Parvizi Javad, Chakravarty Rajit, Og Bora, Rodriguez-Paez Adriana
Department of Orthopaedic Surgery, Rothman Institute of Orthopaedics, Thomas Jefferson University Hospital, Philadelphia, PA 19107, USA.
Injury. 2008 Jun;39(6):651-5. doi: 10.1016/j.injury.2008.02.010. Epub 2008 May 27.
Informed consent plays a pivotal role in human clinical research. It serves as a marker for the subject's comprehension of all the pertinent elements of the study. It is also a pledge by the investigator that during the trial, the rights and safety of the subject will be protected. Informed consent attempts to ensure that ethical behaviour will be upheld throughout the study. However, obtaining informed consent from certain vulnerable populations is a challenge, and thus warrants improvement. While informed consent is mandated for almost all clinical trial involving human subjects, there are situations of emergency research and trials with minimal risk that call for a waiver of the consent.
知情同意在人体临床研究中起着关键作用。它是受试者理解研究所有相关要素的标志。它也是研究者的一种承诺，即在试验期间，受试者的权利和安全将得到保护。知情同意旨在确保在整个研究过程中坚持道德行为。然而，从某些弱势群体中获得知情同意是一项挑战，因此需要改进。虽然几乎所有涉及人类受试者的临床试验都要求获得知情同意，但在紧急研究和风险极小的试验情况下，需要免除同意。
