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Gene Editing Case Study with Human Application + ([[File:G3.png|center|frameless|600x600px]] … [[File:G3.png|center|frameless|600x600px]]Let’s find out more about the proposed study. While watching the next video, imagine that you are a member of an ethics review committee and your role is to make an assessment about whether or not to approve the study, to ask for changes to be made / further information, or to disallow the study. Make a note of any points or questions that arise for you.There may be opposing views on the research ethics committee about whether this study can be approved. It is certainly a proposal that demands careful ethical scrutiny. In the audio below you will hear from some REC members who discuss some of the issues that need to be considered. Check to see whether they address all of the points or queries that you noted.l of the points or queries that you noted.)
Gene Editing Case Study with Human Application + ([[File:G5.png|center|frameless|600x600px]] … [[File:G5.png|center|frameless|600x600px]]Justification for this type of research cannot rest purely upon the assessment of harms and benefits for the participants. There are many other factors to take into account when assessing the ethical permissibility of leading-edge gene editing research with humans. Work through the presentation below to reveal some other important factors that might need to be considered.The assessment of proposals like this is a complex matter and it may demand input from a wide range of perspectives. There are specific technical questions (for instance, regarding what the therapy will involve and the potential for off-target or on-target effects), as well as broader and more general questions, (for instance, ‘does this research need to be done?’ and ‘who stands to benefit from the research?’). The involvement of young children also demands careful consideration, ‘Is children's participation in the research necessary or could the information be obtained in other ways?’; ‘What would be the likely consequences of not involving children?’. These considerations require individual, case by case scrutiny, from a committee with wide-ranging expertise.m a committee with wide-ranging expertise.)
Gene Editing Case Study with Human Application + ([[File:G6.png|center|frameless|600x600px]] … [[File:G6.png|center|frameless|600x600px]]The EU’s approach to genome editing is highly precautionary, particularly when it comes to germline editing. Regulations are largely guided by the European Medicines Agency (EMA), which oversees clinical applications of genome editing therapies.{| class="wikitable"|+!'''Governance at the international level'''The governance of gene editing research is not straightforward because it varies across countries, and encompasses legal, ethical, scientific, and societal dimensions. There have been steps towards development of an international regulatory framework. For instance:The World Health Organization has established advisory committees to provide guidelines on human genome editing. In 2021, the WHO published two reports offering recommendations on the governance and oversight of human genome editing, particularly emphasizing international collaboration and transparency.!|-!'''Governance at the country level'''At the country level, there are varying legal frameworks regarding gene editing research, particularly around its use in humans. For instance, some countries in Europe have banned germline editing outright, while others permit research but with stringent oversight. The Genetic Literacy Tracker tracks the development of gene editing regulations around the globe and can be found here: https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/![[File:G8.png|thumb|link=Special:FilePath/G8.png]]|-|'''Self-regulation'''Some organisations, like the International Society for Stem Cell Research (ISSCR), provide self-regulation guidelines for scientists working with gene editing technologies. These guidelines encourage ethical practices, discourage irresponsible experimentation, and promote high standards of safety.|[[File:G9.png|thumb|link=Special:FilePath/G9.png]]|-|'''Looking to the future'''As gene editing technologies evolve, governance models are also adapting. Emerging discussions focus on the need for adaptive governance, meaning a flexible framework that can evolve in response to technological advances.|[[File:G10.png|thumb]]|-|||}File:G10.png|thumb]] |- | | |})
Gene Editing Case Study with Human Application + ([[File:Ge-Hu1.png|center|frameless|600x600 … [[File:Ge-Hu1.png|center|frameless|600x600px]]In humans, gene therapy via gene editing is a rapidly growing field of research with many potential benefits for health and wellbeing. It involves the editing of genes to modify or knock out specific genes to achieve desired traits, to correct genetic defects, to treat or prevent disease, or to enhance cellular functions.In this module we consider an example proposal for a research project that is based upon a real-world study. The study aims to trial gene therapy for Hunter syndrome in a small group of young children. As you work through the module, we invite you to consider the ethics issues that are associated with this type of study from a variety of perspectives as well as how they might be addressed. We begin with some information about the disease.n with some information about the disease.)
Gene Editing Case Study with Human Application + ([[File:Ge-Hu2.png|center|frameless|600x600 … [[File:Ge-Hu2.png|center|frameless|600x600px]]'''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. with those who benefit from enhancements.)
Gene Editing: Ethics Issues + ([[File:Ge2Image int.png|center|frameless|6 … [[File:Ge2Image int.png|center|frameless|600x600px]]From the eradication of genetic diseases to potential human enhancements, and the place of genetically modified organisms in agriculture, the number of potential uses of gene editing is vast. This module touches upon a wide variety of ethics issues that are associated with research involving gene editing. It includes ethics issues related to both human and non-human applications and the way in which these issues might be assessed and governed.ese issues might be assessed and governed.)
