Applications for ethical approval prior to 1st May 2004

2.—(1) This sub-paragraph applies where a person has made an application for an ethical opinion in relation to a clinical trial before 1st May 2004 to a committee established or recognised for the purpose of advising on the ethics of research investigations on human beings.

(2) Where—

(a)sub-paragraph (1) applies;

(b)the committee has not given its opinion before 1st May 2004; and

(c)the committee has been recognised by the Authority in accordance with regulation 7 for the area in which the trial sites are situated, or for the description or class of clinical trial into which the trial falls,

the committee shall consider the application as if it had been made in accordance with regulation 14.