■急诊临床研究在改善急性病患者的预后方面发挥了重要作用。这部分是由于允许知情同意例外(EFIC)试验的监管措施。美国食品和药物管理局(FDA)要求赞助商调查人员在启动知情同意例外试验之前参与社区咨询和公开披露活动。已经描述了各种社区咨询和公开披露的方法,并根据当地情况和机构审查委员会(IRB)的解释进行了调整。COVID-19大流行排除了通过直接,现场公共场所,要求研究团队找到替代方法来告知社区有关紧急研究。
■PreVent和PreVent2研究是紧急气管插管知情同意试验的两个例外,在PreVent研究的一个地理位置和在PreVent2研究的两个地理位置进行。在两项研究期间,从电话到大流行前后,方法论方法都发生了重大变化,当面,到虚拟设置。
■在两项PreVent试验实施“知情同意例外”活动的10年期间,公众对知情同意试验例外的概念和急诊临床研究的重要性总体上有良好的支持.社区关注的问题很少,而且在联系方法上也没有太大区别。随着虚拟技术的实施,吸引社区成员的出勤率更高,与电话联系或当面事件相比,总体反馈更为积极.然而,远程完成后收到的调查答复的比例,现场活动大幅降低,受教育程度较高的受访者比例更高。这表明在完成同步活动后,参与度较低,并且受访者之间的选择偏见可能更高。重要的是,我们发现,与当地社区领导人的接触是制定与公众联系的适当计划的关键组成部分。
■PreVent的经验说明了主要通过电话进行社区咨询的运营优势和劣势,面对面的活动,或在线活动。提高社区接受度的方法包括与社区领导人合作,在社区会议期间,在机构审查委员会代表的参与下,优化沟通策略和建立信任。研究人员可能需要从亲自计划转向虚拟技术,同时保持与公众进行双向交流的能力。由于积极参与较少,以及响应者选择偏差的可能性,与面对面活动相比,需要进一步研究虚拟社区咨询和公开活动的成本和收益。
UNASSIGNED: Emergency clinical research has played an important role in improving outcomes for acutely ill patients. This is due in part to regulatory measures that allow Exception From Informed Consent (EFIC) trials. The Food and Drug Administration (FDA) requires sponsor-investigators to engage in community consultation and public disclosure activities prior to initiating an Exception From Informed Consent trial. Various approaches to community consultation and public disclosure have been described and adapted to local contexts and Institutional Review Board (IRB) interpretations. The COVID-19 pandemic has precluded the ability to engage local communities through direct, in-person public venues, requiring research teams to find alternative ways to inform communities about emergency research.
UNASSIGNED: The PreVent and PreVent 2 studies were two Exception From Informed Consent trials of emergency endotracheal intubation, conducted in one geographic location for the PreVent Study and in two geographic locations for the PreVent 2 Study. During the period of the two studies, there was a substantial shift in the methodological approach spanning across the periods before and after the pandemic from telephone, to in-person, to virtual settings.
UNASSIGNED: During the 10 years of implementation of Exception From Informed Consent activities for the two PreVent trials, there was overall favorable public support for the concept of Exception From Informed Consent trials and for the importance of emergency clinical research. Community concerns were few and also did not differ much by method of contact. Attendance was higher with the implementation of virtual technology to reach members of the community, and overall feedback was more positive compared with telephone contacts or in-person events. However, the proportion of survey responses received after completion of the remote, live event was substantially lower, with a greater proportion of respondents having higher education levels. This suggests less active engagement after completion of the synchronous activity and potentially higher selection bias among respondents. Importantly, we found that engagement with local community leaders was a key component to develop appropriate plans to connect with the public.
UNASSIGNED: The PreVent experience illustrated operational advantages and disadvantages to community consultation conducted primarily by telephone, in-person events, or online activities. Approaches to enhance community acceptance included partnering with community leaders to optimize the communication strategies and trust building with the involvement of Institutional Review Board representatives during community meetings. Researchers might need to pivot from in-person planning to virtual techniques while maintaining the ability to engage with the public with two-way communication approaches. Due to less active engagement, and potential for selection bias in the responders, further research is needed to address the costs and benefits of virtual community consultation and public disclosure activities compared to in-person events.