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

1. Purpose and scope

These guidelines describe 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.

Researchers in ongoing MoBa projects intending to participate with project data in meta-analysis co-ordinated by research institutions both nationally and internationally must inform the MoBa administration prior to attending. All analyses of individual-level data must comply with approvals granted for the specific, ongoing MoBa research project.

The purpose of these guidelines is to ensure that MoBas Statutes, Guidelines and Standard terms and conditions http://www.fhi.no/moba are followed.

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.

The PI 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 at any time.

Aggregated MoBa data may be uploaded to a database for the purpose of the analysis and the results from the meta analysis may be shared on the consortia website.

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

2.1 Approval of manuscripts  

Manuscripts for primary meta-analysis 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. Manuscripts from secondary analysis does not require approval by MoBa.

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

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

“The consent given by the MoBa participants does not allow for the storage of individual level data in any repositories or journals. Researchers who request access to MoBa data sets should submit an application through www.helsedata.no. Access to data sets requires approval from The Regional Committee for Medical and Health Research Ethics in Norway and a formal agreement with MoBa.”

A pdf of the published article must be sent to mobaadm@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 

3.1 Email to the MoBa administration 

A researcher in an ongoing MoBa research project intending to participate in a meta-analysis must send an email to mobaadm@fhi.no containing information about the analysis. The email 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 no individual level MoBa data will be uploaded into any repositories for storage and further sharing
• A confirmation that the consortia is informed about MoBas policy on creditation of MoBa in all manuscripts using MoBa data and that a PDF of all articles using the data should be sendt to mobaadm@fhi.no.

Standised form for metaanalyser in ongoing MoBa projekts - download word file

3.2 Handling by the MoBa administration  

The MoBa administration will put information about the participation in the meta analysis and about the consortia on the MoBa website to ensure that participants and other MoBa researchers are informed.

The website will contain information about the following:

• The consortia including a link to the consortia website
• Information on the meta-analysis
• MoBa project and contact person

 4. Definitions