Gene Editing: Ethics Issues + ([[File:Ge2Image2.png|center|frameless|600x … [[File:Ge2Image2.png|center|frameless|600x600px]]In November 2018, an international news story broke about a scientist in China who had genetically altered a gene in human embryos that had resulted in the birth of IVF twins, Lulu and Nana. The gene editing involved the use of CRISPR-Cas9 technology to disable the CCR5 gene with the aim that this would lead to HIV resistance. The scientist, He Jiankui, introduced the CRISPR technology very soon after the embryos were created when they were formed of only one cell each. He Jiankui’s actions were widely condemned as unethical, and the news sparked intense debate about the potential impacts upon the children. How might this genetic modification affect the development, the health and the wellbeing of Lulu and Nana? In the years since their birth there have been many rumours and suggestions about the impacts, including that the twins have enhanced memories and learning abilities, and others that their lives will be shortened. We don’t yet know what attributes can be attributed to the gene editing.tes can be attributed to the gene editing.)
Gene Editing: Ethics Issues + ([[File:Ge2Image3.png|center|frameless|600x … [[File:Ge2Image3.png|center|frameless|600x600px]]What do you think are the main ethics issues for this case? Some of the main ones are listed below. Sort each issue into one of the four categories: Autonomy, Future generations; Potential harms and benefits; and Slippery slope.al harms and benefits; and Slippery slope.)
Gene Editing: Ethics Issues + ([[File:Ge2Image4.png|center|frameless|600x … [[File:Ge2Image4.png|center|frameless|600x600px]]Germline gene editing needs to be undertaken at the earliest stage of embryo development to ensure that all cells carry the changes. When used to correct mutations, it can enable people who are at risk of passing genetic disease to their children to have a child free from severe genetic diseases. It might also be used to enhance immunity or protective factors for many other diseases (as was the intention for Lulu and Nana). Additionally, it may offer the only hope of a biological child in cases where people, due to genetic mutations, face challenges in conceiving healthy embryos through conventional means or in vitro fertilisation. Nevertheless, the long-term risks associated with germline manipulation remain uncertain. Errors in this process could have far-reaching consequences for future generations because germline gene editing affects all cells, germ cells, as well as somatic cells. Hence, the changes will be heritable, and any harmful effects may only be rectified if none of these individuals ever have children of their own.Regarding germline editing regulations, the Lancet reported in 2023 that there is broad consensus around the world that altering embryo DNA should remain forbidden. However, many countries do not have effective oversight and governance mechanisms to enforce existing regulations. In some countries, although altering embryo DNA is generally forbidden, exceptions are allowed. In Europe, the Oviedo Convention, a legally binding instrument established by the Council of Europe, permits somatic genome modifications for preventive, diagnostic, or therapeutic purposes, and prohibits germline editing, but only 29 countries have written it into law.While there is a lack of policy and oversight alignment between countries, there is a risk of ethics dumping – the off-shoring of research that would be forbidden or considered unethical in the researcher’s home country to a region where regulation is lacking, of a lower standard or less well enforced.of a lower standard or less well enforced.)
Gene Editing: Ethics Issues + ([[File:Ge2Image6.png|center|frameless|600x … [[File:Ge2Image6.png|center|frameless|600x600px]]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?There are many important factors to consider. These may include the following:* Does the research comply with relevant laws, regulations, and ethics guidelines in the jurisdiction where it is conducted? * What is the scientific rationale for use of this approach? * Do the research goals clearly justify the gene editing and growth of embryos beyond 14 days old? * Are there any alternative methods or models that could achieve similar research objectives without using human embryos or extending beyond the 14-day limit? * How have the opinions of stakeholders (including researchers, policymakers, ethicists, society, experts etc.) been taken into account? * What are the broad-based and longer-term implications of this study? Decision-making in complex circumstances like this needs to be evidence-informed. By taking time to consider factors carefully, with the involvement of various experts (scientific, legal, ethics) and the general public, informed decisions can be taken about implementation, modification, or potential revision in light of evolving ethical, scientific, and social considerations.Furthermore, these issues need to be navigated within the framework of the national legislation, which can be stricter than the 14-day rule. For research with embryos, or their modification through genome editing, the legal requirements vary, even within the EU. Where it is permitted, the procedures and the requirements for ethical assessments also vary. In the USA, experiments with embryos or with the production of embryos are not publicly funded, but privately funded experiments are possible. Given that the legal and governance frameworks can be very different from country to country, international cooperation for projects involving gene editing of human embryos can be especially difficult.human embryos can be especially difficult.)
Gene Editing: Ethics Issues + ([[File:Ge2Image7.png|center|frameless|600x … [[File:Ge2Image7.png|center|frameless|600x600px]]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.human enhancements seems most appropriate.)
Gene Editing: Ethics Issues + ([[File:Ge2Image8.png|center|frameless|600x … [[File:Ge2Image8.png|center|frameless|600x600px]]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.elopment of extremely expensive therapies.)
A Case of Non-Human Gene Editing + ([[File:Ge3Image1.png|center|frameless|600x … [[File:Ge3Image1.png|center|frameless|600x600px]]Malaria is a life-threatening disease caused by Plasmodium parasites that are transmitted to humans through the bites of infected female Anopheles mosquitoes. Once inside the human body, the parasites travel to the liver, where they mature and multiply before entering the bloodstream, infecting red blood cells. This leads to symptoms that can range from mild to severe, and without timely treatment, malaria can cause serious complications and even death. Common symptoms of malaria include fever, chills, headache, muscle aches, fatigue, nausea, and vomiting. In severe cases, malaria can cause anaemia, respiratory distress, cerebral malaria (affecting the brain), organ failure, and death if left untreated.Current interventions, such as insecticide-treated bed nets and antimalarial medications, have some success but they have failed to eradicate the disease. Consequently, new approaches are needed to tackle the persistent transmission of malaria.le the persistent transmission of malaria.)
