Regulation of professional clinical trial volunteers in New Zealand

This paper aims to form a starting point for a discussion of the regulation of paid clinical research volunteers (professional volunteers) in New Zealand. It will argue that professional volunteers, who are currently unregulated as a class of research participants, present unique issues which are not addressed by existing regulation. The major arguments will be that: by restricting the value of financial compensation that can be provided for volunteering in a clinical trial, existing regulation allows professional volunteers to be exploited; professional volunteers are exposed to unregulated compounded risks and it is unlikely that they are properly informed of these risks; and in failing to recognise the existence of professional volunteers, current regulation fails to address their commodification and dehumanisation. Proposals to address these issues will be evaluated through a human rights lens for consistency with the New Zealand Bill of Rights Act 1990 and the Code of Health and Disability Services Consumers’ Rights 1996. Recommendations for reform will be put forward on the basis of this analysis.