The biobank's right to process samples and related data is based on the biobank consent given to the biobank by the sample donor. Consent given to the biobank is voluntary and sufficient information must be given prior decision-making. Consent must also be given in writing. By giving their consent, the donors authorise the storage of their samples in the biobank and their use in biobank research, the disclosure of their personal data, the merging of register data concerning them and other processing of the sample and the data obtained from it within the scope of the biobank research. Consent can be withdrawn and can also be modified.
An exception to consent as the primary main grounds for processing are the old diagnostic samples and research samples taken before 1 September 2013, which, notwithstanding confidentiality provisions, can be transferred to the biobank. Before the transfer, information on the change to the intended use of the samples and related data must be communicated to the persons concerned. The donor may prohibit the transfer of samples and data.
Everyone has the right to know whether their samples and data are being kept in the biobank and where they have been obtained. In addition, every person has the right to know to whom samples and data taken from the biobank have been disclosed. Upon request, the sample donor also has the right to receive the data concerning his/her state of health that has been specified in biobank research from his/her the samples. The person must also be provided with an opportunity to obtain an explanation of what the data means. A fee may be charged for determining the meaning of data, but this must not exceed the costs of providing the information.
Fimea's guidance for collecting biobank data and samples from minors
According to section 11(3) of the Biobank Act, consent is given on behalf of a minor by their guardian. This consent must be in accordance with the minor's presumed wishes. The Act does not lay down age limits for minors. Instead, the criteria for the assessment are the age and level of maturity of the minor. If the minor, given their age and maturity, is able to understand the significance and nature of biobank research, their written consent is also required.
It is essential to ensure that, before requesting consent, a child or young person deemed sufficiently mature is provided with a sufficient account of the nature of biobank research, possible adverse effects, voluntary consent and any matters laid down in section 11 of the Biobank Act. Information on biobank activities must be provided in the most clear and understandable manner possible.
Fimea recommends that biobanks approach registered minors no later than the point when the person reaches the age of 18 and obtains full self-determination. A person of adult age must be provided with information on biobank activities and the possibility to independently decide on their future participation in these.