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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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.
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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. +
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Treatments and therapies involving gene editing are already undergoing clinical trials for marketing approval in the EU and the US for certain diseases and are likely to incur equivalent costs to those of conventional gene-based therapies that are used for rare genetic diseases. However, they are very costly and may thus be restricted to wealthy patients or citizens in countries with corresponding health insurance or social security systems. The dilemma of resource allocation poses questions about the development of extremely expensive therapies. +
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Antonija Mijatovic shares her thoughts on challenges for data privacy and security.
'''Challenges for data privacy and security'''
When it comes to data security and privacy, the major issues are data breaches. Because many applications in AI involve health data, and health data is sensitive and confidential by nature.
So, data breaches can lead to privacy violations, identity theft, even health risks. And they result in financial losses for healthcare organizations. Because healthcare is the top industry targeted by ransomware. Ransomware is a common cyber-attack. But aside of ransomware, data breaches can occur through hacking, phishing, and even if a device storing health information is lost or stolen. And data breaches can also happen unintentionally. For example, if patient data is emailed to the wrong recipient or posted online. And these incidents happen very often.
For example, in the United States alone, only in the last year there have been more than 500 cases of cyber-attacks. So, this is why it is important to address. Researchers need to take multiple measures to ensure data security and privacy. And these include cyber security measures, such as strong passwords, restricted access, two-factor authentication, and even encryption of very sensitive data. In addition, researchers should create backups of very important folders. And also, because 90% of cyber-attacks were allowed due to human error, researchers who work with sensitive data should receive proper training in the subject.
Ethics reviewers need to check whether researchers took all necessary measures to ensure data privacy and security. And they should also check whether researchers adhered to regulatory compliance. For example, in the European Union, personal data is regulated through the [https://gdpr.eu/what-is-gdpr/ GDPR] and personal data in AI is regulated through the [https://artificialintelligenceact.eu/ Artificial Intelligence Act]. While in the United States there are several guidelines such as the [https://aspe.hhs.gov/reports/health-insurance-portability-accountability-act-1996 Health Accountability and Portability Act].
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In addition to the guidelines discussed below, we have produced a checklist for RECs on the use of biobanking in research, attached at the end of this page. We hope that this will be useful for REC members considering proposals involving biobanking. Please also see the further resources section which includes the most relevant EU or international guidelines or standards related to biobanking, a bibliography and useful websites.
In Europe, biobanking is governed by regulations in the [https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:102:0048:0058:en:PDF European Union's Clinical Trials Regulation and the Human Tissue and Cells Directive] which provides guidelines for sample collection, storage, and ethical considerations. Guideline 8 in [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9357355/ CIOMS International ethical guidelines for health-related research involving humans] sets out recommended practices for the collection, storage and use of biological materials and related data. Also relevant is the [https://www.isber.org/page/BPR General Data Protection Regulation] (GDPR), which addresses the processing of personal data.
[https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf The International Society for Biological and Environmental Repositories] (ISBER) provides guidelines for best practices, and the [https://www.oecd.org/health/biotech/guidelines-for-human-biobanks-and-genetic-research-databases.htm OECD's Guidelines on Human Biobanks and Genetic Research Databases] offer international recommendations. [https://doi.org/10.3390/genes15010066 Multiple national and regional regulations] further shape biobanking practices worldwide, emphasising ethical, legal, and privacy considerations.
It is important to remember that different guidelines and regulations will apply to biobanks and related research projects in order to comply with the requirements of different institutions, organisations and geographical locations. The further resources section lists and provides links to other relevant EU, African and other international guidelines or standards related to biobanking in health and healthcare, but you may need to explore further afield to locate those that apply to different situations.
[https://classroom.eneri.eu/sites/default/files/2024-11/Checklist%20for%20use%20of%20biobanking.pdf Checklist for RECS on the use of biobanking in research.]
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Now we return to the research ethics committee perspective. Below is a hypothetical debate between members of a research ethics committee that is informed by the checklist about whether this VR study should be approved. The debate involves the following five characters:
*Dr Taylor (Chair of research ethics committee)
*Dr Evans (Bioethicist)
*Dr Brown (Psychologist)
*Dr Adams (Data privacy specialist)
*And Ms Amanda Lee (Lay member)
Did the research ethics committee discuss all of the issues you identified in the proposal? Did they miss anything important? They are clearly concerned about safeguarding participant wellbeing, privacy and data protection measures, but have they looked for fair participant recruitment or identified all risks and benefits, for example? +
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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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The TRUST Code, a global code of conduct for equitable research partnerships, was designed to address ethics dumping. You can watch two videos here about the code: one gives an overview of the code, and one introduces its 23 articles. +
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Informed consent is the cornerstone of ethical research with humans. It is of fundamental importance that people understand what a research project is about and provide their consent for taking part.
There are seven key ingredients for valid informed consent. Match the following ingredients to their meanings. +
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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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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?
Helicopter research occurs when researchers from affluent countries extract data or resources from lower-income regions without considering local needs or ethical concerns. A notable example occurred during the Ebola crisis in 2014. Researchers from high-income countries requested access to vast amounts of mobile phone data from Sierra Leone, Guinea, and Liberia to track population movements, claiming that it would provide significant insights into Ebola transmission.
The contrast between the handling of mobile phone data during the Ebola crisis and the German floods of 2021 underscores the double standards often present in helicopter research. +
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XR manipulation refers to the intentional alteration or distortion of reality within virtual environments. XR manipulation can alter users' perception of reality, create illusions or deceptions that trick users into perceiving virtual content as part of their physical environment. It can also be used to control the narrative within immersive experiences to shape their understanding, interpretation, and beliefs. The emergence of virtual beings, (for instance, avatars representing deceased individuals) introduces complex ethical questions regarding identity and agency.
Immersive technologies can also incorporate nudging techniques that are used to guide users' actions, shape their experiences, or promote certain outcomes. In the context of VR, ‘nudging’ refers to the application of certain measures to subtly influence the user’s decision-making. For instance, it may involve prompts, reminders, or visual cues; the presentation of options in specific ways; portraying particular behaviours as the social norm; or the offering of rewards or incentives. Given the intention to influence, the use of nudging techniques has ethical implications related to user autonomy and informed consent, so needs to be considered carefully.
While these facets can enhance immersion and entertainment value, they can also invoke ethical concerns related to transparency, consent, and user agency. XR manipulation can be exploited for malicious purposes, such as spreading misinformation, creating deceptive experiences, or manipulating users' behaviour for financial or political gain. Safeguards need to be implemented to prevent misuse of XR technologies and protect users from harmful manipulation. +
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. +
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. +
