Legal requirements for the use of human genomics technologies

The SIENNA project's ethical guidelines for human enhancement research and development have just been published in Science. They cover a broad range of interventions, drugs, treatments and other technologies that can improve human abilities, that fall outside the scope of medical interventions.

The SIENNA project's proposal for an international Code of Conduct for data sharing in genomics was recently published in Developing World Bioethics. Want to know more? 

Want to take a look at our ethical frameworks for AI & Robotics, Human Enhancement and Genetics & Genomics? The last of the SIENNA project's reports were recently made public on Zenodo and are now available for download!

SIENNA was announced a champion project at the World Summit on the Information Society prizes award ceremony on 31 May 2022. The WSIS Prizes contest was developed after requests from stakeholders to create a mechanism to evaluate projects and activities that have leveraged the power of information and communication technologies to advance sustainable development in different ways. 

The SIENNA project has issued a series of policy briefs that have now been translated to Greek!

Ethical principles alone are poorly equipped to engage with and address the impacts of artificial intelligence (AI). Whether it be material impacts or the generation of socio-political issues, high-level ethical principles don’t always offer the tools needed to address them. In a recent Open Research Europe paper, SIENNA’s Anaïs Resseguier and Rowena Rodrigues advocate for AI ethics that pays attention to context.  

The European Parliament STOA panel organised a workshop on 23 March that took its point of departure from current discussion and legislative agenda in relation to artificial intelligence. Together with the SHERPA and PANELFIT projects, SIENNA helped move the discussion beyond AI to find out how can we build on what was learned from that discourse to prepare for the next wave of scientific and technological advances. Miss the workshop? The event was recorded and is now available for everyone to watch!

Technological developments and breakthroughs often bring shocking and spectacular changes to society. Highly complex, disruptive and transformative, they challenge human values, freedoms and societies. To maximise the benefit for society and minimise potential harms, we need to understand and address the ethical and social implications of new and emerging technologies. Making sure we are not forgetting marginalised and vulnerable populations. As the SIENNA project ends, a new Horizon2020 project begins. Building on our results to bring ethical and societal values into the design and development of new and emerging technologies. Want to know more? We suggest you sign up to the TechEthos newsletter and follow them on Twitter!

On 5 March 2021, the SIENNA project organised a webinar to present and discuss outcomes from our work on addressing societal concerns in public research funding. Miss the webinar? Don't worry, a recording of the presentation by Nicole Santiago is now available!

Some human enhancement is controversial socially and morally. They promise the advancement of humanity, but also introduce serious risks to health and well-being, freedom, and equality. Human enhancement research and development can be missed in ethical and legislative review. The field is broad, and enhancement potential can be difficult to predict, especially if such potential is not actively sought. In all cases, guidance is needed. The SIENNA project just published a policy brief that aims to addresses the need for policies aimed at ethical guidance for research, development and deployment of human enhancement technologies.

The SIENNA project ended on 31 March 2021. The results of our 3,5 year project were presented at a three day conference: Discussing the ethical and human rights issues raised by emerging technologies, and the methods and instruments propose to govern need for ethical guidance and governance of emerging technologies. We have recorded our presentations on regulation, innovation policies, research ethics frameworks, Ethics by Design methodologies, education and training progammes, standards, and certification. Did you miss the event? Don't worry! We recorded it!

Trust and transparency in artificial intelligence (AI) are hotly debated themes and central to the responsible governance of this expanding technology field. The Ethics and Society Subproject of the Human Brain Project (HBP) has developed an Opinion to further the debate on key ethical and social issues that arise from the use of AI. It draws on findings from social science and humanities research, including a series of consultancies, webinars and workshops with citizens, scientists, policy makers and other stakeholders.

In the SIENNA Final Conference on 11 March 2021, we facilitated a session on AI and robotics: regulatory and policy recommendatiions. The session was led by Rowena Rodrigues form Trilateral Research and covered SIENNA legal analysis work for AI and robotics and our recommendations. SIENNA’s objective in its legal analysis work and recommendations is to support and ensure ethical and human-rights respectful ​design, development, deployment and use ​of AI and robotics technologies​. During the session, we asked our audience to share their views live with us on two questions. Curious about the results?

