emergency research

  • 文章类型: Journal Article
    机构审查委员会(IRB)对当地情况进行审查的性质含糊不清。对多中心试验进行单一IRB审查的要求需要更好地理解当地背景审查的解释和实施,以及如何最好地集中实施此类审查。我们通过探索利益相关者的态度和看法,寻求对IRB本地背景审查的务实理解。与26名IRB成员和工作人员进行了半结构化访谈,机构官员,研究人员与80项类似利益相关者的调查进行了整合,并通过基于主题的定性文本分析和描述性统计分析进行了分析。利益相关者描述了他们认为是当地的情况,地方背景审查的价值,以及用于实施对一般当地情况的审查以及除知情同意外进行的紧急情况研究的关键过程。与会者表达了集中审查当地情况的关切和潜在优势。视角的变化表明,本地背景审查不是一个离散的过程,这为定义单一IRB审查的途径提供了机会。
    The nature of the review of local context by institutional review boards (IRBs) is vague. Requirements for single IRB review of multicenter trials create a need to better understand interpretation and implementation of local-context review and how to best implement such reviews centrally. We sought a pragmatic understanding of IRB local-context review by exploring stakeholders\' attitudes and perceptions. Semistructured interviews with 26 IRB members and staff members, institutional officials, and investigators were integrated with 80 surveys of similar stakeholders and analyzed with qualitative theme-based text analysis and descriptive statistical analysis. Stakeholders described what they considered to be local context, the value of local-context review, and key processes used to implement review of local context in general and for emergency research conducted with an exception from informed consent. Concerns and potential advantages of centralized review of local context were expressed. Variability in perspectives suggests that local-context review is not a discrete process, which presents opportunities for defining pathways for single IRB review.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    急诊研究是高风险的研究,通常是对病重的患者进行的,许多患者或监护人在参与之前没有机会提供充分的知情同意书。许多急诊研究自我选择更健康的患者,他们可以提前了解研究过程。不幸的是,这些参与者的结果可能对病情较重的患者的未来护理没有意义.这不可避免地会造成浪费,并使不知情的护理和对未来患者的持续伤害长期存在。放弃或延迟同意程序是一种替代模式,可用于招募无法给予前瞻性同意参加研究的患病患者。然而,这一过程产生了截然不同的利益相关者观点,有可能对研究和知识造成不可逆转的障碍。在涉及新生儿的研究中,必须征求父母或监护人的同意,如果婴儿病得很重,这给已经令人担忧的情况增加了另一层复杂性。在这份手稿中,我们讨论了为什么放弃同意或推迟同意程序对于某些类型的新生儿研究至关重要的原因,尤其是在出生时和出生前后发生的。我们提供了一个框架,在同意放弃的情况下进行新生儿急诊研究,这将确保患者的最佳利益,而不会损害道德,有益的,和信息知识获取,以改善患病新生儿的未来护理。
    Emergency research studies are high-stakes studies that are usually performed on the sickest patients, where many patients or guardians have no opportunity to provide full informed consent prior to participation. Many emergency studies self-select healthier patients who can be informed ahead of time about the study process. Unfortunately, results from such participants may not be informative for the future care of sicker patients. This inevitably creates waste and perpetuates uninformed care and continued harm to future patients. The waiver or deferred consent process is an alternative model that may be used to enroll sick patients who are unable to give prospective consent to participate in a study. However, this process generates vastly different stakeholder views which have the potential to create irreversible impediments to research and knowledge. In studies involving newborn infants, consent must be sought from a parent or guardian, and this adds another layer of complexity to already fraught situations if the infant is very sick. In this manuscript, we discuss reasons why consent waiver or deferred consent processes are vital for some types of neonatal research, especially those occurring at and around the time of birth. We provide a framework for conducting neonatal emergency research under consent waiver that will ensure the patient\'s best interests without compromising ethical, beneficial, and informative knowledge acquisition to improve the future care of sick newborn infants.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    背景:在急诊环境中进行研究对于促进与治疗急性病患者相关的知识和经验至关重要。然而,情况的复杂性给基本上处理紧急案件的研究人员带来了相当大的道德挑战。这项研究旨在确定医疗保健提供者(HCP)对知情同意(EFIC)例外的态度以及约旦急诊研究的注册意愿。
    方法:面试官在2019年的6个月期间进行了面对面问卷的定量研究。调查措施包括与EFIC政策相关的项目以及HCPs参与或支持其家庭成员参与紧急情况研究的总体意愿。
    结果:在约旦的急诊科(ED)共招募了151名HCP。参与者对紧急情况研究持积极态度;约有21.9%的参与者报告了以前进行紧急情况研究的经验,而12.3%的参与者有相关出版物。关于EFIC政策,大多数审查项目存在分歧的普遍共识。当被问及家庭成员或公众参与紧急情况研究时,有一种趋势是很少支持EFIC政策,然而,急诊研究中受访者的自我纳入接受了EFIC的申请.差异无统计学意义(P=0.37),在来自不同学科的参与者中,报告了对EFIC项目的态度或参加急诊研究的意愿。
    结论:一般来说,尽管在EFIC条款方面存在分歧,但HCP报告对紧急情况研究的总体积极支持。因此,建议继续进行未来的研究,以比较消息灵通的受试者;从发达的机构招募有关紧急研究潜力的人员;目前的基本态度监测,以消除这种混杂因素的影响,并更好地了解与紧急研究和EFIC相关的实际态度。此外,研究人员和政策制定者之间有效的多学科沟通渠道可以为合作研究和同时创新提供高质量的急诊护理开辟道路。
    BACKGROUND: Research conduction in emergency settings is of paramount importance to promote knowledge and experiences related to treating acutely ill patients. However, the complexity of situations creates a considerable ethical challenge facing researchers who basically deal with emergent cases. This study aimed to determine attitudes of healthcare providers (HCPs) towards exception from informed consent (EFIC) and enrollment willingness in emergency research in Jordan.
    METHODS: A quantitative research with face-to-face questionnaire was conducted by an interviewer during 6-month period in 2019. Survey measures included items related to EFIC policy and overall willingness of HCPs to participate or support their family members\' participation in emergency research.
