GENETIC DATABASES: SOCIO-ETHICAL ISSUES IN THE
COLLECTION AND USE OF DNA.
Ed by Richard Tutton and Oonagh Corrigan.
London, New York: Routledge, 2004. vii and 211 pp(incl index). ISBN
0-415-31679-0 (hb). ISBN 0-415-31680-4 (pb). £22.99
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| DOI: 10.2966/scrip.010304.510 | ||
Genetic databases have been and probably will be
in the spotlight of the contemporary debate over the collection and
use of DNA. This book constitutes an important contribution to this
debate by exploring traditional questions around genetic databases as
well as raising somewhat less explored issues. This makes the book
valuable for everyone writing on the topic of genetic databases. The
book was first presented to -a selected audience in London on 8 June
2004.
The Editors, Richard Tutton, University of York,
and Oonagh Corrigan, University of Cambridge, have succeeded in
bringing together ethicists, sociologists, and lawyers - from
different universities of the UK, with one exception - Klaus Hoyer
from the University of Copenhagen. However, it would be erroneous to
draw a conclusion that the book is much too UK-centred since in most
articles comparative methods are used and the situation in other
countries, including Iceland, Estonia, the United States, Sweden, has
been dealt with. The fact that the book contains articles both from
contributors that have extensively written in this field, for
instance Sue Weldon and Graham Lewis, as well as from a new
generation of scientists is another achievement of the Editors.
As to the general drawbacks of this book the time
issue has to be mentioned. Given that the field of genetic databases
changes with every month if not faster, editing of such a book should
have been completed rapidly. Regarding this book, it seems that it
took more than a year for the Editors to complete editing of the book
and the articles in it are therefore on some occasions not up to
date. More recent articles from several contributors to this book,
for example Sue Weldon, Jane Kaye, Erica Haimes, Michael Whong-Barr,
can be found published in journals.1
In the first chapter, the Editors provide an
overview and summary of the main ideas across the book. These ideas
can be divided into three topics – the issue of language and
definitions, the commercial context and the concept of consent and
control. The editors rightly point out that the definition of the
term “genetic databases” is not clear and is widely used
with very different meanings. Unfortunately, they do not aim to
deliver a unified definition of the term even for the purposes of
this book and therefore different authors use different terms. -
Chapter 2 is the first contribution to the topic
of language. In his article „Person, property and gift”
Richard Tutton reviews the gift relationship that underlies the
contemporary relationship between a researcher and research
participants. The gift relationship as it has been applied to blood
donation is now also standard in the context of genetic research, due
to the need to ensure altruism and solidarity. Also the gift
relationship allows the exclusion of the person, from whom the tissue
derives, from all kind of property rights in respect of the tissue
and hence, makes it a potentially lucrative resource for researchers
and industry. Against this background, Tutton deals with different
proposals to overcome the situation and to increase the role of the
person. One way to do it, suggests Tutton, is to differentiate
between tissue on the one hand and genetic information on the other
hand so that both non-commercial donation of tissue as well as the
commercial domain of genetic information could co-exist.
In Chapter 3 „Blood donation for genetic
research”, Helen Busby continues the topic of language by
exploring what we can learn from donors, narratives. After a short
analytical section she turns to two case studies. Within the
framework of the first study, one hundred short interviews with
people donating blood for the National Blood Service (NBS) were
conducted. It appeared that, in general, people are not worried about
what happens to their blood once it has been collected but they do
not seem to know the wide range of applications that their blood can
be used for. Another case study was carried out on people donating
blood for a specific genetic research project. Interestingly,
participants did not consider genetic research as something special
in itself but Busby warns against applying these outcomes to the UK
Biobank context given the scale of research protocol.
Chapter 4 is report of a case study of the North
Cumbria Community Genetics Project conducted by Erica Haimes and
Michael Whong-Barr. They claim that the exceptionally high
participation rate (nearly 90 per cent) can be explained by
analysing what is meant by “participation”. Although at
the first glance, the term participation is unambiguous, they still
manage to show that there are different levels and styles of
participation in this NCCG project.
