後基因體時代的生醫素養
與倫理法制
陳錦生
John Naisbitt
in “Megatrends 2000”
你也許不懂生物科技
但你不能不知道它的最新發展
否則你就是縱容別人以上帝自居
基因改造過的生物會不會破壞自然生態
將來會不會有人頭馬之類的怪物出現
人類憑什麼干預生命的奧秘過程
科學家會不會唯利是圖 濫用科技
你推卸不了道義責任
生物技術的世紀
 1980年,第一個人工

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改造的細菌獲得專利
1977年,「桃麗羊」
複製成功
2000年,「人體基因
組解碼」獲初步成功
基因工程技術的蓬勃
發展
複製人?
人體基因體計畫
 「人類基因體計劃」(Human Genome Project)是由美國、
英國、法國、德國、中國與日本等六國科學家所組成的龐大
團隊,經費大部份來自美國聯邦政府的「國家衛生研究院」
(NIH)與英國的「衛爾康基金會」(WellcomeTrust)。
「賽雷拉公司」(Celera Genomics)則是由科學界的傳奇
人物文特博士所創立,在一九九八年以異軍突起之姿投入破
解人類基因密碼的競技場,而且成果斐然。 但是繪製人類基
因圖譜只是破解人類基因密碼的基礎,科學家必須進一步確
認人體所有的基因、了解基因的功能與控制方式、基因與人
體生理以及疾病的關聯,然後才能開發出嶄新的藥品與治療
方式,其成果將為人類醫學與文明帶來革命性的進展與衝擊。
後基因體時代來臨
 美國官方主導的國際「人類基因體計劃」與美國民間「賽雷
拉公司」,在90年1月全球五大城市共同發布他們解讀人類
基因體的最新成果,而兩者含括人類基因體定序初稿與其解
析的研究報告也分別刊載於「自然」與「科學」雜誌。 這兩
份研究報告雖然運用的方法不同,但結論大致相近,其中有
幾項發現最受矚目:人類基因的數目遠少於以往科學界的預
估(十萬個),大約只有三萬到四萬個,僅僅是果蠅、線蟲
等低等生物的兩倍多。而且與老鼠比較,人類只有三百餘個
基因是老鼠身上找不到的。「人類基因體計劃」的領導人柯
林斯說:「這對我們人類的自尊是個打擊,不過這也顯示了
人類的複雜性來自其他源頭,我們必須開始搜尋。」
生物科技倫理議題
 胚胎地位的爭議
 動物權
 基因改造食品
 基因專利及商業化
 人體基因計畫
 生物資料庫(biobank)
 複製技術帶來的社會衝
 宗教議題
擊
 生殖科技
 幹細胞
 基因行為學
 生態衝擊
何謂醫學倫理學四大原則?
 尊重自主原則(the principle of respect
for autonomy)、
 不傷害原則(the principle of
nonmaleficence)、
 行善原則 (the principle of beneficence)
 公平正義原則(the principle of justice)。
後基因體時代的生技倫理
 1960年生物倫理學成為專門領域
 1992年,美國各院醫院規定必須要有生物倫
理學家駐院,或訂定醫學倫理準則。
 2000年人體基因體解碼完成,進入後基因體
時代。
 後基因體時代的生技倫理學不是因應醫學的
新發展,而是預測新科技可能帶來的貢獻和
災害。
Bioethics
Science asks "Can we?"
Law asks "May we?"
Morality asks "Should we?"
