tailieunhanh - Báo cáo khoa học: "Bench-to-bedside review: Human subjects research – are more standards needed"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học Critical Care giúp cho các bạn có thêm kiến thức về ngành y học đề tài: Bench-to-bedside review: Human subjects research – are more standards needed? | Available online http content 10 6 244 Review Bench-to-bedside review Human subjects research - are more standards needed David T Huang1 and Mehrnaz Hadian2 1CRISMA Laboratory Department of Critical Care Medicine Department of Emergency Medicine University of Pittsburgh 641 Scaife Hall Pittsburgh PA 15261 USA 2Department of Critical Care Medicine University of Pittsburgh 641 Scaife Hall Pittsburgh PA 15261 USA Corresponding author David T Huang huangdt@ Published 15 December 2006 This article is online at http content 10 6 244 2006 BioMed Central Ltd Critical Care 2006 10 244 doi cc5114 Abstract There are many controversial issues surrounding ethics in study design and conduct of human subjects research. In this review we briefly touch on the origin of ethics in clinical research and how the current regulations and standards came into practice. We then discuss current controversies regarding informed consent conflicts of interest institutional review boards and other relevant issues such as innovative procedures and quality improvement projects. The question of whether we need more standards is a very important yet challenging one to which there is no simple answer. We address this question by reviewing and commenting on relevant literature. We conclude that what is needed are not more standards per se but rather refinement and uniformity of current standards and their interpretation and application both to protect human subjects and to advance medicine. Introduction Ethics and standards in human subjects research have long been controversial even after decades of debate experience and regulation. Most recently in February 2006 the US National Institutes of Health NIH announced several programs to address these issues 1 . Shortly after in March 2006 a British drug trial resulted in the hospitalization of six participants bringing new attention to the issue of standards in human subjects research 2 . Multiple questions .

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