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Biobanking: Ethics Issues + ([[File:Bio2Image11.png|center|frameless|600x600px]])
Biobanking: Ethics Issues + ([[File:Bio2Image12.png|center|frameless|60 … [[File:Bio2Image12.png|center|frameless|600x600px]]'''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.% went on to further clinical assessments.)
Biobanking: Ethics Issues + ([[File:Bio2Image13.png|center|frameless|60 … [[File:Bio2Image13.png|center|frameless|600x600px]]Work has been conducted in [https://www.nature.com/articles/s41431-023-01299-8 Germany] and the [https://www.bbmri.nl/sites/bbmri/files/Erasmus_MC_Handreiking_Interactieve_pdf_Engels_29_04_2020_V3.pdf Netherlands] to design guidelines for dealing with incidental findings arising from biobank research. Both sets of guidelines emphasise that processes for dealing with incidental findings need to be in place from the design stage of studies.'''Feedback'''Researchers working with secondary data collected by biobanks need to be aware of the original conditions of consent given by biobank donors, including whether they have been given the option to be notified of incidental findings and if so, did they opt in or out. Other considerations to take into account are the length of time that has passed since the donation was made, and whether the data has been utilised previously by other researchers. Notification of findings long after the donation, or by multiple researchers may be unwelcome to the donor. However, any such decisions about communicating incidental findings derived from secondary biobank data should be guided by the conditions of consent under which the original data was contributed.r which the original data was contributed.)
Biobanking: Ethics Issues + ([[File:Bio2Image14.png|center|frameless|60 … [[File:Bio2Image14.png|center|frameless|600x600px]]'''Ethics review processes for biobanking'''Ethics review processes for biobanking vary across the world. Looking at European countries as an example of the variations, we see that in many countries, independent ethics review bodies, typically RECs, evaluate the ethical acceptability of research projects that intend to use biobank resources. In some countries, RECs also review the establishment of a biobank itself. In other countries, REC approval for biobank research is only necessary in exceptional cases. For example, in the UK, biobanks may obtain general ethics approval to conduct a broad range of biobank research, thereby relieving researchers of the need to seek separate ethics approval. In Finland, REC permission is required to set up a biobank, and the evaluation of biobank research is typically performed by the directors of the biobank, with REC approval necessary only under specific circumstances.It is also worth noting that in some countries, RECs are responsible for additional obligations, such as allowing biobank controllers to identify and contact gene donors to get their written consent for renewing, supplementing or verifying a description of their state of health. They might also be responsible for authorising the transfer of biobanked samples and health-related data to other biobanks established in the same country or abroad.Different ethics governance practices across different biobanks in Europe also reflect different models of oversight recommended at the international level. For instance, the [https://www.oecd.org/health/biotech/guidelines-for-human-biobanks-and-genetic-research-databases.htm OECD guidelines for Human Biobanks and Genetic Research Databases] recommend that RECs should assess biobank research with a specific focus on determining whether the purpose of the planned biobank research study falls within the scope of previously given consent or whether it requires (re)consent. Meanwhile, the [https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/ WMA Taipei Declaration] expands the scope of ethical oversight by recommending that RECs should evaluate not only biobank research, but also approve the establishment of a biobank and monitor ongoing biobank activities.nk and monitor ongoing biobank activities.)
Biobanking: Ethics Issues + ([[File:Bio2Image15.png|center|frameless|60 … [[File:Bio2Image15.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.What is a key distinction between the broad consent and study-specific consent models used for individuals donating biological samples to a biobank? donating biological samples to a biobank?)
Biobanking: Ethics Issues + ([[File:Bio2Image2.png|center|frameless|600 … [[File:Bio2Image2.png|center|frameless|600x600px]]'''Issues relating to consent to donate biomaterials and data to biobanks'''Clear procedures enabling biobank donors to give their informed consent to donate biological materials and health-related information are vital to ensure that they fully understand how their samples and data will be used. Donors should be made aware that biobanks do not routinely provide individual diagnoses, so that they are not falsely reassured when they do not receive results from the analysis of their biospecimens and data. RECs must assess the clarity and comprehensibility of consent forms, addressing any potential risks and benefits.[https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/ The WMA’s Declaration of Taipei] sets out the following criteria for informed consent for multiple and indefinite uses of biomaterials stored in a biobank, stating that consent is only valid if the concerned individuals have been adequately informed about: the purpose of the health database or biobank; the risks and burdens associated with collection, storage and use of data and material; the nature of the data or material to be collected; the procedures for return of results including incidental findings; the rules of access to the health database or biobank; how privacy is protected; the governance arrangements of the biobank; That if the data and material are made non-identifiable the individual may not be able to know what is done with their data/material and that they will not have the option of withdrawing their consent; Their fundamental rights and safeguards established in the Declaration; and when applicable, commercial use and benefit sharing, intellectual property issues and the transfer of data or material to other institutions or third countries. to other institutions or third countries.)
Biobanking: Ethics Issues + ([[File:Bio2Image3.png|center|frameless|600 … [[File:Bio2Image3.png|center|frameless|600x600px]]Different models of consent offer distinct advantages and drawbacks in balancing ethical considerations and scientific advancements. We will first look at broad consent, before moving on to look at other models. For this form of consent, participants give permission for their data or biological samples to be used in a range of future research studies, rather than being limited to a single, specific study.Jurate Lekstutiene shares her thoughts on how the broad consent model is used in biobanking. Biobanking would not be possible without support from the society, without consent from biobank participants. However, during the consent process, usually it's impossible to accurately determine which health-related research will be conducted in the future.There are several ways how we could address this uncertainty. And the idea behind the broad consent model is that a person gives consent once, usually in writing, and then based on this consent, a biobank can collect and store samples and data for unlimited time, even after a biobank participants' death. And these samples and data can be used for extensive research involving different diseases.ive research involving different diseases.)
Biobanking: Ethics Issues + ([[File:Bio2Image4.png|center|frameless|600 … [[File:Bio2Image4.png|center|frameless|600x600px]]=== '''Dynamic Consent''' ===Dynamic consent utilises digital technology to enable ongoing communication with donors. It allows donors to tailor their consent preferences over time, providing a mechanism for enhanced donor engagement. While it fosters a more participatory approach to consent, its implementation can be resource-intensive and may pose technical and practical challenges. Practically, the need for continuous engagement puts a greater administrative burden on biobanks. This includes the labour associated with managing donor inquiries, concerns, and requests for consent withdrawal or modification, which can escalate costs and require more personnel. Furthermore, it can create a potential digital divide if some donors lack access to or familiarity with the necessary technology to engage with the consent process, potentially raising issues of equity and inclusivity.=== '''Study Specific Consent''' ===Involves donors providing informed consent for their data and samples being used for a single specific research study. Fresh consent would need to be sought by researchers should they wish to use data or samples in a new study.=== '''Tiered Consent''' ===Involving donors choosing from predefined categories of research by agreeing to the sub-area of medicine for which samples and data can be used in the future. They might, for example, select specific disease groups like cancer or cardiovascular disorders. This model of consent enhances donor autonomy and transparency but may hinder the adaptability of research projects. Additionally, it requires constant updates to accommodate evolving research fields.=== '''Meta Consent''' ===Involving pre-defined consent models for different layers. Based on this model, one person may choose broad consent for all types of health data and their usage contexts. Meanwhile, another person may choose broad consent for nationally funded projects involving genetic data, and specific consent for the use of any data in international and commercial scientific projects. To sum up, meta-consent is not just about granting or prohibiting consent but about applying different consent models to different layers of biobank research.s to different layers of biobank research.)
