Risk Governance of Biobank Deliberation of Glocalizational Risk Governance ~ How is social trust of Biobank possible? ~

1. Risk Governance of Biobank Deliberation of Glocalizational Risk Governance ~ How is social trust of Biobank possible? ~ Chou Kuei-Tien National Taiwan University August 8th 2005

2. I. Structure of analysis • Risk thesis of high-tech disputes and its governance • Biobank as globalizational risk in terms of global ethical concerns by UNESCO/WHO/EU • Globalizational risk governance in terms of discussions by UNESCO/WHO/EU • Discussion of interactive feedback and influence of globalizational and glocalizational risk governance • Comparison of Glocalizational risk governance of UK GMO and UK Biobank • Comparison of Glocalizational risk governance of Taiwan GMO and Taiwan Biobank

3. I. Structure of analysis • Glocalizational structure of risk governance: • According to three years empirical studies of interviews to NGOs, Scientists and analysis of mass media • 2003-2005 Survey of risk communication and public trust about GMO • Combining the two ways empirical studies we figure out the structure of risk governance and culture in Taiwan as Delayed high-tech risk society as well as hidden risk culture and structure. • The delayed hidden risk structure will influence the trust building of Taiwan Biobank. • Biobank risk governance: policy-making process and its problem • 2005 Survey of public trust in Biobank • The main point: how is social trust of Biobank possible?

4. II. Risk Governance

5. Biobank in the World Science 2002;298:1158-61 賴明詔 2005

6. Globalizational Risk of Biobank

7. Basic Risks of Biobank • Understanding of Science • Privacy • Confidentiality • Access by Users • Social discrimination

8. Biobank as globalizational risk Universal Declaration of the Human Genome and Human Right …..announced by UNESCO (1997), it promulgated ethical worries with respect to sample collection and information preservation development of genetic databases globally.

9. Biobank as globalizational risk International Declaration on Human Genetic Data ……issued by UNESCO (2003) which explicated that the particularity of human genetic information lies in the value-related considerations of privacy, confidentiality, access to information, and discrimination in the process of collection, handling, utilization, and preservation of samples.

10. Biobank as globalizational risk Convention on Human Rights and Biomedicine” (from Council of Europe) Genetic Databases – Assessing the Benefits and the Impact on Human & Patient Rights (from WHO) ……from perspectives of common human rights such as rights of privacy, confidentiality, access and control, and being free from discrimination, these reports also probed into possible impacts and worries large-scale biological samples collection might cause and indicate problems of social and ethical uncertainty within global dimension.

11. Biobank as globalizational risk • Deregulation tendency of technological risk in terms of global competitions • Low institution of risk governance in developing countries • The huge risk is potential international links or exchanges of biobanks with household system and medical records via global electronic information networks for commercial benefits • Global risks of ethnic, culture and ethic

12. Risk Governance of Biobank: Strategy

13. Risk Governance of Biobank • UNESCO (2003) Declaration §6 ….“along with large-scale genetic researches, each country should promote the society to extendedly participate in policy decision.

14. Risk Governance of Biobank • UNESCO(2003): UNESCO(2003): International Declaration on Human Genetic Data § 24 – Ethics education, training and informationIn order to promote the principles set out in this Declaration, States should endeavour to foster all forms of ethics education and training at all levels as well as to encourage information and knowledge dissemination programmes about human genetic data.

15. Risk Governance of Biobank • Reports of WHO & EU value Participation and Debate • In WHO report §3.4, it indicated “ethical reflection and scrutiny should be valued”, thus recognized debates on ethics and philosophy of biotechnology and public health are crucial. • Under such context, §3.5 directly cited Article 28 of the Council of Europe” Convention on Human Rights and Biomedicine” to present the importance of public debate.

16. Risk Governance of Biobank • Reports of WHO & EU value Participation and Debate • Further, in §8.1, it is approved that in order to achieve public trust and confidence, it is essential to build transparency in genetic databases and public debate and to provide procedures to form public awareness and foster trust. • It is because as long as the public involve in the process of participation, they can be more aware of problem existence and learn and judge further.

17. Global Risk Governance of Biobank • Policy transparency is necessary • Policy-making process is open to society, particularly to NGO • Recognition of legal protection is fundamental • Trust is fragile without risk communication and awareness • Trust building is fundamental multiple works

18. Global Risk Governance of Biobank • To conduct public deliberation (public panel, citizen conference) • To conduct public consultation system (consultation, genetic counseling) • To conduct professional consultation • To conduct public survey • To conduct risk communication with NGO, mass media or educational system • To conduct acceptable legal protection

19. Global Risk Governance of Biobank • Knowledge of risk, for example Informed Consent, needs good social understanding of science. • Risk governance bases on local political, cultural context. • Risk governance needs to understand local political, cultural context, i.e. technocrats regime, scientific view of risk, risk discourse, risk perception of public, political culture in terms of NGO.

