Long-term Research Registries with "Broad" Purpose /Consent
A long-term research registry, with so-called broad consent, is a registry that collects data for use in future research. If research studies are to be established, where data from a long-term research registry will be used, there must be an independent project-specific treatment basis. At OUS, this is achieved by reporting the study in the usual way through the electronic notification form. Other companies have their own routines. Studies that fall under the Health Research Act must also be approved by the Regional Committees for Medical and Health Research Ethics (REK).
A broad consent confirms that the patient has consented to the collection and use of data for research within specific, broadly defined research purposes. Reuse of collected data is essential. A broad consent within, for example, the category cancer will indicate that data collected in the registry can be used for research in the cancer field. Such consent provides significant flexibility for later use of the data in research. In contrast, a specific consent will limit the use of data to a specified research project, and data reuse may be more difficult. Data can only be collected from patients who have consented to the project itself, and a research participant can withdraw their consent at any time, as well as request collected data to be deleted from the database. For more on consent, see Consent.
A long-term research registry with broad consent may contain research data originating from various clinical IT systems - for example, from a journal. Such a registry may also contain other data that are important for answering one or more research questions. All use of data for research purposes will require an independent decision / treatment basis (cf. first paragraph).