Enrolling subjects by exception from consent versus proxy consent in trauma care research
Enrolling subjects by exception from consent versus proxy consent in trauma care research
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DOI：
10.1016/j.annemergmed.2007.08.021
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发表时间：
2008-04-01
影响因子：
6.2
通讯作者：
Kellermann, Arthur L.
中科院分区：
文献类型：
--
作者：
Wright, David W.;Clark, Pamela L.;Kellermann, Arthur L.
研究目的：对于临床研究，知情同意过程在保护人类受试者方面发挥着关键作用。在紧急研究中，如果干预涉及高度时间敏感的治疗，代理同意可能会造成重大延误，甚至使研究不可行。本研究的目的是比较所需的时间入组脑损伤的创伤患者在一项研究中与代理consent与exception from consent.Methods：我们分析了数据的临床试验（Progressive创伤性脑损伤的实验性临床治疗-ProTECT）的一个有前途的治疗急性脑损伤，使用代理同意受试者登记。将使用代理同意书（实际研究）的性能指标与假设进行研究（假设研究）时会发生的情况进行比较。的总人数和每月的入组率，平均时间从受伤开始的研究治疗，并接受不必要的治疗的任何跨度的时间的受试者人数进行了compared.Results：在30个月的招募期间，实际的研究累计100同意受试者（每月3.3）与122例受试者（每月4.1）的假设研究。平均时间从受伤开始的实验性治疗在实际研究中为379.2标准差118.0分钟，约6.3小时，与122分钟相比，在假设study.Conclusion：同意例外可以减少平均时间从受伤开始研究治疗创伤患者4小时或以上。对于时间紧迫的创伤护理干预，这种差异可能证明精心努力遵守最终规则是合理的。
Study objective: For clinical research, the consent process plays a critical role in protecting human subjects. In emergency research, proxy consent can impose substantial delays or even render a study infeasible if the intervention involves a highly time-sensitive treatment. The objective of this study is to compare the time required to enroll brain-injured trauma patients in a study with proxy consent versus exception from consent.Methods: We analyzed data from a clinical trial (Progesterone for Traumatic brain injury-Experimental Clinical Treatment-ProTECT) of a promising treatment for acute brain injury that used proxy consent for subject enrollment. Performance metrics using proxy consent (actual study) were compared to assumptions of what would have happened if the study had been conducted with exception from consent (hypothetical study). The total number and monthly rate of enrollees, mean time from injury to initiation of the study treatment, and number of subjects receiving unwanted treatment for any span of time were compared.Results: During the 30-month enrollment period, the actual study accrued 100 consenting subjects (3.3 per month) compared with 122 subjects (4.1 per month) for the hypothetical study. Mean time from injury to initiation of experimental treatment in the actual study was 379.2 standard deviation 118.0 minutes, approximately 6.3 hours, compared with 122 minutes in the hypothetical study.Conclusion: Exception from consent can reduce mean time from injury to initiation of study treatment of trauma patients by 4 hours or more. For a time-critical trauma care intervention, this difference may justify elaborate efforts to comply with the Final Rule.