20. Glocalizational risk governance

21. Glocalizational risk governance: • GMO risk governance in UK • Risk governance of UK Biobank

22. UK GMO Risk Governance • FSA held activities including : • focus groups (2003.3-4) • citizen jury (2003.04) • qualitative discussions (2003.03) • school debate (2003) • survey of GMO (2002)

23. UK GMO Risk Governance • GeneWatch held ”GM Nation?” activities empowered by goverment including: • Six regional meetings • Different city council meetings • Nationwide grassroots meetings

24. UK GMO Risk Governance Findings of public debate – GM Nation?” 1. The public was still suspicious to GM products 2. More and more publics were aware of risk of GM products 3. The public disapproved GM plant commercialization 4. Generally, the public were distrust to Government and transnational enterprises 5. The public were supportive and welcomed debates of technological risks 6. The public hoped to know more about GM and its information 7. The public acknowledged that developing countries possess special interests in GM development.

25. UK GMO Risk Governance • The risk Governance of UK GMO engaged in a lot of public participation. • There is critic on the representative problem of participants by FSA holding activities. • The deliberative process changes the tradition of centralized policy-making by UK technocrats and also become good model of risk governance.

26. Risk Governance of UK Biobank • Establishment of UK Biobank Ethics and Governance Council in charge of ethical and legal problem • Establishment of People Science & Policy company in charge of conducting public and professional consultations

27. Risk Governance of UK Biobank • Public perceptions of the collection of human biological samples(2000) • Consultation with primary care health professionals (October 2000) • Public Consultation (2000) • Ethics workshop (April 2002) • Consultation (between January and April 2003) • Consultation with industry (April 2003) • Public panel (May2003) • Public and stakeholder (May2003)

28. Risk Governance and its critics • It was criticized the representative problem of social groups. • It was criticized the problem of conducting official institutional discourses which is not enough for public to build confidence and trust. • Lack of direct participation of “public debate” according to WHO Declaration/ EU “Convention on Human Rights and Biomedicine”

29. Paradigm of Risk Governance • UK Biobank Risk Governance as learning paradigm by other countries • Regarding to reflection of different local structure of risk governance and culture, the UK Biobank Governance could be revised. • The UK tradition of policy-making by dominating technocrats-scientists network is similar to Taiwan

30. III. Glocalizational Risk Governance in Taiwan

31. Thinking Structure of Risk Governance in Taiwan • Historical ground of Authoritative technocrats in terms of Cold War • Legitimacy of technocrats regime with internal scientific networks • Centralized technological Policy-making Process: • From Top to bottom model • Lack of Risk Governance Process • Less scrutiny and political pressure by NGOs

32. Glocalizatioanl GMO Risk Governance According to the estimation of agricultural council, Taiwan imports every year 2 millions tons Soybean containing 50% GMO 6 millions tons Maize containing 30% GMO held activities including

33. Glocalizatioanl GMO Risk Governance Public survey of risk perception, communication and trust of GMO in 2003-05 held activities including

34. Risk Perception

35. Risk Participation

36. Risk Communication

37. Trust in government Yes No No idea Refuse to answer Do you believe the statement declaring that GM foods are no harm to health according to the Department of Health? 2003 2004 2005 2003 2004 2005 2003 2004 2005 2003 2004 2005 19.7 % 27.9 % 21.66% 73.2 % 63.6 % 74.1 % 6.8 % 8.5 % 4.1 % 0.2% 0 % 0.1% Trust in scientists Do you believe that GM foods are controllable in the aspects of health and ecology? 2003 2004 2005 2003 2004 2005 2003 2004 2005 2003 2004 2005 38.3% 35.6% 39.9% 53.7% 52.3% 52.3% 7.8% 11.8% 7.5% 0.2% 0.3% 0.0% Risk Trust of GMO

38. Thinking Risk Governance in terms of GMO Research • It shows ignorance of Trust building • It shows lack of Risk Communication: Public Panel, Public Deliberation or Consultation • It shows a Delayed risk governance without social scrutiny and political pressure of NGOs • Hidden Risk Culture: Unawareness of Scientific Risks

39. Thinking Structure of Risk Governance in Taiwan • The reason of ignoring risk by technocrats is only respected to so called “sound science”in terms of positive scientific assessment, but excluded social opinion and rationality. • Technocrats also ignores public risk perception with regarding public anxiety as irrational, emotional. • Risk hidden culture makes worse ongoing development and becomes one of risk structure that influence the trust building of Taiwan biobank.

