近年來生技醫療產業蓬勃發展，臨床試驗需求日益增加，接受臨床試驗的民眾有越來越多的趨勢。受試者已不僅僅只有病人，因試驗設計的不同而有健康受試者的需求產生。受試者參加試驗的動機，一般而言，病人可以由使用新藥而得到醫療上的好處，但健康受試者大多是為了金錢報酬而參加試驗，甚至變成專業白老鼠，為此而產生許多的倫理爭議及討論。
本研究為了解台灣健康受試者參與臨床試驗的主要動機、認知及人格特質，並探討人口學變項及人格特質是否會影響受試者參與試驗的動機，以三家臨床試驗生技公司的健康受試者為研究樣本，進行問卷調查。共回收有效樣本196份，回收率98%，以百分比及次數分配說明受試者的認知與感受，再以單因子變異數分析及事後分析來了解各個人口學變項間動機的差異，最後以階層迴歸分析了解參與臨床試驗的動機與不同變數間的關聯性。
研究發現，健康受試者族群多為20-24歲的未婚男性，以大學在學學生居多。其人格特質在開放性、外向性及和善性屬偏高度傾向，嚴謹性屬中度傾向，神經質屬低度傾向。主要動機則以金錢報酬首要，其次是免費身體檢查，再者為朋友相約一起參加試驗。
在討論參與臨床試驗的主要動機與不同變項的相關性上，年齡愈大者，愈以免費身體檢查、促進科學及醫學發展為主要動機，愈不以朋友相約為主要動機；教育程度愈高者，愈不以朋友相約為主要動機；有職業工作者相對於學生較不易以促進科學發展為動機；平均月收入在10,000-19,999元的健康受試者相對於無收入者，較易以免費身體檢查、促進科學發展及好奇心為主要動機；參與次數越多者，愈以有其他動機為主，愈不以朋友相約為主要動機；和善性特質愈高者，愈以促進科學及醫學發展為主要動機。
健康受試者對參加臨床試驗的考量單一，最主要動機仍是金錢報酬，對試驗風險評估及自我健康的考量並非首要，未來在臨床試驗執行上，需事前加強受試者對自我身體健康的認知，並且做好事前說明及知情同意，在研究者收案時應針對受試者的健康狀況做更仔細的確認，以避免對健康受試者的健康造成傷害。

Due to the rapidly development in biomedical industry and the progressive needs in clinical trial, the clinical trial has remarkably increased during the past years. The composition of volunteers is not only included patients but also healthy subjects, which catered for the differences of research design of the trial. Thus, many ethical issues related to clinical trials have gained attention, particularly, the motivations of participating in clinical trials from healthy volunteers are crucial issue. The intention of the study is not only to understand the mainly motivation, perception and personality trait of healthy volunteers, but also to discuss the influence of demographic variables and personality trait on the motivation of volunteers participating clinical trials in Taiwan.
This study was a cross-sectional survey research. The study sample included 196 healthy volunteers from three different biomedical clinical trial companies. The self-administered questionnaire contained 15 questions. The internal consistency reliability (α) for the BFI scale was .789. One-way ANOVA and post-hoc analysis were used to examine the differences of the motivation in different demographic variables. In addition, hierarchical regression analysis was employed to investigate the determinants of different motivation.
The results of the study showed most of the healthy volunteers were single male undergraduate students with age 20-24. The types of personality, openness、extraversion and agreeableness, tended to be high tendentiousness. On the other hands, the subjects in neuroticism personality tended to be low tendentiousness. Moreover, the results showed the main motivation of the healthy volunteers is financial rewards, followed by free physical examination and the last is invitation by friends, respectively.
According to the results of the study, the relatedness between the motivation of participating clinical trials and different variables showed that the elder subjects considered the free physical examination and promoting scientific and medical development as the mainly motivation, and showed less concern of companion invitation. Also, the subjects with higher education concerned the invitation by companion as less priority. Comparing with students, the waged volunteers showed less consideration of promoting scientific and medical development as motivation. Moreover, the healthy volunteer with average income between 10,000 to 19,999 NT considered mostly free physical examination, promotion of scientific and medical development and curiosity as the main motivation for the trial. The more involved in clinical trial the more consideration of other motivation and less concern of the invitation by companion. Furthermore, the subjects with more agreeableness personality trait tend to be more consideration of promoting scientific and medical development as their mainly motivation.
