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題名:生醫研究參與者對個別研究結果之近用--法律適用與政策形塑
書刊名:中研院法學期刊
作者:陳仲嶙 引用關係
作者(外文):Chen, Chung-lin
出版日期:2020
卷期:26
頁次:頁1-83
主題關鍵詞:結果提供研究發現偶然發現生物資料庫個人資料接近權分析有效性臨床價值治療誤解動態同意Return of resultsResearch findingsIncidental findingsBiobankRight of access to personal dataAnalytic validityClinical valueTherapeutic misconceptionDynamic consent
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  • 共同引用共同引用:137
  • 點閱點閱:3
期刊論文
1.Baker, C. Edwin(2004)。Autonomy and Informational Privacy, or Gossip: The Central Meaning of the First Amendment。Social Philosophy & Policy,21(2),215-268。  new window
2.陳起行(20001200)。資訊隱私權法理探討--以美國法為中心。政大法學評論,64,297-341。new window  延伸查詢new window
3.周慧蓮(20040100)。資訊隱私保護爭議之國際化。月旦法學,104,112-132。new window  延伸查詢new window
4.顏上詠(20090500)。臺灣人體生物資料庫管理條例草案評析。月旦法學,168,155-171。new window  延伸查詢new window
5.陳秀峯(20020300)。線上個人隱私之保護。月旦法學,82,208-216。new window  延伸查詢new window
6.洪子洵(20131200)。外國法與我國健保資訊應用之比較--以美國醫療保險可攜性及責任法(HIPAA)為鑑。醫事法學,20(2),28-45。new window  延伸查詢new window
7.葉俊榮(20160300)。探尋隱私權的空間意涵--大法官對基本權利的脈絡論證。中研院法學期刊,18,1-40。new window  延伸查詢new window
8.Murphy, Juli、Scott, Joan、Kaufman, David、Geller, Gail、LeRoy, Lisa、Hudson, Kathy(2008)。Public Expectations for Return of Results from Large-cohort Genetic Research。American Journal of Bioethics,8(11),36-43。  new window
9.McGeveran, William、Fatehi, Leili、McGarraugh, Pari(2012)。Deidentification and Reidentification in Returning Individual Findings from Biobank and Secondary Research: Regulatory Challenges and Models for Management。Minnesota Journal of Law, Science & Technology,13,485-539。  new window
10.Wolf, Susan M.、Branum, Rebecca、Koenig, Barbara A.、Petersen, Gloria M.、Berry, Susan A.、Beskow, Laura M.、Daly, Mary B.、Fernandez, Conrad V.、Green, Robert C.、LeRoy, Bonnie S.、Lindor, Noralane M.、O'Rourke, P. Pearl、Breitkopf, Carmen R.、Rothstein, Mark A.、Van Ness, Brian、Wilfond, Benjamin S.(2015)。Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations。Journal of Law, Medicine & Ethics,43(3),440-463。  new window
11.翁逸泓(20161200)。OTT發展之隱私與個人資料保護問題初探。世新法學,10(1),25-85。new window  延伸查詢new window
12.Budin-Ljøsne, Isabelle、Teare, Harriet J. A.、Kaye, Jane、Beck, Stephan、Bentzen, Heidi Beate、Caenazzo, Luciana、Collett, Clive、D'Abramo, Flavio、Felzmann, Heike、Finlay, Teresa、Javaid, Muhammad Kassim、Jones, Erica、Katić, Višnja、Simpson, Amy、Mascalzoni, Deborah(2017)。Dynamic Consent: A Potential Solution to Some of the Challenges of Modern Biomedical Research。BMC Medical Ethics,18(1),(4)1-(4)10。  new window
13.Clayton, Ellen Wright、McGuire, Amy L.(2012)。The Legal Risks of Returning Results of Genomics Research。Genetics in Medicine,14(4),473-477。  new window
14.Forsberg, Joanna Stjemschantz、Hansson, Mats G.、Eriksson, Stefan(2009)。Changing perspectives in biobank research: from individual rights to concerns about public health regarding the return of results。European Journal of Human Genetics,17(12),1544-1549。  new window
15.劉靜怡(20080900)。「以人為對象」的研究和研究倫理委員會--以美國法制下之「言論出版自由」與「思想研究自由」為論述核心。中研院法學期刊,3,201-274。new window  延伸查詢new window
16.邱文聰、莊惠凱(20101200)。建置當代人類研究倫理的治理架構:一個反身凝視的契機。人文與社會科學簡訊,12(1),33-39。  延伸查詢new window
