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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Dr Corry’s report helps Professor Smith and Dr Jones identify the primary AI ethics issues that need to be addressed in their study. Flip the cards to find out ways they might address these issues. +
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The word vulnerability can be broadly used to describe a state or condition of being susceptible to harm, exploitation, or other adverse outcomes due to various factors or circumstances. It is difficult to define precisely because multiple and diverse factors can contribute to vulnerability such as systemic inequalities, health status, social dynamics, environmental conditions, or individual characteristics. Additionally, it can affect individuals, groups, or communities and manifest in various ways. Furthermore, the word vulnerability does not have a precise equivalent in many languages. Still, it is important for researchers to have an understanding of the concept of vulnerability because it has significant implications for research ethics. +
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As AI continues to reshape the healthcare landscape, it brings about a myriad of societal and ethical considerations. This sorting exercise aims to explore the broader issues surrounding the intersection of AI and healthcare.
Please categorise each scenario into the appropriate societal or ethical dimension: +
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Not all research studies need research ethics approval. For example, a study that is solely based on a review of research literature is unlikely to need ethics approval. You can work through the following decision tree to assess whether ethics approval is necessary for a project (real or imagined). +
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What are some of the key benefits of the use of AI applications in healthcare?
As AI continues to evolve, its applications in healthcare hold immense promise for improving the quality of care, optimising resource utilization, and potentially shaping a more patient-centered and efficient healthcare ecosystem. However, careful implementation and ongoing scrutiny is vital to ensure the responsible and beneficial use of AI in healthcare.
If you would like to explore the topic of AI implementation in more depth, you can access the Coalition for Health’s Blueprint for Trustworthy AI Implementation Guidance and Assurance for Healthcare in the further resources section. +
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Now we ask you to drop the stance of the REC member for a moment and try to step into the shoes of a potential participant.
Please answer the following question, your responses will be recorded anonymously.
</div></div>'''Feedback'''<div>
People join studies for all different reasons and they each bring with them their different experiences, expectations etc. Read on to see some possible initial reactions. <div></div></div> +
Participants are supported in formulating a take-home message from the session. The teacher asks the participants to reflect on how their take home message will influence their practice. +
Facilitate a discussion about the topic's relevance to participants' professional lives/studies (splitting into smaller groups if needed) and guide them in formulating key take-home message. +
Hand out a post-it to each trainee and ask them to write down...
#...the most important thing that they have learned.
#...an action they can implement to pay more attention to ethical issues related to biobanking.
(If you started with check-in question Scenario 2 in Step 1 of this module, then you can ask trainees if they would change their answer.)
Depending on the group size and the time available, invite a few or all trainees to share their insights.
'''Evaluation'''
Invite the trainees to complete the evaluation form by sharing a QR code linking to the evaluation form. +
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Given what you understand about the associated harms and benefits, do you think this study is ethically justified if the potential for benefits exceeds the potential for harms?
'''Feedback'''
It’s unlikely that the study would be approved or disallowed based on the brief information that was available to you. Proposals that are reviewed by a research ethics committee are normally highly detailed and researchers are expected to address all anticipated ethical issues. If you would ask for changes or for further information, what would that be?
The case study in this module is based upon a real-world study. The case has been adapted here for teaching purposes, but you can read about the real study by following these links:
https://www.genomicseducation.hee.nhs.uk/blog/world-first-gene-therapy-trial-for-hunter-syndrome-opens/
https://themedicinemaker.com/discovery-development/the-worlds-first-gene-therapy-clinical-trial-for-hunter-syndrome
https://b-s-h.org.uk/about-us/news/gene-therapy-trial-for-hunter-s-syndrome-to-begin +
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So far in this module, we have only referred to ‘research ethics’ but within this broad domain, a distinction is often drawn between matters of research ethics and matters of research integrity. Both are concerned with morality in research but matters of research integrity focus specifically upon the ethics issues that are associated with trustworthiness in research. Research integrity is needed to promote trust and confidence in all aspects of the research process. In the absence of research integrity, research misconduct can lead to the dissemination of unreliable information.
There are many different types of research misconduct. Match the following types to their meanings. +
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Some ethicists argue that we have a moral duty to use gene editing to eliminate hereditary diseases.
