Text (Instruction Step Text)
From The Embassy of Good Science
Describe the actions the user should take to experience the material (including preparation and follow up if any). Write in an active way.
- ⧼SA Foundation Data Type⧽: Text
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Societal values are the shared beliefs, principles, and norms that guide the behaviour and interactions of individuals within a society. These values play a crucial role in shaping the culture, social cohesion, and overall functioning of a community.
AI clearly has the potential to cause harms to society, as was evident in [https://ieeexplore.ieee.org/abstract/document/8436400 the case of Cambridge Analytica] when social media data was misused to manipulate the outcome of democratic elections. Concerns related to accountability/responsibility, patient-healthcare provider relationship, question of trust, surveillance, etc. in AI are significant [https://pubmed.ncbi.nlm.nih.gov/32702587/ and are being studied]. However, in such a rapidly changing field, questions around the continuing evolution and potential uses of AI in healthcare and their broader impacts upon individuals, communities, and society in general will remain open.
The use of robots in the delivery of care offers a useful illustration of the complexity of questions to be considered about the impact of AI machines for individuals, communities, and society. James Wright observed the trialling of three types of care robots in a Japanese care home:
* Hug, an assistive robot, which was used to lift patients out of bed and reduce the need for staff to undertake manual lifting.
* Paro, a robotic furry seal, which was used to provide a form of animal therapy and companionship for elderly residents.
* Pepper, a humanoid robot, which was used to lead activities such as karaoke or exercise sessions.
The introduction of care robots into healthcare settings raises complex ethical and societal issues which extend beyond the concerns of dehumanisation of care, impact on staff morale, confusion of roles, and waste of resources highlighted by this case. Consideration also needs to be given to other values and principles including but not limited to: autonomy, moral agency, trust and reliability. [https://www.sciencedirect.com/science/article/pii/S0921889016305292?pes=vor The ethics of healthcare robotics] sets out the need for a dialogic and collaborative approach to embed ethics throughout such projects, ensuring a responsible approach to research and innovation in this developing field.
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Francis Kombe shares his perspective as a REC chair working in Africa. +
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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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Alexei Grinbaum shares his thoughts on the benefits of AI.
'''Benefits of AI'''
Alexei Grinbaum – French Alternative Energies and Atomic Energy Commission (CEA)
AI in healthcare can bring two kinds of benefits. One for the patients, AI does non-human calculation. It can probably, through computation, discover things that we haven't discovered humanly, meaning new drugs, new treatments. And that is happening already. We are discovering new molecules that we had never thought about humanly. So that's for the patients.
Now for the doctors, for medical doctors, AI can probably free up a lot of time from doing routine things that the doctors don't enjoy doing, like writing reports or things like that AI can have a lot of benefits for all sorts of people involved in healthcare on different sides, for medical professionals and for the patients, but very different kinds of benefits. +
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The XYZ/ABC partnership has not mentioned which donor consent model they plan to use for this new venture. The chair of your REC has asked all members to look at the ethical implications involved in the choice between broad, study-specific, and dynamic consent and make a recommendation. Please watch the video about the different models and then vote in the poll to indicate your recommendation to the chair.
'''Broad consent'''
It should be noted that some African countries (for example Malawi, Zambia and Tanzania) do not permit the use of the broad consent model. For the purposes of this case study, please assume that Country Y does allow the use of broad consent.
Broad consent allows participants to give permission for their biosamples and data to be used not only for the current study but also for future, unspecified research. This model is commonly used in biobanking and large-scale genomic studies. While broad consent offers flexibility for researchers, enabling them to use the samples for a wide range of future projects without needing to recontact participants, it raises ethical concerns about autonomy.
Participants may not fully understand the future uses of their data, potentially leading to trust issues if their samples are used in research they didn’t anticipate or might not support. In this study, if broad consent is used, clear and transparent communication is essential, informing participants of the kinds of studies their samples may be used for and providing mechanisms for withdrawal at any time. Broad consent may be suitable given the scope of this project, but safeguards are needed to protect participants' rights.
