Germline Genome Editing Research: What Are Gamete Donors (Not) Informed About in Consent Forms?

Abstract

The potential for using germline genome editing (GGE) in humans has garnered a lot of attention, both for its scientific possibilities as well as for the ethical, legal, and social challenges it ignites. The ethical debate has focused primarily on the suggestions of using GGE to establish a pregnancy (i.e., to offer it in a clinical setting), which is, to date, illegal in many jurisdictions. The use of GGE in research (where a pregnancy would not be established) has received much less attention, despite the fact that it raises serious ethical and social issues as well. Herein, we report on the analysis of informed consent forms for egg and sperm donation used in a widely publicized study where genome editing was used to correct a disease-causing genetic mutation in human embryos. Importantly, embryos were created using eggs and sperm obtained specifically for these experiments. The analysis indicates deficiencies in how the forms addressed various issues, including limited and potentially misleading information about the sensitive nature of the study, the lack of an explicit mention of genomic sequencing, as well as the poor readability of the forms. Furthermore, the arguably high compensation of U.S.$5,000 for egg donors raises questions about undue inducement to participate in research. Moreover, since the procurement of eggs involves serious health risks, it may be questioned whether research requiring such a procedure should be pursued. If such experiments are continued, donors should be informed about all relevant aspects in order to make informed decisions about participating.

Breaking Boundaries in the Brain—Advances in Editing Tools for Neurogenetic Disorders

“…The consequences of gene editing and the effect that editing has on gametes and heritability in further generations is not well-understood and needs to be considered prior to clinical applications (Niemiec and Howard, 2020 ). Although aiming to edit only somatic cell lines, off-targeted effects could possibly result in editing reproductive cells and have implications on the gametes which can be passed on to further generations (Niemiec and Howard, 2020 ).…”

Responsible Translational Pathways for Germline Gene Editing?

“…Should GGE research advance to a point at which clinical application becomes feasible, there will be significant ethical issues in conducting human subjects research. These include issues about informed consent, accurately judging the risk/benefit profile for prospective persons, the general family of concerns about research on neonates and children, and the real possibility of societal stigma that could affect the first generation of edited subjects [ 15 •, 69 , 70 , 71 •]. One of the biggest problems, however, will be determining the long-term effects of GGE on prospective persons.…”

The Ethics of Genetic Cognitive Enhancement: Gene Editing or Embryo Selection?

“…Their intention is, rather, to donate or sell some of their egg cells, which in turn can be used for research or for human reproduction. This practice, however, has raised some ethical concern relative to informed consent and exploitation of women [47], (for Reference [48] see p. 44). Men, too, can donate sperm cells for altruistic or pecuniary reasons [49][50][51][52], but prohibition of anonymous donation over the last years has led to a shortage of sperm cells in many sperm banks around the world.…”