View source for Instruction:05a252c0-7dfb-4b50-b53a-df046bd702b9

{{Instruction
|Title=Gene Editing: Ethics Issues
|Instruction Goal=To support students, researchers, and research ethics reviewers in learning about and reflecting upon the ethics issues associated with the development and use of gene editing. 

'''Learning outcomes''' 

At the end of this module, learners will be able to: 

# Weigh the potential harms and benefits of different areas of gene editing. 
# Identify safety issues related to the techniques and applications of gene editing.  
# Reflect upon some of the broader ethics issues (like dual use/misuse or slippery slope) associated with gene editing.
# Access the relevant guidelines and regulations for gene editing
|Has Duration=2
|Important For=All stakeholders in research; Students
}}
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{{Instruction Perspective Trainee}}
{{Instruction Step Trainee
|Instruction Step Title=Module Introduction
|Instruction Step Text=[[File:Ge2Image int.png|center|frameless|600x600px]]


From the eradication of genetic diseases to potential human enhancements, and the place of genetically modified organisms in agriculture, the number of potential uses of gene editing is vast. This module touches upon a wide variety of ethics issues that are associated with research involving gene editing. It includes ethics issues related to both human and non-human applications and the way in which these issues might be assessed and governed.
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{{Instruction Step Trainee
|Instruction Step Title=A Case of Gene Editing in Human Embryos
|Instruction Step Text=[[File:Ge2Image2.png|center|frameless|600x600px]]


In November 2018, an international news story broke about a scientist in China who had genetically altered a gene in human embryos that had resulted in the birth of IVF twins, Lulu and Nana. The gene editing involved the use of CRISPR-Cas9 technology to disable the CCR5 gene with the aim that this would lead to HIV resistance. The scientist, He Jiankui, introduced the CRISPR technology very soon after the embryos were created when they were formed of only one cell each. He Jiankui’s actions were widely condemned as unethical, and the news sparked intense debate about the potential impacts upon the children. 


How might this genetic modification affect the development, the health and the wellbeing of Lulu and Nana? In the years since their birth there have been many rumours and suggestions about the impacts, including that the twins have enhanced memories and learning abilities, and others that their lives will be shortened. We don’t yet know what attributes can be attributed to the gene editing.
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{{Instruction Step Trainee
|Instruction Step Title=A Case of Gene Editing in Human Embryos cont.
|Instruction Step Text=[[File:Ge2Image3.png|center|frameless|600x600px]]



What do you think are the main ethics issues for this case? Some of the main ones are listed below. Sort each issue into one of the four categories: Autonomy, Future generations; Potential harms and benefits; and Slippery slope.
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{{Instruction Step Trainee
|Instruction Step Title=Germline Gene Editing
|Instruction Step Text=[[File:Ge2Image4.png|center|frameless|600x600px]]


Germline gene editing needs to be undertaken at the earliest stage of embryo development to ensure that all cells carry the changes. When used to correct mutations, it can enable people who are at risk of passing genetic disease to their children to have a child free from severe genetic diseases. It might also be used to enhance immunity or protective factors for many other diseases (as was the intention for Lulu and Nana). 


Additionally, it may offer the only hope of a biological child in cases where people, due to genetic mutations, face challenges in conceiving healthy embryos through conventional means or in vitro fertilisation. Nevertheless, the long-term risks associated with germline manipulation remain uncertain. Errors in this process could have far-reaching consequences for future generations because germline gene editing affects all cells, germ cells, as well as somatic cells. Hence, the changes will be heritable, and any harmful effects may only be rectified if none of these individuals ever have children of their own.


Regarding germline editing regulations, the Lancet reported in 2023 that there is broad consensus around the world that altering embryo DNA should remain forbidden.  However, many countries do not have effective oversight and governance mechanisms to enforce existing regulations. In some countries, although altering embryo DNA is generally forbidden, exceptions are allowed. In Europe, the Oviedo Convention, a legally binding instrument established by the Council of Europe, permits somatic genome modifications for preventive, diagnostic, or therapeutic purposes, and prohibits germline editing, but only 29 countries have written it into law.


