Regulation 7 Amendment to regulation 6

(1)

Regulation 6 (establishment of ethics committees) is amended as follows.

(2)

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

(3)

In paragraph (1)—

(a)

for “ethics committees” substitute “an ethics committee”;

(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.”.