韓複製專家黃禹錫
因卵子風波辭卸所有職務
以複製世界上第一隻複製狗
「Snuppy」而揚名於世的南韓
幹細胞研究權威、首爾大學教
授黃禹錫,因獲取科研用卵子
的過程而引發的「道德倫理風
波」,今天宣佈辭去包括首爾
國際幹細胞研究中心主任等所
有在政府和民間機構的兼職。
 截止到25日,黃禹錫教授崇拜
者俱樂部“我愛你,黃禹錫
(cafe.daum.net/ilovehws)”
的會員人數已超過25000人。
 東山半夜會(音譯)、佛教人
權委員會、大韓佛教青年會、
佛教生命倫理研究所等12個佛
教團體成立了“爲黃禹錫博士
的韓國在家修行者聚會。”

南韓複製爆醜聞 錢換卵子
黃禹錫承認違反醫事倫理 為隱瞞真相道
歉辭職 韓人仍力挺
 南韓複製爆醜聞,蜚
聲國際的複製先驅黃
禹錫(Hwang Woo-suk,
圖,美聯社)24日召開
記者會,承認明知其
團隊兩名女研究員捐
卵供研究之用,卻應
當事人之請未向外吐
實,承認違反醫事倫
理,為隱瞞真相道歉
辭職。
從孟德爾開始
 Gregor Mendel
(1822-1884)
 在孟德爾之前,大
部分人相信遺傳混
合學說(blending
theory of iheritance)
 孟德爾的豌豆實驗
1953年英國劍橋大學博士生詹姆斯.華生(James D.
Watson),及法蘭西斯.克立克(Francis Crick )發現DN
A的雙螺旋結構,證實了DNA是所有生命的核心
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
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

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A structure for Deoxyribose Nucleic Acid
The year 1953 could be said to mark, in biology at least, the end of history. Here is James Watson and Francis Crick's paper on the structure of DNA, which
ushered in the new era with the celebrated understatement near the end. (as published in NATURE magazine)
2 April 1953
MOLECULAR STRUCTURE OF NUCLEIC ACIDS
A Structure for Deoxyribose Nucleic Acid
We wish to suggest a structure for the salt of deoxyribose nucleic acid (D.N.A.). This structure has novel features which are of considerable biological interest.
A structure for nucleic acid has already been proposed by Pauling and Corey (1). They kindly made their manuscript available to us in advance of publication.
Their model consists of three intertwined chains, with the phosphates near the fibre axis, and the bases on the outside. In our opinion, this structure is
unsatisfactory for two reasons: (1) We believe that the material which gives the X-ray diagrams is the salt, not the free acid. Without the acidic hydrogen atoms it
is not clear what forces would hold the structure together, especially as the negatively charged phosphates near the axis will repel each other. (2) Some of the
van der Waals distances appear to be too small.
Another three-chain structure has also been suggested by Fraser (in the press). In his model the phosphates are on the outside and the bases on the inside,
linked together by hydrogen bonds. This structure as described is rather ill-defined, and for this reason we shall not comment on it.
We wish to put forward a radically different structure for the salt of deoxyribose nucleic acid. This structure has two helical chains each coiled round the same
axis (see diagram). We have made the usual chemical assumptions, namely, that each chain consists of phosphate diester groups joining ß-Ddeoxyribofuranose residues with 3',5' linkages. The two chains (but not their bases) are related by a dyad perpendicular to the fibre axis. Both chains follow
right- handed helices, but owing to the dyad the sequences of the atoms in the two chains run in opposite directions. Each chain loosely resembles Furberg's2
model No. 1; that is, the bases are on the inside of the helix and the phosphates on the outside. The configuration of the sugar and the atoms near it is close to
Furberg's 'standard configuration', the sugar being roughly perpendicular to the attached base. There is a residue on each every 3.4 A. in the z-direction. We
have assumed an angle of 36° between adjacent residues in the same chain, so that the structure repeats after 10 residues on each chain, that is, after 34 A.
The distance of a phosphorus atom from the fibre axis is 10 A. As the phosphates are on the outside, cations have easy access to them.
The structure is an open one, and its water content is rather high. At lower water contents we would expect the bases to tilt so that the structure could become
more compact.
The novel feature of the structure is the manner in which the two chains are held together by the purine and pyrimidine bases. The planes of the bases are
perpendicular to the fibre axis. The are joined together in pairs, a single base from the other chain, so that the two lie side by side with identical z-co-ordinates.
