<EN xmlns="http://www.legislation.gov.uk/namespaces/legislation" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:base="http://www.legislation.gov.uk/id/ukpga/2005/9" xsi:schemaLocation="http://www.legislation.gov.uk/namespaces/legislation http://www.legislation.gov.uk/schema/en.xsd" SchemaVersion="1.0" DocumentURI="http://www.legislation.gov.uk/ukpga/2005/9/notes" IdURI="http://www.legislation.gov.uk/id/ukpga/2005/9/notes"><ukm:Metadata xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:ukm="http://www.legislation.gov.uk/namespaces/metadata">
				<dc:identifier>http://www.legislation.gov.uk/ukpga/2005/9/section/30/notes</dc:identifier><dc:subject>Incapacity</dc:subject><dc:subject>Legislation</dc:subject><dc:subject>Medical and psychiatric treatment</dc:subject><dc:subject>Civil and human rights</dc:subject><dc:subject>Law</dc:subject><dc:title>Explanatory Notes to Mental Capacity Act 2005</dc:title><dc:creator>Department for Constitutional Affairs</dc:creator><dc:publisher>King's Printer of Acts of Parliament</dc:publisher><dc:modified>2020-04-20</dc:modified>
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</ukm:DocumentClassification><ukm:Year Value="2005"/><ukm:Number Value="9"/><ukm:ISBN Value="9780105609056"/></ukm:ENmetadata>
				<ukm:Alternatives><ukm:Alternative Date="2008-03-03" URI="http://www.legislation.gov.uk/ukpga/2005/9/pdfs/ukpgaen_20050009_en.pdf" Title="Explanatory Note"/></ukm:Alternatives>
			</ukm:Metadata><ExplanatoryNotes><ENprelims>
<Title><Citation URI="http://www.legislation.gov.uk/id/ukpga/2005/9" id="c00001" Class="UnitedKingdomPublicGeneralAct" Year="2005" Number="0009">Mental Capacity Act 2005</Citation></Title>
<Number>9</Number>
<DateOfEnactment>
<DateText>7 April 2005</DateText>
</DateOfEnactment>
</ENprelims><Body><Division id="d00007" DocumentURI="http://www.legislation.gov.uk/ukpga/2005/9/notes/division/6" IdURI="http://www.legislation.gov.uk/id/ukpga/2005/9/notes/division/6"><Title>Commentary on Sections</Title><CommentaryPart id="n00004" DocumentURI="http://www.legislation.gov.uk/ukpga/2005/9/notes/division/6/1" IdURI="http://www.legislation.gov.uk/id/ukpga/2005/9/notes/division/6/1"><Title><CitationSubRef id="c00119" URI="http://www.legislation.gov.uk/id/ukpga/2005/9/part/1" CitationRef="c00001" SectionRef="part-1">Part 1</CitationSubRef>: Persons Who Lack Capacity</Title><CommentaryDivision id="n00041" DocumentURI="http://www.legislation.gov.uk/ukpga/2005/9/notes/division/6/1/8" IdURI="http://www.legislation.gov.uk/id/ukpga/2005/9/notes/division/6/1/8"><Title>Research</Title><CommentaryP1 id="n00042" DocumentURI="http://www.legislation.gov.uk/ukpga/2005/9/notes/division/6/1/8/1" IdURI="http://www.legislation.gov.uk/id/ukpga/2005/9/notes/division/6/1/8/1">
<Title><CitationSubRef id="c00457" URI="http://www.legislation.gov.uk/id/ukpga/2005/9/section/30" CitationRef="c00001" SectionRef="section-30">Section 30</CitationSubRef>: Research</Title>
<NumberedPara id="paragraph-96" DocumentURI="http://www.legislation.gov.uk/ukpga/2005/9/notes/paragraph/96" IdURI="http://www.legislation.gov.uk/id/ukpga/2005/9/notes/paragraph/96"><Pnumber>96</Pnumber><Para>
<Text>This section and <Emphasis><CitationSubRef id="c00459" URI="http://www.legislation.gov.uk/id/ukpga/2005/9/section/31" CitationRef="c00001" SectionRef="section-31">sections 31</CitationSubRef></Emphasis> to <Emphasis><CitationSubRef id="c00461" URI="http://www.legislation.gov.uk/id/ukpga/2005/9/section/30/33" CitationRef="c00457" SectionRef="section-30-33">33</CitationSubRef> </Emphasis>allow intrusive research to be lawfully carried out on, or in relation to, a person who lacks capacity, where the research is part of a research project approved by an appropriate body and it is carried out in accordance with the conditions set out in <Emphasis><CitationSubRef id="c00463" URI="http://www.legislation.gov.uk/id/ukpga/2005/9/section/32" CitationRef="c00001" SectionRef="section-32">sections 32</CitationSubRef></Emphasis> and <Emphasis><CitationSubRef id="c00465" URI="http://www.legislation.gov.uk/id/ukpga/2005/9/section/30/33" CitationRef="c00457" SectionRef="section-30-33">33</CitationSubRef></Emphasis>.  The provisions are based on long-standing international standards, for example, those laid down by the World Medical Association and the Council of Europe Convention on Human Rights and Biomedicine.</Text>
</Para></NumberedPara>
<NumberedPara id="paragraph-97" DocumentURI="http://www.legislation.gov.uk/ukpga/2005/9/notes/paragraph/97" IdURI="http://www.legislation.gov.uk/id/ukpga/2005/9/notes/paragraph/97"><Pnumber>97</Pnumber><Para>
<Text>This section relates to intrusive research, which means research that would normally need consent if it involved an adult with capacity. Clinical trials that are currently regulated under the <Citation URI="http://www.legislation.gov.uk/id/uksi/2004/1031" id="c00466" Class="UnitedKingdomStatutoryInstrument" Year="2004" Number="1031">Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)</Citation> (or regulations succeeding or amending them) are excluded from the Act because those Regulations already make provision for trials involving participants who lack capacity. Research on anonymised medical data or tissue is also not included, but may be subject to controls under the Data Protection Act 1998 or the Human Tissue Act 2004.</Text>
</Para></NumberedPara>
<NumberedPara id="paragraph-98" DocumentURI="http://www.legislation.gov.uk/ukpga/2005/9/notes/paragraph/98" IdURI="http://www.legislation.gov.uk/id/ukpga/2005/9/notes/paragraph/98"><Pnumber>98</Pnumber><Para>
<Text>The appropriate authority (the Secretary of State in relation to research in England and the National Assembly for Wales in relation to research in Wales) must specify an appropriate body for approving research projects, such as a Research Ethics Committee (REC).</Text>
</Para></NumberedPara>
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