Text (Instruction Step Text)
From The Embassy of Good Science
Describe the actions the user should take to experience the material (including preparation and follow up if any). Write in an active way.
- ⧼SA Foundation Data Type⧽: Text
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Katılımcılardan diyaloğun değeri ve grup halinde gerçekleştirilecek fikir yürütme/yorumlama süreçlerini teşvik etmede nasıl kullanılabileceği üzerine düşünmelerini isteyin. Araştırmanın hedefleri ile ilgili olarak çıkarılan genel dersler üzerine odaklanın. Bunun için aşağıda örnek olarak verilmiş olan soruları sorabilirsiniz:
* Alıştırmanın hedeflerini göz önünde bulundurarak: bu alıştırmadan neler öğrendiniz? Daha spesifik olarak:
i. Diyalog ve münazara kavramlarının güçlü yanlarına ilişkin farkındalığınız arttı mı?
ii. Diyalog yönteminin fikir yürütme süreçlerinde bir araç olarak nasıl kullanılacağını ve bu şekilde kullanılmasının nasıl teşvik edileceğini öğrenmeniz açısından bu alıştırmanın faydalı olduğunu düşünüyor musunuz?
iii. Alıştırmadan çıkardığınız başka dersler var mı?
* Bu alıştırmadan çıkardığınız dersler gelecekteki eylemlerinizi nasıl etkileyecek?
* Diyaloğu teşvik etmek için nelere ihtiyaç duyarsınız? +
Katılımcılardan gruplar içerisinde tartışılanlara ilişkin kısa bir özet sunmalarını isteyin. Toplu bir oturum yapılması katılımcıların birbirlerine sorular sormasına, yapılan seçimlerin ardında yatan sebeplerin anlaşılmasına ve daha genel temaların belirlenmesine yardımcı olacaktır. Bu aşamada katılımcılardan diğerlerini aktif bir biçimde dinlemelerini ve görüşlerini açıkça dile getirmelerini isteyin. +
Bitte die Teilnehmer:innen, über den Nutzen eines Dialogs zu reflektieren und darüber nachzudenken, wie man einen Dialog nutzen kann, um Gruppenreflexionsprozesse anzustoßen. Konzentriere dich dabei auf allgemeine Erkenntnisse in Zusammenhang mit den Zielen der Übung. Mögliche Fragen sind:
* In Anbetracht der Lernziele der Übung – was hat du gelernt? Genauer:
o Inwiefern wurden die die Stärken eines Dialogs und einer Debatte bewusst?
o Denkst du, die Übung hilft dabei, zu lernen, auf welche Weise man einen Dialog als Werkzeug zum Anstoßen eines Reflexionsprozesses nutzen kann?
o Was hast du darüber hinaus gelernt?
Cave: die Reihenfolge der Übung könnte bei den Teilnehmer:innen den Eindruck hinterlassen, eine Debatte sei „falsch“ und ein Dialog „richtig“. Nutze den letzten Schritt der Übung, um zu betonen, dass ein Dialog sinnvoll und nützlich für Reflexionsprozesse ist, aber eine Debatte in anderen Situationen mit anderen Zielsetzungen angebracht und sinnvoll ist. +
Bitte die Teilnehmenden, sich die Tabelle mit der Übersicht über Perspektiven, Werte / Tugenden und Normen anzusehen. Stelle zum Beispiel die folgenden Fragen, um einen Reflexionsprozess in Gang zu bringen:
* Was fällt euch auf?
* Welche Gemeinsamkeiten gibt es zwischen den verschiedenen Perspektiven? Welche Unterschiede gibt es zwischen den verschiedenen Perspektiven? Stehen sie im Widerspruch zueinander?
* Werden die genannten Werte / Tugenden auch im Europäischen Verhaltenskodex für Integrität in der Forschung erwähnt? Falls ja, welche?
* Ist es möglich, einen Wert / eine Tugend auszuwählen, die in dieser Situation am wichtigsten sein sollte? Falls ja, warum ist dieser Wert / diese Tugend am wichtigsten?
* Versetze dich in die Lage der Person, die den Fall präsentiert hat: Was bräuchtest du (konkret), um den von der Gruppe ausgewählten Wert / Tugend in konkretes Verhalten umzusetzen? Gibt es irgendwelche limitierenden Rahmenbedingungen oder Einschränkungen?
