Gain-of-function research: Ethical analysis

Abstract

Gain-of-function (GOF) research, which involves manipulating pathogens to increase transmissibility and/or virulence, has raised ethical concerns regarding biosecurity and biosafety. While such research aims to advance understanding of disease agents and inform public health interventions, potential risks include accidental release and malevolent use. This paper reviews the ethical debate on GOF research, focusing on biosafety, risk-benefit analysis, risk minimization strategies, and the controversy surrounding the potential benefits of such research. The paper critiques risk-benefit assessment as a sole guide for decision-making and explores alternative ethical and decision-making frameworks, including expected utility maximization, the precautionary principle, rights-based approaches, deontological ethics, and principlism. A novel framework for GOF research decision- and policy-making is presented, encompassing eight principles: research imperative, proportionality, minimization of risks, manageability of risks, justice, good governance, evidence, and international outlook. This framework, designed to guide ethical evaluation of GOF research, considers the multifaceted nature of the issue, emphasizing a spectrum of ethical acceptability rather than rigid categorization. – AI-generated abstract.