Biobanking: Ethics Issues + ([[File:Bio2Image5.png|center|frameless|600 … [[File:Bio2Image5.png|center|frameless|600x600px]]Use the links below to access and read the UK Biobank’s information sheet and consent form.[https://www.ukbiobank.ac.uk/media/ei3bagfb/participant_information_leaflet-baseline.pdf Example of a biobank information sheet from the UK Biobank][https://www.ukbiobank.ac.uk/media/t22hbo35/consent-form.pdf Example of a biobank consent form from the UK Biobank]'''Feedback'''Broad consent models are commonly used by biobanks to streamline sample collection for diverse research purposes. These models allow participants to consent to a wide range of potential future studies, facilitating efficient research while maintaining ethical standards. However, ensuring transparency and understanding among participants regarding the scope of research remains paramount for ethical practice.What type of consent model is UK Biobank using in these examples?del is UK Biobank using in these examples?)
Biobanking: Ethics Issues + ([[File:Bio2Image6.png|center|frameless|600 … [[File:Bio2Image6.png|center|frameless|600x600px]]== '''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.[[File:Bio2Image7.png|center|frameless|300x300px]]'''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.g in the context of biobanking activities.)
Biobanking: Ethics Issues + ([[File:Bio2Image8.png|center|frameless|600 … [[File:Bio2Image8.png|center|frameless|600x600px]]'''The right to withdraw consent'''The right to withdraw consent is a fundamental aspect of ethical research. While the motives behind withdrawal can differ greatly, operationalising withdrawal of consent remains complex, particularly if biobank data or samples have already been used in research. The withdrawal of consent should be documented, and samples and data should be destroyed safely or returned to the donor.'''The death of a donor'''The death of a donor can create ambiguity in terms of ongoing consent for the use of their samples. Guidelines differ globally: some suggest that consent should be presumed to continue after death, others advocate for re-consenting by next of kin.'''The use of samples without consent'''The use of samples without consent, often in the case of historical or residual samples, is another complex issue for consent, as well as for data sharing and privacy issues. In this case, decision-making about the use of samples involves balancing donor interests with the potential scientific value of such samples. '''Respecting cultural norms and practices'''Respecting cultural norms and practices, as in any research study, researchers and RECs should bear in mind the need to respect cultural norms when seeking informed consent from an individual. For instance, in some cultures it is expected that the head of a household or community elders would be asked to provide their consent for a member of the family/community participating in a research study or donating biospecimens and health-related data to a biobank.mens and health-related data to a biobank.)
Biobanking: Ethics Issues + ([[File:Bio2Image9.png|center|frameless|600 … [[File:Bio2Image9.png|center|frameless|600x600px]]Personal data processing in biobanks raises ethical issues that need careful consideration to ensure the protection of individuals' rights, privacy, and the responsible conduct of research. During the Ebola outbreak in Sierra Leone, data processing failures contributed to a lack of a complete inventory of the samples collected, and incomplete information about their potential future use, location and ownership. Navigating such issues requires adherence to established guidelines, ongoing ethical review, and engagement with stakeholders to ensure that data processing in biobanks aligns with ethical principles, legal frameworks, and societal expectations. Some key ethics issues connected to data processing in biobanks are described below after a short clarification of relevant terms.The terms anonymous and de-identified are often used interchangeably but do have different meanings. For the purposes of this module, we are using the terms in this way:* Anonymous – The dataset does not contain any identifiable information and there is no way to link the information back to identifiable information. This is an irreversible process.* De-identified – The dataset does not contain any identifiable information, but there is a way to link the information back to identifiable information.'''Data ownership'''Ethical concerns surrounding data ownership in biobanks revolve around defining and respecting the rights of various stakeholders involved. Donors contribute valuable biospecimens and personal data, raising questions about who ultimately owns this information. Generally, donors retain some rights over their samples and associated data, but biobanks also have responsibilities to steward these resources for the public good. Policies will vary from country to country and across different organisations. As an example, UK Biobank states that it is the owner of the intellectual property rights of the data and samples contained in the resource. The biobank grants researchers a limited, revocable, worldwide, royalty-free, non-exclusive licence (but not ownership rights) to use samples for a permitted purpose only. However, the intellectual property rights to the results data deriving from the research for the permitted purpose will under most circumstances belong to the researcher.Striking a balance between the interests of researchers, institutions, and donors is crucial. Clear and transparent consent processes are essential to inform donors about how their data will be used and who will have ownership or control over it.ho will have ownership or control over it.)
Biobanking Case Study + ([[File:Bio3Image1.png|center|frameless|600 … [[File:Bio3Image1.png|center|frameless|600x600px]]'''The proposal - Investigating the progression of COVID-19 in diverse population subgroups in Country X and Country Y'''(a hypothetical case study) '''Collaborating Institutions:'''- XYZ Global Health Institute, Country X- ABC Medical Research Center, Country Y'''Background:'''COVID-19 has affected populations worldwide, but the progression and severity of the disease appear to vary significantly among different population subgroups, based on factors such as genetics, socioeconomic status, environmental exposures, and healthcare access. These variations are particularly pronounced between high-income countries and low- or middle-income countries. Understanding these differences is critical to improving public health responses to COVID-19 and future pandemics.This study aims to investigate the progression of COVID-19 in two diverse countries—Country X (a high-income country in Europe) and Country Y (a low- or middle-income country in Africa)—to identify genetic, environmental, and social factors influencing COVID-19 outcomes. Insights gained will be used to develop predictive models for disease severity and inform public health strategies for more effective pandemic preparedness and response.'''Research objectives:'''1. Comparative COVID-19 progression analysis: Examine how COVID-19 progresses in different subgroups (e.g., age, gender, ethnicity, and socioeconomic background) in Country X and Country Y.2. Genetic and environmental risk factors: Identify genetic markers and environmental exposures (e.g., air pollution, living conditions) that affect COVID-19 severity and outcomes in the two countries.3. Development of predictive models: Create models to predict disease risk and progression, incorporating genetic, demographic, and environmental data.'''Study design:'''The study will be conducted over three years and will involve both prospective and retrospective analysis. It will combine newly collected biosamples and health data with previously donated samples from existing biobanks.1. Participant recruitment: The study will recruit 5,000 participants from each country. Participants will be selected based on age, gender, ethnicity, and socioeconomic status to ensure diverse representation. 2. Data collection: Biosamples (blood, nasal swabs, saliva) and demographic data (medical history, socioeconomic status, environmental exposures) will be collected from each participant. The samples will be processed and stored in a newly established biobank in both Country X and Country Y for long-term research use.3. Secondary data use: The study will also utilise biosamples from pre-existing biobanks in both countries, originally collected for other health-related research purposes. These samples will be integrated into the analysis.4. Data analysis: Researchers will conduct genomic sequencing and environmental exposure analysis to identify factors influencing disease severity. Statistical models will be developed to predict high-risk groups based on the data.'''Expected outcomes:'''1. Identification of key risk factors: The study will provide insights into the genetic, environmental, and social factors that influence COVID-19 severity in different subgroups across Country X and Country Y.2. Predictive tools: The research will result in the development of predictive models to inform healthcare providers and public health officials about populations at higher risk of severe COVID-19 outcomes.3. Improved public health response: The findings will contribute to more targeted interventions, enhancing pandemic preparedness and healthcare access, particularly for vulnerable groups in Country Y.'''Expected contribution:'''This research will provide critical knowledge about the progression of COVID-19 in diverse populations and help inform global and local public health strategies. It will also contribute to a more equitable understanding of pandemic impacts and ensure that all populations benefit from the insights gained.ulations benefit from the insights gained.)
