Geneva Statement on Heritable Human Genome Editing: The Need for Course Correction

Abstract

As public interest advocates, policy experts, bioethicists, and scientists, we call for a course correction in public discussions about heritable human genome editing. Clarifying misrepresentations, centering societal consequences and concerns, and fostering public empowerment will support robust, global public engagement and meaningful deliberation about altering the genes of future generations.

Full text

Science & Society
Geneva Statement on
Heritable Human
Genome Editing: The
Need for Course
Correction
Roberto Andorno,
1
Françoise Baylis,
2,@
Marcy Darnovsky,
3,@
Donna Dickenson,
4,22
Hille Haker,
5,@
Katie Hasson,
3,
*
,@
Leah Lowthorp,
6
George J. Annas,
7,@
Catherine Bourgain,
8
Katherine Drabiak,
9
Sigrid Graumann,
10
Katrin Grüber,
11
Matthias Kaiser,
12,@
David King,
13
Regine Kollek,
14
Calum MacKellar,
15
Jing-Bao Nie,
16,17
Osagie K. Obasogie,
3,18,22
Mirriam Tyebally Fang,
19
Gabriele Werner-Felmayer,
20
and
Jana Zuscinova
21
As public interest advocates, policy
experts, bioethicists, and scientists,
we call for a course correction in
public discussions about heritable
human genome editing. Clarifying
misrepresentations, centering so-
cietal consequences and concerns,
and fostering public empowerment
will support robust, global public en-
gagement and meaningful delibera-
tion about altering the genes of
future generations.
Heritable Human Genome Editing:
Nearing a Critical Juncture
The impending decision about whether to
develop and use heritable human genome
modification carries high stakes for our
shared future. Deciding to proceed with
altering the genes of future children and
generations would mean abandoning the
restraint urged by the United Nations
(UN) General Assembly’s formal endorse-
ment of the Universal Declaration on the
Human Genome and Human Rights [1]
and required by the laws and regulations
of more than 50 nations (F. Baylis et al.,
in preparation), including 29 that have
ratified the Oviedo Convention, a binding
international treaty [2]. Policymakers put
these prohibitions in place to protect
human rights and the fundamental equality
of all people; to safeguard the physical,
psychological, and social wellbeing of chil-
dren; and to avert the emergence of a new
eugenics.
Despitethepersistenceofthesefunda-
mental and widely shared concerns, a
small but vocal group of scientists and bio-
ethicists now endorse moving forward
with heritable human genome editing
i,ii
[3]. They have taken it as their task to de-
cide how we might proceed toward alter-
ing the genes of future children and
generations. In fact, the question at hand
is whether to proceed at all. Neither the re-
sponsibility for answering that question
nor the authority to answer it can be theirs
alone (Box 1).
We contest moves toward reproductive
use of human genome modification and
affirm the need for broad societal consen-
sus before any decision about whether to
proceed is made. We insist on the need
for genuine public engagement that is in-
clusive, global, transparent, informed,
open in scope, supported by resources,
and given adequate time.
Toward that end, we call for an urgently
needed course correction (Box 2)along
three dimensions.
First, we need to address and clarify several
misrepresentations that have distorted pub-
lic understanding of heritable human ge-
nome modification.
Second, we must reorient the conversation
by foregrounding societal consequences
and undertaking a thorough analysis of
threats to equality.
Third, we need criteria for ‘public empower-
ment’: robust public engagement that
promotes democratic governance through
shared decision-making [4].
Clarifying Misconceptions
Informed deliberations will require setting
the record straight on key points about
heritable human genome editing that have
repeatedly been presented in a confusing
or inaccurate way, distorting understand-
ing and creating barriers to meaningful
public engagement.
Perhaps the most fundamental and wide-
spread misrepresentation is that heritable
human genome editing is needed to treat
or prevent serious genetic diseases. Deliber-
ations about heritable human genome
editing should hence acknowledge these
basic points:
•Heritable human genome editing
would not treat, cure, or prevent dis-
ease in any existing person. Instead,
it would modify the genes of future
children and generations through the
intentional creation of embryos with
altered genomes. This fact makes it
categorically distinct from somatic
gene therapies. Heritable human ge-
nome editing should be understood
not as a medical intervention, but as
a way to satisfy parental desires for
genetically related children or for chil-
dren with specific genetic traits.
•Modifying genes in early embryos,
gametes, or gamete precursor cells
could produce unanticipated biological
effects in resulting children and in their
offspring, creating harm rather than
preventing it. Heritable human genome
editing would also require and nor-
malize the use of in vitro fertilization
(IVF), exposing healthy women to sig-
nificant health burdens [4].
