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Consent of subjects, etc., in clinical trials in emergency situations

Health Products (Clinical Trials) Regulations 2016

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—(1) The consents referred to in regulation 16 need not be obtained in accordance with that regulation in order for a person to be a subject in a clinical trial in an emergency situation if all of the following are satisfied:(a)the Authority has authorised or accepted a notification for the trial, as a clinical trial in an emergency situation;(b)the relevant institutional review board of the trial has reviewed and approved —(i)the circumstances in which the consents referred to in regulation 16 need not be obtained for the purposes of the trial; and(ii)the procedure to be adopted in the trial to ensure that paragraphs (3), (4), (5) and (7) are complied with;(c)an investigator of the trial who is a specialist and one specialist who is not conducting the trial certify in writing before using the person in the trial that —(i)the person is facing a life‑threatening situation which necessitates intervention;(ii)the person is unable to consent as a result of the person’s medical condition;(iii)it is not feasible to obtain consent from the legal representative of the person within the window period; and(iv)neither the person nor the legal representative of the person nor any member of the person’s family has informed any investigator of any objection to the person being a subject in the trial.(2) Despite paragraph (1), paragraphs (3) to (7) must be complied with.(3) If the consent of the person who is to be or is a subject in the clinical trial in an emergency situation cannot be obtained because of the medical condition of the person and if, at any time, the person regains capacity to give such consent, the principal investigator must ensure that, at the earliest feasible opportunity —(a)the person is given a full and reasonable explanation of the matters referred to in regulation 19(1)(a) to (u), in accordance with regulation 19(3); and(b)the consent of the person to be or to continue to be a subject in the trial is obtained.(4) If the consent of the person who is to be a subject in the clinical trial in an emergency situation cannot be obtained because of the medical condition of the person, the principal investigator must ensure that, at the earliest feasible opportunity (including during the window period) —(a)all reasonable efforts are made to contact the legal representative of the person;(b)the legal representative is given a full and reasonable explanation of the matters referred to in regulation 19(1)(a) to (u), in accordance with regulation 19(3); and(c)the legal representative’s consent for the person to be or to continue to be a subject in the trial is obtained.(5) Without prejudice to paragraph (4), where the consent of the person who is to be a subject in the clinical trial in an emergency situation cannot be obtained because of the medical condition of the person and it is not feasible to obtain consent from the legal representative of the person within the window period, then the principal investigator must ensure that, at the earliest feasible opportunity (including during the window period) —(a)all reasonable efforts are made to contact any member of the person’s family; and(b)the member of the person’s family is given a full and reasonable explanation of the matters referred to in regulation 19(1)(a) to (u), in accordance with regulation 19(3).(6) To avoid doubt —(a)despite (pursuant to paragraph (4)) the legal representative of the person consenting to the person being or continuing to be a subject in the clinical trial in an emergency situation, paragraph (3) continues to apply; and once the consent under paragraph (3) is obtained, paragraph (4) ceases to apply; and(b)despite (pursuant to paragraph (5)) a member of the person’s family being contacted and not objecting to the person being or continuing to be a subject in the clinical trial in an emergency situation, paragraphs (3) and (4) continue to apply; and once the consent under paragraph (3) or (4) is obtained, paragraph (5) ceases to apply.(7) The principal investigator must ensure that a person is not or ceases to be a subject in the clinical trial in an emergency situation if, at any time —(a)the person or the legal representative of the person refuses to give the consent referred to in paragraph (3) or (4), as the case may be; or(b)where neither the consent of the person nor the consent of the legal representative of the person has been obtained, any member of the person’s family informs the principal investigator of any objection to the person being or continuing to be a subject in the trial.(8) In this regulation, “specialist” means a person registered as a specialist under section 22 of the Medical Registration Act 1997 in the branch of medicine under which the subject is to be treated.

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