International regulatory landscape and integration of corrective genome editing into in vitro fertilization

Abstract

Genome editing technology, including zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and clustered regularly interspaced short palindromic repeat (CRISPR)/Cas, has enabled far more efficient genetic engineering even in non-human primates. This biotechnology is more likely to develop into medicine for preventing a genetic disease if corrective genome editing is integrated into assisted reproductive technology, represented by in vitro fertilization. Although rapid advances in genome editing are expected to make germline gene correction feasible in a clinical setting, there are many issues that still need to be addressed before this could occur. We herein examine current status of genome editing in mammalian embryonic stem cells and zygotes and discuss potential issues in the international regulatory landscape regarding human germline gene modification. Moreover, we address some ethical and social issues that would be raised when each country considers whether genome editing-mediated germline gene correction for preventive medicine should be permitted.Electronic supplementary materialThe online version of this article (doi:10.1186/1477-7827-12-108) contains supplementary material, which is available to authorized users.

The illusion of control in germline-engineering policy

“…Indeed, current regulations related to germline interventions vary considerably across the globe 19,20 . They encompass bans-based on law or lessenforceable governmental or research council guidelines-that prohibit both research and clinical or reproductive applications; or that prohibit clinical or reproductive application only; or that remain sufficiently unclear to raise doubts as to whether they cover human germline gene modification at all ( Table 1).…”

Human Germline Genome Editing

“…There are both national and international policies that regulate embryo research and interventions early in human development [26][27][28] that apply to research and the potential clinical translation of human germline genome editing. Their underlying normative frameworks typically address the broad ethical context of human-assisted reproduction technologies and human subjects and genomics research and take into consideration core ethical principles of autonomy, beneficence, non-maleficence, and justice.…”

Genome Games: Market Challenges, Investment Opportunities and Patent Battles

“…Modern legislation on the embryo editing varies in different countries, from total ban to biased interpretation of legal standards [21]. Hence, there is no answer to a question on the birthplace of the first "edited" child.…”