The Ethical Viability of Germline Cell Editing by Adithi Ramganesh
- Feb 25, 2024
- 7 min read
Germline cell editing should be allowed to proceed and be used primarily for research
purposes, following a strict regulatory framework. Even though potential health risks pose a
challenge due to many unforeseeable effects of CRISPR on germline cells as well as the ethical
concerns surrounding the potential to genetically edit an “ideal baby,” CRISPR Cas-9 systems is
the most efficient and accessible treatment at the moment to be able to treat severe genetic
disorders such as sickle cell disease, human immunodeficiency virus (HIV), cystic fibrosis, etc.
and being able to make small advances through clinical research can help advance our
knowledge and understanding of the such effects of CRISPR on germline cells and the altered
offspring’s procession into childhood. Therefore, germline cell editing should not be prohibited,
but instead more regulated in order to enhance the medical treatment of those with incurable
medical disorders in the future.
In the United States, as of recently, the House of Representatives had placed restrictions
on the FDA that banned requests “in which a human embryo is intentionally created or modified
to include a heritable genetic modification” (Kaiser, 2019). Dr. Kevin Smith, a bioethicist at
Abertay University proposed a claim about the intervention of HGCM by looking at a more
utilitarian perspective, assessing its practical usefulness in the future of the medical field over its
attractiveness. While admitting that risks do exist, he believes that the level of technological
advancement in this industry has strong enough grounds to genetically modify germline cells at
an acceptable amount of risk. He claims that a long term, prohibitory ban on HGCM would, “be
antithetical to progress in biomedical innovation,” even stating that by progressing and
intervening with germline cell editing, willing parents are presented with this viable option of
embryonic modification instead of having to naturally conceive a child that has strong chances,
of developing the genetic disorder (Smith, 2020). Smith claims that this thereby, “boosts utility
in respect of these parents,” but may also lead to less parent couples choosing the route of
adoption which “would be a disutility as the happiness of orphaned children can be greatly
increased through adoption” (Smith, 2020). However, Jennifer Gumer, adjunct professor of
bioethics at Columbia University, states otherwise, that an international ban on HGCM is
absolutely necessary and that its technological benefits are outweighed by its risks and
inconsistencies. She claims that state governments need to pass more comprehensive
moratoriums, completely preventing the usage of CRISPR to manipulate human embryos.
Technologically and from a health treatment standpoint she claims, “there are relatively few
health conditions that are linked to a single gene and similarly, relatively few people who suffer
from it,” and goes on to claim that diseases like Huntington’s disease, caused by a copy of a
single gene, can be prevented from being passed onto offspring without using CRISPR, opting
for procedures like in vitro fertilization, (IVF) (Gumer, 2019).
Another crucial aspect of HGCM that plays a large role in its viability is its ethical
evaluation, and where it stands in the eyes of researchers in terms of morality and willingness to
keep banned. As Gumer mentioned earlier, lots of current ethical debate circulates the state at
which HGCM is at currently, which is either entirely banned legislatively, or used/ researched
with in very few areas due to private funding methods (Gumer, 2019). Another factor taken into
account is the precautionary principle in relation to germline cell editing which assesses whether
an action may be subject to posing uncertain/ grave threats, in this case, risks on human health
and livelihood. Research fellows, Julian Koplin, Christopher Gynell, and professor, Julian
Savulescu in the biomedical ethics department of Murdoch Children Research Institute presented
research stating that most often, the precautionary principle is evidence used to refute the
progression of HGCM, but in some cases, it can be used in a positive sense to promote germline
cell editing to prevent, “catastrophic genetic mutations and/or to promote the long term
robustness of human populations” (Koplin, et.al, 2020). This leads us to believe that there can be
positive implications of the precautionary principle, which can then help promote its ethical
viability in promoting general public health and preventing the worsening of genetic health in
our society today. The researchers also propose a new form of the precautionary principle, the
sufficientarian precautionary principle (SPP) to establish the claim that in some cases, the
precautionary principle actually might endorse germline cell editing, and poses no certified
answer, denying the usage of germline modification definitively (Koplin, et. al, 2020). This
furthers the case that the precautionary principle nowhere explicitly states or implies that
germline cell editing is illegal or unethical, and therefore within regulatory range, is usable and
can be permitted to use. However a weakness and objection to their claim may be imposed as
their argument includes SPP to assess the influences of germline cell editing, but as it was
self-developed by the authors themselves, it may prove to be an unusable stance of the
precautionary principle to other researchers or bioethicists.
Refuting this point, germline cell editing is also viewed to exist at a very risky borderline
of violating ethical principles of experimentation due to its possible exploitation of a human
subject’s health long term, and the inability to assess whether the CRISPR editing systems will
leave behind any unpredictable effects (Malmqvist, 2021). For instance, the chances of off-target
effects occurring, which are small mutations (point, inverse, translocation) in the “area of the
genome that are sensitive to double-stranded breaks,” when using single guide RNAs (Cribbs,
Perera, 2017). Ethics behind germline editing involves discussions about eugenics as well, taking
into account past historical events, where the idea of having “favorable,” or ideal traits were
shown as a representation of superiority. Germline cell editing could turn into practice of not just
being able to prevent the expression of a certain genome, but a practice of creating the “ideal
child,” one of increased intelligence and heightened abilities and traits (Cribbs, Perera, 2017).