In conclusion, the financial rewards is the priority consideration and shows remarkable influence to the motivation for the healthy volunteers, compared with the risk assessment and the consideration of personal health conditions. Thus, the clinical trials companies should balance between the rewards and health conditions. Particularly, the understandable and fully explanation as well informed consent before any trial implementation are necessary. Moreover, the researcher should be carefully concern about the health condition enrolling volunteers, in order to prevent the volunteer form harm.

論文審定書 I
誌 謝 II
摘 要 III
ABSTRACT V
目 錄 VII
圖 次 IX
表 次 IX
第一章 緒論 1
第一節 研究背景及動機 1
第二節 研究目的 3
第二章 文獻查證 4
第一節 健康受試者 4
第二節 臨床試驗 6
第三節 受試者參與臨床試驗原因 8
一、 參與臨床試驗的原因 8
二、 專業白老鼠現象 9
三、 臨床試驗補償給付與倫理考量 10
四、 應該給付多少才合理 13
五、 小結 14
第四節 受試者知情同意及受試者同意書 16
第五節 受試者臨床試驗資訊來源、受試者認知及決策行為 19
一、 臨床試驗資訊來源 19
二、 受試者的認知與決策行為過程 20
第六節 五大人格特質與健康受試者的人格特質 22
一、 五大人格特質 22
二、 健康受試者的人格特質及影響 23
第三章 研究方法 27
第一節 研究假設與架構 27
一、 研究假設 27
二、 研究架構 28
第二節 研究對象、資料收集程序與抽樣方法 29
一、 研究對象 29
二、 資料收集 29
第三節 研究工具問卷設計 31
一、 問卷編製過程 31
二、 研究變項的操作型定義 32
第四節 問卷信效度分析 38
一、 效度分析 38
二、 信度分析 38
第五節 資料處理與分析方法 40
一、 描述性統計分析 40
二、 推論性統計分析 40
第四章 研究分析與結果 41
第一節 描述性統計分析 41
一、 基本資料分析 41
二、 認知與感受問卷分析 43
三、 人格特質測量問卷分析 50
第二節 推論性統計分析 52
一、 基本變項、參與次數對臨床試驗參與主要動機之影響 52
二、 人格特質與參與臨床試驗主要動機的迴歸 55
第五章 討論與建議 72
第一節 研究討論 72
一、 健康受試者的人口學特性及人格特質 72
二、 健康受試者參與臨床試驗的認知與感受 72
三、 健康受試者參與臨床試驗主要動機 73
四、 健康受試者人格特質對參與臨床試驗動機的影響 75
第二節 研究限制 76
第三節 建議 77
參考文獻 79
一、 中文文獻 79
二、 英文文獻 82
附 錄 86
一、 人體試驗委員會核准同意函 86
二、 作者同意函 90
三、 「健康受試者參與臨床試驗問卷」問卷初稿(Version 1) 92
四、 「健康受試者參與臨床試驗問卷」正式問卷(Version 2) 98
五、 專家評定內容及調整題目選項內容 104
六、 專家效度問卷 108

一、 中文文獻
期刊文章
范玉玲、蔡嘉玲、林川州 (2001)。彰化地區大學生休閒參與及阻礙因素之研究。國立屏東商業技術學院學報，(3)，301-327。取自 http://tzyy-ling.leader.edu.tw/referance_article/net_leisure_activity/彰化地區大學生休閒參與及阻礙因素之研究.pdf
蔡甫昌 (2009)。醫學研究中之知情同意。臺灣醫學，13(3)，284-293。取自 http://www.airitilibrary.com/searchdetail.aspx?DocIDs=10281916-200905-13-3-284-293-a
黃政仁、林志六、陳恆德、王薏雯、廖宗志 (2007)。新藥臨床試驗受試者同意書現況分析。臺灣家庭醫學研究，5(2)，81-88。取自 http://www.airiti.com/ceps/ec/ecjnlarticleView.aspx?jnlcattype=1&jnlptype=5&jnltype=44&jnliid=4500&issueiid=79664&atliid=1503687
書籍
林宗鴻(譯) (2007a)。人格心理學 (原作者：Burger, J. M.)，[Personality]，(第3版)。台北市：新加坡商亞洲湯姆生國際出版。
林宗鴻(譯) (2007b)。第七章 特質學派：理論、應用與衡鑑。載於人格心理學 (原作者：Burger, J. M.)，[Personality]，(第3版，199-248頁)。台北市：新加坡商亞洲湯姆生國際出版.
