Prentice E D, Gordon B G, Lin M H
University of Nebraska Medical Center, Omaha 68198-6810, USA.
J Extra Corpor Technol. 1997 Jun;29(2):88-91.
The boundary between therapy and research may at times be difficult to distinguish, and it is, therefore, important for health care professionals to recognize when a clinical activity should be properly classified as research. Research may be subject to federal regulations which require advance review and approval by an Institutional Review Board (IRB) in order to protect the rights and welfare of patients who serve as human subjects. This paper will discuss the criteria health care professionals can use to distinguish between therapy, innovative therapy, and therapeutic or clinical research.
治疗与研究之间的界限有时可能难以区分，因此，医疗保健专业人员认识到何时一项临床活动应被恰当地归类为研究非常重要。研究可能要遵循联邦法规，这些法规要求由机构审查委员会（IRB）进行预先审查和批准，以保护作为人类受试者的患者的权利和福利。本文将讨论医疗保健专业人员可用于区分治疗、创新治疗以及治疗性或临床研究的标准。
