Hand-held optical imagers are developed towards clinical breast cancer imaging. Herein, a Gen-2 hand-held optical imager has been developed with unique features: (i) image curved breast tissues with ~86% surface contact, and (ii) perform reflectance and transillumination imaging using the novel forked probe heads. Extensive phantom studies were performed using 1% Liposyn solution (background, ~ 300 ml and 1000 ml volumes) and 0.45 cc India Ink (absorption) targets, under different target:background contrast ratios and target depths. Two-dimensional surface images detected target(s) up to 2.5 cm deep via reflectance imaging, and up to 5 cm deep via transillumination imaging. Preliminary studies on gel-based breast phantoms (~700 ml) detected targets via reflectance and transillumination imaging. Preliminary in-vivo reflectance studies on normal and cancerous breast tissues also detected targets, although with artifacts. In future, the portable Gen-2 imager has potential for clinical breast imaging via reflectance and transillumination approach after extensive in-vivo studies.

近年來，病人自主權意識高漲，醫療糾紛頻傳，每個醫師無不戒慎恐懼，而醫療爭議之處理模式與醫師專門職業之道德責任都受到社會高度的檢視及廣泛的討論。事實上，醫學的進步需要依賴不斷地創新與大膽地試驗研究，因此人體試驗相關的問題也受到大眾的關注。 由於人體試驗所面對的是複雜而變化多端的情境，所以參與人體試驗之受試者將會面對甚而遭到危險或傷害。我國人體試驗的相關法規，多散置於醫療法、醫師法、藥事法、藥品優良臨床試驗準則、藥品優良臨床試驗規範等，除了無整體之法規範外，且多為行政法令，在法律位階上均較低，加上衛生署主管機關無法落實對試驗過程中之管理與監控，因此參與人體試驗之受試者往往會受到損害而無法得到應有的保障。因為人體試驗的特殊性與常規醫療是不同的，如果僅由既有的傳統醫療糾紛處理方式，如醫療契約於受試者的關係、侵權行為於違反保護他人法律的標準、醫療倫理不傷害原則於人體試驗規範等，這些恐怕都是必須的，但是仍嫌不足。 本文參考國外人體試驗規範包括紐倫堡法則、赫爾辛基宣言、美國貝爾蒙特報告、美國聯邦法規、CIOMS國際生物醫學研究人體試驗倫理準則、國際醫藥法規協和會之優良人體臨床試驗準則等等，然後針對個別議題如受試者保護之告知後同意，受試者權益之醫療契約關係及侵權行為責任，受試者受傷害之損害賠償責任，作一整理分析與檢討，並進一步配合我國現行法律制度與社會倫理規範做出建議。 本文共分為七章，分別為「序論」、「人體試驗」、「人體試驗告知後同意法則」、「國外人體試驗之民事責任」、「我國人體試驗之民事責任」、「人體試驗之賠償責任及機制」及「結論」。 / In recent years, patients’ consciousness of self-determination has raised and many medical disputes occurred; doctors feel discomfort and developed the high intensity of self-defense. The solution of medical malpractice and professional liability of doctors have became the major public issues and received many discussions. We are quite sure that the medical progress is based on innovative and intensive clinical study on human subjects. Under this background, the topics on human subject research have been attracted more attention than ever. Since the situations in human research are complex and variable. If relative clinical standards and legal protections are not adequately provided, the human subjects involved in clinical researches may face many risks and even injured. In Taiwan, we don’t have a systemic regulations on human subject research, all regulations are distributed in different code, act, proceeding, and agreement. Furthermore, the government does not have enough resource and manpower to monitor or inspect the processes of human research, the issues of protection of human rights and benefits of testee has raised serious concern. The human subject research is not exactly the same as the clinical medical treatment, it’s impossible for legislators or institutions to regulate research through traditional medical regulations such as medical ethics doctor-involved informed consent, medical agreement (contract), tort laws, and compensation for injury. In this thesis, firstly, I reviewed the most important publications related to human subject research include Nuremberg Code, Declaration of Helsinki, USA’s Belmont Report and Code of Federal Regulations, CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, and ICH-GCP; secondly, focus on each specific topics especially the value of informed consent, the importance of medical agreement, the liabilities of torts and the policy of compensation for injury. Finally, I’ll make my comments and suggestions to the health care authorities to update and implement new regulating policies to protect human rights of subjects involved in clinical researches. My thesis is restricted to discuss the impact of civil liability on human subjects research focus on drug clinical trial and divided into seven chapters as follows: “Introduction”, “Human subject research”, “Principles of informed consent”, “International liability of civil law on human subject research”, “Liability of Taiwan civil law on human subject research”, “Policy of compensation for injured human research subject” and “Conclusion”.

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.