While there is a lack of policy and oversight alignment between countries, there is a risk of ethics dumping – the off-shoring of research that would be forbidden or considered unethical in the researcher’s home country to a region where regulation is lacking, of a lower standard or less well enforced.
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{{Instruction Step Trainee
|Instruction Step Title=Gene Editing and Human Embryos
|Instruction Step Text=To develop and improve methods of gene editing, both germline and somatic, research on human embryos is currently necessary, although it may be possible in the future through generating germ cells in vitro. Research with human embryos raises moral objections for many, not least because the embryos will be destroyed when used for research.


Some countries have enacted outright bans on certain types of embryo research, such as research involving the creation of embryos solely for research purposes or research aimed at modifying the human germline. Consensus does not exist regarding the moral status of an embryo, and many people oppose research on embryos categorically.


Regulations for embryo research often impose limits on the duration embryos can be cultured for research purposes. For example, some jurisdictions allow research only on embryos up to 14 days old, as this is when the primitive streak (an early stage of nervous system development) typically forms. However, an extension of the 14-day rule for embryo research (which is legally binding in some countries) has been under discussion for many years. The International Society for Stem Cell Research (ISSCR) relaxed its guideline on this limit in 2021. 


Therein, it is suggested that studies proposing to grow human embryos beyond the two-week mark be considered on a case-by-case basis, involving institutional or national bodies as well as extensive public engagement. Allowing embryos to grow past 14 days might improve understanding of human development and many health-related questions, for example, why many pregnancies fail.
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{{Instruction Step Trainee
|Instruction Step Title=Reflection Activity
|Instruction Step Text=[[File:Ge2Image6.png|center|frameless|600x600px]]



The ISSCR suggests that studies proposing to grow human embryos beyond two weeks should be considered on a case-by-case basis. Imagine that you are a member of a committee that has been asked to approve a study that involves gene editing of embryos that will be grown for 28 days. How would you go about this, and what sort of things might you include in your deliberations?


There are many important factors to consider. These may include the following:


* Does the research comply with relevant laws, regulations, and ethics guidelines in the jurisdiction where it is conducted? 
* What is the scientific rationale for use of this approach? 
* Do the research goals clearly justify the gene editing and growth of embryos beyond 14 days old?  
* Are there any alternative methods or models that could achieve similar research objectives without using human embryos or extending beyond the 14-day limit? 
* How have the opinions of stakeholders (including researchers, policymakers, ethicists, society, experts etc.) been taken into account?  
* What are the broad-based and longer-term implications of this study? 


Decision-making in complex circumstances like this needs to be evidence-informed. By taking time to consider factors carefully, with the involvement of various experts (scientific, legal, ethics) and the general public, informed decisions can be taken about implementation, modification, or potential revision in light of evolving ethical, scientific, and social considerations.

Furthermore, these issues need to be navigated within the framework of the national legislation, which can be stricter than the 14-day rule. For research with embryos, or their modification through genome editing, the legal requirements vary, even within the EU. Where it is permitted, the procedures and the requirements for ethical assessments also vary. 


In the USA, experiments with embryos or with the production of embryos are not publicly funded, but privately funded experiments are possible. Given that the legal and governance frameworks can be very different from country to country, international cooperation for projects involving gene editing of human embryos can be especially difficult.
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{{Instruction Step Trainee
|Instruction Step Title=Expert Interview on Slippery Slope
|Instruction Step Text=The term Slippery Slope is an argument that claims that an initial action will trigger a series of other events that will lead to basically some undesirable outcomes in the end. So, if we decide to allow

a procedure that heals cystic fibrosis in patients, for example. The argument claims that this will lead to

more controversial procedures, such as basically, for example, editing cells in terms of, let's say, growth, editing the height of people, and this will then lead to enhancements such as choosing the eye colour of people or other very controversial procedures.