Oonagh Corrigan introduces the topic of consent
and control in Chapter 5. She argues that the multi-layered consent
forms routinely used by pharmaceutical companies in drug research
that give to the company the right to use the sample for the future
studies overreach the boundaries of informed consent and constitute a
form of exploitation of research subjects. According to Corrigan, the
concept of informed consent is not suitable for providing a balance
between risk and benefits of the research participants and commercial
interests of the industry.
In Chapter 6, Klaus Hoyer presents his conclusions
from a study that he conducted on people donating blood to the famous
Medical Biobank in Västerbotten, the biobank that failed to
establish a public-private partnership with UmanGenomics.2
His study reveals similar results as the above referred studies of
Busby, in that people seldom scrutinized the provided information
before consenting and have only few fears about the misuse of their
tissue – they rarely asked any questions and seemed to have
decided in favour of participation even before showing up at the
medical facility. He claims that such behaviour is not irrational
since the function of informed consent in genetic databases is
different than in traditional medical research.
For the lawyers, the most interesting chapter in
this book is written by Jane Kaye. Her article, titled “Abandoning
informed consent”, is based on her PhD thesis recently defended
at the University of Oxford and will most likely be as often cited as
her previous articles.3
She starts with distinguishing between two concepts of informed
consent – traditional informed consent as set out in the
Declaration of Helsinki and consent required by the Personal Data
Protection Directive 95/467EC.4
She argues that the consent sought within the framework of population
based genetic databases is unable to meet either of these consent
standards, furthermore, none of the consent exemptions are
applicable. She concludes that a new concept is needed and proposes
her two stage approach. First, at the stage of collection of
information and obtaining tissue sample, only a broad consent is
possible.. Second, once the specific research has been determined,
researchers should have an obligation to inform potential
participants about it and provide them an opportunity to opt out from
the contemplated research project. Additionally, some safeguards to
protect trust and participation in the research should be set out.
In Chapter 8, Emma Williamson, Trudy Goodenough,
Julie Kent and Richard Ashcroft explore the issues of consent and
control in the context of “Children’s participation in
genetic epidemiology” using the Avon Longitudinal Study of
Parents and Children (ALSPAC) as the example. A central ethical
question in this chapter is whether the parents have the right to
consent to the long term biomedical research on behalf of children at
all and where should we set the balance between parental rights and
the interests of the children.
Sue Weldon’s starting point in Chapter 8
“’Public Consent’ or ‘scientific
citizenship’” examines the limit of individual informed
consent. She raises the question of whether, and to what extent,
individual consent can be replaced or accompanied with public consent
or scientific citizenship. One type of public consent is used in the
context of the Icelandic Health Sector Database with a result that
individual consent is not needed. Though people have the right to
opt-put from the project, such a solution is still problematic.
Scientific citizenship, a concept that aims to ensure better
involvement of the public in designing and implementing scientific
projects, seems to offer a more promising solution.
In the last Chapter “Tissue collection and
the pharmaceutical industry”, Graham Lewis delivers an overview
of corporate biobanks – these are the biobanks that
pharmaceutical companies have already established for their own
research ends. He distinguishes between in-house collections,
clinical genomics companies as repositories, collaborations with
existing public collections and other collections. The total number
of samples being currently held in these collections is unknown but
exceeds several hundred million. Given thescale and the fact that
these collections are far less explored and publicly controlled,
further ethical scrutiny should be directed towards these biobanks.
The book “Genetic Databases” provides refreshing reading on genetic databases from thought provoking angles. It remains to be seen to what extent these provoked thoughts will be reflected in the scientific literature and, what is probably more important, in the protocol for the UK Biobank.
Ants Nõmper
University of Tartu, Estonia
1 Trames, “Human Genetic Databases: ethical, legal and social issues”, 8 Journal of the Humanities and Social Sciences (2004)
3 J Kaye, P Martin, “Safeguards for research using large scale DNA collections” (1999) 321, British Medical Jounal 1146-1149.
4 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. OJ 1995 L281/31.