Notiere die Antworten der Teilnehmenden am Flipchart. Dafür kannst du Stichpunkte aufschreiben, unterschiedliche Farben zur Hervorhebung benutzen, oder vorhandene Wörter unterstreichen.
Vor allem wenn du die Übung zum ersten Mal durchführst, kann es hilfreich sein, alle oben genannten Fragen anzuwenden, um eine dialogische Reflexion zu ermöglichen. Vergiss nicht, den Europäischen Verhaltenskodex für Integrität in der Forschung zu erwähnen. Du könntest sogar ein ausgedrucktes Exemplar des Kodex mitbringen, wenn du möchtest. Bei den Fragen solltest du dir nicht zu viel Zeit bei den einzelnen Fragen lassen. Wenn die Teilnehmenden anfangen abzuschweifen oder sich in einer Diskussion verlieren, solltest du sie auf die eigentliche Frage zurück lenken.
Falls sich die Teilnehmenden nicht auf einen Wert / eine Tugend einigen können, ist das kein Problem. Trage dann einfach verschiedene Schlussfolgerungen in die Tabelle auf dem Flipchart ein.
Tipp: Hab keine Angst vor einer schweigenden Gruppe. Lass die Leute über ihre Antwort nachdenken. Gib ihnen Zeit, über deine Fragen nachzudenken. Gib ihnen aber nicht zu viel Zeit. Wenn es keine Beiträge aus der Gruppe mehr gibt, fahre mit der Übung fort.
Invite participants to look at the overview and ask the following questions in order to foster reflection:
o What do you perceive as remarkable?
o Are there similarities/differences between different perspectives? Are they in conflict with each other?
o Are these virtues also mentioned or implied in the European Code for Research Integrity? If yes which ones?
o Are we able to select a virtue which is supposed to be the most important in this situation? If so, why is this virtue the most important?
o Putting yourselves in the case presenter’s shoes: what do you need (concretely) to act upon the virtue which the group selected? Are there any constraints?
Report people’s answers on the board. You can use different colours, underline words, and take short notes.
If you are using this exercise for the first time please use the above questions to facilitate a dialogical reflection. Don’t forget to mention the European Code of Conduct for Research Integrity. You could even consider bringing a copy of the code with you. Do not take too long for each question. If people start debating, or if they go off topic, guide them back towards the question at stake.
If people cannot agree on one virtue that is also fine. Report the different conclusions on the table.
TIP:
Don't be afraid of silence. Let people think about the answer. Give them time but not too much, if there are no inputs move on. +
Return to the icebreaker activity or learning goals (mind mapping or Mentimeter results) and ask participants if their expectations were met.
Share a QR code linking to the evaluation form and online modules for continued learning.
Thank participants for their contributions and encourage them to apply their insights in their work and spread the word about the irecs modules. +
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Since Kuhn, use of the word ‘paradigm’ has been broadened and nowadays people apply it in many different settings, but these are the key lessons. +
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Well actually, vulnerability emerges when you have life challenges, and you have limited resources. And vulnerability can be intrinsic to the person, or it can be something that emerges at some point of your life. So, if you think about for instance, persons with visibility impairments, so they are not able at some point to understand exactly what the research is about or to have a full understanding of the informed consent. So, this is a group of vulnerable people. +
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It is important for students, researchers and research ethics reviewers involved with research using and/or developing AI technologies in the healthcare domain to be aware of relevant guidelines and regulations that apply to their projects.
The [https://www.who.int/publications/i/item/9789240029200 WHO’s Ethics and governance of artificial intelligence for health] calls for the embedding of ethics and human rights at the heart of AI design, deployment.
Click on the hotspots below to see WHO’s key ethical principles for research involving AI in healthcare.
The guidelines state that ‘each component in itself is necessary but not sufficient for the achievement of Trustworthy AI. Ideally, all three components work in harmony and overlap in their operation. If, in practice, tensions arise between these components, society should endeavour to align them’. +
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Requirements for ethics approval differ between institutions and some may insist upon completion of an ethics form for every study, even if just to make it clear that formal ethics approval is not needed. But other institutions may not even have a REC. What do you think researchers should do when they do not have ready access to a REC? +
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Take a moment to reflect on how you feel about the use of gene editing for some non-therapeutic human enhancements.
