Ethical aspects of registry-based research in the Nordic countries

doi:10.2147/CLEP.S90589

Review

. 2015 Nov 23:7:491-508.

doi: 10.2147/CLEP.S90589. eCollection 2015.

Ethical aspects of registry-based research in the Nordic countries

Jonas F Ludvigsson¹, Siri E Håberg², Gun Peggy Knudsen², Pierre Lafolie³, Helga Zoega⁴, Catharina Sarkkola⁵, Stephanie von Kraemer⁵, Elisabete Weiderpass⁶, Mette Nørgaard⁷

Affiliations

¹ Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden ; Department of Pediatrics, Örebro University Hospital, Örebro, Sweden.
² Norwegian Institute of Public Health, Oslo, Norway.
³ Department of Medicine, Clinical Pharmacology Unit, Karolinska Institutet, Stockholm, Sweden ; The Stockholm Regional Ethical Review Board, Karolinska Institutet, Stockholm, Sweden.
⁴ Center of Public Health Sciences, Faculty of Medicine, University of Iceland, Reykjavík, Iceland.
⁵ Genetic Epidemiology Group, Folkhälsan Research Center, Helsinki, Finland.
⁶ 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.
⁷ Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.

PMID: 26648756
PMCID: PMC4664438
DOI: 10.2147/CLEP.S90589

Review

Ethical aspects of registry-based research in the Nordic countries

Jonas F Ludvigsson et al. Clin Epidemiol. 2015.

. 2015 Nov 23:7:491-508.

doi: 10.2147/CLEP.S90589. eCollection 2015.

Authors

Jonas F Ludvigsson¹, Siri E Håberg², Gun Peggy Knudsen², Pierre Lafolie³, Helga Zoega⁴, Catharina Sarkkola⁵, Stephanie von Kraemer⁵, Elisabete Weiderpass⁶, Mette Nørgaard⁷

Affiliations

¹ Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden ; Department of Pediatrics, Örebro University Hospital, Örebro, Sweden.
² Norwegian Institute of Public Health, Oslo, Norway.
³ Department of Medicine, Clinical Pharmacology Unit, Karolinska Institutet, Stockholm, Sweden ; The Stockholm Regional Ethical Review Board, Karolinska Institutet, Stockholm, Sweden.
⁴ Center of Public Health Sciences, Faculty of Medicine, University of Iceland, Reykjavík, Iceland.
⁵ Genetic Epidemiology Group, Folkhälsan Research Center, Helsinki, Finland.
⁶ 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.
⁷ Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.

PMID: 26648756
PMCID: PMC4664438
DOI: 10.2147/CLEP.S90589

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.

Keywords: Nordic countries; ethical review; ethics; informed consent; institutional review board; registry-based research.

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References

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1. Kettis-Lindblad A, Ring L, Viberth E, Hansson MG. Perceptions of potential donors in the Swedish public towards information and consent procedures in relation to use of human tissue samples in biobanks: a population-based study. Scand J Public Health. 2007;35(2):148–156. - PubMed
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1. Ludvigsson JF, Otterblad-Olausson P, Pettersson BU, Ekbom A. The Swedish personal identity number: possibilities and pitfalls in healthcare and medical research. Eur J Epidemiol. 2009;24(11):659–667. - PMC - PubMed
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[1] Anell A. The public-private pendulum – patient choice and equity in Sweden. N Engl J Med. 2015;372(1):1–4. - PubMed

[2] Anell A. The public-private pendulum – patient choice and equity in Sweden. N Engl J Med. 2015;372(1):1–4. - PubMed

[3] Kettis-Lindblad A, Ring L, Viberth E, Hansson MG. Perceptions of potential donors in the Swedish public towards information and consent procedures in relation to use of human tissue samples in biobanks: a population-based study. Scand J Public Health. 2007;35(2):148–156. - PubMed

[4] Kettis-Lindblad A, Ring L, Viberth E, Hansson MG. Perceptions of potential donors in the Swedish public towards information and consent procedures in relation to use of human tissue samples in biobanks: a population-based study. Scand J Public Health. 2007;35(2):148–156. - PubMed

[5] Schmidt M, Pedersen L, Sørensen HT. The Danish Civil Registration System as a tool in epidemiology. Eur J Epidemiol. 2014;29(8):541–549. - PubMed

[6] Schmidt M, Pedersen L, Sørensen HT. The Danish Civil Registration System as a tool in epidemiology. Eur J Epidemiol. 2014;29(8):541–549. - PubMed

[7] Ludvigsson JF, Otterblad-Olausson P, Pettersson BU, Ekbom A. The Swedish personal identity number: possibilities and pitfalls in healthcare and medical research. Eur J Epidemiol. 2009;24(11):659–667. - PMC - PubMed

[8] Ludvigsson JF, Otterblad-Olausson P, Pettersson BU, Ekbom A. The Swedish personal identity number: possibilities and pitfalls in healthcare and medical research. Eur J Epidemiol. 2009;24(11):659–667. - PMC - PubMed

[9] Hemminki K, Li X, Sundquist J, Sundquist K. Familial association between type 1 diabetes and other autoimmune and related diseases. Diabetologia. 2009;52(9):1820–1828. - PubMed

[10] Hemminki K, Li X, Sundquist J, Sundquist K. Familial association between type 1 diabetes and other autoimmune and related diseases. Diabetologia. 2009;52(9):1820–1828. - PubMed

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Ethical aspects of registry-based research in the Nordic countries

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Ethical aspects of registry-based research in the Nordic countries

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