Be part of the CRISPR conversation!

A bioethics resource on genome editing

CRISPR-Cas9 Genome

embl.org/ells
ELLS – European Learning Laboratory for the Life Sciences
About EMBL

EMBL is Europe’s leading laboratory for the life sciences. We are an

intergovernmental organisation supported by over 20 member states and
operating across six sites in Europe.

EMBL performs fundamental research in molecular biology, studying the

story of life. Our research drives the development of new technology and
methods in the life sciences, and we work to transfer this knowledge for
the benefit of society.

About ELLS

The European Learning Laboratory for the Life Sciences (ELLS) is EMBL’s
science education department. We share the scientific discoveries of
EMBL through inspiring learning and outreach experiences.

Our activities are open to European school science teachers, and to young
people of all backgrounds aged between 10 and 19 years.

The ELLS programmes convey complex, cutting-edge topics in life science

research in an exciting and insightful way, fostering the discovery of
current research trends, the scientific method, and scientific career paths.
Our activities are developed and run in close collaboration with EMBL
scientists.

Visit our website for further information about our activities: embl.org/ells

2
 TABLE OF CONTENTS

Table of Contents
Teachers guide 4

Student handout 7

Fact sheets "CRISPR-Cas9 Applications" 16

Annex 23

Task 1 Optional discussion prompts 25

Task 2 Supplementary information on Fact sheets 27

Task 4 EGE Recommendations 30

Quotes & Personas 32

embl.org/ells

3
 Teachers guide
"Be part of the CRISPR conversation!"
A biothics resource on genome editing
ELLS – European Learning Laboratory for the Life Sciences
 TEACHERS GUIDE

Teachers guide

OVERVIEW

Ethical considerations are indivisibly intertwined with issues of genome editing and human health.
They underpin the current boundaries and limitations of research in this area, and will inevitably be
instrumental in predicting (and potentially limiting) future, as yet unforeseen scientific developments.
Yet ethics is often viewed as a separate discipline, to be undertaken by philosophers, lawyers or
bioethicists, far removed from the scientific research itself.

This teaching resource will seek to challenge this perception by putting ethical considerations into
context. It will demonstrate that every student interested in the life sciences more generally - and
genome editing specifically - has a role to play in furthering the debate.

This means that even when the student chooses a career path outside of pure scientific research (such
as journalism, politics, teaching or a medical profession, for example), they are an equally important
piece of the puzzle, and will carry the torch of awareness of these crucial topics for the rest of their
lives.

We believe that foundational knowledge in ethics is essential to ensure we have educated, informed
citizens, who will - of course - eventually be the individuals making the kind of decisions that have the
capacity to impact us all.

LINKS TO CURRICULUM

Content Topics

NGSS HS-LS1-1, HS-LS3-1, HS-LS2-7, HS-ESS3-4

IB (2016 Guide) 3.5, 4.1, O.B.3, O.C.3,
AP (Fall 2020) 5.6, 6.8, 7.4, 7.11, 8.7

SUBJECT AREAS

• Genetics
• Biotechnology
• Ethics
embl.org/ells

5
 TEACHERS GUIDE

LEARNING OUTCOMES

Students will:
• Become familiar with the ethical dimension of genome editing
• Evaluate the application of CRISPR-Cas9 genome editing in different fields
• Identify categories of ethics applicable to genome editing
• Enhance their critical thinking and informed decision-making skills based on scientific
evidence
• Build on their soft skills while engaging actively in value-line decisions with peers on the topic
of genome editing

- Clear communication
- Assertiveness
- Empathy
- Conflict resolution

PREREQUISITS

Student familiarity with concepts such as inheritance, population genetics, ecology and protein func-
tion are required. A basic understanding of genome editing and CRISPR-Cas9 is welcome.

ACTIVITY DELIVERY

The core content of this teaching resource is designed to fit into one school class of up to 45 mins in
length, both in a virtual and in-person setting.
ELLS – European Learning Laboratory for the Life Sciences

To allow for a thorough discussion, we propose a set of tasks: optional and core ones. The optional
exercise(s) are intended to offer a common ground for diving into the topic and to plant a seed of
thought at the end of the class.

The activity also allows for flexibility that matches your preferences: you can choose to run all
exercises at once or separately.

This resource is intended to foster discussion and exchange of opinions based on scientific facts. Thus,
the activity tasks are a mix of individual and group work.

