INSTITUT MENSCH, ETHIK UND WISSENSCHAFT

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Fußnoten

[ 1 ]
http://www.genepi.com.au/uploads/images/PwnW_ylTBVZjNj_3VU5d2w/Paul_Burton.pdf [2005]

[ 2 ]
Informationsmaterial aus Island wurde nur soweit ausgewertet, wie es in Englisch oder Deutsch zugänglich ist.

[ 3 ]
Sie waren, so wird gesagt, Klassenkameraden in derselben Eliteschule.

[ 4 ]
Wie es auf der Homepage von deCODE heißt: "By mining these datasets we can effectively trace the inherited components of a given disease (…)." http://www.decode.com/main/view.jsp?branch=164430 [2005]

[ 5 ]
"steamrollered" war das meistgebrauchte Wort in den Interviews

[ 6 ]
Der Dissens ist wohl darauf zurückzuführen, dass es sich um verschiedene Zeiten handelt. Die öffentliche Debatte setzte ein, nachdem die zweite Fassung des Gesetzes in das Parlament eingebracht wurde (vgl. folgendes Kapitel).

[ 7 ]
http://sec.gov/Archives/edgar/data/1022974 /000104746905006706/a2153601z10-k.htm [2005]

[ 8 ]
http://www.decode.com/main/view.jsp?branch=164470 [2005]

[ 9 ]
http://www.decode.com/main/view.jsp?branch=16451 [2005]

[ 10 ]
Das Vertrauen an diese Kommission hängt von ihrer Zusammensetzung und der Art ihres Zustandekommens ab.

[ 11 ]
Das hat Sigurdsson (2001) dokumentiert.

[ 12 ]
"That some people are becoming very rich." Eirikur Arnason*

[ 13 ]
Dieses genealogische Wissen macht die isländische Population für genetische Untersuchungen besonders attraktiv. Über ihre Zuverlässigkeit gibt es unterschiedliche Einschätzungen.

[ 14 ]
Sein Vorgänger John Newton ist Anfang des Jahres 2005 zurückgetreten.

[ 15 ]
Teilnehmer eines Workshops haben kritisiert, dass die Ernennung durch die Geldgeber erfolgte (People Science & Policy 2003).

[ 16 ]
Richard Nicholson* kritisiert, dass (zum Beispiel) niemand von der Nichtregierungsorganisation Genetic Alert in den Ethikrat berufen wurde. So würden kritische Fragen verhindert.

[ 17 ]
Ursprünglich waren Kohorten für das Alter zwischen 45 und 69 geplant.

[ 18 ]
Damit entspricht ihre Aufgabe der im Ausschreibungstext angegebenen Definition von Biobanken.

[ 19 ]
"To be frank with you at the beginning there were two not totally dissimilar but really fairly polarised school of thoughts. One was to study smaller numbers in more depths and that includes continuous measures, which for each individual concerned is an expensive approach both in terms of their time, their involvement and also in term of the practical financial aspects. And the other school of thought is to study as many people as you can and as efficiently as you can but rather more superficially so that between the two that from the funders perspective we were trying to reconcile those differences and come up with a model that would satisfy a large enough constituency to make the whole project worthwhile doing."

[ 20 ]
Eine Fall-Kontroll-Studie ist eine Studie, "in der eine Gruppe von Personen mit einer interessierenden Krankheit (Fälle) mit einer Gruppe von Personen ohne diese Krankheit (Kontrollen) hinsichtlich verschiedener Risikofaktoren verglichen wird. Eine eingebettete Fall-Kontroll-Studie ist ein Spezialfall einer Fall-Kontroll-Studie, in der alle Fälle und Kontrollen innerhalb einer wohldefinierten Gruppe von Personen, wie z.B. alle Beschäftigten einer großen Fabrik, identifiziert werden." Online im Interent: http://www.hvbg.de/d/bia/pub /rep/rep01/pdf_datei/biar0300/kap_5.pdf [2005]

[ 21 ]
Unter anderem der Website der UK Biobank, Unterpunkt "History", entnommen. Online im Internet: http://www.ukbiobank.ac.uk/about/history.php [2005]

[ 22 ]
Protocol for the UK Biobank. A study of genes, environment and health. Online im Internet: http://www.ukbiobank.ac.uk/docs/draft_protocol.pdf [2005]

[ 23 ]
Definition von metabonomisch: "The quantitative measurement of the time-related multi-parametric metabolic response of living systems to pathophysiological stimuli or genetic modification." (Nicholson et al. zit. nach Poon 2005)

[ 24 ]
Inzwischen sollen Menschen zwischen 40 und 69 untersucht werden.

[ 25 ]
Sie sind nicht identisch mit den sechs Zentren, mit denen die Zentrale in Manchester zusammenarbeitet.