    RESULTS: A total of 151 HCPs in the emergency departments (EDs) in Jordan was recruited. Positive attitude toward emergency research dominated among participants; about 21.9% of participants reported previous experience in the conduction of emergency research and 12.3% had related publications. Regarding EFIC policy, there was a general consensus of disagreement to most of the examined items. There was a trend for little support of EFIC policy when questioned about the enrollment of family members or public in emergency research, however, the application of EFIC was accepted for self-enrollment of respondents in emergency research. No significant differences (P = 0.37), among participants from different disciplines, were reported regarding the attitudes towards EFIC items or willingness to enroll in emergency research.
    CONCLUSIONS: Generally, HCPs reported an overall positive support to emergency research despite a consensus of disagreement related to EFIC terms. Therefore, it is recommended to pursue future studies to compare well-informed subjects; recruited from well-developed institutions in regard to emergency research potentials; with the present basic attitudinal surveillance in order to dissipate the effect of such confounder and to get better insight of the actual attitudes related to emergency research and EFIC. In addition, efficient multidisciplinary communication channels between researchers and policy makers can lather the way to collaborative research with simultaneous innovative delivery of quality emergency care.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    在紧急情况研究的背景下,研究人员可以要求机构审查委员会(IRB)放弃个人在参与研究时提供知情同意书的监管要求.放弃知情同意的要求是,审查IRB必须审查并批准社区咨询和公开披露计划。至关重要的是,作为多站点研究的单一IRB(sIRB)的IRB应彻底了解每个参与站点的本地环境问题,以确定是否正在就个人将被纳入的研究充分咨询站点社区知情同意要求的例外。我们设计了一个sIRB审查模型,用于评估特定地点的社区咨询计划,其中包括本地评估和反馈步骤,我们用四个站点试用了这个模型,儿科知情同意例外(EFIC)临床试验。我们确定了该模型的三个关键角色:sIRB,调查人员,以及该机构的人类研究保护计划(HRPP)的代表。我们成功地收集了评估每个站点的社区咨询计划所需的信息和当地意见,并将这些信息应用于全面的IRB审查,尽管研究地点和sIRB之间的地理距离。
    In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed consent is that the reviewing IRB must review and approve a community consultation and public disclosure plan. It is critical that an IRB serving as the single IRB (sIRB) for multisite research be thoroughly versed in the local context concerns for each participating site to determine whether the site\'s community is being adequately consulted about the research in which individuals will be enrolled under an exception to the informed consent requirement. We designed an sIRB review model for evaluating site-specific community consultation plans that included a local evaluation and feedback step, and we piloted the model with a four-site, pediatric exception from informed consent (EFIC) clinical trial. We identified three key roles for the model: the sIRB, the investigators, and the representative of the institution\'s human research protection program (HRPP). We successfully collected the information and local input needed to evaluate each site\'s community consultation plan and applied the information to a thorough IRB review, despite the geographic distance between the study site and the sIRB.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    许多目前公认的治疗方法在创伤后的第一个关键时刻提供给患者,中风,或心脏骤停尚未在临床研究试验中进行严格测试。无法获得知情同意往往是紧急情况下研究的障碍,在对时间敏感的情况下,患者无法提供知情同意书,其家庭成员也无法立即代表患者提供同意书。应急研究计划,通常除了知情同意外,是一种研究研究,涉及需要紧急干预的危及生命的医疗状况的患者,其中当前的治疗可能未经证实或欠佳,和谁,由于他们目前的状况,无法提供知情同意。本文总结了在计划的紧急情况研究中使用知情同意例外的必要组成部分。了解研究设计,特别是针对时间紧迫的紧急情况的研究过程,将确保担架一侧急诊护士提供的护理将导致最佳的患者结果,并且是急诊护理实践的一个组成部分。
    Many of the current accepted treatment practices provided to patients in the first critical hour after a traumatic injury, stroke, or cardiac arrest have not been rigorously tested in clinical research trials. The inability to obtain informed consent is often a barrier to research in emergency, time-sensitive situations in which the patient is not able to provide informed consent nor is their family member immediately available to provide consent on behalf of the patient. Planned emergency research, often with exception from informed consent, is a type of research study that involves a patient with a life-threatening medical condition that requires urgent interventions, wherein the current treatments may be unproven or suboptimal, and who, because of their current condition, is unable to provide informed consent. This article summarizes the necessary components for using exception from informed consent in planned emergency research. Understanding the research design, particularly research processes specific to time-critical emergency situations, will ensure that the care provided by stretcher-side emergency nurses will result in optimal patient outcomes and is an integral aspect of emergency nursing practice.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Sci-hub)

