Runtime View
This section details the dynamic behavior and specific scenarios involved in the Access Request Review process. It outlines the operational steps, ethical checks, and consensus-building required to evaluate and approve or reject data access applications.
Overview
Perform conformity checks
Central Coordination performs initial conformity checks on the submitted data access application to ensure all requirements are met, generating an Application Conformity Check Report for the User.
Transmit application
Once conformity is verified, Central Coordination transmits the submitted data access application to the Affected National Coordination Points for awareness and further processing.
Perform Ethics checks
For requests that are not related to healthcare re-use or quality management, the 1+MG DAC performs ethics checks on the transmitted application, producing an Ethics Review Report for Central Coordination.
Notify NCPs and give ethics recommendations
If issues are identified during the ethics checks, a Temporary Ethics Board formed by Central Coordination uses the transmitted application and Ethics Review Report to notify National Coordination Points and provide Ethics Recommendations to the 1+MG DAC and Affected National Coordination Points.
Give opinion / recommendation on access
Unless the request is solely for quality management (which bypasses this step), the 1+MG DAC and Affected National Coordination Points review the transmitted application alongside any Ethics Recommendations to formulate their decision. This process generates the 1+MG DAC Access Opinion / Recommendation and Local DACs Access Opinion / Recommendation for Central Coordination.
Find consensus (if deviating opinions) and perform formal approval or rejection
Central Coordination gathers the various access opinions and recommendations. If there are deviating opinions, they facilitate a process to find consensus before performing the formal approval or rejection of the request. The resulting Approval or Rejection Form is then shared with the 1+MG DAC and Affected National Coordination Points.
Start re-dress procedure (if requested)
In the event of a rejection, the User may submit an Appeal Form. Central Coordination will then start a re-dress procedure to review the appeal, producing an Appeal Form Review for the User.
Notify approval
If the request is approved, Central Coordination uses the Approval Form to formally notify the User of the approval, generating the final Project Definition.