{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006/regulation-28",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006/regulation-28.json",
  "legislation": "uksi/2006/1928",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006",
  "path": "regulation/28",
  "kind": "regulation",
  "number": "28",
  "heading": "Amendment of Schedule 2 to the principal Regulations",
  "text": "In Schedule 2 to the principal Regulations (additional provisions relating to ethics committees)—\n(a) in paragraph 1 (interpretation), in the definition of “appointing authority”—\n(i) in sub-paragraph (b), omit “or”,\n(ii) in sub-paragraph (c), for “the Authority;” substitute “the Authority, or”,\n(iii) after sub-paragraph (c), insert the following sub-paragraph—\n“(d) in relation to the Gene Therapy Advisory Committee, the Secretary of State;”;\n(b) in paragraph 6 (committees, meetings and proceedings), after sub-paragraph (4), insert—\n“(5) An ethics committee shall retain all the documents relating to a clinical trial on which it gives an opinion for—\n(a) where the trial proceeds, at least three years from the conclusion of the trial; or\n(b) where the trial does not proceed, at least three years from the date of the opinion.”; and\n(c) in paragraph 8 (deputies and co-opted members), in sub-paragraph (6), for “(4)” substitute “(5)”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2006/1928/regulation/28",
    "retrieved_at": "2026-10-29T04:25:32.359836+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}