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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Divide participants into groups of 3 to 5 and ask them to discuss their inputs in their self-declaration sheets and to relate their inputs to virtues and research integrity .
Provide trainees with the following lists of questions which they can use to stimulate reflection:
1. Share with the group your inputs in the self-declaration sheets on the types of goodness. Explain why you think your example exemplifies a certain type of goodness. Allow your group mates to ask questions.
2. For each typology of goodness, discuss with your group what can happen if a type of goodness is not present.
3. Are there varieties of goodness that are less relevant for research integrity?
4. Are virtues necessary to achieve each typology of goodness?
Give the trainees 20 to 30 minutes to discuss and to decide among themselves who should be the rapporteur. +
After watching one of the Main Course options (Steps 1-4 above), you should now complete the reflection task below. Please keep in mind the questions that you were asked while watching your scenario. +
In this step you invite participants to put themselves in the case presenter’s shoes and think about which facts in the case need more clarification to gain a better understanding of the situation. All the relevant questions, which enable participants to put themselves in the shoes of the case presenter, should be asked at this point. +
[[Guide:Bbe860a3-56a9-45f7-b787-031689729e52|The VIRT2UE Train the Trainer program]] is designed for researchers and educators across various disciplines who wish to become Research Integrity trainers. It adopts a virtue-based approach, encouraging participants to reflect on their own perspectives and understanding of research integrity. The program emphasises personal case reflection and practical experiences, aiming to create a strong link between theoretical knowledge and real-world application. +
[[Guide:Bbe860a3-56a9-45f7-b787-031689729e52|The VIRT2UE Train the Trainer program]] is designed for researchers and educators across various disciplines who wish to become Research Integrity trainers. It adopts a virtue-based approach, encouraging participants to reflect on their own perspectives and understanding of research integrity. The program emphasises personal case reflection and practical experiences, aiming to create a strong link between theoretical knowledge and real-world application. +
Introduce a case (please select one among the ones presented in the IRECs module on the topic of the session). Ask participants to identify the main ethical issues in the case (the aim to increase awareness of the issues related with the topic introduced in the session). You can use the following question to encourage conversation among participants:
- What are the main ethical issues in this case?
'''<u><span lang="EN-US">Trainer Tip</span></u>''' <span lang="EN-US">Allow for a brief open discussion but keep it focused to ensure you stay within the allocated time.</span> +
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Start a dialogue about trainees' personal experiences with biobanking as citizens, allowing them to reflect on ethical issues from a citizen's perspective.
Divide the group in subgroups and invite them to reflect for 10-15 minutes on the following questions (projected on a slide):
*What is your own experience with biobanking as a citizen?
*Have you ever donated blood cells or anything else?
*Do you know what they do with your samples and personal information?
*What would be important to you in terms of privacy, storage and use of data and material – if it was your saliva, urine or blood sample?
Summarize with a plenary wrap-up, inviting trainees to share the key points of their discussions. Building on the previous exercise, continue adding ethical issues to the digital board, including any new ones brought up during the wrap-up. You can ask the trainees: "''What can you conclude based on the last issues we added to the mind map?''"
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Once you have published your Initiative page, it's time to link your content across the Embassy to your project!
When adding or editing [[Special:BrowseData/Instruction|Modules]], [[Special:BrowseData/Guide|Courses]], and [[Resources]] to the Embassy, you will have the option to select a "Related Initiative" (see below)
[[File:Related initiative.png|center|thumb|600x600px]]
Select your project from the drop down menu and then save your content. '''Now your content should be listed on your Initiative page, easily accessible for users!'''
To see an example of what this should look like, check out the page for the [[Initiative:76ef100a-e459-4942-bd1f-701f747e8906|ROSiE project]]. +
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We receive information through one or more of the senses: sight, hearing, smell, touch, and taste, but do we perceive things as they really are? Take a close look at the images below:
{| class="wikitable"
|[[File:Swirl.png|center|frameless|300x300px|link=Special:FilePath/Swirl.pngcenterframeless300x300px]]
|[[File:Man leaning.png|center|frameless|300x300px|link=Special:FilePath/Man_leaning.pngcenterframeless300x300px]]
|-
|[[File:Bird in the hand.png|center|frameless|link=Special:FilePath/Bird_in_the_hand.pngcenterframeless]]
|[[File:Rabbit duck.png|center|frameless|link=Special:FilePath/Rabbit_duck.pngcenterframeless]]
|}
How we interpret the information from our senses to have meaning is termed ‘perception’. Two people might be exposed to the same sensory experience, but the way in which they interpret the information can differ. Perception of the same senses can vary from one person to another because each person interprets stimuli differently based on their learning, memory, emotions, and expectations. For instance, if we ask five people to describe a painting, it is likely that the five descriptions will be different, even though the people are all looking at the same painting. +
The third type of resource that you can add to the Embassy are Educational Materials. Educational materials are resources that are designed to support learning and training in research ethics and integrity. They can include tools, videos, short courses and modules hosted on other platforms. These materials should be aimed at helping researchers, trainers and institutions to understand promote ethical practices and the principles of responsible research conduct.
