1. Human Biobanks: Towards a Global Ethical Framework Agomoni Ganguli Institute of Biomedical Ethics University of Zürich ganguli@ethik.unizh.ch Jakarta, 29 November 2005

2. Background New era of genomics: boom of biobanks Existing biobanking guidelines: contradictory or inconclusive A 2 year qualitative research project investigating the conditions under which biobanks may be established, maintained and used in ethically acceptable ways

3. Team Members Alex Capron: WHO Alex Mauron, Bernice Elger, Andrea Boggio: University of Geneva Nikola Biller-Andorno: University of Zürich

4. Methodology 1.Comparative Analysis of Guidelines 2. Drafting 4 vignettes as basis for semi-structured, one-to-one interviews 3. Over 4O respondents world-wide

5. Vignettes 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

6. Preliminary 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

7. Consent for Subsequent Uses Broad consent is favoured if possible uses mentioned in consent form Re-consenting seen as impractical and sometimes unethical

8. Feedback Feedback mechanism should exist But: - Right no to know - Percentage risk difficult to communicate (Japan, India, Taiwan) - Feedback is dangerous without proper counselling (India)

9. 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

10. Benefit Sharing and Community 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

11. Thank You!