Third-party rights and risks: a forum on informed consent of persons affected by the study of human subjects--conditions, experiences, and concerns in a Nordic country.
In Denmark, health research using personal information can be conducted only with permission from a regional scientific ethical committee and the national Data Protection Office. There are no rules applying to the rights and risks of third parties. In this article, the implications for third-party rights and risks of the type and level of involvement of the subjects are discussed from a Danish point of view. Particular emphasis is put on the current conditions, experiences, and concerns with regard to use of already registered personal information, which in the Nordic countries offers unique opportunities for large-scale, longitudinal, population-based studies also involving third parties. These opportunities have recently been challenged by a European Community Directive, with which all member states must comply, requiring informed consent on every transaction of personal data, but through a political process, it was possible to obtain a series of amendments allowing the special register-based research to continue. Crucial arguments favoring the amendments were that no damage has been observed so far and that such research has no interest in the individual data, only in the statistical distributions and associations. Finally, the article suggests that the rights and risks of third parties might be considered on the basis of use: third-party information provided by the subject only as a source of such information distinct from use of the information as an integral part of the subjects' information about themselves and their lives.
Sørensen
T I
TI
Institute of Preventive Medicine, Kommunehospitalet, DK-1399 Copenhagen K, Denmark. tias@ipm.hosp.dk
D003718:Denmark; D005062:European Union; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D028701:Patient Rights; D012042:Registries; D012106:Research / Q000592:standards*; D018570:Risk Assessment