Text (Instruction Step Text)
From The Embassy of Good Science
Describe the actions the user should take to experience the material (including preparation and follow up if any). Write in an active way.
- ⧼SA Foundation Data Type⧽: Text
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The final video in this module is the winning video from the [https://www.globalewerteallianz.ch/en/ FGVA] sponsored rap, dance and music competition held for the TRUST project. "We are the San", from !Khwa ttu Kids is a representation of the values of fairness, respect, care and honesty through song, film and dance. Congratulations to the team at [https://www.khwattu.org/ !Khwa ttu].
If you want to learn more, please visit the bibliography and further reading page for some relevant resources. +
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Thank you for taking this irecs module!
Your feedback is very valuable to us and will help us to improve future training materials.
We would like to ask for your opinions:
1. To improve the irecs e-learning modules
2. For research purposes to evaluate the outcomes of the irecs project
To this end we have developed a short questionnaire, which will take from 5 to 10 minutes to answer.
Your anonymity is guaranteed; you won’t be asked to share identifying information or any sensitive information. Data will be handled and stored securely and will only be used for the purposes detailed above. You can find the questionnaire by clicking on the link below.
This link will take you to a new page; [https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fforms.office.com%2Fe%2FcimWP1L4tx&data=05%7C02%7CKChatfield%40uclan.ac.uk%7Cde983f54bcc64d66a02908dcd0b50ccd%7Cebf69982036b4cc4b2027aeb194c5065%7C0%7C0%7C638614723283135084%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=mx6LNK14iRC744b7LLnUg8jxZ%2FKLXd%2Blo6I8kmwz%2Bwg%3D&reserved=0 https://forms.office.com/e/cimWP1L4tx]
Thank you! +
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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. +
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Having worked your way through this case study module, how would you feel if a similar proposal was presented to a REC that you were serving on? Do you feel that you would be able to identify where further information or expertise is required, and to locate and apply relevant policies and guidelines? There are many factors to consider, we have touched on several key issues in this case, you might have identified other issues that you would want an ethics committee to take into account in similar situations.
</div></div><div><div></div></div> +
Thank you for taking this irecs module!
Your feedback is very valuable to us and will help us to improve future training materials.
We would like to ask for your opinions:
1. To improve the irecs e-learning modules
2. For research purposes to evaluate the outcomes of the irecs project
To this end we have developed a short questionnaire, which will take from 5 to 10 minutes to answer.
Your anonymity is guaranteed; you won’t be asked to share identifying information or any sensitive information. Data will be handled and stored securely and will only be used for the purposes detailed above. You can find the questionnaire by clicking on the link below.
This link will take you to a new page: [https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fforms.office.com%2Fe%2FUsKC9j09Tx&data=05%7C02%7CKChatfield%40uclan.ac.uk%7Cbe3ccf952ee04506e25608dd19dcde06%7Cebf69982036b4cc4b2027aeb194c5065%7C0%7C0%7C638695158651948095%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=P5sNoxm3jW6tLABNV7bNiETR3fHQUG2VODMd3wk3r9E%3D&reserved=0 https://forms.office.com/e/UsKC9j09Tx]
Thank you! +
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In the final part of this module, we consider how we might become more cognisant of our embedded beliefs and assumptions through critical reflection. This in turn can help us to take a critical approach to ethical analysis. To begin with, we ask you to undertake an exercise.
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Our understanding of the world may have as much to do with our minds as with the world.
Write a short description of the image above. What do you notice? What do you think has happened here? Where do you think it might be? Please note any other thoughts that come to mind in relation to the image. +
<blockquote>In Nairobi, an estimated 30,000 sex workers face significant challenges, including social vulnerability and extreme poverty. During the COVID-19 pandemic, the implementation of lockdown measures, while potentially justified in high-income countries, had a devastating impact on this marginalized community. In this short documentary, Nairobi sex workers share their stories about the impact of lockdown on their lives and on their physical and mental health.</blockquote> +
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Do you think you could identify who is vulnerable in research? Take a moment to consider this issue and then click on the feedback tab below.
