within this location is screened for mutations by
camparing the DNA sequence of healthy and
affected individuals.
In its population genomics program,Decode has
established collaborations in over 30 selected
diseases with close to 100 clinical collaborators.
Cooperation with pharmaceutical companies,
biotechnology firms and other healthcare-related
businesses has been developed and contracts made
for funding ofcertain diseases. In others, the com–
pany is pursuing internally funded research
programs to discover genetic eauses in a number
of disease areas.
In those projects the company utilizes leading–
edge bioinformatics and fully integrated computer
systems developed with proprietary software for
genetic studies. The company operates one of the
world'smost technologically advancedgenotyping
operations, capable ofgeneratingmore than 3mil–
lion genotypes each month.
It is to beexpected that drug target identification
that is based primarilyon expression and functional
studies will be less specific than using the genetic
approach, that may identify the mutated gene ofa
molecular pathway in the pathogenesis of the
disease. The information generated in this way
can enable prediction of which patients are
susceptible to a positive or adverse reaction to
existing drugs. It can also identify genes invalved
in specific diseases, screen compounds and help
develop specific drugs for the disease.
The work is pragressing very weil. The
acceptance by the leelandie people has been
outstanding as weil as project participation. The
forthcoming results wi ll further attest to the
feasibi Iityof research based on the characteristics
of the leelandie population. The cooperationwith
the governing bodies of personal data protection
and science ethics has generatednewmethods and
approaches in data security in research to be copied
by others. All this research is done with the
participants informed consent
The leelandie Realtheare Database (IHD)
InDecemberof 1998 the leelandie parliament pas–
sed the law on healthcare database in leeland.
DecodeGenetics is the solecontender to be granted
the license to build and operate the database for
the next
12
years. The databasewill contain health
90
information derived from hospitals and primary
care centers in addition
to
private institutions, thus
generating halistic health information on
participants. An assumed consent is applied in
building this database and thedata is unidentifiable
as defined by the law. Peoplecanopt out and refrain
from participation at any time.
The data security is to be subject to very strict
regulations with tripleencryption, including a "one
way" encryption, strict actmission criteria and
surveillance. The Data Proteetian Commission,
The National Bioethics Committee, an Operation
Supervisory Committee and a special Database
Science Ethics Committee willmonitor the opera–
tion and approve research proposals of the IHD.
The genealogy database, constructed by an
informed consent from participants, and genotypic
database will be separate from the IHD but a lic–
ense can be granted by the above mentioned
appropriate Commissions for temporary Iinking
during processing of certain previously approved
queries.
A healthy discussion has taken place about the
making of this database for various reasons. The
discussion has included items such as privacy
protection, inforn1ed consent, the freedom of
scientific research and scientist have even
discussed such less scientific matters as business
prospects and laws on commercial competition.
The dispute has crystallized outmany important
aspects about conduct of research in general in
leeland and internationally. This discussion has
already brought about considerable improvement
in research conduct for the protection of personal
data and patients rights in general in Iceland.
When the IHD is campared to many of the
currently operated databases internationally, it
turns out that assumed consent in fact is the rule
rather than exception. Detailed discussions about
this form ofconsent have not taken place anywhere
else to the same extent as in Iceland, but my
prediction is that as people in other countries
become more aware of the presence of such dat–
abases, they will demand the same discussion as
has already taken place in Iceland. The leelandie
Realtheare Database wil l contain information on
longitudinal disease progression, treatments and
treatment response as weil as direct and indirect
east of treatment and cost-effectiveness.The IHD
Kli11isk Kemi
i
Norch'll
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