Estonian Genome Center, University of Tartu
Scheme 1
Data and sample collection at the Estonian Genome Center, University of Tartu
2 The Structure of Governance at the EGCUT
The EGCUT is registered in a database of research and development organisations at the Ministry of Education and Research of Estonia.
The director of the EGCUT is elected to office for a five-year period by the University government, and the seven to nine members of the supervisory board are appointed for 5 years by the rector of the University of Tartu. These members comprise the director, and representatives from the Faculty of Science and Technology and the Faculty of Medicine plus others as required by the EGCUT director. The EGCUT director is the chairman of the supervisory board.
The EGCUT also has an international steering committee, whose five members meet once a year to assess the development plan and its progress.
The quality management system certificate ISO 9001:2008, which regulates all standard operating procedures (SOPs) performed by the EGCUT and authorised processors and data collectors, has been in place since 2003.
3 Historical Overview: From Private to Public
The original project was presented to the public and politicians in 1999 after the Estonian Government reached an agreement that the planning of the project could begin. The Estonian Genome Project Foundation was developed by the Government of the Republic of Estonia in 2001. The first data were collected in a pilot project in October 2002. From 2001 to 2004, the project was a public-private partnership. The private investor funded the project through the company EGeen Ltd, which had a twenty-five-year licence to use the anonymous data in the biobank.
By the end of 2004, the database contained a little more than 10,000 tissue samples and phenotype data entries.
In 2003, conflict arose in the Estonian Genome Project. The vision for the gene bank’s activities differed between the investors and the public sector. The private sector wanted to concentrate more on specific disease groups but the public sector wanted to continue the creation of a population-based biobank. In November 2004, the licensing and financing contract with private investors and with the company EGeen was terminated. The activity of the Genome Project stopped for a few years, as extended negotiations between scientists (under the leadership of Professor Metspalu) and politicians endeavoured to find a way to finance it, to continue data collection, and to achieve the goals developed in 2001.
This discussion ended in 2006 when the Government of Estonia approved a budget to cover these costs (to begin in 2007), and the project was incorporated into the University of Tartu. Active data collection was then restored and, by the end of 2009, the EGCUT database included more than 41,000 tissue samples and phenotypes. Initially, funding was obtained from the Estonian Government through three ministries: the Ministry of Social Affairs, the Ministry of Education and Research, and the Ministry of Economic Affairs and Communications. However, now that the active data collection phase is complete, the activity of the EGCUT is financed by the Ministry of Social Affairs alone. The EGCUT is now a publicly funded biobank.
4 Legal Framework: The Human Genes Research Act and Other Regulatory Activity of the EGCUT
The activities of the EGCUT are required to be based on internationally acceptable norms of ethics and good practice in order to protect the rights of participants and guarantee the success of the project by avoiding fragmentation of societal solidarity and ensuring public acceptability and respectability. The data collected by the EGCUT will be useful for a very long time and can be used repeatedly, since there is no expiry date for its use. As the developments and opportunities of genetic research are unpredictable, it was seen necessary to regulate the process of data collection for the genetic database.
Legal regulations were prepared by an international workgroup under the leadership of Bartha-Maria Knoppers. The Human Genes Research Act (HGRA) was founded on two international regulations dealing with genetic research: UNESCO’s Universal Declaration on the Human Genome and Human Rights (1997) and the Council of Europe’s Convention on Human Rights and Biomedicine (1997). The HGRA was prepared in 1999 and was passed by the Parliament of Estonia on December 13, 2000.
According to the HGRA and the Data Protection Act, the chief processor of data for the EGC is the University of Tartu and the data also belong to the University of Tartu (HGRA Chap. 3 article §15).
The HGRA was passed because it ensures the confidentiality and privacy of each participant. The main goals of the HGRA were to regulate the maintenance of the EGCUT, to organise the necessary genetic research, and to protect people from misuse of their genetic data and discrimination based on the interpretation of the structure of their DNA and any genetic risks arising from that.
The main provisions of the HGRA were to describe:
1.
the conditions for processing tissue samples, descriptions of DNA, descriptions of the state of health and genealogies in the gene bank;
2.
the rights and obligations of gene donors, the chief processor and other authorised processors of the gene bank, and of genetic researchers, in relation to tissue samples, descriptions of DNA, descriptions of the state of health and genealogies;
3.
the conditions for the establishment and maintenance of the gene bank;
4.
the restrictions on the use of tissue samples, descriptions of DNA, descriptions of the state of health and genealogies collected by the gene bank; and