[ 26 ]
Walker (2005) geht von einer Quote von ca. 30 Prozent aus.

[ 27 ]
Die Kosten für das Tagebuch werden auf ca. 1 Million Pfund geschätzt.

[ 28 ]
"When cases and controls are selected from among subjects in a cohort study the term ′nested case-control study′ is used."

[ 29 ]
Im Protokoll wird festgelegt, dass mit Exposition alle Faktoren gemeint sind, "die mit einem Risiko in Verbindung gebracht werden, außer dem Genotyp, das heißt demografische, Umwelt-, Lebensstil-, reproduktive, medizinische und physiologische Faktoren" (UK Biobank 2002).

[ 30 ]
"(…) any person with misgivings about any aspect of the study should consider declining participation."

[ 31 ]
G: "In view of the potential benefits for health prevention, treatment and public health in general, I feel confident that in the long-term this investment will be considered to give value for the money."

[ 32 ]
C: "Whether a study mainly based on dichotomous outcomes and nested case-control studies will still be in a position to produce relevant results 10 years from now in a highly competitive field is difficult to predict."

[ 33 ]
D: "Without going into detail at this stage, I would have a tendency to urge that all questions that can be answered by other means than a prospective follow-up should be answered by other means. (…) DNA does not change after persons develop a disease."

[ 34 ]
I: "This design includes the serious and real danger in genetic association studies of spurious associations caused by populations stratification."

[ 35 ]
D: "The humility that in the end long-term disease prediction (except in small subgroups) will remain as fundamentally impossible as long-term weather prediction might be a pervasive attitude in this project. It might also help not to oversell the expectations, neither to the public nor the scientists involved."

[ 36 ]
H: "The need for database and statistical genetic expertise is tremendous and the task of these experts in the data collection phase will be overwhelming.

[ 37 ]
"The major problem is how this all relates to commercial companies and commercial interests, and this document sidesteps the issue (…). It′s no good making decisions on a case-by-case basis; we need to have ground rules from the start." (Hagan 2003)

[ 38 ]
"To act as an independent guardian of the UK Biobank Ethics and Governance Framework (EGF) and advise on its revision; to monitor and report publicly on the conformity of the UK Biobank project with the EGF; to advise more generally on the interests of research participants and the general public in relation to UK Biobank." Online im Internet: http://www.wellcome.ac.uk/doc_wtd003504.html

[ 39 ]
Seven Principles of Public Life: selflessness, integrity, objectivity, accountability, openness, honesty, leadership.

[ 40 ]
Es enthält acht Prinzipien zum Datenschutz. Der Gebrauch der Daten ist zum Beispiel nur für einen eingeschränkten Zweck zulässig, die Daten dürfen nicht länger als notwendig gespeichert werden. Das Gesetz räumt jedoch Ausnahmen ein, zum Beispiel wenn ein Minister dies verlangt.

[ 41 ]
"The number of people who will be able to re-identify data and samples will be kept to a minimum."

[ 42 ]
"Ultimately there will remain a remote possibility that identifiable information will be released from the UK Biobank and that this must be clearly explained when seeking consent. The safeguards to ensure confidentiality will need to be clearly spelt out, along with the possible nature and type of breaches of confidentiality."

[ 43 ]
http://www.ukbiobank.ac.uk/about/faqs.php [2005]

[ 44 ]
"Although this is a considerable challenge there is a long history of an altruistic approach to the donation of materials for medical purposes and research in the UK."

[ 45 ]
People Science & Policy Ltd ist eine im Jahr 2000 gegründete Agentur, die über Fragen aus Wissenschaft und Gesellschaft berät (www.peoplescienceandpolicy.com).

[ 46 ]
Die folgenden Zeilen sind eine freie Übersetzung des Originals.

[ 47 ]
Dies ist vorgesehen (UK Biobank 2002).

[ 48 ]
"Is it the best use of the data resource? Is it coming from an organisation we are happy about?" (Walker*)

[ 49 ]
"I like to think, it is a practical consent (…). That recognises the duration of the study and the difficulty in predicting what is going to happen in fifteen years."

[ 50 ]
"It is not clear to us that Biobank was peer-reviewed and funded on the same basis as any other grant proposal. Our impression is that a scientific case for Biobank has been put together by the funders to support a politically driven project."

[ 51 ]
Francis Collins trug bei der Shattuck Lecture 1999 die Vision vor, die Feststellung des individuellen Profils könne effektiv zur Prävention von Krankheiten beitragen (Smith et al. 2005).