One of the pair must be a purine and the other a pyrimidine for bonding to occur. The hydrogen bonds are made as follows : purine position 1 to pyrimidine
position 1 ; purine position 6 to pyrimidine position 6.
If it is assumed that the bases only occur in the structure in the most plausible tautomeric forms (that is, with the keto rather than the enol configurations) it is
found that only specific pairs of bases can bond together. These pairs are : adenine (purine) with thymine (pyrimidine), and guanine (purine) with cytosine
(pyrimidine).
In other words, if an adenine forms one member of a pair, on either chain, then on these assumptions the other member must be thymine ; similarly for guanine
and cytosine. The sequence of bases on a single chain does not appear to be restricted in any way. However, if only specific pairs of bases can be formed, it
follows that if the sequence of bases on one chain is given, then the sequence on the other chain is automatically determined.
It has been found experimentally (3,4) that the ratio of the amounts of adenine to thymine, and the ration of guanine to cytosine, are always bery close to unity
for deoxyribose nucleic acid.
It is probably impossible to build this structure with a ribose sugar in place of the deoxyribose, as the extra oxygen atom would make too close a van der Waals
contact. The previously published X-ray data (5,6) on deoxyribose nucleic acid are insufficient for a rigorous test of our structure. So far as we can tell, it is
roughly compatible with the experimental data, but it must be regarded as unproved until it has been checked against more exact results. Some of these are
given in the following communications. We were not aware of the details of the results presented there when we devised our structure, which rests mainly
though not entirely on published experimental data and stereochemical arguments.
It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the genetic material.
Full details of the structure, including the conditions assumed in building it, together with a set of co-ordinates for the atoms, will be published elsewhere.
We are much indebted to Dr. Jerry Donohue for constant advice and criticism, especially on interatomic distances. We have also been stimulated by a
knowledge of the general nature of the unpublished experimental results and ideas of Dr. M. H. F. Wilkins, Dr. R. E. Franklin and their co-workers at King's
College, London. One of us (J. D. W.) has been aided by a fellowship from the National Foundation for Infantile Paralysis.
J. D. WATSON F. H. C. CRICK
Medical Research Council Unit for the Study of Molecular Structure of Biological Systems, Cavendish Laboratory, Cambridge. April 2.
1. Pauling, L., and Corey, R. B., Nature, 171, 346 (1953); Proc. U.S. Nat. Acad. Sci., 39, 84 (1953).
2. Furberg, S., Acta Chem. Scand., 6, 634 (1952).
3. Chargaff, E., for references see Zamenhof, S., Brawerman, G., and Chargaff, E., Biochim. et Biophys. Acta, 9, 402 (1952).
4. Wyatt, G. R., J. Gen. Physiol., 36, 201 (1952).
5. Astbury, W. T., Symp. Soc. Exp. Biol. 1, Nucleic Acid, 66 (Camb. Univ. Press, 1947).
6. Wilkins, M. H. F., and Randall, J. T., Biochim. et Biophys. Acta, 10, 192 (1953).
VOL 171, page737, 1953
基因科技
基因Gene
 基因位於染色體上,是一段DNA序列。
 基因可以指引特定的胺基酸序列形成,而形成特定
的蛋白質。
 基因的特性:
 具備調控細胞或生物的發育與代謝、行為能力的訊息。
 細胞分裂時,能穩定且高度正確的複製,方能使這訊息
物質代代相傳。
 能夠產生突變,以產生演化過程中的遺傳變異。
基因工程
 剪刀:限制酶(restriction nuclease )
 醬糊:連結酶(Ligase)
 交通工具:載體(Vector)
 目的地:宿主 (Host)
基因工程的應用
 醫學:
 胰島素、B肝疫苗、生長激素、複製製藥活體工廠、IQ基




因、疾病檢測(25 oncogens、糖尿病、巴金森、老化)、
生殖技術
農學:
 超級蕃茄、吃豆如吃肉、快速生長之家畜、
環境:
 分解原油、鎘米、可分解的塑膠袋
法醫:
 鑑定、微量證據、微量證據、親子鑑定、PCR
其他:
 化工
基因工程的影響
 影響:既興奮又害怕(科學樂觀派vs.科學悲觀派)
 新優生學:基因族vs.自然族(何謂優?)
