http://www.legislation.gov.uk/asp/2000/4/section/51/2016-11-30Adults with Incapacity (Scotland) Act 2000An Act of the Scottish Parliament to make provision as to the property, financial affairs and personal welfare of adults who are incapable by reason of mental disorder or inability to communicate; and for connected purposes.2000-05-09texttext/xmlenStatute Law Database2024-05-15Expert Participation2016-11-30 PART 5 MEDICAL TREATMENT AND RESEARCH Authority for research511No surgical, medical, nursing, dental or psychological research shall be carried out on any adult who is incapable in relation to a decision about participation in the research unless—aresearch of a similar nature cannot be carried out on an adult who is capable in relation to such a decision; andbthe circumstances mentioned in subsection (2) are satisfied.2The circumstances referred to in subsection (1) are that—athe purpose of the research is to obtain knowledge of—ithe causes, diagnosis, treatment or care of the adult’s incapacity; oriithe effect of any treatment or care given during his incapacity to the adult which relates to that incapacity; andbSubject to subsection (3A),the conditions mentioned in subsection (3) are fulfilled.3The conditions are—athe research is likely to produce real and direct benefit to the adult;bthe adult does not indicate unwillingness to participate in the research;cthe research has been approved by the Ethics Committee;dthe research entails no foreseeable risk, or only a minimal foreseeable risk, to the adult;ethe research imposes no discomfort, or only minimal discomfort, on the adult; andfconsent has been obtained from any guardian or welfare attorney who has power to consent to the adult’s participation in research or, where there is no such guardian or welfare attorney, from the adult’s nearest relative.3AWhere the research consists of a clinical trial of a medicinal product, the research may be carried out—awithout being approved by the Ethics Committee, if a favourable opinion on the trial has been given by an ethics committee, other than the Ethics Committee, in accordance with regulation 15 of the Medicines for Human Use (Clinical Trials) Regulations 2004; . . . bwithout the consent of any guardian or welfare attorney, or the adult’s nearest relative, if—iit has not been practicable to contact any such person before the decision to enter the adult as a subject of the clinical trial is made, andiiconsent has been obtained from a person, other than a person connected with the conduct of the clinical trial, who is—Athe doctor primarily responsible for the medical treatment provided to that adult, orBa person nominated by the relevant health care provider.cwithout the consent of any guardian or welfare attorney, or the adult's nearest relative, if—itreatment is being, or is about to be, provided for an adult who is incapable in relation to a decision about participation in the research as a matter of urgency;iihaving regard to the nature of the clinical trial and of the particular circumstances of the case it is necessary to take action for the purposes of the clinical trial as amatter of urgency;iiiit has not been reasonably practicable to obtain the consent of any such person;ivit has not been reasonably practicable to obtain the consent of any of the persons mentioned in paragraph (b)(ii)(A) or (B);andvthe action to be taken is carried out in accordance with a procedure approved by the Ethics Committee or any other ethics committee or by an appeal panel appointed underSchedule 4 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031) at the time it gave its favourable opinion in relation to theclinical trial.4Where the research is not likely to produce real and direct benefit to the adult, it may nevertheless be carried out if it will contribute through significant improvement in the scientific understanding of the adult’s incapacity to the attainment of real and direct benefit to the adult or to other persons having the same incapacity, provided the other circumstances or conditions mentioned in subsections (1) to (3) are fulfilled.5In granting approval under subsection (3)(c), the Ethics Committee may impose such conditions as it sees fit.6The Ethics Committee shall be constituted by regulations made by the Scottish Ministers and such regulations may make provision as to the composition of, appointments to and procedures of the Ethics Committee and may make such provision for the payment of such remuneration, expenses and superannuation as the Scottish Ministers may determine.7Regulations made by the Scottish Ministers under subsection (6) may prescribe particular matters which the Ethics Committee shall take into account when deciding whether to approve any research under this Part.8In this section any reference to—aa guardian shall include a reference to a guardian (however called) appointed under the law of any country to, or entitled under the law of any country to act for, an adult during his incapacity, if the guardianship is recognised by the law of Scotland;ba welfare attorney shall include a reference to a person granted, under a contract, grant or appointment governed by the law of any country, powers (however expressed) relating to the granter’s personal welfare and having effect during the granter’s incapacity.9In this section—clinical trial on a medicinal product” means a clinical trial as defined by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004;an ethics committee” has the meaning given by that regulation;“person connected with the conduct of the trial” and “relevant health care provider” have the meanings given by Schedule 1 to those regulations.Words in s. 51(2)(b) inserted (1.5.2004) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 54, Sch. 10 para. 21(a)S. 51(3A) inserted (1.5.2004) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 54, Sch. 10 para. 21(b)Word in s. 51(3A)(a) repealed (12.12.2006) by The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006 (S.I. 2006/2984), reg. 3(a)S. 51(3A)(c) inserted (12.12.2006) by The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006 (S.I. 2006/2984), reg. 3(b)S. 51(9) inserted (1.5.2004) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 54, Sch. 10 para. 21(c)
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<Title> MEDICAL TREATMENT AND RESEARCH</Title>
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<Title> Authority for research</Title>
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<Text>No surgical, medical, nursing, dental or psychological research shall be carried out on any adult who is incapable in relation to a decision about participation in the research unless—</Text>
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<Text>The circumstances referred to in subsection (1) are that—</Text>
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<Text>the causes, diagnosis, treatment or care of the adult’s incapacity; or</Text>
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<Text>the effect of any treatment or care given during his incapacity to the adult which relates to that incapacity; and</Text>
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<Addition ChangeId="d29p3951" CommentaryRef="c18068521">Subject to subsection (3A),</Addition>
the conditions mentioned in subsection (3) are fulfilled.