'''Have you developed educational materials which are hosted on a different website and are open for anyone to use?''' You can describe it and link to it directly on the Embassy!
To add an educational material, you need:
*A Title
*Some text in the "What is this about?" box
*Some selections in the "For whom is this important?" box
*A URL to the material in the "Link" box
For inspiration, check out our existing educational materials [https://embassy.science/wiki/Special:BrowseData/Resource?_search_Resource_Type%5B0%5D=Education here]. +
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Professor Smith asks Dr Jones if he knows anything about ethics dumping and helicopter research. Dr Jones contacts an old colleague, Dr Langa, to ask for his advice.
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'''Final Thoughts'''
By aligning the malaria research proposal with the TRUST Code, the project can transition from a potentially extractive model to an inclusive and equitable approach. This will not only safeguard the rights and welfare of the local communities but will strengthen the overall impact and sustainability of the research. Following the TRUST Code will also foster genuine partnerships between African and international researchers, helping to build a foundation for ethical, impactful research that truly addresses the health challenges of local populations.
</div></div> +
<span lang="EN-US">The Reproducibility Promotion Plan for Funders (RPP) has developed a policy template with recommendations for funders to foster reproducible practices both in the research they fund across three key areas of funding work: evaluation and monitoring, policy and definitions, and incentives. The RPP provides actionable recommendations and best practice examples that funders and funding institutions can adapt to meet their specific needs.</span>
All drafts of the RPP can be found on [https://osf.io/3fpbj/ OSF].
[[File:RPP4F One Pager.jpg|center|thumb]] +
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‘Leaving no one behind’ is a principle often invoked in the context of social justice. It emphasises the importance of ensuring that progress and development benefits all individuals and groups within society, particularly those who may be marginalised or vulnerable. The concept recognises that systemic inequalities and discrimination can prevent certain groups from fully participating in and benefiting from development initiatives.
Marginalization in research refers to the systematic exclusion, underrepresentation, or neglect of certain individuals or groups within the research process. Marginalized groups can include those who are disadvantaged or oppressed based on factors such as race, ethnicity, gender, sexual orientation, socioeconomic status, disability, or other identity markers. Marginalization can occur at various stages of the research process, including study design, data collection, analysis, interpretation, and dissemination. +
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Sometimes, the people who own or provide access to the resources are left with no benefits at all. For a long time, this was the case for the San Indigenous peoples of South Africa. You can hear from members of the San talk about protecting their Indigenous knowledge in this video. Listen to Jan Van Der Westhuizen talk about protecting San Indigenous knowledge. +
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How and at what points can bias be introduced into AI systems in healthcare? Click on the image below to find out more.
It is important for researchers and reviewers of research to be aware of the data-related ethics issues, that may arise in projects using AI technologies in the healthcare domain.
Vigilance about these matters is essential at the initial design stages and throughout projects. +
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Artificial Intelligence (AI) is revolutionising the healthcare domain, introducing transformative applications that can enhance diagnosis, treatment, and patient care. The synergy between advanced algorithms, machine learning, and healthcare data has paved the way for innovative solutions with the potential to improve outcomes, increase efficiency, and streamline processes.
Key applications of AI in the healthcare sector include:
'''Diagnostic imagery:''' AI excels in interpreting medical imaging data, such as X-rays, MRIs, and CT scans. Deep learning algorithms can detect patterns and abnormalities, aiding radiologists in accurate and swift diagnoses. This not only speeds up the diagnostic process but also enhances precision when identifying subtle anomalies.
'''Disease prediction & prevention:''' Predictive analytics powered by AI enables healthcare providers to forecast disease risks and identify individuals who may be predisposed to certain conditions. By analysing patient data and lifestyle factors, AI models can assist in implementing preventive measures and personalised interventions to mitigate potential health risks.
'''Drug discovery & development:''' AI can accelerate the drug discovery process by analysing vast datasets to identify potential drug candidates and predict their efficacy. Machine learning algorithms can analyse molecular structures, predict drug interactions, and optimise formulations, significantly reducing the time and cost associated with bringing new drugs to market.
