財務報酬對健康人參與人體研究之影響──國際文獻與質性訪談臺灣大學生之發現

The Effect of Financial Reward on Healthy Subjects’Participation in Human Subject Research: International Literature and Qualitative Research

國際上針對健康人參與第一期臨床試驗之動機研究顯示，財務誘因扮演重要角色。雖然適當補償參與者的付出與花費時間具有倫理上的正當性，不當的金錢報酬卻可能影響參與者的自願性，也有可能使受試者因為過度關注於財務報酬而使研究結果失真。近年來國內大學校園中招募健康參與者參與人體研究之情形日益普遍，為了解健康大學生參與人體研究的動機及財務報酬對大學生參與決策產生的影響，以及他們是否是在了解研究本質及潛在風險的情形下決定參與研究，本研究先透過系統性文獻回顧分析國際實證資料，再透過校園公開資訊及滾雪球方式招募大學部之學生進行半結構式訪談，並使用紮根理論之質性研究方法分析訪談資料。最終訪談14位大學生。訪談結果主要發現：受訪者參與研究之考量因素通常非單一，而最常被提及的動機為財務報酬、自我學習以及利他動機，且「自我學習」動機影響力與「財務報酬」相當；知情同意過程對受試者保護不足，受訪者對於自己所參與的研究並不完全了解，對風險之理解亦不足。建議倫理委員會綜合考量研究中不同情形，建立更明確的合理報酬標準，避免金錢成為受試者衡量是否參與的主要因素。除委員會事前審核招募廣告外，主管機關可針對研究者在校園中的招募活動進行查核，以受試者文件及受試者抽訪作為查核重點，並開設定期課程，促進研究社群的權利保護認知，善盡監管責任與義務。本研究規模較小，且受抽樣方法限制，未來可將社會中不同族群背景納入考量，針對不同種類的試驗擴大規模進行相關研究。

International studies about the motivation of healthy subjects’participation in phase 1 clinical trials have shown that financial incentives play an important role. While it is ethically justified to appropriately compensate participants for their efforts and time spend, improper financial remuneration may affect participants’voluntariness and may distort the results of research due to excessive attention to financial rewards. Recently, it has become more common for university to recruit healthy participants to participate in human subject research. In order to understand healthy college students’motivation to participate in research and how financial reward makes impact on their decision-making, and whether they understand the objectives and potential risks of research, this study first analyzed the international empirical data through systematic review. Then, recruited college students to conduct semi-structured interviews through campus public information and Snowball sampling, and use qualitative research method based on grounded theory to analyze the interview data. Finally, 14 college students were interviewed. The main findings of interviews were that the subjects’considerations for participating in the research were usually not single. The most commonly cited motivations were financial reward, self-learning and altruistic motivation, and the influence of ''self-learning'' motivation was comparable to that of ''financial reward''. The informed consent process was inadequately protective of participants, finding that they didn’t have sufficient understanding about the research and underlying risks. This article suggests that the ethics committee should comprehensively consider different situations of studies and establish a clearer reasonable remuneration standard, so as to avoid financial reward becoming the main factor for subjects to evaluate whether they participate. In addition to the committee's prior review of recruitment advertisements, the competent authority may conduct a review of recruitment activities on campus, focusing on subject documents and subject random interviews, and hold regular courses to promote the awareness of the rights protection of the research community and fulfill its regulatory responsibilities and obligations. The scale of this study was small and limited by sampling methods. Future research could scale up the backgrounds of different social groups and types of trials.