A Case of Non-Human Gene Editing + ([[File:Ge3Image10.png|center|frameless|600 … [[File:Ge3Image10.png|center|frameless|600x600px]]'''Allele''': One of two or more versions of a gene. Organisms inherit one allele from each parent for every gene. Different alleles can produce variations in traits, such as eye colour or disease susceptibility. '''Cas9 (CRISPR-associated protein 9):''' An enzyme that acts like molecular scissors, capable of cutting DNA at a specific location, allowing for targeted gene edits. '''CRISPR-Cas9:''' A gene-editing tool that uses a protein called Cas9 and a guide RNA to cut DNA at specific locations, allowing for targeted modifications. '''CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats):''' A sequence of DNA found in the genomes of bacteria and archaea that provides a genetic record of viral infections, used as the basis for gene editing technology. '''Dominant trait:''' A trait that is expressed when at least one copy of the dominant allele is present. '''Ex vivo editing:''' A gene-editing technique where cells are modified outside the body (in a lab) and then reintroduced into the patient. '''Gene:''' A segment of DNA that contains the instructions for producing a specific protein or trait. '''Gene drive:''' A genetic mechanism that increases the likelihood of a particular gene being inherited by offspring, often used to spread specific traits through a population. '''Gene editing:''' The process of making precise changes to the DNA of an organism, either by adding, deleting, or altering genetic material. '''Genome:''' The complete set of genetic material (DNA) in an organism, including all its genes. '''Genotype:''' The genetic constitution of an organism, referring to the specific alleles an individual carries. '''Gene therapy:''' A medical approach that involves altering genes within a patient's cells to treat or prevent disease, often using tools like CRISPR-Cas9. '''Germline editing:''' Gene editing of reproductive cells or embryos, resulting in changes that can be passed on to future generations. '''Guide RNA (gRNA):''' A short RNA sequence that directs the Cas9 enzyme to the specific part of the genome that needs editing by matching its complementary DNA sequence. '''Horizontal gene transfer:''' The movement of genetic material between organisms in a manner other than traditional reproduction. '''In vivo editing:''' A gene-editing technique where the CRISPR-Cas9 system is delivered directly into the body to modify cells within the patient. '''Knock-in:''' A genetic modification where new genetic material is inserted into a specific location in the genome using CRISPR-Cas9. '''Knockout:''' A genetic modification where a specific gene is completely inactivated or "knocked out" to study its function or disable a harmful gene. '''Mendelian Genetics:''' The branch of genetics that studies how traits are inherited according to the principles discovered by Gregor Mendel through his work on pea plants. '''Mosaicism:''' If not all cells may receive the intended modification, this can lead to mosaicism whereby some cells carry the edited gene, while others do not. This is more commons when gene editing is done at the embryonic stage or in early development. '''Mutation:''' A change in the DNA sequence of a gene, which can alter the function of the gene or result in a new trait. '''Off-target effects:''' Unintended modifications made by CRISPR-Cas9 at sites other than the intended target, which can result in unwanted mutations. '''On-target effects:''' Even at the intended target site, gene editing can result in unintended changes. For example, small insertions or deletions that can alter the function of nearby genes or regulatory elements. '''Phenotype:''' The observable characteristics or traits of an organism, which are determined by its genetic makeup (genotype) and environmental factors. '''Recessive trait:''' A trait that is expressed only when two copies of the recessive allele are present. '''Somatic cells:''' All cells in the body except for sperm and egg cells. Somatic cell gene editing: Gene editing performed on somatic (non-reproductive) cells, affecting only the individual and not their offspring. '''Targeted mutation:''' A deliberate alteration in a specific gene sequence to study gene function or produce a desired trait. gene function or produce a desired trait.)
A Case of Non-Human Gene Editing + ([[File:Ge3Image2.png|center|frameless|600x … [[File:Ge3Image2.png|center|frameless|600x600px]]Let’s find out more about the proposed study. While working through the presentation, make a note of any points or questions that arise for you about the potential benefits and risks associated with this study.fits and risks associated with this study.)
A Case of Non-Human Gene Editing + ([[File:Ge3Image3.png|center|frameless|600x … [[File:Ge3Image3.png|center|frameless|600x600px]]Try to put yourself in the shoes of a person living in the target zone where malaria poses a great risk. You know many persons who have suffered with malaria and some who have died, including young children. You can watch this video to help you imagine what it might be like.to help you imagine what it might be like.)
A Case of Non-Human Gene Editing + ([[File:Ge3Image4.png|center|frameless|600x … [[File:Ge3Image4.png|center|frameless|600x600px]]What do you think? It’s clear that this ecologist would not want the study to go ahead. In your role as a member of a research ethics committee, do the concerns the ecologist has raised convince you that the study should not proceed?'''Feedback'''While we have considered some of the potential risks and benefits, we need a fuller picture to provide a firm foundation for ethical decision-making. For this case, that would likely require specialist knowledge from a range of experts. On the next page you can read about more of the potential risks and benefits that we identified.ial risks and benefits that we identified.)
