臺灣博碩士論文加值系統

醫學之進步立基於科學研究，而以人為對象的研究最重要的考量便是倫理。人體試驗委員會（Institutional Review Board, IRB）負責人體研究受試者保護的任務。在審查人體研究計畫時，主要是考量尊重自主、善益與正義等基本倫理原則。雖然這些原則在每次IRB會議或訓練課程中都一再強調，但對於IRB委員如何在審查人體研究計畫時進行風險與效益的評估卻知之不詳。因此本研究利用一個心理學研究的案例計畫及問卷探討IRB委員於審查人體研究計畫時進行風險與效益評估過程。
案例計畫與問卷發放給16個經FERCAP認證過的IRB 的 321位委員，共回收了119份完整回答的問卷，回收率為37.1%。針對這個特殊的案例計畫，有較多的IRB委員認為風險比效益大。他們對於風險的考量是以受試者参加研究時的個人風險為主；而他們考慮的效益則是著重在社會層面對於未來病人的效益。風險等級的評量以及IRB委員自己或家人是否會參與該研究與風險效益評估有關。風險效益評估的結果又與對該案例計畫審查結果的建議有顯著關聯。風險效益評估加上風險等級的評量最能正確預測對研究計畫作倫理審查的結果。

Medical progress is based on the evidences from scientific researches. For the researches involving human subjects, ethical issues are the most important concerns. The mission of Institutional Review Board (IRB) is to protect human subjects in researches. The main considerations in reviewing such research protocols are basic ethical principles including respect for persons, beneficence, and justice. While these principles are emphasized and reminded in every IRB meeting and training course, there is little knowledge about how an IRB member makes risk/benefit assessment when he/she is reviewing a research protocol. This study intended to look into the process of risk/benefit assessment of IRB members by asking them to review an example psychological protocol and to complete a questionnaire.
Of 321 IRB members of 16 FERCAP authenticated IRB’s, 119 members completed questionnaires and returned with the response rate of 37.1%. For this particular example protocol, more IRB members thought the risks are greater than the benefits. The risks they were concerned about are mainly personal risks for a subject to participate in the study; whereas the benefits they considered are benefits of social aspect for future patients. Risk grading and whether the IRB member himself or his family member would participate in this research are associated with risk/benefit assessment. The result of risk/benefit assessment is significantly related to the suggestion to the approval of the protocol. Using both risk/benefit assessment and risk grading can best predict the result of ethical review of a research protocol.

目 錄Ⅰ
表目錄Ⅲ
圖目錄Ⅳ
附錄目錄Ⅶ
中文摘要Ⅷ
英文摘要Ⅸ
第一章 緒論1
第一節 研究背景1
第二節 研究動機及重要性4
第三節 研究目的6
第二章 文獻探討7
第一節 人體試驗委員會之發展背景7
第二節 我國人體試驗之相關規範9
第三節 IRB委員審查計畫案之倫理原則12
第三章 研究方法16
第一節 研究架構16
第二節 研究問題18
第三節 研究假設20
第四節 研究對象21
第五節 研究工具24
第六節 研究變項操作型定義31
第七節 進行步驟與資料收集37
第八節 資料處理與統計分析40
第四章 研究結果43
第一節 IRB委員依據風險效益之倫理原則，對案例計畫之評估50
第二節 IRB委員依據尊重自主之倫理原則，對案例計畫之評估81
第三節 IRB委員對案例計畫初審結果之建議83
第四節 探討案例計畫審查相關資訊的關係107
第五節 IRB委員審查之相關教育訓練資訊109
第五章 討論115
第一節 IRB委員審查風險效益之倫理原則115
第二節 IRB委員審查尊重自主之倫理原則119
第三節 審查時間120
第四節 風險效益原則與初審建議之結果不一致122
第五節 研究限制123
第六章 結論與建議124
第一節 結論124
第二節 建議126
參考文獻130

