Nancy M. P. King, J.D., is Professor in the Department of Social Sciences and Health Policy and the Institute for Regenerative Medicine at Wake Forest School of Medicine, and Co-Directer of the Graduate Program in Bioethics and the Center for Bioethics, Health, and Society at Wake Forest University, in Winston-Salem, NC. Her scholarly work addresses a range of bioethics issues, focusing principally on interesting and persistent uncertainties and controversies attendant upon the intersections and transitions between clinical research and medical care.
J Law Med Ethics. 2019 Jun;47(2):203-212. doi: 10.1177/1073110519857276.
Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly "common" in 1991. This change, the addition of a "key information" requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals - which have remained aspirational since the beginning - may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime.
知情同意在临床研究中被广泛认为是有缺陷的，但却是必不可少的。最近一次对其进行改革的尝试是对《通用规则》进行的首次修订的一部分，该规则自 1991 年真正“通用”以来首次进行修订。这一变化，即对大多数知情同意书增加“关键信息”要求，旨在通过潜在的受试者来支持和促进合理的决策过程。关键信息要求既有希望又有问题。它有希望是因为它鼓励对研究参与的清晰和诚实，信息披露的创造性，以及通过研究者-受试者关系进行的相互学习。它有问题是因为这些目标（自一开始就是理想的）可能难以在已经成为过度以合规为导向的监管制度的环境中实现。