A Case of Non-Human Gene Editing + ([[File:Ge3Image4.png|center|frameless|600x … [[File:Ge3Image4.png|center|frameless|600x600px]]The ecologist’s perspectiveAs an ecologist, I have serious concerns about the proposal to use gene drive technology to eradicate malaria-carrying mosquitoes. While the goal of eliminating malaria is undeniably important, the potential risks to ecosystems, biodiversity, and the natural world need to be carefully considered before taking such a drastic step.One of my main concerns is biodiversity disruption. Mosquitoes are not just pests; they play important roles in ecosystems. For example, male mosquitoes are pollinators for some plants, and many species of birds, fish, and bats rely on mosquitoes as a food source. If we wipe out a mosquito species, we could disrupt food chains in ways we can’t fully predict. Ecosystems are incredibly complex and fragile, so the extinction of one species can lead to a chain reaction, potentially causing other species to disappear. In regions that are already struggling with food security, this kind of disruption could lead to further ecological damage and even food shortages. The consequences could be devastating for both nature and the people who rely on it.Then there’s the issue of gene flow to non-target species. In the wild, mosquitoes sometimes interbreed with closely related species. There’s a real risk that the gene drive could spread to non-target mosquitoes, including those that don’t carry malaria. If that happens, we could see a dramatic drop in mosquito populations beyond what’s intended, affecting species that depend on them for food or pollination. Imagine what would happen if all mosquito species suddenly disappeared—we’re talking about a potential collapse of ecosystems that rely on them, creating ripple effects throughout the environment.And let’s not forget about ecosystem irreversibility. Once these gene drives are released into the wild, they’re self-propagating, meaning they spread on their own. If something goes wrong, there’s no way to take it back. We can’t hit an “undo” button on nature. This kind of irreversible interference with ecosystems raises ethical questions about how much we should be tampering with the natural world. We could be altering the balance of mosquito populations forever, and that’s a weighty decision to make.We need to be absolutely sure of the impacts before moving forward, because once this technology is out there, there’s no way to reverse it. We could be making changes to the natural world that we don’t fully understand, with consequences that could last for generations.sequences that could last for generations.)
A Case of Non-Human Gene Editing + ([[File:Ge3Image6.png|center|frameless|600x … [[File:Ge3Image6.png|center|frameless|600x600px]]Did we mention all of the potential risks and benefits that you noted? It’s actually very difficult to capture them all when thinking about a new technology that is to be used in a novel manner. There is always the chance of unforeseen impacts. Additionally, as technologies evolve, new knowledge is created, and our assessment of risks and benefits can change in the light of this new information. This can make ethics review more challenging, but of course, it is vital. So, what can we do?f course, it is vital. So, what can we do?)
A Case of Non-Human Gene Editing + ([[File:Ge3Image7.png|center|frameless|600x … [[File:Ge3Image7.png|center|frameless|600x600px]]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? impacts. Do you think this is sufficient?)
A Case of Non-Human Gene Editing + ([[File:Ge3Image8.png|center|frameless|600x … [[File:Ge3Image8.png|center|frameless|600x600px]]Releasing gene drive organisms into the environment could have transboundary impacts, and neighbouring countries or regions that are not part of the trial could be affected. This raises questions about who should regulate gene drives, how decisions should be made, and how to resolve conflicts between nations or regions with differing views on the technology.Given the potential for irreversible ecological changes, there is a need for strong oversight mechanisms to ensure that gene drive experiments are conducted safely and ethically. If something goes wrong, it is important to establish clear lines of accountability. Who will be responsible if the gene drive causes harm—researchers, institutions, governments, or international bodies?ons, governments, or international bodies?)
A Case of Non-Human Gene Editing + ([[File:Ge3Image9.png|center|frameless|600x … [[File:Ge3Image9.png|center|frameless|600x600px]]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?via less risky and/or less costly methods?)
Gene Editing: Technology Basics + ([[File:Gen Image2.png|center|frameless|550x550px]])
Gene Editing: Technology Basics + ([[File:Gene Image10.png|center|frameless|6 … [[File:Gene Image10.png|center|frameless|600x600px]]<div><div>CRISPR-Cas9 technology also has many implications for agriculture including the precise modification of plant genomes for crop improvement. Here are some examples:</div></div>'''Improved Nutritional Content'''CRISPR can be used to enhance the nutritional value of crops, for instance, via micronutrient biofortification of staple crops, to increase nutritional value. Biofortification is relatively new approach to dealing with deficiencies of micronutrients, especially in in low and middle-income countries. See, for example, the [https://www.goldenrice.org/ Golden Rice Project] in the Philippines where a gene has been genetically modified to contain beta carotene, a plant pigment that the body converts into vitamin A.'''Extended Shelf Life'''CRISPR technology can be used to prolong the shelf life of fruits and vegetables by modifying genes involved in ripening and decay processes, thereby helping to reduce food waste.'''Disease Resistance'''By targeting specific genes responsible for susceptibility to certain diseases, CRISPR can be used to develop plants that are more resilient to pathogens, potentially reducing the need for pesticides.'''Environmental Adaptation'''CRISPR technology offers the potential for developing crops that are better suited to changing environmental conditions. For instance, traits like heat or drought tolerance can be enhanced to help withstand extreme weather conditions. ce can be enhanced to help withstand extreme weather conditions. )
Gene Editing: Technology Basics + ([[File:Gene Image11.png|center|frameless|6 … [[File:Gene Image11.png|center|frameless|600x600px]]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.ntial misuse of gene editing technologies.)