Biobanking Case Study + ([[File:Bio3Image10.png|center|frameless|60 … [[File:Bio3Image10.png|center|frameless|600x600px]]In addition to the guidelines discussed below, we have produced a checklist for RECs on the use of biobanking in research, attached at the end of this page. We hope that this will be useful for REC members considering proposals involving biobanking. Please also see the further resources section which includes the most relevant EU or international guidelines or standards related to biobanking, a bibliography and useful websites.In Europe, biobanking is governed by regulations in the [https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:102:0048:0058:en:PDF European Union's Clinical Trials Regulation and the Human Tissue and Cells Directive] which provides guidelines for sample collection, storage, and ethical considerations. Guideline 8 in [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9357355/ CIOMS International ethical guidelines for health-related research involving humans] sets out recommended practices for the collection, storage and use of biological materials and related data. Also relevant is the [https://www.isber.org/page/BPR General Data Protection Regulation] (GDPR), which addresses the processing of personal data. [https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf The International Society for Biological and Environmental Repositories] (ISBER) provides guidelines for best practices, and the [https://www.oecd.org/health/biotech/guidelines-for-human-biobanks-and-genetic-research-databases.htm OECD's Guidelines on Human Biobanks and Genetic Research Databases] offer international recommendations. [https://doi.org/10.3390/genes15010066 Multiple national and regional regulations] further shape biobanking practices worldwide, emphasising ethical, legal, and privacy considerations. It is important to remember that different guidelines and regulations will apply to biobanks and related research projects in order to comply with the requirements of different institutions, organisations and geographical locations. The further resources section lists and provides links to other relevant EU, African and other international guidelines or standards related to biobanking in health and healthcare, but you may need to explore further afield to locate those that apply to different situations.[https://classroom.eneri.eu/sites/default/files/2024-11/Checklist%20for%20use%20of%20biobanking.pdf Checklist for RECS on the use of biobanking in research.]ECS on the use of biobanking in research.])
Biobanking Case Study + ([[File:Bio3Image2.png|center|frameless|600 … [[File:Bio3Image2.png|center|frameless|600x600px]]<div><div>Please answer the following question, your responses will be recorded anonymously.Question: As a member of the research ethics committee, what is your first impression of this proposal? Do you think that you would be in favour of approval for this project?'''Feedback'''In complex cases like this, it is always advisable to seek more information before making a decision. Research ethics committee members can do their own research around the topic, most often this involves asking the applicants for further information. REC members may also want to discuss the proposal with colleagues and other stakeholders, and if necessary, they can seek expert advice externally.</div></div><div><div></div></div> advice externally. </div></div><div><div></div></div>)
Biobanking Case Study + ([[File:Bio3Image3.png|center|frameless|600 … [[File:Bio3Image3.png|center|frameless|600x600px]]===Reflection activity===As you can see, the REC chairs have each identified some ethical issues in the research proposal, did you spot any others? Can you identify the sections of the proposal which are relevant to the chairs’ concerns? Do you think that the geographical location of the two ethics committees will impact on their perspectives? Make a few notes of the issues that you have identified before moving on.that you have identified before moving on.)
Biobanking Case Study + ([[File:Bio3Image4.png|center|frameless|600 … [[File:Bio3Image4.png|center|frameless|600x600px]]'''Feedback'''<div>Dual ethics approval is an important measure to take to avoid ethics dumping.Ethics dumping refers to the unethical practice of conducting research in low- or middle-income countries (like Country Y) without adhering to the same ethical standards applied in high-income countries (like Country X). This proposal for studying COVID-19 progression in both countries must be vigilant to avoid ethics dumping by ensuring that consent and ethical approval are obtained '''independently in both countries''', respecting local regulations, cultural norms, and standards of care. Participants in Country Y should not face lower ethical protections, and informed consent must be fully explained, ensuring that individuals understand how their data and biosamples will be used. Additionally, any findings or benefits must be equitably shared between both countries to avoid exploitation. Transparency, respect for autonomy, and local ethics oversight in both Country X and Country Y are crucial to ensure that the study is ethical and culturally appropriate across both settings. [https://www.globalcodeofconduct.org/ The TRUST global code of conduct for equitable research partnerships] is a resource for all research stakeholders who want to ensure that international research is equitable and carried out without ‘ethics dumping’ and ‘helicopter research’.</div>thics dumping’ and ‘helicopter research’. </div>)
Biobanking Case Study + ([[File:Bio3Image5.png|center|frameless|600 … [[File:Bio3Image5.png|center|frameless|600x600px]]The XYZ/ABC collaboration inform the REC that reconsent will be sought for the secondary use of biobank samples, where feasible. All new participants will give fully informed consent for the collection and storage of their biosamples and data. However, they do not specify which model(s) of consent will be used. Let us consider some different perspectives on this.Maria:As a potential new donor in Country X, I see the importance of research aimed at understanding COVID-19, especially how it affects different population groups. I appreciate the opportunity to contribute to a study that could potentially improve public health outcomes, not just here in my country, but across the world.But I have some concerns about the collection and use of my biosamples and personal data. I want to make sure that my privacy is protected, and that any data from my samples is handled securely. I would like to know who will have access to my data and for what purposes, especially since this project involves collaboration with another country. Will my samples be used only for this study, or could they be used in future research? If so, I would want to be fully informed and have a say in whether I consent to future uses.Another issue is data security. Given the sensitive nature of genetic and health information, I want to know that there are robust measures in place to prevent unauthorised access or breaches. Lastly, I would like transparency about how any findings, especially those related to my genetic data, might be shared and whether I’ll be informed of any significant results that could impact my health.Pamela:As a staff member in a biobank facility in Country Y, I was pleased to see more biobanking coming to my country. However, I do have some concerns regarding consent arrangements. The consent process should make sure that participants fully understand exactly what they are consenting to. Given the varying levels of literacy and familiarity with medical research in some communities, it’s crucial to ensure that informed consent is genuinely informed. Participants need to know what the study is about, how their samples will be used, and what future research they may contribute to.One of my concerns is making sure that we clearly communicate the potential for secondary use of the samples and data. If their biosamples or data are used for studies beyond the original research, we need to explain that at the beginning, so participants aren't surprised or feel misled later.Additionally, there's the issue of trust. Many people may be wary of how their data, especially genetic information, will be handled, particularly if it is shared across borders or with institutions in Country X. It is essential to reassure them about data security, confidentiality, and how their samples will be used ethically, respecting their autonomy and rights.Adam:When I first donated biosamples and data in Country Y I gave broad consent, which means that I provided consent just on that one occasion, and in doing so I gave permission for my samples to be used for future studies beyond the original research. I initially felt positive about contributing to research that could benefit public health and I trusted the system would handle my data responsibly.But I’ve developed some concerns. Because I consented broadly, I’m unsure about how my samples have been used, or what they might be used for in the future. It’s unclear whether my samples are being used in ways I would agree with today. For example, I wonder if they’re involved in research that might not directly benefit my community or country, and whether any findings will be shared with us.I also worry about the commercial use of my samples. I didn’t consent to my genetic data being used for profit-making ventures, and I would like more transparency on whether pharmaceutical companies or other private entities have accessed my data.Most importantly, I want reassurance that my privacy and confidentiality are safeguarded. I trust that the biobank staff are doing their best, but I would appreciate regular updates on how my samples are being used, and confirmation that I can still withdraw consent if I feel uncomfortable in the future.Lily:As a biobank donor in Country X, I gave study-specific consent for one project, meaning that I was just consenting for my samples and data to be used for one specific piece of research. I felt confident that I understood how my samples and data would be used. Recently, I’ve been approached to allow my samples to be used in a new collaboration studying COVID-19 in both Country X and Country Y. While I understand the importance of this research, I have mixed feelings about expanding the use of my samples beyond the original study.I’m concerned about ‘scope creep’. I initially agreed to a specific study, and now my data is being requested for something quite different. I would need clear information on what this new research involves, who will have access to my samples, and whether this could lead to additional projects I haven’t explicitly agreed to. I’m also unsure how the cross-border collaboration affects data protection and privacy, especially since Country Y may have different standards or regulations.Another concern is control over my samples. If I allow this collaboration to use my data, will I still have the right to withdraw consent later if I change my mind? I need to know that my autonomy will be respected, and that my samples won’t be shared further without my knowledge. Transparency and regular communication will be key to ensuring my trust in this new research effort.ring my trust in this new research effort.)
Biobanking Case Study + ([[File:Bio3Image6.png|center|frameless|600 … [[File:Bio3Image6.png|center|frameless|600x600px]]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).t have cited the results of this project).)
