Any biomedical research project shall be notified to the regional committee on biomedical research ethics, cf. section 8 of the Committee Act.
A biomedical research project is an activity planned according to research methods which aim at producing new, valuable knowledge about human biological and psychological processes, either in relation to healthy persons or for the purpose of prevention, recognition, relief, treatment or cure of disease, symptoms and pain, including affecting bodily functions.
Clinical trials on human biological material must be notified whether the material is identifiable with a person or it is ”anonymous”. Data are identifiable with individual subjects if it is possible to identify such subjects either by name or by code. If just one subject has the "key", the material is identifiable with a subject and is not "anonymous”. Questionnaire-based examinations and interview examinations shall be notified only if the project will include examination of human biological material or examination of individuals.
Clinical trials involving medicinal products and clinical investigations of medical devices, regardless of whether the device are CE approved or not, shall also be notified to the relevant committee. However non-intervention trials involving medicinal products shall not be notified to the committee system as the patient is not exposed to any special harm or risk, and the primary aim of prescribing the medicinal product is treatment. The medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorisation and the decision to prescribe the medicinal product is clearly separated from the decision to include the patient in a study.
For more information see, Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics, 2.0.