PROVIDED RESOURCES

• Reading material on ethics: https://royalsocietypublishing.org/doi/10.1098/rstb.2018.0106

• Harvard Gazette: https://news.harvard.edu/gazette/story/2019/01/perspectives-on-gene-
editing/
• Video: "The ethics of CRISPR gene editing with Jennifer Doudna": https://www.youtube.com/
watch?v=8Ijr1ccYPtI
• Facts Sheets "CRISPR-Cas9 Applications"
• ANNEX

6
 TEACHERS GUIDE

ACTIVITY DELIVERY

The core content of this teaching resource is designed to fit into one school class of up to 45 mins in
length.
To allow for a thorough discussion, we propose a set of tasks: optional and core ones. The optional
exercise(s) are intended to offer a common ground for diving into the topic and to plant a seed of
thought at the end of the class.
The activity also allows for flexibility that matches your preferences: you can choose to run all core
exercises at once or separately.
The resource is intended to foster discussion and exchange of opinions based on scientific facts. Thus,
the activity tasks are a mix of individual and group work.

TASK 1 (10 minutes, individual work)

Students first read the instructions for Task 1 and identify two ethical aspects that are important
to them in their CRISPR-Cas9 genome editing research. Students then briefly explain their ethical
concerns.

Find ethical terms definitions and discussion prompts, as well as sources of information in
the ANNEX.

TASK 2 (15 minutes, group work)

Students watch the video linked here on the somatic- and germline applications of CRISPR-Cas9
genome editing and ethical questions that come with such applications. This will help students
distinguish the potential impact of genome editing under different conditions. In case streaming
videos in class isn’t possible, the instructor can do this by referring to the Harvard Gazette article
linked here.
Have students form groups of two where every student assumes different roles such as the secretary
and the spokesperson.
Groups go over the CRISPR-Cas9 Factsheets on the tool’s application in different fields. As groups go
over the material, they identify practices that undermine or uphold the welfare of humans, animals
and plants and write them down in Table 1 in the student handout.
A spokesperson from each group provides their reasoning to the rest of the class.

Find ethical terms definitions and discussion prompts, as well as sources of information in
the ANNEX.

TASK 3 (15 minutes, individual & group work)

embl.org/ells

Once every spokesperson presents their reasoning, students then determine their stance on the use of
CRISPR-Cas9 genome editing tool by writing their names in the “value-line” drawn on the board.
Value-line Example:

Fearful Neutral Hopeful

7
 TEACHERS GUIDE

Before students start their discussions, here are certain tips for your students on how to run a fruitful
discussion.

Tips for a fruitful discussion:

• being respectful of other opinions;

• allowing everyone to have a voice;
• assuming best intentions;
• providing evidence as you speak.

Students with similar opinions come together again and identify two statements to support their stan-
ce. Students present these ideas to the rest of the class.

OPTIONAL TASK 4 (10 minutes, individual work)

WHERE WE GO FROM HERE?

The European Group on Ethics in Science and New Technologies (EGE) has recently published guide-
lines on the "Ethics of Genome Editing". This is the most up-to-date European commentary on this
issue. The guideline gives seven recommendations* to create a framework around genome editing.

Have students individually review these recommendations on genome editing while keeping in mind
the question of “What kind of an occupational role would you like to assume to help achieve these
recommendations?”.

Find the EGE recommendations on genome editing in the ANNEX.

ELLS – European Learning Laboratory for the Life Sciences

Terms of use
The educational resource is licensed under the Creative Commons Attribution-NonCommercial-
ShareAlike 4.0 International (CC BY-NC-SA 4.0) License. To view a copy of this license, visit
https://www.creativecommons.org/licenses/by-nc-sa/4.0/

Disclaimer for external links

Links to non-EMBL websites are being provided as a convenience and for informational purposes only.
They do not constitute an endorsement or an approval by EMBL. EMBL has no affiliation with the content
owners of those external sites and bears no responsibility for the accuracy, legality or content of the

8
Student handout
"Be part of the CRISPR conversation!"
A biothics resource on genome editing

embl.org/ells

9
 STUDENT HANDOUT

"Be part of theconversation!"

A bioethics resource on genome editing

“The power to control our species’ genetic future is awesome and terrifying. De-
ciding how to handle it may be the biggest challenge we have ever faced.”