'''2. Study-specific consent'''
Study-specific consent limits the use of biosamples and data to the project for which they were originally collected. In this case, participants would consent only to the use of their materials for research on COVID-19 progression in the two countries. This model respects participant autonomy more directly by ensuring they know exactly how their samples will be used.
However, it is more restrictive for researchers. If further research on the same samples is desired, such as future investigations into other diseases or pandemics, researchers would need to contact participants for re-consent, which can be logistically challenging, costly, and may reduce participation rates over time. For the COVID-19 study, study-specific consent could ensure that participants fully understand the research, but it may limit future discoveries or collaborations without additional administrative burdens.
'''3. Dynamic consent'''
Dynamic consent is an evolving, interactive consent model that allows participants to make decisions about the use of their samples over time. Through digital platforms, participants can update their preferences, choose which studies their biosamples can be used for, and even receive updates about how their data is being used. This model enhances autonomy and trust by giving participants more control and engagement throughout the research process.
In the context of this project, dynamic consent could address ethical concerns by ensuring that participants from both Country X and Country Y remain informed and can adjust their consent preferences as research evolves. However, it requires technological infrastructure and regular communication, which may be challenging, particularly in Country Y, where digital access could be limited. Moreover, dynamic consent can be resource-intensive to manage, making it less feasible for large-scale or long-term studies without proper funding.
'''Ethics trade-offs'''
Autonomy vs. flexibility: Study-specific and dynamic consent prioritise participant autonomy, ensuring that individuals have greater control over how their samples are used. In contrast, broad consent offers researchers more flexibility for future research but may compromise participants' ability to make informed decisions about every use of their data.
Participant trust: Broad consent risks eroding trust if participants feel disconnected from how their samples are used over time. Study-specific and dynamic consent foster trust by providing transparency and ongoing participant involvement.
Logistical considerations: Study-specific and dynamic consent models are administratively complex and may require more time, resources, and participant engagement. Broad consent, while simpler to manage for long-term projects, may reduce participant involvement and transparency.
As in any research study, researchers should consider carefully before offering withdrawal from a study at any time. It is preferable to provide the option of withdrawal up to a certain time in the development of the project or research as once anonymised results are published, then it would be very difficult to retract the publications (and other publications that might have cited the results of this project).
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'''Participant wellbeing and non-maleficence'''
#Will the use of XR in the project under reasonable conditions cause or exacerbate physical problems, e.g. motion sickness, eye strain, or fatigue? If so, are appropriate mitigation measures in place such as regular breaks during sessions or monitoring of participants for signs of discomfort?
#Will the use of XR in the project under reasonable conditions cause or exacerbate psychological problems, e.g. emotional stress, anxiety, or dissociation? If so, are appropriate protocols in place for managing emotional distress and offering support (e.g. mental health resources or professional support)?
#Are measures in place to monitor participants for potential cognitive or psychological impacts over time?
#Will the use of XR in the project under reasonable conditions cause lasting personality effects (e.g., detachment from reality, altered social behaviours)?
#What measures are in place to limit offensive, harmful, or violent behaviours in the virtual environment? Are there clear and accessible ways to mitigate and report such behaviours?
'''Autonomy and nudging'''
# Is the XR technique likely to undermine the autonomy of participants? What measures are in place to ensure that XR interactions with avatars (including AI-powered avatars) do not violate participants’ personal space or autonomy?
# Are potential emotional triggers (e.g., fear or joy) justified by the research goals and managed appropriately? Are appropriate measures in place to avoid or minimise the risks of emotional manipulation or excessive nudging in the virtual environment?
# Will participants be fully aware of the nature of the study, the role of XR technologies, the nature of the technologies and any potential impacts on their mental or physical state? Is information provided in a clear and comprehensible manner?
# Is the system likely to expose users to catfishing (deception)? Is deception explicitly used in the project? If so, is it minimal, justified, and followed by debriefing?
'''Inclusivity and accessibility'''
# Does the project ensure inclusion of diverse demographic groups (e.g., gender, age, cultural backgrounds)?
# What measures are in place to ensure sensitivity to cultural and societal norms in the design of virtual environments and interactions?
