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{{Instruction
|Title=Gene Editing: Exploring Ethical Challenges
|Instruction Goal=This module introduces the ethical challenges in gene editing. Using real life cases, it aims to encourage reflection on ethical issues related to this technology.
|Has Requirements='''For trainers:''' <span lang="EN-US">Before using this module trainers should complete the two ENERI e-learning modules on Gene Editing: [https://classroom.eneri.eu/node/306 <u>Gene Editing: Ethics Issues</u>] and [https://classroom.eneri.eu/node/221 <u>Gene Editing: Technology Basics</u>]</span>

<span lang="EN-US">'''For trainees:''' No prior expertise in gene editing is required, but participants should have a basic understanding of research ethics concepts. Participants are encouraged to complete the ENERI e-learning module on [https://classroom.eneri.eu/node/146 <u>Research Ethics And Integrity Basics</u>]</span>  
|Has Duration=3
|Important For=RECs
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|Has Practical Tips=* <span lang="EN-US">Familiarize yourself with the irecs materials on gene editing and identify where are the videos and cases you will use for this session</span> 

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* <span lang="EN-US">Test all digital tools (Mentimeter, digital whiteboards) in advance.</span>  
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* <span lang="EN-US">Be aware of the diverse cultural and regulatory backgrounds of the trainees in your group.</span> 
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* <span lang="EN-US">Share additional resources and the rest of e-modules at the end of the session.</span>
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* <span lang="EN-US">Collect feedback through the evaluation form to improve future sessions.</span> 
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{{Instruction Step Trainer
|Instruction Step Title=Welcome (10-15 minutes) & introduction of the session program and objectives
|Instruction Step Text=<span lang="EN-US">'''Introduce yourself and share the plan for the session presented below:'''</span> 

*<span lang="EN-US">Ice-breaker</span>
*<span lang="EN-US">Short introductory lecture</span>  
*<span lang="EN-US">Case discussion in smaller groups</span>
*<span lang="EN-US">Plenary discussion</span>



'''Introduce the ''Learning Objectives -'' a<span lang="EN-US">fter the session participants are able to:</span>''' <div>
#''<span lang="EN-US">Weigh the potential harms and benefits of different areas of gene editing. </span>''
#''<span lang="EN-US">Reflect upon some of the ethics issues (like dual use/misuse or long-term ethical and societal implications) associated with gene editing.</span>''
#''<span lang="EN-US">Recognize ethical and safety concerns associated with gene editing techniques and their applications.</span>''
</div><span lang="EN-US">'''Use a warm up question to introduce the topic:'''</span> 

<span lang="EN-US">Use this as an interactive exercise before starting with the session. Ask participants one of these questions, encouraging participants to share their answers with the group:</span> <div>
*''<span lang="EN-US">What’s one word that comes to mind when you think of gene editing?</span>''
*<span lang="EN-US">''What's one aspect of gene editing that makes you feel excited or uneasy?''</span>
</div><span lang="EN-US">'''Briefly introduce the topic:'''</span><div>


''<span lang="EN-US">Gene editing is a transformative and evolving technology that has a big potential for addressing problems in healthcare, agriculture, among others. However, it also raises critical ethical questions since it can have severe societal and environmental long-term consequences. Since the CRISPR-Cas9 became a reality, many debates about human enhancement and justice issues regarding access to the technology have surrounded gene editing.</span>'' 
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''<span lang="EN-US">This training session is designed to equip participants with the knowledge and tools to navigate the complex ethical issues that arise from gene editing. By exploring and discussing real cases, participants will develop a deeper understanding of the challenges and responsibilities associated to gene editing.</span>'' 
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'''<u><span lang="EN-US">Trainer Tip</span></u><span lang="EN-US">:</span>''' <span lang="EN-US">Use this moment to create a '''welcoming''' and '''open''' environment, emphasizing that the session wants to '''encourage ethical reflection''' in an open and '''safe''' space.</span>  
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{{Instruction Step Trainer
|Instruction Step Title=Ice breaker (10 minutes)
|Instruction Step Text=<span lang="EN-US">The aim of this activity is to invite participants to '''reflect''' on their '''expectations'''. This is useful both for trainers and participants.</span> 


 <span lang="EN-US">'''Trainers can pick between two possible activities:'''</span> 

<span lang="EN-US">'''OPTION 1:'''</span> 

<span lang="EN-US">''Mind map activity → small group activity: in sub-groups participants create a mind map of their current knowledge on the topic.''</span>

<span lang="EN-US">The following steps can support trainers in organizing this activity:</span> 

