CS Baby Biome : Access to Data

Version 30th August, 2023

General Principles

CS Baby Biome is a trial in which we aimed to investigate if timing of intrapartum antibiotics given to mother influences the infant gut microbiome composition. For this we conducted a randomized controlled trial (RCT) in women delivering via elective CS, who received antibiotics prior to skin incision (AB+) or after umbilical cord clamping (AB-).

The study team welcomes access requests to the anonymized sequencing data generated by the Project from third-party researchers.

Access to this data is contingent upon the guidelines set in the CS Baby Biome informed consent, the Data Access Procedure, and the Data Access Agreement’s terms. A “qualified researcher” is defined as a senior investigator with a proven track record in the field and affiliation with an academic, non-profit, or government institution. 

Data Description

This study comprises microbiome data from stool samples collected from 28 mothers and their corresponding infants who participate in CS Baby Biome The details can be found in the paper titled “CS Baby Biome: Timing of maternal antibiotic prophylaxis during a cesarean section and the early infant gut microbiome”. Sinha et al. (currently submitted).

Associated Publications

CS Baby Biome: Timing of maternal antibiotic prophylaxis during a cesarean section and the early infant gut microbiome”. Sinha et al. (currently submitted).

Data Access Committee

To access the Project Data, applications must be submitted to the CS Baby Biome Data Access Committee (DAC). The DAC for CS Baby Biome includes representatives from the CS Baby Biome LLNEXT Consortium.

Data Access Procedure

1. Application Procedure

Applications for Project Data access are managed by the UMCG on behalf of the Consortium. To apply, use the “Application Form for Access to CS Baby Biome Data.” Application details will remain confidential, limited to the review committee. All applications and associated agreements will be recorded. Unless permitted by the applicant, this information will not be used outside the application evaluation. For highly sensitive content, applicants may request a separate confidentiality agreement.

2. Handling Multiple Applications

Data must only be used for the purpose outlined in the application. A new purpose requires a new application and subsequent approval. While the DAC will review applications that list collaborators, each associated institution must complete a distinct Data Access Agreement. If collaborators not initially approved require data access, they must submit a separate application. Overlapping applications may prompt the DAC to recommend that applicants consolidate their submissions.

3. Evaluation Criteria

Applications seeking to reserve Project Data for unspecified research goals will not be considered. Applications for access to Project Data must be Specific, Measurable, Attainable, Resourced and Timely (SMART). Specifically, the CS Baby Biome DAC will assess each application to determine whether:

i.  it has been submitted by a qualified researcher or researchers who are employed by or legitimately affiliated with a recognized research institution that can provide institutional responsibility for appropriate research governance;

ii. its proposed use of the Project Data is in accordance with and meets the objectives of the CS Baby Biome Project and the objectives of the associated cohorts and collections;

iii. its proposed use of the Project Data constitutes research in the context of the individual sample donor consent process and is likely to be understood as such by the individual sample donors;

iv. it would breach any of the ethical permissions or restrictions in the consent form;

v. all required ethical-legal approvals, restrictions and commitments for the proposed use of the Project Data have been obtained and adhered to;

vi. the proposed research has any adverse potential impact, specifically whether the proposed research could affect minorities;

vii. the nature of the funding of the application and the applicant.

viii. the research proposal has been peer-reviewed, and, if not, whether the proposal satisfies applicable scientific standards;

ix. the requested data are, quantitatively and qualitatively, suitable and not excessive for the applicant’s proposed research;

x. the applicant has warranted that they have obtained all required ethical-legal approvals, restrictions and commitments, without limitation, their data subject consent and approval of their pertinent medical ethical review board for their proposed use of their data in combination with the Project Data, if applicable.

4. Decision on Access

The DAC typically makes a decision within 7 working days upon receiving complete information. However, complex legal issues might extend this period to three weeks. Rejected applications will be provided with reasons.

Mode of Data Access; Limitations and Verification

The Consortium will deliver anonymized Project Data using an agreed method. The UMCG will oversee the Data Access Agreement and Project Data provision.

Conditions for Data Access

Access to Project Data requires the Consortium to have a signed Data Access Agreement form. The consortium reserves the right to amend the Data Access Agreement at any time

Data Access Agreement

This agreement delineates the conditions under which access to the Project Data generated by the CS Baby Biome 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 CS Baby Biome Consortium from the University Medical Center Groningen (UMCG).

“Project” signifies the CS Baby Biome 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 commit to utilizing the Project Data exclusively for the progression of scientific and medical research.
  2. 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.
  3. You recognize that the provided Project Data is anonymized. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. Project Data sharing, either in entirety or partially, is forbidden unless with a named and approved collaborator per the CS Baby Biome Data Access Procedure.
  11. 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.
  12. You understand that Project Data may be updated. If such updates are ethically mandated, you must discard older versions.
  13. Once the resulting research is published, you commit to destroying the Project Data. 
  14. Any work deriving from the Project Data must duly acknowledge the source, as stated in Schedule 1.
  15. You acknowledge:

a) The Consortium, original data generators, and funders are not liable for the data’s accuracy or completeness.

b) Neither shall they be held accountable for any consequences arising from the Project Data’s usage or unavailability.

16. Project Data is protected by intellectual property rights. Unauthorized duplication, distribution, or other exploitations are prohibited.

17. 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.

18. You accept that any breach will result in immediate termination of this agreement, necessitating the destruction of all Project Data in possession.

19. 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.

20. Adherence to relevant national and international laws protecting Project Data is your responsibility. 

21. This agreement is subject to the laws of the Netherlands, with the district court of Utrecht holding exclusive jurisdiction.

SCHEDULE 1

Publication Policy

Publications should acknowledge the CS Baby Biome consortium and cite the relevant primary CS Baby Biome publications.