 對症療法vs.對因療法
 基因決定我們vs.我們決定基因
 基因歧視、基因隱私(如果嬰兒基因有缺陷)
 基因單一化(缺乏多樣性)
 商業化、專利化(有錢才能享受)
 科學解問題或製造問題?
 chance vs. choices; profit vs. problem; change vs.
challenge
基因組是什麼?
 基因組就是一個生命
體的遺傳信息的總和。
那麼在這裏我們就不
是單個基因,而是所
有的基因。它所編碼
所有的氨基酸相互之
間的這個關係。
人體基因組研究
What is the Human Genome Project?
 U.S. govt. project coordinated by the Department
of Energy and the National Institutes of Health
 goals (1998-2003)
 identify the approximate 30,000 genes in human DNA
 determine the sequences of the 3 billion bases that
make up human DNA
 store this information in databases
 develop tools for data analysis
 address the ethical, legal, and social issues that arise
from genome research
Why is the Department of Energy
involved?
 after atomic bombs were dropped during
War War II, Congress told DOE to conduct
studies to understand the biological and
health effects of radiation and chemical byproducts of all energy production
 -best way to study these effects is at the
DNA level
Whose genome is being sequenced?
 the first reference genome is a composite
genome from several different people
 generated from 10-20 primary samples
taken from numerous anonymous donors
across racial and ethnic groups
The human and chimp genomes are about 99.2%
identical.© alamy.com/GettyImages
人類的基因組,和黑猩猩
的相較,其中有99.2%是雷
同的,在基因組中功能上較
重要的部分,該雷同上升到
99.5%。研究人員比較了人
類、黑猩猩和老鼠的7千5百
個基因。把老鼠當作外群,
就顯示出人類和黑猩猩自共
同祖先演化到分家之後,各
自累積的差異。分析的結果
顯示,人類和黑猩猩分家後,
有約1千5百多個基因受到了
選擇的影響。
Gene Facts
 size of human genome: 3.4 billion base pairs (bp)
 number of human genes: ~100,000
 實驗室常用的大、小鼠的基因體據估有3萬個基因。另一
實驗室常用生物的線蟲(C. elegans),其基因總數約
有1萬9千個,而果蠅則有約1萬3千個。小型開花植物阿
拉伯芥(Arabidopsis)的2萬7千個基因搞不好就比人類
的還多。
 genes vary in length and can cover thousands of bases
- avg. size: ~3,000 bp
 only about 5% of the human genome contains genes
 function of much of the genome is unknown
Chromosome: 1
Chromosome: 4
第一個完整中國人基因組圖譜繪製完成
2007-10-11 19:05:53 來源: 新華社(北京)
中國科學家2007年10月11日對外宣佈,他們已經成功繪製
完成第一個完整中國人基因組圖譜(又稱“炎黃一號”),
這也是第一個亞洲人全基因序列圖譜。
黑猩猩基因定序 台灣有成2004/5/28
 在解開人類第四對染色體鹼基定序、靈芝基因定序之後,國內
基因研究再度締造了傲人記錄,台灣團隊兩年前加入了國際定
序團隊,在「基因體醫學國家型科技計畫」的經費支持下,順
利完成了世界首例精確定序的「非人類」靈長類物種染色體—
黑猩猩第22號染色體定序,正確率高達99.998%。
 這項研究係由國家衛生研究院與陽明大學所組成的基因定序團
隊執行,歷經兩年多終於完成了黑猩猩第22號染色體3330萬個
鹼基的定序及比較分析
 黑猩猩是和人類最接近的哺乳類動物,兩者基因差異只有1.5%,
大腦認知功能也最接近,而黑猩猩第22號染色體與人類第21號
染色體相當,這項研究結果將有助於釐清人類阿茲海默氏症、
帕金森氏症等腦部退化疾病的致病機轉。下一步研究人員將透
過基因解碼找出致病基因,並對人類生理及行為特徵形成的相
關研究,提供先驅指標。
 國衛院表示,這項成果對於人類的進化演變,更帶來了突破上
的進展,先找出人猿演化成人類的分歧點,破解人類演化之謎。
Benefits of HGP Research
Medical Benefits
 improved diagnosis of disease
 earlier detection of predispositions to




disease
rational drug design
gene therapy and control systems for drugs
pharmacogenomics personal drugs
organ replacement
gene therapy
Benefits of HGP Research
Microbial Genome Research
 new energy sources (biofuels)
 生物燃料(Biofuels)是指以生物質為載體的能源,直接
或間接地源於植物的光合作用,例如乾草、渣滓、牛糞
等等。不同於石油、煤炭、核能等傳統燃料,這新興的
生物燃料是種可再生燃料。另一種定義是至少80%的體
積,由10年內生產的有機活體物質所提煉出的燃料。
 environmental monitoring to detect pollutants
