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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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Changes to the process of seeking informed consent must not be allowed to compromise potential participants’ understanding of a research project. This includes ensuring that research participants do not mistake research for treatment (‘therapeutic misconception’), especially when healthcare staff rather than researchers seek consent +
Try to answer the questions about the case. +
From biological samples to precision medicine for patients. Virchows Arch. 2021 Aug;479(2):23Annaratone L, De Palma G, Bonizzi G, Sapino A, Botti G, Berrino E, Mannelli C, Arcella P, Di Martino S, Steffan A, Daidone MG, Canzonieri V, Parodi B, Paradiso AV, Barberis M, Marchiò C;Alleanza Contro il Cancro (ACC) Pathology and Biobanking Working Group (2021) Basic principles of biobanking:3-246. doi: 10.1007/s00428-021-03151-0. Epub 2021 Jul 13. PMID: 34255145;PMCID: PMC8275637.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8275637/
BBMRI-ERIC Common Service ELSI
https://www.bbmri-eric.eu/services/common-service-elsi/
European Commission (2018) Data protection in the EU
https://commission.europa.eu/law/law-topic/data-protection/data-protection-eu_en
Council of Europe (2016) Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin https://search.coe.int/cm/Pages/result_details.aspx?ObjectId=090000168064e8ff
Harati, M.D., Williams, R.R., Movassaghi, M., Hojat, A., Lucey, G.M., Yong, W.H. (2019). An Introduction to Starting a Biobank. In: Yong, W. (eds) Biobanking. Methods in Molecular Biology, vol 1897. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-8935-5_2
Healthtalk.org What is biobanking and why is it important? https://healthtalk.org/experiences/biobanking/what-is-biobanking-and-why-is-it-important/
ISBER (International Society for Biological and Environmental Repositories) (2024) Best practices for repositories https://www.isber.org/page/BPR
NIH (2024) Genomic Data Sharing (GDS) Policy https://sharing.nih.gov/genomic-data-sharing-policy
OECD Guidelines for Human Biobanks and Genetic Research Databases (HBGRDs)
https://www.oecd.org/health/biotech/guidelines-for-human-biobanks-and-genetic-research-databases.htm
World Medical Association (2016) Declaration of Tapei on ethical considerations regarding health databases and biobanks
https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/
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Gene editing technologies hold great promise for treating genetic diseases, improving agricultural yields, and addressing many other challenges. However, they also come with ethical, social, and safety considerations. Some of the risks associated with gene editing include:
'''Off-Target Effects '''
Gene editing tools may unintentionally modify genomic regions other than the target, leading to unintended consequences. Off-target effects could potentially cause new genetic mutations or disrupt the function of other essential genes.
'''On-Target Effects '''
Gene editing tools may unintentionally modify the target DNA in the wrong way with unwanted deletions or insertions. For instance, the DNA coding for the Cas protein may become built into the DNA target sequence of the cell, which would lead to the gene in question not functioning properly.
'''Mosaicism'''
Genetic mosaicism is the presence of more than one genotype in one individual. Some cells in the target region undergo the desired genetic modification while others still carry the original DNA resulting in a mosaic pattern of edited and unedited cells. This can lead to problems in communication between cells.
'''Immunogenicity'''
The use of gene editing tools, especially those involving viral vectors to deliver editing components, may trigger an immune response in the organism. The immune response could limit the effectiveness of the treatment or cause adverse reactions.
'''Germline Gene Editing'''
The ability to edit the human germline, which includes sperm and egg cells, raises ethical concerns about the potential for heritable genetic modifications. The long-term consequences and unintended effects on future generations are not fully understood;if the modifications turn out to be harmful, they will not only have consequences for a single individual, but also for future generations.
'''Unintended Consequences'''
Modifying one gene may have unintended consequences for other genes or biological processes. For instance, the unintended consequences of releasing GMOs into the environment, could result in gene flow to wild populations, disruption of ecosystems, and the emergence of resistant pests or weeds. Or the de-extinction of certain species could lead to other species becoming extinct or other disruptions of the ecosystem.
'''Human Enhancement'''
The ability to edit genes raises ethical questions about the potential for "designer babies," where genetic enhancements are made for non-medical reasons. This raises concerns about social inequality, discrimination, and the potential misuse of gene editing technologies.
