Give your biobank consent to Auria Biobank

Auria Biobank’s info sheet for giving consent and approval

You are being asked for your consent to allow your samples and related data to be collected in Auria Biobank. This concerns samples that will be taken from you in the future as well as previously collected samples (e.g. taken in connection with medical examinations and diagnostics). We also request your approval to link to the sample your health data and information concerning factors affecting your health, so that they can also be assigned for research purposes from the biobank. Transferring samples and data related to the samples to the biobank requires both consent and approval.

A biobank is a unit, as referred to in the Biobank Act (688/2012), that is supervised by a regulatory authority and which collects samples and sensitive data (especially health and genetic information) related to the samples for medical research. The legal basis for processing personal data in the biobank is the public interest related to public health, in accordance with the Biobank Act and the EU’s General Data Protection Regulation (2016/679), Article 6(1)(e), and Article 9(2)(i). The biobank grants access to samples and data for domestic and international research projects. Once the research is completed, the results obtained from the samples are returned to the biobank for use in new research.

Biobank samples and data. Samples may be collected during treatment or while taking part in a medical study, and sometimes specifically for the biobank. Previously taken samples can also be transferred to the biobank. Auria Biobank operates in the wellbeing services counties of Southwest Finland, Satakunta and Ostrobothnia. The wellbeing counties also own the samples, unless otherwise has been agreed in the transfer of the samples. Samples may consist of, e.g. tissue (biopsy; fine-needle, bone marrow and exfoliative cytology samples; surgical tissue samples), blood, bodily fluids (urine, saliva, mucus, stool) or DNA or cells isolated from the samples. General information about the sample and the donor is attached to the sample: i.e. age and sex, as well as health information (e.g. diagnoses, medical procedures, treatment, lab results, imaging records) and sample-based data, such as genome information. Additional data may be collected from the donor, patient records, another biobank, national social and healthcare registers (such as the Care Register for Social Welfare and Health Care, Cancer Registry, Social Security Institution’s special reimbursement register), medical and Statistics Finland’s registers or material collected in a research project, and linked to the biobank’s material on a research-specific basis when access to the biobank’s materials is granted for biobank research.

Giving consent and approval. Giving consent to the collection of samples and approval to linking data is voluntary. You can give your consent and approval by submitting the signed form to Auria Biobank or by returning it to the medical staff. The form can be found on the website www.auria.fi/biobank or it can be mailed to you. People over 18 can also give their biobank consent and approval at www.auria.fi/consent/ . Healthcare services will be available to you as usual, even if you do not give your consent and approval. The granted consent and approval enter into force once the biobank receives information thereon, and the consent and approval are valid indefinitely. The consent and approval given to Auria Biobank apply only to Auria Biobank.

Cancellation of consent, and/or exercising the right to object. You can cancel your consent before giving a sample or at the latest before granting access to your sample and its related data to the biobank. You can also object to the processing of your sample and data by the biobank at any time, without giving a reason and with no negative consequences (EU General Data Protection Regulation, Article 21, Right to object). You can cancel your consent and/or exercise your right to object by submitting the signed refusal form to Auria Biobank or by returning it to the medical staff. The form can be found at www.auria.fi/biobank or it can be mailed to you. People over 18 can cancel their consent and/or exercise their right to object at www.auria.fi/refusal/ . The right to object applies to all samples and data and cannot be restricted or limited. The cancellation of consent, and/or exercising the right to object, enters into force once the biobank receives information thereon. Once the biobank has received the refusal form, your samples and data will no longer be collected or used, nor will they be assigned for new research. The cancellation of consent, and exercising the right to object, with Auria Biobank apply only to Auria Biobank.

Benefits and drawbacks for the donor. Generally, no immediate treatment benefits are to be expected by giving the biobank consent to access samples and data, as the biobank exists primarily for research purposes. The biobank cannot guarantee the quality of the data from the analyzed samples or that the research will reveal information that is significant for you or which can be used by you or by health care. The biobank handles the samples and data in compliance with the data security requirements that apply to confidential information. The name and other identifiers of the donor of the sample are replaced by a code, and the code key is stored separately. It is nearly impossible to identify an individual based on the encoded data. Access to samples or data with identifiers can only be granted if there is a justified need for it, for example, in order to link previous data collected by a researcher to the biobank’s samples or data. Access to samples and data can also be granted for research in countries outside the EU and EEA, in which case the level of statutory data security may vary. Data security is ensured by encoding samples and data and by drawing up detailed contracts regarding how they are handled. The biobank’s samples and data cannot be used in criminal investigations, in administrative or other decision-making involving the donor, in evaluating or determining the donor’s capacity to work or in decision-making by credit and insurance institutions.