The CRISPR Journal

Volume 1, Number 6, 2018

Mary Ann Liebert, Inc.
DOI: 10.1089/crispr.2018.0051

PERSPECTIVE

Draft Ethical Principles for Therapeutic Assisted

Reproductive Technologies
He Jiankui,1,* Ryan Ferrell,1 Chen Yuanlin,1 Qin Jinzhou,1,2 and Chen Yangran1

Abstract
The germline gene-editing field has several detailed preclinical research guidelines but lacks concise and plain-
language ethics statements on ultimate clinical uses. The general public deserves a clear vision of the future to
gauge the field’s ultimate intentions and have meaningful input and discussion about its progress. We propose
the identification of a core set of fundamental human values to frame, guide, and restrict clinical applications that
communities around the world can share and localize based on religious beliefs, culture, and public-health challenges.

Introduction Respondents rejected enhancements, with the notable ex-

More than seven million children are born every year
with lethal or debilitating diseases of genetic or partially
genetic origin.1 Gene surgeries, including CRISPR* gene
editing and mitochondrial donation techniques, promise
new therapeutic strategies during in vitro fertilization
(IVF) to cure or prevent these diseases before a child
can suffer.
The potential utility and, for some, the controversy of
gene editing to treat unborn children, including the avail-
ability and effectiveness of preimplantation genetic diag-
nosis for many genetic diseases, has prompted scientific
societies and other worldwide organizations to publish
a raft of guidelines about permissible preclinical re-
search.2 Guidelines for ultimate clinical practices, how-
ever, remain less defined. What should be our proposed
ethics and actual red lines?
A clear vision of the future, succinctly stated in plain
language, is needed for the public to gauge the field’s
eventual intentions and have meaningful conversations
about how gene surgery may or may not affect their fam-
ily, friends, and neighbors.
Surveys conducted in 2018 of >2,500 Americans3 and
4,000 Chinese4 show the general public of both count-
ries are generally receptive to gene surgery in human
embryos—if the sole purpose is to treat serious diseases.
*Clustered Regularly Interspaced Short Palindromic Repeats.
1
Department of Biology, Southern University of Science and Technology, Shenzhen, P.R. China; 2Department of Human Reproductive Medicine Center, Third Affiliated Hospital of
Shenzhen University, Shenzhen, China.
ample of increasing intelligence being opposed by about
80% of Americans and 70% of Chinese respondents.
Despite contrasting regulatory frameworks—the United
States passed a law in 2015 explicitly to prohibit the
U.S. Food and Drug Administration from reviewing of
any applications,5 whereas China maintains a ministerial
guideline6 drafted in response to cloning concerns7 some
15 years prior to the emergence of CRISPR—a cross-
cultural ethical divide did not emerge in the American
and Chinese surveys. Support for therapeutic uses of
gene surgery in embryos was high, even among a major-
ity of highly religious Americans.
On the other hand, many survey respondents also
reported they were relatively uninformed about the
gene-editing field. So, current public views on gene sur-
gery may be forming based on widely shared personal
ethics toward medicine and mercy. This is an open invi-
tation for the scientific community to support the public
in making informed decisions about gene surgery’s clin-
ical utility, limitations, risks, regulatory needs, and future
role in society.
Open Dialogue
Open dialogue has helped shape regulations and advance
cultural attitudes in the field of IVF and other assisted re-
productive technologies (ART) for >40 years. As a result,
initial worries and warnings around eugenic applications

*Address correspondence to: He Jiankui, Department of Biology, Southern University of Science and Technology, 1088 Xueyuan Boulevard, Shenzhen, Guangdong 518055,
P.R. China, E-mail: hejk@sustc.edu.cn

ª He Jiankui et al., 2018; Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative Commons License
(http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

1
2 JIANKUI ET AL.

have not transpired. Clinicians have proven responsible
stewards of medical procedures that have helped fertility-
challenged couples raise more than eight million healthy
children.8
We believe the gene-editing research community
therefore has a duty to speak more openly and plainly
to the public and lawmakers, despite this being an unfa-
miliar role for many scientists (including ourselves).
Our community should also address ethics more inclu-
sively, as others including Montoliu et al.9 and Jasanoff
and Hurlbut have argued,10 by discussing and developing
guidelines in more cosmopolitan and inclusive venues
that include affected families and public stakeholders.
Proactively educating journalists is crucial too.
Likewise, science journalists and editors share a duty
to translate research responsibly for the general public.
Sensationalism has been an unfortunate part of media
coverage since the emergence of IVF in the 1970s,11
with the prophesy of Huxley’s Brave New World,12,13
rapid cultural extinction,14,15 and barcoded or discombob-
ulated babies serving as fallback tropes16–20 that many pa-
tient groups would prefer not share equal footing with
balanced reporting.21 Another fallback is the overused
term ‘‘designer baby’’: this is an epithet aimed at invoking
disgust, which is a common mechanism behind hate.22,23
Parents hope to protect their newborn’s life from a known
debilitating, familial disease. Call them ‘‘gene surgery
babies’’ if one must or better yet ordinary people who
have had surgery to save their life or prevent a disease.
Core Principles
To help advance the constructive dialogue over the past
40 years that has ensured the ethical use of ART to help
fertility-challenged couples conceive healthy children,

