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Original research
Intergenerational monitoring in clinical trials of germline gene editing
  1. Bryan Cwik
  1. Philosophy and University Studies, Portland State University, Portland, Oregon, USA
  1. Correspondence to Dr Bryan Cwik, Philosophy, Portland State University, Portland, OR 97201, USA; bcwik{at}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.

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

http://dx.doi.org/10.1136/medethics-2019-105620

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    Footnotes

    • Presented at Material in this paper was presented at the 2018 American Society for Andrology Annual Meeting in Portland, OR; the 2018 Philosophy of the Life Sciences Workshop at Portland State University; and at the Kegley Institute for Ethics at California State University, Bakersfield, in December 2017.

    • Contributors BC is the sole author of the paper.

    • Funding Work on this paper was supported by the National Human Genome Research Institute of the National Institutes of Health under award number R03HG010417.

    • Disclaimer The content is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health.

    • 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.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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