Ethical aspects of registry-based research in the Nordic countries

• Published in: Clinical Epidemiology
• Main Authors: Ludvigsson,Jonas F, HÃ¥berg,Siri E, Knudsen,Gun Peggy, Lafolie,Pierre, Zoega,Helga, Sarkkola,Catharina, von Kraemer,Stephanie, Weiderpass,Elisabete, Nørgaard,Mette
• Format: Article in Journal/Newspaper
• Language: English
• Published: Dove Press 2015
• Subjects: Clinical Epidemiology; Arctic; Reykjavík; Norway; Tromsø; Knudsen; Iceland; Arctic University of Norway; University of Tromsø
• Online Access: https://www.dovepress.com/ethical-aspects-of-registry-based-research-in-the-nordic-countries-peer-reviewed-fulltext-article-CLEP

Jonas F Ludvigsson,1,2 Siri E Håberg,3 Gun Peggy Knudsen,3 Pierre Lafolie,4,5 Helga Zoega,6 Catharina Sarkkola,7 Stephanie von Kraemer,7 Elisabete Weiderpass,1,7–10 Mette Nørgaard11 1Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, 2Department of Pediatrics, Örebro University Hospital, Örebro, Sweden; 3Norwegian Institute of Public Health, Oslo, Norway; 4Department of Medicine, Clinical Pharmacology Unit, 5The Stockholm Regional Ethical Review Board, Karolinska Institutet, Stockholm, Sweden; 6Center of Public Health Sciences, Faculty of Medicine, University of Iceland, Reykjavík, Iceland; 7Genetic Epidemiology Group, Folkhälsan Research Center, Helsinki, Finland; 8Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, 9The Arctic University of Norway, Tromsø, 10Department of Research, Cancer Registry of Norway, Oslo, Norway; 11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark Abstract: National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are ...