We will develop this guideline in the style of Minimum Information Checklists that researchers are already familiar with.
Minimal Information can be used on its own for the manual reporting of projects and resulting human datasets, particularly in scenarios where the data is to be shared for secondary use. In addition, the guideline can be picked up by the developer teams of DAISY and ERPA to eventually upgrade them and introduce new interoperability features into these tools.
Research data from human subjects that is not of an anonymized nature is considered personal data and as such it is subject to the EU GDPR regulation. For research projects, the GDPR entails, among others, increased record keeping requirements throughout the data lifecycle, starting from data’s collection through to its deposition to repositories for secondary use – typically under controlled-access regimes. The said records are expected to contain a GDPR-oriented characterisation of data subjects and data sets, the legal grounds and the nature of data processing, the parties involved, allowed data uses and retention periods as well as logs of report-worthy activities in the data lifecycle, such as data transfers.
- Research support staff responsible for GDPR compliance
- Researchers processing sensitive data
- Researchers with knowledge of JSON schema and JSON-LD
Initial work was done on BioHackaton Germany 2022 under project named "Towards a minimum information checklist for biomedical research projects with sensitive human data (only remote)" with following team composition: Pinar Alper (PNED), Vilém Děd (ELIXIR-LU), Christoph Kämpf (IZI-Fraunhofer), Nene Djenaba Barry (ELIXIR-LU), Danielle Welter (PNED), Valérie Barbié (ELIXIR-CH), Marina Popleteeva (ELIXIR-LU), Frédéric Erard (ELIXIR-CH)