Taking these into consideration, halting the progression of germline cell editing
completely and initiating legalized bans against it don’t account for the fact that limiting the
usage of germline cell editing completely might have negative effects on the future
advancements of medicine and patient care. CRISPR is considered dangerous and more
researchers are hesitant to proceed in germline editing because there is still so much we don’t
know. Germline cell editing should not be prohibited, but instead more regulated in order to
enhance the medical treatment of those with incurable medical disorders/ dispairments. A
solution proposed by Niklaus Evitt, Shamik Mascharak, and Russ Altman, affiliated under
Stanford University, with certified publication in the American Journal of Bioethics, bring about
a more regulatory usage of CRISPR germline editing therapies (CGETs) allowing for
checkpoints asserting that the usage of CRISPR follows health and ethical guidelines (Evitt, et.
al, 2015). Earlier, Gumer made a claim stating that CRISPR isn’t the most effective piece of
biotechnology to incise out single disease causing genes without creating too much risk, instead
proposing IVF, or pre-implantation genetic diagnosis (PGD), used in tandem with IVF to reduce
the chances of passing down inherited genes (Gumer, 2019). However Evitt, et. al propose a
solution that looks at the moral viability of using CRISPR if the risks of using PGD and IVF
exceed those of CRISPR. They claim that embryos hold a certain moral status, so the constant
embryonic destruction and cyclic nature of IVF actually pose a higher population-wide embryo
loss when compared to using CGETs, making the usage of CGETs more ethically acceptable
(Evitt, et. al, 2015). Not only that, but the proposed CGETs come with many regulatory
benchmarks initially looking at its distinct benefit, leading to testing such modification on animal
models, before entering pre-clinical research (with parental consent), and then an assessment of
participants over a period of 15 years as a way of studying their development and effects of
modifications on their physical state (Evitt, et. al, 2015). With a regulatory framework as the one
proposed, and the reassurance of following ethical guidelines, clinical research can take place
with CRISPR germline cell modifications in a safe fashion to enhance medical treatment.
Another proposed solution by Smith, seeks to highlight the need for a “risk-averse,”
precautionary delay for a period of 1-2 years in order to maximize utility of intervening within
germline editing (Smith, 2020). His solution brings attention to the refinement of technology
used by CRISPR during that period of 1-2 years, which isn’t discussed by Evitt, et. al. Smith
explains the reason why technology has not been able to advance to a more acceptable stage is
due to the unknown correlation of CRISPR editing on human health (Smith, 2020). Both
solutions encourage the intervention of germline cell editing, sooner than later, however Smith’s
solution doesn’t provide enough insight into the regulatory pathways CRISPR must take in order
to be ethically acceptable, meanwhile the solution proposed by Evitt, et. al can be used to make
significant advancements on the knowledge of CRISPR’s effects on human health long term,
which can eventually lead to more advanced technology to support better treatment methods in
the future, therefore presenting as a stronger solution.
While many people advocate for a temporary delay in the advancement of germline cell
editing, limited advancements should be able to take place under a regulatory framework, as they
can aid with the progression of CRISPR, and ultimately lessen the amount of unknowns we have
about CRISPR and its long term effects on germline cell editing.
Works Cited
Cribbs, A. P., & Perera, S. M. W. (2017). Science and Bioethics of CRISPR-Cas9 Gene Editing:
An Analysis Towards Separating Facts and Fiction. The Yale Journal of Biology and
Medicine, 90(4), 625–634. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5733851/
Evitt, N. H., Mascharak, S., & Altman, R. B. (2015). Human Germline CRISPR-Cas
Modification: Toward a Regulatory Framework. American Journal of Bioethics, 15(12),
Gumer, J. M. (2019). The Wisdom of Germline Editing: An Ethical Analysis of the Use of
CRISPR-Cas9 to Edit Human Embryos. New Bioethics, 25(2), 137–152.
Kaiser, J. (2019, June 4). Update: House spending panel restores U.S. ban on gene-edited
babies. Www.science.org.
e-edited-babies
Koplin, J. J., Gyngell, C., & Savulescu, J. (2020). Germline gene editing and the precautionary
principle. Bioethics, 34(1), 49–59. https://doi.org/10.1111/bioe.12609
Medline Plus. (2020, September 18). What are genome editing and CRISPR-Cas9?
Medlineplus.gov; Medlineplus.
Smith, K. (2020). Time to start intervening in the human germline? A utilitarian perspective.
Bioethics, 34(1), 90–104. https://doi.org/10.1111/bioe.12691
Sykora, P., & Caplan, A. (2017). The Council of Europe should not reaffirm the ban on germline
genome editing in humans. EMBO Reports, 18(11), 1871–1872.
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