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論生物醫學人體研究受試者之保護:以告知後同意及相關行政管制為核心 / On the protection of human subjects in biomedical researches:the informed consent and the related administrative regulations林綠紅 Unknown Date (has links)
紐倫堡法典之後,生物醫學研究中人類受試者的處境開始受到關注。為避免受試者遭到濫用,進而保障其權益,國際間陸續頒佈與人體研究受試者保護相關之倫理規範,而各國亦逐步將倫理規範落實為國內法規,作為管制手段。涉及受試者之人體研究倫理規範與法規中,自紐倫堡法典以降,逐步確立以告知後同意以及倫理審查為核心,建立確保受試者自主權之管制機制,作為平衡受試者與研究者兩方在知識與處境上的不平等的關係。
本文以當代生物醫學上告知後同意法則發展,以及人體研究受試者保護之相關行政管制為取徑,首先,考察人體研究所涉及的法律、倫理的爭議,以及相關倫理規範發展。進而探討告知後同意在當代生命倫理與醫療法律之意義、內涵,以及如何實踐於生物醫學人體研究上作為確保受試者自主權之手段及所遭遇之限制。其次,分析並比較美國、荷蘭以及我國受試者保護之法規體系,並進一步討論其特色與優、劣。最後,探討我國人體研究受試者保護法規範之現況與不足,並提出法律修正上的建議。 / Since Nuremberg Code, the biomedical researches involving human subjects, based upon the informed consent and human autonomy, has drawn the increasing public attention. The related normative restrictions as well as legal regulations have been regarded as a significant way to abuse-avoidance and interest-protection on the part of human subjects involved. Thus, it becomes a confirmed tendency that the constitution of normative and legal foundation with a consideration of informed consent and ethico-medical review can ensure the human autonomy and strike a balance between the researchers and human subjects.
In this thesis, we focus on the development of informed consent and the related normative/legal regulations. Several issues which we will deal with can list as follows: firstly, the trajectory and its legal/ethical controversies, with which the biomedical researches involving human subjects develop and revolve, will be clarified, so as to investigate the ethical/legal implications of informed consent and human autonomy. Secondly, by making a comparison of legal regulations among the United States, Holland and Taiwan, we will illustrate the advantages and drawbacks that different legal systems have on the biomedical researches involving human subjects. At the last part of this thesis, several possible suggestions will be provided to the future legislation on the biomedical researches involving human subjects.
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Platonic Craft and Medical EthicsBader, Daniel 14 February 2011 (has links)
Platonic Craft and Medical Ethics examines the Platonic theory of craft and shows its application to different ethical problems in medicine, both ancient and modern. I begin by elucidating the Platonic use of the term “craft” or “technē”, using especially the paradigmatic craft of medicine, and explicate a number of important principles inherent in his use of the term. I then show how Plato’s framework of crafts can be applied to two ancient debates. First, I show how Plato’s understanding of crafts is used in discussing the definition of medicine, and how he deals with the issue of “bivalence”, that medicine seems to be capable of generating disease as well as curing it. I follow this discussion into Aristotle, who, though he has a different interpretation of bivalence, has a solution in many ways similar to Plato’s. Second, I discuss the relevance of knowledge to persuasion and freedom. Rhetors like Gorgias challenge the traditional connections of persuasion to freedom and force to slavery by characterizing persuasion as a type of force. Plato addresses this be dividing persuasion between sorcerous and didactic persuasion, and sets knowledge as the new criterion for freedom. Finally, I discuss three modern issues in medical ethics using a Platonic understanding of crafts: paternalism, conclusions in meta-analyses and therapeutic misconceptions in research ethics. In discussing paternalism, I argue that tools with multiple excellences, like the body, should not be evaluated independently of the uses to which the patient intends to put them. In discussing meta-analyses, I show how the division of crafts into goal-oriented and causal parts in the Phaedrus exposes the confusion inherent in saying that practical conclusions can follow directly from statistical results. Finally, I argue that authors like Franklin G. Miller and Howard Brody fail to recognize the hierarchical relationship between medical research and medicine when they argue that medical research ethics should be autonomous from medical ethics per se.
