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J Med Ethics. 2019 Aug 31. pii: medethics-2019-105620. doi: 10.1136/medethics-2019-105620. [Epub ahead of print]

Intergenerational monitoring in clinical trials of germline gene editing.

Author information

1
Philosophy and University Studies, Portland State University, Portland, Oregon, USA bcwik@pdx.edu.

Abstract

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring-long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals' health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued.

KEYWORDS:

Clinical trials; Gene Therapy/Transfer; Reproductive Medicine; Research Ethics

Conflict of interest statement

Competing interests: BC reports grants from the National Human Genome Research Institute during the conduct of the study. Shoukhrat Mitalipov, director of the Oregon Health and Science University Center for Embryonic, Cell, and Gene Therapy, and principal investigator and coauthor of two studies on germline gene therapy cited in this paper, is on the advisory committee for a grant that funded work on this paper.

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