Preliminary Work
A decision must be made whether or not to obtain a consent to use collected data for research studies from the included participant/patient. A well-designed consent letter will allow for a broad, useful and correct use of the collected data for the future. It is therefore very important to design as comprehensive a consent as possible in relation to the intended use of data in either the study or the registry. The main rule is that one should always obtain consent from a patient before including it in a study or in a registry. The exception is if you do quality assurance of your own medical practice; then it is not required to obtain a consent to use already collected health information. In cases involving patients who are very ill, dead or where it may otherwise be difficult to obtain a consent, the Regional Committees for Medical and Health Research Ethics (REK) may grant exemption from the consent requirement.