Application to the Regional Committees for Medical and Health Research Ethics (REC)
How to submit an application?
Applications are sent in electronic form to REC (The Regional Committees for Medical and Health Research Ethics).
To send an application, you must create a user account in the portal. You will find information about application deadlines and forms under "Deadlines and forms".
For information about application requirements, about prior approval and research protocol requirements, see the Regulations relating to the organisation of medical and health research, Sections 7 and 8.
The Dean, as the person responsible for research at the unit, or a person authorised by the Dean, is listed as the contact person in the application. Check with your faculty how this is to be filled in in the application.
Can I appeal a decision made by REC?
Decisions made by REC can be appealed to the National Committee for Medical and Health Research Ethics (NEM), cf. Section 10 last paragraph of the Research Ethics Act. The NEM decision is final and cannot be appealed.
What do I do if there are any changes in the project?
The project amendments form must be used when a project manager applies for continued approval from REC for new conditions for the project. You must apply for continued approval when you wish to make significant changes to the project's objective, method, schedule or organisation (Section 11 of the Health Research Act). You must also report changes in conditions that are significant to the soundness of the project and the research participants' safety, welfare and general integrity, e.g. new knowledge about risks and benefits.
If the changes in the project are so significant that they must be seen, in REC's opinion, as constituting a new project, you must apply for new prior approval.
The application form for project amendments and more information about how to apply are found on REC's case portal.
Where can I get the research project archived?
Applications to REC and all correspondence must be filed in Public 360. The project manager is responsible for checking with his/her faculty how this is to be done.
Where can I get an overview of research projects approved by REC?
You can find an overview of research projects approved by REC on REC's web page. You can search for research projects and general research biobanks for which the primary application was submitted after 5 May 2009.
What do I do by the conclusion of project?
When the project is concluded, you must submit a final report to REC using a special form. Information about the form is found on REC's case portal.
You must also submit a final report if the project is not carried out as planned.
If I need it, where can I store project data after conclusion?
It is possible to get a long-term storage of research data, see web page long-term storage of data