The problem with human enhancement is that there is no consent, because human enhancement needs to be done before the birth of a baby. So, there's no consent from the baby, obviously. So, we would need to ask the parents. And that could be a problem, because the parents' intentions might not be aligned with the baby's intentions.

There's also the problem of accessibility, because obviously if people have to pay for it, then it would be accessible for rich people, but not for poorer ones. And that also leads to a problem of fairness.

And it could lead to a two-class system where rich people have access to enhancement, whereas poorer people don't have access. And that would be a problem for society as well.
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{{Instruction Step Trainee
|Instruction Step Title=Human Enhancement
|Instruction Step Text=[[File:Ge2Image7.png|center|frameless|600x600px]]


Some ethicists argue that we have a moral duty to use gene editing to eliminate hereditary diseases.


Others assert that gene editing, initially aimed at therapy, might lead to non-therapeutic enhancements and the application of gene editing for enhancing the human body and brain raises numerous ethical concerns. These include matters of safety, the concept of 'designer babies', potential discrimination against non-enhanced individuals, and potential longer-term effects. Let's hear from someone who has many concerns.


In the realm of enhancement, I’m concerned about children being subjected to parental experimentation without the children’s informed consent. The procedures involved carry significant risks that may impact their entire lives as well as those of their children.


There are also ‘slippery slope’ risks. If genetic enhancement becomes acceptable for certain characteristics, the boundaries of what is considered acceptable will soon be pushed. Additionally, people may begin to feel pressure to enhance to ensure that their children are not disadvantaged in comparison with those who benefit from enhancements.


Additionally, the possibility of enhancement and ‘designer babies’ raises serious issues about equity regarding equal access and the unfair distribution of benefits, as well as a potential drift towards eugenics. If gene editing becomes widely available, there's a risk of selectively enhancing desirable traits and suppressing undesirable ones, which might foster societal intolerance for imperfection.


While individuals may benefit personally, there are broader societal impacts. How might it affect those already living with disabilities? This raises questions about inclusivity, diversity, resource allocation, and the rights of individuals with disabilities. Balancing individual autonomy with societal wellbeing is at the core of this dilemma.


A major problem for ethics assessment is that there are currently no clear guidelines about human enhancements. Furthermore, the line between therapy and enhancement is often blurred and there can be dual effects, both therapy and enhancement, in some cases.


Research ethics committee members need to be aware of the mechanisms and drivers of the use of genome editing and related technologies by the global fertility industry. This is necessary to ensure that research ethics reviewers can support the research community in applying the precautionary principle to specific research fields with dual benefit potential. For instance, therapy of life-threatening diseases versus selection of desirable traits.


'''Feedback'''

The precautionary principle states that if an activity or technology has the potential to cause harm, and if there is scientific uncertainty about the extent or nature of that harm, then precautionary measures should be taken to prevent or minimise the harm, even if conclusive evidence of harm is lacking. Given the gaps in our understanding of the consequences, and the lack of clear, shared guidelines, adoption of a precautionary approach to the use of gene editing for non-therapeutic human enhancements seems most appropriate.
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{{Instruction Step Trainee
|Instruction Step Title=Human Enhancement - Poll
|Instruction Step Text=<div><div>
Take a moment to reflect on how you feel about the use of gene editing for some non-therapeutic human enhancements.


