Citation

Manning JM. Med. Law Rev. 2017; 25(3): 397-427.

Affiliation

Faculty of Law, University of Auckland, Auckland, New Zealand.

Copyright

(Copyright © 2017, Centre of Medical Law and Ethics, King's College London, Publisher Oxford University Press)

DOI

10.1093/medlaw/fwx019

PMID

28453790

Abstract

Despite a consensus that society owes an ethical obligation to compensate for research-related injury, and that no-fault is the best ethical response, an assessment of the compensation arrangements in place in the UK, Australia and New Zealand shows that in general compensation arrangements fall below this ethical expectation. Most subjects rely on ex gratia payment or an unenforceable assurance of payment in the event of injury. It is also likely that, given significant deficiencies in participant information about compensation arrangements in place for trials recommended by the supervisory ethics agencies in each jurisdiction, subjects only find out about their financial exposure in the event of injury. Industry-drafted guidelines governing compensation in commercially sponsored trials do not protect subjects' interests, but operate primarily to protect the interests of industry. The article considers potential solutions to the ethical deficiency of the compensation arrangements, and argues that the ethical corollary of the fact that society is the ultimate beneficiary of its members' participation in clinical research, is that society as a whole should bear the cost of participant injuries, through establishment of a central no-fault compensation fund financed either by the state or those directly involved in biomedical research.

© The Author 2017. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oup.com.

Language: en

Keywords

Clinical trials; Compensation for research-related injury; Ex gratia compensation; Informed consent to compensation arrangement in research