一项观察性毒理学研究的选择退出设计,涉及在舞蹈音乐活动中醉酒的患者

Q2 Social Sciences
Paul Calle, Peter Blanckaert, Sabine Lemoyne, Robert Rubens
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引用次数: 0

摘要

在2013年至2015年比利时的电子舞曲活动中,当主治医生确定他们需要静脉注射治疗时,看似中毒的患者在未经知情同意的情况下被纳入一项观察性毒理学研究。所有纳入的患者都收到一封信息信,邀请他们联系首席研究员(PI)以获取有关研究的更多信息和/或告知PI他们希望被排除在研究之外。总共有238名患者被纳入研究。9名参与者(4%)自行或通过父母回复了信息信;他们中没有人要求被排除在研究之外。所有受访者都对他们收到的信息表示感谢。选择退出研究的设计似乎是可以接受的病人-参与者,它提供了一个更全面的图片与药物有关的医疗事故在这样的音乐活动中比可能通过一个研究,只包括那些明确选择参加。这些发现可能有助于机构审查委员会在评估涉及娱乐性药物使用的研究设计时,特别是在电子舞曲活动中。然而,我们警告不要将其推断到其他难以获得知情同意的环境。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Opt-Out Design for an Observational Toxicology Study Involving Intoxicated Patients at a Dance Music Event

At electronic dance music events in Belgium in 2013 to 2015, seemingly intoxicated patients were included without their informed consent in an observational toxicology study when the attending physicians determined that they needed treatment with an intravenous line. All included patients received an information letter inviting them to contact the principal investigator (PI) to obtain more information about the study and/or to inform the PI that they wanted to be excluded from it. Overall, 238 patients were included in the study. Nine participants (4%) responded to the information letter, either on their own or through their parent; none of them asked to be excluded from the study. All respondents expressed their gratitude for the information they received. The opt-out study design seemed to be acceptable to the patient-participants, and it provided a fuller picture of the drug-related medical incidents at such music events than what could likely be achieved through a study that includes only people who explicitly choose to participate. These findings may help institutional review boards when evaluating study designs involving recreational drug use, especially at electronic dance music events. Nevertheless, we warn against extrapolation to other settings where informed consent is difficult to obtain.

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来源期刊
Ethics & human research
Ethics & human research Social Sciences-Health (social science)
CiteScore
2.90
自引率
0.00%
发文量
35
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