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落空的權利—從法律多重製圖觀點看日月潭邵族原住民族土地同意權的實踐 / The Hollow Rights: The Practice of Thao’s Indigenous Land Rights in Taiwan from the Perspective of "Multi-Layered Mapping of Law"沈世祐, Shen, Shih Yu Unknown Date (has links)
《原住民族基本法》於2005年通過,是台灣原住民族運動努力多年的成果,但是近年來原住民族仍持續面對各種壓迫。在土地權利方面,該法第21條規定政府或私人於原住民族土地進行開發利用時,需事先諮詢當地原住民族之同意或參與(簡稱「同意權」),然而在許多案件中,原住民族主張此條文表達反對時,經常未能得到行政部門正面回應。本研究以日月潭邵族反對向山旅館開發案為例,理解「同意權」如何變成「落空的權利」。
許多文獻討論,將原住民族權利與實踐的落差歸因於「個人權」(individual right)與「集體權」(collective right)兩種概念的差異及行政部門本位主義因素。本研究則想更進一步釐清,又有哪些其他因素也影響原住民族權利的落實? 在這些因素的影響下,「同意權」的規範運作又產生了何種實際效用?
本研究將從「法律多重製圖」之觀點回答上述問題,首先將探究「同意權」概念在國際法、國內法與行政實踐中的規範生產與運作,分析在不同的場域下,場域內的參與者如何對「同意權」進行法律製圖。本文主張,法律生產過程中對權利概念的意義內涵轉換、法律生產與運作場域的邏輯結構,皆影響原住民族權利的實踐。同時,本研究進一步以日月潭邵族的案例,說明原住民族土地權中「自由與事先知情同意原則」或「同意權」規範,理想上是以原住民族的「參與」並實現自決權為目標,但在邵族的案例中,實際運作卻是不斷「排除」原住民族的過程,法律成為排除原住民族權利的合理化機制,更避開各種議題對立面的討論。
權利的落空一方面指權利主張不被理解與正視,更進一步指原住民族社會愈遠離「集體」的過程,因而我們需對原住民族同意權或各種集體權的運作有更多的反省,並持續探詢屬於每個部落或族群中所謂「好生活」(good life)的意義。本文最後藉用「草根後現代主義」(grassroots post-modernism)之概念,介紹原住民族在追求「好生活」的道路上,如何藉著在地思考、找回與族群內部的連結,以此對抗全球化、新自由主義趨勢下對原住民族權利的影響與侷限。 / Though its enactment in 2005 can be regarded as an achievement of Indigenous movement in Taiwan, The Indigenous Peoples Basic Law does not work as it promises. The indigenous people are still struggling for the fulfillment of rights. With respect to land rights, Article 21 of the Law requires the participation and consent of local indigenous people before the development and utilization of the indigenous land. However, the article is often neglected by the government in many cases.
This case study then focuses on Thao people (邵族)who live around Sun-Moon Lake (日月潭)and their opposition to a Hotel program located in Xiangshan(向山), which is regarded as the traditional territory of Thao. By adopting the perspective of “Multi-Layered Mapping of Law”, I hope to analyze the enactment process and the effect of law concerning the principle of Free, Prior and Informed Consent as well as land rights of indigenous people, and try to describe how the “right to consent” becomes a “hollow right” in practice.
The study depicts the right as “hollow” for two meanings. On the one hand, it shows the situation for indigenous people facing the gap between the law’s promise and law’s practice in the complex process of law making and law enforcement. On the other hand, it further describes the more distance from collectiveness within indigenous society. The study suggests that more dialogue and more reflection is needed when claiming rights.
The last part of the study then introduces the idea of “grassroots post-modernism” which discuss the way to “Good Life" and the way of resistance against globalization and neoliberalism. Although the issues need further discussion in future studies, the idea can be a guidance for indigenous people as they pursue the fulfillment of land rights, autonomy and self-determination.
