Significant changes in research projects must be submitted to the Regional Committees for Medical and Health Research Ethics (REK). Examples of changes that may require reporting are:

  • Changes in study design, inclusion and exclusion criteria, recruitment procedures or consent forms
  • Changes in sample size or diagnosis
  • New knowledge of risks, disadvantages or benefits
  • Change of project manager/PI, research manager or person responsible for research biobank
  • Postponement or extension of the project period

Adverse Medical Events

The project manager/PI is obliged to give written notice to the authorities about serious as well as undesirable and unexpected medical events that are believed to be related to the research. The project manager and all project staff each have an independent responsibility to provide information to the authorities (Helsetilsynet) on matters that may endanger the safety of the research participants. In the event of an unnatural death, the police must be notified immediately.

The project manager must also immediately inform the research participants if they have been injured or complications have arisen as a result of the research project, including informing the research participant about the right to seek compensation from the Norwegian System of Patient Injury Compensation (NPE).

OUS has a guideline on reporting of adverse events and non-conformity in research.

For clinical drug trials there are special procedures for reporting adverse events, see Clinical Trials - Drugs and Medical Devices.