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•Prospective parents at risk of trans-
mitting a genetic condition already
have several options to avoid doing
so, should they find them acceptable.
For example, prospective parents
may seek to have unaffected children
via third-party gametes or adoption.
•In nearly every case, prospective par-
ents at risk of transmitting a genetic
condition who wish to avoid doing so
and to have genetically related chil-
dren can accomplish this with the
existing embryo screening technique
preimplantation genetic diagnosis
(PGD) [5]. While PGD also raises trou-
bling ethical questions about what
kind of lives we welcome into the
world, modifying or introducing traits
through genome editing would vastly
intensify these concerns. Genome
editing cannot be considered an alter-
native to PGD, because PGD would
remain a necessary step in any em-
bryo editing procedure.
Centering Societal Consequences
and Concerns
To date, most conversations about herita-
ble human genome editing have neither
adequately analyzed its societal context
nor meaningfully explored its social justice
and human rights implications, despite
their seriousness.
We share widespread concerns that the ac-
cumulation of individual choices shaped by
cultural and market forces could result
in heritable human genome modification
ushering in a new form of eugenics. Particu-
larly troubling is the prospect that heritable
humangenomeeditingwouldbeusedin
efforts to alter a wide range of human
traits. Although several recent proposals
would limit it to genes associated with
medical conditions, none adequately
grapples with how the tenuous distinc-
tion between ‘therapy’and ‘enhancement’
uses would be defined or enforced. Even
well-intentioned efforts to restrict its use to
specified conditions would be unlikely to
hold, especially under the self-regulatory
arrangements often envisioned.
Some dismiss such concerns, saying that
it will not be possible to genetically en-
hance traits like intelligence or appearance
because their genetic underpinnings are
too complex
iii
. This point is important but
not decisive. Some prospective parents
are likely to find fertility clinics’marketing
appeals compelling even when the genetic
modifications offered are dubious. It is
clear that social inequality and discrimina-
tion can be spurred by the mere percep-
tion that some humans are biologically
‘better’than others.
Deliberations about heritable human ge-
nome modification must seriously investi-
gate the implications of social and
historical dynamics such as these:
•Competitive pressures to ‘get ahead’,
coupled with commercial incentives in
the fertility industry (especially where it
operates in the private sector), could
foster the adoption of heritable human
genome editing by those able to afford
it. Unequal access to perceived genetic
‘upgrades’could then exacerbate the
recent dramatic rise in socioeconomic
inequality.
•Racism and xenophobia are resurgent
around the world, fueled by discredited
scientific and popular assumptions
about biological differences among ra-
cially categorized populations. Eugenic
thinking, which aims to ‘improve’human-
ity through genetic and reproductive
technologies and practices, persists
in popular discourse and could be
reinvigorated by the availability of herita-
ble human genome editing
iv
[6,7]. These
pernicious ideas increase stigma and
discrimination against those
considered genetically disadvantaged,
including disabled people and communi-
ties, and undermine the fundamental
equality of all people.
•Outcomes in related biotechnological
spheres provide examples of the likely
trajectory of heritable human genome
editing if commercialized. These include
the promotion of social sex selection by
fertility clinics and of unproven and risky
‘treatments’by commercial stem cell
clinics.
Public engagement and empowerment
are likely to reveal additional concerns
that have not yet surfaced, particularly if
we commit to including and listening to a
broad range of voices and perspectives.
Fostering Public Empowerment
Despite widespread recognition that deci-
sions about this powerful technology
cannot be made by scientists alone,
public involvement is often devalued,
undermined, or limited to predetermined
issues (e.g., selecting conditions for
which germline editing should be avail-
able). What is often proposed in lieu of
genuine public engagement is a top-
down project of educating the uninformed
public with the explicit goal of engineering
acceptance. A related approach sidelines
Box 1. Why Another Statement?
We write as a group of public interest advocates, social science and humanities scholars, ethicists, policy experts,
and life scientists who share a commitment to social justice, human rights, and democratic governance of science
and technology. In January 2019, we met at the Brocher Foundation near Geneva, Switzerland to assess and dis-
cuss public engagement and the governance of heritable human genome editing. As an international group including
both academic experts and civil society representatives, we necessarily produced a different kind of statement.
