A decision analytic model to guide early‐stage government regulatory action: Applications for synthetic biology

Abstract

Synthetic biology (SB) involves the alteration of living cells and biomolecules for specific purposes. Products developed using these approaches could have significant societal benefits, but also pose uncertain risks to human and environmental health. Policymakers currently face decisions regarding how stringently to regulate and monitor various SB applications. This is a complex task, in which policymakers must balance uncertain economic, political, social, and health‐related decision factors associated with SB use. We argue that formal decision analytical tools could serve as a method to integrate available evidence‐based information and expert judgment on the impacts associated with SB innovations, synthesize that information into quantitative indicators, and serve as the first step toward guiding governance of these emerging technologies. For this paper, we apply multi‐criteria decision analysis to a specific case of SB, a micro‐robot based on biological cells called “cyberplasm.” We use data from a Delphi study to assess cyberplasm governance options and demonstrate how such decision tools may be used for assessments of SB oversight.

Converging and emerging threats to health security

“…In addition, risk analysis frameworks play an important role in biosecurity decision-making and policy. Using the approach of multiple criteria based upon emerging biotechnologies such as synthetic biology, traditional risk assessment such as health and environmental data, and other characteristics such as the uncertainty, reversibility, manageability of risk and levels of public concern (Cummings and Kuzma 2017; Trump et al 2017), can be integrated to provide evidence-based information to government, academia and non-governmental organisations. Such risk analysis methods could assist decision-makers to rank policy priorities and to improve the governance of biosecurity.…”

Comparative, collaborative, and integrative risk governance for emerging technologies

“…Second, recognizing that comprehensive quantitative data will be either unavailable or involve too much uncertainty to be reliable, governance should not require the collection of absolute measures of acceptable risk. Instead, governance should be based on collaboration between policymakers, regulators, industrial developers, workers, experts, and representatives of society from multiple disciplines, in a manner that establishes safe guidelines and best practices consistent with recent scientific advancements and expected new developments (Renn 2005;Trump et al 2017;Kuiken et al 2014). Such effort requires assessment across a material's life cycle, including insight from laboratory researchers and workers involved in the initial production of a material who are particularly at risk, to safe containment and shipping, to consumer product safety, to proper end-of-life disposal.…”

“…Since risk is a function of both hazard and exposure, much of the uncertainty associated with new chemicals entering the marketplace is due to the paucity of reliable information regarding the toxicity, and even greater uncertainty about the frequency and extent of an individual's contact with a specific compound given typical utilizations of that chemical (e.g., cosmetics, cleaning products, etc.) and individuals' use patterns compared to the intended use (Grieger et al 2009;Wilson and Schwarzman 2009;Ferson and Sentz 2016;Linkov et al 2017).…”

The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies

“…Therefore, a framework must be sufficiently adaptable as to allow the included tools to be updated for future generations of NMs, and to incorporate learning over time. Such an adaptive style of governance should be flexible enough to account for the unique political and institutional realities of a given jurisdiction, and allow existing regulatory structures to iteratively incorporate new risk knowledge over time such as via TSCA in the United States, or REACH regulations in the European Union Comprehensive consideration of the motivation of various users .…”

“…Such an adaptive style of governance should be flexible enough to account for the unique political and institutional realities of a given jurisdiction, and allow existing regulatory structures to iteratively incorporate new risk knowledge over time such as via TSCA in the United States, or REACH regulations in the European Union. (28) Comprehensive consideration of the motivation of various users. For a framework to be effective, it has to accommodate the responses of the various parties (e.g., employers, workers, regulators, policymakers, insurers, general public) in order to motivate compliance and best practices.…”