Gene Editing: Technology Basics + ([[File:Gene Image12.png|center|frameless|600x600px]])

Gene Editing: Technology Basics + ([[File:Gene Image13.png|center|frameless|6 … [[File:Gene Image13.png|center|frameless|600x600px]]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-babieshelp-or-harm-first-ever-gene-edited-babies)
Gene Editing: Technology Basics + ([[File:Gene Image3.png|center|frameless|60 … [[File:Gene Image3.png|center|frameless|600x600px]]Gene editing is used in many different types of research, and for many different purposes. Work through the following presentation to hear about some of the different functions.'''Some functions of gene editing'''Gene editing is used for many different purposes. Here are some examples:'''Gene editing in organoids -''' Organoids are three-dimensional structures derived from stem cells that mimic the structure and function of human organs. Genome editing techniques can be applied to manipulate the genetic makeup of organoids, allowing researchers to study the effects of specific genetic mutations or modifications on organ development, function, and disease. For instance, genome editing can be used to introduce disease-relevant mutations into organoids, allowing researchers to assess drug efficacy, toxicity, and safety without the involvement of humans or animals.'''Gene editing and embryoids -''' Embryoids, also known as ‘synthetic embryos’, are three-dimensional structures derived from stem cells that mimic the early stages of embryonic development. They serve as models for studying embryogenesis, organogenesis, and developmental disorders. Gene editing techniques can be applied to embryoids to manipulate their genetic makeup, enabling researchers to investigate the role of specific genes in embryonic development and disease. For instance, via gene editing, researchers can introduce disease-associated mutations into embryoids, allowing them to study disease mechanisms, screen potential therapies, and develop personalised treatment approaches.'''Gene editing and xenotransplantation -''' Xenotransplantation involves the transplantation of living cells, tissues, or organs from one species to another. It holds potential as a solution to the shortage of human organs for transplantation. Gene editing technologies offer opportunities to overcome some of the barriers and challenges associated with xenotransplantation. For instance, gene editing can be used to modify the genomes of donor animals to make their organs more compatible with the recipient's immune system or to inactivate retroviruses genes thereby reducing the risk of viral transmission between species.'''Gene editing and reproductive technologies -''' Gene editing technologies have the potential to enable precise manipulation of the genetic material in gametes (the sperm and eggs), embryos, and reproductive cells. For instance, genome editing can be used in conjunction with pregenetic diagnosis and screening techniques to screen embryos for genetic abnormalities or disease-causing mutations and correcting them before implantation during in vitro fertilization (IVF). This allows for the selection of healthy embryos for transfer, reducing the risk of transmitting genetic disorders to offspring.ansmitting genetic disorders to offspring.)
Gene Editing: Technology Basics + ([[File:Gene Image4.png|center|frameless|60 … [[File:Gene Image4.png|center|frameless|600x600px]]Stem cells are undifferentiated cells that have the ability to develop into various types of cells in the body. This unique characteristic makes them incredibly valuable for research.[[File:Gene Image5.png|center|frameless|600x600px]]<div>The type of cells into which stem cells can differentiate depends upon whether they are omnipotent or pluripotent. Do you know what this means?</div>pluripotent. Do you know what this means? </div>)
Gene Editing: Technology Basics + ([[File:Gene Image6.png|center|frameless|60 … [[File:Gene Image6.png|center|frameless|600x600px]]Gene editing and stem cell research intersect in many different ways. For instance, stem cells, particularly induced pluripotent stem cells, can be derived from patients with genetic diseases. These cells can then be edited using CRISPR-Cas9 to introduce or correct disease-causing mutations, allowing researchers to study the underlying mechanisms of the disease in a controlled laboratory environment. This approach can also be used to screen potential drugs for treating genetic disorders. Additionally, by combining stem cell technology with gene editing techniques, researchers aim to develop more effective and targeted gene therapies for a wide range of disorders. There are three main types of stem cells, embryonic stem cells, induced pluripotent stem cells and adult stem cells. ipotent stem cells and adult stem cells. )
Gene Editing: Technology Basics + ([[File:Gene Image7.png|center|frameless|60 … [[File:Gene Image7.png|center|frameless|600x600px]]When gene editing is used for therapeutic purposes, it is known as gene therapy. Watch the following two videos to find out more about what gene therapy is, and some of the primary benefits.Gene therapy involves the introduction of genetic material or gene editing tools into cells to correct or compensate for a genetic defect, treat or prevent disease, or enhance cellular functions. Gene therapy falls into three main types: #Gene transfer therapy, which involves introducing new healthy genetic material into cells to replace or supplement defective genes.#Gene silencing, whereby small RNA molecules are used to silence or moderate the expression of specific genes. #Gene editing, which involves the introduction of gene-editing tools that can change the existing DNA in the cell. CRISPR-Cas9 technologies can be used to add, remove or alter genetic material at precise locations in the genome, correcting mutations or disrupting harmful sequences.Genetic material or gene-editing tools are inserted into a cell via a carrier (vector) that has been genetically modified to carry and deliver the material. Modified viruses are often used as vectors to deliver the genetic material or gene-editing tools by infecting the cell. The vector can be delivered intravenously into a specific tissue in the body, or a sample of the patient's cells can be removed and exposed to the vector in a laboratory. The cells containing the vector are then returned to the patient.e vector are then returned to the patient.)
