The Informed Consent And Off-Label Use In Human Subject Research Of Clinical Treatment

• Main Authors: WANG, YI-CHEN, 王怡臻
• Other Authors: Yang, CHIH-CHIEH
• Format: Others
• Language: zh-TW
• Published: 2017
• Online Access: http://ndltd.ncl.edu.tw/handle/692rz2

碩士 === 國立雲林科技大學 === 科技法律研究所 === 105 === 　　Medical progress requires constant innovation and research, thus thus Human Subject Research Ethics becomes very important recently. Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers. Potential participants must be provided with information about the research project that is understandable and that permits them to make an informed and voluntary decision about whether or not to participate. The amount of information and the manner of presentation will vary depending on the complexity and risk involved in the research study. Informed consent is an ongoing educational interaction between the investigator and the research participant that continues throughout the study. 　　This requirement is founded on the principle of respect for persons, one of the three ethical principles governing human subjects research described in the Nuremberg Code, the Declaration of Helsinki, the Belmont report. The principle of respect for persons requires that individuals be treated as autonomous agents and that the rights and welfare of persons with diminished autonomy be appropriately protected. 　　In our study, we discuss substantive decisions as the research object, and collect judgments which are related to clinical Human Subject Research disputes related to the new therapy or therapy without proven indication (Off-Label Use) . 　　The aim of our review, while helpful to physician practice groups and hospitals, makes clear the responsibility of physicians to obtain informed consent and to ensure that this is a conscious part of practice routine.