S. 112 in force at 1.1.2015 by S.I. 2014/2473, art. 5(d)

S. 113 in force at 1.1.2015 by S.I. 2014/2473, art. 5(e)

S. 114 in force at 1.1.2015 by S.I. 2014/2473, art. 5(f)

S. 115 in force at 1.1.2015 by S.I. 2014/2473, art. 5(g)

S. 116 in force at 1.1.2015 by S.I. 2014/2473, art. 5(h)

http://www.legislation.gov.uk/ukpga/2014/23/part/3/chapter/2/crossheading/research-ethics-committees/2018-04-11Care Act 2014An Act to make provision to reform the law relating to care and support for adults and the law relating to support for carers; to make provision about safeguarding adults from abuse or neglect; to make provision about care standards; to establish and make provision about Health Education England; to establish and make provision about the Health Research Authority; to make provision about integrating care and support with health services; and for connected purposes.texttext/xmlenStatute Law Database2024-05-18Expert Participation2018-04-11PART 3HealthCHAPTER 2Health Research AuthorityResearch ethics committees
112The 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)

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).

(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.

(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 financial assistance).

(5)

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

(a)

membership;

(b)

proceedings;

(c)

staff;

(d)

accommodation and facilities;

(e)

expenses;

(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 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.

(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 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.

113Approval 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 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 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.

(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.

114Recognition 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 113(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)

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.

(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 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,

(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 109, 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 HRA 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 109).

115Establishment by the HRA(1)

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

(a)

approving research of the kind referred to in section 113(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 section.

116Membership 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)—

(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 ”.