Gene Editing: Technology Basics + ([[File:Gene Image8.png|center|frameless|60 … [[File:Gene Image8.png|center|frameless|600x600px]]For each of the following characteristics, decide whether it relates to somatic gene editing or germline gene editing.The key distinction between somatic gene editing and germline gene editing lies in the target cells and the heritability of the genetic modifications. Somatic gene editing involves making changes to the DNA of somatic cells, which are the non-reproductive cells of an organism.Germline gene editing involves making changes to the DNA of germline cells, which are the cells that give rise to eggs and sperm.Germline gene editing has the potential to address genetic diseases at the root level by correcting or eliminating the underlying genetic mutations in the germline. However, the use of germline gene editing is a topic of ongoing ethical and scientific debate due to concerns about safety, unintended consequences, and the potential for ‘designer babies.’, and the potential for ‘designer babies.’)
Gene Editing: Technology Basics + ([[File:Gene Image9.png|center|frameless|60 … [[File:Gene Image9.png|center|frameless|600x600px]]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. of the transmission of malaria parasites.)
Gene Editing: Technology Basics + ([[File:Gene-Tech1.png|center|frameless|600 … [[File:Gene-Tech1.png|center|frameless|600x600px]]'''What is gene editing?'''Genes are made up of sequences of DNA that are arranged at specific locations on chromosomes in the nucleus of the cells that make up an organism. Gene editing technology can be used to make precise changes to the DNA of living organisms, including humans, plants, and animals. It is also often referred to as genome editing because a change to specific genes also means a change to the genome.The genome consists of the entire set of DNA found in a cell, which in humans consists of around 20,000 to 25,000 protein-coding genes on 23 pairs of chromosomes, as well as a small chromosome in the cell's mitochondria.The goal of gene editing is to modify or knock out specific genes to achieve desired traits or to correct genetic defects. This is achieved by adding, removing, or replacing specific sequences using programmed proteins or protein/ ribonucleic acid (RNA) complexes.In this module we will consider how and why gene editing is used in both human and non-human applications as well as some of the associated risks.s as well as some of the associated risks.)
Critical Thinking, Standpoint & Ethics + ([[File:Glass and iron lattice 2.png|center|frameless|600x600px]] Since Kuhn, use of the word ‘paradigm’ has been broadened and nowadays people apply it in many different settings, but these are the key lessons.)
Critical Thinking, Standpoint & Ethics + ([[File:Glass and iron lattice.png|center|f … [[File:Glass and iron lattice.png|center|frameless|600x600px]]'''Video Transcript'''The concept of scientific paradigms was introduced by Thomas Kuhn in 1962 in the book: The Structure of Scientific Revolutions. By ‘scientific revolution’ Kuhn has in mind a major turning point in the development of science, such as is associated with Copernicus, Newton, or Einstein. Each of these figures initiated a spectacular change of course in the development of science, which is often characterised as a revolutionary change.<div>According to Kuhn, a scientific revolution is not so much a leap forward as a change of direction. When a scientific revolution occurs, science does not progress more rapidly along a pre-determined path, but rather sets out along a different path altogether.Researchers who share a paradigm will also share certain basic beliefs; they share a particular understanding of what science is all about, and how it can be pursued. In essence, they share a way of seeing the world. Once there is convergence on a paradigm, there is a framework in which problems can be solved, researchers in the field have a clear idea of where the problems lie, and of what might count as a solution to them. The researchers speak a common language.</div> The researchers speak a common language. </div>)
Research Ethics and Integrity: Governance and Processes + ([[File:GovProc img3.png|center|frameless|6 … [[File:GovProc img3.png|center|frameless|600x600px]]Research governance mechanisms typically include a system for ethics approval of research. For many types of research, including research with humans, human data or animals, ethics review is compulsory, and approval must be granted before data collection can begin. Reviews are normally undertaken by committees who seek to protect the interests of research participants, the institution, and other stakeholders.They also ensure that research complies with local and internationally accepted ethics guidelines and legal requirements. In many countries, these committees are known as research ethics committees or RECs. In other countries, they may be known institutional review boards (IRBs); ethics review boards (ERBs); or ethics review panels (ERPs). RECs are normally comprised of members from a range of disciplines or professional backgrounds to ensure relevant expertise and input from different perspectives. RECs must be free from influence by the researchers, funders or other stakeholders so they can provide an unbiased opinion.RECs have the power to authorise a project, request modifications or prevent studies that do not conform to accepted ethical norms and standards. There are different types of RECs. For instance, many countries have centralised systems for clinical research that involves patients or healthcare staff. Many universities have their own RECs and some have different RECs for different disciplines.RECs can have different templates and processes for applications, but all have the same basic requirements. They want to know:**About the research proposal - why the research is being conducted and exactly what it will involve**How the research and the researchers are complying with all the relevant legal and ethical requirements**What risks are associated with the project and how these are being mitigatedRECs have a critical role in upholding ethical standards in research. With their significant combined expertise, they can spot potential problems in research proposals and help to ensure that both researchers and participants are protected from harm. and participants are protected from harm.)
