世界醫療產業龍頭之一的美國於2017年就聯邦法規之受試者保護規範——共通規則完成修法、公告，並預計於2019年施行上路，本文將藉由詳細介紹修法前之共通規則、實務於實踐時遇到之阻礙、修法相關討論及最終之新修規範，並針對「修改告知後同意規定，以促進理解與充分告知」及「允許使用概括式同意」，此次修法中與告知後同意相關之二重要部分進行相關學理討論，以爬梳美國此次修法之脈絡。
最後嘗試借鏡美國之修法歷程並參酌學者之解決方案，提出對台灣現行規範體系與告知後同意相關之修改建議：（一）加強受試者同意書理解化、（二）於告知後同意過程提供理解輔助、（三）修改我人體研究相關法規之規範範圍、（四）新增告知後同意事項，期能使受試者權益保障與生物科技產業之蓬勃發展能和諧進行，亦使相關人員有所依循。

Since the United States completed the revision and announcement of the federal regulations on the subject protection – Common Rule in 2017, and is expected to be implemented in 2019, this article will introduce and analyze the Common Rule before the revision, the obstacles encountered in practice, the public's critique of the common rules, the final revision of the Common Rule, and the two important matters related to the revision : "Change of the informed consent process and elements ", “allow to use broad consent" for relevant academic discussions.
In the end, based on the discussion, this article tried to propose possible revision to the scheme of Taiwan's current regulatory system, and advice to add new elements that should be provided to subjects in the informed consent process.
This article hope that based on these discussion, the current Taiwan standard will be feasible, and can ensure the harmonious development of the biotechnology industry while protecting the right of the human subjects.

第一章 緒論 3
第一節 研究動機 3
第二節 研究目的 4
第三節 研究方法 6
第四節 研究範圍 6
第五節 論文章節架構 8
第二章 美國2019年前對於受試者保護之規範 9
第一節 近代人類受試者保護意識之興起 9
第一節 美國之「受試者保護」發展歷程 9
第二節 舊共通規則之規範內容 11
第一項 何類研究須受管制？—— 管制標的 11
第二項 機構審查委員會（IRB）之設立與職責 12
第三項 告知後同意事項（Informed Consent） 15
第四項 僅涉及「現存」數據或生物檢體之研究 16
第三章 美國新修共通規則於受試者保護之規範範圍 18
第一節 修法背景 18
第二節 2018年後新修之聯邦規範 20
第一項 定義之變革 20
第二項 管制標的 24
第四章 美國新修共通規則關於告知後同意之規範 30
第一節 重要事項記載於前 30
第一項 NPRM提案 30
第二項 公眾評論 31
第三項 新法內容與說明 32
第二節 新增告知事項 34
第一項 NPRM提案 34
第二項 公眾評論 35
第三項 新法內容與說明 35
第三節 允許使用「概括同意」 38
第一項 NPRM提案 39
第二項 公眾評論 40
第三項 新法內容與說明 41
第五章 告知後同意過程之缺失 44
第一節 治療誤解（therapeutic misconception） 44
第一項 「治療」與「人體試驗」之差異 44
第二項 治療誤解及其倫理問題 46
第二節 理解（comprehension）困難 47
第一項 實證研究 48
第二項 小結 50
第三節 資訊過剩（information overload） 50
第一項 資訊是否充足之爭論 50
第二項 實證研究 50
第三項 小結 51
第六章 對參與者之「間接」研究 52
第一節 遺傳與基因體研究之特性與其所造成之挑戰 52
第二節 蒐集和儲存生物檢體或私人訊息時應行之告知後同意 54
第三節 使用儲存的生物檢體或私人訊息進行研究之告知後同意 58
第四節 小結：同意應為繼續溝通的過程 61
第七章 我國之規範狀況與修法建議 63
第一節 規範範圍 63
第二節 告知後同意相關規範 66
第三節 問題與分析 71
第一項 規範範圍 71
第二項 告知後同意事項 72
第八章 代結論 - 告知後同意程序之改進與我國之修法建議 74
參考文獻 77

一、 英文文獻
(一) 書籍
 Ana Maria Rodríguez. 2006. Edward Jenner: Conqueror of Smallpox. USA: Enslow Publishers, Inc.
 Edward P. Richards & Jerry Menikoff. 2006. What the Doctor Didn't Say: The Hidden Truth About Medical Research. England: Oxford University Press.
 James F. Childress & Tom L. Beauchamp. 2001. Principles of Biomedical Ethics. England: Oxford University Press.

