Biology Reference
In-Depth Information
relating to post-study obligations (see Chap. 3 ). For instance, one of deCODE's
founders, physician Ernir Snorrason (who left the company and became one of its
main critics), wrote a letter to the parliamentary committee on health as the Health
Sector Database Bill was being debated in parliament, arguing that free medica-
tions would harm patients' health, as older, well-known drugs would be replaced
by free medications fresh from clinical trials with little-known side effects. (Some
side effects emerge only once a drug is on the market and in wide use.) Ernir
Snorrason suggested that Roche wanted to use the Icelandic population to test
drugs for efficacy and side effects (Snorrason 1998 ).
An affluent, democratic country such as Iceland, with a high level of education
and universal health care, may seem far from vulnerable to exploitation. But even
in this case there are issues of vulnerability and potential exploitation to consider.
One issue concerns the so-called 'presumed consent' policy for the Health Sector
Database. Instead of the entity proposing the tests seeking informed consent from
research participants, as is the rule for human genetic research, every resident in
Iceland who used medical services was to be included as a research participant in
the database, unless he or she signed a document to opt out. This policy is problem-
atic for a number of reasons, but especially for failing to protect vulnerable individu-
als. In particular, those who would normally not be allowed to participate in research
because they are legally incapable of giving informed consent would be included in
the database by default. Many patients with mental illness or serious physical illness,
and those suffering from drug or alcohol abuse, would be doubly vulnerable: their
conditions make them less able to inform themselves and to make or act upon a deci-
sion on whether to opt out, even though they may have a greater interest in opting
out, because their medical information is more sensitive than that of most people.
It could therefore be reasonably argued that these vulnerable citizens would
be exploited simply by the inclusion of their data in the Health Sector Database.
Their data would be used to benefit others without any assurance that they had
considered the proposal and decided not to opt out. More likely, their ignorance of
the database or their inability to withdraw from it might explain their 'presumed
consent'. In this sense, their participation would benefit the researchers, the phar-
maceutical companies conducting the studies and the commercial company oper-
ating the database. The latter would obtain substantial medical data which would
usually be unavailable were informed consent required. As a result, these vulner-
able individuals could be exposed to risks which they could avoid more easily if
informed, rather than presumed, consent was required.
Vulnerability and potential exploitation are concerns not only at the level of
individuals, but also at the level of the population. Many of these vulnerabilities
were discussed during the debate on the Health Sector Database in Iceland. First,
in general, privacy concerns have a low priority in Iceland, although the debate
about the database increased public awareness of privacy issues in medicine and
medical research. Second, the Icelandic public consider scientists and physicians
very trustworthy, a situation which can facilitate potential exploitation. 10 Third,
10 For a general discussion on this issue, see Andanda ( 2005 ).
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