# Are people with disabilities involved in or affected by the project? If so, are accessibility measures planned?
# Does the project purposefully exclude certain groups of individuals (e.g. people with disabilities)?
Each group formulates advice and reports it back to the plenary session. The teacher facilitates the presentation of each group's advice and encourages the group to ask questions and reflect on similarities and differences among groups' opinions and advice. +
Each group formulates advice and reports it back to the plenary session. The teacher facilitates the presentation of each group's advice and encourages the group to ask questions and reflect on similarities and differences among groups' opinions and advice. +
*<span lang="EN-US">Ask each group to present their analysis (5 minutes per group, depending on the number of groups).</span>
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*<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?<div><div></div></div>
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To introduce participants to the topic, you can either invite an expert to give a lecture or present the topic yourself (perhaps you are the expert).
Your lecture should cover the core ethical concepts related to [the topic of this session] and apply them to practical cases. The IRECS modules, including videos and examples, can be used to develop your lecture.
You can find an example of this [https://embassy.science/wiki-wiki/index.php/Instruction:D51b8272-661c-49eb-875a-13da8a955df5 here].
After the lecure dedicate 10 min to Q&A (if you are working with an expert some questions can be prepared in advance to get the discussion going).
'''<u><span lang="EN-US">Trainer Tip</span></u>''' <span lang="EN-US">Use questions to keep the lecture dynamic and engaging. Consider takinga breack at this point.</span> +
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To continue reflection on ethical issues related to biobanking in more dept, encourage trainees to explore and discuss a few statements. This exercise will provide trainees insight in the complexity of the ethical challenges and the values which are at stake.
You can create an imaginary line in the room, numbered from one to ten, where ‘''one''’ represents complete disagreement and ‘''ten''’ signifies full agreement. As a trainer, you will read statements aloud and ask trainees to stand on the line based on how much they agree with each statement.
You can use the following statements:
</div><div>
*Researchers should inform participants about genetic findings that could affect their health.
*Participants should be re-contacted for consent if their samples are used for new research.
*The collection of digital DNA material through biobanking should be halted, as complete data security cannot be fully guaranteed.
Read the first statement aloud and invite trainees to take a position on the line. Once everyone has selected a position on the line you can encourage dialogue between trainees using the following questions: ''Could you explain why are you standing there?'' ''Could you ask an open question to someone who is standing at the opposite end of the line? What would you like to know from someone else’s perspective? What value is at stake for you? Is there anything that would move you to another side of the line?''
</div> +
Is it ethical to intentionally infect healthy volunteers with a deadly virus? This video discusses the ethical controversy surrounding human challenge studies, particularly those involving SARS-CoV-2, the virus that causes COVID-19. While these studies can be valuable for scientific progress, they raise concerns about the Hippocratic Oath, which states "first do no harm." Human challenge studies have been used in the development of other vaccines, such as malaria. However, the comparison between malaria and COVID-19 is problematic, as there are approved treatment options for malaria, while at the time of the early COVID-19 human challenge studies, there were no treatment options. Additionally, COVID-19 can cause potentially severe long-term complications. +
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The EU’s approach to genome editing is highly precautionary, particularly when it comes to germline editing. Regulations are largely guided by the European Medicines Agency (EMA), which oversees clinical applications of genome editing therapies.
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!'''Governance at the international level'''
The governance of gene editing research is not straightforward because it varies across countries, and encompasses legal, ethical, scientific, and societal dimensions. There have been steps towards development of an international regulatory framework. For instance:
The World Health Organization has established advisory committees to provide guidelines on human genome editing. In 2021, the WHO published two reports offering recommendations on the governance and oversight of human genome editing, particularly emphasizing international collaboration and transparency.
!
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!'''Governance at the country level'''
At the country level, there are varying legal frameworks regarding gene editing research, particularly around its use in humans. For instance, some countries in Europe have banned germline editing outright, while others permit research but with stringent oversight. The Genetic Literacy Tracker tracks the development of gene editing regulations around the globe and can be found here: https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/
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|'''Self-regulation'''
Some organisations, like the International Society for Stem Cell Research (ISSCR), provide self-regulation guidelines for scientists working with gene editing technologies. These guidelines encourage ethical practices, discourage irresponsible experimentation, and promote high standards of safety.