~ Jennifer A. Doudna

OVERVIEW

Initially discovered as a bacterial defence mechanism, CRISPR proved to be an extremely powerful

genome editing tool that allows scientists to edit target sites in the genome with high precision. When
applied to embryos and germline cells, changes that are engineered through CRISPR-Cas9 can even
be inherited by the next generation (1). This application alone has the potential to drive a whole spe-
cies into extinction. In this activity, you will be discussing the use of CRISPR-Cas9 as a genome editing
tool, its overall potential impact on human, non-human animal (from here onwards just animals) and
plant wellbeing. You will also discuss the ethical concerns that come with the use of this powerful
technology.

TASK 1 (10 MINS, GROUP WORK)

Instructions
ELLS – European Learning Laboratory for the Life Sciences

Imagine you are a scientist who prepares to start using CRISPR-Cas9 as part of your research project.
Having in mind the great potential of genome editing to change our lives, would you consider any eth-
ical aspects that might set the scene for your work. List 2 ethical aspects that you think are important
to inform yourself about before the start of your project and briefly explain your reasoning.

Here are some examples that you may consider: human, dignity, safety, freedom, autonomy,
emerging technologies, experimenting with boundaries, social justice, diversity, animal and
plant rights.

Ethics aspect 1:

Ethics aspect 2:

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 STUDENT HANDOUT

TASK 2 (15 MINS, GROUP WORK)

In this task you will be working in groups to explore different fields where CRISPR-Cas9 genome
editing can be applied and whether these applications undermine or uphold human, animal, and plant
welfare.

Instructions

1. Form groups of two and check the available Facts sheets "CRISPR-Cas9 Applications" regarding
the use of CRISPR-Cas9 genome editing in various fields.
2. Identify practices that undermine or uphold the welfare of animals, humans and plants and fill
them in a table.
3. After you identify these practices and your reasonings, present them to the rest of the class.

Table 1: CRISPR Applications and Ethics

Undermining OR
CRISPR-Cas9 Upholding the welfare of
Reasoning
application humans, animals and/or
plants

embl.org/ells

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 STUDENT HANDOUT

“Society needs to figure out if we all want to do this, if this is good for society, and
that takes time. If we do, we need to have guidelines first so that the people who
do this work can proceed in a responsible way, with the right oversight and quali-
ty controls.”

~ Feng Zhang

TASK 3 (15 MINS, INDIVIDUAL & GROUP WORK)

In this section, you will be determining your stance on the use of CRISPR-Cas9 genome editing appli-
cations by working on a value-line.

Instructions

Individual work
1. Recall your previous discussions with your partners regarding the use of CRISPR-Cas9 genome
editing tool. Are you hopeful, neutral or fearful over the prospects of technology’s use on humans,
animals and plants? Note down a few statements that support/justify your stance.
2. Write your name on the value line depending on your stance.

Group work
3. People sharing the same opinions form groups and explain their reasoning by presenting two
statements in front of the class. Use your notes to help you easily identify your supporting state-
ments.
ELLS – European Learning Laboratory for the Life Sciences

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 STUDENT HANDOUT

“Science has this huge advantage over most professional thought in that it has a
universal language. Scientists can hop from lab to lab internationally in a way that
lawyers cannot because laws are written in many languages and don’t translate
easily. It takes a very long time for people to understand each other across these
boundaries. A foundational concept for human dignity? It would not be the same
thing between cultures. I would like to see a ‘global observatory’ that goes be-
yond gene editing and addresses emerging technologies more broadly.”

~ Sheila Jasanoff

OPTIONAL TASK 4 (10 MINS, INDIVIDUAL WORK)

WHERE WE GO FROM HERE?

EU Recommendations on Future Ethical Frameworks

The European Group on Ethics in Science and New Technologies (EGE) has recently published guide-
lines on the "Ethics of Genome Editing". This is the most up-to-date European commentary on this
issue.

Instructions

1. Review the EU recommendation assigned to you by your instructor.

2. Identify an occupational role (such as in journalism, politics, teaching, research or a medical
profession, for example) you might want to assume to help achieve these recommendations and
discuss with the class.

