Correspondence
Chinese Academy of
Engineering calls for
actions on the birth of
gene-edited infants
At the Second International Summit
on Human Genome Editing held in
Hong Kong, China, on Nov 27­–29, 2018,
Jiankui He, the leading researcher
involved in the birth of what he claims
are gene-edited infants, described their
work using CRISPR-Cas9 mediated
genome editing of the CCR5 gene
in human germ cells and embryos.1
This claim has caused outrage among
the scientific community and society
worldwide.
The Chinese Academy of Engineering
(CAE) is a national organisation
com­ posed of elected members in
engineering science and technology.
The Division of Medicine and Health of
CAE provides national and international
advice on issues relating to health,
medicine, health policy, and biomedical
sciences. The Division and the Scientific
Ethics Committee of CAE issue the
following response to this event.2
Academically and technically,
the presented work by Jiankui He
and colleagues does not provide
a new advance in the science, and
the application of genome editing
technology in human embryos for
reproductive purposes is inappropriate.
Ethically and morally, without
solid scientific validation and full
consideration of the unpredictable
safety risks, these researchers have
not adhered to scientific integrity and
ethical norms in this clinical operation
of human germ cell genome editing
for reproductive purposes.
In terms of laws and regulations,
the work He and colleagues claim to
have done has violated China’s policies
and regulations on gene-related
research,3–5 and their clinical operations
are explicitly prohibited.
We are concerned about the
wellbeing of the infant twins involved
in this case. We urge the scientific
community and society to work
www.thelancet.com Vol 393 January 5, 2019
together to develop a comprehensive
strategy to ensure the twin babies’
privacy and to provide preventive
measurement for potential health and
social issues related to the genome
editing.
We call on all science and technology
professionals to strengthen self-
discipline of research ethics and strictly
comply with all ethical norms, laws, and
regulations in their research activities.
When new situations emerge in the
process of scientific and technological
development, we should undertake
solid, ethical research, strengthen
education in related areas, and
anticipate possible risks and challenges.
The related ethical guidelines should
also be improved to ensure responsible
research. The relevant authorities
should improve related laws and
regulations, scrutinise regulatory and
supervisory processes, advance the
relevant legislative work, and prevent
ethical misconduct.
We will pay close attention to the
ensuing investigation and its outcome,
and will provide necessary scientific and
technical advice and support.
We believe the above statement
represents the main voice of our
scientific community. With the rapid
development of increasingly powerful
genome editing technologies that
could potentially alter human genetic
make-up, we must act now and face
the challenges. It is time to formulate
relevant legislation, laws, regulations,
and guidelines, and make adaptive
amendments as necessary to establish
focused supervisory systems to avoid
any inappropriate technical uses of this
technology.
We declare no competing interests.
Boli Zhang, Zuoning Chen, Jian Yi,
Haiying Tang, *Chen Wang, on behalf
of Chinese Academy of Engineering
wangchen@cae.cn
Chinese Academy of Engineering, Beijing 100088,
China
1 China News. He Jiankui appeared in Hong Kong:
results disclosing and question answer.
China News. Nov 28, 2018. http://news.sina.
com.cn/o/2018-11-28/doc-ihmutuec4407821.
shtml (accessed Nov 29, 2018; in Chinese).
2 Chinese Academy of Engineering. Chinese
Academy of Engineering statement on the
birth of gene-edited infants. Nov 28, 2018.
http://www.cae.cn/cae/html/main/col1/2018-
11/28/20181128193924990854695_1.html
(accessed Nov 29, 2018; in Chinese).
3 Ministry of Science and Technology and
Ministry of Health. Guiding principles of ethics
for human embryonic stem cell research.
Beijing: Ministry of Science and Technology
Tek Image/Science Photo Library
and Ministry of Health, 2003 (in Chinese).
4 Ministry of Health. Ethics principles for human
assisted reproductive technology and human
sperm bank. Beijing: Ministry of Health, 2016
(in Chinese).
5 National Health and Family Planning
Commission. Ethical review measures for
biomedical research involving human beings.
Beijing: National Health and Family Planning Published Online
Commission, 2016 (in Chinese). November 30, 2018
http://dx.doi.org/10.1016/
S0140-6736(18)33081-2
Gene-edited babies:
Chinese Academy of
Medical Sciences’
response and action
CRISPR-Cas9, a powerful tool for Published Online
genome editing, has provided novel November 30, 2018
http://dx.doi.org/10.1016/
strategies and potential for treating S0140-6736(18)33080-0
human diseases. However, the ethical
challenges remain unsolved for many
clinical applications. As researchers
from the Chinese Academy of Medical
Sciences, the national biomedical
research institution in China, we and
our colleagues are deeply concerned
about media reports of the claim of the
first gene-edited twin babies “immune
to HIV” by Jiankui He and colleagues.1
At the Second International Summit
on Human Genome Editing in Hong
Kong, China, Jiankui He disclosed
their work on CRISPR-Cas9 mediated
genome editing of the CCR5 gene in
human germ cells and embryos.2 If their
claims are verified, we feel compelled
to state our position and concerns for
the potential scientific ramifications
and ethical impacts to our scientific
community.3
We are opposed to any clinical
operation of human embryo genome
editing for reproductive purposes in
violation of laws, regulations, and Submissions should be
made via our electronic
ethical norms in the absence of full submission system at
scientific evaluation. In the rapidly http://ees.elsevier.com/
developing area of genome editing thelancet/
25
 Correspondence
technology, our scientific community
should uphold the highest standards
of bioethics in undertaking responsible
biomedical research and applications
and uphold our scientific reputation,
the basic dignity of human life, and
the collective integrity of our scientific
community.