1. Mercy for families in need (悲 悲し之 之心)

A broken gene, infertility, or a preventable disease should not extinguish life or undermine a
loving couple’s union.
For a few families, early gene surgery may be the only viable way to heal a heritable
disease and save a child from a lifetime of suffering.

2. Only for serious disease, never vanity (有 有所ᷢ更 更有所不ᷢ)

Gene surgery is a serious medical procedure that should never be used for aesthetics, enhancement,
or sex selection purposes — or in any way that would compromise a child’s welfare, joy, or free
will. No one has a right to determine a child’s genetics except to prevent disease.
Gene surgery exposes a child to potential safety risks that can be permanent. Performing
gene surgery is only permissible when the risks of the procedure are outweighed by a serious
medical need.

3. Respect a child’s autonomy (探 探索你自由)

A life is more than our physical body and its DNA. After gene surgery, a child has equal rights to
live life freely, to choose his or her occupation, to citizenship, and to privacy. No obligations exist
to his or her parents or any organization, including paying for the procedure.

4. Genes do not define you (生 生活需要⣳斗 斗)

Our DNA does not predetermine our purpose or what we could achieve. We flourish from our own
hard work, nutrition, and support from society and our loved ones. Whatever our genes may be, we
are equal in dignity and potential.

5. Everyone deserves freedom from genetic disease (促 促徃普 普惠的健康㛫)

Wealth should not determine health. Organizations developing genetic cures have a deep moral
obligation to serve families of every background.

FIG. 1. Five core principles for gene surgery in human embryos.

DRAFT ETHICAL PRINCIPLES FOR THERAPEUTIC ART
we suggest the medical and patient community identify a
core set of fundamental human values that clarify for the
public the clinical future of early-in-life genetic surgery
in plain terms and within a document as brief as possible.
Lawmakers in countries wishing to permit clinical trials
and eventual regulatory submissions could build on these
values to write cohesive rules that can still account for
their country’s distinctive mix of religious beliefs, culture,
and public-health challenges. (A preface to a final docu-
ment could also helpfully summarize the known risks,
existing options such as preimplantation genetic diagnosis,
how gene surgery/genome editing works, its limitations,
and example use cases.)
As our laboratory (at South University of Science
and Technology in Shenzhen, P.R. China) has studied
the feasibility and safety of CRISPR/Cas9-mediated ge-
netic surgery in nonviable and viable human and monkey
embryos for several diseases over the past several years,
we have thought deeply about ethical foundations for
regulation in discussions between researchers, patients
and advocates, and ethicists both in China and abroad.
These discussions lead us to propose that, at a minimum,
five core principles should be addressed in a moderniza-
tion of Chinese regulations—and indeed any country’s
guidelines or laws—permitting gene surgery for ART:
(1) a clear social purpose, (2) impermissible uses, (3)
rights after treatment, (4) the human spirit’s transcen-
dence of DNA, and (5) a special duty to reduce economic
inequality. We therefore propose five plain-language
principles as a first draft of an ethical foundation to
guide and restrict the use of therapeutic ART (see Fig. 1).
Of note, we hold additional but less universal beliefs
that further restrict the use of gene surgery, including
the need to prioritize local population health needs and
focus only on treating disease via prevalent, natural ge-
netic variants. We expect other groups will also hold ad-
ditional views beyond the principles outlined here
(Fig. 1). That diversity will make the world better.
We hope this call to action will help foster a more
frank and plain-language dialogue about the ethics of
gene surgery. In particular, we hope this approach may
provide an additional way to solicit meaningful collabo-
ration with the millions of valued members of our society
who live with disabilities or serious medical conditions
and who deserve to have a key role in shaping any guide-
lines that direct this field’s future, whether that happens at
traditionally scientific conferences, in print, or elsewhere.
We also hope that the humanity of this debate is not
forgotten amid controversy. Many parents have lost
children to genetic diseases. While these families are
a minority, real lives and suffering are at stake.
3
Author Disclosure Statement
No competing financial interests exist.
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