Biobanking Case Study + ([[File:Bio3Image7.png|center|frameless|600 … [[File:Bio3Image7.png|center|frameless|600x600px]]Which consent model would you recommend to be used by the XYZ/ABC partnership? Please select one answer from the choices below and then click to reveal how others have voted.'''Feedback'''For this COVID-19 study, broad consent might be appropriate if combined with strong safeguards for participant rights and mechanisms for withdrawal. However, if participant autonomy is a priority, especially given the cultural diversity between Country X and Country Y, dynamic consent may be the ideal model, despite its logistical challenges. Study-specific consent could also be ethically valid for this particular study, though it may limit future research potential.gh it may limit future research potential.)
Biobanking Case Study + ([[File:Bio3Image9.png|center|frameless|600 … [[File:Bio3Image9.png|center|frameless|600x600px]]The governance of biobanking research is critical to ensuring that the collection, storage, and use of biosamples and data are conducted ethically and responsibly, especially in a cross-border, multi-institutional study such as the COVID-19 progression research in Country X and Country Y.Here are some further issues that need consideration:1. Collection and storage of biosamples and dataBoth RECs need to satisfy themselves that governance protocols are in place to ensure that biosamples and data collected in both Country X and Country Y are handled with the highest ethical standards. This involves securing informed consent that is clear, culturally appropriate, and specific about how the samples will be stored, used, and potentially shared. The governance framework should include procedures to manage sample storage in biobanks, ensuring that materials are properly catalogued, securely stored, and accessible only to authorised personnel under strictly controlled conditions. Data must be pseudonymised or de-identified to protect participant identities and ensure confidentiality, particularly when genomic data or sensitive health information is involved.Additionally, the implications of any return of results to donors should also be considered. The indefinite or long-term storage of biosamples in biobanks can present issues if participants are not fully aware of the potential for their data and samples to be used in future research beyond COVID-19. Participants must have the ability to withdraw consent at any time, with clear procedures for the destruction of their biosamples and data if requested.Privacy and data security: The collection of sensitive health and genetic data raises privacy concerns. De-identification or pseudonymisation must be used to protect participants' identities, but even this carries the risk of re-identification. Strict data protection protocols, including secure storage, encryption, and restricted access, must be implemented to prevent data breaches, especially when data is shared across borders. Both countries' legal frameworks must be respected, particularly data protection laws like the GDPR in Country X. Given the evolving nature of regulations, particularly with the [https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en European Health Data Space] and its impact on data sharing, RECs must remain agile. Ethical guidelines should be regularly reviewed to stay aligned with changing policies and participant rights.3. Cross-border transfers of biosamples and dataIn a collaborative project between Country X (Europe) and Country Y (Africa), governance must address the challenges of cross-border transfers of biosamples and data, which are subject to different regulatory regimes. In Country X, strict [https://gdpr.eu/ GDPR regulations] govern data protection and privacy, requiring explicit consent for cross-border data sharing. Similar standards may not exist in Country Y, which raises ethical concerns around participant rights and the safeguarding of data once it leaves the country. Material Transfer Agreements (MTAs) and Data Sharing Agreements (DSAs) must be in place to ensure that samples and data transferred between countries are subject to harmonised standards of privacy, security, and ethical use, regardless of the country of origin. It would be wise for the RECs to secure advice from an expert with specialist knowledge of collaborations between the EU and Africa to ensure that procedures are aligned.4. Potential for racial biasGovernance mechanisms must also address the potential for racial bias in the collection, analysis, and interpretation of biosamples and data, particularly when comparing diverse population groups across Country X and Country Y. Without careful oversight, the study may unintentionally perpetuate biased assumptions or lead to misinterpretation of genetic differences. Researchers must adopt an ethically sound approach that recognises the socioeconomic and environmental factors that contribute to health disparities, rather than attributing differences solely to genetic or racial categories. Particular attention should also be paid to the language used in all documentation to avoid perpetuating such biases. Governance should include independent ethics advisory boards to monitor the study’s methodology and ensure that findings are not used to justify or reinforce racial stereotypes. Both RECs should inquire as to the extent that AI and machine learning will be used – and what protocols will be in place to manage potential biases, transparency issues and ethical risks associated with automated decision-making.5. Commercial vs. public partnershipThe nature of the partnership—whether commercial or public—significantly impacts the ethical landscape of biobanking governance. In a commercial partnership, the risk of exploitation of biosamples for profit, particularly those from Country Y, is heightened. There may be concerns about whether the benefits of the research will be equitably shared or if the data will be used to develop commercial products that primarily benefit private entities in high-income countries. Governance should establish clear benefit-sharing mechanisms, ensuring that any IP or products developed from the research provide fair returns to both Country Y and its participants.In contrast, a public partnership involving government or academic institutions might focus more on public health goals and equity, but governance frameworks should still ensure that public interests are protected, and that transparency is maintained regarding the use of samples and data. Regardless of whether the collaboration is public or private, governance should include oversight committees that ensure ethical standards are upheld, and that participants' rights and interests are prioritised. Both RECs should seek further information about whether this is a commercial partnership and if there are any plans to develop commercial products.ConclusionGovernance of biobanking research in the COVID-19 study must prioritise ethical collection, storage, and use of biosamples and data, especially in a cross-border setting. It should address the potential for racial bias in the study’s design and ensure equitable benefit-sharing regardless of whether the partnership is commercial or public. Strong governance frameworks will ensure that all stakeholders, especially participants, are protected and that the research contributes to the greater public good without exploitation or harm. public good without exploitation or harm.)
Biobanking Case Study + ([[File:BioImage8.png|center|frameless|600x … [[File:BioImage8.png|center|frameless|600x600px]]<div><div>In the proposed study issues surrounding the ownership of biosamples, data, and intellectual property or IP are critical and must be addressed to avoid ethical conflicts. The following video provides an overview of ways in which this could be managed.</div></div>w of ways in which this could be managed. </div></div>)
Research Ethics and Integrity Basics + ([[File:Consent spelled out on blocks.jpg|a … [[File:Consent spelled out on blocks.jpg|alt=consent spelled out on blocks|center|frameless|600x600px|consent spelled out on blocks]]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.e following ingredients to their meanings.)
Biobanking: Technology Basics + ([[File:Data.png|center|frameless|600x600px … [[File:Data.png|center|frameless|600x600px]]Researchers access biobanks’ collections of samples to conduct a wide range of studies, including genetic research, biomarker discovery, disease modelling, and the development of personalized medicine approaches. The diversity of biological samples allows for comprehensive investigations into the complexities of human health and diseases.In addition to collecting biospecimens from donors, biobanks also collect a wide variety of health-related data. The types of data collected and stored may be categorized into 4 main categories.Drag and drop the types of health-related data that may be collected by biobanks into the relevant column. It's important to note that the specific data collected can vary depending on the focus and objectives of the biobank. The contextual information provided by clinical, demographic, and lifestyle data enhances the scientific utility of biospecimens. Researchers can correlate genetic details with health histories, enabling insights into disease mechanisms, personalized treatments, and biomarker discovery. Longitudinal data aids in tracking disease progression, contributing to better prognostics. Collecting comprehensive data alongside biospecimens ensures the quality, relevance, and ethical use of stored samples, fostering advancements in precision medicine and therapeutic development.sion medicine and therapeutic development.)
Biobanking: Technology Basics + ([[File:Donating Samples.png|center|framele … [[File:Donating Samples.png|center|frameless|600x600px]]Alison, a 42-year-old woman in robust health, was invited to contribute to scientific advancement by donating biological material along with health-related information (data) to a biobank. Alison explained to her friends and family that she wanted to contribute to medical research ‘to give something back’ after seeing her father’s successful treatment for cancer.The biobank provided Alison with detailed information about the purpose of the biobank, the types of samples and data needed, risks and potential benefits related to the donation to biobanking and the right to withdraw consent.Alison then gave her consent to the donation process, acknowledging her understanding and agreement to participate.Before donating the samples, Alison underwent a thorough screening process which included a review of her medical history and a physical examination.The samples were carefully labelled, processed, and stored in secure, controlled environments. Storage conditions also comply with stringent ethical and privacy protocols, ensuring the preservation of Alison’s privacy and confidentiality.Alison was told that her personal information would be de-identified or pseudonymized to protect her identity. As part of the consent process, Alison also gave permission for the biobank to contact her in the future to follow up on her health as she ages and potentially invite her to participate in further studies beyond the scope of her original donation. Maintaining contact with donors is crucial for biobanks when samples are used for longitudinal studies or when follow-up health information is needed.Alison's donation is now part of a valuable resource for researchers studying various health conditions, including genetic predispositions and disease markers. Her contribution will allow scientists to conduct longitudinal studies, advancing the understanding of health and potential breakthroughs in personalized medicine. Alison's decision exemplifies the vital role individuals can play in shaping the future of medical research through biobank donations.edical research through biobank donations.)

