Human Biomedical Research Act 2015 · 2020 Revised Edition · Part 3 · Consent
10. Consent for removal or use of tissue for research from minors
Feedback & supportWhere the prospective tissue donor is a minor, the appropriate consent for the removal or use of human tissue must be obtained from the following persons in the following circumstances:
tissue
“human tissue” or “tissue” means any human biological material but excludes human biological material specified in the First Schedule;
where the minor has sufficient understanding and intelligence to enable the minor to understand what is proposed in the procedure, consent is obtained from both the minor and at least one adult parent or guardian of the minor;
where the minor does not have sufficient understanding and intelligence to enable the minor to understand what is proposed in the procedure and the removal of the tissue is primarily for a therapeutic or diagnostic purpose, consent is obtained from at least one adult parent or guardian of the minor;
where the minor lacks mental capacity and the removal of the tissue is primarily for a therapeutic or diagnostic purpose, consent is obtained from —
a deputy who is authorised to give consent for the removal or use of the tissue on behalf of the minor; or
at least one adult parent or guardian of the minor.
For the purposes of subsection (1), the deputy, adult parent or guardian of a minor must, in determining whether to give consent under that subsection, have regard to such matters, considerations and procedures as may be prescribed.
deputy
“deputy”, in relation to an adult who lacks mental capacity, means a deputy appointed by the court under the Mental Capacity Act 2008;
To avoid doubt, subsections (1)(b) and (c) and (2) apply as if there is no requirement that the removal of the tissue is primarily for a therapeutic or diagnostic purpose where the institutional review board has waived such requirement under section 37(3).
institutional review board
“institutional review board” means a board or committee appointed by a research institution under section 15 or 16 to conduct an ethics review of proposed human biomedical research;