What is deviation?
Deviations are non-fulfilment of requirements in the regulations and internal routines. Examples can be:
- Harm to research participants
- Harm to employees
- Lack of approval from REK and other approving authorities
- Lack of/invalid consent from research participants
- Failure to follow up on procedures according to the Health Research Act
- Violation of personal data security
How to report deviations and unwanted incidents at UNN?
Projects covered by the Health Research Act have reporting and information obligations in connection with unwanted incidents and deviations. As the responsible research institution, the University Hospital of Northern Norway (UNN) is obligated to establish procedures for receiving reports of deviations, as well as ensuring that deviations are followed up on and corrected.
Therefore, a separate procedure for unintended incidents and deviations in connection with research at UNN has been established. This is available in Docmap (accessible via the intranet).