Local Ethical Approval
USN currently does not have a local ethics committee to provide ethical pre-approval for research projects that fall outside the scope of the Health Research Act. Such a local ethics committee is expected to be in place by the first half of 2027.
Some international journals require ethical pre-approval to publish research results. In Norway, however, this is not a legal requirement for most projects outside the Health Research Act. If a publication requires more than an assessment from Sikt, you may contact forskningsetikk@usn.no to request an information letter explaining the Norwegian research ethics system and the roles and responsibilities for ethical assessments in Norwegian research projects.
The project manager is responsible for conducting ethical assessments in a research project.
Key elements of such an assessment include:
- Role understanding
- Consent
- The precautionary principle
- Participant vulnerability
If you are unsure about how research ethics are safeguarded in your project or uncertain about the ethical assessments, you should use the national research ethics guidelines as support and resource.
If in doubt, do the following:
- Read the national research ethics guidelines
- Ask experienced colleagues or your immediate supervisor for advice
- Contact the Department for Research, Innovation and Library at forskningsetikk@usn.no
- Ask the national research ethics committees for advice
Resources for Local Ethical Research
- National Research Ethics Committees
- General guidelines
- Guidelines for social sciences and humanities
- Guidelines for natural sciences and technology
- Guidelines for medicine and health sciences
- Statement on ethical evaluation in EU projects
Medicines and Medical Devices
In some cases, it may be difficult to determine what qualifies as a medical device and which regulations apply.
Resources for Medicines and Medical Devices
- Clinical investigations of medical devices
- Health technology assessments
- Submission of documentation for single technology assessments
The Norwegian Directorate must approve clinical trials involving medicines and medical devices (including apps) for Medical Products (DMP).
Biolab
Biolabs may require specific approvals. For example, approval from the Norwegian Labour Inspection Authority is required for Biosafety Level 2 laboratories.
See also: Changes to the routine for applying to access health information – in Norwegian only.