Research Ethics and Integrity: Governance and Processes + ([[File:GovProc img5.png|center|frameless|6 … [[File:GovProc img5.png|center|frameless|600x600px]]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).ecessary for a project (real or imagined).)
Research Ethics and Integrity: Governance and Processes + ([[File:GovProc img6.png|center|frameless|6 … [[File:GovProc img6.png|center|frameless|600x600px]]Requirements for ethics approval differ between institutions and some may insist upon completion of an ethics form for every study, even if just to make it clear that formal ethics approval is not needed. But other institutions may not even have a REC. What do you think researchers should do when they do not have ready access to a REC?en they do not have ready access to a REC?)
Research Ethics and Integrity: Governance and Processes + ([[File:GovProc10.png|center|frameless|600x … [[File:GovProc10.png|center|frameless|600x600px]]'''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., stakeholders, and the broader community.)
Research Ethics and Integrity: Governance and Processes + ([[File:GovProc7.png|center|frameless|600x6 … [[File:GovProc7.png|center|frameless|600x600px]]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.[[File:GovProc8.png|center|frameless|600x600px]]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.d ethics guidance as it becomes available.)
Research Ethics and Integrity: Governance and Processes + ([[File:GovProc9.png|center|frameless|600x600px]] 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.)
Research Ethics and Integrity: Governance and Processes + ([[File:Governance under torn paper.png|cen … [[File:Governance under torn paper.png|center|frameless|600x600px]]Research governance can be thought of as the broad range of regulations, principles, processes and systems that help to ensure good practice in the management and conduct of research. Governance regulations and systems aim to:*safeguard the interests of those who are affected by the research (for example, participants, researchers, animals, environments, society, and institutions),*foster accountability and trustworthiness, and*promote high-quality research.It is often repeated that research ethics was ‘born in scandal’ because its evolution has been repeatedly triggered by revelations about exploitation of participants in research. For instance, early medical experiments undertaken by physicians and biomedical scientist involved the use of vulnerable individuals (like orphaned children or prisoners) as ‘human guinea pigs’. History shows us that many of the early ethics codes and governance mechanisms were developed in response to such scandals in research. For instance, the Nuremberg Code was formulated in 1947, as a direct response to the abhorrent medical experiments by Nazi and Japanese doctors during the Second World War. While major scandals in research may not be commonplace nowadays, the development and refinement of research ethics codes and processes is ongoing as new ethical challenges and problems come to light. Today, there are a multitude of ethics codes, policies and systems for research governance at international, national, organisational, and institutional levels. Finding out which governance mechanisms are relevant to a research study is of primary importance for all researchers when designing and conducting research.rs when designing and conducting research.)
Research Ethics and Integrity: Governance and Processes + ([[File:Govproc img4.png|center|frameless|600x600px]] Francis Kombe shares his perspective as a REC chair working in Africa.)
Research Ethics and Integrity Basics + ([[File:Handful of pills.jpg|alt=handful of … [[File:Handful of pills.jpg|alt=handful of pills|center|frameless|600x600px|handful of pills]]What does the Declaration of Helsinki say about this?Placebos should only be used:''Where there are compelling and scientifically sound reasons why it is necessary to determine efficacy or safety, and the patients who receive placebo will not be subject to additional risks of serious or irreversible harm.''But how do we know what counts as compelling and scientifically sound? And how do we know whether people who receive placebo are being put at risk?As with many ethical guidelines, there can be disagreement about what they mean in practice. In this situation, when making decisions about the design of a study, it can help to remember the Golden Rule. Imagine yourself in the shoes of someone who is being invited to participate. What would you want to know and how would you want to be treated?know and how would you want to be treated?)
Gene Editing Case Study with Human Application + ([[File:Hunter syndrome block letters.jpg|c … [[File:Hunter syndrome block letters.jpg|center|frameless|600x600px]]Now that you know a little about the syndrome, imagine that you are the parent of a 12-month-old child who has been diagnosed with severe Hunter syndrome. Your child is being offered the chance to try a new experimental therapy for the disease, but the treatment is untested in humans.Are you likely to agree to their participation? Please select a response and then check to see how others have responded.==== Feedback ====Decisions about whether or not to participate in studies that are testing novel interventions can be challenging for anyone. Why not just let others take the risk in an experimental trial and wait to see what the outcomes are? For the parents or guardians of young children who are unable to consent for themselves, the decision-making is much more complex. As you work through the rest of the module, see whether you change your mind about your response. you change your mind about your response.)