Nearly all previous statementson heritable human genome editing have been authoredby groups dominated by
scientists and bioethics professionals and based in scientific and medical perspectives. By contrast, this state-
ment foregrounds social justice, human rights, and civil society perspectives. Its aim is to reorient the conversa-
tion around heritable human genome editing by identifying misrepresentations and misunderstandings that
muddy the discourse and by encouraging a robust consideration of the social, historical, and commercial con-
texts that would influence the development of heritable human genome editing and shape its societal effects.
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public engagement by framing heritable
human genome modification as inevitable
while ignoring social and medical alterna-
tives, as well as the numerous policies
prohibiting it.
Public empowerment requires that partici-
pants set the scope and framework of
assessment. All facets of the question –
especially whether heritable human ge-
nome modification should be pursued
at all –must remain open to debate. De-
liberations must proceed with a clear,
shared understanding of what is in ques-
tion and at stake and with transparency
about financial or other interests shaping
the conversations. Further, the out-
comes of public deliberations need to
be taken into account by policymakers
and integrated into formal decision-making
processes.
Robust public engagement must also be
global and inclusive, involving a range of
publics whose voices have, to date, been
overlooked or minimized [8]. While scien-
tists’contributions are important, their
voices should not dominate; social values
and implications must be at the center.
Thus, in addition to scholars in the social
sciences and humanities, legal and policy
specialists, and other experts, delibera-
tions must include a broad swath of orga-
nized civil society, with special attention
to public interest organizations focused
on women’s health, reproductive rights
and justice, racial justice, environmental
justice, gender equality, disability rights,
and human rights.
Concluding Remarks
No decision about whether to pursue herita-
ble human genome modification can be
legitimate without broadly inclusive and
substantively meaningful public engage-
ment and empowerment. Such delibera-
tions may be challenging and messy. They
will take time and organizing them will ne-
cessitate creativity, hard work, and signifi-
cant human and financial resources [9].
The course correction proposed here is es-
sential to these efforts.
We must in the meantime respect the pre-
dominant policy position against pursuing
heritable human genome modification, if
we are to prevent individual scientists or
small committees from making this mo-
mentous decision for us all. This will pre-
serve time to cultivate an informed and
engaged public that can consider and dis-
cuss the societal consequences of altering
the genes of future generations and make
wise, democratic decisions about the
shared future we aspire to build.
Acknowledgments
The authors gratefully acknowledge the Brocher
Foundation (www.brocher.ch), Geneva, Switzer-
land, for hosting the workshop that initiated this
statement and for generously providing financial
support for Open Access publication. We also
thank Kathrin Martin for her assistance.
Resources
i
www8.nationalacademies.org/onpinews/newsitem.
aspx?RecordID=11282018b
ii
http://nuffieldbioethics.org/project/genome-editing-
human-reproduction
iii
www.nytimes.com/2017/08/04/science/gene-
editing-embryos-designer-babies.html
iv
www.washingtonpost.com/opinions/if-we-start-
editing-genes-people-like-me-might-not-exist/2017/
08/10/e9adf206-7d27-11e7-a669-b400c5c7e1cc_
story.html
v
www8.nationalacademies.org/onpinews/newsitem.
aspx?RecordID=12032015a
vi
www8.nationalacademies.org/onpinews/newsitem.
aspx?RecordID=11282018b
vii
www.eshg.org/index.php?id=910&tx_news_pi1
[news]=16&tx_news_pi1[controller]=News&tx_news_
pi1[action]=detail&cHash=
50d16c4b8e5abef5e2693e7864b7e2e5
viii
www.eshre.eu/Press-Room/ESHRE-News
ix
www.irdirc.org/irdirc-supports-the-call-for-a-
moratorium-on-hereditary-genome-editing/
x
www.asgct.org/research/ne ws/april-2019/scientific-
leaders-call-for-global-moratorium-on-g)
1
School of Law of the University of Zurich, Zurich, Switzerland
2
Dalhousie University, Halifax, NS, Canada
3
Center for Genetics and Society, Berkeley, CA, USA
4
Medical Ethics and Humanities, University of London, London,
UK
5
Loyola University Chicago, Chicago, IL, USA
6
University of Oregon, Eugene, OR, USA
7
Center for Health Law, Ethics and Human Rights, Boston
University School of Public Health, Boston, MA, USA
8
Center for Research in Medicine, Science, Health, Mental
Health, and Society, National Institute of Health and Medical
Research (INSERM), Paris, France
9
College of Public Health and College of Medicine, University of
South Florida, Tampa, FL, USA
10
Protestant University of Applied Sciences, Bochum, Germany
11
Institut Mensch, Ethik und Wissenschaft, Berlin, Germany
12
Centre for the Study of the Sciences and Humanities (SVT),
University of Bergen, Bergen, Norway
13
Human Genetics Alert, London, UK
14
Hamburg University, Hamburg, Germany
15
Scottish Council on Human Bioethics, Edinburgh, UK
16
Bioethics Centre, Dunedin School of Medicine, University of
Otago, Dunedin, New Zealand
17
Peking University Health Science Center, Beijing, China
18
University of California, Berkeley, Joint Medical Program,
School of Public Health, Berkeley, CA, USA
19
Institute of Biomedical Ethics and History of Medicine,
University of Zurich, Zurich, Switzerland
20
Institute of Biological Chemistry and Bioethics Network
Ethucation, Medical University of Innsbruck, Innsbruck,
Austria
21
EPP Working Group on Bioethics and Human Dignity,
European Parliament, Brussels, Belgium
22
These authors were unable to attend the workshop at
the Brocher Foundation in Geneva but were involved with
the planning and preparation of the meeting and
manuscript.
