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GDI-SOP0002_NCPs-veto-EDIC-decision.md

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European GDI - NCPs veto EDIC decision

Metadata Value
Template SOP number GDI-SOP0002
Template SOP version v1
Topic Helpdesk & operations
Template SOP Type Node-specific SOP
GDI Node
Instance version

Index

  1. Document History
  2. Glossary
  3. Roles and Responsibilities
  4. Purpose
  5. Scope
  6. Introduction and Background Information
  7. Summary or Context Diagram
  8. Procedure
  9. References

1. Document History

Template Version Instance version Author(s) Description of changes Date
v1 Marcos Casado Barbero Transform document to markdown 2024.09.27
v0.1 Dylan Spalding Comments addressed and first draft of SOP 2024.08.14

2. Glossary

Find GDI SOPs common Glossary at the charter document.

Abbreviation Description
1+MG 1+ Million Genomes
DAC Data Access Committee
EDIC European Digital Infrastructure Consortium
NCP National Coordination Point
SOP Standard Operating Procedure
Term Definition
Permit Authority National body responsible for data access decisions

3. Roles and Responsibilities

See the qualifications and responsibilities of the roles at the Organisational Roles and Responsibilities document.

Role Full name GDI/node role Organisation
Author Dylan Spalding Finland / Pillar II co-lead CSC
Author Marcos Casado Barbero Task 4.3 Lead EMBL-EBI
Reviewer Regina Becker LU / Pillar I co-lead LNDS
Approver Gabriele Rinck Task 4.3 member EMBL-EBI
Approver Markus Englund Task 4.3 member UU / NBIS

4. Purpose

The purpose of this SOP is to delineate a standardised process for NCPs to review and potentially veto decisions made by the 1+MG EDIC regarding data access requests. This will ensure that data access is consistent with national regulations and ethical standards.

5. Scope

This SOP applies to all NCPs and Permit Authorities involved in the GDI project across participating countries, and relates to the 1+MG Data Governance (See 1+MG Data Governance for Research). It covers the procedures for reviewing and vetoing data access decisions made by the 1+MG DAC.

6. Introduction and Background Information

The GDI project aims to facilitate the integration and accessibility of genomic data across Europe, underpinned by the 1+MG initiative. The 1+MG EDIC is a central legal entity established through a Commission Implementing Decision. It orchestrates the infrastructure implementation of the multi-country project based on the 1+MG Declaration, central to overseeing data access requests. Given the strategic importance and sensitivity of genomic data, the role of NCPs and Permit Authorities are critical in ensuring that access decisions by the 1+MG DAC adhere to both national and European standards.

7. Summary or Context Diagram

1+MG DAC, NCP, and Permit Authority processes for approval or veto of a 1+MG recommendation Figure 1: 1+MG DAC, NCP, and Permit Authority processes for approval or veto of a 1+MG recommendation 

8. Procedure

1. NCP Distribute the application recommendation

Step identifier When Who
1 Receipt of 1+MG DAC decision NCP

Once the 1+MG DAC issues a decision, as the NCP, you should distribute the application recommendation to the appropriate 1+MG Data Holders and Permit Authority(ies), who will approve or deny the recommendation. Remind them to respond within 10 working days.

Depending on the response that you receive from these authorities and data holders:

  • If a decision is not communicated within 10 working days, move to step step 4.
  • If a decision is communicated within 10 working days:
    • If veto is not exercised in the response you receive, let the 1+MG DAC know and move to step 4
    • If veto is exercised in the response you receive, move to step 2.

2. Communicate justification of veto

Step identifier When Who
2 After step 1 and within 1 working day NCP

If the veto of the 1+MG DAC's recommendation is exercised, as the NCP you shall communicate a detailed justification to the 1+MG DAC within one day. In this communication, you shall cite discrepancies between the ethical assessment of the 1+MG DAC and the national decision maker(s).

Move to step 3.

3. Review of veto by 1+MG DAC

Step identifier When Who
3 After step 2 1+MG DAC

If veto is exercised on some or all of the relevant data, as the 1+MG DAC, review the justification provided by the NCP.

Depending on the outcome of this evaluation:

  • If veto is accepted, move to step 7.
  • If the justification is not accepted in full, move to step 6.
  • If no veto was exercised, or the time lapse from step 1 is greater than 10 working days, move to step 4.

4. Inform NCP and User about the decision

Step identifier When Who
4 After step 3 or 6 1+MG DAC

As the 1+MG DAC, inform the NCP and User (whose request was initially recommended) of the decision: approved access request.

Move to step 5.

5. Inform data subjects

Step identifier When Who
5 After step 4 NCP

As the NCP, inform the relevant data subjects of the proposed research within 1 working day.

This concludes the process resulting in final approval of the data access request.

6. Consensus building process

Step identifier When Who
6 After step 3 1+MG DAC

If the justification is not accepted in full, as the 1+MG DAC, initiate the consensus-building process between the 1+MG DAC and the national data holders and/or permit authorities.

Depending on the outcome of the process:

  • If consensus is reached, move to step 4.
  • If consensus is not reached, move to step 7.

7. Inform User and other NCPs of the final decision

Step identifier When Who
7 After step 3 or 6 1+MG DAC

As the 1+MG DAC, inform the User and the User’s institution of the final decision, as well as other NCPs for whom the decision to veto may be relevant.

This concludes the process resulting in the rejection of the data access request.

9. References

Reference Description
1 European GDI - SOP Charter (including Glossary)
2 1+MG Data Governance for Research