Principal investigators responsibility - MoBa
The principal investigator (PI) is responsible for data and biological material that is lent from MoBa to the project.
The project's PI (project leader) is responsible for the data (personal information) and / or biological material that is lent from MoBa to the project. Furthermore, the PI is responsible for following up obligations in the agreement entered into with NIPH / MoBa, or that is set in the decision letter issued from MoBa, as well as ensuring that all project members also follow these. The PI is the person who is specified as the project leader in a decision from REK.
This applies to all PIs, regardless of in which institution or country the research is carried out. The obligations include the following:
- To apply to the Regional Committee for Medical and Health Research Ethics (REK) prior to project start and prior to any changes in the project
- To perform a Data Protection Impact Assessment (DPIA) prior to project start and prior to any changes in the project
- To apply to data owners at project start and prior to any changes in the project. This also applies if you wish to extend the project period.
- To ensure that project members follow the project's agreements and only use data and biological material for the purpose for which permission has been granted in the agreement / decision
- To inform REK and data owners about changes in project members continuously
- To adhere to project end dates and data deletion dates
- To enter into agreements with all institutions where the project members are employed
- To enter into agreements with laboratories that are used for analysis of biological material
- To enter into EU agreements if the project has project members outside the EU / EEA or if projects use a laboratory outside the EU / EEA
- To inform MoBa about publications and doctoral degrees where project data are included, as well as following MoBa's publication guidelines.
Responsibility of PI at the end of projects
Research projects are terminated on the date set as the end date in the agreement or decision letter from MoBa. Further work with data and / or biological material in the project is no longer permitted after this. For projects with access to genetic data, access to TSD rooms where genetic data is located will be closed.
The MoBa administration (MoBa adm) does NOT issue notices of project termination to the PI.
The PI is responsible for fulfilling all requirements set in decision letters from REK, including any storage obligation.
- Projects without a storage obligation must delete the data file and all possible copies.
- Projects with a storage obligation must follow this. When the obligation expires, the project must delete the data file and all possible copies.
How to apply to extend the project period
For more information on how to apply for an extension of the project period - see the section «Changing approved project applications» on the MoBa website for detailed information.
For projects that use TSD
The TSD account is closed by UiO according to REK end date. For projects where the project end date differs from the REK end date, the PI must send a written enquiry about closing the TSD account to TSD due to the project end.
Return of results, data and generated variables from research projects to MoBa
Results from analysis of biological material from MoBa (both raw data and quality-controlled / processed data) must be sent (returned) to MoBa as soon as the analyses are completed. Collected data in projects with new data collection and generated variables based on calculations shall be transferred to MoBa in accordance with the agreement. The PI is responsible for the data being transferred to MoBa.
Residual material at the analysis laboratory shall be destroyed with the exception of those cases where MoBa has specifically requested that the material be returned to the MoBa Biobank. The PI must send a written confirmation of the destruction of the remaining biological material to MoBa adm firstname.lastname@example.org.
For guidance on REK approval or requirements in accordance with the privacy regulations and the EU Privacy Regulation GDPR, please contact:
- Research administrative support at your institution or
- The privacy representative (PVO) at your institution
More information is also available on the Data Inspectorate's website.
- Datatilsynet (external website)
Case manager in MoBa (MoBaadm@fhi.no):
- General questions about the use of MoBa for research
- Discussion about possibility of a research project
- Commercial actors
Data manager in MoBa (MorBarnData@fhi.no):
- Questions related to which data and variables are available in MoBa
- Questions about linkage to other data sources available in MoBa (MorBarnData@fhi.no)
- For return of analysis results, collected data og variables generated in the project
- Questions on available material in the biobank.
To access data and biological material in MoBa, the application must be sent to MoBa.