本文試圖探究行動電話於當代普及所帶來的影響。一直以來，網際網路及隨之而生的「模控空間」都被看作是我們這個時代最重要的媒介與文化發展。然而，晚近十年間的電子媒介技術發展卻顯示出，行動電話已然成為網際網路之外同樣影響人們日常生活甚鉅的一種媒介。甚至，如同Howard Rheingold所指出的，它已逐漸地改變了我們當下與未來的生活形式。循此，簡言之，本文的目的即在於，試圖理解行動電話所帶來的是什麼樣的生活世界，以及這又是如何可能的？在回答此一問題時，本文所採取的基本理論觀點與分析架構乃是一種試圖超越過去技術決定論的新取徑。亦即，立基於「人─技術─世界」相互關連的關係性基礎上，本文主張，人們日常使用與操作技術的實作實際上總是展開於技術物所形塑的結構脈絡之中，同時，此一結構脈絡本身卻也是由人們的實作過程「有方法地」反身維繫與再建構的。換言之，本文將說明，實際上行動電話普及所帶來的影響不僅僅導因於技術特性的結構作用，同時也是人們日常實作持續建構與維繫的結果。 更清楚地說，在論文中我們指出了行動電話普及所導致的結構性變遷與影響為（1）由行動電話「水平嵌合」的延伸形式所帶來的「混雜實在」。也就是說，行動電話的使用者實際上是處於一種「雙面舞台」的情境之中。透過行動電話的中介，人們如今理所當然地將其脈絡視為是混雜交織著虛擬／物質、遠處／近在的指涉。（2）源自於行動電話「流動」的技術特性而逐漸形成的「即刻化時間」與「個人化社會空間」的時空框架。正是在這一轉變的時空框架中，浮現了本文稱之為「隨傳隨到的個人社群」的新形態人際關係樣態。而這些結構性的變遷與影響，在本文看來，同時也是人們日常實作持續「有方法地」完成、維繫與再生產的產物。以俗民方法學為基礎，本文回到實際日常使用與操作行動電話的實作過程中，探究人們是如何有方法地完成「打行動電話」的日常生活。例如，我們指出了「體現」與「轉譯」乃是人們操作行動電話理所當然地依賴著的方法；此外，由於「打行動電話」的實作仍「在」當下既存的互動場景之中，其完成也就有賴於「協同實作」的打造；人們的實作也顯示出，並不只是由於行動電話的技術特性與設計，更是因為人們總是有方法地管理、完成「打行動電話」的過程，人際之間的連結才呈現為「個人化即刻連繫」之樣態。 總之，藉由這些觀察與分析，本文試圖指出行動電話造就的「結構」實際上也是實作建構的產物。然而，雖然本文主張人們實際上參與了框限著自身的「結構」的建構，但這並不意味著人們就必然只能如此生存著。相反地，從「人─技術─世界」的相互關連來看，既然我們的日常生活並非單純由「技術」所決定的、既然我們的生存樣態同樣也取決於自身的「實作」，本文在最後試圖說明的便是，我們也就總是有著「不必然如此」的可能性。藉由三個案例的呈現，本文說明了「多元」的行動電話使用與操作實作如何可能。些實作並不是意圖正面對抗、顛覆既那些與行動電話實作相關的既有「常識」與「預設」，但在其迴避、繞道、偏離與走出的各種形式中，我們卻能清楚地看到實際行動電話的使用與操作中，如何不斷地逾越了既有的軌跡與秩序。換言之，回過頭來，本文試圖說明的是，「理解」行動電話同時也意味著我們必須要在各種「捨」與「得」的權衡之中做出選擇。在每一刻的行動電話操作實作之中，我們不僅選擇了如何完成當下的秩序，同時也選擇了走向什麼樣的「行動未來」。這不僅是「如何生活」──亦即，如何使用行動電話的選擇──的問題，同時也是關於「如何存在」──亦即，在更根本的層次上成為什麼樣的存有──的反思。 / This thesis attempts to discuss the impacts brought by the prevalence of mobile phones. Although the Internet and the cyberspace have been thought as the most important media and cultural development of our age, the progress of the electronic media in recent decade has showed that mobile phones have also brought important structural changes in our life. Accordingly, what we want to understand is how mobile phones have changed our life world. In response to this question, the thesis adopts a new approach which goes beyond the traditional technological determinism. That is, based on the interrelationship of the “human-technics-world”, it proposes that the everyday technological practices always unfold in the context structured by our technics, and the structured context itself is also, at the same time, constructed reflexively by user’s technological practices. First, the thesis indicates the structural changes brought by mobile phones as follows: (1) the “hybrid reality” emerging from the extending and mediation of mobile phones; (2) the “immediatization of time” and the “individualization of social space” resulted from the widespread use of mobile phones. Second, based on ethnomethodology, we explore how the user accomplishes the everyday “using” of the mobile phone skillfully and reflexively. The investigation shows that, for example, (1) the user, while using the mobile phone, depends upon the methods of “embodiment” and “translation”, and takes them for granted; (2) the accomplishments of the using practices actually are the products of the “cooperation” between the user and the members at the scene because the user is still “in” the present situation; (3) the using practices also show that the “individualized and immediatized connection” which emerges as the figure of our interpersonal relationship is not only due to the technical characteristics of mobile phones, but also the product of user’s skillful using practices. Third, although the thesis advocates that the everyday using practices reflexively construct the structural changes which in turn shape the practices themselves, it also attempts to point out that we still have the possibility of transgressing the given structural constraints. We explicate, by three cases, how different and multiple ways of mobile phone using are possible. These “variant practices” do not represent the opposition and the subversion of the given structure shaped by mobile phones, but indicate that we still could choose different ways of using, and different kinds of life.

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