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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The TRUST Code, a global code of conduct for equitable research partnerships, was designed to address ethics dumping. You can watch two videos here about the code: one gives an overview of the code, and one introduces its 23 articles. +
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Informed consent is the cornerstone of ethical research with humans. It is of fundamental importance that people understand what a research project is about and provide their consent for taking part.
There are seven key ingredients for valid informed consent. Match the following ingredients to their meanings. +
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Gene editing technologies hold great promise for treating genetic diseases, improving agricultural yields, and addressing many other challenges. However, they also come with ethical, social, and safety considerations. Some of the risks associated with gene editing include:
'''Off-Target Effects '''
Gene editing tools may unintentionally modify genomic regions other than the target, leading to unintended consequences. Off-target effects could potentially cause new genetic mutations or disrupt the function of other essential genes.
'''On-Target Effects '''
Gene editing tools may unintentionally modify the target DNA in the wrong way with unwanted deletions or insertions. For instance, the DNA coding for the Cas protein may become built into the DNA target sequence of the cell, which would lead to the gene in question not functioning properly.
'''Mosaicism'''
Genetic mosaicism is the presence of more than one genotype in one individual. Some cells in the target region undergo the desired genetic modification while others still carry the original DNA resulting in a mosaic pattern of edited and unedited cells. This can lead to problems in communication between cells.
'''Immunogenicity'''
The use of gene editing tools, especially those involving viral vectors to deliver editing components, may trigger an immune response in the organism. The immune response could limit the effectiveness of the treatment or cause adverse reactions.
'''Germline Gene Editing'''
The ability to edit the human germline, which includes sperm and egg cells, raises ethical concerns about the potential for heritable genetic modifications. The long-term consequences and unintended effects on future generations are not fully understood; if the modifications turn out to be harmful, they will not only have consequences for a single individual, but also for future generations.
'''Unintended Consequences'''
Modifying one gene may have unintended consequences for other genes or biological processes. For instance, the unintended consequences of releasing GMOs into the environment, could result in gene flow to wild populations, disruption of ecosystems, and the emergence of resistant pests or weeds. Or the de-extinction of certain species could lead to other species becoming extinct or other disruptions of the ecosystem.
'''Human Enhancement'''
The ability to edit genes raises ethical questions about the potential for "designer babies," where genetic enhancements are made for non-medical reasons. This raises concerns about social inequality, discrimination, and the potential misuse of gene editing technologies.
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This checklist is intended for use as a supplement to the usual ethics review process regarding matters that are mainly specific to the use of gene drive technology in research. All usual aspects of research ethics review will also need to be considered, for instance, compliance with national and international regulations and the appropriate health and safety measures. Additionally, the checklist is not exhaustive; there may be other issues pertaining to individual studies that are not included here. Nevertheless, alongside general guidelines and processes, it provides a useful starting point for ethics reviewers.
Environmental impacts
# Do the project activities risk ecosystem disruption?
# Has a thorough environmental impact assessment has been conducted, including for the potential effects on biodiversity, ecosystems, and food chains?
# If yes, what does this tell us?
# If no, are there plans to conduct this before any release of the gene drive?
# Do the researchers have a reasonable plan to monitor and manage unintended ecological consequences?
# How have the researchers taken account of the possibility of irreversible ecological changes?
# What safeguards are in place to protect biodiversity?
# Have the researchers paid due attention to the broader, global implications of releasing the gene drive?
# How will the technology be responsibly managed if it extends beyond the target regions?
Human health and wellbeing
# Are there risks to human health and wellbeing?
# If so, are appropriate measures in place to minimise harm to local populations (e.g., healthcare support, disease monitoring).
# Are appropriate measures in place for delivering health benefits to the local populations?
# Is there an appropriate plan for long-term monitoring of human health impacts?
Technological and other risks
# Do the researchers have an appropriate plan to monitor and manage unintended evolutionary consequences?
# Have the risks of gene flow to non-target species (e.g., through hybridization) been properly assessed and are appropriate precautions are in place?
# Is there an appropriate strategy to monitor and respond to evolutionary resistance, including adjustments to the gene drive or alternative interventions if resistance develops?
# Do the researchers have an appropriate contingency plan for halting or reversing the gene drive if negative effects are observed (for instance, gene drive off switches, or self-limiting mechanisms)?
