http://news.bmn.com/hmsbeagle/110/notes/feature12
TRENDS
PREVIEW 3
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This article will appear in a forthcoming issue of Trends in
Molecular Medicine. |
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Abstract
The first population collection established
specifically for genetic research was the Health Sector Database in Iceland [1]. Since
then, a succession of collections has been proposed in Estonia [2], Tonga [3],
Newfoundland [4],
Sweden [5],
Singapore [6]
and in the U.K. These large databases of identifiable medical information are
established to facilitate "the search for potentially very subtle correlations
between health outcomes, genetics and environmental factors [7]." In
March 2001, the U.K. House of Lords Select Committee on Science and Technology
Report on Human Genetic Databases recommended "a population-based approach
to the collection of health and genetic information through the delivery of
routine health care." [8] If the
recommendations of this Report are followed all clinical data held by the NHS
on the British population over the past fifty years will be computer linked for
the purposes of genetic research. This is, in effect, a national population
collection on a scale of 60 million - far bigger than the other proposed
population collections [9], or the
proposed U.K. Biomedical Population Collection of 500,000 [10].
The flaw in the House of Lord's Report is that it regards the linkage of
clinical information for genetic research as being little different from what
the NHS currently does. Although this is true on one level, at another it
ignores the norms that have developed for population collections and the full
implications of establishing a database linking system of this complexity and
comprehensiveness for genetic research. Although it might be acceptable to link
health data for general purposes, for genetic research on whole populations -
which are in the "super league" of genetic databases - different
normative principles are being established. The purpose of this paper is to highlight
some of the key issues in the establishment of population collections, which I
believe have been ignored in the House of Lords Report.
Community Consultation
Ethical guidelines for research on populations require that both the group
and individuals should be consulted before the undertaking of research [11]. It is
not sufficient just to seek individual consent for inclusion of personal
information in a population collection. This is because a population study has
implications not simply for the individual but for families and the population
as a whole, in terms of the potential for discrimination, stigmatization, and
the characterization of potentially negative traits [13]. It is
also important for the population to assess the social implications of
establishing such a comprehensive body of sensitive information, and to decide
upon issues such as access by third parties and whether uses other than medical
research should be allowed. Community consultation enables the society to
debate these issues in a meaningful and inclusive way, before a collection is
established, "either through the democratic process or through the
media" [14].
Thorough community consultation should also engage the population "as
partners in planning and carrying out the research and not just as research
subjects" [12].
Community consultation provides information so that individuals can then make
an informed decision when deciding whether to give individual consent.
The House of Lords Report makes no mention of the need for community consent
or for public debate. If the recommendations of the report are followed, a
population collection will be established incrementally by the systematic
linkage of different databases in the NHS using the NHS number as a national
identifier [15],
without public consultation. At the same time the Select Committee did
recognize that it "is essential that there is high public confidence in
this activity, otherwise some or many of the benefits to be gained from the
advances in genetics will not be realised" [16]. One way
of gaining public confidence is through consultation and engaging the public in
the planning of the population collection and its implications. This approach
would treat the population as participants in the research, and would
acknowledge their contribution.
Consent
It is possible to obtain informed consent for the taking of a DNA sample,
and for inclusion in a specific research project, and this is regarded as the
norm in international research practice [17]. However,
it is not clear what kind of consent is required for secondary research, when
all the possible uses of the information cannot be anticipated at the time of
collection [18],
or when existing information, such as medical records, are used for another
purpose such as medical research. Population collections also involve linking
this information to other collections of data to "mine" the research
possibilities of the data. To make it possible to link individuals across
different databases there needs to be a common personal identifier. Should this
kind of research just require research ethics approval, such as in epidemiology
[19] or
should individual consent be required? In Iceland the governments' decision not
to seek consent for the inclusion of medical records in the population
collection provoked domestic and international condemnation and resulted in
this being changed to an "opt out" system [*]. Since
then, all the population collections that have followed have sought consent,
for instance Estonia, Sweden, and Tonga. Consent, or the possibility of being
able to choose whether your clinical data is used for research purposes has
become the norm for population collections.
