Human Biomedical Research Act 2015 · 2020 Revised Edition · Schedules
Schedule 1 · Human biological material excluded from definition of human tissue
Feedback & supportFIRST SCHEDULESections 2 and 62(1)Human biological material excluded from definition of human tissue
human biological material
“human biological material” or “biological material” means any biological material obtained from the human body that consists of, or includes, human cells;
1. Hair shaft, cut without dermal hair root or follicle.
2. Nail plate, cut without underlying dermal tissue.
tissue
“human tissue” or “tissue” means any human biological material but excludes human biological material specified in the First Schedule;
3. Naturally excreted bodily fluids and waste products such as saliva, sweat, urine and faeces.4.—
Any other human biological material that is not individually‑identifiable and has been processed in such a manner that its functional, structural and biological characteristics are substantially manipulated as compared to the time of collection.
individually‑identifiable
“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;
For the purposes of and without limiting sub‑paragraph (1), human biological material is not deemed to be substantially manipulated merely because it has been processed by any of, or any combination of, the following methods:
cutting;
grinding;
shaping;
centrifugation;
soaking in antibiotic or antimicrobial solutions;
sterilization;
low-level irradiation;
cell separation, concentration or purification;
filtering;
lyophilisation;
freezing;
cryopreservation;
vitrification.