How will personal data be protected?
Information about an individual’s genome is highly sensitive personal information, and FarGen handles information in accordance with the Personal Data Act (Persónsupplýsingarlógin). All samples and data will be encrypted and stored anonymously at the Genetic Biobank. Data will be produced, stored and analysed on computers with strictly restricted access. The data will only be processed globally as a whole set, and therefore nothing can be concluded about your concrete genetic traits. This also means that no personal data will be published that may lead back to you. The researchers who are allowed to access data from the FarGen database will only be allowed to access anonymised data.
Can I withdraw my samples and data from the FarGen project?
Participation in the project is voluntary and you can withdraw from the project at any time and request that your blood sample is disposed of. You will not be required to provide any explanation or reasons for your withdrawal. You may also request to have your blood sample given to you, but a special reason would be required for this, such as medical treatment or testing. Please contact the Genetic Biobank if you wish to withdraw from the project. If you withdraw your consent to participation, this will in no way affect any future treatment you may need from the public health services. Data that has already been used for a project will be kept. Any unused data will be erased.
Who has access to my personal data?
Your participation in FarGen is strictly confidential, and no personal data will be published. Your data will only be available under a number, which in no way reveals who you are. Only staff at the Genetic Biobank and researchers working on authorised projects will have access to the anonymised data. The only persons with the key to the anonymity, i.e. access to both your name and number, are the clinician responsible and IT staff at the Genetic Biobank. If a research project is launched, which needs your data, your consent will be required. Such research projects must always be approved by the Research Ethics Board, Data Protection Agency and Genetic Biobank before they can start, and access will only be granted to anonymised data.
I have previously donated blood samples to research. Can FarGen use those samples?
No, FarGen cannot use blood samples drawn for other purposes. A new blood sample will be needed and when it is taken you will also have to sign a so-called informed consent, where you declare that you have received sufficient information about the project and about your participation.
Am I entitled to receive information about me?
No. In this project your genome will be read and digitalised. FarGen will not examine what the data says about the potential medical conditions or traits of each individual. Data will only be processed globally, which means that no information will be available about your concrete inherited characteristics. You will therefore not receive any feedback when you participate in this project and you are not entitled to any information about yourself. However, genes may be found by chance, which could cause serious illness. If this illness can definitely be prevented or treated, the clinician responsible has a duty to inform you about what has been detected and to make sure that you receive thorough information and genetic counselling.
Do I have a right to ask not to receive any information found about me?
Although the FarGen project will not test for specific medical conditions or genes in individuals, genetic defects causing serious medical conditions may be detected by chance. If it is possible to prevent or treat this condition, the clinician responsible for the project has a duty to notify you and offer you expert advice.
Can my family become involved in the project because of my participation?
Although the FarGen project does not examine any individual for concrete medical conditions or specific genes, by chance genes may be found, which could cause serious illness. If this illness can definitely be prevented or treated, the clinician responsible has a duty to inform you about what has been detected and to offer you genetic counselling. Should this happen then it may have consequences for your family, because they may carry the same genetic defect as you.
What are the risks of participating?
The potential risks of participating in the project are mainly: • that breaches of confidentiality and data security can occur • that hackers and thieves access the data • that although this project does not examine any individual for concrete medical conditions or specific genes, by chance genes may be found, which could cause serious illness. If it is possible to prevent or treat this condition, the clinician responsible has a duty to inform you and to offer you expert counselling.
How much information can be found with genome testing?
Genome testing is still in its infancy and researchers are still studying which knowledge genome data can convey. However, genome testing can already be used to find indications of medical conditions and the physiological traits of individuals. Information obtained exclusively through genome testing can, however, still be complex and imprecise. At present, it is therefore only possible to make predictions about monogenic conditions by genome testing, meaning conditions caused by a single genetic defect. The available knowledge is still too limited to assess polygenic conditions by genome testing (refer to the dictionary).
Will my sample and data be used for projects other than FarGen?
One of the main purposes of the FarGen project is to develop a platform that will generate opportunities to research Faroese genes. Your samples and data will, however, only be used for projects that you consent to take part in. FarGen’s database will only be available to research projects that are authorised by the Research Ethics Council, Data Protection Agency and Genetic Biobank.
How will data be protected?
Data will be produced, stored and analysed on computers with strictly restricted access. The data will only be processed globally as a whole set, and therefore nothing can be concluded about your concrete genetic traits. This also means that no personal data will be published that may lead back to you. Research projects will only be granted access to anonymised and encrypted data, and researchers will therefore not know who owns the data or samples they are working on.
Who will access the data?
Staff at the Genetic Biobank has access to the data. Researchers working on an authorised research project can only access anonymised data if you grant access for that specific project. All research projects must be authorised by the Research Ethics Council, Data Protection Agency and Genetic Biobank in order to access data in the FarGen database.
How unique is my genome?
Each individual’s genome is unique, because no DNA helix is the same. However, the human genome has many shared traits. There is a natural similarity between the genome of parents and children, but the genomes of residents in isolated areas with limited immigration also display clear similarities. When a person’s DNA helix (genome) is read, a precise calculation can be made of how much that individual’s genome differs from an average genome, for example the Faroese reference genome. As a fun fact, we can mention that, on average, a human genome only differs from that of a chimpanzee by 4%.
Is it possible to use my genome to identify me if the data is published?
No individual genomes or data will be published from the FarGen project. However, if we imagine that each participant’s genome were made public one by one it would, at present, not be possible to identify individual participants, unless other personal data were also accessed. It is possible, however, that in future data from the genomes of all Faroese people might be accessible to doctors and hospitals. In that case, genome data could be linked to the individual through the public health services system. If this should becomes a reality, there would be a need for data storage solutions with strict security protocols in order to protect personal data.
Is it possible to patent a genome?
It is not possible to patent natural genes or genomes. It is, however, possible to patent artificially made sequences (e.g. for biotech production) and knowledge obtained by researching genomes or individual genes.
Can genome data be used commercially?
It is possible to patent knowledge obtained from genomes. This knowledge can be used commercially, for example in the case of knowledge that can be translated into concrete outcomes such as diagnostics or medicines.
How is FarGen funded?
FarGen has been allocated an appropriate in the Faroese national budget. In addition, the Danish Parliament has granted DKK 10 million over a period of two years to sequence the genomes of the first 1,500 Faroese people. Work is underway to also secure funding for preparing a Faroese reference genome.
Will FarGen participants be offered any payment?
No. A general principle of research ethics is that no payment is offered for taking part in scientific research. Participation must be voluntary and not linked to any expected financial gain.