Data Access Conditions and Committee
Researchers from universities, research institutions and
Smart4Health Data Access Committee
The Smart4Health Data Access Committee is a body constituted of named individuals from the Smart4Health consortium. They are responsible for granting (or denying) external requestors (researchers) access to data. The decision is based on the citizen’s consent, the Smart4Health Data Sharing Policy, and an ethics approval of the research project obtained and presented by the researcher.
Members of the Data Access Committee
The Data Access Committee is not yet constituted and therefore the members not defined.
Data Sharing Policy
The Data Sharing Policy is currently under revision and will be published soon.
Restrictions
Access to the data is controlled and researchers can work with the data only on the research platform (no download of data is allowed).
The data must not be used by other researchers or for other purposes than defined in the research project. Your health data will be used exclusively for scientific purposes. Using data for scientific purpose includes publishing results in a form that does not allow any conclusions about or links to your identity.
Data access is restricted to researchers from EU countries or from countries where the EU has determined that adequate data protection measures are in place.
Though your data will not be sold, the provider of the Smart4Health research platform may collect a handling fee from the respective researchers, in the future
Data Access Criteria
Data Access Requests are reviewed by the Data Access Committee by these criteria:
Applicant status
- Identity of applicant/institutions
- Ethics approval is in place
- Qualification of applicant or his/her PI (publications)
- Summary description of research project
Description of research project
In accordance with:
- Access criteria provided in consent, Data Access Agreement and Data Sharing Policy
- Feasibility of research
- Risk mitigation of citizen re-identification
- Adequate security protocols stated in application
Citizen-Contacting
Researchers can contact the data-providing citizen using the Citizen-Contacting Service. This is a one-way double-blind communication that protects the identity of the citizen.
Details
Only cohorts of not less than 20 participants can be contacted and not individuals. The feedback is provided in aggregated numbers, e.g., 25 participants reached of which 15 read the message. Citizen-contact messages may contain invites to participate in other research studies. Note that linking the study results to the data in the Smart4Health Research Platform is not possible. Each message to a cohort must be approved by the Data Access Committee.
To make this process legitimate and compliant, the Smart4Health Research Platform provides functionality for the researcher to generate an encrypted file with the details of the citizen cohort (Number of patients, Age distribution, Dataset version, Gender distribution, Query parameters, Pseudonym IDs).
Application
Researchers need to file a new Data Access Request, which will be reviewed by the Data Access Committee by these additional criteria:
- Covered by existing Ethics approval?
- If contacting cohort to participate in a study, check ethics approval of that study
- Methodology of the citizen contacting is feasible
- Number of citizens to be re-contacted is > 20, no outlier, minimize possibility to single out individual