40. Glocalizatinal Risk Governance of Taiwan Biobank

41. Policy-making of Taiwan Biobank • 1995, Taiwan Government positively encouraged researches on related biotechnology techniques, genetic medicine • Suggestion of Taiwan Biobank initiation in 2000. • In 2000 July Academia Sinica suggested to establish “population databases”, which imitated Iceland’s experiences • In October 2002, Academia Sinica formerly established “Genetic Database of Chinese in Taiwan”, which also called “super control genomic database” • This database will collect 3,312 samples

42. Policy-making of Taiwan Biobank • In February 2004, Executive Yuan decided to improve and establish “Taiwan Biobank” • In February 2004, president of Institute or Biomedical Sciences, Academic Sinica proposed to form a practicable assessment of ”Taiwan Biobank” • In December 2004, new councilor of political affairs proposed the concept of “Island Taiwan of Bio-medicine and Biotechnology” • In April 6th 2005, the Executive Yuan announced officially a investment of 15 billions NT to the establishment of “Island Taiwan of Biomedicine and Biotechnology” • Taiwan Biobank estimated to collect genetic information of 3,000 samples in 2005 (called pilot project) and to finish information collection of 200 thousand samples in the future

43. Problem of Risk Governance • Highly centralized policy-making by technocrats and scientists network • Misunderstanding of de-Code/Ice Land experience • There is ignorance of confidentiality problem • Lack of transparency of policy-making • Urgently start to collect sample from July 2005 without ELSI works

44. Reflection of Risk Governance • Social discrimination experience in 2003 SARS event • Risk hidden culture by collecting sample: case of Hwalien Aboriginal • Technocrats and scientists used to lack understanding of public risk perception, for example in GMO, SARS events

45. Reflection of Risk Governance • Technocrats and scientists misjudged public concerns as weakness of building Biobank in their SWOT analysis • Technocrats and scientists used to urge official institutional discourse: it is less enough for public to build their trust • Lack of public participation in the policy-making process of Biobank • Lack of public debate in order to create the access of building social trust according to WHO Declaration and EU Convention

46. Survey on Attitudes towards Genetic Database in 2005 • This year’s national-wide telephone survey was conducted by Center for Survey Research, Academic Sinica from April 18 to June 9, 2005. Total samples collected (calls dailed) were 33,288 cases. Finished cases were 854 cases, with male - 407 cases (47.66％); female – 447 cases (52.34％). Rejected calls were 2,968 cases. All results were based on confidence level of 95% and the standard error was 3.4%. • The methodology of Survey is designed for one condition that interviewee who has heard about GMO (only 48%) can continue to follow those questionnaires of Genetic Database.

47. Items:(1)Extremely trust [35] 4.10% (2)Trust [284] 33.26% (3)No opinion[6] 0.70% (4)Distrust (Half and half) [346] 40.52%(5)Extremely distrust[161] 18.85%(7)No idea[22] 2.58% (8)Refuse to answer[0] 0.00% 1. Generally speaking, do you trust that medical staffs ro research personnel will keep your examining records confidential? (1)Extremely trust [35] (2)Trust [284] (3)No opinion [6] (4)Distrust (Half and half [346] (5)Extremely distrust [161] (7)No idea [22] (8)Refusr to answer [0]

48. Items:(1)Extremely agree[75] 8.78% (2)Agree[310] 36.30% (3)No opinion[12] 1.41% (4)Disagree[306] 35.83%(5)Extremely disagree[131] 15.34% (7)No idea[20] 2.34% (8)Refuse to answer[0] 0.00% 2. Would you agree to provide 15 c.c. of your blood for establishment of genetic database? (1)Extremely agree [75] (2)Agree [310] (3)No opinion [12] (4)Disagree [306] (5)Extremely disagree [131] (7)No idea [20] (8)Refuse to answer [0]

49. Items:(1)Extremely worry about[369] 43.21%(2)Worry about[293] 34.31%(3)No opinion[7] 0.82% (4)Not worry about[137] 16.04% (5)Not worry about it at all[37] 4.33% (7)No idea[10] 1.17% (8)Refuse to answer[1] 0.12% 3. Are you worrying about that genetic information may be disclosed for commercial purposes? (1)Extremely worry about [369] (2)Worry about [293] (3)No opinion [7] (4)Not worry about [137] (5)Not worry about it at all [37] (7)No idea [10] (8)Refuse to answer [1]

50. Item:(1)Extremely agree[101] 11.83%(2)Agree[321] 37.59%(3)No opinion[12] 1.41% (4)Disagree[247] 28.92%(5)Extremely disagree[159] 18.62%(7)No idea[14] 1.64% (8)Refuse to answer[0] 0.00% 4. If there are laws to protect personal information in genetic database from disclosure, would you agree to provide 15 c.c. of your blood? (1)Extremely agree [101] (2)Agree [321] 37.59% (3)No opinion [12] (4)Disagree [247] (5)Extremely disagree [159] (7)No idea [14] (8)Refuse to answer [0]