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<Text>The conditions are—</Text>
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<Text>the adult does not indicate unwillingness to participate in the research;</Text>
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<Text>the research has been approved by the Ethics Committee;</Text>
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<Text>the research entails no foreseeable risk, or only a minimal foreseeable risk, to the adult;</Text>
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<Text>the research imposes no discomfort, or only minimal discomfort, on the adult; and</Text>
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<Text>consent has been obtained from any guardian or welfare attorney who has power to consent to the adult’s participation in research or, where there is no such guardian or welfare attorney, from the adult’s nearest relative.</Text>
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<Addition ChangeId="d29p3997" CommentaryRef="c18068561">Where the research consists of a clinical trial of a medicinal product, the research may be carried out—</Addition>
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<Addition ChangeId="d29p3997" CommentaryRef="c18068561">without being approved by the Ethics Committee, if a favourable opinion on the trial has been given by an ethics committee, other than the Ethics Committee, in accordance with regulation 15 of the Medicines for Human Use (Clinical Trials) Regulations 2004; </Addition>
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<Addition ChangeId="d29p3997" CommentaryRef="c18068561">it has not been practicable to contact any such person before the decision to enter the adult as a subject of the clinical trial is made, and</Addition>
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<Addition ChangeId="d29p3997" CommentaryRef="c18068561">the doctor primarily responsible for the medical treatment provided to that adult, or</Addition>
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<Text>
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">a person nominated by the relevant health care provider.</Addition>
</Text>
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<Addition ChangeId="d29p4042" CommentaryRef="c18279251">without the consent of any guardian or welfare attorney, or the adult's nearest relative, if—</Addition>
</Addition>
</Text>
<P4 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/3A/c/i/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/3A/c/i" id="section-51-3A-c-i">
<Pnumber>
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">
<Addition ChangeId="d29p4042" CommentaryRef="c18279251">i</Addition>
</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">
<Addition ChangeId="d29p4042" CommentaryRef="c18279251">treatment is being, or is about to be, provided for an adult who is incapable in relation to a decision about participation in the research as a matter of urgency;</Addition>
</Addition>
</Text>
</P4para>
</P4>
<P4 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/3A/c/ii/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/3A/c/ii" id="section-51-3A-c-ii">
<Pnumber>
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">
<Addition ChangeId="d29p4042" CommentaryRef="c18279251">ii</Addition>
</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">
<Addition ChangeId="d29p4042" CommentaryRef="c18279251">having regard to the nature of the clinical trial and of the particular circumstances of the case it is necessary to take action for the purposes of the clinical trial as amatter of urgency;</Addition>
</Addition>
</Text>
</P4para>
</P4>
<P4 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/3A/c/iii/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/3A/c/iii" id="section-51-3A-c-iii">
<Pnumber>
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">
<Addition ChangeId="d29p4042" CommentaryRef="c18279251">iii</Addition>
</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">
<Addition ChangeId="d29p4042" CommentaryRef="c18279251">it has not been reasonably practicable to obtain the consent of any such person;</Addition>
</Addition>
</Text>
</P4para>
</P4>
<P4 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/3A/c/iv/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/3A/c/iv" id="section-51-3A-c-iv">
<Pnumber>
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">
<Addition ChangeId="d29p4042" CommentaryRef="c18279251">iv</Addition>
</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">
