{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-1/part-1/paragraph-3",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-1/part-1/paragraph-3.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": "schedule/1/part/1/paragraph/3",
  "kind": "paragraph",
  "number": "3",
  "heading": null,
  "text": "(1) Subject to sub-paragraph (3), for the purposes of this Schedule, a person gives informed consent to take part, or that a participant is to take part, in a clinical trial only if his decision—\n(a) is given freely after that person is informed of the nature, significance, implications and risks of the trial; and\n(b) either—\n(i) is evidenced in writing, dated and signed, or otherwise marked, by that person so as to indicate his consent, or\n(ii) if the person is unable to sign or to mark a document so as to indicate his consent, is communicated (whether by talking, using sign language or any other means) in the presence of at least one witness and recorded in writing.\n(2) For the purposes of this Schedule, references to informed consent—\n(a) shall be construed in accordance with paragraph (1); and\n(b) include references to informed consent given or refused by an adult unable by virtue of physical or mental incapacity to give informed consent, prior to the onset of that incapacity.\n(3) Where sub-paragraph (4) applies, the protocol for the clinical trial for which consent is given may make provision for simplified arrangements for obtaining and evidencing consent, which shall include—\n(a) the reason for obtaining consent using simplified arrangements;\n(b) the information to be provided to the participant, and the means of providing that information; and\n(c) the means by which consent shall be evidenced.\n(4) This sub-paragraph applies where—\n(a) the investigational medicinal product or, if there is more than one, each of the investigational medicinal products, is authorised for use in the United Kingdom and is used in accordance with that authorisation;\n(b) the investigational medicinal product or, if there is more than one, each of the investigational medicinal products, is given to the participant in the course of that participant’s routine health care; and\n(c) the participant receives no additional medication and undergoes no additional intervention or diagnostic procedure, solely for the purposes of the clinical trial.\n(5) For the purposes of sub-paragraph (4)—\n“intervention” includes complementary or alternative therapies, the taking of tissue samples, and requirements in relation to imaging and radiotherapy; and\n“medication” includes nutritional products and alternative remedies.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 1 Pt. 1 para. 3(1) inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 37(3)(f)(i)(aa)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Sch. 1 Pt. 1 substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 37(3)(c)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Sch. 1 Pt. 1 para. 3(1)(b)(ii) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 37(3)(f)(i)(bb)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Sch. 1 Pt. 1 para. 3(3)-(5) inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 37(3)(f)(ii)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/schedule/1/part/1/paragraph/3",
    "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."
}