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(4) A person may resign from office as a non-executive member by giving notice
to the Secretary of State.

(5) The Secretary of State may remove a person from office as a non-executive
member on any of the following grounds—

(a) 5incapacity;

(b) misbehaviour;

(c) failure to carry out his or her duties as a non-executive member.

(6) The Secretary of State may suspend a person from office as a non-executive
member if it appears to the Secretary of State that there are or may be
10grounds to remove that person from office under sub-paragraph (5).

Non-executive members: suspension from office

3 (1) Having decided to suspend a person under paragraph 2(6), the Secretary of
State must give notice of the decision to the person; and the suspension takes
effect when the person receives the notice.

(2) 15The notice may be—

(a) delivered in person (in which case the person is taken to receive it
when it is delivered), or

(b) sent by first class post to the person’s last known address (in which
case, the person is taken to receive it on the third day after the day on
20which it is posted).

(3) The initial period of suspension must not exceed six months.

(4) The Secretary of State may review the suspension.

(5) The Secretary of State—

(a) must review the suspension, if requested in writing by the person to
25do so, but

(b) need not review the suspension less than three months after the
beginning of the initial period of suspension.

(6) Following a review during a period of suspension, the Secretary of State
may—

(a) 30revoke the suspension, or

(b) suspend the person for a period of no more than six months from the
expiry of the current period.

(7) The Secretary of State must revoke the suspension if the Secretary of State—

(a) decides that there are no grounds to remove the person from office
35under paragraph 2(5), or

(b) decides that there are grounds to do so but nonetheless decides not
to do so.

4 (1) Where a person is suspended from office as the chair under paragraph 2(6),
the Secretary of State may appoint a non-executive member as interim chair
40to exercise the chair’s functions.

(2) Appointment as interim chair is for a term not exceeding the shorter of—

(a) the period ending with either—

(i) the appointment of a new chair, or

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(ii) the revocation or expiry of the existing chair’s suspension,
and

(b) the remainder of the interim chair’s term as a non-executive member.

(3) A person who ceases to be the interim chair is eligible for re-appointment.

5Non-executive members: pay

5 (1) The HRA must pay its non-executive members such remuneration as the
Secretary of State may decide.

(2) The HRA must pay, or provide for the payment of, such allowances or
gratuities as the Secretary of State may decide to a person who is or has been
10a non-executive member of the HRA.

Employees: terms of office

6 (1) Each executive member of the HRA is appointed as an employee of the HRA
on such terms as it decides.

(2) A person may not be appointed as chief executive without the consent of the
15Secretary of State.

(3) The HRA may appoint, on such terms as it decides, other persons as
employees of the HRA (in addition to those appointed as executive
members).

Employees: pay

7 (1) 20The HRA must pay its employees such remuneration as it decides.

(2) The HRA may pay, or provide for the payment of, such pensions,
allowances or gratuities as it decides to or in respect of a person who is or
has been an employee of the HRA.

(3) Before making a decision about pay under this paragraph, the HRA must
25obtain the approval of the Secretary of State to its policy on the matter.

Committees and sub-committees

8 (1) The HRA must appoint a committee for the purpose of giving advice—

(a) to the HRA in connection with the exercise of the HRA’s function
under regulation 5(1)(a) of the Health Service (Control of Patient
30Information) Regulations 2002 (S.I. 2002/1438S.I. 2002/1438) (approval for
processing confidential patient information);

(b) to the Secretary of State in connection with the exercise of the
Secretary of State’s functions under regulations 2, 3(4) and 5 of those
Regulations (processing of confidential patient information).

(2) 35The HRA may appoint other committees and sub-committees.

(3) The committee appointed under sub-paragraph (1) must consist of persons
who are not members or employees of the HRA.

(4) Any other committee or sub-committee may consist of or include such
persons.

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(5) The HRA may pay such remuneration and allowances as it decides to a
person who is a member of a committee or sub-committee, but is not an
employee of the HRA, regardless of whether the person is a non-executive
member of the HRA.

5Procedure

9 (1) The HRA may regulate its own procedure.

(2) A vacancy among the members of the HRA, or a defect in the appointment
of a member, does not affect the validity of any act of the HRA.