(二) 期刊文獻
 Aaronson, N. K. et al. 1996. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. Journal of Clinical Oncology. 14:984-996.
 Abdallath Daar, Ross EG Upshur & Tmothy Caulfield. 2003. DNA databanks and consent: a suggested policy option involving an authorization model. BMC medical ethics. , 4:1-4.
 Alastair Vincent Campbell, Christine E. Marx, Edimansyah Abdin, Yuen Yeng Ong, Mythily Subramaniam & Siow-Ann Chong. 2009. An assessment of the understanding and motivations of patients with schizophrenia about partici-pating in a clinical trial. Contemporary clinical trials. 30:446-450.
 Amy L. McGuire & Laura M. Beskow. 2010. Informed consent in genomics and genetic research. Annual review of genomics and human genetics. 11:361-381.
 Amy M. Medley. 2009. An intervention to improve cancer patients’ under-standing of early-phase clinical trials. Irb. 31:1-10.
 Amy, L. Corneli et al. 2012. Improving participant understanding of informed consent in an HIV-prevention clinical trial: a comparison of methods. AIDS and behavior. 16: 412-421.
 Ana Palacio, Erin N. Marcus, Leonardo Tamariz & Mauricio Robert. 2013. Improving the informed consent process for research subjects with low liter-acy: a systematic review. Journal of general internal medicine. 28:121-126.
 B. M.Knoppers, G.Cardinal, K. C. Glass & M. Deschenes. 2001. Human genetic research, DNA banking and consent: a question of ‘form’?. Clinical Genetics. 59:221-239.
 Ben Berkman, Christine Grady, Dan Brock, Lisa Eckstein, Robert Cook-Deegan & Stephanie M. Fullerton. 2015. Broad consent for research with biological samples: workshop conclusions. The America Journal of Bioethics. 15:34-42.
 Bert-Ove Olofsson et al. 2004. Informed consent and biobanks: a popula-tion-based study of attitudes towards tissue donation for genetic re-search. Scandinavian Journal of Public Health. 32:224-229.
 Cario Petrini. 2010. “Broad” consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose. Social science & medicine. 70:217-220.
 Charles Lidz, Loren H. Roth & Paul S. Appelbaum. 1982. The therapeutic mis-conception: informed consent in psychiatric research. International Journal of Law and Psychiatry. 5:319-329.
 Charles W. Lidz. 2006. The therapeutic misconception and our models of competency and informed consent. Behavioral Science & the Law. 24:535-546.
 Christine Grady & David Wendler. 2008. What should research participants understand to understand they are participants in research? Bioethics. 22:203-208.
 Christine Grady et al. 2015. Broad consent for research with biological sam-ples: workshop conclusions. The American Journal of Bioethics. 15:34-42.
 Christine Grady, Ezekiel Emanuel, Gabriella Bedarida, Leanne Stunkel, Lousie McLellan, Meredith Benson & Ninet Sinaii. 2010. Comprehension and in-formed consent: assessing the effect of a short consent form. IRB. 32:1-9.
 Claire Lammie, Carolyn J. Espie & Kate M. Davidson. 2011. Conducting ran-domised controlled trials: Finding better ways to explain research to people with anti‐social personality disorder who have low literacy levels. Criminal Behavior and Mental Health. 21:265-278.
 Claude M. Laberge & Bartha Maria Knoppers. 1995. Research and stored tis-sues: persons as sources, samples as persons? JAMA 274:1806-1807.
 Claus R. Bartram, Gert Helgesson, Joakim Dillner, Joyce A Carlson & Mats G Hansson. 2006. Should donors be allowed to give broad consent to future biobank research?. The lancent oncology. 7:266-269.
 David Shatz. 1990. Randomized clinical trials and the problem of suboptimal care: An overview of the controversy. Cancer Investigation. 8:191-205.
 David Waxman et al. 2008. Pleiotropic scaling of gene effects and the ‘cost of complexity’. Nature. 452:470-472.
 Dean A. Fergusson, Glyn Elwyn, Jamie C. Brehaut, Jonathan Kimmelman, Ka-veh G. Shojania & Raphael Saginur. 2010. Using decision aids may improve informed consent for research. Contemporary clinical trials. 31:218-220.
 Donald L. Rosenstein et al. 2005. Research with stored biological samples: what do research participants want?. Archive of Internal Medi-cine. 165:652-655.
 Doris Schroeder & Garrath Williams. 2004. Human genetic banking: altruism, benefit and consent. New Genetics and Society. 23:89-103.
 Elaine L. Larson, Elizabeth Gross Cohn, Haomiao Jia, Katherine Erwin & Win-ifred Chapman Smith. 2011. Measuring the process and quality of informed consent for clinical research: development and testing. Oncology Nursing Fo-rum. 38:417-422.
 Elizabeth Dean & Laura M. Beskow. 2008. Informed consent for bioreposito-ries: assessing prospective participants' understanding and opinions. Cancer Epidemiology and Prevention Biomarkers. 17:1440-1451.
 Ellen Wright Clayton & Kyle B. Brothers. 2012. Parental perspectives on a pe-diatric human non-subjects biobank. AJOB primary research. 3:21-29.
 Ellen Wright Clayton et al. 1995. Informed consent for genetic research on stored tissue samples. JAMA. 274:1786-1792.
 Emma Beardsley, Linda Mileshkin & Michael Jefford. 2007. Longer consent forms for clinical trials compromise patient understanding: so why are they lengthening?. Journal of Clinical Oncology. 25:13-14.
 Gustafsson Stolt U., Helgesson G., & Ludvigsson J. 2005. How to handle in-formed consent in longitudinal studies when participants have a limited un-derstanding of the study. Journal of Medical Ethics. 31:670-673.
 Harvey A. Taub& Marilyn T. Baker. 1983. The effect of repeated testing upon comprehension of informed consent materials by elderly volunteers. Experi-mental aging research. 9:135-138.
 Kristin J McLaughlin, Megan Prictor, Rebecca Ryan & Sophie Hill. 2008. Au-dio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Systematic Review. 1:13-17.
 Laura M. Beskow & Sondra J. Smolek. 2009. Prospective biorepository partici-pants' perspectives on access to research results. Journal of Empirical Re-search on Human Research Ethics. 4:99-111.
 Laura M. Pfeifer, Michael K. Paasche-Orlow & Timothy W. Bickmore. 2009. Using computer agents to explain medical documents to patients with low health literacy. Patient education and counseling.75:315-320.
 Mark R. Boshar, Phillip R. Reilly & Steven H. Holtzman. 1997. Ethical issues in genetic research: disclosure and informed consent. Nature genetics. 15:16-20.
 Patrick Taylor. 2008. Personal genomes: when consent gets in the way. Nature. 456:32-33.
 Peter M. Currie. 2005. Balancing privacy protections with efficient research: Institutional review boards and the use of certificates of confidentiality. IRB: Ethics & Human Research. 27:7-12.
 Robert J. Levine. 1991. Informed consent: some challenges to the universal validity of the Western model. The Journal of Law, Medicine & Ethics. 19:207-213.
 Sharona Hoffman. 2003. Regulating clinical research: informed consent, pri-vacy, and IRBs. Capital University Law Review. 31:71-95
 Timothy Caulfield. 2007. Biobanks and blanket consent: the proper place of the public good and public perception rationales. King’s Law Journal. 18:209-226.

