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      Ethical aspects of registry-based research in the Nordic countries

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          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.

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          Most cited references57

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          Medication for attention deficit-hyperactivity disorder and criminality.

          Attention deficit-hyperactivity disorder (ADHD) is a common disorder that has been associated with criminal behavior in some studies. Pharmacologic treatment is available for ADHD and may reduce the risk of criminality. Using Swedish national registers, we gathered information on 25,656 patients with a diagnosis of ADHD, their pharmacologic treatment, and subsequent criminal convictions in Sweden from 2006 through 2009. We used stratified Cox regression analyses to compare the rate of criminality while the patients were receiving ADHD medication, as compared with the rate for the same patients while not receiving medication. As compared with nonmedication periods, among patients receiving ADHD medication, there was a significant reduction of 32% in the criminality rate for men (adjusted hazard ratio, 0.68; 95% confidence interval [CI], 0.63 to 0.73) and 41% for women (hazard ratio, 0.59; 95% CI, 0.50 to 0.70). The rate reduction remained between 17% and 46% in sensitivity analyses among men, with factors that included different types of drugs (e.g., stimulant vs. nonstimulant) and outcomes (e.g., type of crime). Among patients with ADHD, rates of criminality were lower during periods when they were receiving ADHD medication. These findings raise the possibility that the use of medication reduces the risk of criminality among patients with ADHD. (Funded by the Swedish Research Council and others.).
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            The Danish Cancer Registry--history, content, quality and use.

            The Danish Cancer Registry is a population-based registry containing data on the incidence of cancer throughout Denmark since 1943. Reporting of cancer was made mandatory by administrative order in 1987. Details of individual cases of cancer are available according to the 7th revision of the International Classification of Diseases (ICD) for all years, and according to the ICD-O since 1978. A core data set is kept on each individual which includes date of birth, sex, date of cancer diagnosis, method of verification, date of death and cause of death. This paper describes the history of the registry, its data sources and its procedures, including quality control and access to data. Integration of both research activities and registration since the inception of the Registry has maintained the completeness and validity of the data for 1943-1996.
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              Review of 103 Swedish Healthcare Quality Registries.

              In the past two decades, an increasing number of nationwide, Swedish Healthcare Quality Registries (QRs) focusing on specific disorders have been initiated, mostly by physicians. Here, we describe the purpose, organization, variables, coverage and completeness of 103 Swedish QRs.
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                Author and article information

                Journal
                Clin Epidemiol
                Clin Epidemiol
                Clinical Epidemiology
                Clinical Epidemiology
                Dove Medical Press
                1179-1349
                2015
                23 November 2015
                : 7
                : 491-508
                Affiliations
                [1 ]Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
                [2 ]Department of Pediatrics, Örebro University Hospital, Örebro, Sweden
                [3 ]Norwegian Institute of Public Health, Oslo, Norway
                [4 ]Department of Medicine, Clinical Pharmacology Unit, Karolinska Institutet, Stockholm, Sweden
                [5 ]The Stockholm Regional Ethical Review Board, Karolinska Institutet, Stockholm, Sweden
                [6 ]Center of Public Health Sciences, Faculty of Medicine, University of Iceland, Reykjavík, Iceland
                [7 ]Genetic Epidemiology Group, Folkhälsan Research Center, Helsinki, Finland
                [8 ]Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, Tromsø, Norway
                [9 ]The Arctic University of Norway, Tromsø, Norway
                [10 ]Department of Research, Cancer Registry of Norway, Oslo, Norway
                [11 ]Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
                Author notes
                Correspondence: Jonas F Ludvigsson, Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Solnavägen 1, 17177 Solna, Stockholm, Sweden, Tel +46 8 5248 0000, Fax +46 0 8 314 975, Email jonasludvigsson@ 123456yahoo.com
                Article
                clep-7-491
                10.2147/CLEP.S90589
                4664438
                26648756
                b7beb173-fdb6-4e11-9c24-a6e52945a639
                © 2015 Ludvigsson et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
                Categories
                Review

                Public health
                ethical review,ethics,institutional review board,nordic countries,registry-based research,informed consent

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