Human Biomedical Research Act 2015

Human Biomedical Research Act 2015 2020 REVISED EDITION This revised edition incorporates all amendments up to and including 1 December 2021 and comes into operation on 31 December 2021 An Act to regulate the conduct of human biomedical research, to further regulate certain restricted human biomedical research, to prohibit certain types of human biomedical research, to regulate tissue banks and tissue banking activities, to prohibit commercial trading of human tissue and to provide for matters connected therewith. [1 July 2016: Except sections 6 to 39, 64, 65 and 68 and the Third, Fourth and Fifth Schedules; 1 January 2017: Sections 32 and 33; 1 November 2017: Sections 6 to 31, 65, and 68 and the Third, Fourth and Fifth Schedules; 1 November 2019: Sections 34, 35, 36, 37, 38, 39 and 64] PART 1 PRELIMINARY Short title 1. This Act is the Human Biomedical Research Act 2015. General interpretation 2. In this Act, unless the context otherwise requires — “adult” means a person who is 21 years of age or older or a person below 21 years of age who was or is married; “adult who lacks mental capacity” means an adult who lacks capacity within the meaning of section 4 of the Mental Capacity Act 2008; “appropriate consent” means the consent given by a person or, where applicable, by another person on his or her behalf, in accordance with Part 3; “authorised officer” means any public officer or any officer of any statutory body appointed by the Director‑General under section 4(2); [Act 11 of 2023 wef 01/05/2023] “biomedical research”, except for the purposes of section 3, has the same meaning as “human biomedical research”; “cytoplasmic hybrid embryo” means a human-animal combination embryo created — (a) by replacing the nucleus of an animal egg or of an animal cell, or 2 animal pronuclei, with — (i) 2 human pronuclei; (ii) one nucleus of a human gamete or of any other human cell; or (iii) one human gamete or other human cell; or (b) by replacing the nucleus of a human egg or of a human cell, or 2 human pronuclei, with — (i) 2 animal pronuclei; (ii) one nucleus of an animal gamete or of any other animal cell; or (iii) one animal gamete or other animal cell; “declaration of compliance” means a declaration by a research institution or a tissue bank of its compliance with the requirements of this Act; “deputy”, in relation to an adult who lacks mental capacity, means a deputy appointed by the court under the Mental Capacity Act 2008; [Act 11 of 2023[Deleted by Act 11 of 2023 wef 01/05/2023]] “Director‑General” means the Director‑General of Health; [Act 11 of 2023 wef 01/05/2023] “donee”, in relation to an adult who lacks mental capacity, means the donee of that adult’s lasting power of attorney; “donor”, in relation to human tissue, means a natural person, whether living or dead, from whose body the human tissue is obtained; “health information” means information pertaining to an individual — (a) obtained in the course of or in connection with providing healthcare services; or (b) relating to the study, prevention, prognostication, diagnosis, or alleviation of a disease, disorder, or injury; “healthcare institution” means — (a) the holder of a licence granted under the Healthcare Services Act 2020; or [Act 19 of 2025 wef 05/12/2025] (aa) [Deleted by Act 19 of 2025 wef 05/12/2025] (b) any facility, premises or conveyance which is declared by the Minister, by order in the Gazette, to be a healthcare institution for the purposes of this Act; “human biological material” or “biological material” means any biological material obtained from the human body that consists of, or includes, human cells; “human biomedical research” has the meaning given by section 3; “human tissue” or “tissue” means any human biological material but excludes human biological material specified in the First Schedule; “incidental finding”, in relation to human biomedical research, means a finding about a research subject that has potential health or reproductive importance to the research subject and is discovered in the course of conducting research but is unrelated to the purposes, objectives or variables of the study; “individually‑identifiable”, in relation to human biological material or health information pertaining to an individual, means that the individual can be identified — (a) from the human biological material or health information; or (b) from that human biological material or health information and other information to which the person, research institution, tissue bank or other organisation has or is likely to have access; “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; “lasting power of attorney” means a valid lasting power of attorney registered under the Mental Capacity Act 2008; “medical practitioner” means a person who is registered, or deemed to be registered, as a medical practitioner under the Medical Registration Act 1997; “minimal risk”, in relation to human biomedical research or tissue banking activity, means the probability and magnitude of harm and discomfort anticipated in the research or the removal of human tissue that are not greater, in and of themselves, than those ordinarily encountered — (a) in the daily life of normal and healthy persons; or (b) during the performance of routine physical or psychological examinations or tests; “minor” means a