Part 3Amendment to Part 2 (Ethics Committees)

Amendment to regulation 5

regulation 6 + 6.—(1) Regulation 5 (United Kingdom Ethics Committees Authority) is amended as follows.

(2) In paragraphs (1), (2) and (3)—

regulation 6 2 a + (a)for “National Assembly for Wales”, in each place where it occurs, substitute “Welsh Ministers”;

regulation 6 2 b + (b)for “Department for Health, Social Services and Public Safety for Northern Ireland”, in each place where it occurs, substitute “Department of Health in Northern Ireland”.

(3) In paragraph (4), omit “(including conditions as to remuneration, benefits, allowances and reimbursement for expenses)”.

(4) In paragraph (5), omit sub-paragraph (b) and the “or” preceding it.

Amendment to regulation 6

regulation 7 + 7.—(1) Regulation 6 (establishment of ethics committees) is amended as follows.

(2) In the heading, after “establishment” insert “and abolition”.

(3) In paragraph (1)—

regulation 7 3 a + (a)for “ethics committees” substitute “an ethics committee”;

regulation 7 3 b + (b)omit sub-paragraph (a).

(4) After paragraph (1) insert—

“(1A) The Authority must ensure that the arrangements for the membership and operation of that committee—

(a)enable that committee to perform the functions of an ethics committee; and

(b)comply with regulation 9.”.

(5) For paragraph (2) substitute—

“(2) The Authority may—

(a)specify any conditions or limitations that apply to an ethics committee, including whether that committee may act for the entire United Kingdom or only for a particular area of the United Kingdom;

(b)where they consider it necessary or appropriate to do so—

(i)vary the description or class of clinical trial in relation to which that committee may act as an ethics committee, or

(ii)vary or revoke any conditions or limitations imposed under paragraph (2)(a); and

(c)abolish any such committee if the Authority is satisfied that—

(i)the arrangements for the membership and operation of that committee are no longer such that the committee is able to adequately perform its functions under these Regulations,

(ii)the committee is failing to perform its functions under these Regulations adequately or at all, or

(iii)it is otherwise necessary or appropriate to do so.”.

(6) After paragraph (2) insert—

“(3) Where the Authority abolishes an ethics committee or an ethics committee ceases operation—

(a)the Authority may nominate another committee to be responsible for the work of that committee;

(b)the committee nominated in accordance with sub-paragraph (a) must—

(i)consider any applications made to the old committee in accordance with regulation 15, if the old committee had not given an opinion before the date of abolition or ceasing of operation, and

(ii)be the relevant ethics committee for any clinical trial in relation to which the old committee had given a favourable opinion in accordance with regulation 18 or 18B.”.

Omission of regulations 7 and 8

regulation 8 + 8.  Omit regulations 7 (recognition of ethics committees)(1) and 8 (revocation of recognition).

Substitution of regulation 9

regulation 9 + 9.  For regulation 9 (constitution and operation of ethics committees) substitute—

Operation of ethics committees

9.—(1) This regulation does not apply in relation to an Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000.

(2) An ethics committee established under regulation 6 must—

(a)be constituted of 5 or more members, appointed by the Authority, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial; and

(b)include one member appointed by the Authority to be a Chairperson.

(3) An ethics committee may—

(a)establish sub-committees consisting of members of the committee; and

(b)make arrangements for the exercise, on behalf of the committee, of any of its functions by such a sub-committee,

in accordance with the standing orders and standard operating procedures adopted under paragraph (4).

(4) An ethics committee—

(a)must, subject to the approval of the Authority, make standing orders, and adopt standard operating procedures for the regulation of its proceedings and business; and

(b)may, subject to the approval of the Authority, vary or revoke such orders or procedures.

(5) The meetings and proceedings of an ethics committee and its sub-committees must be conducted in accordance with the standing orders made, and the standard operating procedures adopted, under paragraph (4).

(6) All applications for an ethics committee opinion must be considered by a full meeting of an ethics committee.

(7) In this regulation—

“a full meeting of an ethics committee” means a meeting at which—

“lay member” means an individual who does not have a formal qualification related to, or professional experience in, the field of clinical research or healthcare.”.