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

2. Genetic databases: Population Information Data Basis Technical remarks
Exchanging Health Information
Structure UK – Biobank (workflow)
Iceland
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD

3. Genetic databases: Population
Iceland’s Decode,
UK BioBank,
Quebec’s CartaGene,
Estonian Genome Project
etc.:
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD

4. Benefits?
A long-term resource for the study of genes, environment and health in relation to any common condition
Better knowledge of the causes of health and illness in different populations
Characterise disease states more precisely
Identify important early markers of disease
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD

5. Information (Data) Bases
Exploring ramifications of the human genome
Privacy regulation
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD

6. Technical remarks
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD

7. Exchanging Health Information
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD
Source: Health Privacy Project

8. Structure of the workflow and Datamanegement (source UK BIOBank)
Excample:UK – BIOBank
Structure of the workflow and Datamanegement (source UK BIOBank)

9. Data Management (UK-Biobank)
NPfIT
Primary Care – GP Record
Longitudinal
“Read” Coded
Prescribing
Diagnosis
Allergies
Test Results
Events
Booking & Scheduling
Recruitment
Structured Questionnaire
Sample Processing
Blood Analysis
Sample Management
Genetic Information
Secure Database
Hospital Record
Episodic
Departmental
ICD, OPCS, SNOMed Coded
Sample Storage
NHS National Records
NWCS, Spine, Admin Register,
Screening, Payments
Source: UK-Biobank
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD

10. Information Flows & IT Systems
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD
Source: UK-Biobank

11. Informed consent in genetic research is problematic
Public awareness and understanding of genetics is growing but still incomplete
Nature of genetic information is different
Shared with relatives
Permanent
Predictive
Highly personal / identity / secular soul
Impossible to foresee uses
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD

12. Right to privacy = human right
UN Int’l Covenant on Civil and Political Rights, Article 17:
(1) No one shall be subjected to arbitrary or unlawful interference with his privacy, family, home or correspondence, nor to unlawful attacks on his honour and reputation.
(2) Everyone has the right to the protection of the law against such interference or attacks.
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD

13. European Convention on Human Rights, Article 8
Everyone has the right to respect for his private and family life, his home and his correspondence.
There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD

14. Key Issues in Consent for Genetic Research
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
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD

15. Iceland: Highcourt decission
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD

16. DeCode 1996: found 1997: submitted the idea of a biobank
1998: the Health Sector Database Act was passed by the Icelandic parliament on 17 December, 1998
October 1998, as an opposition to the Icelandic genebank, the organisation Mannvernd
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD

17. The idea
was to utilize the already existing medical and genealogical records of all Icelanders and combine this information with the genetic information gained from tissue samples of the entire population
Dr.phil. Dr. rer. publ. Brigitte Jansen, Research Center Biotechnology and Law, EUROACAD