authority (Establishment and Constitution) Order
252011 (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
provision about an order under this section, see section 108.

30General functions

100 The HRA’s functions

(1) The main functions of the HRA are—

(a) functions relating to the co-ordination and standardisation of practice
relating to the regulation of health and social care research (see section
35101);

(b) functions relating to research ethics committees (see sections 102 to
105);

(c) functions as a member of the United Kingdom Ethics Committee
Authority (see section 106 and the Medicines for Human Use (Clinical
Trials) Regulations 2004 (S.I. 2004/1031S.I. 2004/1031));

(d) functions relating to approvals for processing confidential information
5relating to patients (see section 107 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) to protect participants and potential participants in health or social care
research and the general public by encouraging research that is safe and
10ethical, and

(b) to promote the interests of those participants and potential participants
and the general public by facilitating the conduct of such research.

(3) Health 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
15anything 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,
physical or mental illness, disability, pregnancy, childbirth, dependence on
alcohol or drugs or other similar circumstances; and “illness” has the meaning
20given 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
devolved legislature.

(6) A reference to research that is ethical is a reference to research that conforms to
25generally 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) functions being taken away from the HRA, or

(c) changes to the description of functions that the HRA has for the time
30being.

Regulatory practice

101 Co-ordinating and promoting regulatory practice etc.

(1) The 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,
35with a view to co-ordinating and standardising practice relating to the
regulation of such research—

(a) the Secretary of State;

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

(c) the Health and Social Care Information Centre;

(d) 40the Chief Medical Officer of the Department of Health;

(e) the Human Fertilisation and Embryology Authority;

(f) the Human Tissue Authority;

(g) the 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
need—

(a) 5to 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) 10The 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
15exercise 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
20research 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
25and 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
30foundation 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
35being within subsection (1), does not apply to functions of that person relating
to health or social care research.

(10) Section 100(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.

40Research ethics committees

102 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.

(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;

(b) 5by 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).

(3) 10For 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.

(4) 15The 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) 20develop 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—

(a) 25membership;

(b) proceedings;

(c) staff;

(d) accommodation and facilities;

(e) expenses;

(f) 30objectives 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
35imposed 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) the devolved authorities, and

(b) such other persons as it considers appropriate.

(8) 40The 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
45party for loss, damage or injury arising from the committee’s exercise of its
functions in assessing the ethics of health or social care research.

103 Approval of research

(1) The 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
5individuals 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
conduct research of that kind to obtain that approval.

(2) Before publishing guidance under subsection (1), the HRA must—

(a) 10consult the devolved authorities and such other persons as the HRA
considers appropriate, and

(b) obtain 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
15guidance 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.

104 Recognition by the HRA

(1) The HRA may, on an application made by or on behalf of a group of persons,
20recognise the group as a research ethics committee which is capable of—

(a) approving research of the kind referred to in section 103(1), and

(b) giving such other approvals as enactments require.

(2) The HRA may not recognise a group under this section unless it is satisfied
that—

(a) 25the 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.

(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
30by 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
which it should be able to make an application for recognition under this
section that is likely to succeed.

(5) 35The 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,

(b) the group is not (or is not properly) carrying out its function of
assessing the ethical aspects of research, or

(c) 40revocation is necessary or desirable for some other reason.

(6) A group in existence immediately before the commencement of section 99, and
established 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
45HRA under this section.

(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 99).

105 Establishment by the HRA

(1) 5The HRA may establish research ethics committees which have the following
functions—

(a) approving research of the kind referred to in section 103(1);

(b) giving such other approvals as enactments require.

(2) The HRA must ensure that a research ethics committee established under this
10section complies with the requirements set out in the REC policy document.

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

106 Membership of the United Kingdom Ethics Committee Authority

In regulation 5 of the Medicines for Human Use (Clinical Trials) Regulations
152004 (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”.

20Patient information

107 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
25information”)—

(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) 30After 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) 35The 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
40or”, and