BBMRI.cz (as well as BBMRI-ERIC) is focused on providing access to human biological material and data. Therefore, the applicability of “open access” in the common sense of this phrase is legally limited (e.g., only possible to very specific datasets, either anonymized with very low residual risks of re-identification or subject to very special informed consent because of inherent privacy risks related to large-scale sensitive human data sharing). This has been recognized Europe-wide and the newer paradigms no longer refer to “open access” but rather to FAIR access principles: Findable, Accessible, Interoperable, and Reusable.
The aim is to ensure the findability of biobanking and biomolecular resources using the Directory tool that contains aggregated information about biobanks, their samples and data collections.
Therefore, the word “accessible” does not assume “wildly open access”, but rather accessibility under well-defined preconditions including any restrictions applicable to human material and data.
In order to exchange biological samples and data, collaborations between biobanks is required. This makes it possible to facilitate the reuse of bio-resources and related data by harmonising biobanking and biomedical research.
Data are issued with a clear and appropriate licenses for their use and also correspond domain-relevant community standards.
Summary of biobanking policy
Taken together, the access policy of the BBMRI.cz to its services is compliant to:
- Local and European legislation on access to the human personal data as outlined in the OECD guidelines;
- Data Protection Directive 95/46/EC and relevant national regulations on data security and privacy protection;
- ESFRI charter on access to the RIs; and
- BBMRI-ERIC Access Framework document submitted as a part of H2020 ADOPT BBRMI-ERIC project in Fall 2016, which is expected to turn into BBMRI-ERIC Access Policy during 2017.
The European legal landscape is profoundly influenced by the upcoming General Data Protection Regulation (GDPR – approved in 2016 at European level, in force from May 2018). BBRMI-ERIC is already leading efforts to harmonize application of GDPR to medical research using Code of Conduct on the European scale. Codes of Conduct will define specific guidelines for different domains where GDPR is applicable and their existence is presumed by GDPR itself.
BBMRI.cz works with Ministry of Health within a working group under the coordination of Deputy Minister of Health on contributing to the Code of Conduct as well as on the national implementation of GDPR for purposes of the medical research in the Czech Republic.