Seal and evidence

10 (1) 10The application of the HRA’s seal must be authenticated by the signature of
a member of the HRA or a person who has been authorised (whether
generally or specifically) for the purpose.

(2) A document purporting to be duly executed under the HRA’s seal or to be
signed on its behalf must be received in evidence and, unless the contrary is
15proved, taken to be so executed or signed.

(3) But this paragraph does not apply in relation to a document which is, or is
to be, signed in accordance with the law of Scotland.

Status of the HRA

11 (1) The HRA is not to be regarded as a servant or agent of the Crown, or as
20enjoying any status, privilege or immunity of the Crown.

(2) The HRA’s property is not to be regarded as property of, or property held
on behalf of, the Crown.

Part 2 Functions

25Exercise of functions

12 (1) The HRA must exercise its functions effectively, efficiently and
economically.

(2) The HRA may arrange for any of its committees, sub-committees or
members or any other person (other than a devolved authority) to exercise
30any of its functions on its behalf.

(3) The HRA may arrange for any person to help it in the exercise of its functions
(whether in a particular case or in cases of a particular description).

(4) Arrangements under sub-paragraph (2) or (3) may provide for the payment
of remuneration and allowances to the persons with whom the HRA makes
35the arrangements.

(5) The HRA may do anything which appears to it to be necessary or desirable
for the purposes of or in connection with the exercise of its functions.

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Help or advice for other public authorities

13 (1) The HRA may provide help or advice to another public authority for the
purpose of the exercise by that authority of its functions.

(2) Help or advice under this paragraph may be provided on such terms as the
5HRA decides (including terms relating to payment of remuneration and
allowances).

(3) “Public authority”—

(a) includes any person certain of whose functions are functions of a
public nature, but

(b) 10does not include either House of Parliament or a person exercising
functions in connection with proceedings in Parliament.

(4) A reference to a public authority—

(a) includes a public authority in the Channel Islands or the Isle of Man,
but

(b) 15subject to that, does not include a reference to a public authority
outside the United Kingdom.

Arrangements with devolved authorities

14 (1) The HRA may arrange with a devolved authority for the HRA

(a) to exercise on behalf of the devolved authority any function which
20corresponds to a function of the HRA;

(b) to provide services or facilities in so far as the devolved authority
requires them in connection with the exercise of such a function.

(2) The terms and conditions on which arrangements under this paragraph may
be made include provision for payment to the HRA in respect of its costs in
25giving effect to the arrangements.

Failure to exercise functions

15 (1) If the Secretary of State considers that the HRA is failing or has failed to
exercise any of its functions, and that the failure is significant, the Secretary
of State may direct the HRA to exercise such of its functions, in such manner
30and within such period, as the direction specifies.

(2) If the HRA fails to comply with a direction under this paragraph, the
Secretary of State may—

(a) exercise the functions specified in the direction, or

(b) make arrangements for some other person to exercise them on the
35Secretary of State’s behalf.

(3) Where the Secretary of State exercises a power under sub-paragraph (1) or
(2), the Secretary of State must publish the reasons for doing so.

(4) The reference in sub-paragraph (1) to exercising a function includes a
reference to exercising it properly.

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Part 3 Finance and reports

Funding

16 The Secretary of State may, with the consent of the Treasury, make payments
5to the HRA at such times and on such conditions (if any) as the Secretary of
State considers appropriate.

Fees and indemnities

17 (1) Regulations may require payment of a fee in relation to the exercise of a
specified function of the HRA; and the amount of the fee is to be the amount
10specified in, or determined in accordance with, the regulations.

(2) Where the amount of a fee is to be specified in regulations under this
paragraph—

(a) the Secretary of State must, before specifying the amount of the fee,
have regard to the cost incurred in the exercise of the function to
15which the fee relates, and

(b) the HRA must provide the Secretary of State with such information,
in such form, as the Secretary of State may request.

(3) Regulations under this paragraph may require the HRA to determine the
amount of a fee; and, where they do so, the regulations—

(a) 20must require the HRA, before determining the amount of the fee, to
have regard to the cost incurred in the exercise of the function to
which the fee relates, and

(b) must require the HRA to obtain the approval of the Secretary of State
to the proposed amount of the fee.

(4) 25Regulations under this paragraph which provide for the amount of a fee to
be determined may specify factors in accordance with which it is to be
determined.

