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ORIGINAL RESEARCH
Ethical review of innovative biotechnologies: the principle of non-maleficence in an uncertain environment
Yaroslavl State Medical University, Yaroslavl, Russia
Corresponding author: Irina S Mylnikova
Ostrovityanova St., 1, Moscow, 117997, Russia; ur.liam@dem.trepxe
This paper examines the ethical review of innovative biotechnologies under conditions of deep uncertainty regarding their long-term consequences. Traditional models of biomedical ethics, developed primarily for clinical contexts, presuppose a relatively well-defined and localized type of risk. Genome editing, synthetic biology, and cellular therapies, however, alter the epistemic status of risk: its effects may be delayed, difficult to reverse, distributed across populations, intergenerational, and poorly characterized. The paper argues for a reconceptualization of the principle of non-maleficence under uncertainty: from a logic of prohibition to a logic of precaution; from risk estimation to the management of uncertainty; and from individual consent to collective participation in decision-making.
Keywords: genome editing, bioethics, ethical review, innovative biotechnologies, uncertainty, principle of non-maleficence, precautionary principle