'''Feedback'''
</div>The use of gene editing for non-therapeutic human enhancements is a complex matter which many people feel conflicted about. On one hand, the potential to improve human capabilities is exciting and could lead to incredible advancements. On the other hand, there are concerns about the ethical implications and the possibility of creating a society with even greater inequality and unforeseen health risks.<div></div></div>
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{{Instruction Step Trainee
|Instruction Step Title=Gene Editing, Justice, and Equality
|Instruction Step Text=[[File:Ge2Image8.png|center|frameless|600x600px]]



Treatments and therapies involving gene editing are already undergoing clinical trials for marketing approval in the EU and the US for certain diseases and are likely to incur equivalent costs to those of conventional gene-based therapies that are used for rare genetic diseases. However, they are very costly and may thus be restricted to wealthy patients or citizens in countries with corresponding health insurance or social security systems. The dilemma of resource allocation poses questions about the development of extremely expensive therapies.
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{{Instruction Step Trainee
|Instruction Step Title=Gene Editing, Justice, And Equality - Poll
|Instruction Step Text=Should research into treatments and therapies involving gene editing be pursued if the healthcare system is unlikely to be able to afford them?

'''Feedback'''

decisions may require cost-benefit analyses, factoring in potential savings in lifetime treatment costs for genetic illnesses. If provided to a larger number of citizens, they may push healthcare systems, even in wealthier nations, to their limits, resulting in decreased resource availability for other patient groups.
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{{Instruction Step Trainee
|Instruction Step Title=Gene Editing, Justice, and Equality cont.
|Instruction Step Text=[[File:Ge2Image9.png|center|frameless|600x600px]]


Researchers working in innovative or pioneering areas of clinical research could be required to secure and demonstrate broad consultation prior to commencing research and as a condition of ethics approval.  There are many potential benefits. Click on the hotspots to read about the main benefits.  


Broad engagement regarding gene editing for healthcare research: what are the benefits?

Regarding the issue of human enhancement, broad engagement is even more important, as research and development aimed at non-therapeutic enhancement and overcoming disabilities might increasingly stigmatise people with disabilities and have a negative impact on public investment for other inclusion measures. Moreover, in the longer term, such research and development activities may exacerbate socio-economic inequalities in general. Consideration of such social aspects should be systematically included in any work undertaken by the research ethics committees for developments relevant to this topic.


Lastly, while on the subject of gene editing, justice, and equality, we should keep in mind that the potential benefits of CRISPR technology are not limited to therapeutic or enhancement effects. There are also financial benefits for the technology developers and owners, but the issue of who developed or owns CRISPR is complex as summarised in the next video.  
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{{Instruction Step Trainee
|Instruction Step Title=Who Profits Financially From CRISPR-Cas9?
|Instruction Step Text=[[File:Ge2Image11.png|center|frameless|600x600px]]



Given the wide variety of applications, whoever owns the commercial or IP rights to CRISPR-Cas9 has the potential to generate immense financial returns. But patent wars over who developed and owns CRISPR technology have been vociferous and ongoing. While thousands of patents have already been granted for CRISPR-related technologies, several key patents are owned by academic institutions, research organisations, biotech companies, and individuals who made significant contributions to its development. These patents provide exclusive rights to the patented inventions, allowing the holders to control the use, commercialisation, and licensing of CRISPR-related technologies. However, the patenting and commercialisation of CRISPR technology raises ethical, legal, and societal implications, including questions about access to CRISPR-based therapies, affordability, equitable distribution of benefits, and the impacts upon global health and agriculture. Navigating the complex landscape of CRISPR patents requires careful consideration of legal and regulatory factors whilst also trying to ensure the responsible and equitable use of this technology.  
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{{Instruction Step Trainee
|Instruction Step Title=Gene Editing, Misuse, and Dual Use
|Instruction Step Text=[[File:Ge2Image12.png|center|frameless|600x600px]]


Genome editing has the potential for both misuse and dual use. For instance, CRISPR-Cas9 could be used to create so-called ‘super soldiers’, or to enhance the virulence or resistance of harmful pathogens, such as viruses or bacteria, making them more virulent or resistant to existing treatments. The modified pathogens could then be released intentionally to cause widespread illness or even fatalities among targeted populations.


'''Misuse''' refers to the intentional or unintentional application of a technology, knowledge, or material for harmful or unethical purposes. This can involve the deliberate use of a tool or resource in a manner that causes harm, such as the development of biological weapons using biotechnological research, or the exploitation of vulnerabilities in computer systems for cyberattacks.