英文文獻
1.Beecher HK (1966) Ethics and Clinical Research. The New England Journal of Medicine. 274:1354-60.
2.De Vries R, DeBruin DA & Goodgame A. (2004). Ethics review of social, behavioral, and economic research: where should we fo from here? Ethics & Behavior. 14:4:351-368.
3.Kodish E, Stocking C, Ratain MJ, Kohrman A & Siegler M. (1992) Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons. Journal of Clinical Oncology. 10:11:1810-1816.
4.Lo B & Groman M. (2003) Oversight of quality improvement: focusing on benefits and risks. Archives of Internal Medicine. 163:23: 1481-1486.
5.Martin DK, Meslin EM, Kohut N & Singer PA. (1995) The incommensurability of research risks and benefits: practical help for research ethics committees. IRB: Ethics and Human Research. 17:2:8-10.
6.Miller PB & Weijer C. (2004) When are research risks reasonable in relation to anticipated benefits? Nature Medicine. 10:6:570-573.
7.Musschenga AW, van Luijn HEM, Keus RB & Aaronson NK. (2007) Are risks and benefits of oncological research protocols both incommensurable and incompensable? Accountability in Research. 14:179-196.
8.Reynolds D. (2000). Protecting the human subjects of social science research--the role of institutional review boards. Bioethics Forum. 16:4:31-36.
9.Shah S, Whittle A, Wilfond B, Gensler G & Wendler D. (2004) How do institutional review boards apply the Federal risk and benefit standards for pediatric research? JAMA. 291(4):476-482.
10.van Luijn HEM, Musschenga AW, Keus RB, Robinson WM & Aaronson NK. (2002). Assessment of the risk/benefit ratio of phase II cancer clinical trials by Institutional Review Board (IRB) members. Annals of Oncology. 13: 1307-1313.
11.van Luijn HEM, Aaronson NK, Keus RB & Musschenga AW. (2006). The evaluation of the risks and benefits of phase II cancer clinical trials by institutional review board (IRB) members: a case study. Jounal of Medical Ethics. 32: 170-176.
12.van Luijn HEM, Musschenga AW, Keus RB & Aaronson NK. (2007). Evaluating the Risks and Benefits of Phase II and III cancer clinical trials: A Look at Institutional Review Board Members in the Netherlands. IRB: Ethics and Human Research. 29:1:13-18.

網頁
1.Belmont Report (n.d.). Retrieved June 11, 2010, from http;//ohrp.osophs.dhhs.gov/humansubjects/guidance/Belmont.htm
2.CITI (n.d.). Assessing Risk in Social and Behavioral Sciences. Retrieved May 14, 2010, from https://www.citiprogram.org/members/learnersII/moduletext.asp?strKeyID=01F2CC5B-226E-430A-BF15-7AFCADF51387-5963514&module=503
3.Code of Federal Regulations Title 45 Part 46 (n.d.). Retrieved June 21, 2010, from http;//ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm
4.Guideline for Good Clinical Practice (n.d.). Retrieved May 7, 2010, from www.emea.eu.int/pdfs/human/ich/013595en.pdf
5.HA Linstone, M Turoff. (2002) The Delphi Method:Techniques and Applications. Retrieved July 14, 2010, from http://is.njit.edu/pubs/delphibook/
6.The Declaration of Helsinki. (n.d.). Retrieved June 11, 2010, from http://www.wma.net/e/ethicsunit/helsinki.htm
7.The Nuremberg Code Retrieved June 11, 2010, http://www.hhs.gov/ohrp/references/nurcode.htm

中文文獻
1.行政院國家科學委員會（2009），國家科學技術發展計畫（民國98 年至101 年）
2.林志六（2000），人體基因治療規範機制之研究－以機構內審查制度為中心－，臺灣大學法律學研究所碩士論文。
3.陳玉寧（1996），醫院評鑑對醫療品質之影響，高雄醫學院公共衛生學研究所碩士論文。
4.張永源（2006）社會與行為科學之風險評估，「受試者應有的權益及法規」研討會

法規
1.醫療法 總統華總一義字第5913號令公布，1986.11.24；總統華總一義字第 09800125131 號令修正公布，98.5.20
2.醫療法施行細則 衛署醫字第 674946 號令公布，1987.8.7；衛署醫字第 0990260760 號令修正發布，99.3.12
3.醫療機構人體試驗委員會組織及作業基準 衛署醫字第0920202507號令發布，92.11.12
4.藥品優良臨床試驗準則 衛署藥字第0930338510號令發布，94.1.6
5.醫療機構人體試驗委員會得快速審查之案件範圍 衛署醫字第0940218247號，95.2.3
6.人體試驗管理辦法 衛署醫字第 0980263557號令發布，98.12.14
7.人體生物資料庫管理條例 總統華總一義字第09900022481號令公布，99.2.3