Recommendation One: foster broad and inclusive societal deliberation on genome

editing in all fields of application and with a global scope
• Genome editing should not be applied without a general agreement resulting from informed
global dialogue.
• Public debate should address how genome editing is perceived and assessed by citizens, which
opinions, hopes and fears they hold, across fields of application, and whether germline ge-
nome editing is seen as necessary and/or acceptable, or would be so under what conditions.
• Fora for debate should be organised on local and European levels that are integrated in interna-
tional dialogue, acquiring global scope.
• Increase of resources to develop and employ innovative formats for public engagement (in-
cluding, but not limited to, education) and deliberation (e.g. citizens’ assemblies) on ethical
embl.org/ells

questions related to genome editing.

• Such deliberation should be based on democratic principles, be open to everyone, involve a
wide variety of stakeholders and forms of expertise and be inclusive, interdisciplinary and
pluralistic.

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 STUDENT HANDPOUT

Recommendation Two: avoid narrow conceptualisations

• The ‘safe enough’ narrative limits reflections on ethics and governance to considerations about
safety; it purports that it is sufficient for a given level of safety to be reached in order for a
technology to be rolled out unhindered, thereby eschewing ethically important questions such
as whether genome editing is in fact necessary, acceptable, and under what conditions.
• Notably, those who are using the technology must ensure that they are monitoring for unpre-
dicted and unintended events, and act upon them accordingly and without delay. This also
extends to questions of coordination, inequalities and power relations.
• In fact, ‘safety’ or ‘trustworthiness’ do not pertain solely to technologies but also to institutions
and forms of governance in societies – including matters of oversight as well as of democracy
and rule of law.

Recommendation Three: develop international guidelines and strengthen national,

regional and global governance tools
• The EGE recommends that the European Commission, together with appropriate international
bodies who are also already working in this area (notably WHO, FAO, ISO), develop standards
and guidelines for the ethical and safe use of genome editing across all areas of application.
• The EGE also recommends establishing regulatory oversight for ‘do-it- yourself’ (DIY) genome
editing tools.
• For the application of genome editing tools in other organisms, the EGE proposes to establish
regulatory structures that assess risk of application for the organism and the environment and
certifies their safety.
• The European Commission is advised to develop mechanisms to avoid or mitigate harm through
unregulated availability of DIY kits on the internet, for example, by implementing strong
liability rules.
ELLS – European Learning Laboratory for the Life Sciences

Recommendation Four: engage in global governance initiatives and create a plat-

form for information sharing and inclusive debate on germline genome editing
• The EGE asks the European Commission to engage in a global mechanism to guarantee that
heritable human genome editing is not prematurely clinically applied and is not applied for
purposes other than against serious diseases that cannot be prevented or treated other-
wise.
• On this basis, the EGE calls for the creation of a European Platform to facilitate exchange of
information and a broad and open public debate on the ethical and social implications of
germline genome editing in human beings on the basis of sound and evidence-based infor-
mation.
• The functioning of the platform should, importantly, also integrate international dialogue and
cooperation beyond Europe, for example, with the Global Observatory for Genome Editing,
in order to acquire global scope and contribute to processes towards global consensus.

Recommendation Five: establish a public registry for research on germline genome

editing
• Transparency and evidence-based information is of utmost importance to foster an inclusive
societal debate.

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 STUDENT HANDOUT

• To support an informed debate, the EGE recommends establishing a European and/or global
registry for germline genome editing (that could also be part of the proposed European Plat-
form). It should cooperate with the global registry for human genome editing established by
the WHO.
• The registry should be publicly accessible to ensure transparency for monitoring scientific pro-
gress and ethical soundness. Ethical approval and legal compliance must be a precondition for
any registry entry.
• Project registration is already compulsory for all research on germline genome editing funded
by the EU and should become mandatory for all research.

Recommendation Six: protect social justice, diversity and equality

• Given the potential of genome editing techniques to be used for interventions that are not
related to preventing or treating diseases but primarily serve enhancement purposes, their
potential for fostering social inequality and undermining diversity should be considered.
• The EGE recommends to proactively safeguard against enhancement or de- enhancement of
traits and to ensure that investments in research on germline genome editing have the pur-
pose of protecting health.
• This also serves to protect human dignity, identity, diversity, equality, social justice and solidar-
ity.
• In this context, guidelines should be developed that allow research ethics committees to distin-
guish between technologies and applications of genome editing that are to be considered as
preventive, diagnostic or therapeutic, and those that are to be considered as ‘human enhance-
ment’, if such distinctions are to be used.
• Somatic genome editing has the potential to alleviate suffering from diseases that could not
be treated effectively before. The EGE recommends that access to clinical studies and, once
approved, to clinical application in healthcare is granted according to the principle of social
justice and without discrimination.

