What is a Designated Chapter?
Section 5.1.6 of the National Statement states that the following types of research require review by a Human Research Ethics Committee (HREC) (except where research on collections of non-identifiable data under these chapters satisfies the conditions for exemption from review): • Chapter 3.3: Interventions and therapies, including clinical and non-clinical trials, and innovations • Chapter 3.5: Human genetics, • Chapter 3.6: Human stem cells, • Chapter 4.1: Women who are pregnant and the human foetus, • Chapter 4.4: People highly dependent on medical care who may be unable to give consent, • Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness, • Chapter 4.7: Aboriginal and Torres Strait Islander Peoples, • Chapter 4.6: People who may be involved in illegal activities (Where research is intended to study or expose illegal activity or that is likely to discover it must be reviewed and approved by a Human Ethics Research Committee (HREC), exce
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