葉光輝(譯) (2005)。第8章 特質論：五大因素特質模型與性格特質論之應用評估。載於性格心理學理論與研究(原作者：Pervin, L. A., Cervone, D., & John, O. P.)，[Personality: theory and research 9/E]，(第9版，307-360頁)。台北市：雙葉書廊。
王玫、王薏雯、江虹瑾、吳建華、李元鳳、汪徽五…蘇莉莉(2008)。新藥開發與臨床試驗 (第1版)。台北市：紅螞蟻圖書。
盧瑞芬、謝啓瑞(2000)。醫療經濟學 [Health Economics] (第1版)。台北市：學富文化。
研討會論文
周祝瑛(2005)。高學費 Vs.低學費：台灣地區大學生生活費調查研究。兩岸高等教育研討會，台北，淡江大學。1-10。取自
http://www3.nccu.edu.tw/~iaezcpc/Chinese%20Publications_研討會論文/高學費%20vs.低學費_renew.pdf
碩士論文
和綠華(2005)。「告知後同意」原則適用於人體試驗之研究 -以受試者自主權為核心-。(碩士，中原大學財經法律學系)。
陳立愷(2006)。知情同意之研究：以手術同意書為例。(碩士，東吳大學法律學系碩士在職專班法律專業組)。
法規及宣言
赫爾辛基宣言(2008)。取自http://www.e-pharm.info/content_pages/files_add/doc_arb/L01_9809101014.pdf
醫療法(1986)。取自
http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDAT01.asp?lsid=FL013534
藥品優良臨床試驗準則(2005b)。取自http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDAT01.asp?lsid=FL033502
藥品臨床試驗申請須知(2007)。取自
http://www.doh.gov.tw/ufile/doc/藥品臨床試驗申請須知9609.pdf
人體試驗管理辦法(2009a)。取自http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDAT01.asp?lsid=FL051384
藥品生體可用率及生體相等性試驗準則(2009b)。取自http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDAT01.asp?lsid=FL048497
雜誌文章
薛秀宜、陳利銘、洪佩圓(2006)。人格理論新紀元：人格五因素模式之測驗工具與其應用。研習資訊雙月刊，23(1)，109-118。取自 http://study.naer.edu.tw/UploadFilePath//dissertation/l023_01_17vol023_01_17.pdf
網頁資料
行政院衛生署(2005a)。建構生醫科技島新聞稿。擷取日期 2/18，2011，取自 http://www.stag.gov.tw/content/application/stag/common_info/guest-cnt-browse.php?vars=3e83390f4d53e535aa49b4af402dcbfc7a86bb827f86e932300403b9c5471096
行政院衛生署(2010)。衛生署臨床試驗與研究推動小組 台灣生醫科技島。擷取日期2/18，2011，取自 http://science.doh.gov.tw/cectr/island.htm


 
二、 英文文獻
期刊文章
Almeida, L., Azevedo, B., Nunes, T., Vaz-da-Silva, M., & Soares-da-Silva, P. (2007). Why healthy subjects volunteer for phase I studies and how they perceive their participation? European Journal of Clinical Pharmacology, 63(11), 1085-1094. doi:10.1007/s00228-007-0368-3
Almeida, L., Coelho, R., Albino-Teixeira, A., & Soares-da-Silva, P. (2008). Adverse non-drug-related complaints by healthy volunteers in phase I studies compared to the healthy general population. International Journal of Clinical Pharmacology and Therapeutics, 46(11), 574-583. doi:10.5414/CPP46574
Almeida, L., Falcao, A., Coelho, R., Albino-Teixeira, A., & Soares-da-Silva, P. (2008). The role of socioeconomic conditions and psychological factors in the willingness to volunteer for phase I studies. Pharmaceutical Medicine, 22(6), 367-374. Retrieved from http://www.ingentaconnect.com/content/adis/phm/2008/00000022/00000006/art00007
Almeida, L., Falcao, A., Vaz-da-Silva, M., Coelho, R., Albino-Teixeira, A., & Soares-da-Silva, P. (2008). Personality characteristics of volunteers in phase 1 studies and likelihood of reporting adverse events. International Journal of Clinical Pharmacology and Therapeutics, 46(7), 340-348. doi:10.5414/CPP46340
Almeida, L., Kashdan, T. B., Coelho, R., Albino-Teixeira, A., & Soares-da-Silva, P. (2008). Healthy subjects volunteering for phase I studies: Influence of curiosity, exploratory tendencies and perceived self-efficacy. International Journal of Clinical Pharmacology and Therapeutics, 46(3), 109-118. doi:10.5414/CPP46109
