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.

The First Decade with the Swedish Prescribed Drug Register – A Systematic Review of the Output in the Scientific Literature

“…In Sweden, the Swedish Prescribed Drug Register (SPDR) was expanded to include the identity of the patient on 1 July 2005 [5]. Thus, since then and for research purposes after ethics application [6], the unique personal identity number given to all Swedish citizens has allowed linkage between drug dispensing data and other registers [7].The Swedish Prescribed Drug Register now contains one decade of patient-level data on all dispensed prescription drugs in Sweden. The first 10 calender years of SPDR include purchases of 891 million prescriptions and 44,829 million defined daily doses [8].…”

“…In Sweden, the Swedish Prescribed Drug Register (SPDR) was expanded to include the identity of the patient on 1 July 2005 [5]. Thus, since then and for research purposes after ethics application [6], the unique personal identity number given to all Swedish citizens has allowed linkage between drug dispensing data and other registers [7].…”

Science belongs to no one—and to everyone

“…The Scandinavian National Healthcare registries were created in Finland in 1969, Denmark in 1977, Sweden in 1987, Iceland in 1999, and Norway in 2008 [20]. These different country-specific patient registries manifest not only advantages, but also have evinced ethical concerns [21]. A paradox for scientists is simultaneous fascination and bafflement as well as depression.…”

Nasjonale registerkilder i epidemiologisk forskning

“…For å kunne bruke helseopplysninger og informasjon om familiaere forhold, sosioøkonomiske forhold, og risikofaktorer som finnes i registre og helseundersø-kelser, er det en forutsetning at befolkningen har tillit til at opplysningene oppbevares trygt og at personvernet og sikkerheten ivaretas i all forskning med slike data 60 . I registerstudier har forskerne som regel ikke tilgang til direkte personidentifiserende kjennetegn (som navn eller fødselsnummer) men bruker prosjektspesifikke løpenummer.…”