‘Serious’ factor—a relevant starting point for further debate: a response

Abstract

In this reply, we wish to defend our original position and address several of the points raised by two excellent responses. The first response (De Miguel Beriain) questions the relevance of the notion of ‘serious’ within the context of human germline genome modification (HGGM). We argue that the ‘serious’ factor is relevant and that there is a need for medical and social lenses to delineate the limits of acceptability and initial permissible applications of HGGM. In this way, ‘serious’ acts as a starting point for further discussions and debates on the acceptability of the potential clinical translation of HGGM. Therefore, there is a pressing need to clarify its scope, from a regulatory perspective, so as to prevent individuals from using HGGM for non-therapeutic or enhancement purposes. The second response (Kalsi) criticizes the narrow interpretation of the objectivist approach and the apparent bias towards material innovations when discussing the right to benefit from scientific advancements. As an in-depth discussion of the objectivist and constructivist approaches was beyond the scope of our original paper, we chose to focus on one specific objectivist account, one which focuses on biological and scientific facts. We agree, however, with the critique that material innovations should not be the sole focus of the right to benefit from scientific advancements, which also incorporates freedom of scientific research and access to scientific knowledge scientific freedom and knowledge, including the influence of these on ethical thinking and cultures.

Initial heritable genome editing: mapping a responsible pathway from basic research to the clinic

“…In their 2020 Report, the International Commission on the Clinical Use of Human Germline Genome Editing concluded that i-HGE should be limited to serious monogenic diseases and to ‘changing a pathogenic genetic variant … to a sequence that is common in the relevant population and that is known not to be disease-causing’ (National Academy of Medicine et al 2020 , p. 3 [recommendation 4.2]). Erika Kleiderman and colleagues likewise stated that the ‘seriousness’ of a condition is relevant to decision-making regarding the use of i-HGE, as a greater benefit could offset the risks associated with a previously untested procedure (Kleiderman, Ravitsky, and Knoppers 2019 ; 2020 ). The authors further derive the significance of seriousness from a human rights-based framework, specifically in the ‘right to science’ and the ‘right to the highest attainable health’, to bridge the divide between objective and subjective definitions of health (Kleiderman, Ravitsky, and Knoppers 2019 ; 2020 ).…”

“…Erika Kleiderman and colleagues likewise stated that the ‘seriousness’ of a condition is relevant to decision-making regarding the use of i-HGE, as a greater benefit could offset the risks associated with a previously untested procedure (Kleiderman, Ravitsky, and Knoppers 2019 ; 2020 ). The authors further derive the significance of seriousness from a human rights-based framework, specifically in the ‘right to science’ and the ‘right to the highest attainable health’, to bridge the divide between objective and subjective definitions of health (Kleiderman, Ravitsky, and Knoppers 2019 ; 2020 ).…”