博碩士論文 93134016 完整後設資料紀錄

DC 欄位 語言
DC.contributor哲學研究所在職專班zh_TW
DC.creator劉陽明zh_TW
DC.creatorYang-ming Liuen_US
dc.date.accessioned2009-7-27T07:39:07Z
dc.date.available2009-7-27T07:39:07Z
dc.date.issued2009
dc.identifier.urihttp://ir.lib.ncu.edu.tw:88/thesis/view_etd.asp?URN=93134016
dc.contributor.department哲學研究所在職專班zh_TW
DC.description國立中央大學zh_TW
DC.descriptionNational Central Universityen_US
dc.description.abstract以人作為試驗藥物的對象,在20 世紀前出現不多,也較沒有不道德的爭議。 20 世紀開始有許多濫用醫療試驗的事情發生,引起不少爭議性。美國、德國、 日本先後出現不人道的人體試驗。為了規範世界各國避免將人體試驗濫用,因此 國際上先後陸續發展出『紐倫堡守則』、『赫爾辛基宣言』、『涉及人體之醫藥研究 的國際倫理指引』、『貝爾蒙報告書』等重要文獻。這些文獻明確訂定有關人體試 驗研究倫理的規範。直到20 世紀末21 世紀年初,人類基因體進入後基因體時代、 研發各種基因的技術,其中涉及基因人體試驗的基因技術有基因治療、基因增 強、人類胚胎幹細胞的研究、醫藥的研究等,為了避免世界各國因基因科技所帶 來的經濟效益大,在競爭之中可能會發生違反倫理與人道事件的狀況。因此、聯 合國依據世界人權宣言制訂相關規範『人類基因組與人權宣言』『世界人類基因 資料宣言』『世界生命倫理宣言』作為普遍的國際倫理規範。 本文綜述和分析自20 世紀以來有關人體實驗的各國和國際的守則或宣言, 包括20 世紀初的德國法令,和二次大戰時納粹黨在猶太人身上所作的不人道實 驗所引發的紐綸堡守則,以及美國在本土所作的傷害受試者的案例,所引發的貝 爾蒙報告書等。本文原則主義所列舉的尊重自律、仁愛、不傷害和公義原則分析 各國這些條文和國際宣言的規範內容,以建立一評審的架構,並進而分析在後基 因體時代涉及人體試驗產生的問題。由此得出在人體實驗規範中。關於受試者生 命健康安全方面必須嚴格監控所產生的症狀,此時嚴格篩選受試者就非常重要。 同時必定要完成風險利益評估有絕對必要性,必須確保受試者從中獲得利益大於 所受到的傷害,為了能完成風險利益評估的最好方式就是透過已建立好的倫理審 查與監控的機制進行審查,絕對不能流於形式。在受試者方面需貫徹告知同意原 則,同時為了避免受試者的傷害也必須建立一套有關人體試驗的保險機制。關於 基因隱私的問題,基因資訊絕對必須給予保障不得任意公開,以及隱私權與知情 權的兩難衝突的問題,如果基因缺陷涉及生命安全時,就有必要讓家族成員知 情,夫妻之間也必須為家庭與下一代負責,所以必須滿足雙方的知情權。最後, 關於涉及社會公正問題,為了避免基因科技只有富人享有的情形,必須由政府依 據聯合國規範制訂成果利益分享的規範。例如可考量納入全民健保制度或另制訂 其他的共享機制。關於弱勢族群的權益也必須特別的保障。 最後,本文進行國內外相關人體試驗規範試著從試驗前、中、後進行比較, 試驗設計方面必須考量無行為能力時是否尊重未成年人的意見或是只尊重父母 親意見情形,當兩者相衝突時,應如何規範等課題。試驗審查方面倫理審查委員 會絕對不能流於形式必須審慎的審查,才能發揮應有的審查機制功能,增加衛生 署有定期檢查、不定期抽查的規定,同時增加醫療機構的定期報告及遇到緊急狀 況時應即向中央主管機關報告的義務。試驗期間,建議除了醫療法明訂罰則,給 予醫療機構警惕不能忽視受試者的醫療權益。更重的是基因隱私的部分,各國應 遵守國際國際人類基因資料宣言規定,努力保護個人隱私,同時所有的基因資料 不應向第三者披露,也不能讓他們查詢基因相關資訊。試驗後的基因成果分享機 制,建議國內相關單位可建立人體試驗分配利益機制,且必須符合公平公正的原 則。 zh_TW
dc.description.abstractBefore 20th Century, there were few experiments on human being and mostly were morally acceptable. There are more and more experiments employing human subjects and cases of abuse abound. In United States, Germany and Japan there were revealed many cases of inhuman treatment of subjects in experiments. International associations set up a number of important rules such as the Nuremburg Code, Helsinki Declaration, Belmont Report and others. These documents specified the rules for human experiments. By the end of the 20th and the beginning of 21st century, the Human Genome Project brought into view a new wave of different experiments such as those concern genetic therapy, embryonic stem cell research, pharmacogenomics and others. United Nation consequently issued a number of declarations such as Declaration of Human Genome and Human Rights, International Declarations on Bioethics, so as to provide a universal guideline for the field. Using the four basic principles of respect for autonomy, benevolence and non-maleficience and justice, this thesis examines the various code of ethics and declarations on ethical conducts in human subject research and experiment and builds up an evaluation framework , which is subsequently applied to the post genome era as well as the situations in Taiwan. The basic elements of an ethical experiment involving human subjects include the strict regulation and monitoring of such research, with special emphasis on the safety and health of the subject. The selection of subjects becomes very significant. It is also emphasis that risk and benefit analysis and the benfit of the subjects should out-weight the harm to them. An adequate insurance mechanism need be introduced. Applying to genetic research, confidentiality needs be uphold, the dilemma of privacy and right to know and sometimes not to know is very intrique. It is contended that when it involves life and death, family members have the right to know. Furthermore, married couples are responsible for their child and should respect each other’s the right to know. Lastly, government must regulate the sharing of the benefit and burden of the population according to rules set down by the United Nation in order to avoid the monopoly of the wealthy in advance genetic technology. It is proper to consider the employment of genetic therapy into the universal health insurance. The vulnerable groups such as rare disease groups need be taken special care of. en_US
DC.subject人類基因組與人權宣言zh_TW
DC.subject貝爾蒙報告書zh_TW
DC.subject人體試驗zh_TW
DC.subject紐綸堡守則zh_TW
DC.subjecthuman subject experimenten_US
DC.subjectNuremburg Codeen_US
DC.subjectBelmont Reporten_US
DC.title論人體試驗之國際規範:從傳統到後基因體的研究zh_TW
dc.language.isozh-TWzh-TW
DC.titleInternational Norms about Human Experiment:Traditional Genomics and Post-Genomics Researchen_US
DC.type博碩士論文zh_TW
DC.typethesisen_US
DC.publisherNational Central Universityen_US

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