17.張腕純(20190200)。個資保護與公共事務資料應用之權衡--歐盟GDPR公共利益歸檔、科學或歷史研究或統計之例外規定及英國之實踐。科技法律透析,31(2),17-27。  延伸查詢new window
18.劉靜怡(20190300)。淺談GDPR的國際衝擊及其可能因應之道。月旦法學,286,5-31。new window  延伸查詢new window
19.Alessi, Stephanie A.(2013)。The Return of Results in Genetic Testing: Who Owes What to Whom, When, and Why?。Hastings Law Journal,64,1697-1728。  new window
20.Allen, Nicole L.、Karlson, E. W.、Malspeis, S.、Lu, B.、Seidman, C. E.、Lehmann, L. S.(2014)。Biobank Participants' Preferences for Disclosure of Genetic Research Results: Perspectives from the Our Genes, Our Health, Our Community Project。Mayo Clinic Proceedings,89,738-746。  new window
21.Beskow, Laura M.、O'Rourke, P. Pearl(2015)。Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles。The Journal of Law, Medicine & Ethics,43,502-513。  new window
22.Beskow, Laura M.、Burke, W.、Fullerton, Stephanie M.、Sharp, Richard R.(2012)。Offering Aggregate Results to Participants in Genomic Research: Opportunities and Challenges。Genetics In Medicine,14,490-496。  new window
23.Branum, Rebecca、Wolf, Susan M.(2015)。International Policies on Sharing Genomic Research Results with Relatives: Approaches to Balancing Privacy with Access。The Journal of Law, Medicine & Ethics,43,576-593。  new window
24.Breitkopf, Carmen Radecki、Petersen, Gloria M.、Wolf, Susan M.、Chaffee, Kari G.、Robinson, Marguerite E.、Gordon, Deborah R.、Lindor, Noralane M.、Koenig, Barbara A.(2015)。Preferences Regarding Return of Genomic Results to Relatives of Research Participants, Including after Participant Death: Empirical Results from a Cancer Biobank。The Journal of Law, Medicine & Ethics,43,464-475。  new window
25.Cassa, Christopher A.、Savage, Sarah K.、Taylor, Patrick L.、Green, Robert C.、McGuire, Amy L.、Mandl, Kenneth D.(2012)。Disclosing Pathogenic Genetic Variants to Research Participants: Quantifying an Emerging Ethical Responsibility。Genome Research,22,421-428。  new window
26.Chan, Ben、Facio, Flavia M.、Eidem, Haley、Hull, Sara C.、Biesecker, Leslie G.、Berkman, Benjamin E.(2012)。Genomic Inheritances: Disclosing Individual Research Results from Whole-Exome Sequencing to Deceased Participants' Relatives。The American Journal of Bioethics,12(10),1-8。  new window
27.Chen, Chung-Lin(2009)。Reconciling Family Paternalism and Autonomy in Taiwan's Health Information Law。Australian Journal of Asian Law,11,247-272。  new window
28.Chen, Chung-Lin(2010)。In Search of a New Approach of Information Privacy Judicial Review: Interpretation No. 603 of Taiwan's Constitutional Court as a Guide。Indiana International and Comparative Law Review,20,21-46。  new window
29.Eckstein, Lisa、Garrett, J. R.、Berkman, B. E.(2014)。A Framework for Analyzing the Ethics of Disclosing Genetic Research Findings。The Journal of Law, Medicine & Ethics,42,190-207。  new window
30.Fabsitz, Richard R.、McGuire, Amy、Sharp, Richard R.、Puggal, Mona、Beskow, Laura M.、Biesecker, Leslie G.、Bookman, Ebony、Burke, Wylie、Burchard, Esteban Gonzalez、Church, George、Clayton, Ellen Wright、Eckfeldt, John H.、Fernandez, Conrad V.、Fisher, Rebecca、Fullerton, Stephanie M.、Gabriel, Stacey、Gachupin, Francine、James, Cynthia、Jarvik, Gail P.、Kittles, Rick、Leib, Jennifer R.、O'Donnell, Christopher、O'Rourke, P. Pearl、Rodriguez, Laura Lyman、Schully, Sheri D.、Shuldiner, Alan R.、Sze, Rebecca K. F.、Thakuria, Joseph V.、Wolf, Susan M.、Burke, Gregory L.、National Heart, Lung, and Blood Institute work(2010)。Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines from a National Heart, Lung, and Blood Institute Working Group。Circulation: Cardiovascular Genetics,3,574-580。  new window
