Scottish Statutory Instruments
ADULTS WITH INCAPACITY
Made
15th April 2002
Laid before the Scottish Parliament
17th April 2002
Coming into force
1st July 2002
The Scottish Ministers, in exercise of the powers conferred by sections 51(6) and (7) and 86(2) of the Adults with Incapacity (Scotland) Act 2000M1 and of all other powers enabling them in that behalf, hereby make the following Regulations:
Marginal Citations
M12000 asp 4. Section 87(1) contains a definition of “prescribed” relevant to the making of these Regulations.
1. These Regulations may be cited as the Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002 and come into force on 1st July 2002.
2. There is hereby constituted an Ethics Committee (“the Committee”) for the purposes specified in section 51 of the Adults with Incapacity (Scotland) Act 2000.
3.—(1) The members of the Committee may be appointed by the Scottish Ministers on such terms and conditions as the Scottish Ministers consider appropriate.
(2) No more than [F130] members shall be appointed to the Committee at any time.
(3) The membership of the Committee shall, so far as practical, include at least–
(a)one person who has experience in relation to the treatment of adults who are incapable;
(b)one medical practitioner who provides [F2primary medical services pursuant to Part I] of the National Health Service (Scotland) Act 1978 M2;
(c)one registered nurse or registered midwife;
(d)one registered medical practitioner having experience in clinical pharmacology;
(e)one [F3pharmacist registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010] or a registered person as defined by Article 2(2) of the Pharmacy (Northern Ireland) Order 1976 M3;
(f)one registered medical practitioner who holds the position of hospital consultant;
(g)one registered medical practitioner having experience in the field of public health medicine;
(h)one member who is registered as a member of a profession to which the [F4Health Professions Order 2001 applies]; and
(i)three lay members.
(4) Each member may be appointed for a period not exceeding 5 years but no member may be appointed for consecutive periods exceeding [F512] years.
(5) Where a person has been appointed as a member for a total of [F612] years consecutively that person may only be appointed again as a member under paragraph (4) above after the expiration of a period of 2 years from the end of the person’s previous membership.
Textual Amendments
F1Word in reg. 3(2) substituted (20.2.2007) by The Adults with Incapacity (Ethics Committee) (Scotland) Amendment Regulations 2007 (S.S.I. 2007/22), regs. 1, 2(2)
F2Words in reg. 3(3)(b) substituted (31.5.2004) by virtue of The Primary Medical Services (Consequential and Ancillary Amendments) (Scotland) Order 2004 (S.S.I. 2004/212), art. 1, sch. 1 para. 11
F3Words in reg. 3(3)(e) substituted (27.9.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(5), Sch. 4 para. 35 (with Sch. 5); S.I. 2010/1621, art. 2(1), Sch.
F4Words in reg. 3(3)(h) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 3 para. 6; S.I. 2019/1436, reg. 2(b)
F5Word in reg. 3(4) substituted (21.5.2020) by The Adults with Incapacity (Ethics Committee) (Scotland) (Coronavirus) Amendment Regulations 2020 (S.S.I. 2020/151), regs. 1, 2(2)
F6Word in reg. 3(5) substituted (21.5.2020) by The Adults with Incapacity (Ethics Committee) (Scotland) (Coronavirus) Amendment Regulations 2020 (S.S.I. 2020/151), regs. 1, 2(2)
Marginal Citations
M21978 c.29. Section 17C was inserted by section 21(2) of the National Health Service (Primary Care) Act 1997 (c.46) (“the 1997 Act”). Section 19 was amended by section 4 of and paragraph 29 of the Schedule to the Medical (Professional Performance) Act 1995 (c.51) and section 41(10) and (11) of and paragraph 39 of Schedule 2 to the 1997 Act (c.46).
4. Subject to regulation 3(4) and (5) above, the Scottish Ministers may appoint, from among the members of the Committee, a Chair[F7, ] a Vice-Chair [F8and up to two Alternate Vice-Chairs] of the Committee for such period or periods as the Scottish Ministers consider appropriate.
Textual Amendments
F7Comma in reg. 4 substituted for word (21.5.2020) by The Adults with Incapacity (Ethics Committee) (Scotland) (Coronavirus) Amendment Regulations 2020 (S.S.I. 2020/151), regs. 1, 2(3)(a)
F8Words in reg. 4 inserted (21.5.2020) by The Adults with Incapacity (Ethics Committee) (Scotland) (Coronavirus) Amendment Regulations 2020 (S.S.I. 2020/151), regs. 1, 2(3)(b)
5. The Scottish Ministers may pay, to members of the Committee, such expenses related to their membership of the Committee as the Scottish Ministers consider appropriate.
