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題名:緊急的倫理:新型冠狀肺炎疫苗之臨床試驗及緊急授權的法制與倫理分析
書刊名:國立臺灣大學法學論叢
作者:張兆恬
作者(外文):Chang, Chao-tien
出版日期:2021
卷期:50:特刊
頁次:頁1073-1165
主題關鍵詞:新冠病毒疫苗公衛倫理公衛緊急狀態臨床試驗倫理人體研究倫理緊急授權司法院釋字第690號解釋藥事法COVID-19VaccinePublic health ethicsPublic health emergencyClinical research ethicsHuman subjects ethicsEmergency use authorizationJ. Y. Interpretation No. 690Pharmaceutical Affairs Act
原始連結:連回原系統網址new window
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  • 被引用次數被引用次數:期刊(1) 博士論文(0) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:1
  • 共同引用共同引用:13
  • 點閱點閱:3
期刊論文
1.李建良(20111015)。人身自由的憲法保障與強制隔離的違憲審查--釋字第690號解釋。臺灣法學雜誌,186,60-79。  延伸查詢new window
2.Deming, Meagan E.、Michael, Nelson L.、Robb, Merlin、Cohen, Myron S.、Neuzil, Kathleen M.(2020)。Accelerating Development of SARS-CoV-2 Vaccines: The Role for Controlled Human Infection Models。The New England Journal of Medicine,383(10)。  new window
3.陳仲嶙(20200600)。從防疫出國禁令爭議再訪法律保留的疆界。法律與生命科學,9(1),1-37。new window  延伸查詢new window
4.李建良(2020)。在瘟疫中思索自由。人文與社會科學簡訊,22(1),30-33。  延伸查詢new window
5.Singh, Jerome Amir、Kochhar, Sonali、Wolff, Jonathan、The WHO ACT-Accelerator Ethics & Governance Working Group(2021)。Placebo use and unblinding in COVID-19 vaccine trials: recommendations of a WHO Expert Working Group。Nature Medicine,27(4),569-570。  new window
6.林明昕(20210114)。再論嚴重特殊傳染性肺炎防治及紓困振興特別條例第7條之合憲性爭議。臺灣法學雜誌,407,53-67。  延伸查詢new window
7.吳全峰、劉靜怡、劉定基、翁逸泓、邱文聰(20210500)。科技防疫與個人資料保護。月旦裁判時報,107,88-104。  延伸查詢new window
8.施明遠(20210500)。從公共衛生危機到國家安全意識--美國醫療對應措施立法之演進與分析。月旦法學,312,46-69。new window  延伸查詢new window
9.林欣柔(20200600)。新冠肺炎流行下的公衛權力與界限。法律與生命科學,9(1),67-89。new window  延伸查詢new window
10.徐千惠、吳馥羽、吳彥慧(2020)。人體攻毒試驗應用於疫苗研發:過去、今日與未來。當代醫藥法規月刊,120,1-17。  延伸查詢new window
11.許育典(20210700)。不同於憲法緊急狀態的法治國防疫措施--以法治國的國家保護義務為核心。月旦法學,314,182-190。new window  延伸查詢new window
12.詹祐維(20200600)。傳染病防治法強制隔離措施之檢討--以釋字690號解釋為中心。萬國法律,231,13-23。  延伸查詢new window
13.雷文玫(20210500)。防疫共同體的物資整備--從我國口罩光榮動員經驗看下一波超前部署所需要的法制整備。月旦法學,312,23-45。new window  延伸查詢new window
14.劉宏恩(2020)。評我國食藥署關於COVID-9疫苗臨床試驗受試者徵求及緊急授權使用(EUA)之政策。生物醫學,13(4),237-239。  延伸查詢new window
15.Adashi, E. Y.、Rajan, R. S.、Cohen, I. G.(2019)。When Science and Politics Collide: Enhancing the FDA。Science,364(6441),628-631。  new window
16.Anomaly, J.、Savulescu, J.(2019)。Compensation for Cures: Why We Should Pay a Premium for Participation in 'Challenge Studies'。Bioethics,33(7),792-797。  new window
17.Blum, J. D.、Paradise, J.(2018)。Public Health Preparedness & Response: An Exercise in Administrative Law。The DePaul Journal of Health Care Law,20(2),(1)1-(1)21。  new window
18.Borah, R.(2020)。Every Minute Matters: Improving the Regulatory Response to Vaccine Development During a Public Health Emergency。Food and Drug Law Journal,75(2),311-345。  new window
19.Coglianese, C.(20200420)。Obligation Alleviation During the COVID-19 Crisis。Regulatory Review。  new window
20.Coglianese, C.、Scheffler, G.、Walters, D. E.(2021)。Unrules。Stanford Law Review,73(4),885-967。  new window
21.Eyal, N.(2020)。Why Challenge Trials of SARS-CoV-2 Vaccines Could Be Ethical Despite Risk of Severe Adverse Events。Ethics & Human Research,42(4),24-34。  new window