<Addition ChangeId="d29p4042" CommentaryRef="c18279251">it has not been reasonably practicable to obtain the consent of any of the persons mentioned in paragraph (b)(ii)(A) or (B);and</Addition>
</Addition>
</Text>
</P4para>
</P4>
<P4 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/3A/c/v/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/3A/c/v" id="section-51-3A-c-v">
<Pnumber>
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">
<Addition ChangeId="d29p4042" CommentaryRef="c18279251">v</Addition>
</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">
<Addition ChangeId="d29p4042" CommentaryRef="c18279251">the action to be taken is carried out in accordance with a procedure approved by the Ethics Committee or any other ethics committee or by an appeal panel appointed underSchedule 4 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (</Addition>
</Addition>
<Acronym Expansion="Statutory Instrument">
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">
<Addition ChangeId="d29p4042" CommentaryRef="c18279251">S.I.</Addition>
</Addition>
</Acronym>
<Addition ChangeId="d29p3997" CommentaryRef="c18068561">
<Addition ChangeId="d29p4042" CommentaryRef="c18279251"> 2004/1031) at the time it gave its favourable opinion in relation to theclinical trial.</Addition>
</Addition>
</Text>
</P4para>
</P4>
</P3para>
</P3>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/4/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/4" id="section-51-4">
<Pnumber>4</Pnumber>
<P2para>
<Text>Where the research is not likely to produce real and direct benefit to the adult, it may nevertheless be carried out if it will contribute through significant improvement in the scientific understanding of the adult’s incapacity to the attainment of real and direct benefit to the adult or to other persons having the same incapacity, provided the other circumstances or conditions mentioned in subsections (1) to (3) are fulfilled.</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/5/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/5" id="section-51-5">
<Pnumber>5</Pnumber>
<P2para>
<Text>In granting approval under subsection (3)(c), the Ethics Committee may impose such conditions as it sees fit.</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/6/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/6" id="section-51-6">
<Pnumber>6</Pnumber>
<P2para>
<Text>The Ethics Committee shall be constituted by regulations made by the Scottish Ministers and such regulations may make provision as to the composition of, appointments to and procedures of the Ethics Committee and may make such provision for the payment of such remuneration, expenses and superannuation as the Scottish Ministers may determine.</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/7/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/7" id="section-51-7">
<Pnumber>7</Pnumber>
<P2para>
<Text>Regulations made by the Scottish Ministers under subsection (6) may prescribe particular matters which the Ethics Committee shall take into account when deciding whether to approve any research under this Part.</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/8/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/8" id="section-51-8">
<Pnumber>8</Pnumber>
<P2para>
<Text>In this section any reference to—</Text>
<P3 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/8/a/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/8/a" id="section-51-8-a">
<Pnumber>a</Pnumber>
<P3para>
<Text>a guardian shall include a reference to a guardian (however called) appointed under the law of any country to, or entitled under the law of any country to act for, an adult during his incapacity, if the guardianship is recognised by the law of Scotland;</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/8/b/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/8/b" id="section-51-8-b">
<Pnumber>b</Pnumber>
<P3para>
<Text>a welfare attorney shall include a reference to a person granted, under a contract, grant or appointment governed by the law of any country, powers (however expressed) relating to the granter’s personal welfare and having effect during the granter’s incapacity.</Text>
</P3para>
</P3>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/asp/2000/4/section/51/9/2016-11-30" IdURI="http://www.legislation.gov.uk/id/asp/2000/4/section/51/9" id="section-51-9">
<Pnumber>
<Addition ChangeId="d29p4123" CommentaryRef="c18068581">9</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="d29p4123" CommentaryRef="c18068581">In this section—</Addition>
</Text>
</P2para>
</P2>
<UnorderedList Decoration="none" Class="Definition">
<ListItem>
<Para>
<Text>
<Addition ChangeId="d29p4123" CommentaryRef="c18068581"></Addition>