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|'''Looking to the future'''
As gene editing technologies evolve, governance models are also adapting. Emerging discussions focus on the need for adaptive governance, meaning a flexible framework that can evolve in response to technological advances.
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By adhering to these procedures, biobanks ensure that biological samples remain well-preserved, maintaining their scientific utility for years or even decades.
This meticulous approach is crucial for supporting diverse research initiatives and contributing to advancements in medicine and healthcare.
Biological samples in biobanks are stored with meticulous care to ensure their preservation, integrity, and long-term stability. The storage process involves several key steps:
1. '''Sample Processing:''' After collection, biological samples undergo processing to prepare them for storage. This may include centrifugation, separation, and aliquoting to obtain specific components like DNA, RNA, or serum.
2. '''Barcoding And Labelling:''' Each sample is assigned a unique barcode or identifier, linking it to relevant donor and sample information. This labelling system ensures accurate tracking and minimizes the risk of errors during storage and retrieval.
3. '''Temperature Control:''' Samples are stored at controlled temperatures to prevent degradation. Common storage conditions include ultra-low temperatures (-80°C or -196°C in liquid nitrogen) for DNA, RNA, and tissues, or -20°C for certain proteins and blood components.
4. '''Cryopreservation:''' For long-term storage, particularly for cells and tissues, cryopreservation is employed. This involves freezing the samples rapidly to extremely low temperatures, often in liquid nitrogen, to halt biological activity and prevent cellular damage.
5. '''Automated Storage Systems:''' Many modern biobanks utilize automated storage systems with robotic retrieval mechanisms. These systems enhance efficiency, accuracy, and minimize the need for human intervention, reducing the risk of contamination or mishandling.
6. '''Quality Control Checks:''' Regular quality control checks are conducted to ensure sample integrity. This includes monitoring temperature stability, confirming sample identity through barcodes, and assessing sample condition over time.
7. '''Security Measures:''' Biobanks implement stringent security measures to safeguard samples. Access to storage facilities is restricted, and environmental monitoring systems detect any deviations from optimal storage conditions.
8. '''Backup Systems:''' Biobanks often have backup systems in place, such as back-up freezers and power sources, to mitigate the risk of sample loss in case of equipment failure or unforeseen events.
9. '''Data Management:''' Accurate and secure data management systems track the entire lifecycle of each sample, including collection, processing, storage, and retrieval. This comprehensive documentation ensures traceability and transparency.
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What does the Declaration of Helsinki say about this?
Placebos should only be used:
''Where there are compelling and scientifically sound reasons why it is necessary to determine efficacy or safety, and the patients who receive placebo will not be subject to additional risks of serious or irreversible harm.''
But how do we know what counts as compelling and scientifically sound? And how do we know whether people who receive placebo are being put at risk?
As with many ethical guidelines, there can be disagreement about what they mean in practice. In this situation, when making decisions about the design of a study, it can help to remember the Golden Rule. Imagine yourself in the shoes of someone who is being invited to participate. What would you want to know and how would you want to be treated? +
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When gene editing is used for therapeutic purposes, it is known as gene therapy. Watch the following two videos to find out more about what gene therapy is, and some of the primary benefits.
Gene therapy involves the introduction of genetic material or gene editing tools into cells to correct or compensate for a genetic defect, treat or prevent disease, or enhance cellular functions. Gene therapy falls into three main types:
#Gene transfer therapy, which involves introducing new healthy genetic material into cells to replace or supplement defective genes.
#Gene silencing, whereby small RNA molecules are used to silence or moderate the expression of specific genes.
#Gene editing, which involves the introduction of gene-editing tools that can change the existing DNA in the cell. CRISPR-Cas9 technologies can be used to add, remove or alter genetic material at precise locations in the genome, correcting mutations or disrupting harmful sequences.