The genome editing of germ cells or
early embryos is still in the stage of basic
research, and its safety and validity
need to be fully evaluated. Therefore,
scientific research institutions and
researchers should not undertake
clinical operations of genome editing
of human germ cells for reproductive
purposes, nor should they fund such
research.
Preclinical research on genome
editing of human repro­ductive cell
lines must follow technical standards
and ethical norms. Sufficient evidence
for the safety and effectiveness of this
technology should be obtained through
in-vitro studies of human tissues and
embryonic genome editing studies
of non-human animals, including
Published Online primates.
November 30, 2018 The Chinese Government pro­hibits
http://dx.doi.org/10.1016/
S0140-6736(18)33082-4
the genetic manipulation of human
gametes, zygotes, and embryos for
reproductive purposes. The relevant
government regulations and guide­
lines are clearly stated in the Guiding
Principles of Ethics for Human
Embryonic Stem Cell Research (2003),4
the Ethics Principles for Human
Assisted Reproductive Technology
and Human Sperm Bank (2003),5 the
Ethical Review Measures for Biomedical
Research Involving Human Beings
(2016),6 and the Safety Management
Measures for Biotechnology Research
and Development (2017).7 Jiankui He’s
operations violated these regulations.
Scientists must place social
responsibility before their research and
evaluate and prevent any potential
risks to human health before the
implementation of high-risk research.
Clearly, more practical guidelines are
necessary for emerging technologies.
In view of the technological progress
of genome editing and new challenges
26
to medical ethics, we will develop and
issue further operational technical and
ethical guidelines as soon as possible
to guide and standardise relevant
research and applications to prevent
any potential ethical misconduct and
to provide authoritative guidance for
the development of research according
to the highest scientific and ethical
standards.
We advocate that all research
and medical institutions should
strengthen the organisation of ethical
committees and supervision of the
ethical review and research processes,
provide ethical education and training
programmes for researchers and
medical practitioners, and promote
public education programmes of
scientific knowledge and ethical
awareness. Comprehensive education
and training programmes are essential
for responsible medical research.
Medical researchers and practitioners
are guardians of human health. We
call for the protection of the personal
privacy of the twin babies and for
proper care to ensure their healthy
development, psychologically and
physiologically. We must abide by
the laws and follow the highest
scientific and ethical standards to
ensure the safe translation of scientific
advances to human health benefit.
New technologies, such as CRISPR,
potentially revolutionise medicine and
we are confident—with the collective
wisdom of scientific community and
government support—that we can
reach common ground and policies
to guide the rapid development and
applications in health sciences.
We declare no competing interests.
Chen Wang, Xiaomei Zhai,
Xinqing Zhang, Limin Li,
*Jianwei Wang, De-pei Liu, on behalf of
Chinese Academy of Medical Sciences
jianwei.wang@ipbcams.ac.cn
Chinese Academy of Medical Sciences, Beijing
100730, China
1 SinaTech. Birth of first gene-edited babies in
China. SinaTech. Nov 26, 2011. https://tech.
sina.com.cn/d/f/2018-11-26/doc-
ihmutuec3749997.shtml (accessed
Nov 29, 2018; in Chinese).
2 China News. He Jiankui appeared in Hong Kong:
results disclosing and question answer.
China News. Nov 28, 2018. http://news.sina.
com.cn/o/2018-11-28/doc-ihmutuec4407821.
shtml (accessed Nov 29, 2018; in Chinese).
3 Chinese Academy of Medical Sciences.
Statement on first gene-edited babies.
Nov 28, 2018. http://www.cams.cn/blog
(accessed Nov 29, 2018; in Chinese).
4 Ministry of Science and Technology and Ministry
of Health. Guiding principles of ethics for human
embryonic stem cell research. Beijing: Ministry of
Science and Technology and Ministry of Health,
2003 (in Chinese).
5 Ministry of Health. Ethics principles for human
assisted peproductive technology and human
sperm bank. Beijing: Ministry of Health, 2016
(in Chinese).
6 National Health and Family Planning
Commission. Ethical review measures for
biomedical research involving human beings.
Beijing: National Health and Family Planning
Commission, 2016 (in Chinese).
7 Ministry of Science and Technology. Safety
management measures for biotechnology
research and development. Beijing: Ministry of
Science and Technology, 2017 (in Chinese).
Open letter from Chinese
HIV professionals on
human genome editing
On Nov 28, 2018, during the Second
International Summit on Human
Genome Editing in Hong Kong,
Jiankui He and colleagues from
China claimed that they have edited
the human embryonic genome to
disable the CCR5 gene in work that
resulted in the birth of twin sisters.1
The announcement generated serious
concerns relating to scientific ethics.
As Chinese professionals engaged
in HIV research and prevention, we
strongly oppose genome editing on
healthy human germline cells and
embryos for reproductive purposes
and HIV prevention. We call for
policies and regulatory authorities to
thoroughly investigate this incident
and to fully protect the privacy and
rights of the babies and associated
family members. We commend the
Chinese Government agencies in
swiftly halting such experiments
and initiating a series of nationwide
efforts to safeguard the highest
scientific and ethical standards in
genome editing research. Rules and
www.thelancet.com Vol 393 January 5, 2019