31.Fernandez, Conrad V.、O'Rourke, P. Pearl、Beskow, Laura M.(2015)。Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families。The Journal of Law, Medicine & Ethics,43,514-522。  new window
32.Ferriere, Michael、Van Ness, B.(2012)。Return of Individual Research Results and Incidental Findings in the Clinical Trials Cooperative Group Setting。Genetics in Medicine,14,411-416。  new window
33.Green, Robert C.、Berg, Jonathan S.、Berry, Gerard T.、Biesecker, Leslie G.、Dimmock, David P.、Evans, James P.、Grody, Wayne W.、Hegde, Madhuri R.、Kalia, Sarah、Korf, Bruce R.、Krantz, Ian、McGuire, Amy L.、Miller, David T.、Murray, Michael F.、Nussbaum, Robert L.、Plon, Sharon E.、Rehm, Heidi L.、Jacob, Howard J.(2012)。Exploring Concordance and Discordance for Return of Incidental Findings from Clinical Sequencing。Genetics in Medicine,14,405-410。  new window
34.Henderson, Gail E.、Churchill, Larry R.、Davis, Arlene M.、Easter, Michele M.、Grady, Christine、Joffe, Steven、Kass, Nancy、King, Nancy M. P.、Lidz, Charles W.、Miller, Franklin G.、Nelson, Daniel K.、Peppercorn, Jeffrey、Rothschild, Barbra Bluestone、Sankar, Pamela、Wilfond, Benjamin S.、Zimmer, Catherine R.(2007)。Clinical Trials and Medical Care: Defining the Therapeutic Misconception。PLoS Medicine,4(11),1735-1738。  new window
35.Henderson, Gail E.、Wolf, Susan M.、Kuczynski, Kristine J.、Joffe, Steven、Sharp, Richard R.、Parsons, D. Williams、Knoppers, Bartha M.、Yu, Joon-Ho、Appelbaum, Paul S.(2014)。The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations。The Journal of Law, Medicine & Ethics,42,344-355。  new window
36.Henry, Leslie Meltzer(2006)。Undesirable Implications of Disclosing Individual Genetic Results to Research Participants。The American Journal of Bioethics,6(6),28-30。  new window
37.Hens, Kristien、Nys, H.、Cassiman, J. J.、Dierickx, K.(2011)。The Return of Individual Research Findings in Paediatric Genetic Research。Journal of Medical Ethics,37,179-183。  new window
38.Jarvik, Gail P.、Amendola, Laura M.、Berg, Jonathan S.、Brothers, Kyle、Clayton, Ellen W.、Chung, Wendy、Evans, Barbara J.、Evans, James P.、Fullerton, Stephanie M.、Gallego, Carlos J.、Garrison, Nanibaa A.、Gray, Stacy W.、Holm, Ingrid A.、Kullo, Iftikhar J.、Lehmann, Lisa S.、McCarty, Cathy、Prows, Cynthia A.、Rehm, Heidi L.、Sharp, Richard R.、Salama, Joseph、Sanderson, Saskia、Van Driest, Sara L.、Williams, Marc S.、Wolf, Susan M.、Wolf, Wendy A.、eMERGE Act-ROR Committee、CERC Committee、CSER Act-ROR Working Group、Burke, W.(2014)。Return of Genomic Results to Research Participants: The Floor, the Ceiling, and the Choices in Between。The American Journal of Human Genetics,94,818-826。  new window
39.Johns, Amber L.、Miller, D. K.、Simpson, S. H.、Gill, A. J.、Kassahn, K. S.、Humphris, J. L.、Samra, J. S.、Tucker, K.、Andrews, L.、Chang, D. K.、Waddell, N.、Pajic, M.、Pearson, J. V.、Grimmond, S. M.、Biankin, A. V.、Zeps, N.(2014)。Returning Individual Research Results for Genome Sequences of Pancreatic Cancer。Genome Medicine,6(42),1-8。  new window