Genetic material or gene-editing tools are inserted into a cell via a carrier (vector) that has been genetically modified to carry and deliver the material. Modified viruses are often used as vectors to deliver the genetic material or gene-editing tools by infecting the cell. The vector can be delivered intravenously into a specific tissue in the body, or a sample of the patient's cells can be removed and exposed to the vector in a laboratory. The cells containing the vector are then returned to the patient. +
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In this module we have considered key concepts associated with XR, like metaverse, presence and interoperability, and the different types of hardware necessary for VR and AR. In the next module, Extended Reality: Ethics Issues, we explore the risks associated with the use of XR technologies and how they might be addressed. +
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== '''Consent Issues for Children Donating Materials to Biobanks''' ==
Consent extends beyond choosing an appropriate model for use, to other nuanced issues that need addressing in the training of researchers. These include involving children in biobanking, allowing for the withdrawal of consent, managing consent upon a donor's death, handling samples used without consent, respecting cultural norms and practices, and public health emergencies.
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'''Consent issues for children donating materials to biobanks'''
In most jurisdictions, children cannot provide legally valid consent on their own, particularly for complex matters such as donating biological materials to biobanks. The ability to provide informed consent is typically associated with reaching the age of majority, which varies globally but is often around 18 years old.
In situations involving children, the consent process usually involves obtaining permission from parents or legal guardians. These individuals are considered to have the legal authority to make decisions on behalf of the child, taking into account the child's best interests. The process of obtaining parental or guardian consent involves providing comprehensive information about the purpose of the donation, potential risks, and the intended use of the biological materials and health-related data.
However, ethical considerations become more nuanced when dealing with older minors who may demonstrate the capacity for informed decision-making. In such cases, the involvement of the minor in the consent process, along with parental or guardian consent, may be considered. The specific regulations and ethical guidelines surrounding the involvement of minors in research may vary by jurisdiction and should be followed carefully to ensure the protection of minors' rights and wellbeing in the context of biobanking activities. +
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What do you think? It’s clear that this ecologist would not want the study to go ahead. In your role as a member of a research ethics committee, do the concerns the ecologist has raised convince you that the study should not proceed?
'''Feedback'''
While we have considered some of the potential risks and benefits, we need a fuller picture to provide a firm foundation for ethical decision-making. For this case, that would likely require specialist knowledge from a range of experts. On the next page you can read about more of the potential risks and benefits that we identified. +
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Moral equivalence in the context of VR and XR refers to the comparison of ethical behaviours and actions in digital environments with those in the real world. It raises questions about whether actions taken in virtual spaces—such as violence, harassment, or manipulation—should be judged or treated with the same moral standards as in physical reality. This concept highlights the challenge of defining ethical responsibility in immersive, simulated environments. In this expert interview, Alexi Grinbaum discusses moral equivalence, the potential impact on the wellbeing of users of VR and XR, and on wider society.
We wrote an article with a colleague about what we call moral equivalence between virtual worlds and material worlds. Now, what do we mean by that? In the material world, we have thoughts, feelings, emotions. In the virtual world, these are all imitated through computation by avatars. So, an avatar doesn't have thoughts or emotions, but it appears to having them. It creates an illusion in us humans, that if you meet an avatar in the virtual world, then this avatar may be happy or mad at us or, you know, or maybe thirsty. But of course, an avatar is never really hungry or thirsty. But these projections, these, you know, feelings by projection, these are illusions because, of course, behind there is just digital computation. But we feel that they somehow make something to us. So, they are kind of real to us through the relation that we establish with these avatars as we interact with them.
So, the question, the deep question is, these feelings by projection, these emotions by projection, they can go very far, responsibility by projection, crime and punishment by projection. When they do something to us through this relation, is that the same? Is it equivalent to what is happening in the material world? If there is an avatar that does something nasty, or something very nice to us in the virtual world and we feel for it. I mean, we do have feelings. Do these feelings matter as much as feelings in the material world?
That's the question of equivalence. And it's a dilemma. We can't really solve it here and now. We can't say yes or no because there are arguments for and against. But this is a deep philosophical and ethical dilemma of our relation to these non-material entities because they do something very real to us. Again, real, not in the sense of material, but in the sense of feeling real.
Virtual worlds are part of our reality. So how do we live with that? Do we need societal rules? Do we need laws? Do we need regulation? Do we let everyone decide for themselves or should society decide? Should a parliament decide? These are the big questions which all follow from this fundamental ethical dilemma, the question of equivalence, which doesn't have a simple solution.