(5) Regulations under this paragraph may include provision—

(a) for determining the time by which a fee is payable;

(b) 30for any unpaid balance to be recoverable as a debt due to the HRA
(but for this not to affect any other method of recovery).

(6) Before making regulations under this paragraph, the Secretary of State must
consult such persons as the Secretary of State considers appropriate.

(7) Section 265 of the Public Health Act 1875 (which relates to the protection of
35members and officers of certain authorities from personal liability) has effect
as if there were included in the authorities referred to in that section a
reference to the HRA.

(8) In its application to the HRA as a result of sub-paragraph (7), section 265 of
that Act has effect as if any reference in that section to that Act were a
40reference to this Act.

(9) In section 71(2) of the National Health Service Act 2006 (schemes for meeting
losses and liabilities etc. of certain health service bodies), after paragraph (f)
insert—

(fa) the Health Research Authority;.

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Accounts

18 (1) The HRA must keep accounts in such form as the Secretary of State may
determine.

(2) The HRA must prepare annual accounts in respect of each financial year in
5such form as the Secretary of State may determine.

(3) The HRA must send copies of the annual accounts to—

(a) the Secretary of State, and

(b) the Comptroller and Auditor General,

within such period after the end of the financial year to which the accounts
10relate as the Secretary of State may determine.

(4) The Comptroller and Auditor General must—

(a) examine, certify and report on the annual accounts, and

(b) lay copies of them and the report on them before Parliament.

(5) In this paragraph and paragraph 19, “financial year” includes the period—

(a) 15beginning with the day on which the HRA is established, and

(b) ending with the following 31 March or, if the period ending with that
date is 3 months or less, ending with the 31 March following that
date.

Annual report

19 (1) 20As soon as is feasible after the end of each financial year, the HRA must
prepare an annual report on—

(a) the activities it has undertaken during the year, and

(b) the activities it proposes to undertake during the current financial
year.

(2) 25The report must set out the steps the HRA has taken during the year to fulfil
its main objective (see section 108(2)).

(3) The HRA must—

(a) lay a copy of the report before Parliament, and

(b) send a copy of it to the Secretary of State.

(4) 30The HRA must provide the Secretary of State with such other reports and
information relating to the exercise of its functions as the Secretary of State
may request.

Part 4 Consequential amendments

35Public Records Act 1958

20 In Part 2 of the Table in Schedule 1 to the Public Records Act 1958, at the
appropriate place insert—

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Public Bodies (Admission to Meetings) Act 1960

21 In the Schedule to the Public Bodies (Admission to Meetings) Act 1960, after
paragraph (bm) (inserted by paragraph 30 of Schedule 5 to this Act) insert—

(bn) the Health Research Authority;.

5Parliamentary Commissioner Act 1967

22 In Schedule 2 to the Parliamentary Commissioner Act 1967, at the
appropriate place insert—

House of Commons Disqualification Act 1975

23 10In Part 2 of Schedule 1 to the House of Commons Disqualification Act 1975,
at the appropriate place insert—

Copyright, Designs and Patents Act 1988

24 In section 48(6) of the Copyright, Designs and Patents Act 1988 (definition of
15“the Crown”), after “Health Education England” (inserted by paragraph 33
of Schedule 5 to this Act) insert “, the Health Research Authority”.

Freedom of Information Act 2000

25 In Part 6 of Schedule 1 to the Freedom of Information Act 2000 (other public
bodies), at the appropriate place insert—

Equality Act 2010

26 In Part 1 of Schedule 19 to the Equality Act 2010 (authorities subject to the
public sector equality duty), in the group of entries under the heading
“Health, social care and social security”, after the entry for Health Education
25England (inserted by paragraph 35 of Schedule 5 to this Act) insert—

Section 111

SCHEDULE 8 Research ethics committees: amendments

Ionising Radiation (Medical Exposure) Regulations 2000 (S.I. 2000/1059S.I. 2000/1059)

1 30In regulation 2(1) of the Ionising Radiation (Medical Exposure) Regulations
2000 (S.I. 2000/1059S.I. 2000/1059), in the definition of “ethics committee”—

(a) omit paragraph (a), and

(b) for paragraph (c) substitute—

Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2000 (S.R. 2000/194S.R. 2000/194)