Human genomics, human enhancement, artificial intelligence and robotics offer benefits for both individuals and society. But these technologies also challenge human rights and our notions of what is ethical. SIENNA has developed frameworks and proposals for the ethical management and legal regulation of human genetics and genomics, technologies for human enhancement, artificial intelligence and robotics. Interested to know more? We have published a policy brief summarising the key messages that can be drawn from the SIENNA project!

National policy-makers should ensure that any changes in legislation responding to AI and robotics are fit for purpose and in accordance with the country’s international obligations, especially with regards to human rights and societal values. There is need for legal clarity and guidance.

We invite you to an online event that takes its point of departure from the current discussion and legislative agenda of AI. Focusing on issues and challenges in need of particular attention, and how can they be addressed: Moving beyond AI to find out how can we build on what was learned from that discourse to prepare for the next wave of scientific and technological advances. The SHERPA, SIENNA and PANELFIT projects have been involved in developing the programme and panels, and now we invite you to join the STOA panel on 23 March!.

Both public research funders and researchers have an obligation to the public to ensure that research has a positive impact on society, which includes addressing concerns and mitigating potential harm. Societal concerns about new and emerging technologies relate to ethical, human rights, and socio-economic impacts – many of which were identified in the SIENNA project. Join us online on Friday, March 5 at 13.30 CET to discuss methodology for identifying and addressing societal concerns in public research on new and emerging technologies!  

The existing EU legal frameworks are relevant for regulating human genomic technologies and should be able to cope with many of the challenges that they pose. However, SIENNA has identified various gaps and challenges that must be addressed in order to ensure ethical and human rights respectful design, development, deployment, and use of genomic technologies, On our recent policy brief, we list some of the urgent actions required and recommendations for the European Union institutions, and the Member States.

Patients are key stakeholders in genomic research. On January 18, the SIENNA project organised a webinar to present our proposal for operational guidelines for ethical self-assessment of research in genetics and genomics. The webinar was designed to enable patient organisations, patient advocates, patients and their to give informed input in this process. A recording is now available on YouTube!

Between 11-25 January the SIENNA project shared proposals for public consultation. The documents outline ways to suppor the ethical management of human genetics and genomics, technologies that can be used to enhance human abilities, artificial intelligence and robotics. The input will now feed into the reports we submit to the European Commission. Want to know more? Join us on 11-12 of March when we present the results from the project at our final conference!

The SIENNA project is coming to an end. We invite you to an online event on 10-12 March where we will present and discuss our results and proposals for the ethical management of human genomics, human enhancement, artificial intelligence and robotics. And how the SIENNA approaches can be generalised to other new and emerging technlogies.

Monday 25 January is the last chance to give input in our public consultation on proposals for the ethical management of new and emerging technologies. Don't forget to submit your feedback on our documents!

In practice, existing EU legal frameworks like human rights, data protection, product liability and safety, are fully applicable and should be able to cope with the challenges posed by AI and robotics, and other emerging technologies. SIENNA has identified various gaps and challenges that must be addressed. In our first policy brief, we list some of the urgent actions required and make recommendations for European Union institutions. 

Most genetic disorders are rare and research is necessary to develop treatments for future patients. The SIENNA project has developed stakeholder informed proposals for the ethical management of new and emerging technologies. One of these proposals is an operational guidance for ethical self-assessment of research in genetics and genomics. Patients are key stakeholders for this research. Therefore, the SIENNA project invites patient organisations, patient advocates, patients and their carers to a webinar explaining the proposal with the aim to ensure patients are able to give informed input in this process.

New technologies challenge our notions of what is ethical. The SIENNA project has developed stakeholder informed proposals for the ethical development, deployment and use of new and emerging technologies. Between 11-25 January we invite you to a public consultation of a group of documents with concrete ethical guidance for human genetics and genomics, human enhancement, artificial intelligence and robotics! Want an invitation? Subscribe to our newsletter to make sure you receive information the minute the documents become available.