The most striking commonality across research ethics codes is the suggestion that vulnerability can stem from belonging to a certain group. When vulnerability is mentioned, it is commonly accompanied by examples of the sorts of groups to whom this applies. A problem with the naming of particular groups, even as examples, is the implication that people are to be considered vulnerable simply by virtue of belonging to a certain group. This can render the term unhelpful and patronizing. Nowadays, there is acknowledgement across many codes and guidelines that determining who is vulnerable requires a nuanced approach because vulnerability can stem from a range of factors, for instance, power differentials between researchers and participants, capacity to understand, unrealistic expectations and so on. We need to be careful not to jump to conclusions about who is vulnerable. +
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'''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.
During pandemics, all those involved in the research cycle should strive for respectful engagement with each other in the spirit of equitable and collaborative problem-solving +
Try to answer the questions about the case. +
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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. +
Thank you for taking this irecs module!
Your feedback is very valuable to us and will help us to improve future training materials.
We would like to ask for your opinions:
1. To improve the irecs e-learning modules
2. For research purposes to evaluate the outcomes of the irecs project
To this end we have developed a short questionnaire, which will take from 5 to 10 minutes to answer.
Your anonymity is guaranteed; you won’t be asked to share identifying information or any sensitive information. Data will be handled and stored securely and will only be used for the purposes detailed above. You can find the questionnaire by clicking on the link below.
This link will take you to a new page; [https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fforms.office.com%2Fe%2F3puN6rfFYS&data=05%7C02%7CKChatfield%40uclan.ac.uk%7Cde983f54bcc64d66a02908dcd0b50ccd%7Cebf69982036b4cc4b2027aeb194c5065%7C0%7C0%7C638614723283142461%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=noGJNHMbkeQtmNkEzmf2zx2ua3sxX%2F7ta9F8pmckrSQ%3D&reserved=0 https://forms.office.com/e/3puN6rfFYS]
Thank you! +
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'''Accountability'''
In the context of research governance, accountability entails researchers and research institutions taking responsibility for the ethical conduct, integrity, and outcomes of their research activities. This includes adhering to regulatory requirements, ethical guidelines, and best practices in research methodology. Accountability in research governance also involves transparency in reporting findings, acknowledging conflicts of interest, and ensuring that research benefits society while minimising potential harm.
'''Ethics dumping'''
Ethics dumping is a term used to describe situations when researchers from privileged settings offshore unethical research to lower income settings. It can happen on purpose, but also due to lack of awareness and cultural misunderstandings. Probably the best-known type of ethics dumping is the application of double standards, where exploitative practises that are not accepted in a high-income setting are used in a lower income setting.
'''Methodology'''
Methodology refers to the systematic methods or procedures used in a particular field of study or discipline. It encompasses the principles, techniques, and rules for conducting research or investigation within that field. It can be regarded as a framework for planning, executing, and evaluating research activities.
'''Methods'''
In research, the term ‘methods’ refers to the specific tools or processes that are used for data collection or analysis. For instance, methods might take the form of a survey, interviews or experiments.
'''Trustworthiness'''
Trustworthiness in the research context refers to the credibility, reliability, and integrity of the research process and its outcomes. It encompasses adherence to ethical standards, transparency in methods and reporting, consistency in findings, and the avoidance of biases or conflicts of interest. Trustworthiness is essential for establishing confidence in research results among peers, stakeholders, and the broader community.
'''Stewardship'''
In the research context, stewardship involves the ethical and responsible management of research resources, including funding, data, facilities, and intellectual property. It entails ensuring that these resources are used efficiently, transparently, and in accordance with established guidelines and ethical standards. Stewardship in research also involves promoting the integrity of the research process, fostering collaboration, and safeguarding the interests of participants, stakeholders, and the broader community.
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Now that you have considered this case in more depth, it’s time to decide whether you will approve the project.
Please answer the following question, your responses will be recorded anonymously.
</div>Question: What is your decision?
'''Feedback'''
Through this case study we have sought to explore the ethics issues associated with the use of VR, AI avatars and generative AI in a research proposal. The proposed project raises a broad range of concerns, some of which are anticipated in the proposal, but many of which are not mentioned. Hence the proposal is not yet ‘approval ready’. With the help of the document, The use of XR technologies in research: A checklist for research ethics committees, it should be possible for you to spot the omissions in the proposal and formulate a list of requirements.