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Preparing an application for the ethics approval of a research study can be a time-consuming process which is best approached methodically to ensure a coherent application with all required documentation. The process differs between institutions and organisations, but normally involves the following steps.
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Engagement with research ethics and integrity from the very start of a study helps researchers to design studies that are both ethical and of high quality.
Nevertheless, identifying and dealing with ethical issues is not just something that happens at the beginning of a study;ethics awareness is required throughout, as researchers sometimes find themselves dealing with unforeseen consequences and navigating uncharted territory. This is especially the case for research involving new technologies. Some fields, like artificial intelligence and extended reality, are developing rapidly and this requires ongoing assessment of challenges and ethics guidance as it becomes available. +
Varieties of goodness in research - a rotary style exercise (variation to original VIRT2UE exercise)) +
Each subgroup presents the results of the last round to the other groups.
The trainer thanks the participants for their work and the sharing of personal examples;recaps the lessons learnt and might refer to the objectives of the exercise that were presented at the start.
End with evaluation.
Depending on the agreements made prior to the training, the trainer might take a photo of each sheet and share these photo's with the participants so each can look back at the results. +
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Bostrom, Nick, et Rebecca Roache. « Ethical issues in human enhancement ». In New Waves in Applied Ethics, édité par J. Ryberg, T. Petersen, et C. Wolf, 120--152. Palgrave-Macmillan, 2007. (https://www.darpa.mil/program/insect-allies).
Cohen, Y (2019) Did CRISPR help or harm the first-ever gene-edited babies? Science, 1st August [https://www.science.org/content/article/did-crispr-help-or-harm-first-ever-gene-edited-babies https://www.science.org/content/article/did-crispr-help-or-harm-first-ever-gene-edited-] [https://www.science.org/content/article/did-crispr-help-or-harm-first-ever-gene-edited-babies babies]
Kleiderman, Erika, et Ubaka Ogbogu. « Realigning gene editing with clinical research ethics: What the “CRISPR Twins” debacle means for Chinese and international research ethics governance ». Accountability in Research 26 (9 mai 2019): 257-64. https://doi.org/10.1080/08989621.2019.1617138.
Palazzani, Laura. « Gene-Editing: Ethical and Legal Challenges ». Medicina e Morale 72, no 1 (11 avril 2023): 49-57. https://doi.org/10.4081/mem.2023.1227.
Singh SM. Lulu and Nana open Pandora's box far beyond Louise Brown. CMAJ. 2019 Jun 10;191(23):E642-E643. doi: 10.1503/cmaj.71979. PMID: 31182462;PMCID: PMC6565397.
1 AUG 2019
Smyth, Stuart J., Diego M. Macall, Peter W. B. Phillips, et Jeremy de Beer. « Implications of Biological Information Digitization: Access and Benefit Sharing of Plant Genetic Resources ». The Journal of World Intellectual Property 23, no 3-4 (2020): 267-87. https://doi.org/10.1111/jwip.12151.
The Lancet. « Human Genome Editing: Ensuring Responsible Research ». The Lancet 401, no 10380 (mars 2023): 877. https://doi.org/10.1016/S0140-6736(23)00560-3.
Wei, X., & Nielsen, R. (2019). CCR5-∆ 32 is deleterious in the homozygous state in humans. Nature medicine, 25(6), 909-910.
https://www.nature.com/articles/s41591-019-0459-6 +
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This checklist is intended for use as a supplement to the usual ethics review process regarding matters that are mainly specific to the use of gene drive technology in research. All usual aspects of research ethics review will also need to be considered, for instance, compliance with national and international regulations and the appropriate health and safety measures. Additionally, the checklist is not exhaustive;there may be other issues pertaining to individual studies that are not included here. Nevertheless, alongside general guidelines and processes, it provides a useful starting point for ethics reviewers.
Environmental impacts
# Do the project activities risk ecosystem disruption?
# Has a thorough environmental impact assessment has been conducted, including for the potential effects on biodiversity, ecosystems, and food chains?
# If yes, what does this tell us?
# If no, are there plans to conduct this before any release of the gene drive?
# Do the researchers have a reasonable plan to monitor and manage unintended ecological consequences?
# How have the researchers taken account of the possibility of irreversible ecological changes?
# What safeguards are in place to protect biodiversity?
# Have the researchers paid due attention to the broader, global implications of releasing the gene drive?
# How will the technology be responsibly managed if it extends beyond the target regions?
Human health and wellbeing
# Are there risks to human health and wellbeing?
# If so, are appropriate measures in place to minimise harm to local populations (e.g., healthcare support, disease monitoring).
