Correspondence
The Icelandic Healthcare Database
N Engl J Med 2000; 343:1734-1735December 7, 2000
- Article
To the Editor:
Regarding “The Icelandic Healthcare Database and Informed Consent” (June 15 issue)1: legislation passed on May 13 in Iceland makes it clear how deCODE could obtain the DNA they need to complete their genotypic–phenotypic data base. The new act on biobanks takes the “assumed consent” embodied in the plan for a centralized data base of medical records and extends it to patients' blood and tissue. As long as written information on “assumed consent” is available at the clinic, clinical samples may be used for research unless the patient objects. Thus, subject to the approval of a politically appointed committee, blood drawn for routine clinical tests could be legally entered into the deCODE data base for commercial exploitation without the permission, or even knowledge, of the patient.
Where was the debate that Gulcher and Stefánsson claim was so important to the passage of the initial law? Introducing the biobanks bill with two months left in the parliamentary session and refusing to clarify key provisions in the bill, the Icelandic government allowed no constructive discussion and no community consultation. Even worse, a provision that was slipped in at the 11th hour (Article 7, Paragraph 4) would allow researchers to retain cell lines or DNA derived from biologic samples even if a subject decides to withdraw from a study. This provision alone seems to violate the privacy protections of both Article 71 of the Icelandic Constitution and Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, of which Iceland is a bound signatory. Icelandic opponents plan to challenge provisions like these in the Icelandic courts and, if necessary, in the European Court of Human Rights.
1 ReferencesDavid Winickoff
Harvard Law School, Cambridge, MA 021381
Gulcher JR ,Stefansson K . The Icelandic Healthcare Database and informed consent. N Engl J Med 2000;342:1827-1830
Full Text | Web of Science | Medline
To the Editor:
The article by Annas1 in the June 15 issue illuminates the problem with the Icelandic Health Sector Database Act — the lack of a requirement for a priori informed consent. I believe that the Icelandic act is unworkable in a Western democracy because its very nature is totalitarian.
People have the right to be free of unwarranted and unwanted intrusion by governments, corporations, or anyone else into their private affairs and the right to make fully autonomous choices and decisions about themselves. Informed consent is a mechanism for respecting privacy and autonomy. The Health Sector Database Act contravenes these norms because it essentially claims that the government can enter into the confidential relationship between a person and his or her doctor and hand the information generated by this relationship over to a for-profit corporation, with the justification that the data and personal identifiers will be encrypted. The need for a way for citizens to defend themselves is recognized, since those who object can opt out by registering with the government.
This law presents people with the choice between being witting or unwitting participants in the business plan of a corporation or registering their objections with the state and being entered on an opt-out list. The corporation registers information on all those who do not object, and the state registers information on those who do object. The law makes all citizens captives of a corporate–governmental entanglement, whatever they do. This is totalitarian.
What is all this for? Gulcher and Stefánsson argue that “presumed consent” for the use of health records and “broad consent” for use of genetic data are required for a “revolutionary method for studying the interplay between genetics and environment in human disease and health,” since they make possible the “mining [of] large data sets for knowledge, without a priori hypotheses, by systematically juxtaposing various data in the search for the best fit.”
With millions of juxtaposed associations, hundreds of thousands will be statistically significant by chance alone. Even if deCODE possessed twice the claimed “formidable capabilities in statistical genetics,”2 sifting through the rubble of false positives in search of cures for humankind is at best an uncertain venture but more likely a nightmare of interpretation. The argument that doing away with informed consent will make this a revolution in medicine fails to convince.