Research Ethics in a Global Environment + ([[File:Env1.png|center|frameless|600x600px]])

Extended Reality: Technology Basics + ([[File:Ex-tech1.png|center|frameless|600x6 … [[File:Ex-tech1.png|center|frameless|600x600px]][[File:Ex-tech2.png|center|frameless|300x300px]]mage from: Aucouturier E, Grinbaum A (2023) Recommendations to address ethical challenges from research in new technologies. CEA - Commissariat à l’énergie atomique et aux énergies alternatives. https://cea.hal.science/cea-04293426ves. https://cea.hal.science/cea-04293426)
Extended Reality: Technology Basics + ([[File:Ex-tech3.png|center|frameless|600x600px]] VR and AR are used in a very wide range of applications across various industries.)
Extended Reality: Technology Basics + ([[File:Ex-tech4.png|center|frameless|600x6 … [[File:Ex-tech4.png|center|frameless|600x600px]]'''Metaverse'''<div><div><div>The word ‘metaverse’ was first used by the American writer Neal Stephenson in a science fiction novel that was published in 1992 and entitled 'Snow Crash'. It is now used to describe a shared, persistent, real-time 3D, digital model environment where users can interact with computer-generated environments, socialise with others, and engage in various activities, similar to interactions in the physical world. Metaverses are digital spaces and environments that users can explore, interact with, and even shape. These environments may include virtual worlds, simulations, and augmented reality experiences. Social interaction is a fundamental aspect, and the metaverse often includes features like avatars to represent users and communication tools. Users can contribute to the metaverse by creating and sharing content. This may include designing virtual spaces, creating digital objects, and developing interactive experiences. Metaverses can even have their own economy, where users buy, sell, and trade virtual assets, goods, and services. This may involve virtual currencies, digital assets, and a virtual marketplace.</div></div></div>igital assets, and a virtual marketplace. </div></div></div>)
Extended Reality: Technology Basics + ([[File:Ex-tech5.png|center|frameless|600x6 … [[File:Ex-tech5.png|center|frameless|600x600px]]'''Reflection'''Take a few minutes to think about the use of avatars and then check the feedback below. How do you think the user might be affected by their use? How do you think they might feel if their avatar is subjected to harm in the virtual world? '''Feedback'''The bond between users and their avatars can have two major effects - the Embodiment effect, and the Proteus effect.'''Embodiment''' can be described through three aspects of the user's subjective experience. These are:1. The feeling of self-location, that is the spatial experience of being in a body.2. The feeling of agency, which refers to the feeling of being in control of one's actions.3. The feeling of ownership of all, or part, of a body (body ownership) for instance, feeling that the imaginary body is the source of sensations.The '''Proteus''' effect (named after a Greek god with the power of metamorphosis) refers to the influence of an avatar's appearance and behavior on a user's behavior, both in digital space and in real life.An example of the Proteus effect is highlighted in a recent experiment, in which the user is placed in the imaginary skin of another human being, thereby triggering empathy and modifying their behavior. In this experiment, men convicted of acts of violence against women were put in the roles of women who had been assaulted, embodied in female avatars. At the end of the experiment, the participants showed an improved ability to detect fear in a human face.ed ability to detect fear in a human face.)
Extended Reality: Technology Basics + ([[File:Ex-tech6.png|center|frameless|600x6 … [[File:Ex-tech6.png|center|frameless|600x600px]]The hardware needed for VR and AR experiences, can vary depending on the complexity of the application and the level of immersion desired.Click on the hotspots on the image below to find out more about the types of hardware used for VR.e about the types of hardware used for VR.)
Extended Reality: Technology Basics + ([[File:Ex-tech7.png|center|frameless|600x6 … [[File:Ex-tech7.png|center|frameless|600x600px]]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.hnologies and how they might be addressed.)
Extended Reality: Technology Basics + ([[File:Ex-tech8.png|center|frameless|600x600px]])
Extended Reality: Technology Basics + ([[File:Ex-tech9.png|center|frameless|600x6 … [[File:Ex-tech9.png|center|frameless|600x600px]]IEEE SA - The IEEE Global Initiative on Ethics of Extended Reality: https://standards.ieee.org/industry-connections/ethics-extended-reality/ Techethos website (page on Digital extended reality): https://www.techethos.eu/digital-extended-reality/ Zhu, Ling. The Metaverse: Concepts and Issues for Congress. Congressional Research Service, 26 August https://sgp.fas.org/crs/misc/R47224.pdf INRIA’s Website: https://www.inria.fr/en/how-does-virtual-reality-works Basdevant, Adrien, Camille François, et Ronfard. Mission exploratoire sur les métavers. Rapport interministériel. France, Octobre 2022. [https://www.economie.gouv.fr/files/files/2022/Rapport-interministeriel-metavers.pdf https://www.economie.gouv.fr/files/files/2022/Rapport-interministeriel-] [https://www.economie.gouv.fr/files/files/2022/Rapport-interministeriel-metavers.pdf metavers.pdf]The Metaverse Standards Forum: https://metaverse-standards.org/ For a more thorough and philosophical account of the notion of immersive experience Chasid, A. (2021). Imaginative immersion, regulation, and doxastic mediation. Synthese, 199(3), 7083-7106. Langland-Hassan, P. (2020). Explaining imagination (p. 336). Oxford University Press.Schellenberg, S. (2013). Belief and desire in imagination and immersion. The Journal of Philosophy, 110(9), 497-517. For more information on avatars:Ratan, R., Beyea, D., Li, B. J., & Graciano, L. (2020). Avatar characteristics induce users’ behavioral conformity with small-to-medium effect sizes: a meta-analysis of the proteus effect. Media Psychology, 23(5), 651-675.Seinfeld, S., Arroyo-Palacios, J., Iruretagoyena, G., Hortensius, R., Zapata, L. E., Borland, D., ... & Sanchez-Vives, M. V. (2018). Offenders become the victim in virtual reality: impact of changing perspective in domestic violence. Scientific reports, 8(1), 2692.Adomaitis, L., Grinbaum, A., Lenzi, D. (2022) Identification and Specification of Potential Ethical Issues and Impacts and Analysis of Ethical Issues. https://doi.org/10.5281/zenodo.7619852. Aucouturier E, Grinbaum A (2023) Recommendations to address ethical challenges from research in new technologies. CEA - Commissariat à l’énergie atomique et aux énergies alternatives. Available at: https://cea.hal.science/cea-04293426 Zhu, L (2022) The Metaverse: Concepts and Issues for Congress. Congressional Research Service. Available at: https://sgp.fas.org/crs/misc/R47224.pdf. '''Videos'''Kent Bye’s XR Ethics Manifesto: https://www.youtube.com/watch?v=CXgY3YXxqJ8 Masterclass on XR in the classroom (Central Queensland University, Australia): [https://www.studyaustralia.gov.au/english/masterclasses/extended-reality-xr-in-the-classroom https://www.studyaustralia.gov.au/english/masterclasses/extended-] [https://www.studyaustralia.gov.au/english/masterclasses/extended-reality-xr-in-the-classroom reality-xr-in-the-classroom]y-xr-in-the-classroom reality-xr-in-the-classroom])
Extended Reality: Ethics Issues + ([[File:Ext.Image1.png|center|frameless|600 … [[File:Ext.Image1.png|center|frameless|600x600px]]A private technology company is collaborating with a team of university researchers, to design and develop a VR application, that will provide therapy for individuals with social anxiety disorder. Social anxiety disorder is characterized by an overwhelming fear of social situations, so that even everyday activities (like shopping, going to work or speaking on the phone) can cause great distress. The researchers intend to create immersive virtual environments where users can practice social interactions in realistic scenarios, such as job interviews, public speaking, or social gatherings.The VR therapy aims to help users overcome their anxiety by gradually exposing them to challenging situations in a controlled and supportive environment.Imagine that you are being invited to be a participant in this study. What concerns might you have? Take a few minutes to put yourself in the shoes of the participant, and think about the concerns that they might have. Then check against the primary ethics issues that are identified below.'''Feedback'''<div>This brief scenario highlights some of the ethical issues that need to be considered when research involves a VR application. These issues can have impacts at many levels, from personal through to societal and environmental levels. In the rest of this module, we consider this along with the primary ethical issues in more detail. </div>primary ethical issues in more detail. </div>)