  • 文章类型: Clinical Trial, Phase III
    With increased focus on early resuscitation methods following injury to improve patient outcomes, studies are employing exception from informed consent (EFIC) enrollment. Few studies have assessed patients\' opinions following participation in an EFIC study, and none have been conducted within the realm of traumatic hemorrhage. We surveyed those patients and surrogates previously enrolled in the Prehospital Air Medical Plasma (PAMPer) Trial to clarify their opinions related to consent and emergency research.
    Telephone calls were made between January-June 2019 to all patients who were enrolled under EFIC in the PAMPer study at the Pittsburgh site (169 of the 501 total patients enrolled, May 2014-Oct 2017) and their surrogates. Questions gauging approval of EFIC enrollment were asked before discussion of PAMPer trial outcomes, after disclosure of positive outcomes, and after a hypothetical negative trial outcome was proposed.
    Of the total 647 telephone calls made, ninety-three interviews, reflecting 70 of 169 patient enrollments, were conducted. This included 13 in which only the patient was interviewed, 23 in which the patient and a surrogate were interviewed, and 34 in which only a surrogate was interviewed. Nearly half (48.4%) of respondents did not recall their personal or family member enrollment in the study. No patients or surrogates recalled hearing about the study through community consultation or being aware of opt out procedures. Patients and surrogates were glad they were enrolled (90.3%), agreed with EFIC use for their personal enrollment (88.17%), and agreed with the general use of EFIC for the PAMPer study (81.7%). Disclosure of the true positive PAMPer study outcome resulted in a significant increase in opinions regarding personal enrollment, EFIC for personal enrollment, and EFIC for general enrollment (all p < 0.001). Disclosure of a hypothetical neutral or negative study outcome resulted in significant decreases in opinions regarding EFIC for personal enrollment (p = 0.003) and EFIC for general enrollment (p < 0.001).
    Clinical trial participants with traumatic hemorrhagic shock enrolled with EFIC, and surrogates of such participants, are generally accepting of EFIC. The results of the trial in which EFIC was utilized significantly affected patient and surrogate agreement with personal and general EFIC enrollment.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Sci-hub)

       PDF(Pubmed)

  • 文章类型: Journal Article
    临床研究对于对抗COVID-19至关重要,但在大流行的情况下,对人类受试者保护的监管要求有时可能会构成挑战。尽管监管机构为大流行期间的研究提供了一些有用的指导,我们确定了有关机构审查委员会(IRB)审查和批准的进一步合规挑战,知情同意,应急研究,以及涉及被监禁者的研究。我们在这些领域的监管灵活性建议旨在满足保护参与者和促进高质量证据发展以改善患者护理的目标。这些建议可能具有超越COVID-19大流行的相关性,可以更广泛地提高研究监督和参与者保护的效率。
    Clinical research is critical to combatting COVID-19, but regulatory requirements for human subjects protection may sometimes pose a challenge in pandemic circumstances. Although regulators have offered some helpful guidance for research during the pandemic, we identify further compliance challenges regarding institutional review board (IRB) review and approval, informed consent, emergency research, and research involving incarcerated people. Our proposals for regulatory flexibility in these areas seek to satisfy the goals of protecting participants and promoting the development of high-quality evidence to improve patient care. These recommendations may have relevance beyond the COVID-19 pandemic to enhance the efficiency of research oversight and participant protection more broadly.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Sci-hub)

