NLGeneralInformation object

Applied regulatory conventions

Declaration of Helsinki
Other ethical principles for medical research (other than Declaration of Helsinki)
ICH-GCP Guidelines
Other guidelines for good clinical practice (other than ICH-GCP)
National regulatory requirements
Regional regulatory requirements

Applicable national laws

Hospital Act
Data protection Act
Genetical engineering act
Medical device act
Drug act

National regulations for volunteers exist for

Nutrition intervention in healthy people
Pharmaceuticals/drug trials
Invasive procedures
Catheters
Isotopes
Tissue samples
Projects involving volunteers have to be reviewed by Regional Ethics Committee

Official website providing relevant national legislation

REK website in section Acts of Legislation

Additional Information

Lovdata Foundation: Norwegian regulations are publicly available in the legal information system run by the Ministry of Justice and the Faculty of Law in Oslo.
English translation of the Norwegian legislation can be found in the Law Library of the University of Oslo.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395