Regulatory Challenges of Synthetic Biology Trials and Other Highly Innovative Investigational Products

While synthetic biology remains in the early stages of innovation, achieving its posited goal of improving human health will depend on future clinical trials. This article raises questions about Australia’s capacity to ensure that clinical trials involving these kinds of highly innovative investigational products have an acceptable initial and ongoing risk-benefit ratio. Particular challenges include scientific uncertainty surrounding the risks and benefits posed by highly innovative investigational products, as well as the normative nature of assessments of their likelihood and magnitude. These difficulties are compounded by a lack of substantive standards for judging the acceptability of identified trial risks in light of the trial’s potential benefits. In Australia, the Office of the Gene Technology Regulator, the Therapeutic Goods Administration, and Human Research Ethics Committees will share responsibility for assessing risks and benefits for participants in future synthetic biology clinical trials. The article argues that none of these bodies — as they currently operate — are equipped to undertake such reviews and canvasses strategies for better supporting them in this role.