Risk Governance of Biobank

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

Chou Kuei-TienNational Taiwan University

August 8th 2005

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

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?

II. Risk Governance

Biobank in the World

Science 2002;298:1158-61賴明詔 2005

Globalizational Risk of Biobank

Understanding of Science Privacy Confidentiality Access by Users Social discrimination

Basic Risks of Biobank

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.

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.

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.

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

Risk Governance of Biobank:

Strategy

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.

Risk Governance of Biobank UNESCO(2003): UNESCO(2003): International

Declaration on Human Genetic Data

§ 24 – Ethics education, training and information

In 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.

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.

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.

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

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

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.

Glocalizational risk governance

Glocalizational risk governance:

GMO risk governance in UKRisk governance of UK

Biobank

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)

UK GMO Risk Governance

GeneWatch held ”GM Nation?” activities empowered by goverment including:

Six regional meetings Different city council meetings Nationwide grassroots meetings

UK GMO Risk GovernanceFindings of public debate – GM Nation?”1. The public was still suspicious to GM products2. More and more publics were aware of risk of GM

products3. The public disapproved GM plant

commercialization4. Generally, the public were distrust to Government

and transnational enterprises5. The public were supportive and welcomed debates

of technological risks6. The public hoped to know more about GM and its

information7. The public acknowledged that developing countries

possess special interests in GM development.

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.

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

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)

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”

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

III. Glocalizational Risk Governance in Taiwan

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

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

Glocalizatioanl GMO Risk Governance

Public survey of risk perception, communication and trust of GMO in 2003-05

held activities including

Risk Perception

Have knowledge about risks of GM foods

Yes No

Have you ever heard about GM foods?

2003 2004 2005 2003 2004 2005

49% 56% 48% 51% 44% 52%

Are you aware of safety issues related to GM foods or products?

66.1% 68.4% 73.4% 33.9% 31.6% 26.5%

Risk Participation

Yes No No idea

Is there any opportunity that the public participate in the decision-making Process?

2003 2004 2005 2003 2004 2005 2003 2004 2005

20.5%

22.2%

18.6%

65.7

%67.6%

73.3%

13.9%

10.2%

8.0%

Risk Communication

Propagation and Information

Yes No No idea

2003 2004 2005 2003 2004 2005 2003 2004 2005

Did the Department of Health explain or state clearly the risk and safety concerns related to GM foods?

5.7%

11.1%

13.0%

80.5%

83.3%

83.8%

13.8%

5.5%

3.2%

Do the public have sufficient information to understand the safety of GM foods?

6.3%

7.1%

9.3%

90.9%

88.9%

88.9%

2.8%

4.1%

1.8%

Risk Trust of GMO

 

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?

2003200

4200

5200

32004

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?

2003200

4200

5200

32004

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%

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

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.

Glocalizatinal Risk Governance of Taiwan Biobank

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

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

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

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

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

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.

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]

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]

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]

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]

Items:(1)Yes [739] 86.53% (2)No [107] 12.53% (8)Refuse to answer [8] 0.94%

5. Even though there are laws to regulated release of genetic information, do you still agree that genetic sampling information can possibly be disclosed?

(1)Yes [739]

(2)No 〈跳至第 33 題〉 [107]

(8)Refuse to answer [8]

Items:(1)Extremely agree [27] 3.61% (2)Agree [204] 27.31% (3)No opinion [5] 0.67% (4)Disagree [303] 40.56% (5)Extremely disagree [193] 25.84% (7)No idea [14] 1.87% (8)Refuse to answer [1] 0.13%

6. Under this circumstance, do you agree to provide 15 c.c. of your blood for establishment of genetic database?

(1)Extremely agree [27] (2)Agree [204] (3)No opinion [5] (4)Disagree [303]

(5)Extremely disagree [193] (7)No idea [14]

(8)Refuse to answer [1]

Analysis of Public Survey of Biobank Comparison with the result of academic sinica

survey which was conducted in 2004: 75.2% of interviewees were willing to participate the establishment of Taiwan Biobank.

The result of my Survey which was conduct in 2005: 45.1% interviewees agreed providing 15 c.c. blood to take part in the establishment of Taiwan Biobank; but 51.2% interviewees disagreed doing it.

Possible reasons: it happens a lot of events of personal data disclosure which lead to many criminal events of cheating money in this year. It might influence public losing their confidence and trust in participating Taiwan Biobank.

Analysis of Public Survey of Biobank

Public lacks trust of donating blood sample.

Public distrust in confidentiality by medical researchers.

Public highly concerns that personal genetic data will be disclosed in terms of commercial reasons.

Analysis of Public Survey of Biobank

Even if there is legal protection, most of public highly believes that genetic data will be disclosed in current local social context.

Lack of interactive communicative platform between scientists and public.

Conclusion and Suggestion

A need to build a global Biobank risk governance structure.

A need to broaden public participation and deliberation in policy decision-making process for enhancing public trust.

A need to conduct risk communication between scientist and public.

Conclusion and Suggestion Overcome limits of the technocrats’

dominated regime, and Overcome limits of the delay hidden risk

culture, if people want to build the confident social trust of Taiwan biobank.

~ The End ~

Thank you for participation!