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Data and biological material from MoBa
MoBa is a large population based cohort with unique health data and associated biological material managed as a national research infrastructure. MoBa data is used by researchers and research groups at both the Norwegian Institute of Public Health and other research institutions nationally and internationally. The research must adhere to the aims of MoBa and the participants' given consent. All use of data and biological material from MoBa is subject to Norwegian legislation.
The application process is the same regardless of whether you are applying for access to data, genetic data (MoBa Genetics) and/or biological material. We have gathered useful information for MoBa researchers on the following page:
- Important documents for MoBa researchers (article on fhi.no)
The researcher who wishes to apply for access to data and/or biological material must be aware of the following:
- The amount of biological material in the biobank is limited. Thus high scientific quality is required for research projects that will use these samples.
- The applicant must familiarize him or herself with the data and biological material included in MoBa, in order to avoid the need for major changes during the application process. This information is stated in the protocol and in the reference articles.
- Substantial changes after the application has been approved and the applicant has received an agreement will entail that the application must be processed again. Access to data may then be delayed.
- During periods of high demand for biological material, increased processing time and delivery time will have to be expected.
- In general, MoBa will not provide exclusivity for the use of MoBa data.
- Standard variables from the Medical Birth Registry of Norway (MBRN) can be delivered together with data from MoBa without a separate application to MBRN.
- The project investigator (PI) must have research competence corresponding to PhD level.
- The application's scientific aim (s) must comply with the aims of MoBa and the participants' given consent. Data and biological material from MoBa should be used to study the causes of disease. MoBa's aims is described in the protocol.
- Application forms and relevant documentation must be in English.
- Applicants from a research institution outside of Norway must have a partner affiliated with a Norwegian research institution, and research competence corresponding to PhD level.
- Before submitting an application, the following must be clarified:
- The project must be approved by Regional Committees for Medical and Health Research Ethics (REK).
- The project must have a legal basis for processing personal data in accordance with current privacy legislation and the General Data Protection Regulation (GDPR). This must be implemented in the applicant’s research institution.
- Funding for the entire project period must be obtained.
- MoBa has special requirements for access to biological material:
- The scientific aim can only be studied using biological material.
- MoBa material is suitable for the chosen assay method.
- The assay methods used must use the lowest possible sample volume, and should measure multiple components per sample to maximize the utilization of the biological material. Only the amount of material the project needs will be handed out.
- Results from analyses will be made available for new research purposes in MoBa.
- Applicants must enclose an estimate of statistical power in the analyses.
- Fill in the electronic application form in English and enclose the necessary documentation (see point 3).
- The application must describe the specific research questions to be studied, as well as planned publications.
- Only complete applications will be processed. A complete application consists of:
- Completed application form.
- Research Protocol / project description.
- Form for request for data and/or biological material
- MBRN variable list, if relevant.
- Copy of REK application and REK approval, as well as any temporary decisions/ feedback.
- Approved Data Protection Impact Assessment (DPIA) or justification for why data protection impact assessment is not required. The investigation must contain information on the legal basis for handling personal data according to articles 6 and 9 of the General Data Protection Regulation (GDPR).
- Principal investigator's CV for at least the last 5 years.
- Information regarding funding of the project.
- The principal investigator will receive a confirmation of receipt of the application from Datatilgang@fhi.no
- When application is complete: See section "Application processing".
- MoBa processes applications on an ongoing basis. The processing time is approximately 3-5 weeks from when a complete application has been received, but can be longer depending on the complexity of the application. MoBa has the opportunity to reject applications (see section "Application not approved").
- Significant changes after an agreement has been submitted to the project manager may result in the application being processed again.
- The result of the application processing will be communicated to the project manager.
- The application is approved (see section "Application approved"). OR:
- The application is not approved (see section "Application not approved").
- The applicant will receive an e-mail from MoBa regarding the approved project. MoBa (on behalf of the Norwegian Institute of Public Health) enters into an agreement with the research institution to which the principal investigator is employed, where conditions for the approval are stated.
- Entering the agreement entails:
- The MoBa agreement (see point Agreement)
- If biological material and corresponding personal data are to be handed over to institutions outside the EU / EEA, the standard EU agreement will have to be entered into.