Recommendation Seven: ensure adequate competencies in expert bodies

• Genome editing technologies are evolving quickly and expertise to assess research and appli-
cation has to keep pace with new developments.
• It is important to widen the basis of expertise and broaden what counts as relevant knowledge
at the level of expert committees, fora and other bodies established to examine and set guide-
lines and standards for research and application of genome editing technologies.
• In light of the global variety of views on the essence of human nature, it is important to organise
ethics oversight of international research collaboration and prevent ethics dumping.
• Such adequacy of expertise is crucial also for ethics committees charged with approving and
embl.org/ells

supervising clinical trials involving genome editing. The EGE suggests that guidelines for safe-
ty assessments and risk/benefit determinations of clinical trials are developed and training
modules are provided for research ethics committees and other involved bodies to ensure
high-standing and consistent application of ethical standards.
• If national legislation of Member States allows research involving human embryos this sug-
gestion also applies to this kind of research. Different Member States have different laws on
embryo research. The principle of subsidiarity should continue to be respected.

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 Fact sheets "CRISPR-Cas9 Applications"
"Be part of the CRISPR conversation!"
A biothics resource on genome editing
ELLS – European Learning Laboratory for the Life Sciences

16
 FACT SHEETS

Crop Sciences and CRISPR-Cas9 Applications

embl.org/ells

References

Nekrasov V, Wang C, Win J, Lanz C, Weigel D, Kamoun S. Rapid generation of a transgene-free powdery mildew resistant tomato by
genome deletion. Sci Rep. 2017;7(1):482. Published 2017 Mar 28. doi:10.1038/s41598-017-00578-x

OERKE, E. (2006). Crop losses to pests. The Journal of Agricultural Science, 144(1), 31-43. doi:10.1017/S0021859605005708

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 FACT SHEETS

Human Health and CRISPR-Cas9 Applications

ELLS – European Learning Laboratory for the Life Sciences

References

O'Neal TB, Luther EE. Retinitis Pigmentosa. 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK519518/

Gumerson, J.D., Alsufyani, A., Yu, W. et al. Restoration of RPGR expression in vivo using CRISPR/Cas9 gene editing. Gene Ther
(2021). https://doi.org/10.1038/s41434-021-00258-6

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 FACT SHEETS

Gene Drive and CRISPR-Cas9 Applications

embl.org/ells

Reference

Kyrou, K., Hammond, A., Galizi, R. et al. A CRISPR–Cas9 gene drive targeting doublesex causes complete population suppression in
caged Anopheles gambiae mosquitoes. Nat Biotechnol 36, 1062–1066 (2018). https://doi.org/10.1038/nbt.4245

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 FACT SHEETS

Egg indusrty and CRISPR-Cas9 Applications

ELLS – European Learning Laboratory for the Life Sciences

Reference

Lee, H.J., Yoon, J.W., Jung, K.M., Kim, Y.M., Park, J.S., Lee, K.Y., Park, K.J., Hwang, Y.S., Park, Y.H., Rengaraj, D. and Han, J.Y. (2019),
Targeted gene insertion into Z chromosome of chicken primordial germ cells for avian sexing model development. The FASEB
Journal, 33: 8519-8529. https://doi.org/10.1096/fj.201802671R

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 FACT SHEETS

De-extinction and CRISPR-Cas9 Applications

embl.org/ells

Image Permafrost melting in the arctic region of Svalbard, Norway.

Credit: Jeff Vanuga/Getty

Reference

Novak BJ. De-Extinction. Genes (Basel). 2018;9(11):548. Published 2018 Nov 13. doi:10.3390/genes9110548

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 ELLS – European Learning Laboratory for the Life Sciences

NOTES

22
NOTES
Annex
"Be part of the CRISPR conversation!"
A biothics resource on genome editing

embl.org/ells

23
 ANNEX

Annex: Table of Contents

Task 1 Optional discussion prompts 25

Task 2 Supplementary information on Fact Sheets 27

Task 4 EGE Recommendations 30

Quotes & Personas 32

ELLS – European Learning Laboratory for the Life Sciences

24
 ANNEX

TASK 1

Optional discussion prompts

+ Optional additional reading (short UKCEN summary)

Human
• What does it mean to be human?
• What makes us different from animals or plants?
• Consider: sentience, self-awareness, capacity of reason
• NOTE: what if humans do not have these qualities (ie if they have learning difficulties/lack of
capacity, etc)?