22.Eyal, N.、Lipsitch, M.、Smith, P. G.(2020)。Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure。The Journal of Infectious Diseases,221(11),1752-1756。  new window
23.Flore, E. F.、Frontera, W. R.、Andrasik, M. P.、Rio, C.、Mondriguez-Gonzâlez, A.、Price, S. A.、Krantz, E. M.、Pergam, S. A.、Silver, J. K.(2021)。Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials。JAMA Network Open,4(2),(e2037640)1-(e2037640)11。  new window
24.Friesen, P.、Caplan, A. L.、Miller, J. E.(2021)。COVID-19 Vaccine Research and the Trouble with Clinical Equipoise。Lancet,397(10274)。  new window
25.Ganz, D. J.(2020)。Reconsidering Discretion in Expedited Vaccine Approval in Light of the Novel Coronavirus。University of Illinois Law Review Online,2020,203-220。  new window
26.Wiley, L. F.、Bagenstos, S. R.(2020)。The Personal Responsibility Pandemic: Centering Solidarity in Public Health and Employment Law。Arizona State Law Journal,52(4),1235-1302。  new window
27.Witt, J. F.(20200330)。The Law of Salus Populi: Epidemics and the Law。Yale Review。  new window
28.Yearby, R.、Mohapatra, S.(2020)。Law, Structural Racism, and the COVID-19 Pandemic。Journal of Law and the Biosciences,7(1),(lsaa036)1-(lsaa036)20。  new window
29.Sturgis, P.、Brunton-Smith, I.、Jackson, J.(2021)。Trust in Science, Social Consensus and Vaccine Confidence。Nature Human Behaviour,5,1528-1534。  new window
30.Walsh, Daniel(2021)。COVID-19: A Crisis and an Opportunity to Improve the Emergency Use Authorization Process。Minnesota Journal of Law, Science & Technology,22(2),169-220。  new window
31.Whelan, A. M.(2021)。Unequal Representation: Women in Clinical Research。Cornell Law Review Online,106(3),87-128。  new window
32.WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation(2021)。Placebo-Controlled Trials of Covid-19 Vaccines: Why We Still Need Them。New England Journal of Medicine,384(2),(e2)1-(e2)3。  new window
33.Sherwin, B. D.(2021)。Anatomy of a Conspiracy Theory: Law, Politics, and Science Denialism in the Era of COVID-19。Texas A&M Law Review,8(3),537-582。  new window
34.Solbakk, Jan Helge、Bentzen, Heidi Beate、Holm, Søren、Heggestad, Anne Kari Tolo、Hofmann, Bjørn、Robertsen, Annette、Alnæs, Anne Hambro、Cox, Shereen、Pedersen, Reidar、Bernabe, Rose(2021)。Back to WHAT? The Role of Research Ethics in Pandemic Times。Medicine, Health Care and Philosophy,24(1),3-20。  new window
35.Steel, R.、Buchak, L.、Eyal, N.(2020)。Why Continuing Uncertainties Are No Reason to Postpone Challenge Trials for Coronavirus Vaccines。Journal of Medical Ethics,46(12),808-812。  new window
36.Steinzor, R.(20200914)。The pandemic's toll on science。Regulatory Review。  new window
37.Plotkin, S. A.、Caplan, A.(2020)。Extraordinary Diseases Require Extraordinary Solutions。Vaccine,35(24),3987-3988。  new window
38.Reiss, D. R.(2020)。The COVID-19 Vaccine Dilemma。The Administrative Law Review Accord,6(1),49-83。  new window
39.Rizzi, M.(2020)。The Road to a Vaccine for COVID-19: Regulatory and Policy Infrastructure, Incentives and Obstacles。European Pharmaceutical Law Review,4(2),98-103。  new window
40.Shah, Anand、Marks, Peter W.、Hahn, Stephen M.(2020)。Unwavering Regulatory Safeguards for COVID-19 Vaccines。JAMA,324(10),931-932。  new window