'''Dual use''' refers to the inherent potential of certain technologies, knowledge, or materials to be used for both beneficial and harmful purposes. It is often discussed in the context of scientific research, where advances intended for peaceful or beneficial purposes could also be misused for malicious or destructive ends. Unlike misuse, which involves the actual application of a technology for harm, dual use focuses on the inherent characteristics of the technology itself, recognising that the same advancements or capabilities that enable beneficial applications may also be exploited for harmful ends. 


Gene editing might also be used to weaponize gene drives to destroy the crops of an enemy as has been highlighted by the DARPA Insect Allies Program.


The risks associated with dual use or of misuse in gene editing research can be enabled by even the most well-intended research and applications. Addressing concerns often involves efforts to anticipate and mitigate potential risks while maximizing the benefits of technological advancement. But effective regulation of misuse and dual use is difficult since the implications of research and developments are not always predictable. Additionally, if a government decided to pursue unethical use of such a technology, it would be very difficult to enforce a stop. Broad consultation may be needed to explore potential risks for misuse and dual use.  
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{{Instruction Step Trainee
|Instruction Step Title=Ethical Challenges for Non-Human Gene Editing
|Instruction Step Text=[[File:Ge2Image13.png|center|frameless|600x600px]]


We now turn to the ethical challenges associated with gene editing beyond use in humans. For instance, there are ethics challenges associated with the use of gene editing for plants, animals and foods. But first, we consider some of the associated environmental impacts.


'''Environmental impacts'''

Gene drive technologies can promote the rapid spread of a particular genetic element in a population of non-human organisms and can potentially be used to control or eradicate animal-borne diseases, invasive species, and agricultural pests. The most frequently discussed and probably most researched aim is a modification of the mosquito population for sustainable global interruption of the transmission of malaria parasites. However, gene drives, intended to eliminate disease-carrying organisms, can inadvertently alter the environment and/or biodiversity. For instance, if a specific mosquito, known for carrying malaria, is targeted for elimination through gene editing, it could disrupt an entire ecosystem. This mosquito may be a food source for a bird that plays a role in pollinating certain flowers, which in turn are food sources for various insects. Eradicating the mosquito could unintentionally lead to the collapse of this ecosystem. 


Gene editing that introduces genetic changes in crops can also have unintended consequences for ecosystems and biodiversity. Ethical considerations include the potential for gene-edited crops to escape into the environment, interbreed with wild relatives, or disrupt ecological interactions. Researchers and policymakers need to assess the environmental risks associated with gene-edited crops and implement measures to minimise adverse impacts. 


Gene editing can be used to save some species from extinction, and it and might also help to de-extinct species which are long gone. This, however, could create imbalance for ecosystems and have devastating consequences for diversity. For instance, it could lead to the mass extinction of species that are still alive today if the de-extincted species is predatory, or there is competition for the same habitats or food supplies.
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{{Instruction Step Trainee
|Instruction Step Title=Food Safety
|Instruction Step Text=[[File:Ge2Image14.png|center|frameless|600x600px]]


CRISPR-Cas9 technology has many potential implications for agriculture, including the precise modification of plant genomes for crop improvement, but the use of gene editing in agriculture also raises ethical considerations for food safety. 

Click on the hotspots to read about some of the potential challenges:


Thorough allergenicity and toxicity assessments are essential to identify and mitigate any risks, and rigorous screening methods are needed to identify and characterise any unintended genetic modifications.
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{{Instruction Step Trainee
|Instruction Step Title=Broader Ethics Issues
|Instruction Step Text=[[File:Ge2Image16.png|center|frameless|600x600px]]



In addition to the aforementioned specific ethics issues for the environment and agriculture, there are broader concerns associated with the use of gene editing.

