Use of data from the Norwegian Mother, Father and Child Cohort Study (MoBa) in meta-analyses

1. Purpose and scope

These guidelines describe the procedures for the use of data from the Norwegian Mother, Father and Child Cohort study (MoBa) in meta-analyses where MoBa is one of several data contributors.

These guidelines apply to ongoing MoBa research projects that are invited to participate in meta-analysis in ongoing or new consortia. These guidelines do not apply to new MoBa projects or to the use of MoBa data in analyses where individual level data is to be shared, where other regulations apply. The purpose of these guidelines is to ensure that MoBas Statutes, Guidelines and Standard terms and conditions http://www.fhi.no/moba are followed.

Researchers in ongoing MoBa projects intending to participate with project data in meta-analysis co-ordinated by research institutions both nationally and internationally must apply to the MoBa administration for approval for such use. All analyses of individual-level data must comply with approvals granted for the specific, ongoing MoBa research project. Aggregated data may be shared only with the consortia performing the meta-analysis for the specific, approved research purpose and for a specified time period.

2. Conditions for use of MoBa data in meta-analysis

The research purpose for the meta-analysis must fall within the scientific scope of MoBa, and be consistent with the participants' given consent and obtained approvals for the research project.

The principal investigator (PI) of the MoBa project where the meta-analysis is intended to be performed must approve of the meta-analysis and approve of sharing aggregated data.

He/she must also confirm that the meta-analysis study is consistent with the scope and objectives of the background project and is responsible for ensuring that the use of MoBa data is covered by the existing regulatory approvals.

Individual-level MoBa data may not be uploaded into a repository or database. Only aggregated summary-level MoBa data may be used in meta-analyses. These aggregated data may be uploaded to a database for the purpose of analysis, and these data must be deleted after the analyses are completed.

2.1 Manuscripts and publication 

Manuscripts must be sent to the MoBa administration (mobaadm@fhi.no ) for approval prior to submission to a journal. The manuscript must be accompanied with a completed ‘Checklist for papers’ and a protocol.

A copy of the manuscript and the study protocol will be saved for documentation purposes.

This standard text may be used for journals requesting access to the research file:

“The consent provided by the MoBa participants does not allow for the storage of aggregated or individual level data in outside repositories or with journals. Researchers who want to request access to data sets for replication should submit an application to datatilgang@fhi.no. Access to MoBa data sets requires approval from The Regional Committee for Medical and Health Research Ethics in Norway and a formal agreement with MoBa.”

 MoBa summary-level data from genome-wide association studies (GWAS) may be made available on the NIPH website https://www.fhi.no/en/studies/moba/for-forskere-artikler/gwas-data-from-moba/  if required by the journal.

A copy of the published article should be sent to mobaam@fhi.no.

2.2 MoBa Citation and Acknowledgement

MoBa must be acknowledged in articles and the MoBa reference article should be cited (See MoBas Guidelines for papers for more information).

3. Procedure for approval

3.1 Application to the MoBa administration 

A researcher in an ongoing MoBa research project intending to participate in a meta-analysis must submit an application by email to mobaadm@fhi.no. The application may be written in Norwegian or English.

A study protocol describing the meta-analysis (analyseprotokoll) must be attached to the application.

The email should contain the following information given in text or by completing the standardized form attached below:

• Name of principal investigator in the MoBa project
• Institution responsible for the MoBa project
• MoBa project number PDB XXXX
• Name of consortium co-ordinating the meta-analysis
• A description of which MoBa data will be used in the meta-analysis and how the data will be handled (if a study protocol is not available).
• Information on other MoBa projects participating in the consortia, if applicable

The following confirmations must be included in the application:

• A confirmation that the planned use of data is approved by the responsible institution
• A confirmation that the planned use of data is within the scope and objective of the existing MoBa project
• A confirmation that the planned use of data use is covered by existing regulatory approvals (e.g. Norwegian REK) and complies with GDPR
• A confirmation that neither individual nor aggregated-level MoBa data will be uploaded into any repositories for storage and further sharing
• A confirmation that aggregate-level MoBa data that are uploaded for meta-analysis will be deleted when the analysis is completed

Application form (download word-file) 

3.2 Assessment and approval 

The MoBa administration will assess received applications on a weekly basis. If required, internal and external researchers working on MoBa projects answering similar scientific aims may be consulted to avoid any conflict of interest.

An email will be sent to the applicant and the principal investigator indicating whether the application is approved or not with an explanation. An e-mail template is attached below. Once the applicant has received a confirmation e-mail the analysis may start.

 4. Definitions