'''Feedback'''
</div>The use of gene editing for non-therapeutic human enhancements is a complex matter which many people feel conflicted about. On one hand, the potential to improve human capabilities is exciting and could lead to incredible advancements. On the other hand, there are concerns about the ethical implications and the possibility of creating a society with even greater inequality and unforeseen health risks.<div></div></div> +
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<div><div>
As healthcare organizations strive to harness the benefits of AI while safeguarding patient data, a delicate balance must be maintained.
Stringent security protocols, transparent data governance, and ethical AI development practices are crucial for upholding the confidentiality and integrity of healthcare data in the era of AI-driven advancements.
Policymakers, healthcare providers, and technology developers must work collaboratively to establish robust frameworks, regulations, and ethical guidelines to ensure the responsible and secure use of health data in AI applications.
</div></div><div></div> +
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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 data
Both 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 data
In 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 bias
Governance 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 partnership
The 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.
Conclusion
Governance 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.
Return to the icebreaker activity or learning goals (mind mapping or Mentimeter results) and ask participants if their expectations were met.
Share a QR code linking to the evaluation form and online modules for continued learning.
Thank participants for their contributions and encourage them to apply their insights in their work and spread the word about the irecs modules. +
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Humanities’ challenges require global research, yet global research can have a dark side. Ethics dumping. When researchers from privileged settings offshore unethical research to lower income settings, that's ethics dumping. It can happen on purpose, but also due to lack of awareness and cultural misunderstandings. +
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People can be involved in research in many different ways. For instance, they might be asked to take part in a survey, be interviewed, be observed, or participate in a clinical study. They might also be involved via use of their personal data or biological samples.
Here we touch upon three of the primary ethics requirements when research involves humans:
# The need for informed consent.
# The need to minimise harms.
# The need to respect privacy. +
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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]
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'''Data sharing across borders'''
International collaborations strive for diverse sample populations to avoid biases in research outcomes and to ensure that research findings are applicable and beneficial to global populations. However, the sharing of data across international borders increases the risk of privacy breaches and unauthorised access due to variations in data protection laws, hence robust security measures and compliance with diverse regulatory frameworks are crucial.
Informed consent for international data sharing can be complex due to differences in cultural norms, legal requirements, and language barriers. Respect for the cultural values and norms of different donor populations might require adaption of the protocols for collection and use of samples and data to align with each cultural context.
Additionally, determining who has control and sovereignty over the shared data can be contentious, and striking a balance between collaboration and respecting the rights of individual countries or institutions might pose an ongoing ethical challenge. Researchers and RECs will need to navigate the complexities of multiple jurisdictions to uphold consistent ethical standards. +
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Before Professor Smith and Dr Jones proceed any further with this proposal, they realise that they need seek out local partners in each of the three countries and find out:
Is this research wanted or needed by the communities in Mozambique, Uganda and Tanzania?
What research on the prediction of Malaria outbreaks has already been carried out in these communities?
What interventions are already in place?
How successful are the interventions?
Would the proposed research risk undermining local interventions to mitigate the risk of Malaria outbreaks?
Let’s suppose that they get a positive response from a university in one of the countries who would like to collaborate with them and suggest that it would be preferable to start with a pilot of the project.
Of course, as many of the issues cut across both ethics dumping and AI ethics issues, it will be necessary for the research teams to consult ethics guidelines and codes from both angles as they revise their proposal in collaboration with the local partner institution. +
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Releasing gene drive organisms into the environment could have transboundary impacts, and neighbouring countries or regions that are not part of the trial could be affected. This raises questions about who should regulate gene drives, how decisions should be made, and how to resolve conflicts between nations or regions with differing views on the technology.
Given the potential for irreversible ecological changes, there is a need for strong oversight mechanisms to ensure that gene drive experiments are conducted safely and ethically. If something goes wrong, it is important to establish clear lines of accountability. Who will be responsible if the gene drive causes harm—researchers, institutions, governments, or international bodies? +
