Various experts and organizations advocate for a global governance framework to establish scientific and ethical standards for human genome editing and to approve acceptable gene editing pathways (48, 56, 77). The World Health Organization (WHO) expert committee is set to release its final report on this governance framework in 2021. In a preliminary statement, the committee outlined plans to propose a framework that aims to:
(i) Identify key issues and mechanisms for addressing them, developed in collaboration with a diverse range of stakeholders.
(ii) Be scalable, sustainable, and applicable at international, regional, national, and local levels.
(iii) Function effectively in regions with less stringent regulations regarding scientific and clinical research, where genome editing is still emerging.
(iv) Equip governance roles in human genome editing with necessary tools and guidance (106, p. 2).
One suggested model is inspired by the UK's Human Fertilisation and Embryology Authority, requiring researchers to obtain approval for specific heritable gene editing projects (85). Researchers must adhere to a code of conduct encompassing ethical principles (85). This global framework may also incorporate legal measures to prevent and penalize unacceptable research (85, p. 145).
Proposed governance frameworks often lack clarity on the institutional entity that would oversee them but generally anticipate a formal body to replace the current informal governance systems (56). One potential option is an established international organization like the WHO, which could provide scientific and ethical guidelines, despite its advisory rather than regulatory role. The WHO has previously influenced governance frameworks for other health technologies, such as xenotransplantation (53). Other possibilities for hosting the governance framework include UNESCO and the OECD (56). Alternatively, a new institutional entity could be created, potentially functioning similarly to existing frameworks for tobacco or nanotechnology (1, 99). A third option could involve a self-regulatory model based on the Helsinki Declaration principles, which relies on national governments and professional bodies for enforcement, offering less engagement than the previous two models (109).