Human Biomedical Research Act 2015 · 2020 Revised Edition · Schedules
Schedule 2 · Research, studies and matters excluded from definition of human biomedical research
Feedback & supportSECOND SCHEDULESections 3(4) and 62(1)Research, studies and matters excluded from definition of human biomedical research
research
“research” means any systematic investigation with the intention of developing or contributing to generalisable knowledge;
1. Research and studies on normal human psychological responses and behaviours —
which are not designed or intended to study psychiatric or psychological disorders; and
which involve no more than minimal risk to the research subject.
minimal risk
“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;
2. Research, studies and tests to measure human intelligence —
which are not designed or intended to study mental or intellectual disability; and
which involve no more than minimal risk to the research subject.
research subject
“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;
3. National public health research as defined in and conducted in accordance with section 59A of the Infectious Diseases Act 1976.
4. Collection and compilation by the National Registry of Diseases of health information for epidemiological or statistical purposes in accordance with the National Registry of Diseases Act 2007.
health information
“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;
5. Collection and compilation of health information for statistical purposes in accordance with the Statistics Act 1973.
6. Clinical trials of health products conducted in accordance with the Health Products Act 2007.
7. Clinical trials of medicinal products conducted in accordance with the Medicines Act 1975.[S 334/2019]