Germline genome editing: Moratorium, hard law, or an informed adaptive consensus?

With the development of practical means of human germline genome editing (HGGE) in recent years, there have been calls for stricter regulation and oversight over HGGE interventions with potential for heritable changes in the germline. An international moratorium has been advocated. We examine the practicality of such a proposal, as well as of a regulation through the "traditional" mechanisms of international and municipal laws. We argue that these mechanisms are unlikely to achieve their intended objectives and that the better approach is to engage the international community of stakeholders, researchers, scientists, clinicians, and other workers directly involved in the field in working toward the development of an "informed adaptive consensus". We offer suggestions as to how this may be achieved and how existing indirect levers of regulation may be harnessed toward this end.

Legal aspects of genetic databases for international biomedical research: the example of the International Cancer Genome Consortium (ICGC).

There is a noticeable lack of international regulation on personal data exchange and management in research. This article sheds light in this area by describing how the International Cancer Genome Consortium is developing policies and procedures to address the ethical and legal issues raised by the international transfer of data and results. These policies and procedures aim, first and most importantly, to safeguard the interests of the research participants and other involved stakeholders and, secondly, to facilitate the sharing of data and results to realize greater benefits from this kind of internationally collaborative genetic research.