2 ReferencesEinar Arnason, Ph.D.
University of Iceland, 108 Reykjavik, Iceland1
Annas GJ . Rules for research on human genetic variation -- lessons from Iceland. N Engl J Med 2000;342:1830-1833
Full Text | Web of Science | Medline2
Edwards JH . Unifactorial models are not appropriate for multifactorial disease. BMJ 1999;318:1353-1354
CrossRef | Web of Science | Medline
Author/Editor Response
Drs. Gulcher and Stefánsson reply:
To the Editor: Arnason expresses the view that the law on the Icelandic Health Sector Database is “unworkable in a Western democracy because its very nature is totalitarian.” The argument he gives to support this view is that the law allows the use of data from medical records without the informed consent of patients. If it is incompatible with a Western democracy to allow the use of information from medical records without informed consent, then there is no Western democracy. There is not a nation in the Western world that bans the use of data from medical records under presumed consent. For example, Iceland, whose parliament passed the law on the Heath Sector Database, which accepts the use of data from medical records under presumed consent, has always used data from medical records under presumed consent, and there are numerous recently published studies that prove this point.1-4 Hence, in embracing the use of health care information without informed consent, the law on the Health Sector Database did nothing but endorse and put a legal frame around what is a common practice all over the world.
Furthermore, Arnason exposes another subtle misunderstanding when he comments on the problems faced by those who want to establish associations through the mining of data in health care data bases when he says, “with millions of juxtaposed associations, hundreds of thousands will be statistically significant by chance alone.” The misunderstanding here lies in the fact that associations are statistically significant only when they are greater than accounted for by chance alone. Statistics provide us with the tools to determine whether associations are indeed greater than can be accounted for by chance alone, and among them are methods to account for the effect of multiple testing. The challenges of mining health care data bases for knowledge are formidable, but in many ways they are similar to the challenges of mining other data bases. Hence, we can draw on the experience of others at the same time that we work on the development of new methods that are particularly suited to health care data.
The law on the Icelandic Healthcare Database stipulates that this data base will not contain biologic samples or the results of experiments done on biologic samples. However, in his letter Winickoff tries to make us responsible for the lack of debate on the bill on biobanks. We had nothing to do with the latter bill, and the law on biobanks has nothing to do with the Icelandic Healthcare Database.
4 ReferencesJeffrey R. Gulcher, M.D., Ph.D.
Kári Stefánsson, M.D., Ph.D.
deCODE genetics, 110 Reykjavik, Iceland1
Helgason T ,Bjornsson JK ,Zoega T ,Thorsteinsson HS ,Tomasson H . Psychopharmacoepidemiology in Iceland: effects of regulations and new medications. Eur Arch Psychiatry Clin Neurosci 1997;247:93-99
CrossRef | Web of Science | Medline2
Baffoe-Bonnie AB ,Beaty TH , Bailey-Wilson, et al. Genetic epidemiology of breast cancer: segregation analysis of 389 Icelandic pedigrees. Genet Epidemiol 2000;18:81-94
CrossRef | Web of Science | Medline3
Bjornsson S ,Johannsson JH . Inflammatory bowel disease in Iceland, 1990-1994: a prospective, nationwide, epidemiological study. Eur J Gastroenterol Hepatol 2000;12:31-38
CrossRef | Web of Science | Medline4
Ludviksdottir D ,Skulason H ,Jakobsson F , et al. Epidemiology of liver cirrhosis morbidity and mortality in Iceland. Eur J Gastroenterol Hepatol 1997;9:61-66
Web of Science | Medline
- Citing Articles (5)
Citing Articles
1
Helen Swede, Carol L. Stone, Alyssa R. Norwood. (2007) National population-based biobanks for genetic research. Genetics in Medicine 9:3, 141-149
CrossRef2
Einar Árnason, Frank Wells. 2006. deCODE and Iceland: A Critique. .
CrossRef3
Jon F. Merz, Glenn E. McGee, Pamela Sankar. (2004) “Iceland Inc.”?: On the ethics of commercial population genomics. Social Science & Medicine 58:6, 1201-1209
CrossRef4
Mary R Anderlik. (2003) Commercial Biobanks and Genetic Research. American Journal of PharmacoGenomics 3:3, 203-215
CrossRef5
Mary R. Anderlik, Mark A. Rothstein. (2001) P
RIVACY AND CONFIDENTIALITY OF GENETIC INFORMATION : What Rules for the New Science?. Annual Review of Genomics and Human Genetics 2:1, 401-433
CrossRef
