For each biomedical research project, the prior approval of the relevant ethics committee is required. The inclusion of any single participant in such a research project is preceded by his/her written informed consent with prior information and instruction. The inclusion of the participant in the research has no impact on his/her ongoing treatment. Under no circumstances more biological material shall be collected from the participant than necessary for immediate research purposes. After the collection, the samples are registered in the MEDIXBANK database and used exclusively for scientific and academic purposes. Participants do not receive any financial reward for their participation in the research. In cases where the provision of their sample for research leads to scientific or medicinal progress with commercial application, they shall not be entitled to a profit share or any other financial compensation.

The processing and use of personal data are governed by the provisions of Act No. 576/2004 Coll. on health care, services related to the provision of health care, and amendments and supplements to certain acts, as amended (hereinafter referred to as the Act on Health Care) and applicable legislation in the field of personal data protection, in particular, Regulation (EU) 2016/679 of the European Parliament and the Council on the protection of natural persons with regards to the processing of personal data and on the free movement of such data, and Act No. 18/2018 Coll. on the protection of personal data and amendments and supplements to certain acts, as amended (hereinafter collectively referred to as the GDPR Regulations).
The prerequisite for the inclusion of participants in a biomedical research project (hereinafter referred to as research) is the provision of information and the signing of informed consent under § 27 par. 1 and 4 of the Act on Health Care, which contains all information related to the research. The inclusion of a sample of the participant’s biological material in the MEDIXBANK database is always preceded by his/her express written consent. In the event that a participant does not have the legal capacity to grant such consent, his/her legal representative may grant it on their behalf. Inclusion in the research, refusal to be included or withdrawal of consent shall have no impact on the ongoing treatment of the participant, nor shall they have any other adverse consequences for the participant on the part of MEDIXBANK or its healthcare professionals.

The research exclusively uses pseudonymized and anonymized data. The data of research participants will be processed under an assigned identification number. Participant’s personal data and identification numbers will not be freely available and will be protected in an electronic database with access granted only to the professional staff of MEDIXBANK. In the case of the exchange of information and biological material with third parties, this exchange shall only take place in anonymized form. Only anonymized data will be published (without providing information that could lead to the identification of a specific sample donor participating in the research). As part of the research, MEDIXBANK will process the personal data of the research participant (including data on their state of health and samples of biological materials) in compliance with the applicable GDPR Regulations for scientific and academic purposes (i.e. to conduct research) and the related provision of health care (§ 18 and § 26 of the Act on Health Care).”
The participant may withdraw their informed consent to participate in the research at any time without providing any specific reason for doing so. Subsequently, his/her data and biological samples will be removed from MEDIXBANK.

Each MEDIXBANK project is regulated and pre-approved as biomedical research under Section 26 et seq. of the Act on Health Care. Individual activities of MEDIXBANK concerning research participants are carried out by professionally qualified healthcare professionals in compliance with the Act on Health Care as the provision of health care.

MEDIXBANK is operated by MEDIREX GROUP ACADEMY n. o., the non-profit organization with its registered office at Novozámocká 1/67, 949 05 Nitra, Company ID: 37 986 805, registration: Nitra District Authority, reg. no.: VVS/NO-6/2021, as a health care provider with a permit issued by the Ministry of Health of the Slovak Republic for the provision of health care under Act No. 578/2004 Coll. on health care providers, healthcare professionals, professional organizations in health care and on amendments and supplements to certain acts, as amended.