{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-15",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-15.json",
  "legislation": "uksi/2004/1031",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004",
  "path": "regulation/15",
  "kind": "regulation",
  "number": "15",
  "heading": "Application for ethics committee opinion",
  "text": "(1) The sponsor must make an application for an ethics committee opinion in relation to a clinical trial in accordance with the procedure set out in regulation 16.\n(2) The application must be made to one ethics committee only, regardless of the number of trial locations at which the trial is to be conducted.\n(3) Subject to paragraph (4), the application must be made to an ethics committee established or recognised—\n(a) for the entire United Kingdom; and\n(b) in relation to a description or class of clinical trial into which the proposed trial falls.\n(4) If—\n(a) a clinical trial is conducted at one or more trial locations in Scotland;\n(b) the trial involves adults unable by virtue of physical or mental incapacity to give informed consent; and\n(c) the chief investigator is professionally based at a hospital, health centre, surgery or other establishment or facility in Scotland,\nthe application for an ethics committee opinion in relation to that trial must be made to an Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000.\n(5) For the purposes of paragraph (4), a chief investigator is professionally based at the hospital, health centre, surgery or other establishment or facility at or from which the chief investigator’s professional practice is primarily conducted.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 14-26 substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 14"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/regulation/15",
    "retrieved_at": "2026-10-29T05:28:03.775386+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."
}