Abstract:
Despite a broad 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 reveals that in general compensation arrangements fall below this ethical expectation. Most subjects rely on an unenforceable assurance of payment or ex gratia payment in the event of injury. It is also likely that, given significant deficiencies in participant information about the compensation arrangement in place for the trial recommended by supervisory bodies in each jurisdiction, subjects only find out about their financial exposure in the event of injury when submitting a claim. Reliance on industry-drafted guidelines regulating compensation in commercially-sponsored trials has not served to protect subjects’ interests, but have been drafted and function to protect the interests of industry. The article considers potential solutions to the ethical deficiency of the compensation arrangements: legal action by injured participants; ethics committees exercising their powers to decline to approve trials where a no-fault compensation arrangement backed by appropriate insurance is not in place; and the establishment of a central no-fault compensation fund. It is argued that since society as a whole is the ultimate beneficiary of its members’ participation in clinical research, the ethical corollary is that the fund be financed and administered by the state.
