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the recent announcement of the claimed births of CRISPR-edited babies has prompted both widespread condemnation and calls by leading scientists for a moratorium on any further germline genome editing (GGE) for reproductive purposes (Lander et al. 2019; Regalado 2018). Concurrently, national and international bodies are calling for the development of robust guidelines and requirements that will identify permissible conditions under which such GGE efforts may proceed (NAS 2017; Nuffield Council on Bioethics 2018a). As detailed recommendations to navigate this unique terrain are under development, we suggest an approach that begins with identifying serious concerns about social exclusion and social justice that arise with GGE. These concerns, we argue, are not captured by a utilitarian ethics framework, which seeks to maximize positive over negative health outcomes. Rather, these concerns reflect people's rights, rights that have standing independently of outcome assessment and that set constraints on the means to achieving an otherwise positive end like the goal of improving population health. To operationalize an approach that takes the promise of technologies to improve health seriously, while also constraining the means to this end according to rights considerations, we propose using the Human Rights Impact Assessment (HRIA) (Gostin and Mann 1994).
Before developing an effective regulatory framework with an emphasis on human rights, we must identify the distinct features that trigger societal concerns over GGE. The rapid and widespread emergence of discussions surrounding the CRISPR babies case confirms that scientists engineering heritable changes to human beings touches on something core to the human experience. This kind of genome editing goes beyond the conventional concerns about the safety and effectiveness of the technology. In contrast to GGE, applications of non-heritable genome editing tend to generate a more subdued response from both the public and the scientific or medical communities. For example, when undertaken in FDA-approved clinical trials, editing the CCR5 gene in adults with the goal of treating HIV infection was heralded as an important medical step forward (US National Library of Medicine 2018). Scientists involved in the CRISPR babies experiment targeted the same CCR5 gene, aiming to prevent HIV infection, yet many saw this milestone as a step backwards. This is not to say that all theoretical non-heritable genome editing applications are immune from societal concern. For example,...