Community involvement
# Have the local community been meaningfully involved in decision-making processes related to the project design and implementation?
# How is the consent process being managed?
# How will it be ensured that all those affected (including individuals, groups, and local leaders) understand the potential risks and benefits fully?
# How is the option to opt out of the study managed?
Equity
# Is the research to be situated in a low or lower-middle income country?
# If so, how are the researchers taking steps to avoid ethics dumping?
# Who are the potential beneficiaries of this study?
# Will the resultant benefits be accessible to the local populations?
# Has a plan for equitable sharing of the benefits arising from the research been agreed with the local communities?
# Will the local population have the capacity and resources to manage and monitor the technology after the research phase concludes, ensuring local control over future developments?
Study justification
# Is there a justifiable need for this study?
# Might the same objectives be achieved via less risky and/or less costly methods?
Helicopter research occurs when researchers from affluent countries extract data or resources from lower-income regions without considering local needs or ethical concerns. A notable example occurred during the Ebola crisis in 2014. Researchers from high-income countries requested access to vast amounts of mobile phone data from Sierra Leone, Guinea, and Liberia to track population movements, claiming that it would provide significant insights into Ebola transmission.
The contrast between the handling of mobile phone data during the Ebola crisis and the German floods of 2021 underscores the double standards often present in helicopter research. +
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XR manipulation refers to the intentional alteration or distortion of reality within virtual environments. XR manipulation can alter users' perception of reality, create illusions or deceptions that trick users into perceiving virtual content as part of their physical environment. It can also be used to control the narrative within immersive experiences to shape their understanding, interpretation, and beliefs. The emergence of virtual beings, (for instance, avatars representing deceased individuals) introduces complex ethical questions regarding identity and agency.
Immersive technologies can also incorporate nudging techniques that are used to guide users' actions, shape their experiences, or promote certain outcomes. In the context of VR, ‘nudging’ refers to the application of certain measures to subtly influence the user’s decision-making. For instance, it may involve prompts, reminders, or visual cues; the presentation of options in specific ways; portraying particular behaviours as the social norm; or the offering of rewards or incentives. Given the intention to influence, the use of nudging techniques has ethical implications related to user autonomy and informed consent, so needs to be considered carefully.
While these facets can enhance immersion and entertainment value, they can also invoke ethical concerns related to transparency, consent, and user agency. XR manipulation can be exploited for malicious purposes, such as spreading misinformation, creating deceptive experiences, or manipulating users' behaviour for financial or political gain. Safeguards need to be implemented to prevent misuse of XR technologies and protect users from harmful manipulation. +
Changes to the process of seeking informed consent must not be allowed to compromise potential participants’ understanding of a research project. This includes ensuring that research participants do not mistake research for treatment (‘therapeutic misconception’), especially when healthcare staff rather than researchers seek consent +
Try to answer the questions about the case. +
Ask participants to shortly evaluate the session and your facilitation. In this step you may ask participants questions such as:
- Were the instructions clear enough?
- Do you think that the case was appropriate?
- Would you have any suggestions to do the session differently?
- What do you think the strong aspects of this session are?
- Are there any points to improve? +
Katılımcılardan oturumu ve sizin kolaylaştırıcı olarak performansınızı kısaca değerlendirmelerini isteyin. Bu noktada katılımcılara aşağıdakilere benzer sorular sorabilirsiniz:
- Verilen talimatlar yeterince açık mıydı?
- Ele alınan vakanın uygun olduğunu düşünüyor musunuz?
- Oturumun farklı bir şekilde gerçekleştirilmesine yönelik önerileriniz var mı?
- Bu oturumun güçlü yanları nelerdi?
- Geliştirilmesi gereken noktalar var mı? +
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Alexei Grinbaum shares some considerations for researchers and research ethics reviewers. In this interview, you will hear Alexei discuss different categories of questions that need to be asked about studies involving the use of AI technologies in healthcare. [https://classroom.eneri.eu/sites/default/files/2024-10/20240513%20Checklist%20AI%20in%20health.pdf The Ethics of AI in Healthcare: A checklist for Research Ethics Committees], which we mentioned at the beginning of the module is a useful resource to identify relevant questions. +
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ou 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. +
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One aspect that is not fully described by the researchers or explored by the research ethics committee is that of the AI involvement in the study.
