Overview the establishment of Taiwan Biobank Issues about ELSI

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Overview the establishment of Taiwan Bio-bank
-Issues about ELSI
PanelistFan Chien-Te and Liao Chia-Cheng
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?. Introduction

• For the purpose of thoroughly understand various
  kinds of the phenomenon of human body,
  large-scale data bases about tissue of human body
  have gradually been set up
• At the same period of striding the biotechnology
  era worldwide, Taiwan also start its own program,
  that is, island of biotechnology plan

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?. Introduction

• Accordingly, how to build up Taiwan Bio-bank is
  the most important project, we are hoping to have
  a chance to obtain the breakthrough power in the
  field of Taiwans medicine research.
• What are the problems of current legislations?
  What is the respective solution?

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?. Characteristics of Gene Message

• Gene is a section of DNA (deoxyribonucleic acid)
  with particular function, which is the
  fundamental unit of creature cell, could be
  handed down from generation to generation
• According to the international announcement of
  gene data released by UNESCO, the information
  carried by gene has totally four characteristics
  (7/8)

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?. Characteristics of Gene Message

• firstly, anticipation of personal gene structure
  
• secondly, immense potential influence to
  population, family, offspring
• thirdly, important information hided in gene may
  not know before collection
• fourth, gene is of great importance to groups
  culture of individual.

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?. Establishment of Gene Data Base

• Intending to understand the relationship among
  gene, disease and human phenotype, small scale
  collection of specimen cannot satisfy the
  necessity of research. Because the small-scale
  data base may be limited in particular disease,
  area and population,while the causing of human
  disease is due to multiple factors. At this
  point, deeper research needs a large number of
  research specimens.

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?. Establishment of Gene Data Base

• At this point, deeper research needs a large
  number of research specimens.
• Moreover, only when we have a great quantity of
  specimen and statistical data, the relationship
  of gene, situation and disease could be known by
  the accurate count.

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?. Establishment of Gene Data Base

• And then, providing a large number of gene
  specimen for comparing is the mainly function of
  gene data base.
• Following the establishment of gene data base,
  the focusing center of physical gene research is
  to spread the research from individual to the
  whole population.

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?. Establishment of Gene Data Base

• By combining the gene information of healthy
  medical treatment record, livelihood type and
  family tree, then we can utilize relevant
  technique to look for significant knowledge of
  gene.

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?. Establishment of Gene Data Base

• the advanced countries are proceeding to have
  their own program of gene data base, which is for
  the purpose of understanding various diseases
  caused by living custom, and hoping to develop
  the tactics of anticipating diseases happen,
  develop new medicine and therapy

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? Profile of Taiwans Development

• In order to promote Taiwans domestic research
  level of biotechnology, highest level of
  executive branch has invited central research
  institute, scientific commission, hygiene office,
  economic department and research institute of
  hygiene to plan together for the program of
  Biotechnology Island
• Taiwan Bio-bank is playing an important role in it

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? Profile of Taiwans Development

• Taiwan Bio-bank is willing to explore the mutual
  affect among gene phenomenon, disease and
  environment and making full use of it to
  individual disease diagnosis, therapy and
  prophylaxis
• To think about the executive aspect of Taiwan
  Bio-bank program is extensive, so feasibility
  study becomes the necessary research route.
• The program is actually executed by research
  institute of biotechnology

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? Profile of Taiwans Development

• For legitimacy and morality concerns, feasibility
  study will mainly focus on the design of
  procedure and evaluation of result without
  collecting any human tissue.

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?. Related Subject of ELSI on Taiwan Bio-bank

• Summary
• this article centers Informed Consent,
  Protection of Privacy, Benefit Sharing and Public
  Participation, to survey the disputing topics and
  observe Taiwans recent legislation, especially
  if such legislation is following the regulations
  of UNESCO.

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?. Related Subject of ELSI on Taiwan Bio-bank

• Relevant Subjects
• 1. Informed Consent
• 2. Management of Data and Maintain of
  Privacy
• 3. Benefit Sharing
• 4. Participation of the Public
• 5. Particular Theme for Discussion Solution
  of Dispute

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?. Related Subject of ELSI on Taiwan Bio-bank

• Informed Consent
• 1.Informed Consent is one of the popular
  principles of medical treatment and morality. In
  the early, this principle is for esteeming and
  protecting the people who participate in medicine
  research, especially the human body
  experimentation. Before the experimentation, the
  researchers must tell the people about the
  details and obtain the consent.

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?. Related Subject of ELSI on Taiwan Bio-bank

• 2.The principle of Informed Consent is sometimes
  discussed under the field of medical treatment
  conduct in Taiwan. However, the utilizing part of
  genetic information was less to touch upon.
• 3.To think of the specific announced before,
  this causes a lot of dispute in how to apply the
  principle of Informed Consent. The crucial
  reasons are about who should be informed what
  is the scope of authorizing consent.

