Banks of biological material have been established to foster biomedical research. The ethical and legal frameworks of biobanks activities are still under discussion due to their relative recent emergence. Activities of BBM 1FM CU are carried out according to current Czech legislation and ethical standards of biomedical research found in international conventions and recommendations. One of the BBM 1FM CU highest priorities is a protection of biospecimens and donors’ health data from the potential misuse. Privacy, voluntary donation of biological material and control over the scientific use of samples and data are the main ethical standards BBM 1FM CU is devoted to.
The goal of BBM 1FM CU is to develop into a trustworthy institution with transparent system which can guarantee the ethical standards of biospecimens and data use. Therefore, biobank closely cooperates with Ethics Committee of General University Hospital which guarantees the independent ethical governance over BBM 1FM CU activities. All updates of the documents used are submitted for assessment to the Ethics Committee, it is informed about essential aspects of the activities of the BBM 1FM CU and, where appropriate, provides an opinion on the research use of samples and data stored in the biobank.
Link to the website of the VFN Ethics Commission:
https://www.vfn.cz/odbornici/eticka-komise/informace-o-eticke-komisi-vfn/
Privacy
BBM 1FM CU pays due attention in its activities to protecting the confidentiality of information about the health status of donors and preserving the anonymity of their samples in research. All samples of biological material are stripped of all identifying information and marked with a code before being processed for long-term storage. Under the same code, information (e.g. on the health status of the donor) that is important for further research use of the sample is stored in the BBM 1FM CU database. If the sample is used in a research project, it is always given to scientists only under a code designation, as well as information about health status. The identification data of the sample donors is never given to the scientists, so they always remain an anonymous person for the scientists.
Voluntariness
All biospecimens and associated data are stored at BBM 1FM CU upon the consent of their donors which are informed in advance about nature and aim of biobank, conditions of sample and data storage and potential use of samples including genetic research. Potential donors can freely decide about their participation in BBM 1FM CU. Their decision doesn´t affect the health care they receive. Donors can withdraw at any time and their samples will be discarded and associated data removed from biobank database.
Ethics of research
Approval committee of BBM 1FM CU reviews received applications to permit the access to the stored samples and data and its use in research. First, ethical aspects of the application are reviewed concerning the use of samples according to biobank ethical standards and aims. The access to the stored samples and data is permitted only when used for research field specified in the donor consent. The following main criteria include the scientific impact and accuracy, credibility and competence of the applicant and the institution where the research will be performed. This way BBM 1FM CU ensures the effective use of biospecimens in research while protecting privacy of donors. If applicable, the review is requested from the Ethics Committee of General University Hospital which guarantees the independent ethical governance over BBM 1FM CU activities.