 protection from biological and chemical warfare
 safe, efficient toxic waste cleanup
Benefits of HGP Research
DNA Forensics
 identify potential suspects at crime scenes
 exonerate wrongly accused persons
 identify crime and catastrophe victims
 establish paternity and other family relations
 identify endangered and protected species
as an aid to wildlife officials (prosecution of
poachers)
Benefits of HGP Research
DNA Forensics – cont.
 detect bacteria and other organisms that
may pollute air, water, soil, and food
 match organ donors with recipients in
transplant programs
 determine pedigree for seed or livestock
breeds
 authenticate consumables such as caviar
and wine
Benefits of HGP Research
Agriculture and Livestock
 disease-, insect- and drought-resistant crops
 healthier, more productive, disease-resistant farm




animals
more nutritious produce
biopesticides
edible vaccines incorporated into food products
new environmental cleanup uses for plants like
tobacco
biopesticides
蘇力菌(Bti)
Benefits of HGP Research
Evolution and Human Migration
 use germline mutations in lineages to study
evolution
 study migration of different population groups
based on female genetic inheritance
 study mutations on the evolutionarily stable Y
chromosome to trace lineage and migration
 compare breakpoints in the evolution of mutations
with ages of populations and historical events
Human Migration
Benefits of HGP Research
Risk Assessment
 assess health damage and risks caused by
radiation exposure, including low-dose
exposures
 assess health damage and risks caused by
exposure to mutagenic chemicals and
cancer-causing toxins
 reduce the likelihood of heritable mutations
Ethical, Legal, and Social
Issues
 The U.S. Department of Energy (DOE) and
the National Institutes of Health (NIH) have
devoted 3% to 5% of their annual Human
Genome Project (HGP) budgets toward
studying the ethical, legal, and social issues
(ELSI) surrounding availability of genetic
information. This represents the world's
largest bioethics program, which has become
a model for ELSI programs around the world.
Ethical, Legal, and Social
Implications of HGP Research
 fairness in the use of genetic information
 privacy and confidentiality
 psychological impact and stigmatization
 genetic testing
 reproductive issues
 education, standards, and quality control
 commercialization
 conceptual and philosophical implications
ELSI: Fairness and Privacy
 Who should have access to one genetic
information?
 How should it be used?
 Who owns and controls it?
 Consider these would-be owners:
- insurers, employers, courts, schools,
adoption agencies, the military
ELSI: Commercialization
 property rights
 patents, copyrights and trade secrets
 accessibility of data and materials
Monsanto VS. Shmeiser
ELSI: Psychological Stigmatization
 How does knowing one predisposition to
disease affect an individual?
