Medical and health research must be carried out in a safe manner. In order to ensure that health research projects are organized in a sound way, approvals are required.

External approval is required from the Regional Committees for Medical and Health Research Ethics (REK). For testing of drugs or medical devices, approval from the Norwegian Medicines Agency (SLV) is also required.

Internal approval comprises the hospital’s routines for registering research activities, assigning legal basis for data processing and ensuring compliance with internal routines. Approval requirements may vary between hospitals.

Before the research can be initiated, the project manager must conduct a risk assessment, ensure that the study is anchored in a research group, and that it is approved by the responsible line manager for research.

Health research projects planned to be conducted at OUS must be reported to the Data Protection Officer and Chief Information Security Officer in an electronic notification form. The form must also be used for significant changes that require ethics committee (REK) approval.

The project manager is responsible for obtaining prior approval from the Regional Committees for Medical and Health Research Ethics (REK) before study start. All health research projects shall, in addition to REK approval, have an explicitly specified lawfulness of processing in accordance with GDPR Art. 6 and Art. 9

Once the project manager has submitted relevant documentation via the electronic notification form and REK approval has been granted, the project manager will receive an email stating the legal basis for data processing for the study.

The project cannot start until the necessary approvals and legal basis are in place. Clinical trials must also be registered in ClinicalTrials.gov and in Helsenorge.no before inclusion of the first subject, see OUS procedure.

Research involving collaboration between several institutions must be formalized in a separate agreement. This is especially important where research involves sharing and distribution of research data. Usually the research responsible institution, where the project manager is employed, is responsible for drafting an agreement. Agreement templates are also available on the Research Support website; Agreements and Templates.

For assistance with agreements and any legal questions, you can also contact one of our resources directly; Law, ethics and privacy.