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The Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002

S.S.I. 2002/190 · Made 15 April 2002 · Extends to Scotland

Up to date with all changes known to legislation.gov.uk, revised to 21 May 2020.

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:

Annotations to the whole text

Marginal citations

M1

2000 asp 4. Section 87(1) contains a definition of “prescribed” relevant to the making of these Regulations.

Contents

  1. 1Citation and commencement
  2. 2Ethics Committee
  3. 3Membership of the Committee
  4. 4Chair and Vice-Chair
  5. 5Remuneration
  6. 6Approval of Research
  7. 7Procedures
  8. Signature
  9. Explanatory note

1Citation and commencement

These Regulations may be cited as the Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002 and come into force on 1st July 2002.

2Ethics Committee

There is hereby constituted an Ethics Committee (“the Committee”) for the purposes specified in section 51 of the Adults with Incapacity (Scotland) Act 2000.

3Membership of the Committee

(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 M1;

(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 M2;

(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.

4Chair and Vice-Chair

Subject to regulation 3(4) and (5) above, the Scottish Ministers may appoint, from among the members of the Committee, a ChairF1, a Vice-Chair F2and up to two Alternate Vice-Chairs of the Committee for such period or periods as the Scottish Ministers consider appropriate.

5Remuneration

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.

6Approval of Research

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.

7Procedures

(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 F1F23 members are present and those members include–

(a)

the Chair, or in the Chair’s absence, the Vice-Chair F3or an Alternate Vice-Chair;

(b)

F4a member from among those appointed under sub-paragraphs (a) to (h) of regulation 3(3) above; and

(c)

F5a 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.

Signature

HUGH HENRY

Authorised to sign by the Scottish Ministers

St Andrew’s House, Edinburgh

Explanatory note

(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);

(b)

make provision as to the membership, the qualifications of certain members and length of membership of the Committee (regulation 3);

(c)

make provision for the appointment of a Chair and Vice-Chair of the Committee (regulation 4);

(d)

make provision for payment by the Scottish Ministers of expenses of members of the Committee (regulation 5);

(e)

specify certain matters which the Committee must consider before approving research (regulation 6); and

(f)

makes certain procedural provision in relation to the conduct of the Committee in particular by–

(i)

permitting the Committee to consider applications in such manner as it considers appropriate (regulation 7(1)),

(ii)

providing for quorum arrangements (regulation 7(2)),

(iii)

providing that a vacancy in membership will not invalidate its proceedings (regulation 7(3)),

(iv)

permitting the Committee to determine the form of applications (regulation 7(4)),

(v)

allowing the Committee to call for information from applicants and assistance from others (regulation 7(5)), and

(vi)

permitting the Committee to remit matters to one or more members for report or recommendation (regulation 7(6)).