In the U.K., the House of Lords Select Committee recommended that the type
of consent should be broad, and that approval for the secondary use of the data
should be entrusted to a Medical Data Panel as in the Danish health system [20]. With
the passing of section 60 of the Health and Social Care Act in May 2001,
personally identifiable medical information can be used for medical research
without consent if an appointed Committee gives approval. The rationale behind
section 60 was to allow the continued collection of identifiable information by
Cancer Registries [21], but
this section could also be used for approval for the systematic linking of NHS
clinical information to create a population collection for genetic research. It
is still uncertain whether the recommendations of the House of Lords Report
will be followed or whether section 60 will be utilized. If this section is
used, the British population would not have to give consent or even have the
possibility of opting out of research, which would be contrary to the
international principles that have been established for population collections.
Oversight Mechanisms
There is a tendency to focus on consent as the means to protect privacy,
which ignores the fact that there also needs to be technical, procedural, and
supervisory mechanisms to maintain the security of the data and public
confidence in population collections [22]. Ironically,
the controversy over the handling of consent in the Icelandic database has led
to the development of a good model of oversight. The features of this model are
five separately constituted bodies to oversee the establishment and running of
the database [23],
with clear separation of duties and responsibilities and powers of enforcement
and supervision. This structure ensures that the handlers of the raw data, the
encrypters of the data, the enforcement bodies, and the licensee (deCODE
Genetics), are different organizations. This transparency, as well as very
tight technical computer procedures and requirements, has helped to build
public confidence in Iceland as well as maintaining investor support, but still
remains to be fully tested.
The type of oversight mechanisms needed for large databases of sensitive
information were not considered fully by the House of Lords Select Committee.
The Report recommended the establishment of a Medical Data Panel, whose role
was to approve projects, write policy guidelines for research ethics
committees, and advise government on issues relating to secondary medical
research [24].
Unlike the Icelandic model, the Panel has no powers of investigation,
enforcement, or sanction. The Patient Information Advisory Group that has been
established under section 60 of the Health and Social Care Act could in effect
be the Medical Data Panel that was recommended by the House of Lords. If this
is so, the Medical Data Panel has been reduced to just another tier in the
research ethics committee structure without the broader roles envisaged by the
House of Lords.
Tangible Benefits
Genetic research has raised many concerns about the possible exploitation of
a population and the injustice of using information given freely by individuals
for commercial gain that does not directly benefit them. The existing
population collections that have been established by private enterprises have
sought the support of the community and government with the promise of
returning benefits. Many of the initiators of population collections, have
entered agreements where the community receives benefits in the form of profit
sharing [25],
the results of individual genetic tests and education [26], or free
drugs such as in Iceland and Tonga. In Newfoundland, 1% of the net intellectual
property royalties formed as a result of research work goes to a charity
non-profit population foundation fund [27]. If NHS
clinical information is used for genetic research commercial partnerships will
be needed to fund the data linkage and to develop the results of the research [28]. This
issue was not addressed in the House of Lords Report, but a recent survey shows
that commercial use maybe of concern to the British public [29]. The
untested European Directive on the Legal Protection of Biotechnological
Inventions may require consent from the human source for patents that are based
on biological material [30], which
also has implications for commercially orientated research. Individuals would
have to know that personal information was being used for genetic research.
The Next Step
The House of Lords Select Committee Report represents a starting point for
an informed debate about the secondary use of clinical information and the
linkage of different databases for medical research. Since the Report was
written section 60 of the Health and Social Care Act has introduced the
possibility that consent may not be needed for the systematic linkage of
clinical information. It is now up to the NHS and the research community to
decide whether the section 60 avenue is used or whether consent is sought for
the proposed population collection. Consent, transparency, public consultation,
and debate have been features of every population collection that has been
proposed since the Icelandic Health Sector Database was first initiated. The
House of Lords Report does not deal adequately with these particular issues or
the issues of oversight or returns to the community. To encourage public
confidence and support in this proposal it is essential that these issues be
considered in depth. To ignore them runs the risk of public disapproval and the
possibility of condemnation by the international community.
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