# Are appropriate measures in place for delivering health benefits to the local populations?
# Is there an appropriate plan for long-term monitoring of human health impacts?
Technological and other risks
# Do the researchers have an appropriate plan to monitor and manage unintended evolutionary consequences?
# Have the risks of gene flow to non-target species (e.g., through hybridization) been properly assessed and are appropriate precautions are in place?
# Is there an appropriate strategy to monitor and respond to evolutionary resistance, including adjustments to the gene drive or alternative interventions if resistance develops?
# Do the researchers have an appropriate contingency plan for halting or reversing the gene drive if negative effects are observed (for instance, gene drive off switches, or self-limiting mechanisms)?
Community involvement
# Have the local community been meaningfully involved in decision-making processes related to the project design and implementation?
# How is the consent process being managed?
# How will it be ensured that all those affected (including individuals, groups, and local leaders) understand the potential risks and benefits fully?
# How is the option to opt out of the study managed?
Equity
# Is the research to be situated in a low or lower-middle income country?
# If so, how are the researchers taking steps to avoid ethics dumping?
# Who are the potential beneficiaries of this study?
# Will the resultant benefits be accessible to the local populations?
# Has a plan for equitable sharing of the benefits arising from the research been agreed with the local communities?
# Will the local population have the capacity and resources to manage and monitor the technology after the research phase concludes, ensuring local control over future developments?
Study justification
# Is there a justifiable need for this study?
# Might the same objectives be achieved via less risky and/or less costly methods?
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While many research ethics codes and guidelines have something to say about the inclusion of vulnerable people in research, in general they promote the same two messages: first, that most vulnerabilities are associated with voluntariness, and second, that certain groups should be awarded more protection than others.
When vulnerability is mentioned in research ethics codes, it is primarily in relation to the ability to provide informed consent. This can be associated with innate characteristics (for instance, young children or adults with severe cognitive dysfunctions). It can also be associated with circumstances that might impact upon the voluntariness of their consent (for instance, with prisoners or employees).
Some codes also mention risk-based vulnerabilities whereby vulnerability stems from being at an increased risk of mental or physical harm (for instance, pregnant women).
'''Exercise Feedback'''
The Australian National Statement (2023, p12) provides an extensive list of the sorts of harm to which research participants might be vulnerable including:
*physical harm: including injury, illness, pain or death;*psychological harm: including feelings of worthlessness, distress, guilt, anger, fear or anxiety related, for example, to disclosure of sensitive information, an experience of re-traumatisation, or learning about a genetic possibility of developing an untreatable disease;*devaluation of personal worth: including being humiliated, manipulated or in other ways treated disrespectfully or unjustly;*cultural harm: including misunderstanding, misrepresenting or misappropriating cultural beliefs, customs or practices;*social harm: including damage to social networks or relationships with others, discrimination in access to benefits, services, employment or insurance, social stigmatization, and unauthorized disclosure of personal information;*economic harm: including the imposition of direct or indirect costs on participants;*legal harm: including discovery and prosecution of criminal conduct.
Ask participants to shortly evaluate the session and your facilitation. In this step you may ask participants questions such as:
- Were the instructions clear enough?
- Do you think that the case was appropriate?
- Would you have any suggestions to do the session differently?
- What do you think the strong aspects of this session are?
- Are there any points to improve? +
Katılımcılardan oturumu ve sizin kolaylaştırıcı olarak performansınızı kısaca değerlendirmelerini isteyin. Bu noktada katılımcılara aşağıdakilere benzer sorular sorabilirsiniz:
- Verilen talimatlar yeterince açık mıydı?
- Ele alınan vakanın uygun olduğunu düşünüyor musunuz?
- Oturumun farklı bir şekilde gerçekleştirilmesine yönelik önerileriniz var mı?
- Bu oturumun güçlü yanları nelerdi?
- Geliştirilmesi gereken noktalar var mı? +
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Alexei Grinbaum shares some considerations for researchers and research ethics reviewers. In this interview, you will hear Alexei discuss different categories of questions that need to be asked about studies involving the use of AI technologies in healthcare. [https://classroom.eneri.eu/sites/default/files/2024-10/20240513%20Checklist%20AI%20in%20health.pdf The Ethics of AI in Healthcare: A checklist for Research Ethics Committees], which we mentioned at the beginning of the module is a useful resource to identify relevant questions. +
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ou 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. +
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One aspect that is not fully described by the researchers or explored by the research ethics committee is that of the AI involvement in the study.
