SCHEDULE 4APPEAL AGAINST UNFAVOURABLE ETHICS COMMITTEE OPINION
1
1
Subject to the following sub-paragraphs, where the United Kingdom Ethics Committee Authority (“the Authority”) receive a notice pursuant to regulation 16(3) F1, (4)(b) or (7) that a chief investigator wishes to appeal against an ethics committee opinion which is not favourable, the Authority shall, subject to sub-paragraph (2)—
a
direct that the application for that opinion may be considered by another ethics committee specified in the direction; or
b
appoint a panel in accordance with paragraph 3 (“an appeal panel”) and refer the opinion to that panel.
2
Subject to sub-paragraph (4), the Authority may refuse to give a direction or appoint a panel pursuant to sub-paragraph (1) where it considers that the grounds for appealing against the opinion are unfounded.
3
Where the Authority refuse to give a direction or appoint a panel pursuant to sub-paragraph (1), the Authority shall send a notice to the chief investigator setting out their reasons for refusal.
4
Where the opinion was given by the Gene Therapy Advisory Committee, the Authority must appoint a panel in accordance with paragraph 3 and refer the opinion to that panel.