Informed Democratic Consent? the Case of the Icelandic Database
Arnason, Vilhjalmur, Arnason, Gardar, Trames
The following discussion is about plans currently being carried out in Iceland to create a single health sector database for the whole nation, intended in part for research in human genomics and genetic epidemiology. The rapid rise of genetics and the unprecedented tensions between public and commercial interests in this type of scientific research create new problems and magnify old ones concerning the role of government in defending public interests and the efficacy of democratic procedures in securing such ethical requirements as privacy and confidentiality of medical records and genetic material. The question of democratic consent will be of particular interest: We are not concerned with the question of whether community consent is at all possible (1), but we argue that the debate about the Health Sector Database (HSD) in Iceland does not exemplify well community consent, and that the procedure through which the HSD was made possible was seriously flawed.
The Health Sector Database will contain information gathered from medical records and it will be linked with two other databases, one containing genealogical data for every Icelander alive and, going centuries back, most of those deceased, and the other containing genetic information. A private company, deCODE genetics, (2) has been granted exclusive rights for 12 years to construct the database, maintain it and sell access to the information.
We shall first, in subsection 2, briefly describe the database project and some of the main ethical issues involved. In subsection 3 we discuss democratic community consent in the context of the Icelandic HSD debate. In subsection 4 we analyse the political procedures and the debate, which led to a controversial bill being passed by the Icelandic parliament on December 17th 1998. The bill contained the changes to Icelandic laws required for the HSD project to go ahead. We conclude that informed democratic consent has to meet both procedural and substantive criteria, and that in this case it failed on both accounts.
2. The Icelandic Health Sector Database
The Health Sector Database will contain information taken from medical records in Iceland. The data gathered for the database includes most medically relevant data that are codable, such as symptoms, test results, diagnosis, stage and duration of disease, medication, treatment, results, side-effects and cost of treatment, who provides treatment, where and for how long, and some personal information, such as the patient's age group. Patients' narratives will not be included, nor personal information that is not medically relevant. It is not clear whether information about diet, life-style (other than smoking and drinking habits), sexual orientation, race, vocation or income bracket will be included, all of which can be medically relevant. (3)
The database laws, as they were approved by the parliament, make clear that the Health Sector Database may only include data from medical records, but it can be linked with other databases containing genealogical and genetic data (with the approval of the Data Protection Commission). These two types of data are at opposite ends with regard to sensitivity and privacy. Genealogical information is considered public information in Iceland, no privacy restrictions apply to it and it is frequently published in books and newspapers. In order to keep individuals unidentifiable, genealogical information will only appear in query results from the database as degree of kinship, not as family trees. Genetic data, however, are considered as private in Iceland as in other Western countries and, according to ethical codes established by deCODE itself, they will only be entered in the database if the individual has given his or her explicit consent. (4)
There are two worries here concerning the handling of genetic data. One is the claim that no one can give informed consent for providing genetic data for the database as there are no specific research plans available. …