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<heading>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
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<subsection eId="section-112-1">
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<content>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
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.
</p>
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<p>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—</p>
</intro>
<level class="para1" eId="section-112-2-a">
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<content>
<p>by obtaining information from them;</p>
</content>
</level>
<level class="para1" eId="section-112-2-b">
<num>(b)</num>
<content>
<p>by obtaining bodily tissue or fluid from them;</p>
</content>
</level>
<level class="para1" eId="section-112-2-c">
<num>(c)</num>
<content>
<p>by using information, tissue or fluid obtained from them on a previous occasion;</p>
</content>
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<level class="para1" eId="section-112-2-d">
<num>(d)</num>
<content>
<p>by requiring them to undergo a test or other process (including xenotransplantation).</p>
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</subsection>
<subsection eId="section-112-3">
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<intro>
<p>
For the purposes of subsection (1), the
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
</p>
</intro>
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<num>(a)</num>
<content>
<p>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</p>
</content>
</level>
<level class="para1" eId="section-112-3-b">
<num>(b)</num>
<content>
<p>must monitor their compliance with those requirements.</p>
</content>
</level>
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<subsection eId="section-112-4">
<num>(4)</num>
<intro>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
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—
</p>
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<level class="para1" eId="section-112-4-a">
<num>(a)</num>
<content>
<p>co-ordinate their work;</p>
</content>
</level>
<level class="para1" eId="section-112-4-b">
<num>(b)</num>
<content>
<p>allocate work to them;</p>
</content>
</level>
<level class="para1" eId="section-112-4-c">
<num>(c)</num>
<content>
<p>develop and maintain training programmes designed to ensure that their members and staff can carry out their work effectively;</p>
</content>
</level>
<level class="para1" eId="section-112-4-d">
<num>(d)</num>
<content>
<p>provide them with advice and help (including help in the form of financial assistance).</p>
</content>
</level>
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<intro>
<p>The requirements in the REC policy document may, for example, relate to—</p>
</intro>
<level class="para1" eId="section-112-5-a">
<num>(a)</num>
<content>
<p>membership;</p>
</content>
</level>
<level class="para1" eId="section-112-5-b">
<num>(b)</num>
<content>
<p>proceedings;</p>
</content>
</level>
<level class="para1" eId="section-112-5-c">
<num>(c)</num>
<content>
<p>staff;</p>
</content>
</level>
<level class="para1" eId="section-112-5-d">
<num>(d)</num>
<content>
<p>accommodation and facilities;</p>
</content>
</level>
<level class="para1" eId="section-112-5-e">
<num>(e)</num>
<content>
<p>expenses;</p>
</content>
</level>
<level class="para1" eId="section-112-5-f">
<num>(f)</num>
<content>
<p>objectives and functions;</p>
</content>
</level>
<level class="para1" eId="section-112-5-g">
<num>(g)</num>
<content>
<p>accountability;</p>
</content>
</level>
<level class="para1" eId="section-112-5-h">
<num>(h)</num>
<content>
<p>procedures for challenging decisions.</p>
</content>
</level>
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<content>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
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 (
<abbr class="acronym" title="Statutory Instrument">S.I.</abbr>
2004/1031).
</p>
</content>
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<subsection eId="section-112-7">
<num>(7)</num>
<intro>
<p>
Before publishing the REC policy document, the
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
must consult—
</p>
</intro>
<level class="para1" eId="section-112-7-a">
<num>(a)</num>
<content>
<p>the devolved authorities, and</p>
</content>
</level>
<level class="para1" eId="section-112-7-b">
<num>(b)</num>
<content>
<p>such other persons as it considers appropriate.</p>
</content>
</level>
</subsection>
<subsection eId="section-112-8">
<num>(8)</num>
<content>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
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
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
considers the revisions significant.
</p>
</content>
</subsection>
<subsection eId="section-112-9">
<num>(9)</num>
<content>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
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.
</p>
</content>
</subsection>
</section>
<section eId="section-113">
<num>113</num>
<heading>Approval of research</heading>
<subsection eId="section-113-1">
<num>(1)</num>
<intro>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
must publish guidance about—
</p>
</intro>
<level class="para1" eId="section-113-1-a">
<num>(a)</num>
<content>
<p>
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
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
under this Chapter, and
</p>
</content>
</level>
<level class="para1" eId="section-113-1-b">
<num>(b)</num>
<content>
<p>the cases in which an enactment requires a person proposing to conduct research of that kind to obtain that approval.</p>
</content>
</level>
</subsection>
<subsection eId="section-113-2">
<num>(2)</num>
<intro>
<p>
Before publishing guidance under subsection (1), the
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
must—
</p>
</intro>
<level class="para1" eId="section-113-2-a">
<num>(a)</num>
<content>
<p>
consult the devolved authorities and such other persons as the
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
considers appropriate, and
</p>
</content>
</level>
<level class="para1" eId="section-113-2-b">
<num>(b)</num>
<content>
<p>obtain the approval of the Secretary of State.</p>
</content>
</level>
</subsection>
<subsection eId="section-113-3">
<num>(3)</num>
<content>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
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
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
considers the revisions significant.
</p>
</content>
</subsection>
<subsection eId="section-113-4">
<num>(4)</num>
<content>
<p>Schedule 8 (which amends various references to research ethics committees in secondary legislation) has effect.</p>
</content>
</subsection>
</section>
<section eId="section-114">
<num>114</num>
<heading>
Recognition by the
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
</heading>
<subsection eId="section-114-1">
<num>(1)</num>
<intro>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
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—
</p>
</intro>
<level class="para1" eId="section-114-1-a">
<num>(a)</num>
<content>
<p>approving research of the kind referred to in section 113(1), and</p>
</content>
</level>
<level class="para1" eId="section-114-1-b">
<num>(b)</num>
<content>
<p>giving such other approvals as enactments require.</p>
</content>
</level>
</subsection>
<subsection eId="section-114-2">
<num>(2)</num>
<intro>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
may not recognise a group under this section unless it is satisfied that—
</p>
</intro>
<level class="para1" eId="section-114-2-a">
<num>(a)</num>
<content>
<p>the group will, if recognised, comply with the requirements set out in the REC policy document, and</p>
</content>
</level>
<level class="para1" eId="section-114-2-b">
<num>(b)</num>
<content>
<p>there is or will be a demand for such a group.</p>
</content>
</level>
</subsection>
<subsection eId="section-114-3">
<num>(3)</num>
<content>
<p>
In deciding whether to recognise a group under this section, the
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
must have regard to whether the group is recognised as a research ethics committee by or on behalf of a devolved authority.
</p>
</content>
</subsection>
<subsection eId="section-114-4">
<num>(4)</num>
<content>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
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.
</p>
</content>
</subsection>
<subsection eId="section-114-5">
<num>(5)</num>
<intro>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
may revoke a recognition under this section if it is satisfied that—
</p>
</intro>
<level class="para1" eId="section-114-5-a">
<num>(a)</num>
<content>
<p>the group to which the recognition applies is not complying with the requirements specified in the REC policy document,</p>
</content>
</level>
<level class="para1" eId="section-114-5-b">
<num>(b)</num>
<content>
<p>the group is not (or is not properly) carrying out its function of assessing the ethical aspects of research, or</p>
</content>
</level>
<level class="para1" eId="section-114-5-c">
<num>(c)</num>
<content>
<p>revocation is necessary or desirable for some other reason.</p>
</content>
</level>
</subsection>
<subsection eId="section-114-6">
<num>(6)</num>
<content>
<p>
A group in existence immediately before the commencement of section 109, 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
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
under this section.
</p>
</content>
</subsection>
<subsection eId="section-114-7">
<num>(7)</num>
<content>
<p>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 109).</p>
</content>
</subsection>
</section>
<section eId="section-115">
<num>115</num>
<heading>
Establishment by the
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
</heading>
<subsection eId="section-115-1">
<num>(1)</num>
<intro>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
may establish research ethics committees which have the following functions—
</p>
</intro>
<level class="para1" eId="section-115-1-a">
<num>(a)</num>
<content>
<p>approving research of the kind referred to in section 113(1);</p>
</content>
</level>
<level class="para1" eId="section-115-1-b">
<num>(b)</num>
<content>
<p>giving such other approvals as enactments require.</p>
</content>
</level>
</subsection>
<subsection eId="section-115-2">
<num>(2)</num>
<content>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
must ensure that a research ethics committee established under this section complies with the requirements set out in the REC policy document.
</p>
</content>
</subsection>
<subsection eId="section-115-3">
<num>(3)</num>
<content>
<p>
The
<abbr class="acronym" title="Housing Revenue Account">HRA</abbr>
may abolish a research ethics committee established under this section.
</p>
</content>
</subsection>
</section>
<section eId="section-116">
<num>116</num>
<heading>Membership of the United Kingdom Ethics Committee Authority</heading>
<intro>
<p>
In regulation 5 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (
<abbr class="acronym" title="Statutory Instrument">S.I.</abbr>
2004/1031) (United Kingdom Ethics Committee Authority)—
</p>
</intro>
<level class="para1" eId="section-116-a">
<num>(a)</num>
<content>
<p>
<mod>
in paragraphs (1), (2) and (3), for “the Secretary of State for Health”, in each place it appears, substitute
<quotedText>“ the Health Research Authority ”</quotedText>
, and
</mod>
</p>
</content>
</level>
<level class="para1" eId="section-116-b">
<num>(b)</num>
<content>
<p>
<mod>
in paragraph (2), for “the Secretary of State” substitute
<quotedText>“ the Health Research Authority ”</quotedText>
.
</mod>
</p>
</content>
</level>
</section>
</hcontainer>
</chapter>
</part>
</body>
</act>
</akomaNtoso>