Others assert that gene editing, initially aimed at therapy, might lead to non-therapeutic enhancements and the application of gene editing for enhancing the human body and brain raises numerous ethical concerns. These include matters of safety, the concept of 'designer babies', potential discrimination against non-enhanced individuals, and potential longer-term effects. Let's hear from someone who has many concerns.
In the realm of enhancement, I’m concerned about children being subjected to parental experimentation without the children’s informed consent. The procedures involved carry significant risks that may impact their entire lives as well as those of their children.
There are also ‘slippery slope’ risks. If genetic enhancement becomes acceptable for certain characteristics, the boundaries of what is considered acceptable will soon be pushed. Additionally, people may begin to feel pressure to enhance to ensure that their children are not disadvantaged in comparison with those who benefit from enhancements.
Additionally, the possibility of enhancement and ‘designer babies’ raises serious issues about equity regarding equal access and the unfair distribution of benefits, as well as a potential drift towards eugenics. If gene editing becomes widely available, there's a risk of selectively enhancing desirable traits and suppressing undesirable ones, which might foster societal intolerance for imperfection.
While individuals may benefit personally, there are broader societal impacts. How might it affect those already living with disabilities? This raises questions about inclusivity, diversity, resource allocation, and the rights of individuals with disabilities. Balancing individual autonomy with societal wellbeing is at the core of this dilemma.
A major problem for ethics assessment is that there are currently no clear guidelines about human enhancements. Furthermore, the line between therapy and enhancement is often blurred and there can be dual effects, both therapy and enhancement, in some cases.
Research ethics committee members need to be aware of the mechanisms and drivers of the use of genome editing and related technologies by the global fertility industry. This is necessary to ensure that research ethics reviewers can support the research community in applying the precautionary principle to specific research fields with dual benefit potential. For instance, therapy of life-threatening diseases versus selection of desirable traits.
'''Feedback'''
The precautionary principle states that if an activity or technology has the potential to cause harm, and if there is scientific uncertainty about the extent or nature of that harm, then precautionary measures should be taken to prevent or minimise the harm, even if conclusive evidence of harm is lacking. Given the gaps in our understanding of the consequences, and the lack of clear, shared guidelines, adoption of a precautionary approach to the use of gene editing for non-therapeutic human enhancements seems most appropriate.
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In addition to the uses in human biomedical research, gene editing is also increasingly used in agricultural and environmental research, including the application of gene drive technologies.
Gene drive is a genetic engineering technique that aims to spread a specific genetic element in a population of non-human organisms resulting in a genetically modified organism (GMO). Unlike traditional Mendelian inheritance, where a gene can be thought of as having a 50% chance of being passed on to offspring, gene drive systems bias inheritance in favour of a particular gene variant, allowing it to spread rapidly within a population. CRISPR-Cas9 is often used to create gene drive systems because the technique allows for the introduction of gene drive elements.
Gene drive technology has applications in various fields, including public health. One of the most frequently discussed applications is a potential modification of the mosquito population that could lead to a sustainable global interruption of the transmission of malaria parasites. +
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In the proposed study issues surrounding the ownership of biosamples, data, and intellectual property or IP are critical and must be addressed to avoid ethical conflicts. The following video provides an overview of ways in which this could be managed.
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Personal data processing in biobanks raises ethical issues that need careful consideration to ensure the protection of individuals' rights, privacy, and the responsible conduct of research. During the Ebola outbreak in Sierra Leone, data processing failures contributed to a lack of a complete inventory of the samples collected, and incomplete information about their potential future use, location and ownership.
Navigating such issues requires adherence to established guidelines, ongoing ethical review, and engagement with stakeholders to ensure that data processing in biobanks aligns with ethical principles, legal frameworks, and societal expectations. Some key ethics issues connected to data processing in biobanks are described below after a short clarification of relevant terms.
The terms anonymous and de-identified are often used interchangeably but do have different meanings. For the purposes of this module, we are using the terms in this way:
* Anonymous – The dataset does not contain any identifiable information and there is no way to link the information back to identifiable information. This is an irreversible process.
* De-identified – The dataset does not contain any identifiable information, but there is a way to link the information back to identifiable information.