40.Kaye, Jane、Kanellopoulou, N.、Hawkins, N.、Gowans, H.、Curren, L.、Melham, K.(2014)。Can I Access My Personal Genome? The Current Legal Position in the UK。Medical Law Review,22,64-86。  new window
41.Knoppers, Bartha Maria(2014)。From the Right to Know to the Right Not to Know。The Journal of Law, Medicine & Ethics,42,6-10。  new window
42.Knoppers, Bartha Maria、Dam, Amy(2011)。Return of Results: Towards a Lexicon?。The Journal of Law, Medicine & Ethics,39,577-582。  new window
43.Knoppers, Bartha Maria、Deschênes, Mylène、Zawati, Ma'n H.、Tassé, Anne M.(2013)。Population Studies: Return of Research Results and Incidental Findings Policy Statement。European Journal of Human Genetics,21,245-247。  new window
44.Lévesque, Emmanuelle、Yann, Joly、Jacques, Simard(2011)。Return of Research Results: General Principles and International Perspectives。The Journal of Law, Medicine & Ethics,39,583-592。  new window
45.Maschke, Karen J.(2012)。Returning Genetic Research Results: Considerations for Existing No-Return and Future Biobanks。Minnesota Journal of Law, Science & Technology,13,559-573。  new window
46.Middleton, Anna、Morley, Katherine I.、Bragin, Eugene、Firth, Helen V.、Hurles, Matthew E.、Wright, Caroline F.、Parker, Michael、The Deciphering Developmental Disorders study(2016)。Attitudes of Nearly 7000 Health Professionals, Genomic Researchers and Publics toward the Return of Incidental Results from Sequencing Research。European Journal of Human Genetics,24,21-29。  new window
47.Ortiz-Osorno, Alberto (Betto)、Ehler, Linda A.、Brooks, Judith(2015)。Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research。The Journal of Law, Medicine & Ethics,43,619-632。  new window
48.Parker, Lisa S.(2012)。Returning Individual Research Results: What Role Should People's Preferences Play?。Minnesota Journal of Law, Science & Technology,13,449-484。  new window
49.Petersen, Gloria M.、Van Ness, B.(2015)。Returning a Research Participant's Genomic Results to Relatives: Perspectives from Managers of Two Distinct Research Biobanks。The Journal of Law, Medicine & Ethics,43,523-528。  new window
50.Pike, Elizabeth R.、Rothenberg, Karen H.、Berkman, Benjamin E.(2014)。Finding Fault? Exploring Legal Duties to Return Incidental Findings in Genomic Research。The Georgetown Law Journal,102,795-843。  new window
51.Prince, Anya E. R.、Conley, John M.、Davis, Arlene M.、Lázaro-Muñoz, Gabriel、Cadigan, R. Jean(2015)。Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?。The Journal of Law, Medicine & Ethics,43,827-842。  new window
52.Ramoni, Rachel B.、McGuire, A. L.、Robinson, J. O.、Morley, D. S.、Plon, S. E.、Joffe, S.(2013)。Experiences and Attitudes of Genome Investigators Regarding Return of Individual Genetic Test Results。Genetics in Medicine,15,882-887。  new window
53.Renegar, Gaile、Webster, Christopher J.、Stuerzebecher, Steffen、Harty, Lea、Ide, Susan E.、Balkite, Beth、Rogalski-Salter, Taryn A.、Cohen, N.、Spear, Brian B.、Barnes, Diane M.、Brazell, Celia(2006)。Returning Genetic Research Results to Individuals: Points-to-Consider。Bioethics,20,24-36。  new window
