Jasti Jamie, Fernandez Antonio R, Schmidt Terri A, Lerner E Brooke
Prehosp Emerg Care. 2016;20(1):22-7. doi: 10.3109/10903127.2015.1051679. Epub 2015 Aug 13.
The purpose of this study was to evaluate the attitudes and opinions of a broad population of EMS providers on enrolling patients in research without consent. A survey was conducted in 2010 of all EMS providers who participated in the National Registry of Emergency Medical Technicians (NREMT) reregistration process, which included half of all registered providers. Each reregistration packet included our optional survey, which had nine 6-point Likert scale questions concerning their opinion of research studies without consent as well as 8 demographic questions. Responses were collapsed to agree and disagree and then analyzed using descriptive statistics with 99% confidence intervals. A total of 65,993 EMS providers received the survey and 23,832 (36%) participated. Most respondents agreed (98.4%, 99%CI: 98.2-98.6) that EMS research is important, but only 30.9% (99%CI: 30.1-31.6) agreed with enrolling patients without their consent when it is important to learn about a new treatment. Only 46.6% (99%Cl: 45.7-47.4) were personally willing to be enrolled in a study without their consent. A majority (68.5% [99%Cl: 67.7-69.3]) of respondents believed that EMS providers should have the individual right to refuse to enroll patients in EMS research. While the majority of respondents agreed that EMS research is important, considerably less agree with enrolling patients without consent and less than half would be willing to be enrolled in a study without their consent. Prior to starting an Exception from Informed Consent (EFIC) study, researchers should discuss with EMS providers their perceptions of enrolling patients without consent and address their concerns.
本研究的目的是评估广大急救医疗服务（EMS）提供者对于在未经患者同意的情况下将其纳入研究的态度和看法。2010年，我们对所有参与国家紧急医疗技术员注册系统（NREMT）重新注册流程的EMS提供者进行了一项调查，这些提供者占所有注册提供者的一半。每个重新注册包都包含我们的可选调查问卷，其中有九个6级李克特量表问题，涉及他们对未经同意的研究的看法，以及八个人口统计学问题。回答被归纳为同意和不同意，然后使用99%置信区间的描述性统计方法进行分析。共有65,993名EMS提供者收到了调查问卷，其中23,832人（36%）参与了调查。大多数受访者（98.4%，99%置信区间：98.2 - 98.6）认为EMS研究很重要，但只有30.9%（99%置信区间：30.1 - 31.6）同意在了解新治疗方法很重要时未经患者同意就将其纳入研究。只有46.6%（99%置信区间：45.7 - 47.4）的人个人愿意在未经自己同意的情况下被纳入研究。大多数受访者（68.5% [99%置信区间：67.7 - 69.3]）认为EMS提供者应有权个人拒绝将患者纳入EMS研究。虽然大多数受访者同意EMS研究很重要，但相当少的人同意未经同意就将患者纳入研究，并且不到一半的人愿意在未经自己同意的情况下被纳入研究。在开始一项免除知情同意（EFIC）研究之前，研究人员应与EMS提供者讨论他们对未经同意将患者纳入研究的看法，并解决他们的担忧。
