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Exemption from need to provide certain information if biological material or health information obtained before 1 November 2018

Human Biomedical Research (Requirements for Appropriate Consent — Exemption) Regulations 2019

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—(1) Sections 12, 22(2)(c) and 25 of the Act do not apply in relation to the use of any individually‑identifiable biological material or health information of a research subject in research where —(a)the individually-identifiable biological material or health information was obtained before 1 November 2018;(b)there is documentary evidence indicating that the research subject or the person authorised to give consent mentioned in paragraph (2) —(i)had given relevant consent in writing before 1 November 2018 for the use of the individually‑identifiable biological material or health information; and(ii)had been informed of the matters in section 12(1)(a), (b), (c), (d), (h), (k) and (n) of the Act, before the relevant consent was obtained; and(c)the relevant consent was not withdrawn at any time before 1 November 2018.(2) In paragraph (1), “relevant consent”, in relation to research that is not restricted human biomedical research and a research subject who is a minor or an adult who lacks mental capacity or was deceased when the individually‑identifiable biological material or health information was obtained, means the consent given on behalf of the research subject by any of the following individuals:(a)the donee or deputy of the research subject;(b)the spouse of the research subject;(c)an adult son or daughter of the research subject;(d)either parent or a guardian of the research subject;(e)an adult brother or sister of the research subject.

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