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
9
Varieties of goodness in research - a rotary style exercise (variation to original VIRT2UE exercise)) +
This round is especially important when there are more subgroups than rounds, because in that case not all participants have reflected on the different Varieties of Goodness that are discussed. The task of the subgroup is to summarize what is on the sheet and to select the main take home messages of the sheet. The trainer might also ask the groups to select what they found striking or surprising. +
Ask participants to reflect on the value of dialogue and how to use it for fostering group reflection. Focus on the overall lessons learned related to the objectives of the exercise. You might ask questions like:
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*Taking in account the objectives, what did you learn from this exercise? More specifically: i) Did you become more aware of the strengths of dialogue and debate? ii) Do you think the exercise was useful to learn how to use and to encourage dialogue as a tool for reflection processes? iii) Did you learn anything else?
*How will the lessons learned influence your future actions?
*What do you need to foster a dialogue?
The order of the exercise might give the participants the impression that debate is ‘wrong’ and dialogue is ‘right’. Try to emphasize in this last step that dialogue is useful and helpful in reflection processes but that a debate can be good and useful in other situations with other purposes. +
You will be asked to reflect on the process, and to evaluate if the learning objectives were met. You will be invited to have a brief dialogue on what you might have just learned as a group. You may be asked to seek answers to questions such as the following:
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*Was it easy or difficult to identify the relevant principles and virtues in the chosen dilemma?
*Did this exercise help you with identifying and connecting to formally defined principles, such as those in the European Code of Conduct for Research Integrity?
*Did most of the players agree or disagree with the final choice?
*What were the main points of contention?
*How come people disagreed (e.g. differences in experience, training, background, values, norms…)?
*Was any alternative option proposed?
*Did anybody change her/his mind as a result of the discussion?
*What is needed in order to do the moral good in your work setting? What were the most convincing arguments used in the discussion?
*On which areas do you feel there is insufficient consensus?
*How to best address such future dilemmas in your daily work? +
The link to the instruction "Reflecting on experiences and practicing exercises" can be found [https://public.3.basecamp.com/p/am3nj24vLEAHNWQ9Tyg3hp3K here]. +
Epidemiology is the branch of medicine which deals with the incidence, distribution, and control of diseases and other factors relating to health. The word ‘epidemiology’ is derived from Greek and literally means ‘the study of what is upon the people’. Epidemiology is widely applied to cover the description and causation of epidemic and infectious diseases such as COVID-19, but also of diseases in general including their related conditions. Thus, epidemiologists are interested in examining other areas of healthcare such as high blood pressure, mental illness, diabetes and obesity. +
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 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. +
[[File:Glass and iron lattice 2.png|center|frameless|600x600px]]
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. +
[[File:AI Img8.png|center|frameless|600x600px]]
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? +
<div><div>
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> +
[[File:AI Image8.png|center|frameless|600x600px]]
<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. +