       PDF(Pubmed)

  • 文章类型: Journal Article
    In this series we address research topics in emergency medicine. While traditionally there was an almost exclusive focus on the efficacy and effectiveness of interventions in emergency research, analysis of the costs and the societal impact of different approaches and pathways have become increasingly important. In this paper we will address what health economics means and discuss the different types and key features of economic evaluation relevant for clinical researchers.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Sci-hub)

  • 文章类型: Journal Article
    知情同意(EFIC)的例外允许临床医生科学家进行急需的紧急研究。获得此异常,然而,需要与社区团体举行多次会议进行协商,这可能会使该过程耗时且昂贵。我们的目标是确定使用社交媒体代替某些社区会议以获得EFIC的影响。
    对四个随机临床试验进行了经济分析。成本是使用人员成本保守估计的,社交媒体成本,并调整至2016年美元。如果人们参加了社区会议或通过社交媒体被引导到研究网站并花费≥1分钟,则认为他们已经达到。
    早期全血研究需要14次会议,272人费用为8260美元(每人达到30美元)。务实,随机最佳血小板和血浆比率研究需要14次会议,达到260人,整体费用为7479美元(每人29美元)。院前氨甲环酸用于创伤性脑损伤研究需要12次会议,达到198人,费用为6340美元(每人达到32美元)。只有损害控制剖腹手术试验利用社交媒体代替一些社区会议。损害控制剖腹手术试验需要六次会议,有137人参加。这项价值1000美元的社交媒体活动吸引了229人。总体费用为3977美元,每人达到11美元。
    在EFIC过程中包括社交媒体活动,增加了潜在患者的数量,并减少了总和每人成本达到的成本。通过纳入社交媒体活动可以促进获得用于未来紧急临床试验的EFIC。
    Exception from informed consent (EFIC) allows clinician scientists to perform much needed emergency research. Obtaining this exception, however, requires many meetings with community groups for consultation, which can make the process time-consuming and expensive. We aim to determine the impact of using social media in lieu of some community meetings in an effort to obtain an EFIC.
    An economic analysis of four randomized clinical trials was performed. Costs were conservatively estimated using personnel costs, social media costs, and adjusted to 2016 US dollars. People were considered reached if they attended a community meeting or were directed to the study website by social media and spent ≥1 min.
    The Early Whole Blood study required 14 meetings, reached 272 people, and cost $8260 ($30/person reached). The Pragmatic, Randomized Optimal Platelet and Plasma Ratios study required 14 meetings, reached 260 people, and cost $7479 overall ($29/person reached). The Prehospital Tranexamic Acid Use for Traumatic Brain Injury study required 12 meetings, reached 198 people, and cost $6340 ($32/person reached). Only the damage control laparotomy trial utilized social media in lieu of some community meetings. The damage control laparotomy trial required six meetings at which 137 people were reached. The $1000 social media campaign reached 229 people. The cost was $3977 overall and $11/person reached.
    Including a social media campaign during the EFIC process increased the number of potential patients reached and reduced total and per person costs reached costs. Obtaining an EFIC for future emergency clinical trials may be facilitated by the inclusion of a social media campaign.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    Sudden cardiac arrest (SCA) accounts for half of all cardiac deaths in Europe. In recent years, large-scale SCA registries have been set up to enable observational studies into risk factors and the effect of treatment approaches. The increasing scale and variety of data sources, coupled with the implementation of a new European data protection legal framework, causes researchers to struggle with how to handle these \'big data\'. Data protection in the SCA setting is especially complex since patients become at least temporarily incapacitated, and are thus unable to provide prospective informed consent, and because the majority of patients do not survive. A narrative review employing a systematic literature search was conducted to thematically analyse ethical aspects of non-interventional emergency medicine and critical care research. Although the identified issues may apply to a wider patient population, we describe them within the context of SCA research. Potential harms were found to include: privacy breaches, genetic discrimination and issues associated with the disclosure of individual findings, study design and application of research results. Measures proposed to mitigate harms were: alternative informed consent models including deferred or waived consent and data governance approaches promoting data security, responsible sharing and public engagement. The themes identified in this study may serve as a basis for a much-needed ethical framework regarding research with data from patients with acute and critical illness such as SCA.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

公众号