# The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, Regulation 28: Amendment of Schedule 2 to the principal Regulations


In Schedule 2 to the principal Regulations (additional provisions relating to ethics committees)—
(a) in paragraph 1 (interpretation), in the definition of “appointing authority”—
(i) in sub-paragraph (b), omit “or”,
(ii) in sub-paragraph (c), for “the Authority;” substitute “the Authority, or”,
(iii) after sub-paragraph (c), insert the following sub-paragraph—
“(d) in relation to the Gene Therapy Advisory Committee, the Secretary of State;”;
(b) in paragraph 6 (committees, meetings and proceedings), after sub-paragraph (4), insert—
“(5) An ethics committee shall retain all the documents relating to a clinical trial on which it gives an opinion for—
(a) where the trial proceeds, at least three years from the conclusion of the trial; or
(b) where the trial does not proceed, at least three years from the date of the opinion.”; and
(c) in paragraph 8 (deputies and co-opted members), in sub-paragraph (6), for “(4)” substitute “(5)”.

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Source: https://www.legislation.gov.uk/uksi/2006/1928/regulation/28 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006/regulation-28
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.