A Jurisprudential Study of the Human Subject Research : Focusing on Conflict of Interests

• Main Authors: Li, Hui-Chun, 李慧君
• Other Authors: 楊奕華
• Format: Others
• Language: zh-TW
• Published: 2013
• Online Access: http://ndltd.ncl.edu.tw/handle/85590495929021720224

碩士 === 東吳大學 === 法律學系 === 101 === Several disasters of human subject related researches were happened in the early twentieth century, such as Nazi concentration camps in Germany, unit 731 Japanese army in Northeast China, and Tuskegee syphilis study in Alabama, USA. Due to the scale and severity of these human subject researches, international organizations established several ethical principles, such as Nuremberg Code, Declaration of Helsinki, and The Belmont Report, as the foundation to establish formal regulations of human subject research. Three major ethical principles, such as respect for persons, beneficence, and justice, have been formed in The Belmont Report and used as the guidance for human subject research regulations. The purpose of establishing these ethical principles is to prohibit the reappearance of tragic human subject researches which were not protecting human welfare. The enforcement of obtaining testing human subject’s informed consent and reviewing process by independent Institutional Review Board (IRB) of human subject research study plan is expected to achieve the goal of human subject protection. Conflict of interests was defined as a set of conditions where the professional judgment related to primary interest might be unduly affected by a secondary interest. The primary interest in human subject research could be patient’s well-being or scientific study integrity. The secondary interest in human subject research could be from financial or non-financial aspect, such as the provided research funding from company to the research execution institution (financial aspect), or the gained reputation of researchers and publications after completing the study (non-financial aspect). Several parties are directly or indirectly involved in the human subject research process, and different parties might focus on protecting individual or institutional secondary interests while ignoring the primary interest of the scientific study such as human right protection of the testing human subjects or the integrity of scientific study. The final outcome of conflict of interests could end with a biased test result or the wrong impression of public against human subject research. This article defined the scope of human subject research under Taiwan’s regulations, described different stages of clinical researches with human subject during new drug development, explained the interest theory of Roscoe Pound’s theory, and discussed the conflict of interests during human subject research execution process, the three major ethical principles of conducting human subject research, and the IRB related regulation in the U.S.A. and Taiwan. Taking the established regulations of conflict of interest in public officials and other professionals as an example, it’s expected to establish general rules of regulations of human subject researches in the levels of institutional and individual conflict of interests involved. Independent conflict of interest committee is suggested to be established to deal with the complicated interests from different parties involved beyond the current IRB system for monitoring the possibility of unduly influence of the secondary interests from all parties. The regulation of waiver system of the IRB members is also suggested to be established for eliminating the possibility of inappropriate secondary interest influencing integrity of scientific study or patient’s well-being. In summary, the transparency of the information for the human subject research is a critical factor of protecting testing human subject’s rights.