'''Personalised medicine:''' AI enables the development of personalised treatment plans by analysing patient-specific data, including genetic information, medical history, and lifestyle factors. This approach allows healthcare providers to tailor interventions and medications to individual patient needs, improving treatment effectiveness and minimising adverse effects.
'''Chatbots:''' Chatbots and virtual health assistants powered by AI are used to enhance patient engagement and provide on-demand healthcare information. These tools can offer guidance on symptoms, medication reminders, and lifestyle recommendations. Proponents of virtual health assistants claim that they can improve patient adherence to treatment plans and foster better communication between patients and healthcare providers. However, this is disputed by those who are concerned about what may be lost through a decrease in human-to-human interactions.
'''Natural language processing and health records: T'''he use of NLP algorithms to extract valuable insights from unstructured clinical notes and electronic health records facilitates efficient data management, enables faster information retrieval, and supports clinical decision-making. NLP also plays a crucial role in automating administrative tasks, allowing healthcare professionals to focus more on patient care.
'''Robotic surgery assistance:''' AI-powered robotic systems assist surgeons in performing complex procedures with precision and minimal invasiveness. These robotic platforms enhance surgical outcomes, reduce recovery times, and contribute to advancements in minimally invasive surgery techniques.
'''Remote patient monitoring:''' AI can be used to facilitate the continuous monitoring of patients' health remotely through wearable devices and sensors. Real-time data analysis allows healthcare providers to track vital signs, detect abnormalities, and intervene promptly, especially for patients with chronic conditions.
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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.
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In the following exercise we ask you to consider the points in each section of the document The use of XR technologies in research: A checklist for research ethics committees in terms of your role as a research ethics committee member. The exercise will take you through one section of the checklist at a time. For each section, we ask you to select the relevant items from a list of the roles of a research ethics committee. For example, when considering the section on data processing, if you think this is relevant to three of the itemised roles, you should select all three from the list.
'''Role of XR technologies in the project'''
# Does the project use an XR device (e.g., a headset) /XR technique, develop an XR device/technique, or both?
# If an XR device/technique is developed in the project, up to which technology readiness level will it be developed (research / industrial prototype / scalable commercial product)? Are compliance checks and certification included?
# If a third-party XR device is used in the project, is it already commercially available or a research prototype? Is it certified? Is a user manual included and made available to all participants?
'''Use of Artificial Intelligence (AI) in the Project'''
# Will an AI system be used or developed in the project together with the XR device? If so, is it compliant with the AI Act?
# Is the AI system operated under human supervision? Is this supervision occasional or continuous? What control powers does the supervisor have?
# Is it clear to participants which avatars or interactions in XR are controlled by humans, and which are controlled by AI, to avoid confusion and/or potential manipulation?
# Does the AI system use unsupervised or self-supervised learning, particularly on brain data? Are measures to enhance explicability included?
# Does the project include AI ethics experts or an ethics committee to oversee the development of the AI system?
# Does the project provide a procedure for assigning responsibility in case of damages caused by the AI system?
'''Data processing'''
# What are the procedures for data collection and storage? Is financial (or other) compensation offered in exchange for the collected data?
# If sensitive data (including biometric data, face photographs, video or audio recordings of people) is collected, is it clear how it will be used, stored, and used? Is data collection proportional to the purpose?
# If brain data is collected, is it clear how it will be used, stored, and used? Is data collection proportional to the purpose?
# Does the project include a clear and comprehensive informed consent procedure for data collection? Do participants have the option to withdraw or delete their data?
