Data sharing agreements between parties protect against data misuse and promote early communication among the group about the questions of data and sample handling and use. To ensure that research data can be made available for future reuse, it is important that consent for future reuse of data/samples by other researchers is always sought from their participants. Consent must be appropriate for the country and institution where the research is undertaken, but in general terms participants must always be informed as to how their research data/sample will be stored, preserved and used in the long-term, and how their confidentiality will be protected. This information must be apparent in every Patient Consent Form. This consortium ensures sensitive data/sample is available for reuse by implementing strict procedures and regulations that set conditions for how the data can be accessed and used, and provides a framework for data sharing agreements as per GDPR , GCP and local guidelines. Anonymized data are exempt from the General Data Protection Regulation (GDPR).
- The Requester (person/institution who wants the data/sample) must complete the relevant sections of the E-DLB Consortium <<‘internal E-DLB Consortium Request for Data/Sample Sharing’>> and send to the E-DLB Steering Committee for approval/ comments.
- Once agreement has been given by the Steering committee, the Requester will further discuss with the Provider. It is the responsibility of the individual Principal Investigators (P.I.) to make arrangements with the provider for the transportation and delivery of the material. All costs will be met by the requesting PI unless otherwise negotiated.
DATA OWNERSHIP:
Each Centre owns their own data. For specific and approved projects, each center can grant permission to use their data in multicenter analyses. Data from other centers cannot be used without specific permission. (see chapter five of this document) The E-DLB Castor database has secure center-specific elements, and only the E-DLB PI and Project manager will have access to the full database, i.e. all data from each center. Data Entry is site specific. Internal data monitoring will be conducted with a random selection of ten patients for compliance to data entry. When specific reports are required, the steering committee must by informed for permission to action.
AUTHORSHIP AND PUBLICATIONS
The general rule is that projects and publications are undertaken by members of the E- DLB, and that for each publication authorship must comply with ICJME authorship rules and would comprise of
a) The team responsible for the leadership of the project and
b) For each center contributing data, one person will be offered co-authorship, which needs to comply with authorship rules.
c) Any center that contributes more than 40 cases or 10% of the total study cohort is a candidate to have two authors per center, otherwise other authors must be added (researchers who provided data or contributed to the manuscript) in name of the E-DLB Consortium.