- If a project has international employees, access to data must only be provided via a secure access platform, for example the Service for Sensitive Data (TSD) at the University of Oslo. Exceptions to this must be justified separately.
- In the case of involvement of third parties, e.g. when using external laboratories for serviced assignments, any specific terms will be stated in the agreement.
- Once the agreement is signed and all required forms are completed and returned, the access to data process starts.
Application not approved
- The applicant will receive feedback on rejection of the application. The reason for rejection can be:
- The project is not within the scope of MoBa's aims and / or the participants' consent.
- The scientific aims can be studied without the use of biological material from MoBa.
- Biological material has already been approved for investigating similar scientific aims in other MoBa projects.
- There is too little biological material available.
- What can the applicant do upon rejection:
- The applicant can change or adjust the application and resubmit it. The application will then be treated as a new application.
- The applicant can complain about the rejection. Such a right of appeal is permitted by the Public Administration Act §28. Any complaint must be sent to MoBaadm@fhi.no with a three-week deadline.
The MoBa contract agreement describes how to access and use data and biological material from MoBa for research purposes. This consists of statutes, guidelines and agreement with standard terms and conditions.
- MoBa Statutes: includes organizational provisions for MoBa.
- MoBa Guidelines: includes the conditions that apply when a researcher applies for access to data and biological material from MoBa, and for application processing.
- The agreement: consists of both external framework conditions (e.g. laws, regulations, approvals and consent), and the conditions for access to use of MoBa. The agreement is structured as follows:
- Project- specific part for signing
- Project- specific attachment based on electronic application and decision
- Financial provisions
- Standard terms for access and use of MoBa that are not subject to negotiations:
Delivery of biological material
The process for extracting biological material, for projects that require this, consists of two parts:
- A list of participants (the study population) to be included in the study. This is done in collaboration with the data unit, MorBarnData@fhi.no.
- Retrieval of the agreed sample material from the Biobank. Estimation of the time of delivery is only made when the design of the study population starts.
When we send out the biological material from the Biobank to the laboratory, we will attach the following two documents, which the applicant will need to fill out and return:
- A form for recording the receipt of the samples from the laboratory. This must be returned to the Biobank: firstname.lastname@example.org.
- Quality Report. This is completed after the analyses have been carried out and returned to the data unit: MorBarnData@fhi.no
When the applicant has returned the receipt of the samples and the quality report, the delivery of the questionnaire data will take place in dialogue with the MoBa data unit.
Delivery of questionnaire data and access to genetic data
Delivery of questionnaire data takes place in dialogue with the data unit. Access to MoBa Genetics is provided via the Service for Sensitive Data (TSD) at the University of Oslo after approval from MoBa.
Separate invoices will be sent to the project manager for the delivery of biological material, questionnaire data and access to MoBa Genetics, according to the agreement.
When a research project is approved and an agreement has been entered, information about the project will be published on the NIPH website.
Contact the Executive officer (MoBaadm@fhi.no) in MoBa for:
- General questions about MoBa
- Questions about the suitability of a research project
- Commercial actors
Contact the Data manager (MorBarnData@fhi.no) in MoBa for:
- Questions related to which data and variables are available in MoBa
- Questions about linking to other data sources
Contact the Biobank (email@example.com) for:
- Questions about available sample material in the Biobank
Costs for using MoBa in research projects
Costs for using MoBa in research projects can be found in the price list:
Articles based on MoBa
Articles based on MoBa must be submitted to firstname.lastname@example.org for review before submitting the article to a journal. This is to ensure that the analyses are performed according to the agreement and that MoBa is properly described in the manuscript. MoBa does not do a scientific review of the manuscript. You can find more information on article approval and what needs to be submitted with the article on the following page:
- Checklist for papers (publication guidelines and checklist)
Changes to approved project applications
Applications for substantial changes or extensions of ongoing projects should be sent to MoBa (email@example.com). The application must contain the following:
- Completed form: Application for changes to approved projects (downloadable Word file for completion).
- Research protocol / project description where the changes are described.
- Copy of REK application and REK approval, as well as any temporary decisions and feedback
- Approved DPIA or justification for why this is not necessary. The assessment must contain information on the legal basis of treatment according to Articles 6 and 9 of GDPR.
- Data request form, if relevant.
- MBRN variable list, if relevant.