Box 2. The Need for Course Correction
The organizing committee of the 2015 International Summit on Human Gene Editing asserted that clinical
use of germline editing should not proceed without ‘broad societal consensus’
v
.Insteadofsustainedcom-
mitment and the allocation of significant resources toward this prerequisite, we have seen steady efforts to
weaken it. Perhaps the clearest example came from the organizing committee of the 2018 International
Summit on Human Genome Editing. Meeting in the shadow of He Jiankui’s utterly unethical experiments,
this group issued a call for a ‘translational pathway to germline editing’,withonlyacursorymentionof
‘attention to societal effects’
vi
.
More recently, the need for broad societal consensus was rea ffirmed in the call for a global moratorium on
heritable human genome editing by an international group of scientists and ethicists, including two of the three
scientists most often recognized as CRISPR pioneers [5]. Subsequent endorsements of their statement
vii–ix
[10] and additional calls for a moratorium from scientists, bioethicists,and biotechnology executives
x
[11] pro-
vide a welcome reminder that enthusiasm for heritable human genome editing is far from universally shared in
scientific and industry circles. The proposed moratorium would allow time to develop the more substantive,
inclusive, and empowering forms of public engagement needed in deliberations about heritable human
genome editing.
Trends in Biotechnology
Trends in Biotechnology, Month 2020, Vol. xx, No. xx 3

*Correspondence:
khasson@geneticsandsociety.org (K. Hasson).
@
Twitter: @FrancoiseBaylis (F. Baylis),
@C_G_S (M. Darnovsky and K. Hasson), @hillehaker (H. Haker),
@georgejannas (G.J. Annas), and @matthiaskaise14 (M. Kaiser).
https://doi.org/10.1016/j.tibtech.2019.12.022
© 2020 The Author(s). Published by Elsevier Ltd. This is an
open access article under the CC BY license
(http://creativecommons.org/licenses/by/4.0/).
References
1. UNESCO (1997) In U niversal Declar ation on the Human
Genome and Human Rights (UNESCO, ed.)
2. Council of Europe (1997) Convention for the Protection
of Human Rights and Dignity of the Human Being with
Regard to the Application of Biology and Medicine:
Convention on Human Rights and Biomedicine (Oviedo
Convention), Council of Europe
3. National Academies of Sciences, Engineering, and
Medicine (2017) Human Genome Editing: Science, Ethics,
and Governance, National Academies Press
4. Baylis, F. (2019) Altered Inheritance: CRISPR and the
Ethics of Human Genome Editing, Harvard University
Press
5. Lander, E. et al. (2019) Adopt a moratori um on heritable
genome editing. Nature 567, 165–168
6. Stern, A.M. (2019) Proud Boys and the White Ethnostate:
How the Alt-Right i s Warping the Ameri can Imagination,
Beacon Press
7. Roberts, D. (2011) Fatal Invention: How Science, Politics,
and Big Business Re-Create Race in the Twenty-First
Century, New Press
8. Hurlbut, J.B. et al. (2018) Building capacity for g lobal
genome editing observatory: conceptual challenges.
Trends Biotechnol. 36, 639–641
9. Saha, K. et al. (2018) Building capacity for a global
genome editing observator y: institutional design. Tre nds
Biotechnol. 36, 741–743
10. Wollinetz, C. and Collins, F. (2019) NIH supports call
for moratorium on cli nical uses of germline ge ne editing.
Nature 567, 175
11. German Ethics Cou ncil (2019) Inte rvening in the Hum an
Germline, German Ethics Council
Trends in Biotechnology
4Trends in Biotechnology, Month 2020, Vol. xx, No. xx