Classification as a HBRA-regulated study/activity
- YES, if it is Human Biomedical Research as defined by the HBRA.
- YES, if it involves human tissues or tissue banking.
Your study will be classified as HBR if the following 3 criteria are met:
1. The study is “Research”
i.e. Systematic investigation to develop or contribute generalisable knowledge (Sections 3(2)(a), (b) & (c) HBRA).
2. The study involves human subject research with a certain purpose and method
Purposive Element: Prevention, treatment and alleviation of disease/injury or aesthetic clinical procedures or human performance/endurance (Sections 3(2)(a), (b) & (c) HBRA)
Method Element: Physical/physiological/mental human intervention or uses individually-identifiable human biological material or uses individually-identifiable health information (Section 3(2)(i), (ii) & (iii) HBRA)
3. The study is not an excluded study
i.e. is not a study on normal psychological responses and behaviours, measuring human intelligence, health information for statistics purpose or a study under Infectious Disease Act, Medicines (Clinical Trials) Regulations or Health Products (Clinical Trials) Regulations (2nd Schedule, HBRA)
Study activities involve "tissues" or "human tissues" if the biomaterials meet all of the following 3 criteria:
1. The biomaterials contain cells
i.e. “human biological material” as defined in HBRA
2. The biomaterials are not ordinarily excreted or shed
Such as saliva, urine, sweat, hair, nail clippings, faeces (1st Schedule HBRA)
3. The biomaterials have not been de-identified and have not been substantially manipulated
Substantial manipulation results in a change to its biological, functional or structural properties.
(Paragraph 4(1), 2nd Schedule, HBRA)
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