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European 1 million genome project is still advancing Despite legal obstacles
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European 1 million genome project is still advancing Despite legal obstacles.
The European One Million Genome Project was proposed in April 2018 to allow researchers in the region to obtain 1 million genome data, while legal obstacles to the privacy of suspected citizens have always existed.
At present, the 1 million genome project is currently exploring various methods to make this diverse system interoperable while minimizing interference with any national legislation. At the same time, the EU is also actively promoting the establishment of this large and rich genome data set.
A European initiative is to allow researchers in the region to have access to 1 million genome data by 2022. The initiative is working to achieve this goal the best way to solve legal problems.
Since data is stored at the national level, this means restrictions on cross-border data sharing. Investigators involved in this work are exploring new mechanisms for providing data, and at the same time promised to expand and maintain this initiative after 2022.
Regina Becker, a research scientist at the University of Luxembourg, is concerned about the ethical and legal issues of the project.
She said that the goal of the project is to provide 1 million genomes for cross-border research in Europe based on technology, language, and legal interoperability, which will require “great efforts” by member states, especially considering the existence of protecting the privacy of European citizens. Legal obstacles.
The project is currently working hard to obtain the final framework of 1+MG and a clearer idea of how to implement the framework.
The 1+MG plan was proposed in April 2018. Representatives of 22 European Union countries, as well as the United Kingdom and Norway signed the statement, promising to complete the sequencing of 1 million genomes and make them available to researchers by 2022.
Some countries, including France, Ireland, Poland, and Switzerland, are official observers of the plan, but have not yet signed the declaration.
Although the concept of sharing 1 million genomes seems achievable in three years, the legal framework for doing so remains a challenge. Different countries impose different legal restrictions on sharing genomic data.
For example, the Nordic countries tend to associate data sharing for research purposes with the public interest, while southern European countries often require the consent of the person who provides the database with the sample before sharing the data.
According to Becker, the 1+MG project is currently exploring various methods to make this diverse system interoperable while minimizing interference in any country’s legislation.
One solution proposed is that when national laws restrict the use of genomic data, these data sets can be accompanied by additional instructions on the use of data, a so-called flexible method.
However, researchers will still find such restrictions to be troublesome, and there may be different potentially conflicting rules that apply to the same data set.
Therefore, the initiative is also exploring the idea of unified legislation around data sharing, that is, all signatories have the same rules on genomic data sharing.
The main goal is to be consistent with the European General Data Protection Regulation (GDPR). Becker said this allows EU member states to impose additional restrictions on the sharing of genomic data and healthcare data, as well as other rules and requirements, such as safeguards for scientific research data processing.
According to Becker, the efforts of the 1+MG project have been directed by EU research. She pointed out that the European Commission has commissioned several studies to explore these issues. For example, the EU Ministry of Justice investigated all national regulations based on the opening clauses of the Convention.
The Ministry of Health and Food Safety has focused on implementing the European General Data Protection Regulations to support health data. Although these studies are very helpful, they are only part of the European data protection framework, that is, sharing health data and genomic data for secondary use.
Becker added that under the current circumstances, 1+MG cannot bypass national legislation protecting genetic data, and the initiative itself cannot reshape the European legal framework.
However, she pointed out that 1+MG does not operate in isolation. The EU is currently setting up a European Health Data Center (EHDS), which should promote the exchange and access of different types of health data including genomics data. EHDS is constructed in a way that protects individual data and is consistent with GDPR.
This work will include the development of new European legislation around the use of healthcare data across borders. The European Commission is in contact with member states to achieve EHDS goals, an effort that overlaps with 1+MG’s ambitions.
Therefore, in the next step, what 1+MG hopes to achieve by 2022 is not to achieve seamless interoperability, but to adopt ethical and legal frameworks internally to support future interoperability. However, considering the current challenges of data sharing, I think it would be a great achievement to have this framework.
In order to support 1+MG, the European Commission allocated 4 million euros (4.7 million US dollars) last year to fund a related coordination and support project called “Beyond 1 Million Genomics”. When it was established, the goal was to connect research infrastructure, academia, and other stakeholders to develop legal guidance, best practices, and recommendations, and achieve more than 1 million genome projects.
B1MG started operations in June 2020 and will continue until May 2023. Part of its authority is to support the goals of the 1+MG program by defining requirements, formulating guidelines, and developing models that support long-term operations. The ultimate goal is to maintain a secure cross-border technical infrastructure to support cross-border data access and the introduction of genomics into the healthcare field in the future.
This will include standardized sequencing data and recommendations for linking phenotypic and clinical information. In addition to the legal challenges that Becker talked about, there are also language issues, such as the 27 or more languages contained in electronic health records.
Establishing and maintaining technological infrastructure is not without challenges, but the project is making progress, focusing on proving a concept through standards and service workflows to access genomic data for rare diseases, most of which will be applicable to other use cases: Cancer, common complex diseases and infectious diseases.
This year, the B1MG project also conducted virtual country visits to Estonia, Finland and the United Kingdom to observe how different countries participating in 1+MG use and manage genomics data. Regarding the legal challenges facing the project, Scholen emphasized that these problems will be overcome.
Scholen said: “Personalized medicine is the future, no matter how complicated and uncertain it may seem now.” We have recently seen that in the public health crisis of infectious diseases, many obstacles to infrastructure and data sharing have been overcome. Scholen said: “We need to unite as researchers, industry, funders, government and citizens to be able to collect and access large, rich data sets.”
European 1 million genome project is still advancing Despite legal obstacles
(source:internet, reference only)