'''Data ownership'''
Ethical concerns surrounding data ownership in biobanks revolve around defining and respecting the rights of various stakeholders involved. Donors contribute valuable biospecimens and personal data, raising questions about who ultimately owns this information. Generally, donors retain some rights over their samples and associated data, but biobanks also have responsibilities to steward these resources for the public good.
Policies will vary from country to country and across different organisations. As an example, UK Biobank states that it is the owner of the intellectual property rights of the data and samples contained in the resource. The biobank grants researchers a limited, revocable, worldwide, royalty-free, non-exclusive licence (but not ownership rights) to use samples for a permitted purpose only. However, the intellectual property rights to the results data deriving from the research for the permitted purpose will under most circumstances belong to the researcher.
Striking a balance between the interests of researchers, institutions, and donors is crucial. Clear and transparent consent processes are essential to inform donors about how their data will be used and who will have ownership or control over it.
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The identification of potential benefits and risks is necessary but is not sufficient for ethics assessment. In order to weigh the benefits and risks, we also need more information about who will benefit and how, as well as the steps that will be taken to avoid and/or mitigate the risks.
Who benefits from the research?
While we hope that, ultimately, this research will benefit populations around the world where malaria is endemic, the companies or research institutions developing gene drive technology might benefit more financially than the local population where this study will take place. This raises important ethical questions about equity, justice, and the distribution of benefits.
They are also likely to have more influence over the direction and application of the research, particularly if they control the intellectual property rights. This creates an inherent power imbalance, where local populations rely on external actors to solve a local problem. If the technology becomes commercialized, the local communities might not even be able to afford to use it, or conduct the necessary post-study monitoring, even though they are the ones facing the direct impact of malaria and are taking the risks by acting as a test site for the intervention.
Without proper engagement and consent, this could be seen as exploiting vulnerable populations for scientific experimentation and commercial gain. To avoid exploitation, it is critical that local populations are not simply a test case for technology that will later profit wealthy institutions elsewhere. Careful and inclusive planning, with clear contracts and ethical agreements can help prevent exploitation and ensure that the local population’s needs and interests are prioritised.
Ensuring transparent governance and local decision-making power is essential. Local communities and governments should have a strong say in how the gene drive is developed and deployed. This can include setting up oversight committees that involve representatives from the local population, NGOs, and international experts, so that decisions about the gene drive’s use prioritise community interests and ethical concerns.
Additionally, long-term sustainability plans should be developed to ensure that local populations are not dependent on foreign manufacturers or researchers for their ongoing health needs. Building local capacities to monitor and maintain the gene drive populations could ensure that the benefits continue without external oversight, empowering communities to control their own health futures.
The study team are obviously aware of the potential for ecological disruption. Hence, they intend to undertake biodiversity surveys to monitor the potential ecological consequences of mosquito population reduction, including the impacts on predators and other insect species. They believe that if initial release is on a small scale in remote areas, that can be closely monitored, they should be able to avoid broadscale ecological impacts. Do you think this is sufficient?
The war in Ukraine has sparked a debate about the future of scientific collaboration with Russia. Some support a boycott, while others argue that collaboration should continue. The German Ministry of Education and Research says that the decision lies with science itself. These different views show the complexity of the issue. +
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To address virtual harassment in VR environments, developers and platform operators can implement various measures. +
<span lang="EN-GB">As outcomes are less tangible than outputs and might involve less quantifiable patterns such as behavioural change, the appropriate identification/development of key performance indicators (KPIs) is crucial to track observable longer-term trends, such as an increase in skills or shifts in the behaviour of certain population segments, which is potentially caused by successful interventions of our implementation. Consider at least one key performance indicator (KPI) with which a durable outcome can be measured for later analysis.</span>
<span lang="EN-GB">· What are the KPIs with which to measure the long-term effects and impact of the applied scenario?</span>
<span lang="EN-GB">· Is the KPI strategically aligned with my organisation or project?</span>
<span lang="EN-GB">· Is the KPI operationally actionable within my organisation or project? </span>
<span lang="EN-GB">· How long will it take to reach your objective/s?</span>
<span lang="EN-GB">· How do you measure these KPIs in a conceivable way?</span>
<span lang="EN-GB">· Foresight: In which ways has the scenario application impacted your organisation or project?</span> +
Community researchers are part of the research team and should be treated and respected as researchers, including during pandemic +