 How does it affect friends? and family
perceptions of that individual?
 How does it affect society’s perceptions of
that individual?
ELSI: Reproductive Issues
 informed consent for procedures
 use of genetic information in decision
making
 reproductive rights
ELSI: Clinical Issues
 education of health service providers,
patients, and the general public
 implementation of standards and quality
control measures in testing procedures
ELSI: Conceptual and Philosophical
Implications
 human responsibility
 free will versus genetic determinism
 concepts of disease and health
ELSI: Genetic Testing
 Should testing be done for susceptibility genes?
- role of environmental factors in disease
development
 Should parents have the right to have their minor
children tested for adult-onset diseases?
 Are current genetic tests reliable and interpretable
by the medical community?
優生學( eugenics)的隱憂
 第二次世界大戰期間,納粹黨認為日耳曼民族是最
優秀的人種,猶太人卻是劣等民族,所以要將他們
趕盡殺絕,以免「污染日耳曼純淨的優秀血統」。
 美國也有人鼓吹白種人有較優秀基因的言論。
 E L S I 卻發表一份聲明,抨擊智商的高低主要是由
遺傳基因所決定這種不成熟的誇大說法。
 歐美社會確有「精子庫」( sperm banks)專門收
集諾貝爾獎得主和某些「傑出」男性的精液,高價
賣給不育的夫婦,又或不願結婚而想生育的單身女
性,以人工受孕的方式,協助他們生產「優秀」的
兒女。這都是「優秀人種」主義的搖籃, 是種族歧
視的武器。
ELSI: Genetic Testing
 Should testing be done only when there is
a family history to make informed prenatal
/ diagnosis decisions?
 Should population screening be done?
- (newborn, premarital, and occupational)
 Should testing be done when no treatment
is available?
「世界人類基因宣言」的摘錄
 第一條:人類基因是全體人類最基本的元素,應受到全體人






類的尊重,它的多元、多樣化,應視為人類的自然資產。
第二條:不論基因的特點、差異,每一個人的權益都應受到
尊重;更不應將個人縮減到視為基因的組成。
第四條:人類的基因不該成為金錢交易的目標。
第五條:用醫藥研究、治療、診斷的需要,而改變原來的基
因,必須先徵求個人的同意。
第六條:不可因個人基因的特點,作為歧視的理由。
第七條:個人的基因秘密,應受到嚴密保護。
第十一條:不允許損壞人類尊嚴的舉動,如利用基因工程複
製人的行為。
後基因體時代的知情同意權
 1949: Nuremberg Code
 right of self-decision; right to self-determination
 1964: Declaration of Helsinki (WMA)
 Informed Consent
 1979: Belmont report
 Center of Medical Ethics
 Patient autonomy
 Respect for person
 Personal decision-making
 Protection of privacy
Informed consent :
traditional vs. post-genomic era
 Traditional IC
 Patient
 diseases
 Individual
 In Hospital
 Easy to explain
 For treatment
 Given only once
 Short-term
 Non profit
 Post-genomic era IC
 Non-patient
 DNA database
 Family or population
 In anywhere
 Difficult to explain
 For research
 Covers any time
 Long-term
 Commercial goal(?)
Case study: Taiwan aboriginal
people
In a related report, dated July 31, 1999, on the Taiwan
Government's Public Television Service's Formosa
Aboriginal News Magazine program, Aboriginal activists
charged that as many as 10,000 blood samples had been
taken from Taiwan Aboriginal people by various research
institutes for research purposes. This short documentary
also featured several research pirates explaining their
research into unique genetic mutations amongst Taiwan's
Aboriginal peoples.