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Platonic Craft and Medical EthicsBader, Daniel 14 February 2011 (has links)
Platonic Craft and Medical Ethics examines the Platonic theory of craft and shows its application to different ethical problems in medicine, both ancient and modern. I begin by elucidating the Platonic use of the term “craft” or “technē”, using especially the paradigmatic craft of medicine, and explicate a number of important principles inherent in his use of the term. I then show how Plato’s framework of crafts can be applied to two ancient debates. First, I show how Plato’s understanding of crafts is used in discussing the definition of medicine, and how he deals with the issue of “bivalence”, that medicine seems to be capable of generating disease as well as curing it. I follow this discussion into Aristotle, who, though he has a different interpretation of bivalence, has a solution in many ways similar to Plato’s. Second, I discuss the relevance of knowledge to persuasion and freedom. Rhetors like Gorgias challenge the traditional connections of persuasion to freedom and force to slavery by characterizing persuasion as a type of force. Plato addresses this be dividing persuasion between sorcerous and didactic persuasion, and sets knowledge as the new criterion for freedom. Finally, I discuss three modern issues in medical ethics using a Platonic understanding of crafts: paternalism, conclusions in meta-analyses and therapeutic misconceptions in research ethics. In discussing paternalism, I argue that tools with multiple excellences, like the body, should not be evaluated independently of the uses to which the patient intends to put them. In discussing meta-analyses, I show how the division of crafts into goal-oriented and causal parts in the Phaedrus exposes the confusion inherent in saying that practical conclusions can follow directly from statistical results. Finally, I argue that authors like Franklin G. Miller and Howard Brody fail to recognize the hierarchical relationship between medical research and medicine when they argue that medical research ethics should be autonomous from medical ethics per se.
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兒童醫療自主之探討-以病童臨床經驗出發 / Patient autonomy of children - from the clinical experiences on pediatric patients張濱璿, Chang, Pin Hsuan Unknown Date (has links)
因為醫病互動關係的改變,病患自主權在經過歐美數十年來的覺醒與詮釋,並定位於不論是人性尊嚴或是隱私權內涵中之憲法層級,以及在告知後同意於近二十年來引進國內並蓬勃發展之後,病患的自主決定權在現今醫療過程中已經受到相當的重視。青少年也因接近成人的年齡及成熟度,在法律及臨床實務上也逐漸肯認其對於自身的醫療決定擁有自主決定權。然而,兒童不論在法律或是社會觀念之中,均被認定為能力尚未成熟,傳統上認為必須由父母代替其做醫療決定。可是在作者身為一位臨床兒科醫師的臨床實務經驗當中,許多病童往往能表達自己對於醫療決定甚至是臨終決定的自主意見,卻不受到父母或其他成年代理人的採納。
因此,本文將從臨床經驗出發,將所發現許多兒童有能力決定、以及父母無法做出符合兒童利益決定的案例,提出作為本文探討的思考起源。本文主要鎖定未成年人中未滿12歲的兒童進行討論,排除許多文獻早已熱烈討論的青少年人;另外因為立法例上並未賦予未成年人擁有「自主權」,故本文暫不深究兒童法律上的自主權利,而是以探討兒童實質上的「自主性」作為探討的主軸,並以此為未來法律發展的基礎。
本文將首先從「醫病關係的演進」開始,探討一般性「病患自主決定權」之倫理與法律。醫學倫理上涉及包括「生物醫學倫理四原則」以及「告知後同意」;多數國家也將「自主決定權」在法律上定位為憲法層級之人權保障。聯合國兒童權利公約則為現今國際上兒童人權維護的重要指引,也是對於兒童一般自主權正當性的重要依據。至於兒童的自主決定與其決定能力相關,也涉及父母代理決定的討論,故從法律上對於父母子女關係及未成年人保護的討論出發,探討代理決定時的最佳利益判斷,思考兒童醫療決定的問題及衝突,以及在不同年齡適合該年齡得以決定的事項。
在兒童醫療決定上,難題包括為何要重視兒童自主、何人有權決定、如何決定等等,在此議題受到各國重視並不斷發展之下應如何運作。在本文中主要參考了美國以及英國的發展經驗以及建議,提出對於臨床操作的看法。本文認為,可以用兒童醫療「表意權」的行使作為對兒童自主性的肯認,從兒童決定能力的判斷開始,對於具有決定能力的兒童表達其合理意見應充分尊重;若是缺乏決定能力的兒童,則在考量其最佳利益後由父母代理其做出醫療決定。醫療人員基於必須對於病童負責的角色及責任,亦應檢視父母決定是否合理,適時地介入決定以維護兒童最佳利益。
至於在兒童的最佳利益的判斷上,除了要考慮所面對的病況以外,還需要針對兒童未來生理發育和心智發展的影響,整體考量其未來的生活品質;對於臨終的兒童,則應考量是否得到有尊嚴的死亡,此與成年人的思考並無相左。最後,本文將進一步探討較為特殊的臨床狀況,包括面對重症以及急症的病童應如何操作及思考,並重新檢視本文所提出之實際臨床困難案例,建議較為適合的做法,以作為更多臨床個案判斷的參考指引。 / Patients' awareness of self-determination has raised and their rights have been taken into account in clinical consideration because of the change of doctor-patient relationship in recent decades. The right to autonomy was highly positioned at the constitutional level no matter it is contained in the concept of human dignity or the right of privacy. It is also highly valued after “the doctrine of informed consent” was introduced into our country with vigorous development in recent years.