person who is below 21 years of age and who has never been married; “prohibited human biomedical research” means any human biomedical research specified in the Third Schedule; “research” means any systematic investigation with the intention of developing or contributing to generalisable knowledge; “research institution” means a body of persons, whether corporate or unincorporate or other organisation, or ministry or department of the Government who or which — (a) engages, directly or indirectly (either through contractual or other arrangements), one or more researchers to conduct human biomedical research in Singapore; and (b) exercises supervision and control over human biomedical research conducted in Singapore by the researchers the institution has engaged; “research subject” means a natural person, whether living or dead — (a) whom a researcher involves in human biomedical research; or (b) from whom human biological material or health information is obtained for use in the human biomedical research; “researcher” means any natural person who conducts human biomedical research under the supervision and control of a research institution; “restricted human biomedical research” means any human biomedical research specified in the Fourth Schedule; “reviewing authority”, in relation to human biomedical research, means the institutional review board responsible for the initial or continuing review of the research; “serious adverse event” — (a) in relation to human biomedical research, means any untoward medical occurrence as a result of any human biomedical research which — (i) results in or contributes to death; (ii) is life‑threatening; (iii) requires in‑patient hospitalisation or prolongation of existing hospitalisation; (iv) results in or contributes to persistent or significant disability or incapacity; (v) results in or contributes to a congenital anomaly or birth defect; or (vi) results in such other event as may be prescribed; (b) in relation to tissue banking activity, means any untoward occurrence associated with the procurement, testing, processing, storage or distribution of human tissue (including gametes or embryos) intended for human application which — (i) results in or contributes to death; (ii) is life‑threatening; (iii) requires in‑patient hospitalisation or prolongation of existing hospitalisation; (iv) results in or contributes to persistent or significant disability or incapacity; (v) results in the transmission of a communicable disease; (vi) results in any misidentification or mix‑up of any type of tissue, gametes or embryo; or (vii) results in such other event as may be prescribed; “tissue bank” means an individual or a body of persons, whether corporate or unincorporate, or other organisation, that carries on or conducts any tissue banking activity but excludes an individual, a body of persons or an organisation that conducts any tissue banking activity solely for the purpose of the person’s or organisation’s own human biomedical research approved or exempted from review by an institutional review board; “tissue banking activity” means a structured and an organised activity involving human tissue for the purposes of facilitating current or future research or for public health or epidemiological purposes or any combination of such purposes including any of the following activities: (a) the collection, storage, procurement or importation of human tissue; (b) the supply, provision or export of human tissue. Meanings of “human biomedical research” and “supervision and control” 3.—(1) In this Act, “human biomedical research” means the research specified in subsection (2) or (3) but subject to subsection (4). (2) Any research that is intended to study — (a) the prevention, prognostication, diagnosis or alleviation of any disease, disorder or injury affecting the human body; (b) the restoration, maintenance or promotion of the aesthetic appearance of human individuals through clinical procedures or techniques; or (c) the performance or endurance of human individuals, where the research involves — (d) subjecting an individual to any intervention (including any wilful act or omission) that has a physical, mental or physiological effect (whether temporary or permanent) on the body of the individual; (e) the use of any individually‑identifiable human biological material; or (f) the use of any individually‑identifiable health information. (3) Any research that involves — (a) human gametes or human embryos; (b) cytoplasmic hybrid embryos; (c) the introduction of any human-animal combination embryo into an animal or a human; (d) the introduction of human stem cells (including induced pluripotent stem cells) or human neural cells into an animal at any stage of development (including a prenatal animal foetus or animal embryo); or (e) any entity created as a result of any process referred to in paragraph (c) or (d). (4) Subsections (2) and (3) do not apply to such research, studies or activities that are specified in the Second Schedule. (5) For the purposes of this Act, human biomedical research is treated as conducted under the supervision and control of a research institution if the research institution is identified as the research institution for that research and that research has been reviewed by an institutional review board appointed by that research institution.