Biopiracy against Taiwan's Aboriginal Peoples
by Mark Munsterhjelm, August 4, 1999
Genes, ethics and Aborigines
As Taiwan begins
collecting samples to
create a DNA database,
scientists are facing
criticism over the methods
they have used to obtain
blood from Aborigines blood that is now highly
valued for research
projects
Genes, ethics and Aborigines
In keeping with the global trend, Academia Sinica members last
month urged the government to establish a Taiwanese gene
database of Taiwan's ethnic groups for the purposes of medical
research and further study of the diversity of human populations
and languages.
 But some researchers have expressed reservations about the
plan, saying the database should be used only for disease
research, not for ethnic studies, lest these give rise to political
disputes.
 In addition, some say the classification of ethnic groups in Taiwan
is based on a biased theory in the first place, and distorts the
proportions of the population that different ethnic groups in
Taiwan represent.
 More importantly, the ethics of genetic research is of primary
concern. It has been discussed in many other countries within the
past decade and recently became controversial in Taiwan,
particularly among Aborigines, who some say have been subject
to gene sampling more than other ethnic groups in Taiwan

By Liu Shao-hua
(TAIPEI TIMES,Tuesday, Aug 29)
The Lack of Informed Consent
 Since 1990, Mackay Memorial Hospital has used
Aboriginal blood for genetic research. It has targeted 11
ethnic groups of Aborigines, 1377 individuals, and used red
blood cells of 37 kinds of blood types.
 In 1998, the Pintung County Government, on instructions
from the former provincial health bureau and in cooperation
with Pintung Christian Hospital, drew 10ml of blood from
1,900 Aborigines for health checks.
 All of the blood extracted for research purposes so far has
been conducted along with free health checks, and mostly
under the arrangement of official health centers.
 The ethical principle of informed consent was ignored in all
the above activities
Case Study: Rural China
 A January 2002 report in China Daily, raises troubling
ethical concerns about U.S. government sponsored genetic
research in rural China.
 The research under question involved thousands of
peasants in one of China's poorest rural provinces, Anhui,
where basic medical care is lacking. It was sponsored
jointly by the National Institutes of Health and Harvard
University, School of Public Health. A Harvard research
team conducted the research involving blood draws for
genetic screening purposes. Nine projects sought to find
hereditary links to diseases such as hypertension, obesity,
asthma and osteoporosis, among others.
 Alliance for Human Research Protection, 18 February
2002
Harvard-Anhui study
(Harvard Public Health Review, 1995)
And halfway around the world in China’s remote Anhui
province, thousand of people are being screened in
an epidemiologic dragnet that researchers hope will
lead them to the genes for asthma and hypertension
Because of limited transport, the population has a very
stable base
The use of blood pressure medication in rural China is
uncommon, our hypertensive cases tend to reflect the
natural progression of disease
China offers a low-cost research venue
Harvard-Anhui study
The study was approved by the
IRB of the Harvard School of
Public Health, and all subjects
gave informed consent (HPHR,
1995)
The program will study diseases
of civilization – DM, HT, Obesity,
Heart disease, Arthritis,
Asthma, Schizophrenia
(Science, 1996)
The study delegated all authority
and responsibility for oversight
to a local IRB in Anqing, China
 Questions are being raised in the Chinese press, whether
a group of American scientists from elite academic
institutions are applying a lesser ethical standard when
conducting genetic research on people in Third World
countries, such as China?
 Were the Chinese subjects in Anhui afforded the respect
required under national and international ethical standards
of voluntary, informed consent?
 Were adequate measures taken to ensure the subjects'
confidentiality was protected from intrusive government
surveillance?
Research by Harvard University in
China Suspended
 Several reports, sent to Harvard University by the
"Human Beings Study and Protection Office"
within FBI of United States, charged its 14 projects
on the study of human beings carried out in the
rural areas of China's Anhui Province with severely
violating regulations. The research had been
suspended and so far no illness case is reported.
