受試者保護的歷史變遷【本期企劃】 試閱
Brief History of Human Subject Protection
以人為研究對象必然會對受試者造成傷害。如何在醫學進步和受試者傷害中取得平衡，是受試者保護相關人員永遠要面對的課題。過去歷史上為保護受試者所設立的IRB制度，雖然用意良善，但也造成部分研究人員的反彈。國內人體研究法之施行，讓IRB審查成為人體研究的法定程序之一。美國更新法規，則希望能「減少IRB不必要的工作」並「強化受試者保護」。國內的受試者保護工作應考慮東西文化差異，在做法上適當調整，以落實受試者保護工作。
The important of human subject protection cannot be over emphasized. Unethical research is common before National Research Act was implemented in 1974.However, the IRB system is endangered by excessive paperwork. Many complains come from research community such as over regulation and under protection of research subjects. Revised common rule was issued in 2017 to resolve these complains. Human subject protection in Taiwan was enforced by Human Subjects Research Act in 2011. However, the difference between Eastern and Western cultures did not well addressed in human subject protection practice. More academic and practical reflections are needed to improve human subject protection in Taiwan.
009-018