41.Gouglas, D.、Le, T. T.、Henderson, K.、Kaloudis, A.、Danielsen, T.、Hammersland, N. C.、Robinson, J. M.、Heaton, P. M.、Rottingen, J.(2018)。Estimating the Cost of Vaccine Development Against Epidemic Infectious Diseases: a Cost Minimisation Study。The Lancet Global Health,6(12),e1386-e1396。  new window
42.Grady, C.(2004)。Ethics of Vaccine Research。Nature Immunology,5(5),465-468。  new window
43.Hermes, C.、Wethington, N.(2020)。Balancing Hope and Proof: Investigational Products During the COVID-19 Pandemic。Health Lawyer,33(2),6-9。  new window
44.Hodge, J. G.、Piatt, J. L.、Reinke, H. N.、Carey, E.(2021)。COVID's Constitutional Conundrum: Assessing Individual Rights in Public Health Emergencies。Tennessee Law Review,88(1)。  new window
45.Hsu, N. S.、Hendriks, S.、Ramos, K. M.、Grady, C.(2021)。Ethical Considerations of COVID-19-Related Adjustments to Clinical Research。Nature Medicine,27(2),191-193。  new window
46.Johnson, E. E.、Bailey, T. C.(2020)。Legal Lessons from a Very Fast Problem: COVID-19。Stanford Law Review Online,73,89-103。  new window
47.Karako-Eyal, N.(2019)。Beyond the Ethical Boundaries of Solidarity: Increasing Vaccination Rates Through Mandatory Education to Solidarity。Texas A&M Law Review,6(2),345-390。  new window
48.Krammer, F.(2020)。SARS-CoV-2 Vaccines in Development。Nature,586(7830),516-527。  new window
49.Largent, E. A.(2016)。EBOLA and FDA: Reviewing the Response to the 2014 Outbreak, to Find Lessons for the Future。Journal of Law and the Biosciences,3(3),489-537。  new window
50.Lin, Ching-Fu、Wu, Chien-Huei、Wu, Chuan-Feng(2020)。Reimagining the Administrative State in Times of Global Health Crisis: An Anatomy of Taiwan's Regulatory Actions in Response to the COVID-19 Pandemic。European Journal of Risk Regulation,11(S2),256-272。  new window
51.Lee, K.、Eyal, N.(20210513)。Do Controlled Human Infection Studies Put Bystanders at Higher Risk Than Conventional Field Trials?。Journal of Medical Ethics。  new window
52.London, Alex John、Kimmelman, Jonathan(2020)。Against pandemic research exceptionalism。Science,368(6490),476-477。  new window
53.Nguyen, X.(2021)。Contract as Emergency Law。Washington International Law Journal,30(3),420-469。  new window
54.Paradise, J.、Bavlsik, B.(2021)。Pandemic Politics, Public Health, and the FDA。Belmont Law Review,8(2),301-341。  new window
55.Lynch, H. F.、Joffe, S.、McCoy, M. S.(2021)。The Limits of Acceptable Political Influence over the FDA。Nature Medicine,27(2),188-190。  new window
56.Lynch, H. F.、Dickert, N. W.、Zettler, P. J.、Joffe, S.、Largent, E. A.(2020)。Regulatory Flexibility for COVID-19 Research。Journal of Law and the Biosciences,7(1),(lsaa057)1-(lsaa057)10。  new window
57.Lurie, N.、Cramer, J. P.、Hatchett, R. J.(2021)。The Vaccine Revolution: How mRNA Can Stop the Next Pandemic Before It Starts。Foreign Affairs,100(3),128-135。  new window
58.陳嘉新(20200600)。防疫共同體的生命政治。臺灣社會學刊,67,237+239-246。new window  延伸查詢new window
59.吳秦雯(20200600)。從SARS到COVID-19:司法院釋字第690號解釋架構下之傳染病防治法制與基本權限制。法律與生命科學,9(1),91-112。new window  延伸查詢new window
研究報告
1.Lynch, H. F.、Darton, T.、Largent, E. A.、Levy, J.、McCormick, F.、Ogbogu, U.、Payne, R.、Roth, A. E.、Shah, A. J.、Smiley, T.(2020)。Ethical Payment to Participants in Human Infection Challenge Studies, With a Focus on Sars-Cov-2: Report and Recommendations。  new window