Extended Reality: Ethics Issues + ([[File:Ext.Image10.png|center|frameless|60 … [[File:Ext.Image10.png|center|frameless|600x600px]]While the aims of the research projects that you encounter are likely to be positive and beneficial, it is essential to recognise that the growing use of XR technologies opens new opportunities for criminal behaviour. Criminal behaviour might take the form of cybercrimes.Cybercriminals might exploit vulnerabilities in XR software or networks to steal personal information, financial data, or intellectual property. XR technologies might also be exploited for fraudulent activities and scams.Fraudulent activities could include deceptive advertising, phishing schemes, or through XR-enabled communication channels. Crimes can also be conducted in the virtual world, for example, rape or other forms of virtual assault/violence on an avatar, which, given the bond between a person and their avatar, can be seriously impactful for the victim. Correspondingly, there is ongoing debate about the status of crimes in the virtual world and whether they are equivalent to crimes in the real world. For instance, concerns about the sexual assault and rape of avatars raise questions about virtual crimes and their impact on users' emotional wellbeing. Issues like violence, murder, or unwanted disappearance of avatars, as well as child crime in XR, demand ethical scrutiny regarding the depiction and consequences of violence in these digital spaces. Furthermore, the involvement of non-human agents, including AI, in violent or criminal acts complicates the attribution of responsibility in virtual environments.If someone engages in harmful or aggressive behaviour towards another in a virtual environment, do you think they should they incur the same consequences as they would in the real world?The continuum of immersive experience perceived by human users highlights the impossibility of drawing rigorous or fixed boundaries between the material and the virtual environments at which ethical questions of XR would no longer apply. XR technologies can provide highly immersive experiences, blurring the lines between the virtual and physical worlds. As a result, violent content in XR has the potential to be more emotionally impactful and realistic than traditional media forms, potentially desensitising users to violence or causing psychological distress.Do you think that violent content in XR is likely to increase, decrease or have no effect upon the tendency for violent behaviours in the real world? There is ongoing debate regarding the impact of violent XR content on user behaviour. Some studies suggest that exposure to violent virtual environments may lead to increased aggression or desensitisation to violence, while others argue that the effects may vary depending on individual factors and context.Addressing crime in the context of XR requires collaboration between XR developers, platform operators, law enforcement agencies, policymakers, and users. Strategies for addressing XR-related crime may include implementing robust security measures, enforcing community guidelines and codes of conduct, providing user education and awareness programs, and establishing legal frameworks to address virtual crimes that have real-world impacts.rtual crimes that have real-world impacts.)
Extended Reality: Ethics Issues + ([[File:Ext.Image11.png|center|frameless|60 … [[File:Ext.Image11.png|center|frameless|600x600px]]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.d protect users from harmful manipulation.)
Extended Reality: Ethics Issues + ([[File:Ext.Image12.png|center|frameless|60 … [[File:Ext.Image12.png|center|frameless|600x600px]]Miltos Ladikas shares his thoughts on manipulation in XR. People are susceptible to manipulation particularly with extended reality more than any other technology, I believe. Because extended reality intrudes into people's mind like no other technology that we know of. The reason is that extended reality creates, basically, reality. That's why it's called extended reality. And this reality, which is not exactly real, it might be augmented, might be totally virtual, but in any case, it's something that our brain, our mind, our cognitive functions, accept as real.And once you get to that point, then the possibilities for manipulation are manifold, actually. And we know that from research that psychologists have done by using extended reality, especially these [https://c/Users/hpartington/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/83I5BQ72/cave CAVE] systems, as they call them, whereby you are in an extended reality environment, totally immersed in this environment. And so they use that to achieve, and they have achieved, better results in psychotherapy as a matter of fact. For example, acrophobia, height phobia, vertigo, for instance. And although this is, of course, a good aspect of, a good use, let's say, of extended reality, it shows how far it can go into manipulating our minds and even our belief systems, and how this manipulation can be really long term.So, yes, there is a real risk of manipulation by using extended reality. We should be aware of that. As I said before, of course, manipulation can have good aspects. Like, you know, we need to manipulate in psychology, instance, we do need to manipulate, the mind in order to create a better functioning. If you like, in a very blunt way, better functioning, cognitively, at least the mind.But one can imagine a lot of cases where this kind of manipulation, especially in younger people, and don't forget that extended reality is more accepted and more used by the younger generation for a very simple reason. They are more immersed into new technologies, in any case. They accept these new technologies, they have them in their lives, every day, from social media to, well any kind, basically, of new technologies that are out there. It's part of growing up, I suppose, nowadays. But that also means that young minds, which are yet not well-formed, if you like, socially at least, and even individually in many respects, they can really be manipulated through extended reality for, well, any kind of purpose imaginable by the ones that use basically and develop and distribute extended reality.d develop and distribute extended reality.)
Extended Reality: Ethics Issues + ([[File:Ext.Image13.png|center|frameless|60 … [[File:Ext.Image13.png|center|frameless|600x600px]]'''Video Transcript'''When we talk about virtual reality and extended reality, of course there are a lot of typical ethical questions that we always ask with regard to other types of technologies, questions about data, questions about cybersecurity, questions about control, and so on. I would say maybe one of the most important themes of ethical questioning, not just one question but a whole host of questions, are questions about manipulation.Why is that? Because when we wear a virtual reality device, it can interact with our brains in ways that are beyond our conscious control. We call it subliminal interactions. They're not always present to our consciousness. Sometimes these devices use brain data, even if they don't, even if they just present a picture in front of our eyes. Still, the way they do it, is not very natural. They do create illusions. They can probably, incite us or manipulate us into doing something. There is a word to nudge, nudge us into doing something. This can be a good thing. So, maybe they can inform us that we should eat more fruit and vegetables and enjoy the good weather, even if it's raining outside, but we will have an illusion of being happy. This will probably nudge us to some beneficial or nice behaviour. They can also manipulate us into doing things that are not necessarily in our interest.So, there is good and bad there. It's not always bad manipulation. It can be also beneficial or good nudging. But the very existence of this technology begs the question, who decides? Because this is below our conscious control. Even if you tell the human, ‘Well, this device will probably influence you in some ways. Can you please consent to this?’ Because we want to use the device, we will probably sign the informed consent form and still be manipulated. Even if you tell the user, ‘You know, there is a possibility of manipulation,’ they will probably not really notice it because that's in the nature of how these devices interact with our brains, below the threshold of consciousness. So, manipulation is a very difficult, rich and really broad family of ethical questions to think about when we think about virtual and extended reality. think about virtual and extended reality.)