AI involvement in the study
Participants in the VR group will interact with AI driven avatars. This is addressed to some extent as concerns were raised about supervision of the AI system, monitoring of interactions, and accountability etc. Additionally, it was noted that it wasn’t clear whether there would be an AI expert on the research team.
However, there is also no AI expert on the research ethics committee and maybe that is why they failed to address the issues associated with the inclusion of a generative AI element in the project. This is what the proposal states: “Additionally, the study hopes to contribute to improving AI-driven avatars in VR environments, to help make them more lifelike and responsive during human-to-AI interactions.” This statement implies that data from the project will be used to train AI models. Did you spot this in the proposal?
Generative AI models typically require significant amounts of data, often stored for long periods. This increases the risk of data breaches or unauthorized access, especially given the sensitive nature data collected in this project. Biometric data, coupled with detailed interaction metrics (e.g., frequency, duration of social interactions), can be highly personal and although efforts can be made to anonymise data, the detailed nature of biometric and interaction data could lead to re-identification risks. Secure anonymisation protocols must be emphasised to protect participant identities. If people in the project are not fully aware that their data is being used to train AI models this raises concerns about autonomy and trust.
Additionally, there are issues related to data bias and fairness as unrepresentative datasets might skew the AI model’s predictions. The large datasets on which generative AI models are trained can contain biases or stereotypes leading AI avatars to exhibit biased behaviours or make stereotyped assumptions. Participants from underrepresented groups might encounter responses from avatars that reflect these biases, and there may be a lack of nuanced cultural understanding, leading to responses that feel inappropriate or insensitive.
Mitigating these risks will require transparency about AI’s nature, strict data handling policies and bias mitigation strategies including fairness in participant recruitment.
For proposals like this where there are ethics issues that cross both the involvement of XR and AI, it will be helpful to also consult the document Ethics of [https://classroom.eneri.eu/sites/default/files/2024-12/The%20use%20of%20XR%20technologies%20in%20research.pdf AI in Healthcare: A checklist for Research Ethics Committees.]
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<div><div>
Think about places where data relating to your own health might be stored – tick all that apply
</div></div><div>
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In the next video you will hear from some of the people who were involved in developing the TRUST Code, summarizing the 23 articles that promote equitable research partnerships in international collaborative research. +
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'''Human enhancement'''
The ability to edit genes raises ethical questions about the potential for "designer babies," where genetic enhancements are made for non-medical reasons. This raises concerns about social inequality, discrimination, and the potential misuse of gene editing technologies.
'''Immunogenicity'''
The use of gene editing tools, especially those involving viral vectors to deliver editing components, may trigger an immune response in the organism. The immune response could limit the effectiveness of the treatment or cause adverse reactions.
'''Off-Target Effects'''
Gene editing tools may unintentionally modify genomic regions other than the target, leading to unintended consequences. Off-target effects could potentially cause new genetic mutations or disrupt the function of other essential genes.
'''On-target effects'''
Gene editing tools may unintentionally modify the target DNA in the wrong way with unwanted deletions or insertions. For instance, the DNA coding for the Cas protein may become built into the DNA target sequence of the cell, which would lead to the gene in question not functioning properly.
'''Mosaicism'''
Genetic mosaicism is the presence of more than one genotype in one individual. Some cells in the target region undergo the desired genetic modification while others still carry the original DNA resulting in a mosaic pattern of edited and unedited cells. This can lead to problems in communication between cells.
'''Slippery slope'''
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. +
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'''An example of a protocol to deal with incidental findings'''
In addition to collecting biological samples, the population-based UK [https://www.nature.com/articles/s41467-020-15948-9#Sec19 Biobank also collect multi-modal images] from some donors which include MRIs, x-rays, and ultrasounds. Their protocol for dealing with incidental findings included the recruitment of 3rd party consultant radiologists to review scans that the biobank radiologists had flagged up if they had noticed signs of something clinically serious at the time of collection. The consultant radiologist then reviewed the images and advised the biobank if the donor and their healthcare practitioner should be notified. Of the donors who were notified of an incidental finding, all consulted their doctor, and 90% went on to further clinical assessments. +