Dignity
• Do we have worth beyond our "usefulness"?
• Who is worthy of dignity? Should it be exclusive to humans or extended to animals or the en-
vironment?
• Consider: the concept of absolute, intrinsic and unconditional value
• NOTE: the preamble to the Universal Declaration of Human Rights recognises the “inherent
dignity” of “all members of the human family”. By recognising dignity, the Declaration ack-
nowledges ethical limits to the ways we can treat other people.

Safe
• How could / should society assess the safety of genome editing?
• How do we plan for future developments in / the application of technologies like genome
editing?
• Consider: limitations and boundaries, the "slippery slope" argument
• NOTE: Who decides what is 'safe' (ie legal/religious/medical, etc)?

Freedom
• What makes us free? How does freedom relate to responsibility?
• What freedoms are relevant re genome editing and human health?
• Consider: the position from different stakeholder perspectives - ie a parent of a child with a
genetic disease, vs a religious leader, etc
• NOTE: the overlap between freedom and the concept of human rights

Autonomy
• What is autonomy?
• Why is autonomy important in healthcare ethics?
• Consider: the idea of choice, informed choice and patient empowerment
• NOTE: The four principles of Beauchamp and Childress - autonomy, non-maleficence, bene-
ficence and justice - have been extremely influential in the field of medical ethics, and are
fundamental for understanding the current approach to ethical assessment in health care.

Emerging Technologies
• What are some relevant emerging technologies (ie, genome editing, AI, etc)?
• What is the societal perception of emerging technology?
• Consider: issues such as Dolly the sheep, genetically engineered food, Lulu and Nana (first use
of genome editing in humans).
• NOTE: concepts of risk and reward (for example, as presented in this Royal Society summary)

Boundaries
• Why are boundaries important?
embl.org/ells

• Whose views should be considered/prevail?

• Consider: possible legal, ethical and societal boundaries
• NOTE: how do we get researchers to comply? What are the implications of overshooting boun-
daries?

25
 ANNEX

Justice
• What does justice mean in the context of human health?
• How do we achieve justice?
• Consider: the concepts of distributing benefits, risks and costs fairly; the notion that patients
in similar positions should be treated in a similar manner.
• NOTE: Justice – in the context of medical ethics – is the principle that when weighing up if
something is ethical or not, we have to think about whether it’s compatible with the law, the
patient’s rights, and if it’s fair and balanced.It also means that we must ensure no one is un-
fairly disadvantaged when it comes to access to healthcare.

Diversity
• What do we mean by diversity?
• Why is diversity a relevant concept to medical/scientific ethics?
• Consider: historical approaches to medical ethics (gender, race, disability, etc)
• NOTE: there are many interesting case studies to choose from - the most obvious being the
Nuremberg Code, Tuskegee and Henrietta Lacks.
ELLS – European Learning Laboratory for the Life Sciences

26
 ANNEX

TASK 2

Supplementary information on Fact Sheets "CRSPR-Cas9 Applications"

embl.org/ells

Reference

Acevedo-Garcia, J., Kusch, S. and Panstruga, R. (2014), Magical mystery tour: MLO proteins in plant immunity and beyond. New
Phytol, 204: 273-281. https://doi.org/10.1111/nph.12889

27
 ANNEX
ELLS – European Learning Laboratory for the Life Sciences

Reference

Kyrou, K., Hammond, A., Galizi, R. et al. A CRISPR–Cas9 gene drive targeting doublesex causes complete population suppression in
caged Anopheles gambiae mosquitoes. Nat Biotechnol 36, 1062–1066 (2018). https://doi.org/10.1038/nbt.4245

28
 ANNEX

embl.org/ells

Reference

Lynch, Vincent J. et al.

Cell Reports, Volume 12, Issue 2, 217 - 228

29
 ANNEX

OPTIONAL TASK 4

EGE Recommendations

Recommendation One: foster broad and inclusive societal deliberation on genome

editing in all fields of application and with a global scope
• Genome editing should not be applied without a general agreement resulting from informed
global dialogue.
• Public debate should address how genome editing is perceived and assessed by citizens, which
opinions, hopes and fears they hold, across fields of application, and whether germline ge-
nome editing is seen as necessary and/or acceptable, or would be so under what conditions.
• Fora for debate should be organised on local and European levels that are integrated in interna-
tional dialogue, acquiring global scope.
• Increase of resources to develop and employ innovative formats for public engagement (in-
cluding, but not limited to, education) and deliberation (e.g. citizens’ assemblies) on ethical
questions related to genome editing.
• Such deliberation should be based on democratic principles, be open to everyone, involve a
wide variety of stakeholders and forms of expertise and be inclusive, interdisciplinary and
pluralistic.