In the past couple of years many national and international organisations issued ethics guidelines for artificial intelligence (AI).  But the efforts to address ethical issues in AI in other ways have not reached the same prominence.  In the SIENNA project, we have developed an ethical framework for AI and robotics that rests on a multistakeholder strategy that moves far beyond ethical guidelines. 

PhD students are expected to reflect on ethical aspects of their research projects. This requirement is stated in legal premises and regulatory frameworks for academic institutions around the world. When applying for research funding researchers are also expected to make an ethical assessment related to their proposed research project. SIENNA has developed an ethical framework for human genomics. This has been translated to operational guidelines for ethics self-assessment. On 11 January 2021, we invite you to take part in a public consultation. Want to know more? Sign up to receive the documents!

Applications that use artificial Intelligence are trained on large sets of data and often build on other systems. This means that any bias in the data can multiply across different AI applications and cause significant harms. A recent paper from SIENNA points to the legal and human rights implications of AI and calls for an agile approach, not just to AI development, but also to the laws that regulate technology. In her paper, Rowena Rodrigues issues a call to developers and legislators to pay attention to the impact of AI on vulnerable populations.

Neurotechnological developments could shift focus away from complexity and careful consideration of the human condition. In a recent paper, SIENNA’s Yasemin J Erden writes about the convergence of neuroscience, neurotechnology, psychiatry, and artificial intelligence for diagnostic processes. And how taking an over-optimistic approach to technology developments might result in a simplistic view on complex issues like mental illness and psychiatric disorder. 

Education and exercise can enhance our abilities. So can technology: in the form of implants, drugs, genetic enhancement or machines. This comes with ethical, legal and social challenges. On 14 December, SIENNA invites you to participate in a webinar on ethical guidelines for technologies that can, or could, be used to enhance human abilities. 

On 13 November 2020, we submitted our response to the United Nations Committee on the Rights of the Child (the Committee) draft General Comment No. 25 on children’s rights in relation to the digital environment. Our key recommendation is to address children’s rights in relation to all digital technologies. Additional recommendations include adopting stronger ‘red lines’ on digital technologies that impact children, calling for AI that respects children’s rights, and addressing concerns related to digital inequality. 

Until recently, human enhancement technologies were mostly science fiction. Today, implants, drugs and prosthetics are available to enhance human abilities. Despite intense discussions in society and academia, few efforts have been successful in establishing ethical guidance for the use and development of these technologies. Could now be a good time to develop such guidelines? SIENNA researchers are trying to find out. Curious? Download our report! 

On 16 October 2020, the SIENNA project submitted its response to the UNICEF public consultation on draft Policy Guidance on AI for children. Our key recommendations were to address concerns related to “digital inequality”, call for AI that respects human rights, and adopt a stronger stance on problematic technologies.

On 30 October 2020, the SIENNA project submitted its response to the French National Pilot Committee for Digital Ethics (CNPEN) public consultation on the ethics of conversational agents, what is more commonly known as 'chatbots'. Our key recommendations were to reduce the anthropomorphisation of chatbots and conduct impact assessments to identify risks and harms. 

SIENNA findings show that attitudes to human enhancement technologies and research on the genetics of human intelligence vary greatly across different economic, cultural, and social landscapes. One potential way to enhance human abilities, including our cognition, is by interfering in IVF processes. So far, the ethics debate has centred on gene editing using the CRISPR technique. However, there is not as much talk of embryo selection as a method for genetic human enhancement. In a recent publication, Marcelo de Araujo emphasises the need fill this gap. 

Technology used in genetic and genomic research are slowly making their way from research to patients and consumers. This raises ethical, legal and social questions for both individuals and society. We asked 11,000 people in 11 countries about new and emerging technologies. On average, half of respondents were familiar with genetics and DNA. But despite saying they had heard or read about it, a large majority of them said that there is a need for better public understanding of genetics and genomics. Want to know more? Read our report! 

