A Study on Research Ethics of Medical Institutes in Taiwan – Focused on Human Subject Research

• Main Authors: Yu-Chien Huang, 黃于虔
• Other Authors: Ying-Chun Li
• Format: Others
• Language: zh-TW
• Published: 2011
• Online Access: http://ndltd.ncl.edu.tw/handle/25159602181579918389

碩士 === 國立中山大學 === 醫務管理研究所 === 99 === The purpose of this study is to discover the relationship between the specifications of medical institutes, FERCAP (Forum for Ethical Review Committees in Asia and the Western Pacific), TJCHA IRB Accreditation (Taiwan Joint Commission on Hospital Accreditation, TJCHA) and the practice of IRBs. By using questionnaires, and comparing the differences between all these medical institutes, we would have the information Research Ethics and the differentials in all the medical institutes. In this study, 268 completed questionnaires to the most southern region (64.7%), Medical Center (66.4%), physicians (36.9%), research assistants (21.3%), nurses (14.6%) and so on. About 60％ can answer correctly of the knowledge of Human Research Ethics. We found that different medical institutions (Medical Centers and non-medical centers) and distinction (north, south and other regions) score differences in terms of cognition, in "human trials testing program information must be saved after three years", "IRB memberlist should be submitted to DOH", "study of individual or group characteristics or behavior (such as feeling, cognition, motivation, identity, language, communication, cultural beliefs or habits and social behavior, etc.) is expetided review " and "IRB membership and minutes should be open" have significantly difference (p <0.05). Also, we need to pay attention that only 30％ of IRB members and staff have correct answer of "IRB memberlist should be submitted to DOH". Medical Centers and non-medical centers score differences in terms of attitude, in 「unit IRB that the information provided sufficient for you to understand the operation of the IRB」,「IRB promote education in human trials of great help to the project execution」,「IRB review process can focus on the implementation of the risk-benefit plans to provide specific advice」 and 「you are familiar with the regulations of the Department of Health 【such as GCP, Medical Law and Research collected by the human body provides】」have significantly difference (p <0.05). And expect the future to have further information for health policy evaluation and questionnaire data will be cross-comparison analysis of human trials to confirm the operation of the Board to provide further quality assurance and the IRB timely help.