Recommendation Two: avoid narrow conceptualisations

• The ‘safe enough’ narrative limits reflections on ethics and governance to considerations about
safety; it purports that it is sufficient for a given level of safety to be reached in order for a
technology to be rolled out unhindered, thereby eschewing ethically important questions such
as whether genome editing is in fact necessary, acceptable, and under what conditions.
ELLS – European Learning Laboratory for the Life Sciences

• Notably, those who are using the technology must ensure that they are monitoring for unpre-
dicted and unintended events, and act upon them accordingly and without delay. This also
extends to questions of coordination, inequalities and power relations.
• In fact, ‘safety’ or ‘trustworthiness’ do not pertain solely to technologies but also to institutions
and forms of governance in societies – including matters of oversight as well as of democracy
and rule of law.

Recommendation Three: develop international guidelines and strengthen national,

regional and global governance tools
• The EGE recommends that the European Commission, together with appropriate international
bodies who are also already working in this area (notably WHO, FAO, ISO), develop standards
and guidelines for the ethical and safe use of genome editing across all areas of application.
• The EGE also recommends establishing regulatory oversight for ‘do-it- yourself’ (DIY) genome
editing tools.
• For the application of genome editing tools in other organisms, the EGE proposes to establish
regulatory structures that assess risk of application for the organism and the environment and
certifies their safety.
• The European Commission is advised to develop mechanisms to avoid or mitigate harm through
unregulated availability of DIY kits on the internet, for example, by implementing strong
liability rules.

30
 ANNEX

Recommendation Four: engage in global governance initiatives and create a plat-

form for information sharing and inclusive debate on germline genome editing
• The EGE asks the European Commission to engage in a global mechanism to guarantee that
heritable human genome editing is not prematurely clinically applied and is not applied for
purposes other than against serious diseases that cannot be prevented or treated other-
wise.
• On this basis, the EGE calls for the creation of a European Platform to facilitate exchange of
information and a broad and open public debate on the ethical and social implications of
germline genome editing in human beings on the basis of sound and evidence-based infor-
mation.
• The functioning of the platform should, importantly, also integrate international dialogue and
cooperation beyond Europe, for example, with the Global Observatory for Genome Editing,
in order to acquire global scope and contribute to processes towards global consensus.

Recommendation Five: establish a public registry for research on germline genome

editing
• Transparency and evidence-based information is of utmost importance to foster an inclusive
societal debate.
• To support an informed debate, the EGE recommends establishing a European and/or global
registry for germline genome editing (that could also be part of the proposed European Plat-
form). It should cooperate with the global registry for human genome editing established by
the WHO.
• The registry should be publicly accessible to ensure transparency for monitoring scientific pro-
gress and ethical soundness. Ethical approval and legal compliance must be a precondition for
any registry entry.
• Project registration is already compulsory for all research on germline genome editing funded
by the EU and should become mandatory for all research.

Recommendation Six: protect social justice, diversity and equality

• Given the potential of genome editing techniques to be used for interventions that are not
related to preventing or treating diseases but primarily serve enhancement purposes, their
potential for fostering social inequality and undermining diversity should be considered.
• The EGE recommends to proactively safeguard against enhancement or de- enhancement of
traits and to ensure that investments in research on germline genome editing have the pur-
pose of protecting health.
• This also serves to protect human dignity, identity, diversity, equality, social justice and solidar-
ity.
• In this context, guidelines should be developed that allow research ethics committees to distin-
embl.org/ells

guish between technologies and applications of genome editing that are to be considered as
preventive, diagnostic or therapeutic, and those that are to be considered as ‘human enhance-
ment’, if such distinctions are to be used.
• Somatic genome editing has the potential to alleviate suffering from diseases that could not
be treated effectively before. The EGE recommends that access to clinical studies and, once
approved, to clinical application in healthcare is granted according to the principle of social
justice and without discrimination.