Click on the images below to read about some of these broad-based issues for the environment and for agriculture.
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{{Instruction Step Trainee
|Instruction Step Title=Gene Editing In Animals
|Instruction Step Text=[[File:Ge2Image17.png|center|frameless|600x600px]]


Gene editing techniques, particularly CRISPR-Cas9, are used for a wide variety of purposes in animals.

'''Gene editing in animals'''

Most gene editing in animals is undertaken for the benefit of humans and research that will benefit humans.   For instance, genetically modified animals, particularly transgenic mice, are often used to create animal models of human diseases by introducing specific genetic mutations associated with those diseases. They can also be used to study fundamental biological processes, gene function, and the role of specific genes in development, physiology, and behaviour. Additionally, pigs have been genetically engineered to produce human organs for xenotransplantation, potentially addressing the shortage of donor organs for transplantation. 

Gene editing can also be used to introduce desirable traits in livestock animals, such as disease resistance, improved growth rates, or enhanced nutritional quality or quantity of meat or dairy products. For example, gene editing has been used to create pigs with increased resistance to porcine reproductive and respiratory syndrome (PRRS), a devastating viral disease.  


Gene editing techniques are also being used for the benefit of animals and the environment. For instance, via research to explore the use of gene editing to address genetic diseases and reproductive challenges in endangered species, as well as to enhance their resilience to environmental pressures.  
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{{Instruction Step Trainee
|Instruction Step Title=Gene Editing in Animals cont.
|Instruction Step Text=[[File:Ge2Image18.png|center|frameless|600x600px]]


While the regulatory for framework research with gene-edited animals varies across different jurisdictions, in the EU, all experimental research with animals, including those that are genetically modified, is governed by the [https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32010L0063 Directive 2010/63/EU]  for the protection of animals in science.

'''From animals to humans'''

Even when gene editing in animals is not intended as animal modelling for later applications in humans, the possibility of future applications in humans must also be considered. This means that, aside from assessment of the impacts of the research upon the animals themselves, researchers and ethics reviewers need to keep in mind that once the technology has been tested in animals, it might also be applied in humans.
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{{Instruction Step Trainee
|Instruction Step Title=Governance of Gene Editing Research
|Instruction Step Text=[[File:Ge2Image19.png|center|frameless|600x600px]]
<div><div><div><div>
'''In the EU'''

The Directive 2001/18/EC regulates the release of genetically modified organisms (GMOs) into the environment. According to this Directive, any release of a GMO requires authorisation, which may only be granted if prior risk assessment indicates that the release will not have harmful effects on human health or the environment. However, some EU Member States see weaknesses in their current national regulation on the contained use of organisms modified with gene drive technologies (e.g., for experiments in closed research facilities) and consider that the specific characteristics of these organisms should be considered on a case-by-case basis.  


'''The UN Convention for Biological Diversity'''

The Convention, which is legally binding for the countries that have signed it, addressed gene drives in 2018. There is currently no global moratorium on gene drives, but 196 countries agreed on strict rules for the use of gene drives. A final agreement emphasised uncertainties inherent in the use of gene drives and called for caution with regard to experimental research. It also recommends that case-by-case risk assessments should be carried out and risk management measures put in place to minimise potential adverse effects.  


'''Organisations'''

Organisations seeking to release gene drive organisms need to obtain the free, prior, and informed consent (FPIC) of potentially affected communities. However, there is a risk that the requirement for FPIC is ignored, or that members of communities are manipulated. A recent review found ten key guideline documents on gene drive risk assessment, but many do not prescribe engagement of local communities and thus lack an important element.  


'''Human applications'''

As far as human applications of genome editing are concerned, we find ourselves in a somewhat paradoxical situation worldwide. On the one hand, largely conceptual or speculative ethical and legal deliberations on powerful genome editing technologies have been taking place for decades, including the elaboration of governance-oriented guidelines. On the other hand, the practical relevance of this work is still low, for two main reasons: the existing technical limitations and the structural problems of research ethics governance. 


