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Access Policies for the BBMRI-ERIC Directory

BBMRI-ERIC Access Policy

Here you can find the BBMRI-ERIC Policy for Access to and Sharing of Biological Samples and Data.

This access policy presents three areas of guidance:

  1. ethical principles;
  2. governance procedures; and
  3. practical procedures for access.

Together with existing legal frameworks, these three areas provide the ethical and legal framework and practical procedures to guide access to and use of biological samples and associated data, as well as to tools and resources developed by BBMRI-ERIC. This policy is a binding document for BBMRI-ERIC itself, for BBMRI-ERIC Partner Biobanks, and for any requesters, who are seeking access to samples/data from BBMRI-ERIC Partner Biobanks via BBMRI-ERIC. It will not supersede access policies and procedures of individual biobanks but will provide a framework that BBMRI-ERIC Partner Biobanks must adhere to.

This policy will be amended/changed in accordance with changes in the regulatory framework.

Access Policy for CRC-Cohort

The Access Policy of BBMRI-ERIC applies also for access to the centrally collected data set of the CRC-Cohort, with the following exception:

Step 3 of the Access Procedure in the case of the CRC-Cohort is handled directly between requester and BBMRI-ERIC. For controlling access to the data set, BBMRI-ERIC has an Access Committee (see Appendix I) comprising all the contributing partner biobanks, in order to ensure the due data release approvals are in place, particularly when releasing pseudonymous (personal) data. After the access is approved by the Access Committee, BBMRI-ERIC signs a DTA with the requester for the use of the data for the particular project. The DTA also transfers liability on the requester to ensure due data security measures when processing the data.

Setup of Access Committee:

  • The Access Committee is comprised of Data Manager of the CRC-Cohort, one appointed person from Common Service ELSI for the ethics check, and one medical expert on colorectal cancer nominated by BBMRI-ERIC.

Operations of Access Committee and involvement of contributing partner biobanks:

The Access Committee is expected to deliver the decision within 1 month of submitting the request, based on the following procedure:

  • After receiving an access request (project proposal), the Data Manager checks whether the access request conforms with the formal requirements: (a) the identity of the requester is known and their institutional affiliation is provided, (b) the request contains project description.
  • If the formal requirements are fulfilled, the medical expert assesses relevance of the
    project to the scope of CRC-Cohort.
  • If the project is within the scope, Access Committee performs Ethics Check procedure (Appendix G) (either Expedite or Full, depending on whether sufficient previous ethics vote has been provided).
  • If all the previous steps conclude successfully, Access Committee asks all the contributing partner biobanks for veto of the release. If only subset of the CRC-Cohort is requested, only those partner biobanks are contacted, who actually contributed the data specifically subject to the release. The biobanks will be given 14 days for submitting the veto (so that 1 month overall for providing the Access Committee decision is achievable).



European emblem EU The Access Policy was created within ADOPT BBMRI-ERIC, a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 676550.

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The website was co-funded within ADOPT BBMRI-ERIC, a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 676550.
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