圖書
1.National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research(1978)。The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research。  new window
2.Prainsack, Barbara、Buyx, Alena(2011)。Solidarity: Reflections on an Emerging Concept in Bioethics。Nuffield Council on Bioethics。  new window
3.Gostin, Lawrence O.、Wiley, Lindsay F.、蘇玉菊、劉碧波、穆冠群、劉汗曦(2019)。公共衛生法:權力、責任、限制。元照。  延伸查詢new window
4.Allen, D.、Stanczyk, L.、Cohen, I. G.、Shachar, C.、Sethi, R.、Weyl, G.、Brooks, R.(2020)。Securing Justice, Health, and Democracy Against the Covid-19 Threat。Edmond J. Safra Center for Ethics。  new window
5.Cammet, M.、Lieberman, E.(2020)。Building Solidarity: Challenges, Options, and Implications for Covid-19 Responses。  new window
6.Council for International Organizations of Medical Sciences(2016)。International Ethical Guidelines for Health-Related Research Involving Humans。CIOMS。  new window
7.Gostin, L. O.(2010)。Public Health Law and Ethics: A Reader。University of California Press。  new window
8.National Academies of Sciences, Engineering, and Medicine(2017)。Integrating Clinical Research into Epidemic Response: the Ebola Experience。The National Academies Press。  new window
9.Nuffield Council on Bioethics(2020)。Research in Global Health Emergencies: Ethical Issues。Nuffield Council on Bioethics。  new window
其他
1.Chang, Wen-Chen(20200321)。Taiwan's Fight against COVID-19: Constitutionalism, Laws, and the Global Pandemic,https://verfassungsblog.de/taiwans-fight-against-covid-19-constitutionalism-laws-and-the-global-pandemic/。  new window
2.Brown, Beatrice(20201030)。Ethics of Emergency Use Authorization During the Pandemic,https://www.thehastingscenter.org/ethics-of-emergency-use-authorization-during-the-pandemic/。  new window
3.Chernoguz, J.(20200325)。Protecting Rights in a Global Crisis,https://today.law.harvard.edu/protecting-rights-in-a-global-crisis/。  new window
4.Ginsburg, T.,Versteeg, M.(2020)。States of Emergencies: Part I,https://harvardlawreview.org/blog/2020/04/states-of-emergencies-part-i/。  new window
5.Miller, F. G.(20201027)。Ethics of Placebo Controls in Coronavirus Vaccine Trials,https://www.thehastingscenter.org/ethics-of-placebo-controls-in-coronavirus-vaccine-trials/。  new window
6.Macklin, R.(20200615)。Human Challenge Studies for Covid-19 Vaccine: Questions About Benefits and Risks,https://www.thehastingscenter.org/human-challenge-studies-for-covid-19-vaccine-questions-about-benefits-and-risks/。  new window
圖書論文
1.Bayer, R.、Fairchild, A. L.(2010)。The Genesis of Public Health Ethics。Public Health Law and Ethics: A Reader。University of California Press。  new window
2.Callahan, D.、Jennings, B.(2010)。Ethics and Public Health: Forging a Strong Relationship。Public Health Law and Ethics: A Reader。University of California Press。  new window
3.Jennings, B.、Arras, J. D.(2016)。Ethical Aspects of Public Health Emergency Preparedness and Response。Emergency Ethics: Public Health Preparedness and Response。Oxford University Press。  new window
 
 
 
 
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