Extended Reality: Ethics Issues + ([[File:Ext.Image14.png|center|frameless|60 … [[File:Ext.Image14.png|center|frameless|600x600px]]'''Video Transcript'''Access to metaverses requires resources that are not available to most people, including a steady electrical supply, high speed internet connection, a headset and / or haptic devices, for an immersive experience, as well as a powerful computer. Over time, the costs of XR devices and hardware may come down, but it is hard to imagine a time when they will be accessible to all. Aside from the costs, there are inclusivity issues related to use by people with disabilities. For instance, the design of VR headsets can inadvertently exclude individuals with specific disabilities, limiting their participation in metaverses. Current commercially available XR technology may only be comfortable to wear for about 50–60% of the population. How can virtual environments and the technical means of navigating them be adapted to the needs of visually or hearing-impaired persons? Addressing the needs of individuals with disabilities is crucial for creating an accessible and welcoming metaverse, but industries might perceive the market of people with disabilities as less lucrative, potentially leading to a lack of tailored offerings.The use of immersive technologies within the workplace is also a grey area. There has been increased use of immersive technologies in workspaces, and attention needs to be placed on the impact, either positive or negative, on these spaces. If the technology is not inclusive of all workers, then this raises ethical concerns.orkers, then this raises ethical concerns.)
Extended Reality: Ethics Issues + ([[File:Ext.Image15.png|center|frameless|60 … [[File:Ext.Image15.png|center|frameless|600x600px]]'''Video Transcript'''If we think about fairness and equity, I would say, then we take a little bit of a different perspective also on extended reality, because manipulation is one aspect, but let's not forget that extended reality is still a three-dimensional technology. And not everyone can use three-dimensional technology for a simple reason. That we have a certain percentage of the population, it's not very high, but still it's significant. I believe it's around 4% or 5% that they do not have a depth vision, let's say.So, for these people, the use of extended reality is impossible basically. But then we have a big number of people, we don't have a lot of research yet to know exact numbers, that they simply find extended reality too confusing, too nauseatic. They cannot function well. So, all these people, whatever the percentage is, but it's definitely a significant minority, are not able to benefit from extended reality. Even more so they are averse to it. So that means that we have a percentage of the population that cannot use extended reality and will be left behind so far as extended reality is used widely for many reasons. For example, for training, for education, and so on and so forth.ng, for education, and so on and so forth.)
Extended Reality: Ethics Issues + ([[File:Ext.Image16.png|center|frameless|60 … [[File:Ext.Image16.png|center|frameless|600x600px]]Do you know what impacts the use of XR has on the environment? Make a note of as many advantages and disadvantages as you can think of, and then watch the video to check your lists.The potential environmental impacts associated with the use of XR technologies are significant, in both positive and negative ways. Potential positive impacts include the reduction of travel, through remote collaboration, training, and meetings, a reduction of material consumption and waste through virtual prototyping and design, and the use of immersive experiences to raise awareness about environmental issues and sustainable practices.However, the processing power required for high-fidelity VR and AR experiences, can be significant and there are concerns about the energy consumption in public places and cloud gaming server farms. Cloud-based XR applications rely on data centres for processing and storage, which consume substantial amounts of energy. Increasing demand for XR content and services may lead to the expansion of data centre infrastructure, exacerbating environmental concerns if not powered by renewable energy sources. The manufacturing of XR devices requires materials such as plastics, metals, and rare earth elements, which can have environmental impacts associated with extraction, processing, and disposal. The production of XR components and materials may also have indirect environmental impacts, such as habitat destruction, pollution, and resource depletion associated with mining and manufacturing processes.Finally, the disposal of XR hardware contributes to electronic waste. As XR devices evolve rapidly, older models may become obsolete, leading to disposal challenges and environmental pollution if not properly managed. Addressing the environmental impacts of XR requires a holistic approach, including efforts to improve energy efficiency, reduce electronic waste, promote sustainable manufacturing practices, and invest in renewable energy infrastructure. Additionally, raising awareness about the environmental implications of XR technologies and fostering responsible consumption and disposal habits among users can contribute to minimizing their overall environmental footprint.ing their overall environmental footprint.)
Extended Reality: Ethics Issues + ([[File:Ext.Image17.png|center|frameless|60 … [[File:Ext.Image17.png|center|frameless|600x600px]]Many of the ethics issues related to XR are not unique. For instance, matters related to data protection, privacy, and confidentiality in XR, appear to be similar to other technologies like biobanking or the use of artificial intelligence in healthcare. However, some aspects may require specialist consideration. For instance, for the involvement of children, for consideration of perceptions of reality, work training and cybercrime.An ethics-by-design approach is advocated by many, whereby ethical considerations are integrated into the design and development process of products, services, technologies, or systems from the outset. The goal is to proactively identify, address, and mitigate ethical risks and concerns throughout the entire lifecycle of a product or service, rather than addressing them as an afterthought or in response to ethical dilemmas that arise later. However, an ethics by design approach can be difficult to reconcile with standard procedures for ethics approval that generally require a detailed description of how ethics issues will be addressed before the onset of a project.There are currently no specific EU or international guidelines governing XR. Listed in the Further Resources section of this module are the current most relevant sources of ethics guidance as well as the most relevant related regulations. as the most relevant related regulations.)
Extended Reality: Ethics Issues + ([[File:Ext.Image18.png|center|frameless|60 … [[File:Ext.Image18.png|center|frameless|600x600px]]'''Video Transcript'''When researchers work on VR applications or VR headsets, devices or techniques, they should always think about the effects that these devices will have on the user. This is not very new. We typically think about how this or that kind of software will be used. Here, the devices and techniques may have an effect that goes quite far. First, because there is subliminal influence, because these devices don't necessarily present things to the consciousness of the user but can go beyond. Second because these devices and techniques will be used in sectors of human life, which very often influence humans profoundly deeply.Let me take a couple of examples. One is education. Another one is healthcare. When you use a VR device for education, of course you should ask, well, what kind of human are we creating that way?What knowledge, what skills are we creating that way? If we teach a human to swim using a virtual reality device, will that human be able to swim in the real life? If we teach a professional, let's say first aid professional, to deliver first aid through some simulation in extended reality, maybe for the fireman or for medical, healthcare professionals, will they be able to do this in real life? If we use a VR device to study how to fix nuclear explosions, and if, God forbid, there is a nuclear explosion, will we be able to use our virtual skills in the material world?These deep questions are not just pure abstract things, let's figure out later. The researchers should think about these things and try to develop solutions by design. This is what we call, there is an expression favoured by the European Commission, ‘[https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ethics-by-design-and-ethics-of-use-approaches-for-artificial-intelligence_he_en.pdf ethics by design]’. Well, ethics by design doesn't mean that your device will be ethical by design, of course not, but it means that as you're designing a headset or techniques and applications, you're thinking about possible ethical issues that may arise during use, later on when your device or technique will be deployed in the real world, and you're trying to put some checks and balances by design at an early stage.So, depending on the sector where your technique or device will be used, depending on the kind of software, is there machine learning or not? Is it subliminal or not? Depending on the type of the headset or the hardware, does it use a brain computer interface or not? Is it just a screen or maybe much more than just a screen? So, depending on all these things, there should be questions asked by the designers at early stages, and at least some, I would say, solutions or maybe some first ideas of solutions that are developed in the code, in the design of the hardware at an early stage, so that when ethical questions arise later, there will be more traceability, more checks, more metrics more evaluation in order for us to be able later to deal with these kinds of questions, both at the individual level and at the societal level.ndividual level and at the societal level.)
Extended Reality: Ethics Issues + ([[File:Ext.Image19.png|center|frameless|60 … [[File:Ext.Image19.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. What types of personal data can XR platforms and applications potentially collect from users?plications potentially collect from users?)
Extended Reality: Ethics Issues + ([[File:Ext.Image2.png|center|frameless|600 … [[File:Ext.Image2.png|center|frameless|600x600px]]The primary issues related to Extended Reality data processing concern privacy and confidentiality, data security and breaches, the volume of data extracted, and the lack of clarity around the sharing of information.'''Feedback'''XR platforms and applications can collect many different types of personal data from users. This includes biometric information (such as facial expressions or eye movements), location data and device identifiers, as well as potentially sensitive content from personal conversations, or confidential information that is shared within virtual environments.As the technology develops, so new types of data are being processed. For instance, eye tracking technology has the potential to gather highly sensitive data about individuals, including their gaze patterns, attentional focus, and emotional responses. This can be used to reveal personal preferences (including sensitive areas like sexual preferences), and certain health conditions, like autism and attention-deficit/hyperactivity disorder (ADHD).ion-deficit/hyperactivity disorder (ADHD).)
