Questions and answers
Where does the research material of the FinnGen study (samples and data) come from
The study will utilize biobank samples which are collected in connection with patient treatment or research projects. Biobanks are collecting biological samples based on a separate biobank consent, which enables the use of samples and data for various kinds of research. Old, valuable sample collections have been transferred to biobanks by communicating the transfer either by a letter to the participant or in newspapers, if the transfer concerns a large group of people. The transfer and use of samples can be denied any time.
Why would I participate in the FinnGen study? What are the benefits?
By participating in the FinnGen research, as in any biobank research, you can promote medical research. The breakthroughs achieved by medical research in the prevention and treatment of diseases will ultimately benefit all of us.
If I give my consent/sample to a biobank, will my sample end up in the FinnGen study?
Very likely so. In the FinnGen study, the samples gathered by nearly all biobanks in Finland will be used in this project. Samples will be needed from all parts of Finland. The larger the material available for research, the more accurately we can identify, for example, the factors impacting individual risk of developing disease or drug responses.
How can I learn to know if my sample is part of the FinnGen study?
By contacting the biobank to which you have given your consent. Additionally, our website contains information on those research projects the samples of which have been transferred to the THL Biobank. Through the biobanks you may receive information in what kind of research your own samples have been used. All Finnish biobanks have been registered in a register maintained by Valvira. A biobank is operating, available for all Finns, in every region in Finland in connection with university hospitals. In addition, there are also other biobanks. The contact details of all biobanks can be found at: https://www.biopankki.fi/en/finnish-biobanks/.
How can I participate in the FinnGen study?
Should you wish to join participate in the FinnGen study, familiarise yourself with the biobank activities of your own region. You can find further information about how to give your biobank consent at the www.biopankki.fi website.
Can I give a biobank sample, but forbid the use of my sample in the FinnGen study?
The biobank consent is fully voluntary and can be withdrawn any time. If you wish to forbid the use of your biobank sample in the FinnGen study, please contact the biobank of your area. Biobanks have various practices in terms of how they are capable of processing research specific or other restrictions.
How can I withdraw the biobank consent I have given?
The biobank consent can be withdrawn any time with no need to tell the reason. The withdrawal is done in writing as instructed by each biobank. You can find the contact information of biobanks on the www.biopankki.fi website.
Who can make use of my samples?
Biobank samples can be used for medical research project approved by the biobank. The FinnGen study is based on extensive cooperation. The project involves researchers from both research institutions and companies. All data in the research project is coded for processing. The coded genome and health data is stored in an information system maintained by the University of Helsinki. Only the persons nominated by the organisations involved will have access to the system.
In the FinnGen stydy, what is examined out of the sample that I have donated?
DNA will be isolated from the sample in order to produce genome data. In the FinnGen research, the genome data of 500,000 Finns will be combined with data derived from various health registers. Using this data, the researchers will search for associations between individual genetic differences and diseases.
Can my samples or data be delivered abroad?
The right of ownership of the samples and data used in the FinnGen research will remain in Finland. In the FinnGen study, the analysis of the DNA samples will be subcontracted to a reliable company operating outside Finland. The company is not allowed to use the genome data for anything, but will return it to Helsinki University in Finland to be used by the FinnGen research. No copy of the genome data will be left with the company. Both Finnish and international organisations are involved in the research project. The researched nominated by them will have access to the research material consisting of coded genome data and health data to perform the analyses. The system has been built in such a way that the information contained in it cannot be saved or copied.
How is the sample collection and operation of biobanks financed?
A major part of the basic financing of biobanks comes from their host organisations, hospital districts and universities. The projects which utilise the samples and data are charged for a compensation of the expenses caused by delivering the samples and data. The aim is that the operation would correlate with the expenses.
How will the FinnGen research project be financed?
The main financiers of the FinnGen research project are Business Finland and eleven international pharmaceutical companies. The large scope of the project will call for efficient sample collection and the making of costly genome analyses, information system investments and researchers with expertise. This can be implemented by financing the research project.
Are my samples now going to be sold to pharmaceutical companies?
No, they are not. The pharmaceutical companies involved in and financing the project will not become owners of the samples or the data related to them. The FinnGen project is based on extensive and open cooperation. New medication is always developed by the pharmaceutical industry. The FinnGen study will involve nearly all parties which participate in drug development, and owing to the research the parties cooperate in an open and genuine way. Through cooperation, the making of new findings and development of treatments is accelerated, which finally will benefit the patients requiring treatment.
Will the Finns in particular benefit from the study?
It is of importance for Finnish health care and individuals that medical research is done using material which originates from the Finnish population. In this way we will receive information about the impact of our genome variants in the pathogenesis of diseases. It is known that genome variants have an impact on the efficacy and safety of drugs. Therefore, the new drugs that may be developed in the future will probably be suitable specifically for us. The FinnGen research will not, however, have an impact on their price in Finland. From the viewpoint of our national economy it is, however, beneficial if the health of our population can be promoted more efficiently and the burden of diseases can be reduced.
What is the role of pharmaceutical industry in the project and how do pharmaceutical companies benefit from this?
The companies are partners of the project and on top of that they are financing the research together with Business Finland. The benefit gained by pharmaceutical companies will be created through research results. At the moment only a fraction of drugs entering the drug development chain will end up in the market. The research will help the companies receive data related to the efficacy and/or safety of prodrugs which will help them make decisions on molecules to be selected for further development. Thus the aim is to boost and to accelerate drug development.
Is my data stored securely? How do you ascertain information security and can you guarantee it?
Information security is managed with utmost care, and the data of the participants is coded for processing. In the FinnGen research (as in all biobank projects) the participants’ data are coded and processed in a high information security environment, the access rights of which are carefully monitored. The FinnGen study has nominated persons responsible for information security and data protection, whose job is to supervise the information security of the research subjects. We have also had an outside party specialised in the matter to make an assessment on the data protection and security of the project. The risk for misuse of information is very minor.
Can there be any harm to me from participating in the research?
According to the law, the research material and biobank data can only be used for this research. The data must not be given to outsiders, such as insurance companies, employers or for administrative decision-making, genealogies or for criminal investigation. If, nevertheless, despite all precautions, the project were subject to a data breach and the data ended up in wrong hands, according to our current understanding linking the coded data back with the examined persons would be possible in certain exceptional cases only. As regards genome data, linking it with individuals would only be possible when the crackers also had control data in their use, for example, if the participant or his/her near relative had loaded his/her genome data to public databases. Health data can in some cases be more pointing to an individual, which is why the data derived from registers is modified to be less pointing before the research project receives the data.
Who makes the decisions concerning the FinnGen project?
The project is based on a consortium agreement between all parties. A steering group has been established for the project with members equally representing all parties involved. The steering group makes the decision on all central matters and monitors their realisation. The chief science officer with the main responsibility is professor Aarno Palotie. Project Manager Anu Jalanko will be responsible for practical and administrative matters. The University of Helsinki will be responsible for the research and maintaining the research register.