A Census of Clinical Trials Conducted Under the US Exception from Informed Consent Rule

Krista L. Snyder, Jon F. Merz
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Abstract

Background The US Food and Drug Administration and National Institutes of Health adopted the Exception from Informed Consent (EFIC) rule in 1996, permitting waiver of informed consent for certain emergency research, including trials funded by the federal government. The rule requires that prospective consent be sought when practicable from patients or their Legally Authorized Representative(s) (LAR), and for those enrolled without consent, the patient or their LAR must be given information and an opportunity to opt-out from continued participation at the earliest opportunity. We sought to census the trials conducted under the EFIC rule to facilitate research to better understand how the rule is being used.
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在美国知情同意规则例外情况下进行的临床试验普查
美国食品和药物管理局和国家卫生研究院于1996年采用了知情同意例外(EFIC)规则,允许在某些紧急研究中放弃知情同意,包括联邦政府资助的试验。该规则规定,在切实可行的情况下,必须征求患者或其合法授权代表(LAR)的预期同意,对于未经同意而参加试验的患者或其合法授权代表,必须尽早向患者或其合法授权代表提供信息和选择退出继续参与的机会。我们试图对根据EFIC规则进行的试验进行普查,以促进研究,以便更好地了解该规则是如何使用的。
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