'''National and international'''

Both human gene editing and gene editing in plants or animals are generally regulated at the national level as well as at the international level, resulting in a lack of policy alignment between countries. While it is unrealistic to achieve a common international homogenous policy framework, researchers and ethics experts need to be aware of the differences and of the risk of ethics dumping. In some countries, guidance is vague, for instance with a lack of distinction in guidelines between somatic and germline gene editing and between research and treatment. There are also gaps and loopholes resulting in insufficient public consultation, or a lack of monitoring to detect illegal activities.


Addressing the ethical considerations associated with gene editing requires collaboration among scientists, policymakers, farmers, consumers, and other stakeholders. By engaging in transparent and inclusive dialogue, researchers and policymakers can work towards the responsible development and deployment of gene editing technologies that promote health and wellbeing of humans, animals and environments.


For effective ethics assessment, research ethics committees might incorporate or bring in expertise from environmental sciences, critical animal studies, philosophy (beyond applied ethics), legal studies on animal rights and environmental personhood, and science and technology studies (STS). In relation to gene drive technologies, co-development of research designs with local stakeholders is needed to harness local expertise and gain community acceptance. The risks and benefits should be assessed on a case-by-case basis and communicated transparently and honestly to local stakeholders. If local communities prefer other measures for the same purpose, this should be respected.
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{{Instruction Step Trainee
|Instruction Step Title=Expert Interview about  Research Considerations
|Instruction Step Text=Basically, researchers should think about their aims and goals of their research and clearly state that in their proposal so that the ethics experts and the REC members can decide whether these aims and goals are in line with what they want to have and the regulations of the country. And so they can accept or reject single proposals based on these aims and goals and avoid the slippery slope.


I think they also should look for the aims and goals that should be in the proposal, so they know what they deal with and so they can avoid going down a slippery slope by approving some rather controversial aims and goals in research. And I think they should just be open, but still they should consider that there are some problems and there could be controversial discussions going on about certain types of research. 


So, they just need to focus on what the proposal says and then approve it on these grounds that they have. Research ethics reviewers need to conduct a risk-benefit analysis for the participants that are involved in the research as well as society and they should just ask for more information from the researchers if they are unsure about anything in the proposal to just get clarification.
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{{Instruction Step Trainee
|Instruction Step Title=End of Module Quiz
|Instruction Step Text=[[File:Ge2Image20.png|center|frameless|600x600px]]


You can try these questions to see whether your learning from this module addresses the intended learning outcomes. No one else will see your answers. No personal data is collected.  

Which of the following best describes the concept of a "slippery slope" in the context of gene editing?
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{{Instruction Step Trainee
|Instruction Step Title=Module Evaluation
|Instruction Step Text=Thank you for taking this irecs module! 

Your feedback is very valuable to us and will help us to improve future training materials. 

We would like to ask for your opinions:

1. To improve the irecs e-learning modules

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To this end we have developed a short questionnaire, which will take from 5 to 10 minutes to answer. 

Your anonymity is guaranteed; you won’t be asked to share identifying information or any sensitive information. Data will be handled and stored securely and will only be used for the purposes detailed above. You can find the questionnaire by clicking on the link below. 

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{{Instruction Step Trainee
|Instruction Step Title=References and further resources
|Instruction Step Text=[[File:Ge2Image21.png|center|frameless|600x600px]]



WHO guidelines: 

Human genome editing: recommendations : https://www.who.int/publications/i/item/9789240030381 


Human genome editing: a framework for governance : https://www.who.int/publications/i/item/9789240030060 



The EU has a survey of law, governing and regulation principles: 

[https://www.europarl.europa.eu/RegData/etudes/STUD/2022/729506/EPRS_STU(2022)729506_EN.pdf <span lang="DE">https://www.europarl.europa.eu/RegData/etudes/STUD/2022/729506/E</span>] <span lang="DE">[https://www.europarl.europa.eu/RegData/etudes/STUD/2022/729506/EPRS_STU(2022)729506_EN.pdf PRS_STU(2022)729506_EN.pdf]</span> 

