What is Your Duty of Care with Clinical Trials of Innovative Techniques and Therapeutic Goods?
Thursday 28 August 2014 / by Alison Choy Flannigan posted in Health Aged Care & Life Sciences

It is well-established that an individual’s consent is always required before treatment is rendered. In the absence of obtaining the individual’s consent, the treating practitioner may be held liable for trespass to person, assault or battery (1).

For study participant consent to be valid, the treating practitioner is under an obligation to sufficiently inform the participant of the material risks involved in that treatment to allow the individual to make an informed decision with respect to whether or not they choose to undergo the treatment (2). The risks must be communicated to the individual having regard to the individual’s capacity to understand the information provided (3).

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Authors: Alison Choy Flannigan, Partner, Zara Officer, Special Counsel and Vahini Chetty, Associate
August 2014

(1) Hart v Herron (1984)Aust Tort Reports 80-201.
(2) See Chatterton v Gerson (1981) QB 432.
(3) See Rogers v Whitaker (1992) 175 CLR 479 and Wallace v Kam [2013] HCA 19.


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