Table 2 Example of questions needed to be addressed for the ethical, legal, and social issues research (ELSI) of gene editing

ELSI of somatic cell gene editing

Does the current legal framework need amendments/additions to address somatic gene editing? If so, who will further shape the legal framework for somatic gene editing?

Do present clinical trial principles and protocols suffice?

How will trials in somatic gene editing be conducted and evaluated?

Do we need particular protection or status for patients in such trials?

What procedures will be instilled for patients receiving such treatments (e.g., consent, genetic counselling, follow-up monitoring)?

To what extent will commercial companies be able to, or be allowed to offer, potentially upon consumer request, treatments based on techniques where so much uncertainty regarding harms remains?

Which health-care professionals will be involved in the provision of somatic gene therapy and the care of patients who undergo such treatments?

How will we ensure fair access to such technology?

How will we ensure that the use is driven by need and not the technological imperative?

Who will decide on roles and responsibilities in this novel context?

Based on what criteria will the eligible diseases/populations to be treated be chosen?

How can we ensure that research funds are allocated to ELSI research proportional (in some way) to the amount of research on gene editing.

ELSI of heritable gene editing

Should gene editing of human germ line cells, gametes and embryos be allowed in basic research—for the further understanding of human biology (e.g., human development) and without the intention of being used for creating modified human life?

Should gene editing of germ line cells, gametes or embryos or any other cell that results in a heritable alteration be allowed in humans in a clinical setting?

What, if any principles or reasoning would justify the use of hereditary gene editing in humans in a clinical context given the current ban on such techniques in many jurisdictions?

Why should we consider using heritable gene editing in the clinic if there are alternative ways for couples to have healthy (biologically related) children? Who will decide? Based on what criteria?

Should we first understand the risks and benefits of somatic gene editing before even seriously considering heritable gene editing?

What are the roles, and responsibilities of different actors in these decisions?

How do commercial incentives and the technological imperative play a role in these decisions?

If we do entertain its use, what, if any criteria, will be safe enough according to different stakeholders (scientists, ethicists, clinicians, policy makers, patients, general public) for it to be legitimate to consider using gene editing for reproductive use? Who will set this safety threshold and based on what risk/benefit calculations?

If heritable gene editing was allowed, how would the fact that for the first time, a human (scientist or clinician) would be directly editing the nuclear DNA of another human in a heritable way cause some form of segregation of types of humans? Creators and the created?

If ever allowed, should heritable human gene editing be permitted only for specific medical purposes with a particular high chance of developing a disease (e.g., only when parents have a-near-100% risk of having a child affected with a serious disorder), and if so, would it matter if the risk is not 100%, but (much) lower?

How can we, or should we define/demarcate medical reasons from enhancement? And, as was posed above for the use in somatic cells, for what medical conditions will gene editing be considered appropriate for use? What will the criteria be and who will decide?