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*<span lang="EN-US">Divide participants into subgroups.</span>
*<span lang="EN-US">Provide each group with a digital (or physical) board.</span>
*<span lang="EN-US">Ask them to brainstorm and write down the words that come to mind when they think of "gene editing."</span>
*<span lang="EN-US">Ask them to divide the terms into:</span>   <br />
**<span lang="EN-US">Topics they want to learn more about.</span>  
**<span lang="EN-US">Topics they are already familiar with.</span>
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*<span lang="EN-US">After 6-7 minutes of discussion in sub-groups, ask all groups share their maps with the group. Together with the group select the most common unknown topics.</span>

<span lang="EN-US">'''OPTION 2:'''</span> 

<span lang="EN-US">''Learning goals with Mentimeter''</span> <div>
*<span lang="EN-US">Prepare and share a  Mentimeter (or similar tool) with the following question: ''after this session I expect to be able to…''</span>
*<span lang="EN-US">Ask participants to submit two goals, project the results and discuss them with the group.</span>  
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{{Instruction Step Trainer
|Instruction Step Title=Warm up: Case presentation (15 minutes)
|Instruction Step Text=<div>
*<span lang="EN-US">Present the irecs video on the CRISPR-Cas9 case of Lulu and Nana.</span>   <span lang="EN-US">You can find it here: [https://classroom.eneri.eu/node/308 <u>A Case Of Gene Editing In Human Embryos</u>]</span>  
*<span lang="EN-US">After the video, have a brief discussion by asking participants the following questions:</span>   <br />
**<span lang="EN-US">What are the main ethical issues in this case?</span>   
**<span lang="EN-US">How do these issues relate to societal or regulatory concerns?</span>
</div>'''<u><span lang="EN-US">Trainer Tip</span></u><span lang="EN-US">:</span>''' <span lang="EN-US">Allow for a brief open discussion but '''keep it focused''' to ensure you stay within the allocated time.</span>
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{{Instruction Step Trainer
|Instruction Step Title=Interactive lecture (45 minutes)
|Instruction Step Text=<span lang="EN-US">Discuss core ethical concepts related to gene editing, applying the concepts to practical cases. To build your presentation you can use the content of the irecs modules, which will provide you with videos and examples. For more engagement, you can ask participants to select one of the following topics and focus on it in depth:</span> 


'''A) <span lang="EN-US">Gene editing in embryos→</span>''' <span lang="EN-US">key concepts: moral status of embryos, human enhancement, risk/benefit, autonomy and beneficence. Resources:</span>

# <span lang="EN-US">Matching exercise on gene editing in human embryos and its associated ethical issues: [https://classroom.eneri.eu/node/310 <u>Germline Gene Editing.</u>]</span> 
# <span lang="EN-US">Explanation of germline gene editing: [https://classroom.eneri.eu/node/310 <u>Germline Gene Editing.</u>]</span> 
# <span lang="EN-US">Explanation of gene editing in human embryos: [https://classroom.eneri.eu/node/311 <u>Gene Editing And Human Embryos</u>]</span>  


'''B) <span lang="EN-US">Gene editing justice and equality→</span>''' <span lang="EN-US">key concepts: risk/benefits ratio, costs/benefits of gene therapy, patents gains, global considerations, medical need vs. human enhancement, socioeconomic inequalities, inclusion and stigma of people with disabilities.</span> 

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# <span lang="EN-US">Introduction to gene editing and equality issues: [https://classroom.eneri.eu/node/314 <u>Gene Editing, Justice, And Equality</u>]</span>  
# <span lang="EN-US">Potential benefits and risks of gene editing in terms of justice and equality: [https://classroom.eneri.eu/node/315 <u>Gene Editing, Justice, And Equality cont.</u>]</span>  
# <span lang="EN-US">Benefits and financial gains of CRISPR-Cas9: [https://classroom.eneri.eu/node/316 <u>Who Profits Financially From CRISPR-Cas9?</u>]</span>  


