The recent application of tools, such as CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats; Cas9 nuclease), to edit the human genome with the intention of treating or preventing disease and the gaps in our scientific understanding, in addition to some of the proposed applications of human genome editing, raise ethical issues that have highlighted the need for robust oversight in this area. In December 2018, WHO established a global, multidisciplinary expert advisory committee (the Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, hereafter called the Committee) to examine the scientific, ethical, social and legal challenges associated with human genome editing (somatic, germline and heritable).
The governance framework on human genome editing, along with the recommendations of the Committee, form a set of two publications that provide advice and recommendations on appropriate institutional, national, regional and global governance mechanisms for human genome editing. A position paper on human genome editing provides a summary of these two publications.
The Committee developed a governance framework that draws from good practices in the governance of emerging technologies and applied them specifically to human genome editing. The governance framework, which can be implemented in different contexts, is intended to help those tasked with strengthening oversight measures, regardless of whether this is at the institutional, national, regional or international level.
The governance framework identifies values and principles that help explain why governance measures may be needed and how those charged with reviewing or strengthening governance measures may undertake such a task. It reviews a set of tools, institutions and processes and puts forward seven scenarios to demonstrate how the various components of the governance framework come together in practice. The governance framework identifies a number of considerations for the successful implementation of oversight and governance measures for human genome editing.