Genomics: Ethical, legal and social analysis
Today, DNA can be “read” much faster and cheaper than just a decade ago. Genetic testing can reveal information about the health of adults, children, and foetuses. At the same time, another new technology for gene editing has become available: CRISPR/Cas9. It allows for modification of DNA in humans. In the future, this may be used to cure diseases. Yet, some uses of these technologies raise serious ethical concerns that need to be considered carefully.
How can we benefit from knowing our DNA information? What are the risks of sharing genetic data? Should we modify the genome of human embryos in laboratories? The SIENNA project will address these and other ethical, legal and social aspects of genomic technologies using a structured approach.
We started our work with a state-of-the-art review of the field to define what our analysis of the ethical, legal and social implications (ELSI) of human genetics and genomics should cover. In the next steps we:
- Analysed legal documents, including human rights requirements that are relevant to genomics
- Surveyed guidance documents for research ethics protocols and professional ethics codes.
- Identifyied and analysed current and potential future ethical issues related to genomics.
The SIENNA project also engaged a wide range of stakeholders through workshops, surveys and citizen panels. Input from these stakeholders and surveys of public opinion informed our analysesa and proposals.
Proposals for the ethical management of human genetics and genomics
We have developed proposals for the ethical management of human genetics and genomics:
- Recommendations for enhanced regulation
- Code of conduct for genomic data sharing
- Operational guidance for ehics self-assessments of genetic and genomic research
These proposals were presented at the SIENNA final conference.
Ethical impacts of human genomics
Human genomics will significantly impact society, values and human rights. What will change for the better, and what will change for the worse? Which values could change and who will be most affected?
Enhancing EU legal frameworks for genomics
The existing EU legal frameworks (e.g., clinical trials and advanced therapy medicinal products, data protection, in vitro diagnostic medical devices, medical devices, and fundamental rights) are relevant for regulating human genomic technologies and should be able to cope with many of the challenges that they pose. However, SIENNA research 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 and to further the right to enjoy the benefits of scientific progress and its applications. This brief presents some of the urgent actions required and recommendations for the European Union institutions, and the Member States.
Santa Slokenberga. (2021, January 31). Enhancing EU legal frameworks for genetics & genomics research, SIENNA project Policy Brief #2 (Version 2.0). Zenodo. http://doi.org/10.5281/zenodo.4554977
This brief is also available in Greek: Santa Slokenberga. (2021). Βελτιώνοντας το ευρωπαϊκό νομικό πλαίσιο για την έρευνα στη γενετική και τη γονιδιωματική-Σύνοψη πολιτικής του προγράμματος SIENNA αρ. 2 (2.0). Zenodo.https://doi.org/10.5281/zenodo.5550551