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Ethical issues of genetic databases/ Maximising the benefit of human biobanks requires a thoroughly argued ethical framework

English title Ethical issues of genetic databases/ Maximising the benefit of human biobanks requires a thoroughly argued ethical framework
Applicant Elger Bernice
Number 105001
Funding scheme Fellowships for advanced researchers
Research institution
Joseph and Rose Kennedy Institute of Ethics Georgetown University
Center for Bioethics School of Medicine University of Pennsylvania
Institution of higher education Institution abroad - IACH
Main discipline Medical Statistics
Start/End 01.08.2004 - 31.07.2005
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Keywords (12)

human genetic databases; bioethics; population genetics; research ethics; genetic databases; health research ethics; interests; principles; values; biobanks; guidelines; questionnaire

Lay Summary (English)

Lay summary
1. Objectives: To study the conditions under which genetic databases canbe established, kept, and made use of in an ethically acceptable way.

2. The context and importance of the project: Automated analysis of largeDNA sample collections and the processing of the resulting data havedeveloped dramatically during the past years. Protecting the dataavailable from such databases is a highly complex ethical issue in thearena of health policy, in particular when genetic data are combined withinformation on individuals’ health, lifestyle or genealogy. Variousdatabases have been established (Iceland, Estonia, UK, US, Sweden,Canada). Their legal and ethical arrangements have stirred considerablecontroversy. A few countries have regulated genetic databases throughlaws. Several national and international committees have issuedrecommendations. Laws and guidelines disagree on a number of issues. Incomparison to the multitude of existing recommendations, thorough ethicaldiscussion is rather scarce. Many guidelines list principles, includingthe “classical” prima facie principles of autonomy,beneficence and justice, some very general principles used in differentmeanings, such as “human dignity”, and new principles believedto be particular to the era of genetics, such as “genetic solidarityand altruism”. The reasons for different balancing of principles andits underlying values are rarely explicitly discussed. These ethicalquestions need to be addressed thoroughly in order to propose a regulatoryframework for genetic databases that is generally acceptable, while beingspecific enough to provide practical guidance. My project aims to bridgethis gap with the intellectual and logistic support of internationalreference centers in bioethics and their scholars.

3. Scientific frame and methodology: The project will unfold in severalsteps: a comprehensive review of the scientific and bioethical literatureavailable at the world’s reference library in bioethics atGeorgetown University will be followed by a comparative analysis ofexisting normative frameworks. Unresolved or controversial issues will betaken up in semi-structured questionnaires that will contain casevignettes modelled on existing databases. Interviews will be held with20-30 visiting bioethics scholars at the University of Pennsylvania andthe Kennedy Institute of Ethics from countries selected to ensurediversity of regions and levels of economic development. The results ofthese interviews will be combined with the prior analytic work to proposepractical solutions and guidelines for research ethics committees whichwill in turn be refined through a dialogue with bioethicists from theUnited States and other countries during open and semi-open presentationsof the project’s results.
Population genomics research can advance in ways that respect human rightsand fairly distribute risks and benefits only with the recognition ofcommonly shared interests and values. Furthermore, there is a need toadopt practice guidelines that are sensitive to problems which arise outof discrepant economic standards and cultural diversity.

Direct link to Lay Summary Last update: 21.02.2013

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