Step 1 – Pre-Approval
Research projects that involve use of health - and/or personal data must undergo a justification assessment, also known as a pre-approval. This is done by filling in the document Internal pre-approval Helsam. The document must be signed by your Head of Department.
If your project consists of mere text analysis, you do not need a pre-approval, and may proceed to Step 2 of this procedure.
Step 2 – Register your project in Forskpro
When the pre-approval has been completed, register the project in Forskpro and upload the pre-approval.
Register/change project in Forskpro
Step 3 – Submit applications to REK and Sikt
You send an application to REK for an approval of research ethics when the purpose of the research is to generate new knowledge about health and disease. In parallel, you must also notify Sikt for an assessment of privacy-related matters. Separate procedures apply to clinical trials of medical products and/or medical device.
More on clinical trials procedures
Step 4 – Upload approval(s) in Forskpro
As soon as decisions from REK and Sikt are available, you upload them to Forskpro for documentation and storage. All other relevant documents shall also be uploaded; such as DPIA, collaboration agreements etc.
Step 5 – Update and maintain your project's Forskpro page regularly
All new and relevant documentation must be uploaded to Forskpro continuously throughout the life of the project.
We recommend that all project managers review their projects every six months and check that all relevant project data is correct (e.g. end date, project staff, change-notifications).
Who can be a project manager?
The project manager, in terms of the quality assurance system, must be a scientific employee at Helsam for the entire project period, hold a PhD and have relevant research background for the project in question.
Student projects
All student projects must have a project manager who is responsible for registering the project in Forskpro and ensuring that all approvals and agreements are in place.
As a rule, the supervisor is the project manager, and some departments at Helsam have delegated this task to a program manager. If the supervisor does not have a position at the institute throughout the project period, an internal co-supervisor must be appointed to handle the task of registering the project in Forskpro. Therefore, it is necessary to clarify where the research responsibility lies. Exceptionally, the research responsibility (through the project leader) might lie outside Helsam. In these cases, a data processing agreement must be in place it the student's research is conducted under the auspices of another research responsible institution.
The student is responsible for carrying out the student project as a project team member, and the supervisor should assist the students so that the research follows the same guidelines as those applicable to project leaders in research projects.
Contact
If you have any questions, please contact us in the Section for Research Administration Helsam