Brody B A, Katz J, Dula A
Hastings Cent Rep. 1997 Jan-Feb;27(1):7; discussion 7-12.
The Food and Drug Administration (FDA) is amending its current informed consent regulations to permit harmonization of the Department of Health and Human Services' (DHHS) policies on emergency research and to reduce confusion on when such research can proceed without obtaining an individual subject's informed consent. This regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. FDA is taking this action in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.
美国食品药品监督管理局（FDA）正在修订其现行的知情同意规定，以实现卫生与公众服务部（DHHS）关于紧急研究政策的协调统一，并减少在何种情况下此类研究无需获得个体受试者的知情同意即可进行的混乱情况。本规定为在启动实验性干预之前从每位人类受试者或其法定授权代表处获得并记录知情同意的要求提供了一个狭义的例外。该例外适用于一类有限的涉及人类受试者的研究活动，这些受试者需要紧急医疗干预，但由于其危及生命的医疗状况而无法给予知情同意，且没有法定授权人员代表他们。FDA采取这一行动是为了回应越来越多的担忧，即当前的规则使得高质量的急性护理研究活动在对这类研究的需求日益得到认可的时候变得难以开展或无法进行。
