Eyadhy Ayman Al, Razack Saleem
Pediatric Intensive Care Unit, Department of Pediatrics, King Khalid University Hospital, Riyadh, Saudi Arabia.
Paediatr Child Health. 2008 Mar;13(3):181-4. doi: 10.1093/pch/13.3.181.
An innovative therapy is a newly introduced or modified therapy with unproven effect or side effect, and is undertaken in the best interest of the patient. The ethical use of innovative therapies has been controversial. In paediatrics, the conflict between withholding potential rescue therapy and protecting a vulnerable population's rights and welfare must be considered. Therefore, it is necessary to ensure that this innovation is conducted within an ethical framework that recognizes that the therapy is not standard. This should integrate the patient's autonomy, the role of the institution, professional consensus and innovation evaluation. Innovative therapy represents a justifiable departure from inferior conventional therapy in the absence of an accepted standard therapy. Innovation shares with research its experimental nature, but differs from research in its goal and context that exempts innovative therapy from direct governance by research ethics board. Innovative therapy is part of the continuum of hypothesis generation in the advancement of medical knowledge, and its evaluation is a transforming point for clinical research.
创新疗法是一种新引入或经过改良的疗法，其疗效或副作用尚未得到证实，且是为患者的最大利益而采用的。创新疗法的伦理应用一直存在争议。在儿科领域，必须考虑在 withholding 潜在的抢救疗法与保护弱势群体的权利和福利之间的冲突。因此，有必要确保这种创新是在一个认识到该疗法并非标准疗法的伦理框架内进行的。这应整合患者的自主权、机构的作用、专业共识和创新评估。在没有公认的标准疗法的情况下，创新疗法代表着从劣质的传统疗法中合理偏离。创新疗法与研究一样具有实验性质，但其目标和背景与研究不同，这使得创新疗法不受研究伦理委员会的直接监管。创新疗法是医学知识进步中假设生成连续体的一部分，其评估是临床研究的一个转折点。