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Recommendation Seven: ensure adequate competencies in expert bodies

• Genome editing technologies are evolving quickly and expertise to assess research and appli-
cation has to keep pace with new developments.
• It is important to widen the basis of expertise and broaden what counts as relevant knowledge
at the level of expert committees, fora and other bodies established to examine and set guide-
lines and standards for research and application of genome editing technologies.
• In light of the global variety of views on the essence of human nature, it is important to organise
ethics oversight of international research collaboration and prevent ethics dumping.
• Such adequacy of expertise is crucial also for ethics committees charged with approving and
supervising clinical trials involving genome editing. The EGE suggests that guidelines for safe-
ty assessments and risk/benefit determinations of clinical trials are developed and training
modules are provided for research ethics committees and other involved bodies to ensure
high-standing and consistent application of ethical standards.
• If national legislation of Member States allows research involving human embryos this sug-
gestion also applies to this kind of research. Different Member States have different laws on
embryo research. The principle of subsidiarity should continue to be respected.

QUOTES & PERSONAS

+ Optional additional discussion prompts

Quote one
“The power to control our species’ genetic future is awesome and terrifying. Deciding how to handle it
ELLS – European Learning Laboratory for the Life Sciences

may be the biggest challenge we have ever faced.”

~ Jennifer A. Doudna

Jennifer Anne Doudna is an American biochemist who has done pioneering work in CRISPR gene edit-
ing, and made other fundamental contributions in biochemistry and genetics. She received the 2020
Nobel Prize in Chemistry, with Emmanuelle Charpentier, "for the development of a method for genome
editing. She is the Li Ka Shing Chancellor's Chair Professor in the Department of Chemistry and the
Department of Molecular and Cell Biology at the University of California, Berkeley. She has been an
investigator with the Howard Hughes Medical Institute since 1997.

DISCUSSION PROMPT: As a leading light in the field of gene editing, what do Jennifer Doudna's com-
ments say about the ethical application of the techniques she helped create?

Quote two
"Society needs to figure out if we all want to do this, if this is good for society, and that takes time. If
we do, we need to have guidelines first so that the people who do this work can proceed in a responsi-
ble way, with the right oversight and quality controls.”

~ Feng Zhang

Feng Zhang is a Chinese-American biochemist. Zhang currently holds the James and Patricia Poitras
Professorship in Neuroscience at the McGovern Institute for Brain Research and in the departments of
Brain and Cognitive Sciences and Biological Engineering at the Massachusetts Institute of Technology.
He also has appointments with the Broad Institute of MIT and Harvard (where he is a core member).
He is most well known for his central role in the development of optogenetics and CRISPR technolo-
gies.

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DISCUSSION PROMPT: although Feng Zhang is a renowned scientist in the field of CRISPR techno-
logies, he has also drawn attention to the need for guidelines and checks and balances. Do scientists'
views carry more weight in this area? Why is it important to regulate emerging technologies like geno-
me editing?

Quote three

“Science has this huge advantage over most professional thought in that it has a universal language.
Scientists can hop from lab to lab internationally in a way that lawyers cannot because laws are writ-
ten in many languages and don’t translate easily. It takes a very long time for people to understand
each other across these boundaries. A foundational concept for human dignity? It would not be the
same thing between cultures. I would like to see a ‘global observatory’ that goes beyond gene editing
and addresses emerging technologies more broadly.”

~ Sheila Jasanoff

Sheila Sen Jasanoff is an Indian American academic and significant contributor to the field of Science
and Technology Studies. In 2021 she was elected to the American Philosophical Society. Jasanoff
founded and directs the Program on Science, Technology, and Society at the John F. Kennedy School
of Government at Harvard University.[6] Her research focuses on science and the state in contempo-
rary democratic societies. Her work is relevant to science & technology studies, comparative politics,
law and society, political and legal anthropology, sociology and policy analysis. Jasanoff's research
has considerable empirical breadth, spanning the United States, the United Kingdom, Germany, the
European Union, and India, as well as emerging global regimes in areas such as climate and biotech-
nology.

DISCUSSION PROMPT: is it possible to have an international approach to / a global observatory re-

emerging technologies? What fundamental principles should be included when considering such an
initiative?

embl.org/ells

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 European Learning Laboratory for the life Sciences

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69117 Heidelberg
Germany

Tel: +49 6221 387 8805

Mail: ells@embl.de
Website: embl.org/ells

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Version 1: September 2021