'''C) <span lang="EN-US">Gene editing, dual use and non-human use→</span>''' <span lang="EN-US">key concepts: dual use, risk/benefit of gene editing, non-human gene editing, environmental impacts, food safety.</span><div>
# <span lang="EN-US">Introduction to gene editing misuses and dual use: [https://classroom.eneri.eu/node/317 <u>Gene Editing, Misuse, And Dual Use</u>]</span> 
# <span lang="EN-US">Environmental impacts of gene editing: [https://classroom.eneri.eu/node/318 <u>Ethical Challenges For Non-Human Gene Editing</u>]</span> 
# <span lang="EN-US">Overview of the challenges related to agriculture and food safety of gene editing: [https://classroom.eneri.eu/node/319 <u>Food Safety</u>]</span>  
# <span lang="EN-US">Gene editing in animals overview and some ethics issues: [https://classroom.eneri.eu/node/321 <u>Gene Editing In Animals</u>] and [https://classroom.eneri.eu/node/322 <u>Gene Editing In Animals cont.</u>]</span>  
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'''<u><span lang="EN-US">Trainer Tip</span></u><span lang="EN-US">:</span>''' <span lang="EN-US">Use questions to keep the lecture '''dynamic''' and '''engaging'''. Consider takinga break at this point.</span>  
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{{Instruction Step Trainer
|Instruction Step Title=Case discussion in subgroups (45 minutes)
|Instruction Step Text=<span lang="EN-US">Introduce a case. The case must be related to the concepts selected and presented during the interactive lecture.  Therefore, if only one of the topics was covered, the case should be related to that topic.</span><div>
<span lang="EN-US">Below, some case examples are presented. Note that justice issues appear in both cases:</span> 

 

*'''<span lang="EN-US">Case related to topic A&B</span>'''<span lang="EN-US">: ''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? Would you approve this study?'' (case extracted from: [https://classroom.eneri.eu/node/312 <u>Reflection Activity</u>])</span>
*'''<span lang="EN-US">Case related to topic C&B</span>'''<span lang="EN-US">: ''Imagine you are on an ethics committee reviewing a research proposal to produce genetically modified mosquitoes to combat malaria. This would releasing gene-edited organisms into a natural ecosystem in Sub-Saharan countries mostly. As an ethics expert, what criteria would you use to assess this proposal? How would you balance the potential health benefits with ethical concerns around environmental impact, dual-use, etc.?'' (case extracted from: [https://classroom.eneri.eu/node/387 <u>A case of non-human gene editing</u>])</span>  
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'''Instructions for trainer:''' 

*<u><span lang="EN-US">Present the case (10 minutes).</span></u> <span lang="EN-US">In case you need more information, you can retrieve it from the ENERI modules. Take into account the amount of time you have for this exercise. It is advised to project slide with the case, so participants can look at it during the group discussion.</span>
*<span lang="EN-US">Divide participants into subgroups (4-5 members). You can provide each group with a white board/digital board.</span>
*<span lang="EN-US">Provide participants with the following instructions for the subgroup discussion:</span>   <br /><span lang="EN-US">'''a.''' <u>Read the case carefully and reflect on it individually (10 minutes)</u>. Ask yourself: What is important to you, and what would you do if you were part of the REC member evaluating this research proposal? What aspects would you focus on in the ethical evaluation of that research proposal?</span>  
<span lang="EN-US">'''b.''' <u>In dialogue with your group mates (10 minutes)</u> try to identify: research gains, potential risks, connection of the case to the concepts that were discussed in the interactive lecture, other key ethical tensions.</span>    

<span lang="EN-US">'''c.''' <u>Share individual views and try to reach a consensus among the group members (if possible) (10 minutes)</u>: would you approve the research proposal, why? What would be needed for approving it? Under which circumstances would you approve it (if any)?</span>
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{{Instruction Step Trainer
|Instruction Step Title=Group presentations and plenary discussion (30-40 minutes)
|Instruction Step Text=<div>
*<span lang="EN-US">Ask each group to present their analysis (5 minutes per group, depending on the number of groups).</span>
*<span lang="EN-US">Facilitate a plenary discussion to connect insights to real-world practices. Ask participants about their own experiences, (e.g. related real life examples they want to share them with the group).</span>
*<span lang="EN-US">To prompt the discussion you can make use of the following questions:</span>
<span lang="EN-US">How did you experience the exercise?</span>

<span lang="EN-US">Did your view change?</span>

<span lang="EN-US">Do you see any similarities in real life experiences?</span>

Were you surprised by any particular point that was raised during the discussions?
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{{Instruction Step Trainer
|Instruction Step Title=Concluding session (10-20 minutes)
|Instruction Step Text=<div>
* <span lang="EN-US">Return to the icebreaker activity or learning goals (mind mapping or Mentimeter results) and ask participants if their expectations were met.</span> 
* <span lang="EN-US">Share a QR code linking to the evaluation form and online modules for continued learning.</span> 
* <span lang="EN-US">Thank participants for their contributions and encourage them to apply their insights in their work and spread the word about the irecs modules.</span> 
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