54.Scholtes, Emily(2016)。Note, Incorporating Cost into the Return of Incidental Findings Calculus: Defining a Responsible Default for Genetics and Genomics Researchers。Minnesota Law Review,100,1171-1208。  new window
55.Scollon, Sarah、Bergstrom, K.、McCullough, L. B.、McGuire, A. L.、Gutierrez, S.、Kerstein, R.、Parsons, D. W.、Plon, S. E.(2015)。Pediatric Cancer Genetics Research and an Evolving Preventive Ethics Approach for Return of Results after Death of the Subject。The Journal of Law, Medicine & Ethics,43,529-537。  new window
56.Steinsbekk, Kristin Solum、Myskja, B. Kåre、Solberg, Berge(2013)。Broad Consent versus Dynamic Consent in Biobank Research: Is Passive Participation an Ethical Problem?。European Journal of Human Genetics,21,897-902。  new window
57.Tassé, Anne Marie(2011)。The Return of Results of Deceased Research Participants。The Journal of Law, Medicine & Ethics,39,621-630。  new window
58.Wolf, Susan M.(2012)。The Past, Present, and Future of the Debate over Return of Research Results and Incidental Findings。Genetics in Medicine,14,355-357。  new window
59.Wolf, Susan M.、Crock, Brittney N.、Van Ness, Brian、Lawrenz, Frances、Kahn, Jeffrey P.、Beskow, Laura M.、Cho, Mildred K.、Christman, Michael F.、Green, Robert C.、Hall, Ralph、Illes, Judy、Keane, Moira、Knoppers, Bartha M.、Koenig, Barbara A.、Kohane, Isaac S.、Leroy, Bonnie、Maschke, Karen J.、McGeveran, William、Ossorio, Pilar、Parker, Lisa S.、Petersen, Gloria M.、Richardson, Henry S.、Scott, Joan A.、Terry, Sharon F.、Wilfond, Benjamin S.、Wolf, Wendy A.(2012)。Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets。Genetics in Medicine,14,361-384。  new window
60.Wolf, Susan M.、Lawrenz, Frances P.、Nelson, Charles A.、Kahn, Jeffrey P.、Cho, Mildred K.、Clayton, Ellen W.、Fletcher, Joel G.、Georgieff, Michael K.、Hammerschmidt, Dale、Hudson, Kathy、Illes, Judy、Kapur, Vivek、Keane, Moira A.、Koenig, Barbara A.、Leroy, Bonnie S.、McFarland, Elizabeth G.、Paradise, Jordan、Parker, Lisa S.、Terry, Sharon F.、Van Ness, Brian、Wilfond, Benjamin S.(2008)。Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations。The Journal of Law, Medicine & Ethics,36,219-248。  new window
61.Zawati, Ma'n H.、Knoppers, Bartha Maria(2012)。International Normative Perspectives on the Return of Individual Research Results and Incidental Findings in Genomic Biobanks。Genetics in Medicine,14,484-489。  new window
62.李建良(20050800)。「戶籍法第八條捺指紋規定」釋憲案鑑定意見書。臺灣本土法學雜誌,73,38-56。  延伸查詢new window
63.邱文聰(20090500)。從資訊自決與資訊隱私的概念區分--評「電腦處理個人資料保護法修正草案」的結構性問題。月旦法學,168,172-189。new window  延伸查詢new window
學位論文
1.洪敏瑜(2009)。醫學研究中告知後同意之法律意涵(碩士論文)。國立清華大學。  延伸查詢new window
2.賴羿慈(2017)。個人資料保護法制中研究例外規定之比較分析(碩士論文)。國立清華大學。  延伸查詢new window
圖書
1.Laurie, Graeme(2002)。Genetic Privacy: A Challenge to Medico- Legal Norms。Cambridge University Press。  new window
2.Solove, Daniel J.(2004)。The Digital Person: Technology and Privacy in the Information Age。New York University Press。  new window
3.Solove, Daniel J.、Rotenberg, Marc(2003)。Information Privacy Law。Aspen Law & Business。  new window
4.Allen, Anita L.(2011)。Privacy Law and Society。Eagan, MN:West Academic Publishing。  new window
5.Boddington, Paula(2012)。Ethical Challenges in Genomics Research: A Guide to Understanding Ethics in Context。Berlin:Springer-Verlag GmbH。  new window
