title: Ethical aspects of registry-based research in the Nordic countries.
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 similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies.
authors.affiliation: Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden ; Department of Pediatrics, Örebro University Hospital, Örebro, Sweden.
authors.forename: Jonas F
authors.initials: JF
authors.lastname: Ludvigsson
authors.affiliation: Norwegian Institute of Public Health, Oslo, Norway.
authors.forename: Siri E
authors.initials: SE
authors.lastname: Håberg
authors.affiliation: Norwegian Institute of Public Health, Oslo, Norway.
authors.forename: Gun Peggy
authors.initials: GP
authors.lastname: Knudsen
authors.affiliation: Department of Medicine, Clinical Pharmacology Unit, Karolinska Institutet, Stockholm, Sweden ; The Stockholm Regional Ethical Review Board, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Pierre
authors.initials: P
authors.lastname: Lafolie
authors.affiliation: Center of Public Health Sciences, Faculty of Medicine, University of Iceland, Reykjavík, Iceland.
authors.forename: Helga
authors.initials: H
authors.lastname: Zoega
authors.affiliation: Genetic Epidemiology Group, Folkhälsan Research Center, Helsinki, Finland.
authors.forename: Catharina
authors.initials: C
authors.lastname: Sarkkola
authors.affiliation: Genetic Epidemiology Group, Folkhälsan Research Center, Helsinki, Finland.
authors.forename: Stephanie
authors.initials: S
authors.lastname: von Kraemer
authors.affiliation: Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden ; Genetic Epidemiology Group, Folkhälsan Research Center, Helsinki, Finland ; Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, Tromsø, Norway ; The Arctic University of Norway, Tromsø, Norway ; Department of Research, Cancer Registry of Norway, Oslo, Norway.
authors.forename: Elisabete
authors.initials: E
authors.lastname: Weiderpass
authors.affiliation: Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Mette
authors.initials: M
authors.lastname: Nørgaard
keywords: Nordic countries; ethical review; ethics; informed consent; institutional review board; registry-based research