6. Before approving any research under section 51 of the Adults with Incapacity (Scotland) Act 2000 the Committee must take into account–
(a)the objectives, design, methodology, statistical considerations and organisation of the research;
(b)the relevance of the research and the study design;
(c)the justification of predictable risks and inconveniences weighed against the anticipated benefits for the research participants and future participants;
(d)the suitability of the lead researcher;
(e)the adequacy of the written information to be given and the procedure for obtaining consent; and
(f)the arrangements for the recruitment of research participants.
7.—(1) Subject to the provision of this regulation, the Committee shall consider applications in such manner as it considers appropriate in the circumstances.
(2) No approval of research shall be granted by the Committee unless at least [F9[F103] members are present] and those members include–
(a)the Chair, or in the Chair’s absence, the Vice-Chair [F11or an Alternate Vice-Chair];
(b)[F12a member] from among those appointed under sub-paragraphs (a) to (h) of regulation 3(3) above; and
(c)[F13a member] from among those appointed under sub-paragraph (i) of regulation 3(3) above.
(3) The proceedings of the Committee shall not be invalidated by death or other vacancy in its membership.
(4) Application to the Committee for approval of research shall be in such form as the Committee may determine.
(5) The Committee may call for such information from an applicant as it may reasonably require in order to determine the application and may seek such assistance from other persons as it considers necessary for that determination.
(6) The Committee may refer to one or more of its members for report or recommendation on such matters as it considers appropriate in relation to its consideration of an application.
Textual Amendments
F9Words in reg. 7(2) substituted (20.2.2007) by The Adults with Incapacity (Ethics Committee) (Scotland) Amendment Regulations 2007 (S.S.I. 2007/22), regs. 1, 2(3)
F10Word in reg. 7(2) substituted (21.5.2020) by The Adults with Incapacity (Ethics Committee) (Scotland) (Coronavirus) Amendment Regulations 2020 (S.S.I. 2020/151), regs. 1, 2(4)(a)
F11Words in reg. 7(2)(a) inserted (21.5.2020) by The Adults with Incapacity (Ethics Committee) (Scotland) (Coronavirus) Amendment Regulations 2020 (S.S.I. 2020/151), regs. 1, 2(4)(b)
F12Words in reg. 7(2)(b) substituted (21.5.2020) by The Adults with Incapacity (Ethics Committee) (Scotland) (Coronavirus) Amendment Regulations 2020 (S.S.I. 2020/151), regs. 1, 2(4)(c)
F13Words in reg. 7(2)(c) substituted (21.5.2020) by The Adults with Incapacity (Ethics Committee) (Scotland) (Coronavirus) Amendment Regulations 2020 (S.S.I. 2020/151), regs. 1, 2(4)(d)
HUGH HENRY
Authorised to sign by the Scottish Ministers
St Andrew’s House, Edinburgh
(This note is not part of the Regulations)
These Regulations–
(a) constitute the Ethics Committee (“the Committee”) referred to in section 51 of the Adults with Incapacity (Scotland) Act 2000 (“the Act”) (regulation 2);S
(b) make provision as to the membership, the qualifications of certain members and length of membership of the Committee (regulation 3);S
(c) make provision for the appointment of a Chair and Vice-Chair of the Committee (regulation 4);S
(d) make provision for payment by the Scottish Ministers of expenses of members of the Committee (regulation 5);S
(e) specify certain matters which the Committee must consider before approving research (regulation 6); andS
(f) makes certain procedural provision in relation to the conduct of the Committee in particular by–S
(i) permitting the Committee to consider applications in such manner as it considers appropriate (regulation 7(1)),S
(ii) providing for quorum arrangements (regulation 7(2)),S
(iii) providing that a vacancy in membership will not invalidate its proceedings (regulation 7(3)),S
(iv) permitting the Committee to determine the form of applications (regulation 7(4)),S
(v) allowing the Committee to call for information from applicants and assistance from others (regulation 7(5)), andS
(vi) permitting the Committee to remit matters to one or more members for report or recommendation (regulation 7(6)).S