Who can be a project manager (principal investigator)?
In accordance with the Quality assurance system, a project manager must have minimum 20 % employment at IMB in an academic position, posses a doctoral degree and research background that is relevant to the theme of the research project. Emeriti can't be project managers and in case of change of status the project manager, responsibilities must be transferred to another qualified Project manager and this must be updated in Forskpro and the authorities that issued permits. This is to ensure that project manager obligations are fulfilled regardless of the duration and specific objectives of each research project.
The term ‘project manager’ in this instance is distinct from its use in other contexts such as in applications for research funding, where the term can have different implications.
Project managers at IMB must be familiar with the Quality Assurance Rules, responsibilities and procedures.
Be aware that IMB employees must not be project managers in projects that deal with testing of medicinal products and equipment, however they can be partners in such projects. Such projects have additional regulations with regards to insurance, more information can be found in the Procedure 3.
What kind of projects should be registered in Forskpro?
All research projects must be registered in Forskpro.
How to register my project in Forskpro?
Log in and click on the button marked ‘Registrer nytt prosjekt’, click on "Spr?k" in the top right corner of the form and select English from the drop-down menu. Write the title of the project. Fields "project manager" and "Responsible unit" have automatic suggestions, however this can be changed if desired. After that click on "Create"; this button changes from grey to blue after the project leader and department names are completed.
Now you will get to the page with two tabs, "About the project" and "Approvals". Start with filling out the information on the "About the project" tab. Here you can also upload various documents relevant for the project.
After that click "Save". Please note that there is another tab on top - "Approvals". This is where you need to upload permits from institutions (for ongoing projects) and internal approval. Please remember to press the "Save" button when you are done with uploading the files. You should always write justification in case the project does not require ethical permit or other permits.
You can always go back to your project page and change the information/files.
How to get internal approval?
Send an email to your Head of Department. Your email should contain:
- Title of the project
- The resources that is expected to be used in the project. In most cases, the availability of an approved budget should suffice.
- Information showing:
- that the project is registered in Forskpro
- that prior-approval by the Head of Department is required
Projects that already have Regional Ethical Commitee (REK) permit (or other appropriate permit) are considered internally approved and you don't need to ask for that again. All new projects must have prior-approval from the Head of the Department before submitting an application to REK.
How to register prior-approval in Forskpro?
Go to Forskpro. Find the relevant project by searching for your name or the project title in the field marked ‘Finn prosjekt’. Open the project by clicking on the blue button marked ‘Rediger/edit’. On top of the page, click on the tab marked "Approvals", tick off "yes, application approve" and upload the confirmation. Save the page after that.
What to do when I get a permit from REK (or other permits or amendments)?
To register the relevant approvals or amendments for a project, log into Forskpro and find the desired project. Go to the tab marked "Approvals"
Tick off the relevant approval authority or institution i.e. REK, NSD, Datatilsynet or others. Upload approval applications and resolutions as attachments and save. Change notifications must also be uploaded here. Please remember to always provide postmottak@medisin.uio.no as the responsible institution’s contact address in your correspondence with REK. This ensures that we receive responses that are sent to you; this also applies to change notifications, project end notifications and other similar correspondences with REK.
GDPR and data protection?
From 1.1.2020, all medical and health research projects that process personal data must notify NSD. Application for RECs approval is still mandatory.
? Application to REC and notification to NSD can be sent simultaneously.
? NSD will make DPIA for projects where it is required (the Data Inspectorate recommends that DPIA as are made for projects that are not based on consent, using new technology, new or changed use of information already collected etc.).
? NSD will provide guidance and service for researchers and students.
? NSD can provide paid courses for researchers on privacy in research.
You can read more about privacy in research at this website: /for-ansatte/arbeidsstotte/personvern/routine-for- research-with-personal information.html
If you have an ongoing project you will usually not need to notify NSD. Further information here: /for-ansatte/arbeidsstotte/personvern/rutine-for-forskning-med-personoppinformation.html
If you have any doubts about what do, please contact behandlingsansvarlig@uio.no
If you have questions about filling out the application form at NSD webpage, please contact NSD by phone (555 82 117) or e-mail: personverntjenester@nsd.no
For REK-assessed projects, one must wait for final approval from UiO before data collection and the project can start. REK will send approval to UiO and you will be contacted by the data controller. Even if you have received prior approval from REK, it is important to remember that you cannot start the project until you have received final approval from UiO.
Starting a biobank?
In order to ensure that handling of human biological material is in line with Norwegian law, UiO established Procedure 5, which extensively describes rules and responsibilities for Biobanks. In addition to that, a special form has to be filled out by the person responsible for the biobank and should be attached into ethical permit application and project documentation.
If you are going to send human biological material from UiO to other parties, please refer to the dedicated scheme.
Data storage?
To ensure that the health data is stored in line with the Personal Data Act the University has developed procedure 6. The project manager is responsible for proper storage and handling of health data.
You can also find more information on the dedicated page about data storage at UiO. Should you transfer health data to other parties, please refer to the designed form.
How often do I have to check my projects in the system?
UiO requires project manager to check their projects in the system every 6 months. Check to confirm that all the relevant data in your project are correct. Pay special attention to the end date and whether any ethical approval periods have/are about to elapse. Don't forget to save the project page when you are done with changes.
Project end notifications must be uploaded. Do not delete the projects when they are ended, as the permits for data storage are usually valid after the end date.
Heads of Department will get a reminder from IMB administrative personnel twice a year to check the projects. Research group leaders have to report in their yearly report that all information in Forskpro is verified to date and correct.
Who has access to data saved in Forskpro?
UiO developed access levels on the faculty and institute level so that institute, department and administrative personell have access to the information from their institute. The Dean has access to all information for the projects belonging to the Faculty.
Project manager has access to their own documents, but not to documents uploaded by other project managers. Students, PhD candidates and general public can only see a list of project titles.
Questions?
Contact research support at IMB: helseforsk@basalmed.uio.no
Technical questions (about the IT-system Helseforsk) can be forwarded to helseforsk@medisin.uio.no .