LIFELINES NEXT: Access to Data

AGREEMENT ON THE SHARING OF PSEUDONYMIZED PERSONAL PUBLISHED LIFELINES NEXT DATA

(for academic research) LCR number: 155129

Version 19th January, 2023

Step by step instructions to access LLNEXT data on EGA can be found here: https://github.com/GRONINGEN-MICROBIOME-CENTRE/Lifelines_NEXT/blob/main/NEXT_pilot_microbial_transmission_mother_infant/Data_Access_EGA.md

This agreement delineates the conditions under which access to the Project Data generated by the LLNEXT Project will be granted. By signing this agreement, you consent to be bound by the terms and access conditions detailed herein. It should be explicitly noted that the stipulated access conditions in this agreement apply to both the User and the User’s Institution (henceforth defined). Throughout this agreement, the terms “You” and “Your” shall be used to refer to both the User and the User Institution.

Definitions

CONSORTIUM means the LLNEXT Consortium from the University Medical Center Groningen (UMCG).

PROJECT signifies the LLNEXT project.

PROJECT DATA indicates the data produced by the Project.

DATA SUBJECT denotes the individual whose sample was utilized to generate the Project Data.

USER represents a researcher who has been granted access to Project Data.

PUBLICATIONS encompass articles in print journals, electronic journals, reviews, books, posters, and other oral and written research presentations.

USER INSTITUTION designates the organization where the User is employed, affiliated, or enrolled.

Terms and Conditions:

Upon signing this Agreement:

  1. You warrant and represent that you personally will be bound to these Terms and Conditions and that you are authorized to agree with these Terms and Conditions on behalf of the User Institution. 
  2. You commit to utilizing the Project Data exclusively for the progression of scientific and medical research.
  3. You pledge not to use, nor permit the use of, the Project Data in part or whole for commercial purposes, including product or service development for sale, whether by You or third parties.
  4. You recognize that the provided Project Data is pseudonymized. The Consortium will never equip You with the means to identify any Data Subject. You are obligated to uphold the confidentiality of the Project Data and particularly not to exploit it to compromise the privacy of Data Subjects.
  5. You may only share the Project Data with your employees (Authorized Recipients) who strictly need it for your approved study and who maintain confidentiality obligations mirroring or exceeding those in this agreement.
  6. All Authorized Recipients must be briefed about the confidential nature of the Project Data. Upon the Consortium’s request, you must disclose the names of every Authorized Recipient who has accessed the Project Data. You bear responsibility for any breach of this agreement by your Authorized Recipients.
  7. Project Data must be stored on a secure computer system. You ensure that state-of-the-art technical and organizational security measures are in place to deter unauthorized access, loss, or any other illicit processing. Any breach must be promptly reported to the Project administrator, UMCG.
  8. You affirm that all requisite ethical-legal permissions, including data subject consent and the relevant medical ethical review board’s approval for integrating Your data with the Project Data, have been secured.
  9. Should the Project Data be provided with Data Subject-related restrictions, You accept and commit to adhering to these as if they were Your direct obligations. Data Subjects reserve the right to enforce this agreement’s conditions, and any breach could entail compensation for damages.
  10. Linking the Project Data with other datasets, even if legitimately accessible, requires explicit consents and approvals. Control over the Project Data must be maintained, and distribution in any form is strictly prohibited.
  11. Project Data sharing, either in entirety or partially, is forbidden unless with a named and approved collaborator per the LLNEXT Data Access Procedure.
  12. The Project Data must only be used for the explicitly approved purpose and project. Any significant alteration or new purpose necessitates the submission of either an amendment or a new application, respectively.
  13. You understand that Project Data may be updated. If such updates are ethically mandated, you must discard older versions.
  14. Once the resulting research is published, you commit to destroying the Project Data. 
  15. Any work deriving from the Project Data must duly acknowledge the source, as stated in Schedule 1.
  16. You acknowledge:
    1. The Consortium, original data generators, and funders are not liable for the data’s accuracy or completeness.
    1. Neither shall they be held accountable for any consequences arising from the Project Data’s usage or unavailability.
  17. Project Data is protected by intellectual property rights. Unauthorized duplication, distribution, or other exploitations are prohibited.
  18. You accept that this agreement grants Project Data access under the non-transferable, non-exclusive provision of “loan”. No rights, intellectual or otherwise, are transferred to you regarding the Project Data.
  19. You accept that any breach will result in immediate termination of this agreement, necessitating the destruction of all Project Data in possession.
  20. The Consortium may revise this agreement to address emergent concerns. You will be informed of any changes, and your continued use of the data will hinge upon assenting to the updated terms.
  21. Adherence to relevant national and international laws protecting Project Data is your responsibility. 
  22. This agreement is subject to the laws of the Netherlands, with the district court of The Northern Netherlands in Groningen holding exclusive jurisdiction.

SCHEDULE 1

Publication Policy

Publications should acknowledge the LLNEXT consortium and cite the relevant primary LLNEXT publications.