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?. Related Subject of ELSI on Taiwan Bio-bank

• 4.Whether the right of consent involving the
  third party, International Declaration on Human
  Genetic Data didnt give related suggestion
• 5.in Universal Declaration on Bioethics and
  Human Rights set up the authorized consent of
  community or representative person to replace the
  individual consent

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?. Related Subject of ELSI on Taiwan Bio-bank

• 6.At this point, we may infer that the opinion of
  UNESCO about the procedure of decision is mostly
  the Individual Autonomy. If the character of the
  research is for specific population, Group
  Autonomy can be used as a necessary procedure

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?. Related Subject of ELSI on Taiwan Bio-bank

• 7.Some scholar introduced the concept of Group
  Consent when Individual Consent is easily making
  dispute, believing if the analysis of genetic
  information is by the unite of peculiar
  population, the achievements of research making
  out benefits or injure are related to all the
  population. So the Group Consent of mass people
  is the most difficult challenge.
• 8.Therefore, if this is realized, its obvious
  more strict than regulations of UNESCO.

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?. Related Subject of ELSI on Taiwan Bio-bank

• 9.As to the range of authorization, there will be
  a lot of large-scale statistics and comparison of
  genetic data base program between genetic body
  and related factors. The research style is not
  known in future, so the purpose of usage cannot
  be told specifically

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?. Related Subject of ELSI on Taiwan Bio-bank

• 10.However, the principle of Informed Consent
  should follow the conception within international
  declaration of UNESCO for human genetic data and
  international life morality and Declaration of
  the Rights of Man, that is, the principles of
  prior, express, free, informed.

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?. Related Subject of ELSI on Taiwan Bio-bank

• 11.In Taiwan, the team of feasible research
  believes that its necessary to bridge the
  knowledge gap between researchers and
  participants, in order to making the participants
  understand the public welfare as well as the
  necessity of adopting the general consent.
• 12.Still, other appropriate supporting measures
  are needed to maintain the autonomy of
  participant.

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?. Related Subject of ELSI on Taiwan Bio-bank

• Management of Data and Maintain of Privacy
• 1. Firstly, when the genetic information is
  collected and If some kinds of diseases are
  examined in the result suffered later, Is there
  obligation to inform the participants?

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?. Related Subject of ELSI on Taiwan Bio-bank

• 2. Secondly, because of the danger of gene from
  clan, about danger of privacy infringement, the
  benefits of third party should be considered,
  which is announced in UNESCO s international
  declaration

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?. Related Subject of ELSI on Taiwan Bio-bank

• 3. At last, about the management and usage of
  genetic data base, which concerns genetic
  information, how to manage the anonymous
  information, and the use of anonymous data?

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?. Related Subject of ELSI on Taiwan Bio-bank

• Benefit Sharing
• 1. Human Genome Organization deems that
  participants should get somewhat benefits and it
  believe that commercial research organization
  should bring from 1 percent to 3 percent income
  after taxes to provide for the benefit of
  participant, and about non-commercial research
  organization could supply particular population
  with necessary healthy benefit.

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?. Related Subject of ELSI on Taiwan Bio-bank

• 2. International Declaration on Human Genetic
  Data of UNESCO (52) believe that the usage of
  genetic data research result is sharing with
  society, and announcing the possible form of some
  benefits sharing, including special assistance
  for particular population, providing of medical
  treatment and care, new course of treatment or
  supplement of medicines, give of health care,
  assist of establishing research resources and
  facilities.

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?. Related Subject of ELSI on Taiwan Bio-bank

• 3. About the way to favor and benefit, Taiwans
  importance is on choosing of benefit sharing, and
  what is the way and way of feedback with
  participant? The effort is to raise the the
  dispute and bring about the respect of all
  circles. Let common people discuss and understand
  respective benefit groups opinion, instead of
  practical tactic decided by minority of talent
  guys.

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?. Related Subject of ELSI on Taiwan Bio-bank

• Participation of the Public
• 1. The construction of interactive
  communication with masses is important implement
  and research project. On the degree of questions,
  the feasibility studies nowadays are construction
  of inside network to accurately record real data
  according with experts and scholars opinions to
  set up platform of communication on the common
  people, except all above mentioned, circuit
  statement assembles are needed. For instance, the
  way and basis of public communication and review
  and innovation of the way in social inclination
  investigation could be used as one ring of ELSI
  about feasibility study project.

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?. Related Subject of ELSI on Taiwan Bio-bank

• Particular Theme for Discussion Solution of
  Dispute
• 1. The characteristics of disputes arising
  from the bio-banking
• first, the injured is majority second,
  difficulty of proof third, the imbalance of
  bargaining powers

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?. Related Subject of ELSI on Taiwan Bio-bank

• 2. The plan of Taiwans research team is briefly
  schemed below
• form subcommittee of dispute, aim at the
  communication and coordination before dispute and
  individual case when disputes arise, the front
  mentioned subcommittee should arbitrate first.

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?. Related Subject of ELSI on Taiwan Bio-bank

• 3. Other Procedure Subject
• (1). uncertain of damage
• (2). group litigation

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• Thank You