Community Engagement, Bioethics and Outreach Core

社区参与、生物伦理学和外展核心

• 批准号: 10090067
• 负责人: Frank Chessa
• 金额: $ 50.76万
• 依托单位: MAINEHEALTH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-10 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10090067
• 关键词: Acute; Address; Adherence; Aging; Asphyxia; Attitude; Awareness; Bioethics; Caring; Centers of Research Excellence; Clinical; Clinical Research; Communities; Consent; Disadvantaged; Disclosure; Distant; Doctor of Philosophy; Education; Encephalopathies; Enrollment; Ensure; Environment; Ethics; Face; Family; Female; Future; Gender; Geographic Locations; Geography; Health Care Research; Heart Arrest; Hospitals; Hour; Inequality; Informed Consent; Infrastructure; Institutional Review Boards; Legal; Life; Location; Maine; Medical; Medical Research; Medical center; Mentors; Neonatal; Pathway interactions; Patients; Physicians; Preparation; Process; Protocols documentation; Regulation; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Research Training; Resources; Rural; Rural Community; Rural Hospitals; Rural Population; Scientist; Site; Stroke; Teaching Hospitals; Time; Transportation; Trauma; United States Dept. of Health and Human Services; United States National Institutes of Health; Universities; acute care; career; community consultation; community engagement; design; eligible participant; experience; human subject; human subject protection; medical schools; member; outreach; preference; pressure; prognostic; programs; recruit; research and development; rural area; rural disparities; rural healthcare; rural patients; rural setting; rurality; skills; teleconsent; tertiary care; urban area; urban setting

Abstract The Community Engagement, Bioethics, and Outreach (CEBO) Core focuses on expanding the inclusion of rural populations in acute care research projects requiring urgent initiation of therapy. In a rural state such as Maine, urban regions concentrate academic medical resources into a few locations that may be many hours from rural communities and regional hospitals. Patients outside these urban centers are at a significant disadvantage regarding access to tertiary-level care and participation in medical research. Contributing factors to this disparity include lack of awareness of ongoing research, geographic and transportation barriers, lower numbers of eligible participants, and few clinician researchers. These challenges are pronounced for time- pressured research for life-altering medical problems such as stroke, cardiac arrest, and neonatal asphyxiation. Ensuring appropriate human subject protection and enhancing rural enrollment requires informed and experienced researchers, but these essential resources are limited in our urban centers, and critically lacking in our rural healthcare environment. Patients with these acute conditions are often not awake or medically stable enough to provide informed consent, and it is often too late to enroll them hours later when legally authorized representatives arrive at receiving tertiary care centers. To address these challenges, the Department of Health and Human Services developed the Exception From Informed Consent (EFIC) pathway, allowing research to proceed without consent under strict conditions, including robust community consultation and public disclosure prior to initiating the study. Little research has addressed the implications of rurality on EFIC - it is not known whether EFIC is as effective for rural communities as for urban settings, whether EFIC increases recruitment from rural areas, and whether rural patients prefer EFIC or emerging options such as remote teleconsent. The CEBO Core will address these issues to support the COBRE Project Leaders pursuing acute care research in rural and urban settings across Maine. The core will: 1) Provide direct assistance to COBRE Project Leaders in recruitment strategies, consent processes, and document preparation for IRB submission; 2) Engage rural community members (patients, clinicians and other stakeholders) to better understand their perspectives, preferences, and barriers to participation in research requiring urgent treatment, and the ethical tradeoffs associated with different approaches to enrollment; and 3) Enhance research training, regulatory compliance, and proper research conduct among COBRE Project Leaders, early career researchers and mentors at Maine Medical Center, and emerging clinical researchers at rural sites engaged in these COBRE projects by developing research networks and associated educational programs to support expanded acute care clinical research.

抽象的 社区参与，生物伦理学和外展（CEBO）核心侧重于扩大包含 急性护理研究项目中的农村人口需要紧急开始治疗。在农村国家，例如 缅因州，城市地区将学术医疗资源集中到可能是多个小时的几个地点 来自农村社区和地区医院。这些城市中心以外的患者很重要 关于获得第三级护理和参与医学研究的缺点。促成因素 差距包括缺乏对正在进行的研究，地理和运输障碍的认识，较低 合格的参与者数量，少数临床研究人员。这些挑战的发音时间为时间 - 针对改变生活的医学问题的压力研究，例如中风，心脏骤停和新生儿 窒息。确保适当的人类主题保护和增强农村入学率需要知情 和经验丰富的研究人员，但是这些基本资源在我们的城市中心受到限制，并且批判性 缺乏我们的农村医疗保健环境。患有这些急性疾病的患者通常不醒或 在医学上足够稳定以提供知情同意，几个小时后将其注册为太晚了 合法授权的代表到达接受第三纪念中心。为了应对这些挑战， 卫生与公共服务部制定了知情同意书（EFIC）途径的例外， 允许在严格条件下未经同意的情况下进行研究，包括强大的社区咨询 和在启动研究之前公开披露。很少的研究已经解决了乡村的影响 EFIC-尚不清楚EFIC对农村社区是否与城市环境一样有效，是否有效 增加农村地区的招聘，以及农村患者更喜欢EFIC还是新兴选择，例如 远程电信。 CEBO核心将解决这些问题，以支持COBRE项目负责人 在缅因州的农村和城市环境中进行急诊研究。核心将：1）直接提供 协助索布雷项目领导者招聘策略，同意程序和文件准备 提交IRB； 2）让农村社区成员（患者，临床医生和其他利益相关者）更好 了解他们的观点，偏好和参与需要紧急治疗的研究的障碍， 以及与不同入学方法相关的道德权衡； 3）增强研究培训， 早期职业研究人员的监管合规性和鞋垫项目负责人的适当研究行为 以及缅因州医学中心的导师，以及从事这些工作的农村地区的新兴临床研究人员 通过制定研究网络和相关教育计划来支持扩展 急性护理临床研究。