(三) 行政資料
 HHS , Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the use of Three Burden-Reducing Provisions During the Delay Period, 83 Fed. Reg. 2849(June 19, 2018).
 HHS. Federal Policy for the Protection of Human Subjects, 82 Fed. Reg. 7149(January 19, 2017).
 HHS. Human Subjects Research Protections: Enhancing Protections for Re-search Subjects and Reducing Burden, Delay and Ambiguity for Investigators, 76 Fed. Reg. 45512 (July 26, 2011).
 HHS. Federal Policy for the Protection of Human Subjects, 80 Fed. Reg.53931 (September 8, 2015)

(四) 網站資料
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html (最後瀏覽日:2018/5/9)

二、中文文獻
(一) 書籍
 李震山（2001）。〈論生命科技與生命尊嚴〉，收錄於《人性尊嚴與人性保障》。台灣：元照出版股份有限公司。
 范建得等（2010）。《人體生物資料庫管理條例逐條釋義》，初版。新竹市：清大生倫中心。
 宮長為，鄭劍英 （主編）（2005）。《炎帝神農氏：中華遠古文明追索》。北京：中國文史出版社。

(二) 期刊文獻
 胡林英 (2006)。〈論臨床試驗中的治療性誤解及其對策〉，《醫學與哲學》，27卷2期，頁58-60。
 李美秀 (2010)。〈病人的兩難: 可否成为主治醫師研究計畫中的受试者〉，《中國醫學倫理學》，23卷1期，頁64-66。
 劉靜怡 (2008)。〈「以人為對象」的研究和倫理委員會─以美國法制下的「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期，頁201-274。
 曾育裕（2012）。〈人體試驗與個人資料保護〉，《醫療品質雜誌》，6卷1期，頁24-27。
 何建志、陳汝吟 (2012)。〈人體生物資料庫管理條例銷毀檢體之規定-法律疑義及溯及既往違憲問題〉，《醫事法學》，第18期，頁63-78。
 黃惠敏 (2013)，〈個人資料保護法於人體研究活動之適用〉，《萬國法律》，第188期，頁76-89。
1.

(三) 論文:
 李俊良(2015)。《論人體檢體生物醫學研究之管制體系─以委員會控核機制及研究倫理法律義務為核心》，國立臺灣大學法律學院法律學研究所碩士論文，臺北。
 莊豐濱（2013），《人體研究法之法理實務研究》，頁75，東吳大學法律學系碩士班在職專班法律專業組碩士論文，臺北。
 蕭弘毅（2007），《生物醫學人體試驗之管制－以人體試驗委員會為中心－》，國立台灣大學法律學院法律研究所碩士論文，臺北。

(四) 網站資料
 國家衛生研究院 (NHRI) 癌症研究組（2005），《臨床試驗病患教育手冊》。取自：http://sars.nhri.org.tw/publish/clinicaltrial_patienteducation.pdf(最後瀏覽日:2018/5/9)
 衛生福利部，「藥品臨床試驗受試者同意書格式範本」。詳見：https://www.mohw.gov.tw/cp-16-37368-1.html (最後瀏覽日:2018/6/29)

(五) 行政資料
 行政院衛生福利部受試者保護宣導手冊
 衛署醫字第1010064538號函
 衛署醫字第1010265083號函