6.Glenn, R. A.(2003)。The Right to Privacy: Rights and Liberties under the Law。Santa Barbara, CA:Abc-clio。  new window
7.National Academies of Sciences, Engineering, and Medicine(2018)。Returning Individual Research Results to Participants: Guidance for a New Research Paradigm。Washington, D.C.:The National Academies Press。  new window
8.Turkington, Richard C.、Allen, Anita L.(2002)。Privacy Law: Cases and Materials。St. Paul, MN:West Group。  new window
9.李惠宗(2012)。憲法要義。元照。  延伸查詢new window
10.Alan, F. W.(1967)。Privacy and Freedom。New York:Atheneum。  new window
其他
1.United Nations Educational Scientific and Cultural Organization(20031016)。International Declaration on Human Genetic Data,http://portal.unesco.org/en/ev.php-URL_ID=17720&URL_DO=DO_TOPIC&URL_SECTION=201.html。  new window
2.Organization for Economic Co-operation and Development(1980)。OECD guidelines on the protection of privacy and transborder flows of personal data,https://www.oecd.org/sti/ieconomy/oecdguidelinesontheprotectionofprivacyandtransborderflowsofpersonaldata.htm。  new window
3.Asia-Pacific Economic Cooperation(2005)。APEC Privacy Framework,http://publications.apec.org/publication-detail.php?pub_id=390, 。  new window
4.National Institutes of Health(2018)。All of Us Research Program Protocol,https://allofus.nih.gov/about/all-us-research-program-protocol, 。  new window
5.Food and Drug Administration(2005)。Guidance for Industry: Pharmacogenomic Data Submissions,http://www.fda.gov/cder/genomics/regulatory.htm, 。  new window
6.National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research(1979)。The Belmont Report,https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html。  new window
7.National Institutes of Health(2004)。Clinical Research and the HIPAA Privacy Rule,https://privacyruleandresearch.nih.gov/pdf/clin_research.pdf,(04-5495)。  new window
8.Organization for Economic Cooperation and Development(2009)。Guidelines on Human Biobanks and Genetic Research Databases,https://www.oecd.org/sti/biotech/44054609.pdf。  new window
9.Organization for Economic Cooperation and Development(2013)。The OECD Privacy Guidelines,http://www.oecd.org/sti/ieconomy/oecd_privacy_framework.pdf。  new window
10.Precision Medicine Initiative (PMI) Working Group(2015)。The Precision Medicine Initiative Cohort Program--Building a Research Foundation for 21st Century Medicine,https://www.nih.gov/sites/default/files/research-training/initiatives/pmi/pmi-workinggroup-report-20150917-2.pdf。  new window
圖書論文
1.陳春生(2006)。事實行為。行政法。元照。  延伸查詢new window
2.陳仲嶙(2002)。隱私權概念的理解與充填。台灣憲法之縱剖橫切。臺北:元照。new window  延伸查詢new window
3.林子儀(2002)。基因資訊與基因隱私權--從保障隱私權的觀點論基因資訊的利用與法的規制。當代公法新論(中):翁岳生教授七秩誕辰祝壽論文集。臺北:元照。new window  延伸查詢new window
4.李震山(1997)。論資訊自決權。現代國家與憲法--李鴻禧教授六秩華誕祝賀論文集。臺北:月旦出版公司。  延伸查詢new window
5.Reiser, Stanley Joel(2002)。The Ethics Movement in the Biological and Health Sciences: A New Voyage of Discovery。The Ethical Dimensions of the Biological and Health Sciences。Cambridge, MA:Cambridge University Press。  new window
6.黃昭元(2005)。無指紋則無身分證?:換發國民身分證與強制全民捺指紋的憲法爭議分析。民主、人權、正義:蘇俊雄教授七秩華誕祝壽論文集。元照。  延伸查詢new window
 
 
 
 
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