[ 52 ]
Homepage der UK Biobank, Unterpunkte "Ethics & governance" und "Science". http://www.ukbiobank.ac.uk/ethics/ethicsgov.php bzw. http://www.ukbiobank.ac.uk/science/science.php [2005]

[ 53 ]
"UK Biobank aims to build a major resource to support a diverse range of research that will improve the prevention, diagnosis and treatment of illness and promote health through society." Online im Internet: http://www.ukbiobank.ac.uk/about/faqs.php [2005]

[ 54 ]
"This combination of information from participants will create a powerful resource for biomedical researchers. It will enable them to improve our understanding of the biology of disease and develop improved diagnostic tools, prevention strategies and tailor made treatments for disorders that appear in later life." Online im Internet: http://www.mrc.ac.uk/index/public-interest/public-topical_issues/public-ukbiobank.htm [2005]

[ 55 ]
"It will be the biggest of its kind in the world and used to support a wide range of health related research. The long-term aim of UK Biobank is to improve the prevention, diagnosis and treatment of illness and the promotion of health throughout society." Online im Internet: http://www.ukbiobank.ac.uk/about/P1Pfaq.php [2005]

[ 56 ]
"UK Biobank′s design provides a powerful means of identifying the true causes of disease and showing how they interact with one another. UK Biobank will allow the risk of disease to be predicted in populations. Knowing difference in risk in populations can help determine the scope of prevention. Information from UK Biobank will help specify meaningful subgroups of illness and improve the specificity and effectiveness of all kinds of care, not only drugs, but also social and emotional." Online im Internet: http://www.ukbiobank.ac.uk /about/why.php [2005]

[ 57 ]
"Over the next 20 to 30 years UK Biobank will allow fully approved researchers to use these resources to study the progression of illnesses such as cancer, heart disease, diabetes and Alzheimer′s disease. From this they hope to develop new and better ways of preventing, diagnosing and treating such problems." Online im Internet: http://www. ukbiobank.ac.uk/about/overview.php [2005]

[ 58 ]
"(…) the big unknown at the moment is the cost of recruitment - this will depend on the number of people who respond to the invitations and the infrastructure costs of mailing and call centres."span>

[ 59 ]
"Normally when we make a bigger investment, we do not pull out immediately after the first period of funding."

[ 60 ]
"It should be driven by the needs of its users and the users should be trying to do things that fit biobanks purpose which is to support research that promotes health rather than driven by the financial imperative. These two things may not be mutually exclusive."

[ 61 ]
Der Wellcome Trust würde es allerdings bevorzugen, wenn die Tabakindustrie keinen Zugang hätte, weil es seiner Politik entspricht, nur Projekte zu fördern, die mit der Tabakindustrie nicht zusammenarbeiten (Walker*).

[ 62 ]
"UK Biobank Limited will be the legal owner of the database and the sample collection, which conveys certain rights such as the right to sell or destroy the samples. The UK Biobank does not intend to exercise all of these rights; for example, it will not sell samples. Rather, UK Biobank will serve as the ‚steward′ of the resource, maintaining and building it for the public good in accordance with its purpose."

[ 63 ]
"(…) a valuable common resource for research."

[ 64 ]
"There was little understanding of how the dates will be used to identify connections between genes, diseases and lifestyle."

[ 65 ]
"I accept that, but at the end of the day, you′ve got to get a 45 old to go down to the bank [the UK Biobank] and give blood." (Mann aus Plymouth zit. nach People Science & Policy 2003)

[ 66 ]
Freie Übersetzung von: "Genetic Epidemiology is a broad discipline combining aspects of statistics, population genetics, classical epidemiology, and human genetics. The basic goal of genetic epidemiology is to understand the role of specific genes, specific environmental factors, and interactions between genes and environment in determining a particular trait of interest. This trait can be either a binary trait such as a particular disease (hypercholesterolemia; breast cancer) or a quantitative trait (serum cholesterol levels; height)."

[ 67 ]
http://www.infektionsnetz.at/TextExtEpidemiologie.phtml [2005]

[ 68 ]
Zusammengestellt nach Lindpaintner (2003)

[ 69 ]
SNP steht für "single nucleotide polymorphisms", auf Deutsch: Einzel-Nukleotid-Polymor-phismen, also Variationen in einzelnen Bausteinen der DNA. Diese Variationen sind fast gleichmäßig über das gesamte Genom verteilt und treten regelmäßig in einem Abstand von etwa 1.000 Bausteinen auf. Wissenschaftler nutzen sie bei der Analyse des Genoms als Marker. In umfangreichen Assoziationsstudien sollen sie helfen, krankheitsfördernde oder -auslösende Gene leichter zu finden als bisher." http://www.aerztezeitung.de/docs/2000/08/28/150a1202.asp [2005]

[ 70 ]
Sehr freie Übersetzung von: "Unravelling the human genome has not automatically bathed the patient′s bedside in a helpful new light. Indeed, there are those who wonder if the promise might have been exaggerated. The more extreme of those doubters will perhaps be silenced only by medically significant discoveries for common and complex illnesses rather than rarer single-gene-disorders. Success judged that way has been modest so far."

