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Emergency medical service providers' attitudes andexperiences regarding enrolling patients in clinical research trials

机译：紧急医疗服务提供者在招募患者参加临床研究试验中的态度和经验

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Objective: The purpose of this study was to evaluate Emergency Medical Services (EMS) providers' attitudes andexperiences about enrolling patients in clinical research trials utilizing the federal rules for exception from informed consent. We hypothesized that Emergency Medical Technicians (EMTs) would have varied attitudes about research using an exception from informed consent which could have an impact on the research. Methods andsetting: Since January 2007, the EMS system has been participating in a randomized, multi-center interventional trial in which out-of-hospital providers enroll critically injured trauma patients using exception from informed consent.A voluntary, anonymous, written survey was administered to EMS providers during an in-service. The survey included demographics andLikert-type questions about their experiences with andattitudes towards research in general, andresearch using an exception from informed consent for an out-of-hospital clinical trial. Results: The response rate was 79.3 (844/1067). Most respondents, 93.3, agreed that "research in EMS care is important." However, 38.5 also agreed that individual EMTs/paramedics should maintain the personal right of refusal to enroll patients in EMS trials. Fifty-four percent of respondents agreed with the statement that "the right of research subjects to make their own choices is more important than the interests of the general community." In response to statements about the current study, 11.3 agreed that "the study is unethical because the patient cannot consent" and69.2 responded that they would personally be willing to be enrolled in the study before they were able to give consent if they were seriously injured. Those who had not enrolled a patient into the study (681 respondents) were asked their reasons: 76.8 had not encountered an eligible patient or did not work for an agency that carried the fluid; 4.3 did not have time; 4.1 forgot and1.1 stated that they were opposed to enrolling patients in studies without their consent. Conclusion: The majority of EMS personnel in one community support EMS research andthis specific out-of-hospital clinical trial being conducted under an exception from informed consent. Potential barriers to enrollment were identified. Further study in other systems is warranted to better understand EMS provider perspectives about exception from informed consent research.
机译：目的：本研究旨在评估紧急医疗服务（EMS）提供者对于使用联邦规则（知情同意除外）进行临床研究试验中招募患者的态度和经验。我们假设紧急医疗技术人员（EMT）使用知情同意书中的例外会对研究产生不同的态度，这可能会对研究产生影响。方法和背景：自2007年1月以来，EMS系统一直参与一项随机，多中心的干预性试验，其中院外医护人员使用知情同意书中的例外情况招募重伤患者，并进行了自愿，匿名，书面调查在服务期间向EMS供应商提供。该调查包括人口统计学和Likert型问题，涉及他们对一般研究的态度和态度，以及针对院外临床试验使用知情同意的例外情况进行的研究。结果：回应率为79.3（844/1067）。 93.3的大多数受访者同意“对EMS护理的研究很重要”。但是，38.5还同意，个别EMT /护理人员应保留拒绝患者参加EMS试验的个人权利。 54％的受访者同意以下说法：“研究对象做出自己的选择的权利比普通大众的利益更为重要。”在回应有关当前研究的陈述时，11.3同意“该研究是不道德的，因为患者无法同意”，并且69.2回答说，如果他们认真对待，他们本人愿意在能够同意之前加入该研究。受伤了那些没有将患者纳入研究的人（681名受访者）被问到他们的原因：76.8没有遇到合格的患者或未在输送液体的代理商工作; 4.3没有时间; 4.1忘记了和1.1表示他们反对未经患者同意而参加研究。结论：在一个社区中，大多数EMS人员都支持EMS研究，这项特定的院外临床试验是在知情同意的情况下进行的。确定了潜在的入学障碍。有必要在其他系统中进行进一步研究，以更好地理解EMS提供者对知情同意研究中有关例外的观点。

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