Extended Reality: Ethics Issues + ([[File:Ext.Image20.png|center|frameless|60 … [[File:Ext.Image20.png|center|frameless|600x600px]]'''Ethics guidance and regulations'''A not-for-profit organisation, The '''Metaverse Standards Forum''' brings together most of the industrial players involved in the metaverse, with the aim of creating the conditions for its worldwide interoperability:https://metaverse-standards.org/'''AI Act: the EU AI Act of April 2021''' included in its annex the following statement:Annex III, article 1: “Biometric identification and categorization of natural persons: (a) AI systems intended to be used for the ‘real-time’ and ‘post’ remote biometric identification of natural persons;” This statement applies in part to XR, to the collection of biometric data during the user's real-time 3D experience. The January 2024 version of the same AI Act further emphasises risks related to biometric categorisation and emotion recognition, and is also relevant for XR. https://artificialintelligenceact.eu/'''Council of the European Union,''' Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union legislative acts, paragraph 16, 2022: “AI systems deploy subliminal components such as audio, image, video stimuli that persons cannot perceive as those stimuli are beyond human perception or other subliminal techniques that subvert or impair person’s autonomy, decision-making or free choices in ways that people are not consciously aware of, or even if aware not able to control or resist, for example in cases of machine-brain interfaces or virtual reality.”Basdevant, A, François, C, Ronfard, R. (2022) Mission exploratoire sur les métavers. Rapport interministériel. France. Available at:[https://www.economie.gouv.fr/files/files/2022/Rapport-interministeriel-metavers.pdf https://www.economie.gouv.fr/files/files/2022/Rapport-interministeriel-] [https://www.economie.gouv.fr/files/files/2022/Rapport-interministeriel-metavers.pdf metavers.pdf]IEEE SA - The IEEE Global Initiative on Ethics of Extended Reality: https://standards.ieee.org/industry-connections/ethics-extended-reality/INRIA’s Website: https://www.inria.fr/en/how-does-virtual-reality-worksTechethos website (page on Digital XR): https://www.techethos.eu/digital-extended-reality/The Open AR Cloud Code of Conduct: https://www.openarcloud.org/documents/code-of-conductXR Safety Initiative (XRSI) ethical guidelines for developers, users, and organizations: https://xrsi.org/xrsi-code-of-conductZhu, L (2022) The Metaverse: Concepts and Issues for Congress. Congressional Research Service. Available at: https://sgp.fas.org/crs/misc/R47224.pdf.'''Videos'''Kent Bye’s XR Ethics Manifesto: https://www.youtube.com/watch?v=CXgY3YXxqJ8Masterclass on XR in the classroom (Central Queensland University, Australia): [https://www.studyaustralia.gov.au/english/masterclasses/extended-reality-xr-in-the-classroom https://www.studyaustralia.gov.au/english/masterclasses/extended-] [https://www.studyaustralia.gov.au/english/masterclasses/extended-reality-xr-in-the-classroom reality-xr-in-the-classroom]'''Bibliography'''Adomaitis, L., Grinbaum, A., Lenzi, D. (2022) Identification and Specification of Potential Ethical Issues and Impacts and Analysis of Ethical Issues. https://doi.org/10.5281/zenodo.7619852.Aucouturier E, Grinbaum A (2023) Recommendations to address ethical challenges from research in new technologies. CEA - Commissariat à l’énergie atomique et aux énergies alternatives. Available at: https://cea.hal.science/cea-04293426Behr, K. M., Nosper, A., Klimmt, C., & Hartmann, T. (2005). Some practical considerations of ethical issues in VR research. Presence, 14(6), 668-676.Fox, D., & Thornton, I. G. (2022). White Paper-The IEEE Global Initiative on Ethics of Extended Reality (XR) Report--Extended Reality (XR) Ethics and Diversity, Inclusion, and Accessibility. The IEEE Global Initiative on Ethics of Extended Reality (XR) Report--Extended Reality (XR) Ethics and Diversity, Inclusion, and Accessibility, 1-25.Grinbaum, A., & Adomaitis, L. (2022). Moral equivalence in the metaverse. NanoEthics, 16(3), 257-270.Kröger, J. L., Lutz, O. H. M., & Müller, F. (2020). What does your gaze reveal about you? On the privacy implications of eye tracking. In IFIP International Summer School on Privacy and Identity Management (pp. 226-241). Springer, Cham.acy and Identity Management (pp. 226-241). Springer, Cham.)
Extended Reality: Ethics Issues + ([[File:Ext.Image3.png|center|frameless|600 … [[File:Ext.Image3.png|center|frameless|600x600px]]Aside from the processing of personal data, other privacy matters concern the use of specific applications such as telemedicine: (particularly regarding the confidentiality of medical information) the potential use of brain data, data collection for industry purposes, and issues around governmental surveillance. Users need to be informed about the types of data collected, the purposes for which it will be used, and any third parties with whom it may be shared.Informed consent from users may be needed, to ensure that they understand and agree to the terms of data collection and usage within XR environments. Additionally, users should have control over their privacy settings and preferences, allowing them to adjust the settings, manage data sharing permissions, and delete or anonymize their data as wanted.But user consent and control may not always be possible. For instance, AR applications in public spaces raise concerns about reasonable expectations of privacy as they process and aggregate data about a user's broad surroundings in real time. This information gathering may require special consideration for bystander privacy, especially when government and law enforcement agencies use the technology.Regardless of the setting, XR developers and platform operators must comply with relevant privacy laws and regulations, such as the General Data Protection Regulation (GDPR) in the European Union, or the California Consumer Privacy Act (CCPA) in the United States. This includes providing users with rights to access, rectify, and delete their personal data, as well as implementing mechanisms for data portability and transparency.sms for data portability and transparency.)
Extended Reality: Ethics Issues + ([[File:Ext.Image4..png|center|frameless|60 … [[File:Ext.Image4..png|center|frameless|600x600px]]While the use of XR offers many potential benefits (for example, in training, design, or surgical planning), it also presents potential risks to health and wellbeing.[[File:Ext.Image5.png|center|frameless|500x500px]]Furthermore, given that the technology is relatively new, the long-term impacts upon physical health and wellbeing are not yet well understood or evidenced. are not yet well understood or evidenced.)
Extended Reality: Ethics Issues + ([[File:Ext.Image6.png|center|frameless|600 … [[File:Ext.Image6.png|center|frameless|600x600px]]The use of XR also poses risks to mental health and wellbeing, inducing new problems and/or exacerbating existing concerns. Psychological impacts, including addiction and the need for a resting period after extended XR use, underscore the mental health dimensions associated with immersive technologies. However, it must be stressed that many of the alleged risks to mental health and wellbeing are currently tentative. Being a fairly new field of application and research, the evidence for harms and benefits is relatively scant. Consequently, it is difficult to predict who precisely is at risk of harm, in what circumstances, and how this is best addressed. Nevertheless, adherence to the precautionary principle would entail that proactive measures to prevent harm are taken, even in the absence of conclusive scientific evidence. Click on the images to read more about some of the primary concerns for mental health and wellbeing that have been identified to date.From a psychological perspective, there is ongoing debate about the welfare of children using immersive technologies. Children are identified as a highly vulnerable group and, as this module shows, there are many potential harms. Additionally, the long-term impacts upon psychological and emotional development are unknown. They necessitate careful examination to ensure the healthy growth and development of young XR users. growth and development of young XR users.)
Extended Reality: Ethics Issues + ([[File:Ext.Image7.png|center|frameless|600 … [[File:Ext.Image7.png|center|frameless|600x600px]]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.nce, which doesn't have a simple solution.)