Because adolescents’ age and maturity approach adults, they have been recognized to have sufficient ability and right to make their own medical decisions as well as adults. Children, in the general idea of the society, are concerned not to have sufficient decision making ability and therefore need their parents’ help to make their own medical decisions. However, from clinical experiences, many children could not only express their autonomous opinions but even have the ability to consent to their medical treatments, including life-saving treatments. Unfortunately, children’s opinions were usually ignored, and sometimes their parents could not make decisions in their best interest.
This study will discuss the patient autonomy of children whose ages are under 12 years old. We acknowledge that children do not have legal “right” to autonomy but they still have their own autonomous expression. The ethical and legal bases of patient autonomy are firstly illustrated, including “the four principles approach to bioethics”, “the doctrine of informed consent”, the legal status of “the right to autonomy” at the constitutional level, and the United Nations Convention on the Rights of the Child which is an international guide to children’s human right.
Children’s autonomy is closely related to their decision-making capacity or competence and their age. Furthermore, surrogate decision making plays an important role in children’s affairs. When there is a conflict between the parents and children, the principle of best interest of children should be the leading concern.
Regarding the medical decision of children, difficult problems are: why children’s patient autonomy is vital, who has the right to decide, and how to make a decision. I have reviewed the experiences and suggestions from concept leading countries such as the United States and the United Kingdom. I proposed my own viewpoint and suggest some guidelines on the clinical decision process. My opinion is that children’s right to express should be taken as the confirmation of children’s autonomy. For the children with decision making capacity, we should fully respect his rational decision; for the children without it, parents could make the decisions according to the children’s best interest. Medical staffs, including doctors and nurses, also need to reexamine the parents’ decisions suitable for children’s best interest. At the end of the thesis, I re-examine the clinical cases proposed at the beginning of this thesis, to present my resolution to the cases as guides for future clinical situation.
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Legal issues relating to the treatment of persons living with cancerMaimela, Charles 06 1900 (has links)
Cancer is regarded as a global disease and one of the leading killer diseases in the
world. The reason why cancer is so widespread and often misunderstood stems from
multiple factors, namely, the lack of knowledge about cancer, unfair discrimination of
persons living with cancer, inadequate or inappropriate treatment provided to patients,
the stigma attached to cancer, misdiagnosis and late diagnosis of persons living with
cancer, as well as the inadequate provision of screening programs to detect cancer at
an early stage.
The combination of these issues raises alarming medico-legal problems that merit
further attention. The thesis will explore the origin, nature, philosophical and clinical
aspects pertaining to cancer, as well as legal issues related to cancer and oncology.
The study will conclude with recommendations aimed at mitigating and addressing the
shortcomings that exist in the medico-legal framework. The study will also draw on a
legal comparison of relevant South African, English and American laws and
regulations. Since this thesis entails focussing on medico-legal principles, the study
will draw on aspects of medical law, labour law, law of contract, law of delict,
constitutional law and criminal law. / Private Law / LL. D.
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Educator's knowledge of and opinions on child sexual abuseRatlhagane, Kgomotso J. 30 June 2002 (has links)
Sexual abuse of children occurs at a very high rate and most of the victims are young
children who have never been taught about the possibility of being abused. Victims of
abuse are not equipped with appropriate knowledge and vocabulary to enable them to
explain properly when they experience abuse. Acquisition of a vocabulary and
understanding of the concepts of sexuality would assist children in recognizing, resisting
and reporting sexual abuse. The young age at which abuse occurs makes the study at
primary school level important and relevant.
There is little literature on how child sexual abuse can be identified, addressed and
handled by schools or what unique role the school should play in the management of child
sexual abuse cases. Educators are in a position to identify sexually abused children
because of their close and ongoing contact with school-going children. Therefore, young
children place a great deal of trust in their teachers and look to them for protection when
they feel unsafe. Teachers are trained to observe changes in the appearance and
progress of individual children. Therefore, they can also assist in uncovering and reacting
appropriately to disclosures of abuse.