Almeida, L., Kashdan, T. B., Nunes, T., Coelho, R., Albino-Teixeira, A., & Soares-da-Silva, P. (2008). Who volunteers for phase I clinical trials? influences of anxiety, social anxiety and depressive symptoms on self-selection and the reporting of adverse events. European Journal of Clinical Pharmacology, 64(6), 575-582. doi:10.1007/s0228-008-0468-8
Almeida, L., Vaz-da-Sliva, M., Coelho, R., Albino-Teixeira, A., & Soares-da-Silva, P. (2009). Interpersonal values of healthy subjects who volunteer for phase I clinical trials. Pharmaceutical Medicine, 23, 5(6), 299-303. Retrieved from http://www.ingentaconnect.com/content/adis/phm/2009/00000023/F0020005/art00010
Benet-Martinez, V., & John, O. P. (1998). Los cinco grandes across cultures and ethnic groups: Multitrait-multimethod analyses of the big five in spanish and english. Journal of Personality and Social Psychology, 75(3), 729-750. doi:10.1037//0022-3514.75.3.729
Bentley, J. P., & Thacker, P. G. (2004). The influence of risk and monetary payment on the research participation decision making process. Journal of Medical Ethics, 30(3), 293-298. doi:10.1136/jme.2002.001594
Bramstedt, K. A. (2007). Recruiting healthy volunteers for research participation via internet advertising. Clinical Medicine & Research, 5(2), 91-97. doi:10.3121/cmr.2007.718
Corrigan, O. (2003). Empty ethics: The problem with informed consent. Sociology of Health & Illness, 25(7), 768-792. doi:10.1046/j.1467-9566.2003.00369.x
Czarny, M. J., Kass, N. E., Flexner, C., Carson, K. A., Myers, R. K., & Fuchs, E. J. (2010). Payment to healthy volunteers in clinical research: The research subject's perspective. Clinical Pharmacology & Therapeutics, 87(3), 286-293. doi:10.1038/clpt.2009.222
Dickert, N., & Grady, C. (1999). What's the price of a research subject? approaches to payment for research participation. New England Journal of Medicine, 341(3), 198-203. Retrieved from http://www.nejm.org/doi/full/10.1056/NEJM199907153410312
Elliott, C., & Abadie, R. (2008). Exploiting a research underclass in phase 1 clinical trials. New England Journal of Medicine, 358(22), 2316-2317. doi:10.1056/NEJMp0801872
Ferguson, P. R. (2008). Clinical trials and healthy volunteers. Medical Law Review, 16(1), 23-51. doi:10.1093/medlaw/fwm020
Fortun, P., West, J., Chalkley, L., Shonde, A., & Hawkey, C. (2008). Recall of informed consent information by healthy volunteers in clinical trials. QJM, 101(8), 625-629. doi:10.1093/qjmed/hcn067
Grady, C. (2001). Money for research participation: Does it jeopardize informed consent? The American Journal of Bioethics, 1(2), 40-44. doi:10.1162/152651601300169031
Grady, C. (2005). Payment of clinical research subjects. Journal of Clinical Investigation, 115(7), 1681-1687. doi:10.1172/JCI25694
Jones, E., & Liddell, K. (2009). Should healthy volunteers in clinical trials be paid according to risk? yes. BMJ, 339 doi:10.1136/bmj.b4142
Kass, N. E., Myers, R., Fuchs, E. J., Carson, K. A., & Flexner, C. (2007). Balancing justice and autonomy in clinical research with healthy volunteers. Clinical Pharmacology & Therapeutics, 82(2), 219-227. doi:10.1038/sj.clpt.6100192
