{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-1/part-1/paragraph-1",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-1/part-1/paragraph-1.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/1",
  "kind": "paragraph",
  "number": "1",
  "heading": null,
  "text": "(1) The conditions and principles specified in Part 2 apply to all clinical trials.\n(2) If any participant of a clinical trial is—\n(a) an adult able to give informed consent, or\n(b) an adult who has given informed consent to taking part in the clinical trial prior to the onset of incapacity,\nthe conditions and principles specified in Part 3 apply in relation to that participant.\n(3) Subject to sub-paragraphs (6) and (7), if any participant of a clinical trial is a minor, the conditions and principles specified in Part 4 apply in relation to that participant.\n(4) Subject to sub-paragraphs (6) and (7), if any participant —\n(a) is an adult unable by virtue of physical or mental incapacity to give informed consent, and\n(b) did not, prior to the onset of incapacity, give or refuse to give informed consent to taking part in the clinical trial,\nthe conditions and principles specified in Part 5 apply in relation to that participant.\n(5) If any person—\n(a) is an adult unable by virtue of physical or mental incapacity to give informed consent, and\n(b) has, prior to the onset of incapacity, refused to give informed consent to taking part in the clinical trial,\nthat person cannot be included as a participant in the clinical trial.\n(6) Sub-paragraph (7) applies if treatment is being, or is about to be, provided for a participant who is a minor or an incapacitated adult as a matter of urgency and, having regard to the nature of the clinical trial and of the particular circumstances of the case—\n(a) it is also necessary to take action for the purposes of the clinical trial as a matter of urgency; but\n(b) it is not reasonably practicable to meet the conditions set out in paragraphs 1 to 5 of Part 4 in the case of a minor or paragraphs 1 to 5 of Part 5 in the case of an incapacitated adult.\n(7) Where this sub-paragraph applies, paragraphs 1 to 5 of Part 4 in the case of a minor or paragraphs 1 to 5 of Part 5 in the case of an incapacitated adult shall not apply in relation to the participant if the action specified in sub-paragraph (6) is carried out in accordance with a procedure approved by an ethics committee ... at the time it gave its favourable opinion.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "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)(a)"
    },
    {
      "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)(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Sch. 1 Pt. 1 para. 1(3) substituted (1.5.2008) by The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 (S.I. 2008/941), regs. 1(1), 4(2)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in Sch. 1 Pt. 1 para. 1(4) substituted (12.12.2006) by The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006 (S.I. 2006/2984), regs. 1(1), 2(a)"
    },
    {
      "type": "F",
      "label": "F5",
      "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": "F6",
      "text": "Sch. 1 Pt. 1 para. 1(6)(7) inserted (12.12.2006) by The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006 (S.I. 2006/2984), regs. 1(1), 2(b)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Words in Sch. 1 Pt. 1 para. 1(6) inserted (1.5.2008) by The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 (S.I. 2008/941), regs. 1(1), 4(3)(a)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Words in Sch. 1 Pt. 1 para. 1(6) substituted (1.5.2008) by The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 (S.I. 2008/941), regs. 1(1), 4(3)(b)"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Words in Sch. 1 Pt. 1 para. 1(7) substituted (1.5.2008) by The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 (S.I. 2008/941), regs. 1(1), 4(4)"
    },
    {
      "type": "F",
      "label": "F10",
      "text": "Words in Sch. 1 Pt. 1 para. 1(7) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 37(3)(d)(i)"
    },
    {
      "type": "F",
      "label": "F11",
      "text": "Words in Sch. 1 Pt. 1 para. 1(7) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 37(3)(d)(ii)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/schedule/1/part/1/paragraph/1",
    "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."
}