Human Biobanks Dr. phil. Dr. rer. publ. Brigitte Jansen.

Human BiobanksHuman BiobanksDr. phil. Dr. rer. publ. Brigitte Dr. phil. Dr. rer. publ. Brigitte

JansenJansen

Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology anDr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACADd Law, EUROACAD

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• Genetic databases: Population

• Information Data Basis

• Technical remarks– Exchanging Health Information

– Structure UK – Biobank (workflow)

– Exchanging Health Information

• Iceland


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Genetic databases: Population

• Iceland’s Decode, Iceland’s Decode, • UK UK BioBank,• Quebec’s CartaGene,Quebec’s CartaGene,• Estonian Genome Project Estonian Genome Project • etc.:etc.:


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Benefits?Benefits?

• A long-term resource for the study of A long-term resource for the study of genes, environment and health in genes, environment and health in relation to any common conditionrelation to any common condition

• Better knowledge of the causes of health Better knowledge of the causes of health and illness in different populationsand illness in different populations

• Characterise disease states more Characterise disease states more preciselyprecisely

• Identify important early markers of Identify important early markers of diseasedisease


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Information (Data) Bases

• Exploring ramifications of the human Exploring ramifications of the human genomegenome

• Privacy regulationPrivacy regulation


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Technical remarks


77Source: Health Privacy ProjectSource: Health Privacy Project

Exchanging Health Information

Excample:UK – BIOBank Excample:UK – BIOBank

Structure of the workflow and Structure of the workflow and Datamanegement Datamanegement (source UK BIOBank)(source UK BIOBank)


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CORE

Recruitment

Participant Liaison

Clinic Management

External Data(Clinical \)

External Data(Non Clinical)

User Portal

Middleware/Messaging Management

Clinical Repository

LIMSBiological

Repository

Data WarehousesHealth Record

Repository

User Portal

User Portal

Query Tools

Research Community

Information Flows & IT Systems

Source: UK-Biobank


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Informed consent in genetic research is

problematic• Public awareness and understanding of Public awareness and understanding of

genetics is growing but still incompletegenetics is growing but still incomplete• Nature of genetic information is differentNature of genetic information is different

– Shared with relativesShared with relatives– PermanentPermanent– PredictivePredictive– Highly personal / identity / secular soulHighly personal / identity / secular soul

• Impossible to foresee usesImpossible to foresee uses


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Right to privacy = human right

UN Int’l Covenant on Civil and UN Int’l Covenant on Civil and Political Rights, Article 17:Political Rights, Article 17:

(1) (1) No one shall be subjected to arbitrary No one shall be subjected to arbitrary or unlawful interference with his privacy, or unlawful interference with his privacy, family, home or correspondence, nor to family, home or correspondence, nor to unlawful attacks on his honour and unlawful attacks on his honour and reputation. reputation. (2) Everyone has the right to the protection (2) Everyone has the right to the protection of the law against such interference or of the law against such interference or attacks.attacks.


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European Convention on Human Rights, Article 8

1.1. Everyone has the right to respect for his private Everyone has the right to respect for his private and family life, his home and his correspondence.and family life, his home and his correspondence.

2.2. There shall be no interference by a public There shall be no interference by a public authority with the exercise of this right except authority with the exercise of this right except such as is in accordance with the law and is such as is in accordance with the law and is necessary in a democratic society in the interests necessary in a democratic society in the interests of national security, public safety or the of national security, public safety or the economic well-being of the country, for the economic well-being of the country, for the prevention of disorder or crime, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of health or morals, or for the protection of the rights and freedoms of others.protection of the rights and freedoms of others.


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Key Issues in Consent Key Issues in Consent for Genetic Genetic ResearchResearch

• Rules required for any feedback of results• Responsible use of data for research• Must not disclose potentially harmful data

without fully informed consent• Recontact for consent not normally

practical in long term studies• Protection provided by advocate groups,

right to withdraw and anonymity


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Iceland: Highcourt decission


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DeCodeDeCode

• 1996: 1996: foundfound• 1997:1997: submittedsubmitted the idea of a biobank the idea of a biobank• 1998: 1998: the Health Sector Database Act the Health Sector Database Act

was passed by the Icelandic was passed by the Icelandic parliament on 17 December, 1998parliament on 17 December, 1998

• October 1998, as an opposition to the October 1998, as an opposition to the Icelandic Icelandic genebank, genebank, the organisation the organisation MannverndMannvernd


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The idea

• was to utilize the already existing was to utilize the already existing medical and genealogical records of medical and genealogical records of all Icelanders and combine this all Icelanders and combine this information with the genetic information with the genetic information gained from tissue information gained from tissue samples of the entire populationsamples of the entire population

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Human Biobanks Dr. phil. Dr. rer. publ. Brigitte Jansen.

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