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Additional Information

Special requirements are applicable for:

(1) Sampling of biological material is regulated by the Swedish Biobank legislation- further information is provided on the Swedish Biobank website.
(2) Genetic testing currently requires permission from the Data Inspection Board before submission to the EC.
(3) Other interventional biomedical research, for example physiotherapy, only requires submission to the EC.
(4) Some observational studies which involve biological sampling may require submission also to the MPA after EC assessment.
(5) Quality studies (usual care) can be submitted to the EC for guidance, but this is not obligatory.
(6) Submission of authorisation application to the National Board of Health and Welfare NBH/ Socialstyrelsen is not required at the moment, but may be so in the future for some types of human biomedical research. However, the NBH is the authority supervising biomedical research in the health care setting other than clinical trials of medicinal products or medical device.

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