Weisse Allen B
Department of Medicine, UMDNJ-New Jersey Medical School, Springfield, NJ 07081, USA.
Perspect Biol Med. 2009 Summer;52(3):435-41. doi: 10.1353/pbm.0.0100.
The need to ensure the maximal safety of patients participating in clinical research has led to a number of regulations and oversight measures. None of these has had a more profound effect on the way such research is carried out in the United States than the establishment of the Institutional Review Board (IRB) system. While the individual rights of patients must be respected and confidentiality assured, such official scrutiny may actually inhibit the ability of physicians to initiate and conduct clinical research, thus defeating, at times, the very purpose of this research: the ultimate improvement in patient care. The experiences of one physician attempting to operate under this system and later taking part in administering it as an IRB member may offer some insights into both positive and negative aspects of the system.
确保参与临床研究的患者获得最大安全保障的需求催生了一系列法规和监督措施。在美国，这些措施中没有哪一项比机构审查委员会（IRB）制度的建立对这类研究的开展方式产生的影响更为深远。虽然患者的个人权利必须得到尊重，保密性也必须得到保证，但这种官方审查实际上可能会抑制医生发起和开展临床研究的能力，从而有时会违背这项研究的根本目的：最终改善患者护理。一位医生在这个系统下开展工作，后来又作为IRB成员参与管理该系统的经历，可能会为该系统的积极和消极方面提供一些见解。