<Term id="term-clinical-trial-on-a-medicinal-product">
<Addition ChangeId="d29p4123" CommentaryRef="c18068581">clinical trial on a medicinal product</Addition>
</Term>
<Addition ChangeId="d29p4123" CommentaryRef="c18068581">” means a clinical trial as defined by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004;</Addition>
</Text>
</Para>
</ListItem>
<ListItem>
<Para>
<Text>
<Addition ChangeId="d29p4123" CommentaryRef="c18068581"></Addition>
<Term id="term-an-ethics-committee">
<Addition ChangeId="d29p4123" CommentaryRef="c18068581">an ethics committee</Addition>
</Term>
<Addition ChangeId="d29p4123" CommentaryRef="c18068581">” has the meaning given by that regulation;</Addition>
</Text>
</Para>
</ListItem>
<ListItem>
<Para>
<Text>
<Addition ChangeId="d29p4123" CommentaryRef="c18068581">“person connected with the conduct of the trial” and “relevant health care provider” have the meanings given by Schedule 1 to those regulations.</Addition>
</Text>
</Para>
</ListItem>
</UnorderedList>
</P1para>
</P1>
</P1group>
</Part>
</Body>
</Primary>
<Commentaries>
<Commentary id="c18068521" Type="F">
<Para>
<Text>
Words in s. 51(2)(b) inserted (1.5.2004) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2004/1031" id="c00736" Class="UnitedKingdomStatutoryInstrument" Year="2004" Number="1031" Title="The Medicines for Human Use (Clinical Trials) Regulations 2004">The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031)</Citation>
,
<CitationSubRef id="c00737" CitationRef="c00736" URI="http://www.legislation.gov.uk/id/uksi/2004/1031/regulation/54" SectionRef="regulation-54">reg. 54</CitationSubRef>
,
<CitationSubRef id="c00738" CitationRef="c00736" URI="http://www.legislation.gov.uk/id/uksi/2004/1031/schedule/10/paragraph/21/a" SectionRef="schedule-10-paragraph-21-a" Operative="true">Sch. 10 para. 21(a)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="c18068561" Type="F">
<Para>
<Text>
S. 51(3A) inserted (1.5.2004) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2004/1031" id="c00740" Class="UnitedKingdomStatutoryInstrument" Year="2004" Number="1031" Title="The Medicines for Human Use (Clinical Trials) Regulations 2004">The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031)</Citation>
,
<CitationSubRef id="c00741" CitationRef="c00740" URI="http://www.legislation.gov.uk/id/uksi/2004/1031/regulation/54" SectionRef="regulation-54">reg. 54</CitationSubRef>
,
<CitationSubRef id="c00742" CitationRef="c00740" URI="http://www.legislation.gov.uk/id/uksi/2004/1031/schedule/10/paragraph/21/b" SectionRef="schedule-10-paragraph-21-b" Operative="true">Sch. 10 para. 21(b)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="c18279211" Type="F">
<Para>
<Text>
Word in s. 51(3A)(a) repealed (12.12.2006) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2006/2984" id="c00744" Class="UnitedKingdomStatutoryInstrument" Year="2006" Number="2984" Title="The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006">The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006 (S.I. 2006/2984)</Citation>
,
<CitationSubRef id="c00745" CitationRef="c00744" URI="http://www.legislation.gov.uk/id/uksi/2006/2984/regulation/3/a" SectionRef="regulation-3-a" Operative="true">reg. 3(a)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="c18279251" Type="F">
<Para>
<Text>
S. 51(3A)(c) inserted (12.12.2006) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2006/2984" id="c00747" Class="UnitedKingdomStatutoryInstrument" Year="2006" Number="2984" Title="The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006">The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006 (S.I. 2006/2984)</Citation>
,
<CitationSubRef id="c00748" CitationRef="c00747" URI="http://www.legislation.gov.uk/id/uksi/2006/2984/regulation/3/b" SectionRef="regulation-3-b" Operative="true">reg. 3(b)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="c18068581" Type="F">
<Para>
<Text>
S. 51(9) inserted (1.5.2004) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2004/1031" id="c00750" Class="UnitedKingdomStatutoryInstrument" Year="2004" Number="1031" Title="The Medicines for Human Use (Clinical Trials) Regulations 2004">The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031)</Citation>
,
<CitationSubRef id="c00751" CitationRef="c00750" URI="http://www.legislation.gov.uk/id/uksi/2004/1031/regulation/54" SectionRef="regulation-54">reg. 54</CitationSubRef>
,
<CitationSubRef id="c00752" CitationRef="c00750" URI="http://www.legislation.gov.uk/id/uksi/2004/1031/schedule/10/paragraph/21/c" SectionRef="schedule-10-paragraph-21-c" Operative="true">Sch. 10 para. 21(c)</CitationSubRef>
</Text>
</Para>
</Commentary>
</Commentaries>
</Legislation>