# Will the dataset(s) be open?
# Is the data minimization principle respected to ensure that only necessary data is processed?
# Will any third parties (e.g., XR technology providers, cloud storage companies) have access to participants’ data?
<span lang="EN-US">Introduce a case. The case must be related to the concepts selected and presented during the interactive lecture. Therefore, if only one of the topics was covered, the case should be related to that topic.</span><div>
<span lang="EN-US">Below, some case examples are presented. Note that justice issues appear in both cases:</span>
*'''<span lang="EN-US">Case related to topic A&B</span>'''<span lang="EN-US">: ''The ISSCR suggests that studies proposing to grow human embryos beyond two weeks should be considered on a case-by-case basis. Imagine that you are a member of a committee that has been asked to approve a study that involves gene editing of embryos that will be grown for 28 days. How would you go about this, and what sort of things might you include in your deliberations? Would you approve this study?'' (case extracted from: [https://classroom.eneri.eu/node/312 <u>Reflection Activity</u>])</span>
*'''<span lang="EN-US">Case related to topic C&B</span>'''<span lang="EN-US">: ''Imagine you are on an ethics committee reviewing a research proposal to produce genetically modified mosquitoes to combat malaria. This would releasing gene-edited organisms into a natural ecosystem in Sub-Saharan countries mostly. As an ethics expert, what criteria would you use to assess this proposal? How would you balance the potential health benefits with ethical concerns around environmental impact, dual-use, etc.?'' (case extracted from: [https://classroom.eneri.eu/node/387 <u>A case of non-human gene editing</u>])</span>
</div><div>
'''Instructions for trainer:'''<div>
*<u><span lang="EN-US">Present the case (10 minutes).</span></u> <span lang="EN-US">In case you need more information, you can retrieve it from the ENERI modules. Take into account the amount of time you have for this exercise. It is advised to project slide with the case, so participants can look at it during the group discussion.</span>
*<span lang="EN-US">Divide participants into subgroups (4-5 members). You can provide each group with a white board/digital board.</span>
*<span lang="EN-US">Provide participants with the following instructions for the subgroup discussion:</span>
'''a.''' <u>Read the case carefully and reflect on it individually (10 minutes)</u>. Ask yourself: What is important to you, and what would you do if you were part of the REC member evaluating this research proposal? What aspects would you focus on in the ethical evaluation of that research proposal?
<span lang="EN-US">'''b.''' <u>In dialogue with your group mates (10 minutes)</u> try to identify: research gains, potential risks, connection of the case to the concepts that were discussed in the interactive lecture, other key ethical tensions.</span>
<span lang="EN-US">'''c.''' <u>Share individual views and try to reach a consensus among the group members (if possible) (10 minutes)</u>: would you approve the research proposal, why? What would be needed for approving it? Under which circumstances would you approve it (if any)?</span>
</div></div>
<span lang="EN-US">Introduce a case. The case must be related to the concepts selected and presented during the interactive lecture. Therefore, if only one of the topics was covered, the case should be related to that topic.</span><div>
<span lang="EN-US">Below, some case examples are presented. Note that justice issues appear in both cases:</span>
*'''<span lang="EN-US">Case related to topic A&B</span>'''<span lang="EN-US">: ''The ISSCR suggests that studies proposing to grow human embryos beyond two weeks should be considered on a case-by-case basis. Imagine that you are a member of a committee that has been asked to approve a study that involves gene editing of embryos that will be grown for 28 days. How would you go about this, and what sort of things might you include in your deliberations? Would you approve this study?'' (case extracted from: [https://classroom.eneri.eu/node/312 <u>Reflection Activity</u>])</span>
*'''<span lang="EN-US">Case related to topic C&B</span>'''<span lang="EN-US">: ''Imagine you are on an ethics committee reviewing a research proposal to produce genetically modified mosquitoes to combat malaria. This would releasing gene-edited organisms into a natural ecosystem in Sub-Saharan countries mostly. As an ethics expert, what criteria would you use to assess this proposal? How would you balance the potential health benefits with ethical concerns around environmental impact, dual-use, etc.?'' (case extracted from: [https://classroom.eneri.eu/node/387 <u>A case of non-human gene editing</u>])</span> </div><div>'''Instructions for trainer:'''<div>
*<u><span lang="EN-US">Present the case (10 minutes).</span></u> <span lang="EN-US">In case you need more information, you can retrieve it from the ENERI modules. Take into account the amount of time you have for this exercise. It is advised to project slide with the case, so participants can look at it during the group discussion.</span>
*<span lang="EN-US">Divide participants into subgroups (4-5 members). You can provide each group with a white board/digital board.</span>
*<span lang="EN-US">Provide participants with the following instructions for the subgroup discussion:</span>
'''a.''' <u>Read the case carefully and reflect on it individually (10 minutes)</u>. Ask yourself: What is important to you, and what would you do if you were part of the REC member evaluating this research proposal? What aspects would you focus on in the ethical evaluation of that research proposal?
<span lang="EN-US">'''b.''' <u>In dialogue with your group mates (10 minutes)</u> try to identify: research gains, potential risks, connection of the case to the concepts that were discussed in the interactive lecture, other key ethical tensions.</span>
<span lang="EN-US">'''c.''' <u>Share individual views and try to reach a consensus among the group members (if possible) (10 minutes)</u>: would you approve the research proposal, why? What would be needed for approving it? Under which circumstances would you approve it (if any)?</span>
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