2 In regulation 2(1) of the Ionising Radiation (Medical Exposure) Regulations
(Northern Ireland) 2000 (S.R. 2000/194S.R. 2000/194), for the definition of “ethics
committee” substitute—

Health Service (Control of Patient Information) Regulations 2002 (S.I. 2002/1438S.I. 2002/1438)

3 15In regulation 1(2) of the Health Service (Control of Patient Information)
Regulations 2002 (S.I. 2002/1438S.I. 2002/1438), for the definition of “research ethics
committee” substitute—

Nursing Homes Regulations (Northern Ireland) 2005 (S.R. 2005/160S.R. 2005/160)

4 In regulation 2(1) of the Nursing Homes Regulations (Northern Ireland)
2005 (S.R. 2005/160S.R. 2005/160), for the definition of “ethics committee” substitute—

Residential Care Homes Regulations (Northern Ireland) 2005 (S.R. 2005/161S.R. 2005/161)

5 In regulation 2(1) of the Residential Care Homes Regulations (Northern
35Ireland) 2005 (S.R. 2005/161S.R. 2005/161), for the definition of “ethics committee”
substitute—

Independent Health Care Regulations (Northern Ireland) 2005 (S.R. 2005/174S.R. 2005/174)

6 In regulation 2(1) of the Independent Health Care Regulations (Northern
Ireland) 2005 (S.R. 2005/174S.R. 2005/174), for the definition of “ethics committee”

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substitute—

Approval of Research on Organs No Longer Required for Procurator Fiscal Purposes (Specified
Purposes) (Scotland) Order 2006 (S.S.I. 2006/310S.S.I. 2006/310)

7 In article 1(2) of the Approval of Research on Organs No Longer Required
for Procurator Fiscal Purposes (Specified Purposes) (Scotland) Order 2006
10(S.S.I. 2006/310S.S.I. 2006/310), for the definition of “appropriate Research Ethics
Committee” substitute—

Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of
Information about Transplants) Regulations 2006 (S.I. 2006/1260S.I. 2006/1260)

8 In regulation 1(2) of the Human Tissue Act 2004 (Ethical Approval,
Exceptions from Licensing and Supply of Information about Transplants)
20Regulations 2006 (S.I. 2006/1260S.I. 2006/1260), for the definition of “research ethics
authority” substitute—

Mental Capacity Act 2005 (Appropriate Body) (England) Regulations 2006 (S.I. 2006/2810S.I. 2006/2810)

9 In regulation 2 of the Mental Capacity Act 2005 (Appropriate Body)
(England) Regulations 2006 (S.I. 2006/2810S.I. 2006/2810) (definition of “appropriate
body”), for the words from “is a committee” to the end substitute “is a
35research ethics committee recognised or established by or on behalf of the
Health Research Authority under the Care Act 2014.”

Mental Capacity Act 2005 (Appropriate Body) (Wales) Regulations 2007 (S.I. 2007/833S.I. 2007/833)

10 In regulation 2 of the Mental Capacity 2005 (Appropriate Body) (Wales)
Regulations 2007 (S.I. 2007/833S.I. 2007/833) (definition of “appropriate body”), for the
40words from “is a committee” to the end substitute “is a group of persons
which assesses the ethics of research involving individuals and which is
recognised for that purpose by or on behalf of the Welsh Ministers.”

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Human Fertilisation and Embryology (Disclosure of Information for Research Purposes)
Regulations 2010 (S.I. 2010/995S.I. 2010/995)

11 In regulation 2(1) of the Human Fertilisation and Embryology (Disclosure of
Information for Research Purposes) Regulations 2010 (S.I. 2010/995S.I. 2010/995), for the
5definition of “research ethics committee” substitute—

Independent Health Care (Wales) Regulations 2011 (S.I. 2011/734S.I. 2011/734)

12 10In regulation 25 of the Independent Health Care (Wales) Regulations 2011
(S.I. 2011/734S.I. 2011/734) (research), in paragraph (2) for the words from “a research
ethics committee” to the end substitute “a group of persons which assesses
the ethics of research involving individuals and which is recognised for that
purpose by or on behalf of the Welsh Ministers.”

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Contents page 40-49 50-59 60-69 70-79 80-89 90-99 100-109 110-119 120-129 130-139 140-149 Last page