Implants, drugs, genetic enhancement and prosthetics can enhance human abilities. But using technology for human enhancement comes with ethical, legal and social challenges. As a society, we need to discuss the ethical questions of what is normal, what is natural, what is moral and what can be permitted. SIENNA asked 11,000 people in 11 countries what they think about technologies that can be used to improve human abilities. It turns out that South African, Greek and Brazilian respondents were most positive towards the use of different human enhancement technologies, while people in Germany, the US and France were more hesitant. Curious about what they think we should and should not enhance? Read our report! 

Robots and artificial intelligence have caught the public’s imagination. A survey of public attitudes to these technologies in eleven countries shows that people feel uncomfortable with robots that look and behave like humans. A study from the SIENNA project shows that people expect both society and their lives to change as a result of increased use of artificial intelligence and robotics. And they expect inequalities in society to increase with it. 

SIENNA has carried out an extensive ethical analysis of human genetics and genomics. We have identified a number of ethical, legal, and social issues both relating to new and emerging technologies within the next 5-10 years. You will find them outlined in our ethical analysis report. 

On 10 September 2020, the SIENNA project submitted its response to the European Commission public consultation on the Inception Impact Assessment for a regulation of artificial intelligence. Our key recommendation was to adopt an EU-level legislative instrument establishing mandatory requirements, complemented by a voluntary labeling scheme.

Artificial intelligence is developing faster than the ethical frameworks that regulate it. This requires AI ethics that can to adapt to the new and unexpected. Today, the Ethics Blog writes about a call by SIENNA researchers Anaîs Rességuier and Rowena Rodrigues to move from a legal notion of ethics to one that can adapt to new situations.

Ethics has powerful teeth that are not used in the ethics of AI today. In a recently published paper in Big Data & Society, SIENNA’s Anaïs Resseguier and Rowena Rodrigues describe how the teeth of AI ethics are lost with the current “law conception of ethics”.

On 30 July 2020, SIENNA project submitted its response to the UNESCO Online Consultation on Ethics of Artificial Intelligence. We suggest bringing human rights to the fore and focusing on ethical principles that relate to the interaction between AI systems and their environment, including human beings.

Although there are no international research ethics codes or guidelines for the broad overall topic of human enhancement, we have surveyed selected relevant codes and guidelines for technologies that can be used for this purpose. If you want to know more about specific angles on particular contexts, often national or focused on application areas, we are able to offer you a large body of codes and guidelines!

On 13 June 2020, SIENNA project submitted its response to the European Commission public consultation on the White Paper on AI. Our key recommendation was to change the focus of the proposed regulatory framework. Instead of aiming at building consumers’ and businesses’ trust in AI in order to speed up the uptake of the technology, the objectives of the framework should be driven by fundamental rights and societal values.

The SIENNA project recently published its key report “Ethical Analysis of AI and Robotics Technologies”. This 223 page report provides the most comprehensive and up to date overview of ethical issues in AI and robotics available today. Philip Brey, SIENNA coordinator will present the highlights in an open webinar on 1 July at 13:00 CEST!

Want to better understand legal developments and regulatory approaches related human enhancement? The SIENNA project has documented and delivered a critical assessment of the legal issues raised by human enhancement technologies in and outside the EU. We looked at the national, EU and international level. If you want an analysis of EU law and international and regional legal orders in relation to human enhancement, we suggest you download our report!

On 22 May 2020, SIENNA and SHERPA projects, jointly provided feedback on the European Parliament Committee on Legal Affairs Draft report with recommendations to the Commission on a framework of ethical aspects of artificial intelligence, robotics and related technologies (2020/2012(INL) based on the findings and results of the SHERPA and SIENNA EU-funded projects.

We need expert and stakeholder input, because regulating new and emerging technologies raises questions that require broad discussion. The SIENNA project would like to invite join our webinars on 17 June 2020 to discuss how to enhance the legal frameworks for human genomics, human enhancement, artificial intelligence and robotics technologies. Depending on your area of interest, you can join one, two or all of them!

The SIENNA project has documented and delivered a critical assessment of the legal requirements in relation to the use of artificial intelligence and robotics on the national, EU and international level. In the report, we identify the relevant international and regional law and discuss a range of legal and human rights issues. If you want an analysis of EU law and international and regional legal orders in relation to artificial intelligence and robotics, we suggest you download our report!