[https://www.europarl.europa.eu/RegData/etudes/IDAN/2022/690194/EPRS_IDA(2022)690194_EN.pdf https://www.europarl.europa.eu/RegData/etudes/IDAN/2022/690194/E] [https://www.europarl.europa.eu/RegData/etudes/IDAN/2022/690194/EPRS_IDA(2022)690194_EN.pdf PRS_IDA(2022)690194_EN.pdf] (in agriculture) 


The National Academies published a consensus study report: [https://nap.nationalacademies.org/catalog/25665/heritable-human-genome-editing https://nap.nationalacademies.org/catalog/25665/heritable-human-genome-] [https://nap.nationalacademies.org/catalog/25665/heritable-human-genome-editing editing] 

A good overview of regulations in countries and regions can be found here: [https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/ https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org] 


Overarching principles of EU primary law: Precautionary Principle, art. 191 para 2 TFEU 

Identification and clarification of legal problems concerning the contained use of genetically modified micro-organisms, Dir 2009/41/EC 


Identification and clarification of legal problems concerning the deliberate release into the environment of genetically modified organisms, Dir 2001/18/EC 


Overarching principles of EU primary law (e.g. Charter of Fundamental Rights of the EU ECHR) 

European pharmaceutical law (e.g. Reg Nr. 1394/2007 EC) 


Enhancement: Reg 2016/679/EU (GDPR) 


Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 


Guidelines for Stem Cell Research and Clinical Translation https://www.isscr.org/guidelines
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{{Instruction Step Trainee
|Instruction Step Title=Bibliography
|Instruction Step Text=Bostrom, Nick, et Rebecca Roache. « Ethical issues in human enhancement ». In New Waves in Applied Ethics, édité par J. Ryberg, T. Petersen, et C. Wolf, 120--152. Palgrave-Macmillan, 2007. (https://www.darpa.mil/program/insect-allies). 


Cohen, Y (2019) Did CRISPR help or harm the first-ever gene-edited babies? Science, 1st August [https://www.science.org/content/article/did-crispr-help-or-harm-first-ever-gene-edited-babies https://www.science.org/content/article/did-crispr-help-or-harm-first-ever-gene-edited-] [https://www.science.org/content/article/did-crispr-help-or-harm-first-ever-gene-edited-babies babies] 


<span lang="DE">Kleiderman, Erika, et Ubaka Ogbogu.</span> « Realigning gene editing with clinical research ethics: What the “CRISPR Twins” debacle means for Chinese and international research ethics governance ». Accountability in Research 26 (9 mai 2019): 257-64. https://doi.org/10.1080/08989621.2019.1617138. 


Palazzani, Laura. « Gene-Editing: Ethical and Legal Challenges ». Medicina e Morale 72, no 1 (11 avril 2023): 49-57. https://doi.org/10.4081/mem.2023.1227. 


Singh SM. Lulu and Nana open Pandora's box far beyond Louise Brown. CMAJ. 2019 Jun 10;191(23):E642-E643. doi: 10.1503/cmaj.71979. PMID: 31182462; PMCID: PMC6565397. 

1 AUG 2019 


Smyth, Stuart J., Diego M. Macall, Peter W. B. Phillips, et Jeremy de Beer. « Implications of Biological Information Digitization: Access and Benefit Sharing of Plant Genetic Resources ». The Journal of World Intellectual Property 23, no 3-4 (2020): 267-87. https://doi.org/10.1111/jwip.12151. 

The Lancet. « Human Genome Editing: Ensuring Responsible Research ». The Lancet 401, no 10380 (mars 2023): 877. https://doi.org/10.1016/S0140-6736(23)00560-3. 

Wei, X., & Nielsen, R. (2019). CCR5-∆ 32 is deleterious in the homozygous state in humans. Nature medicine, 25(6), 909-910. 

https://www.nature.com/articles/s41591-019-0459-6
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