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(4) A reference to a public authority—

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

(b) subject to that, does not include a reference to a public authority
5outside 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
corresponds to a function of the HRA;

(b) 10to 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
giving effect to the arrangements.

15Failure 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
and within such period, as the direction specifies.

(2) 20If 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
Secretary of State’s behalf.

(3) 25Where 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.

Part 3 30Finance and reports

Funding

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

35Fees 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
specified in, or determined in accordance with, the regulations.

(2) Where the amount of a fee is to be specified in regulations under this
40paragraph—

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(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
which the fee relates, and

(b) the HRA must provide the Secretary of State with such information,
5in 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) must require the HRA, before determining the amount of the fee, to
have regard to the cost incurred in the exercise of the function to
10which 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) Regulations 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
15determined.

(5) Regulations under this paragraph may include provision—

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

(b) for 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) 20Before 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
members and officers of certain authorities from personal liability) has effect
as if there were included in the authorities referred to in that section a
25reference 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
reference to this Act.

(9) In section 71(2) of the National Health Service Act 2006 (schemes for meeting
30losses and liabilities etc. of certain health service bodies), after paragraph (f)
insert—

(fa) the Health Research Authority;.

Accounts

18 (1) The HRA must keep accounts in such form as the Secretary of State may
35determine.

(2) The HRA must prepare annual accounts in respect of each financial year in
such 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) 40the Comptroller and Auditor General,

within such period after the end of the financial year to which the accounts
relate 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) 45lay copies of them and the report on them before Parliament.

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

(a) beginning 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
5date.

Annual report

19 (1) As 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) 10the activities it proposes to undertake during the current financial
year.

(2) The report must set out the steps the HRA has taken during the year to fulfil
its main objective (see section 97(2)).

(3) The HRA must—

(a) 15lay a copy of the report before Parliament, and

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

(4) The 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.

20Part 4 Consequential amendments

Public Records Act 1958

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

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;.

30Parliamentary 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 35In Part 2 of Schedule 1 to the House of Commons Disqualification Act 1975,
at the appropriate place insert—

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Copyright, Designs and Patents Act 1988

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

5Freedom 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 10In 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
England (inserted by paragraph 35 of Schedule 5 to this Act) insert—

Section 100

15SCHEDULE 8 Research ethics committees: amendments

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

1 In 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) 20omit 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—

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

3 In 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)
152005 (S.R. 2005/160S.R. 2005/160), for the definition of “ethics committee” substitute—

20Residential 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
Ireland) 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
30Ireland) 2005 (S.R. 2005/174S.R. 2005/174), for the definition of “ethics committee”
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
40(S.S.I. 2006/310S.S.I. 2006/310), for the definition of “appropriate Research Ethics
Committee” substitute—

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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)
5Regulations 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 group
20of persons which assesses the ethics of research involving individuals and
which is recognised for that purpose by or on behalf of the Secretary of
State.”

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)
25Regulations 2007 (S.I. 2007/833S.I. 2007/833) (definition of “appropriate body”), for the
words 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.”

Human Fertilisation and Embryology (Disclosure of Information for Research Purposes)
30Regulations 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
definition of “research ethics committee” substitute—

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

12 In 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
40ethics 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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