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From The Embassy of Good Science
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[[File:Samples.png|center|frameless|600x600px]] Biobanks collect a variety of biological samples, each serving specific research purposes.  +
[[File:M4..png|center|frameless|600x600px]] Professor Smith is very excited about this proposal, and looking forward to getting started on the research once the study has ethics approval. She feels that by going for dual approval from both her own and Dr Jones’ institution, the team have covered all necessary requirements for ethics approval. However, she hears that two podcasters have got hold of some information about the project and are raising concerns about ethics dumping issues. Please listen to Brad and Janet’s podcast and see if you agree with them. What do you think about the points made by Brad and Janet? Do you think that the issues they raised are valid? Do you have any concerns about the proposal that they didn’t mention? Take a few moments to think this through before moving on to the next screen.  +
[[File:M4.png|center|frameless|600x600px]] '''Social Justice In Research Ethics Codes'''  +
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[[File:AI Img3.png|center|frameless|600x600px]]  +
The identification of ethics codes and guidelines that are relevant to your research is vital from the earliest stages of conceptualising and designing your study. As a researcher, you [[File:GovProc Img1.png|center|frameless|600x600px]] will need to find out which codes and guidelines apply to your research. A good starting point is to find out which of your institutional codes and processes are relevant. We also strongly recommend that you check the professional, national and international requirements that apply generally to your field of research and specifically to any studies that you are involved in. You can seek advice from your institution’s research ethics committee and/or your supervisors or colleagues in the wider research team if you have any doubts about which ethics codes and guidelines are relevant to your research. [[File:GovProc IMG2.png|center|frameless|600x600px]]  +
[[File:AI Image2.png|center|frameless|600x600px]] AI systems are built through a process that involves several key steps. Building AI systems is an iterative process, that involves ongoing refinement and improvement to keep up with evolving requirements and challenges. Additionally, advancements in research and technology may prompt updates to models and algorithms.  +
[[File:Imre3.png|center|frameless|600x600px]] <div> Question: As a member of the research ethics committee, what is your first impression of this proposal? Do you think that you would approve this project? '''Feedback''' On what did you base your decision? If you answered ‘yes’, is it because you think there aren’t any potential ethics issues, or that they are addressed adequately in the proposal? If you answered ‘no’ or ‘I don’t know’, is it because you would need more information before you could approve? Is it because there are aspects of the proposal that you don’t understand? With complex proposals like this, it is normally advisable to seek more information before reaching a decision unless the researchers have already addressed all relevant points that are in the document The use of XR technologies in research: A checklist for research ethics committees. Research ethics committee members might also do their own research about the topic or seek expert advice if there is insufficient technical knowledge and experience amongst the committee members.<div> </div></div><div><div></div></div>  +
The case is presented to the group. It is helpful to distribute the case to participants in printed or digital format, allowing them to access it during group work. Please find the case below: ''In a large hospital the executive board is considering purchasing a new AI system called “HealthAI”. HealthAI is designed to assist healthcare professionals in patient diagnoses based on input of personal data from patients (such as lab results, DNA-material and patient history), it also can be used to assist with administrative tasks. However, at national level concerns have been raised regarding the use of HealthAI due to, for example, privacy risks and system errors (false positive diagnosis). At the same time, the healthcare sector is facing an urgent shortage of health personnel as a result of societal challenges (e.g. aging population).''   ''The executive board has asked to gather a group of experts from different perspectives to look at this situation and to provide them with advice. These experts are invited to have a dialogue and to learn more from each other’s perspectives.''  +
The case is presented to the group. It is helpful to distribute the case to participants in printed or digital format, allowing them to access it during group work. Please find the case below: ''In a large hospital the executive board is considering purchasing a new AI system called “HealthAI”. HealthAI is designed to assist healthcare professionals in patient diagnoses based on input of personal data from patients (such as lab results, DNA-material and patient history), it also can be used to assist with administrative tasks. However, at national level concerns have been raised regarding the use of HealthAI due to, for example, privacy risks and system errors (false positive diagnosis). At the same time, the healthcare sector is facing an urgent shortage of health personnel as a result of societal challenges (e.g. aging population).''   ''The executive board has asked to gather a group of experts from different perspectives to look at this situation and to provide them with advice. These experts are invited to have a dialogue and to learn more from each other’s perspectives.''  +
