Human Biobanks: Human Biobanks: Towards a Global Towards a Global

Ethical FrameworkEthical Framework

Agomoni Ganguli

Institute of Biomedical EthicsUniversity of Zürichganguli@ethik.unizh.ch

Jakarta, 29 November 2005

BackgroundBackground

• New era of genomics: boom of biobanks

• Existing biobanking guidelines: contradictory or inconclusive

A 2 year qualitative research project A 2 year qualitative research project investigating the conditions under which investigating the conditions under which biobanks may be established, maintained biobanks may be established, maintained and used in ethically acceptable ways and used in ethically acceptable ways

Team MembersTeam Members

Alex Capron: WHO

Alex Mauron, Bernice Elger, Andrea Boggio: University of Geneva

Nikola Biller-Andorno: University of Zürich

MethodologyMethodology

1. Comparative Analysis of Guidelines

2. Drafting 4 vignettes as basis for semi-structured, one-to-one interviews

3. Over 4O respondents world-wide

VignettesVignettes

1. Repository established to study a particular genetic disorder, collaborative study

2. Genetic database of the entire population of a country

3. Biotech company approaching indigenous population for samples to be used in pharmacogenetic studies

4. University hospital storing samples from patients for further research

Preliminary ResultsPreliminary Results

• Preliminary analysis of interview results: systematic analysis being developed

• Responses influenced by various factors (cultural, professional, education, policy-making)

• Nine interviews: India, Hong Kong, Japan, Taiwan

Consent for Consent for Subsequent UsesSubsequent Uses

• Broad consent is favoured if possible uses mentioned in consent form

• Re-consenting seen as impractical and sometimes unethical

FeedbackFeedback

• Feedback mechanism should exist

But: - Right no to know

- Percentage risk difficult to communicate

(Japan, India, Taiwan) - Feedback is dangerous without proper counselling (India)

Circulation of Samples Circulation of Samples • Two main positions here: MTA restriction acceptable

1) Territorial limitation unacceptable “common good/heritage of humanity”

2) Territorial limitation acceptable e.g. India “belongs to the nation”

Fees: public good versus profit-making

Benefit Sharing and Benefit Sharing and Community ConsentCommunity Consent

• “Benefits must be beneficial to the whole group”

• Sharing IP rights is impractical• Community consent vs. Individual

consent:- Individual consent important

- Community consent is essential

Thank You!Thank You!