[ 71 ]
"To date, the results of studies relating individual polymorphisms to disease outcomes have been disappointing overall."

[ 72 ]
"For the association between an individual risk factor and a particular disease, the null hypothesis of no effect can be readily formulated and empirically evaluated. For the joint effects of two risk factors, there are myriad of possible null hypotheses for independence of causal action. Consequently, definitive conclusions regarding synergistic and antagonistic effects are generally beyond our grasp."

[ 73 ]
Durch Risiken werden Risikofaktoren charakterisiert. Bei einem relativen genetischen Risiko von 2 tritt eine Krankheit bei Menschen mit der entsprechenden Disposition doppelt so häufig auf wie bei Menschen, die diese Disposition nicht aufweisen.

[ 74 ]
Bis zu 1 Prozent.

[ 75 ]
"The genomics revolution has been accompanied by an unfortunate tendency to hyperbole. This has led to unrealistic expectations among clinicians and to cynicism and pessimism within the genetics community. For genetic researchers, one of the most important tasks now is to not add to the hyperbole but to establish and communicate realistic expectations."

[ 76 ]
"The scientific value of focusing on gene-environment interactions has not been established, and in any case, the technical advantages of cohort studies over case-control studies in detection of statistical interactions between genetics and environmental effects are less clear than has been assumed."

[ 77 ]
Freie Übersetzung von: "A potention problem for association studies using unrelated cases and controls is ethnic stratification, which can mimic the signal of association and lead to more false positive results or to missed real effect. This problem had been put forward as one explanation to replicate positive findings in genetic epidemiology. The effect of population stratification on the results of association analyses are potentially more severe when small effects are studied in very large studies.
This result has important implications for national biobanks and large case-control initiatives. This concern is the subject of much debate and study at the nation level in the UK. Addressing population stratification demands an understanding of both the underlying biology and the relevant epidemiology."

[ 78 ]
"Overall reduction in disease burden based on population intervention irrespective of genotype will generally be more substantial than intervention targeted according to genotype.

[ 79 ]
"The prospect for epidemiology in the post-genome era depends on understanding how to use genetic associations to test hypotheses about causal pathways, rather than on modelling the joint effects of genotype and environment."

[ 80 ]
"Crucially, appropriate account is taken of the biology that underlies the action of genes and the known mechanisms of inheritance."

[ 81 ]
"However, really important extra information may best be obtained from novel innovative genetic epidemiology studies using, for example, a variation on the case-control-family design, even though these could mean many more participants and much more financial support." Sie weisen darauf hin, dass der Aufwand bei populationsbezogenen Kontrollstichproben deutlich zugenommen hat, um eine ausreichende Teilnehmerzahl zu erhalten.

[ 82 ]
"(…) and move genetics from is traditional focus on so-called high risk-families to give it a wider clinical and population health relevance."

[ 83 ]
"In epidemiology, the role of genetic variation can be important in establishing the causal nature of environmental associations in which intervention could have major effects."

[ 84 ]
Diese Methode basiert im Wesentlichen auf dem Vorschlag von Martin Katan, wonach die genetischen Varianten, die mit dem Cholesteringehalt in Verbindung stehen, für Untersuchungen mit der Fragestellung genutzt werden können, ob es eine Assoziation zwischen niedrigem Cholesteringehalt und erhöhtem Krebsrisiko gibt (Smith et al 2005).

[ 85 ]
"As in other areas of genetic epidemiology, pharmacogenetics has been characterised by persistent optimism in the face of failure to replicate initial claims of common variants being related to drug responsiveness, which is likely to be at least partly due to inadequate sample sizes."

[ 86 ]
"As in other areas of genetic epidemiology, pharmacogenetics has been characterised by persistent optimism in the face of failure to replicate initial claims of common variants being related to drug responsiveness, which is likely to be at least partly due to inadequate sample sizes."

[ 87 ]
Erwägenswert scheint ein Verfahren des Staates Illinois zu sein, in welchem die Teilnehmer der Forschung via Internet über die Veränderungen des Vorhabens informiert werden (ebd.: 13).

[ 88 ]
In Großbritannien hat zum Beispiel GeneWatch Fragen an Teilnehmer formuliert (GeneWatch 2001).

[ 89 ]
"The justification for a database is more likely to be grounded in communal value, and less on individual gain (…) it leads to the question whether the individual can remain of paramount importance in this context."

[ 90 ]
Vgl. Fußnote 42.