XR in Research: A Case Study + ([[File:ImRe1.png|center|frameless|600x600p … [[File:ImRe1.png|center|frameless|600x600px]]'''Feedback'''Your opinions and assumptions about the use of XR and related ethics issues will likely be influenced by your prior experiences and understanding. How do you think your current understanding will impact upon your decision-making?As you work through this module try to keep these thoughts in mind and notice whether your opinions or assumptions about XR in research change. Even if you don’t have any experience of XR, as a REC member who is reviewing this project proposal, you are being asked to make an evidence-informed and balanced judgement call.If you are unfamiliar with the use of XR, it might be helpful to watch the following video about some of the benefits that XR has to offer.<div><div></div></div>hat XR has to offer.<div><div></div></div>)
XR in Research: A Case Study + ([[File:ImRe4.png|center|frameless|600x600p … [[File:ImRe4.png|center|frameless|600x600px]]'''Cybersecurity'''# Does the XR device/technique include protection mechanisms against adversarial attacks (exploiting system vulnerabilities) or hacking?# Are robust data security measures, such as encryption, implemented to protect stored data from unauthorized access or breaches?# Is the XR device susceptible to misuse or diversion? Is misuse plausible?<div><div>As you can see from the above exercise, the inclusion of XR in a research project can raise a broad and complex range of ethical issues that require attention from the research ethics committee for a variety of purposes. Some of the items on the checklist are relevant to assessment of the potential harms and benefits, some to the assessment of legal compliance and so on. The research ethics committee have a lot of factors to consider. Use of the document The use of XR technologies in research: A checklist for research ethics committees will help them spot these factors so that they can fulfil all aspects of their role effectively.</div></div><div></div>ts of their role effectively. </div></div><div> </div>)
XR in Research: A Case Study + ([[File:ImRe4.png|center|frameless|600x600p … [[File:ImRe4.png|center|frameless|600x600px]]'''Participant wellbeing and non-maleficence'''#Will the use of XR in the project under reasonable conditions cause or exacerbate physical problems, e.g. motion sickness, eye strain, or fatigue? If so, are appropriate mitigation measures in place such as regular breaks during sessions or monitoring of participants for signs of discomfort?#Will the use of XR in the project under reasonable conditions cause or exacerbate psychological problems, e.g. emotional stress, anxiety, or dissociation? If so, are appropriate protocols in place for managing emotional distress and offering support (e.g. mental health resources or professional support)?#Are measures in place to monitor participants for potential cognitive or psychological impacts over time?#Will the use of XR in the project under reasonable conditions cause lasting personality effects (e.g., detachment from reality, altered social behaviours)?#What measures are in place to limit offensive, harmful, or violent behaviours in the virtual environment? Are there clear and accessible ways to mitigate and report such behaviours?'''Autonomy and nudging'''# Is the XR technique likely to undermine the autonomy of participants? What measures are in place to ensure that XR interactions with avatars (including AI-powered avatars) do not violate participants’ personal space or autonomy? # Are potential emotional triggers (e.g., fear or joy) justified by the research goals and managed appropriately? Are appropriate measures in place to avoid or minimise the risks of emotional manipulation or excessive nudging in the virtual environment?# Will participants be fully aware of the nature of the study, the role of XR technologies, the nature of the technologies and any potential impacts on their mental or physical state? Is information provided in a clear and comprehensible manner? # Is the system likely to expose users to catfishing (deception)? Is deception explicitly used in the project? If so, is it minimal, justified, and followed by debriefing?'''Inclusivity and accessibility'''# Does the project ensure inclusion of diverse demographic groups (e.g., gender, age, cultural backgrounds)?# What measures are in place to ensure sensitivity to cultural and societal norms in the design of virtual environments and interactions? # Are people with disabilities involved in or affected by the project? If so, are accessibility measures planned? # Does the project purposefully exclude certain groups of individuals (e.g. people with disabilities)?dividuals (e.g. people with disabilities)?)
XR in Research: A Case Study + ([[File:ImRe4.png|center|frameless|600x600p … [[File:ImRe4.png|center|frameless|600x600px]]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?panies) have access to participants’ data?)
Biobanking: Technology Basics + ([[File:Image.png|center|frameless|600x600p … [[File:Image.png|center|frameless|600x600px]]Biobanks are specialized repositories that collect and store biological samples and information from various sources (animals, plants, microorganisms, humans, etc.). The focus of this module is on human biobanks, which collect and store biological samples from human donors (e.g., saliva, urine, blood) and health-related data (e.g., health records, family history, lifestyle, genetic, occupational, residential information, etc.) for research purposes and the development of new diagnostic procedures, preventive measures, and treatments. Some biobanks collect health-related data from donors throughout their life, and researchers may continue to access and make use of this data after donors’ demise.These repositories play a crucial role in advancing biomedical research, by providing scientists with access to a diverse array of high-quality biological materials and continuously updated health-related data. Biobanks ensure the preservation of sample integrity, allowing for researchers to conduct longitudinal studies and other investigations into various health conditions at multiple scales.For instance, by analyzing samples and data, researchers can search for biological markers, investigate the relationship between biological markers and the sensitivity of diseases to treatment, the aggressiveness of diseases, progression, risk of death, as well as study the genetic and environmental factors that influence the development of certain diseases.Legal instruments and guidance govern biobank operations to protect the autonomy and dignity of donors, along with their fundamental rights (e.g., private life and data protection) while also advancing the societal benefit of conducting research to address the key public health challenges.Overall, biobanks contribute significantly to the progress of medical science and personalized medicine.medical science and personalized medicine.)