Lemmens, T., & Elliott, C. (1999). Guinea pigs on the payroll: The ethics of paying research subjects. Accountability in Research, 7(1), 3-20. doi:10.1080/08989629908573939
Pasqualetti, G., Gori, G., Blandizzi, C., & Del Tacca, M. (2010). Healthy volunteers and early phases of clinical experimentation. European Journal of Clinical Pharmacology, 7(66), 647-653. doi:10.1007/s00228-010-0827-0
Rabin, C., & Tabak, N. (2006). Healthy participants in phase I clinical trials: The quality of their decision to take part. Journal of Clinical Nursing, 15, 971-979. doi:10.1111/j.1365-2702.2006.01388.x
Resnik, D. B. (2005). Research participation and financial inducements. The American Journal of Bioethics, 1(2), 54-56. doi:10.1162/152651601300169112
Russell, M. L., Moralejo, D. G., & Burgess, E. D. (2000). Paying research subjects: Participants' perspectives. Journal of Medical Ethics, 26(2), 126-130. doi:10.1136/jme.26.2.126
Saunders, J. (2009). Should healthy volunteers in clinical trials be paid according to risk? no. BMJ, 339 doi:10.1136/bmj.b4145
Sears, J. M. (2001). Payment of research subjects: A broader perspective. The American Journal of Bioethics, 1(2), 66-67. doi:10.1162/152651601300169185
Stunkel, L., & Grady, C. (2011). More than the money: A review of the literature examining healthy volunteer motivations. Contemporary Clinical Trials, 32(3), 342-352. doi:10.1016/j.cct.2010.12.003
Tishler, C. L., & Bartholomae, S. (2002). The recruitment of normal healthy volunteers: A review of the literature on the use of financial incentives. The Journal of Clinical Pharmacology, 42(4), 365-375. doi:10.1177/00912700222011409
Tishler, C. L., & Bartholomae, S. (2003). Repeat participation among normal healthy research volunteers: Professional guinea pigs in clinical trials? Perspectives in Biology and Medicine, 46(4), 508-520. doi:10.1353/pbm.2003.0094
Tishler, C. L., Bartholomae, S., & Rhodes, A. R. (2005). Personality profiles of normal healthy research volunteers: A potential concern for clinical drug trial investigators? Medical Hypotheses, 65(1), 1-7. doi:10.1016/j.mehy.2005.01.018
Zink, S. (2001). Maybe we should pay them more. The American Journal of Bioethics, 1(2), 88. doi:10.1162/152651601300169220
書籍
John, O. P., Donahue, E. M., & Kentle, R. L. (1991). The big five inventory (Versions 4a and 54 ed.). Berkeley: University of California: Berkeley, Institute of Personality and Social Research.
John, O. P., Naumann, L. P., & Soto, C. J. (2008). Paradigm shift to the integrative big-five trait taxonomy: History, measurement, and conceptual issues. In O. P. John, R. W. Robins & L. A. Pervin (Eds.), Handbook of personality: Theory and research (pp. 114-158). New York, NY: Guilford Press.
雜誌文章
Belinda, L. (2010, Sep 6). Do we need $75,000 a year to be happy? TIME, Retrieved from http://www.time.com/time/business/article/0,8599,2016291,00.html
Elliott, C. (2008, Jan 7). Guinea-pigging: Healthy human subjects for drug safety trials are in demand. but is it a living? New Yorker (New York, N.Y.: 1925), 83(42), 36-41. Retrieved from http://www.newyorker.com/reporting/2008/01/07/080107fa_fact_elliott