台灣地區華人細胞株及基因資料庫建立調查
資料的管理及個人隱私權的保障
參與本研究計劃的個案,將予一個流水號編碼,所有檢體上只有編碼,
無任何個案之基本資料。自參加者同意參與並簽立同意書開始,即以流
水號方式之條碼進行編碼,以代表每一個參加者之樣本資料;各項資料
間之連結,是以流水編號作為依據,每一件血液檢體及其產生之實驗樣
本、實驗室數據,亦皆以編碼方式作為其識別號碼,不會標示個人姓名
資料。
 於計畫結束收案一年之後,所有可辨識參加者的個人隱私資料即予以刪
除,不會存留於問卷資料或是資料庫電子檔案之中。流水編碼無法直接
追溯回參加者。
 此計畫建立之基因資料庫,將提供國內外醫療遺傳相關研究之用。申請
者提出申請後,需經審核委員會同意,方可取得申請資料。提供申請者
之研究分析資料中,沒有可辨識參加者之個人資料,參加者的個人隱私
無洩漏之虞。

個案參與研究計劃知情同意書內容

告知參加者建立代表台灣地區華人細胞株及基因資料庫之目的在於建立
一個具代表性的台灣地區華人基因資料庫,以用於和”病人”基因做比
較分析之用。此基因資料庫的建立將嘉惠於華人疾病的預防、篩檢及治
療。
告知參與本研究計劃的義務:
 回答一份問卷的資料,內容包括基本資料及健康史、疾病史等。
 配合作血壓、肺功能和體位的測量。
 提供23ml靜脈血,以供臨床血液檢查,並萃取DNA及培養細胞株。
告知參與本研究計劃的相關資訊:

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


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參加本研究可能的風險及受益
保護參與研究個案隱私權的相關措施
說明檢體與醫藥資料的使用權與智慧財產權的歸屬權
檢體的多用途性
解釋細胞株的含意
個案終止參與計劃之權利與程序
認識幹細胞
 全能性幹細胞(totipotent stem cell)
具有完全能力的,每一個細胞均可發育成一個完
整的生物個體(受精卵)
同卵雙胞胎、三胞胎、四胞胎
 豐富潛能幹細胞 (pluripotent stem cells)
具有非完全能力的,受部份限制(胚內細胞質塊)
 多重潛能幹細胞 (multipotent stem cells)
血液、皮膚幹細胞
成人幹細胞
胚胎幹細胞(embryonic stem cells)
 胚胎幹細胞(embryonic
stem cells)就是所謂的多潛
能幹細胞(pluripotent stem
cells) ,pluripotent 是由希
臘語由來,其意是多潛能
(many capabilities)。
 理論上胚胎幹細胞可以用來
移植取代病人任何受損的器
官組織。
動物變得有人性?
 2005年12月美國科學家
宣佈培育出腦部含有
0.01之人類腦細胞的老
鼠
 人與老鼠基因相似度有
97.5%,0.01意義深遠
 神照自己的形象造人,
人卻把動物和人混合了
什麼是臍帶血萬能細胞?
 嬰兒出生時,於臍帶及胎盤所存留的血。
臍帶血中富含『零歲』的幹細胞,是人體製
造血液及免疫系統的主要來源,因而可取代
骨髓移植使用。臍帶血的幹細胞又稱為萬能
細胞,因為它類似胚胎一般,是『年輕』而
較未分化的細胞,可以發展成不同型態之細
胞或組織,做為基因療法及複製療法之用。
萬能幹細胞取得的途徑
 從墮胎下的胎體取得
 殺生?為金錢獲救人而墮
胎?
 從人工受孕剩餘的胚胎
取得
 殺生?生命始於何時?
 利用體細胞核轉殖
 較無倫理問題(但有複製
人爭議)
爭議的問題
 胚胎是生命嗎?
天主教和部份新教的觀點
14天的標準
著床的標準
 扮演上帝?
界限何在?
 疫苗、外科手術、預防醫學、遺傳諮詢
治療性或改進性?
人造人或半機器人(spiritual cyborgs)
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1019陳錦生-生物科技倫理學