<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><div> #<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> # #'''<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>   </div></div>  
<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> <div> #<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> </div></div><div></div><div> '''<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>   </div>  
The aim of this activity is to invite participants to reflect on their expectations. This is useful both for trainers and participants. <span lang="EN-US">Trainers can pick between two possible activities:</span> '''<span lang="EN-US">A)   OPTION 1: Mind map activity</span>''' <span lang="EN-US">→ small group activity: in sub-groups participants create a mind map of their current knowledge on the topic.The following steps can support trainers in organizing this activity:</span> <span lang="EN-US">o  Divide participants into subgroups.</span> <span lang="EN-US">o  Provide each group with a digital (or physical) board.</span> o  Ask them to brainstorm and write down the words that come to mind when they think of [the topic of the session]. <span lang="EN-US">o  Ask them to divide the terms into:</span> <span lang="EN-US">-  Topics they want to learn more about.</span> <span lang="EN-US">- Topics they are already familiar with.</span> '''<span lang="EN-US">B)    </span>OPTION 2: Learning goals with Mentimeter''' <span lang="EN-US">o  Prepare and share a  Mentimeter (or similar tool) with the following question: ''after this session I expect to be able to…''</span> o  Ask participants to submit two goals, project the results and discuss them with the group.<div><div><div><span name="_msocom_1"></span></div></div></div>  +
<div> *Share a QR code linking to the evaluation form and online modules for continued learning. *Thank participants for their contributions and encourage them to apply their insights in their work and spread the word about the irecs modules. </div>  +
During this second mini lecture you can discuss the core ethical issues related to biobanking and 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. You can integrate those in a few PowerPoint slides:<div> *Slide 1: Show a case on biobanking. For example: [https://classroom.eneri.eu/node/328 <u>The Ebola Outbreak in Sierra Leone</u>]. Before watching the video, encourage trainees to pay attention to ethical concerns. *Slide 2: Stimulate trainees to share ethical concerns regarding biobanking. You can use one of these guiding questions: ''What ethical concerns did you hear in the video? What did you hear about the informed consent process? What are the consequences of an incomplete consent in relation to biobanking? What did you hear about exploitation? What effect might exploitation have on the local population?'' Collect the ethical issues that arise from the trainees on a (digital) whiteboard.  Share suggestions and explanations of the ethical issues by using information from the irecs modules. For example: think of [https://classroom.eneri.eu/node/331 <u>Consent Issues for Children</u>], [https://classroom.eneri.eu/node/332 <u>Personal Data Processing Issues</u>] or [https://classroom.eneri.eu/node/334 <u>Dealing With Incidental Findings</u>] <u>Trainer tip:</u> connect information you share during the mini lectures with the elements you have seen on the mind maps of the trainees to keep them involved.   </div>  +
*Share a QR code linking to the evaluation form and online modules for continued learning. * *Thank participants for their contributions and encourage them to apply their insights in their work and spread the word about the irecs modules.   +
When researchers from privileged circumstances conduct ethically questionable studies in lower-income settings, it's known as 'ethics dumping.' Ethics dumping can create significant challenges and is a growing concern. It is therefore essential that researchers work as closely as possible with local collaborators and reflect together on ways to prevent it. This video explores six different ways ethics dumping can occur, from intentional disregard to unintentional cultural misunderstandings.  +
[[File:Woman in laboratory.jpg|alt=woman in laboratory|border|center|frameless|600x600px|woman in laboratory]] Clinical studies commonly include randomised control trials, where the outcomes of two or more groups are compared to test the effects of particular interventions. Sometimes one of the groups is given a placebo (dummy pill) to act as the control, as in this study:  +
[[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.  
[[File:Gene Image4.png|center|frameless|600x600px]] Stem cells are undifferentiated cells that have the ability to develop into various types of cells in the body. This unique characteristic makes them incredibly valuable for research. [[File:Gene Image5.png|center|frameless|600x600px]] <div> The type of cells into which stem cells can differentiate depends upon whether they are omnipotent or pluripotent. Do you know what this means? </div>  +
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