1 Faculty of Law, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand
Because of the extreme difficulty of proving sponsor and/or investigator negligence and a causal link between any such negligence and participant injury, there is a wide consensus that no fault compensation is best ethical response to injured research participants. New Zealand is fortunate to have a taxpayer funded no-fault compensation scheme for accidental injury, included medical injuries. While injured participants in publically-funded research have access to secure and appropriate compensation under the legislative regime, those injured in pharmaceutical sponsored trials do not, having been excluded from cover under it in 1992. Injured subjects must rely instead on compensation assessed in accordance with non-legally binding guidelines imported from the United Kingdom. As a result injured participants are vulnerable to being left uncompensated or undercompensated. Most participants are not aware of this unless and until they are injured and seek compensation, because information sheets do not inform them of the non-legally binding nature of the sponsor’s obligation. This inequitable treatment of injured subjects in industry trials is readily remediable by extending cover under the state no-fault regime to all injured research participants. Relieved of the responsibility for compensating injured subjects, various options for increasing financial incentives on sponsors to exercise care to prevent injuries in clinical research can be considered. Equivalent industry guidelines operate in respect of injuries in industry trials in Australia, where participants must rely principally on ethics committees to ensure that they are fully informed about the “without legal commitment” nature of compensation.
Joanna Manning is a Professor at the Faculty of Law, University of Auckland, where she teaches and has published widely on issues of health law, policy, and ethics; torts, including negligence; and accident compensation, particularly treatment injury and medical misadventure. She was the consumer representative on the Medical Practitioners Disciplinary Committee for approx 10 years, the lawyer member of the National Ethics Advisory Committee from 2005 to 2011 and the lawyer member of the Scientific Advisory Committee of the Heart Foundation NZ (2011-2014).