However, even if the researchers address all these requirements appropriately, there may still be disagreements about whether the study can be approved, whether the potential for benefits justify the potential risks. Whatever your decision, we ask you to reflect back upon the first question we raised, ‘What experiences and understanding about the use of VR do you bring to this case study?’ Have your opinions and assumptions about the use of VR changed?
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In navigating the entry of new actors into the health domain, policymakers, healthcare providers, and technology companies must work together to ensure that innovations align with patient needs, adhere to ethical standards, and contribute to the overall improvement of healthcare delivery. Balancing innovation with regulatory oversight and patient protection remains a key challenge in this evolving landscape. +
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Do you know what is meant by personal data? Look at the following options and identify those that are personal data. +
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UK Genetic Technology (Precision Breeding) Act 2023: https://www.legislation.gov.uk/ukpga/2023/6/contents/enacted
Association for Responsible Research and Innovation in Genome Editing (ARRIGE): https://www.arrige.org/
European Parliament, Directorate-General for Parliamentary Research Services, A Nordberg, et L Antunes. Genome editing in humans – A survey of law, regulation and governance principles. European Parliament, 2022. https://doi.org/10.2861/07058.
The Nuffield Council on Bioethics ethical review on genome editing: this document gives a good overview of the technique of gene editing as well as the ethical and legal questions surrounding it. From the examples given, there could be case studies being developed [https://www.nuffieldbioethics.org/assets/pdfs/Genome-editing-an-ethical-review.pdf https://www.nuffieldbioethics.org/assets/pdfs/Genome-editing-an-ethical-] [https://www.nuffieldbioethics.org/assets/pdfs/Genome-editing-an-ethical-review.pdf review.pdf]
The Nuffield Council on Bioethics social and ethical review on genome editing and human reproduction: very helpful background information on the topic of gene editing which can be used for designing case studies or other kinds of training modules [https://www.nuffieldbioethics.org/assets/pdfs/Genome-editing-and-human-reproduction-report.pdf https://www.nuffieldbioethics.org/assets/pdfs/Genome-] [https://www.nuffieldbioethics.org/assets/pdfs/Genome-editing-and-human-reproduction-report.pdf editing-and-human-reproduction-report.pdf]
A case study from The Royal Society about gene editing in human embryos: [https://royalsociety.org/-/media/policy/projects/gene-tech/case-studies-keywords/case-study-genome-edited-human-embryos.pdf https://royalsociety.org/-/media/policy/projects/gene-tech/case-studies-] [https://royalsociety.org/-/media/policy/projects/gene-tech/case-studies-keywords/case-study-genome-edited-human-embryos.pdf keywords/case-study-genome-edited-human-embryos.pdf]
A case study from The Royal Society about non-heritable human genome editing: [https://royalsociety.org/-/media/policy/projects/gene-tech/case-studies-keywords/case-study-non-heritable-genome-editing.pdf https://royalsociety.org/-/media/policy/projects/gene-tech/case-studies-] [https://royalsociety.org/-/media/policy/projects/gene-tech/case-studies-keywords/case-study-non-heritable-genome-editing.pdf keywords/case-study-non-heritable-genome-editing.pdf]
An overview of success stories related to gene editing and can be used for real life examples for what gene editing can and can’t do: [https://media.nature.com/original/magazine-assets/d41586-021-02737-7/d41586-021-02737-7.pdf https://media.nature.com/original/magazine-assets/d41586-021-02737-] [https://media.nature.com/original/magazine-assets/d41586-021-02737-7/d41586-021-02737-7.pdf 7/d41586-021-02737-7.pdf]
This article reflects on the fundamental ethical dilemma of using gene drives in mosquitoes and its possible effects on people in Africa: [https://www.sciencenews.org/article/gene-drives-mosquito-malaria-crispr-africa-public-outreach https://www.sciencenews.org/article/gene-drives-mosquito-malaria-crispr-] [https://www.sciencenews.org/article/gene-drives-mosquito-malaria-crispr-africa-public-outreach africa-public-outreach]
This article discusses the events involving the birth of the first human babies who were genetically edited by a Chinese researcher to be resistant to HIV. Despite the researcher's intention to protect the babies from HIV, his actions were against the law according to the Chinese government and the scientific community. As a result, he was imprisoned. Nevertheless, the babies are currently alive: https://www.science.org/content/article/did-crispr-help-or-harm-first-ever-gene-edited-babies
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'''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.
