Beyond babies: Implications of human genome editing for women, children, and families

ABSTRACT

Scholarship on human germline editing has centered on the risks to the genetically-modified child. However, far less emphasis is focused on women who will become pregnant with a genetically modified embryo as part of human subject research or the families that raise children whose genomes were modified as an embryo. The lack of attention on women and families places these key stakeholders in genomic technologies at significant medical, ethical, and personal harm as research rapidly moves forward to advance the science of genomic modification. Now is the time to address how the interests of women and families should be represented in the ethical and scientific frameworks of human genomic modification, with specific considerations for Institutional Review Boards who review protocols for rigorous human subject protections and scientists who develop scientific methodologies that dictate the potential risks conferred to research participants. In this paper, we examine the implications of genomic modification of human embryo for women, children, and families to explore how to review a first-in-human clinical protocol of human genomic officiation responsibly.

KEYWORDS:

• Human genomic modification
• inclusion of pregnant women in trials
• research ethics
• social implications of genomic modification

Acknowledgments

The authors gratefully acknowledge Christina Maxey for her assistance with the manuscript. C.T.S. is supported by NIH (NHGRI) award 1RO1HG010332-01.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This work was supported by NIH (NHGRI) [1RO1HG010332-01].