Achieving new levels of recall in consent to research by combining remedial and motivational techniques.
Achieving new levels of recall in consent to research by combining remedial and motivational techniques.
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DOI：
10.1136/medethics-2012-101124
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发表时间：
2014-04
影响因子：
4.1
通讯作者：
Clements NT
中科院分区：
文献类型：
--
作者：
Festinger DS;Dugosh KL;Marlowe DB;Clements NT
研究支持补救性同意程序（纠正反馈）和动机性同意程序（激励）的有效性，以提高对研究知情同意的回忆。虽然这些策略在统计学上上级标准同意，但效果适中，无临床意义。本研究探讨了一个相结合的激励同意和纠正反馈，简化了认知任务，增加了学习同意信息的动机。我们将104名同意参与无关宿主研究的受试者随机分配到同意照常（CAU）条件（n = 52）或激励纠正反馈（ICF）条件（n = 52）。所有参与者都被告知，他们将在基线评估后和4个月的随访中接受关于同意回忆的询问。ICF参与者还被告知，他们将为每个正确的答案获得5美元，并根据需要获得更正的反馈。两种情况下的测验分数在第一次给药时没有差异（p = 0.39，d = 0.2），但后续每次给药时ICF评分显著更高（第二：p = 0.003，Cohen's d = 0.6;第三：p < 0.0001，d = 1.4;第四：p < 0.0001，d = 1.6;第五：p < 0.0001，d = 1.8。）ICF程序将同意回忆从72%增加到83%，而CAU条件下回忆从69%下降到59%。这支持了联合补救和动机同意程序的统计和临床效用，以增强研究信息的回忆和人类研究保护。
Research supports the efficacy of both a remedial consent procedure (corrected feedback) and a motivational consent procedure (incentives) for improving recall of informed consent to research. Although these strategies were statistically superior to standard consent, effects were modest and not clinically significant. This study examines a combined incentivized consent and corrected feedback that simplifies the cognitive task and increases motivation to learn consent information. We randomly assigned 104 individuals consenting to an unrelated host study to a consent as usual (CAU) condition (n = 52) or an incentivized corrected feedback (ICF) condition (n = 52). All participants were told they would be quizzed on their consent recall following their baseline assessment and at 4 monthly follow-ups. ICF participants were also informed that they would earn $5.00 for each correct answer and receive corrected feedback as needed. Quiz scores in the two conditions did not differ at the first administration (p = 0.39, d = 0.2), however ICF scores were significantly higher at each subsequent administration (second : p = 0.003, Cohen’s d = 0.6; third: p < 0.0001, d = 1.4; fourth: p < 0.0001, d = 1.6; fifth: p < 0.0001, d = 1.8.) The ICF procedure increased consent recall from 72% to 83%, compared to the CAU condition in which recall decreased from 69% to 59%. This supports the statistical and clinical utility of a combined remedial and motivational consent procedure for enhancing recall of study information and human research protections.