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Ethical aspects of registry-based research in the Nordic countries

Ludvigsson, Jonas F. (author)
Karolinska Institutet,Region Örebro län,Dept Med Epidemiol & Biostat, Karolinska Inst, Stockholm, Sweden; Dept Pediat, Örebro Univ Hosp, Örebro, Sweden
Haberg, Siri E. (author)
Norwegian Inst Publ Hlth, Oslo, Norway
Knudsen, Gun Peggy (author)
Norwegian Inst Publ Hlth, Oslo, Norway
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Lafolie, Pierre (author)
Karolinska Institutet
Zoega, Helga (author)
Fac Med, Ctr Publ Hlth Sci, Univ Iceland, Reykjavik, Iceland
Sarkkola, Catharina (author)
Genet Epidemiol Grp, Folkhälsan Res Ctr, Helsinki, Finland
von Kraemer, Stephanie (author)
Genet Epidemiol Grp, Folkhälsan Res Ctr, Helsinki, Finland
Weiderpass, Elisabete (author)
Karolinska Institutet
Norgaard, Mette (author)
Dept Clin Epidemiol, Aarhus Univ Hosp, Aarhus, Denmark
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 (creator_code:org_t)
2015
2015
English.
In: Clinical Epidemiology. - 1179-1349. ; 7, s. 491-507
  • Research review (peer-reviewed)
Abstract Subject headings
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  • 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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Hälsovetenskap -- Arbetsmedicin och miljömedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Health Sciences -- Occupational Health and Environmental Health (hsv//eng)

Keyword

ethical review
ethics
institutional review board
Nordic countries
registry-based research
informed consent

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