AI involvement in the study
Participants in the VR group will interact with AI driven avatars. This is addressed to some extent as concerns were raised about supervision of the AI system, monitoring of interactions, and accountability etc. Additionally, it was noted that it wasn’t clear whether there would be an AI expert on the research team.
However, there is also no AI expert on the research ethics committee and maybe that is why they failed to address the issues associated with the inclusion of a generative AI element in the project. This is what the proposal states: “Additionally, the study hopes to contribute to improving AI-driven avatars in VR environments, to help make them more lifelike and responsive during human-to-AI interactions.” This statement implies that data from the project will be used to train AI models. Did you spot this in the proposal?
Generative AI models typically require significant amounts of data, often stored for long periods. This increases the risk of data breaches or unauthorized access, especially given the sensitive nature data collected in this project. Biometric data, coupled with detailed interaction metrics (e.g., frequency, duration of social interactions), can be highly personal and although efforts can be made to anonymise data, the detailed nature of biometric and interaction data could lead to re-identification risks. Secure anonymisation protocols must be emphasised to protect participant identities. If people in the project are not fully aware that their data is being used to train AI models this raises concerns about autonomy and trust.
Additionally, there are issues related to data bias and fairness as unrepresentative datasets might skew the AI model’s predictions. The large datasets on which generative AI models are trained can contain biases or stereotypes leading AI avatars to exhibit biased behaviours or make stereotyped assumptions. Participants from underrepresented groups might encounter responses from avatars that reflect these biases, and there may be a lack of nuanced cultural understanding, leading to responses that feel inappropriate or insensitive.
Mitigating these risks will require transparency about AI’s nature, strict data handling policies and bias mitigation strategies including fairness in participant recruitment.
For proposals like this where there are ethics issues that cross both the involvement of XR and AI, it will be helpful to also consult the document Ethics of [https://classroom.eneri.eu/sites/default/files/2024-12/The%20use%20of%20XR%20technologies%20in%20research.pdf AI in Healthcare: A checklist for Research Ethics Committees.]
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Think about places where data relating to your own health might be stored – tick all that apply
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In the next video you will hear from some of the people who were involved in developing the TRUST Code, summarizing the 23 articles that promote equitable research partnerships in international collaborative research. +
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'''Human enhancement'''
The ability to edit genes raises ethical questions about the potential for "designer babies," where genetic enhancements are made for non-medical reasons. This raises concerns about social inequality, discrimination, and the potential misuse of gene editing technologies.
'''Immunogenicity'''
The use of gene editing tools, especially those involving viral vectors to deliver editing components, may trigger an immune response in the organism. The immune response could limit the effectiveness of the treatment or cause adverse reactions.
'''Off-Target Effects'''
Gene editing tools may unintentionally modify genomic regions other than the target, leading to unintended consequences. Off-target effects could potentially cause new genetic mutations or disrupt the function of other essential genes.
'''On-target effects'''
Gene editing tools may unintentionally modify the target DNA in the wrong way with unwanted deletions or insertions. For instance, the DNA coding for the Cas protein may become built into the DNA target sequence of the cell, which would lead to the gene in question not functioning properly.
'''Mosaicism'''
Genetic mosaicism is the presence of more than one genotype in one individual. Some cells in the target region undergo the desired genetic modification while others still carry the original DNA resulting in a mosaic pattern of edited and unedited cells. This can lead to problems in communication between cells.
'''Slippery slope'''
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. +
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'''An example of a protocol to deal with incidental findings'''
In addition to collecting biological samples, the population-based UK [https://www.nature.com/articles/s41467-020-15948-9#Sec19 Biobank also collect multi-modal images] from some donors which include MRIs, x-rays, and ultrasounds. Their protocol for dealing with incidental findings included the recruitment of 3rd party consultant radiologists to review scans that the biobank radiologists had flagged up if they had noticed signs of something clinically serious at the time of collection. The consultant radiologist then reviewed the images and advised the biobank if the donor and their healthcare practitioner should be notified. Of the donors who were notified of an incidental finding, all consulted their doctor, and 90% went on to further clinical assessments. +
