Competent Authority Process
For all non-interventional studies based solely on statistical, register, patient, and / or biological sample data, respective authorization for using the data has to be applied from the regulatory authority responsible for the administration of the requested data. In case the data is requested from a single authority only (eg. from National Institute for Health and Welfare, THL or University Hospitals), permission is granted by the authority in question. The authorization for permission to access data wil normally take 60 to 90 days.
For combined and multiple data that are collected from the databases and registries of different authorities, authorization is granted centrally by the Ministry of Social Affairs and Health. Permission is sought using a standardized application form which is available only in Finnish at the web site of National Institute for Health and Welfare (THL). If the intention is to link data in the statutory registers with data in client/patient records kept by municipalities in the field of social welfare and health care, the application for permission must be addressed to the National Institute for Health and Welfare (THL). No permission from authorities is needed when the research material consists of data collected with the consent of research subjects (such as surveys and interviews). Certain types of studies are not necessarily needed to be reviewed by the regional Ethics Committee of the hospital district in question but instead by the Authorities responsible for the administration of the requested data, or by local organizational Ethics Committees (i.e. University Research Ethics Committees).
Competent Authority process in registry studies:
- Submit Application to the Ministry of Social Affairs and Health OR
- Submit Application to the National Institute for Health and Welfare
- Apply for Ethics Committee opinion on whether or not the study needs to be reviewed by the Ethics Committee
- Submit Application for Ethics Review, if requested.