The study was conducted in poor, disadvantaged, rural primary schools in a part of the
North West Province. There is a limited access to social work services in rural areas and
therefore, educators are considered to be appropriate people to educate children about
sexual abuse issues because children spend most of their time at school. There is a
relationship between educators, parents and children which creates a proper channel of
communicating information about sexual abuse of children. That is, educators are in a
position not only to educate but also to reinforce what children have learnt at home.
Educators' role have been limited in the identification and dealing with sexual abuse cases
and therefore, there is a need to empower them with appropriate knowledge and skills to
enable them to handle sexual abuse cases at school level successfully. / Psychology / M. A. (Psychology)
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The participation of children in HIV/AIDS clinicals trials : ethical and legal considerationsMujinga, Sandrine Mutumba 06 1900 (has links)
This dissertation examines the legal position relating to the participation of children in
research, especially in HIV preventive clinical research in South Africa. HIV/AIDS
presents a real threat to humanity and particularly to the welfare of children. The
participation of children in this type of trials is therefore vital. Children, as vulnerable
participants, must also be protected from harm resulting from research. The study also
considers the nature of HIV preventive clinical research, pointing to the inconsistencies
in the legislation governing children’s participation in HIV preventive vaccine trials. The
dissertation concludes that the question of the participation of children in HIV preventive
clinical research poses many challenges, as the position in the South African law and
relevant ethical guidelines are inconsistent and contradictory. The study recommends in
the final instance that the relevant statutory provisions and ethical guidelines be
harmonised in order to clear up the inconsistencies. / Jurisprudence / LL.M. (Legal Aspects of HIV/AIDS)
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Law, Psychiatry and psychology : a selection of constitutional, medico-legal and liability issuesSwanepoel, Magdaleen 30 June 2009 (has links)
The purpose of this thesis is to develop a comprehensive process for identifying and addressing primarily constitutional, medico-legal and liability issues, and in addition ethical, social and scientific issues related to the psychiatric and psychology professions in South Africa. In fulfilling this purpose, a comprehensive search is conducted of relevant historical, ethical, philosophical and clinical aspects pertaining to psychiatry and psychology, as well as an evaluation of the current juridical framework regarding the legal liability of the psychiatrist and psychologist balanced against the constitutional rights of the mentally disordered patient in South Africa. Recommendations are made for the establishment of any new controls needed to mitigate and prevent the exposure of mentally disordered patients, further attempting to provide specific remedies to adapt the current juridical framework in South Africa. The examination is conducted within the framework of the South African and United Kingdom's legal systems. Focus is placed on aspects of medical law, human rights law (as envisaged in the Bill of Rights in the Constitution of the Republic of South Africa, 1996), criminal law and the law of delict and, to a lesser extent, administrative law and the law of evidence. / Law / LL.D.
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The right to confidentiality in the context of HIV/AIDSMtunuse, Paul Tobias 02 1900 (has links)
The purpose of this study is to investigate the right to confidentiality in the context of HIV/AIDS through an interdisciplinary lens. This study indicates that whilst confidentiality is important and should be preserved in order to protect persons living with HIV/AIDS against stigmatisation, discrimination and victimisation, this should be balanced by other equally important interests, such as the protection of public health and individual third parties who may be affected by the intentional or negligent infection of others with HIV. As the consideration of the legal issues relating to confidentiality and privacy cannot be divorced from the social context in which HIV/AIDS plays out in South African communities, the study will examine, amongst others, the victimisation, discrimination and stigmatisation experienced by persons living with HIV/AIDS, followed by a critical exploration of the present legal and ethical framework governing privacy and confidentiality, including medical confidentiality, as well as the duty to disclose a positive HIV-status, in the context of HIV/AIDS. Possible limitations on the right to privacy in this context are also examined, which include, amongst others, a consideration of making HIV/AIDS notifiable diseases in South Africa. The study suggests that it is imperative that legal interventions aimed at curbing the spread of HIV will need to be mindful of the unique social, cultural and economic forces that impact on the duty to disclose a positive HIV-status to partners and other affected third parties. Insights gained from philosophical theories relating to Africanism, individualism, communitarianism and utilitarianism are valuable tools in facilitating a clearer understanding of relevant social and cultural factors that keep South African society locked in the present stalemate with regard to the disclosure of HIV status. / Public, Constitutional, and International law / LLD
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