Initial experience using the Food and Drug Administration guidelines for emergency research without consent
Initial experience using the Food and Drug Administration guidelines for emergency research without consent
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DOI：
10.1016/s0196-0644(99)70399-9
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发表时间：
1999-02-01
影响因子：
6.2
通讯作者：
Gregg, L
中科院分区：
文献类型：
--
作者：
Kremers, MS;Whisnant, DR;Gregg, L
从1996年11月6日开始，美国食品药品监督管理局法规21 CFR 50.24允许在有限的情况下未经同意进行研究，同时要求以社区咨询和披露的形式对患者进行额外的保护。我们在多中心背心心肺复苏方案中报告了我们遵守这些法规的经验，这是根据这一新规定进行的第一项研究器械研究。我们发现在解释社区咨询的要求方面存在不确定性。接受未经同意的研究的各方之间暴露于此协议的变化，但无论是医生还是外行公众表示重大保留意见。协商过程费时、费力，而且费用相对较高。对社区咨询标准的进一步澄清和关于这一重要主题的额外对话将有助于促进心肺复苏的额外研究。
Beginning November 6, 1996, Food and Drug Administration regulation 21 CFR 50.24 has allowed research without consent in limited circumstances while requiring additional patient protection in the form of community consultation and disclosure. We report our experience in complying with these regulations in Multicenter Vest CPR protocol, the first investigational device study done under this new ruling. We found uncertainty in interpretation of the requirements for community consultation. The acceptance of research without consent varied among the parties exposed to this protocol, but neither physicians nor the lay public expressed major reservations. The consultation process was time-consuming, demanding, and relatively costly. Further clarification of the community consultation standard and additional dialogue on this important topic will help to foster additional research in cardiopulmonary resuscitation.