Support Services for the NHLBI-Sponsored Data Science Institutional Review Board

为 NHLBI 赞助的数据科学机构审查委员会提供支持服务

• 批准号: 9688366
• 负责人: Laura Covington
• 金额: $ 49.41万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9688366
• 关键词: Accreditation; All of Us Research Program; Biometry; Blood; Businesses; Case-Control Studies; Clinical Research; Clinical Trials; Collaborations; Complex; Computer Systems; Custom; Data; Data Analyses; Data Science; Data Set; Decision Making; Development; Devices; Employee; Ensure; Extramural Activities; Extramural Research Program; Foundations; Funding; Heart; Human; Human Subject Research; Informatics; Information Specialists; Institutes; Institution; Institutional Review Boards; Knowledge; Logistics; Lung; Manufacturer Name; Maryland; Methodology; Modeling; National Cancer Institute; National Heart, Lung, and Blood Institute; Performance; Pharmacologic Substance; Phase; Pilot Projects; Policies; Positioning Attribute; Privatization; Procedures; Process; Protocols documentation; Quality Control; Registries; Regulation; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Role; Schedule; Secure; Services; Site; Sleep; Speed; Support Contracts; System; TimeLine; Training; United States National Institutes of Health; Universities; Woman; Work; data access; data management; design; epidemiologic data; experience; flexibility; high standard; human subject protection; meetings; member; multi-site trial; operation; programs; recruit; response; success

This proposal to serve as the Support Services for the NHLBI-Sponsored Data Science Institutional Review Board partner for the National Heart, Lung, and Blood Institute (NHLBI) has been prepared and submitted by the staff of The Emmes Corporation. The Emmes Corporation is a woman-owned small business of approximately 600 employees, located in Rockville, Maryland, 15 to 20 minutes by car from the NIH main campus. Historically, 80 percent of Emmes’ revenue is from the NIH. Private foundations, universities, pharmaceutical companies, and device manufacturers have provided the remainder. For more than 40 years, Emmes has devoted its efforts exclusively to providing biostatistical, epidemiological, data management, regulatory, computer systems, organizational, and logistical support for clinical research programs, most of which have complex clinical trials operations and methodologies. Emmes staff have designed, implemented and performed data analysis, as well as regulatory, logistical and informational support for Phase 1, 2, 3 and 4 clinical trials, registries and case-control studies. In addition to these activities, and most pertinent to this proposal, Emmes has served as the Operations Office for the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) for over 10 years. In this role, Emmes has supported a complex network of nearly 2000 institutions and hundreds of protocols reviewed by four CIRBs. Emmes has made major contributions to implement an NCI Central Institutional Review Board while supporting informatics aimed at reducing the administrative burdens for multi-site trials. Emmes was instrumental in securing Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) accreditation of the NCI CIRB, including transition of the CIRB from its original facilitated review model to an independent central IRB model. Emmes has also been successful in expanding the scope of the CIRB from two to four CIRBs, having established the newest CIRB in 2015. In addition, Emmes has supported the All of Us IRB for the NIH’s All of Us research program since the IRB was established in early 2016. Emmes has leveraged its experience with the NCI CIRB and Emmes’ own team of Human Subjects Protection experts to support the All of Us IRB as it has developed over the last two years. This has given Emmes unique experience in the start-up of a new single IRB supporting a newly established and dynamic NIH-funded research program. Accordingly, our staff are trained and experienced in activities most relevant to this project: managing and providing administrative and regulatory support to IRB meetings; project, program and meeting management; compliance with federal regulations governing human subjects research protections; conducting and reporting of quality control processes; and developing and managing timelines to optimize project performance. The success of the NHLBI Data Science IRB project hinges on the ability of the partner to provide quick and flexible responses to stated needs, to provide a high level of support and customization for the IRB’s review of new data access requests and protocols proposing research that utilizes Heart, Lung, Blood, and Sleep (HLBS)-relevant datasets stored in the NIH Data Commons, to anticipate problems and work through them in collaboration with NHLBI staff, and to provide a service and technical product that meets the high standards of NHLBI and Emmes. Understanding that the project entails support of an NHLBI Data Science IRB rather than offering commercial IRB services according to its own schedule, policies, and procedures, Emmes anticipates that the project will be highly collaborative with NHLBI staff and NHLBI Data Science IRB members to ensure customization of policies, procedures, and development of IRB operations infrastructure that best meet the needs of the program. This is a service Emmes is uniquely positioned to provide. Features that distinguish Emmes from other potential partners include our years of support as the NCI CIRB Operations Office and the All of Us IRB Operations Office, our focus on support of scientific research combined with speed and flexibility regarding performance of pilot projects and new initiatives, and our staff’s ability to collaboratively define and implement complex work efforts. In its role supporting the NCI CIRB and the All of Us IRB operations, Emmes has recruited, trained, and retained a skilled and experienced team of professionals who have particular expertise in IRB support, centralized IRB review, project management, project coordination, NIH initiatives, and NIH priorities. This team has developed a strong working relationship with NCI, NIH’s All of Us Research Program, and the institutions relying on these central IRBs as the IRB or record and expects to create that same strong relationship with the NHLBI Data Science IRB.

作为国家心肺血液研究所（NHLBI）的NHLBI申办的数据科学机构审查委员会合作伙伴的支持服务的提案已由Emmes Corporation的工作人员编写并提交。埃姆斯公司是一家女性拥有的小企业，约有600名员工，位于马里兰州的罗克维尔，距离NIH主校区15至20分钟车程。从历史上看，埃姆斯80%的收入来自美国国立卫生研究院。私人基金会、大学、制药公司和设备制造商提供了其余的资金。40多年来，Emmes一直致力于为临床研究项目提供生物统计学，流行病学，数据管理，监管，计算机系统，组织和后勤支持，其中大多数具有复杂的临床试验操作和方法。Emmes的工作人员为1、2、3和4期临床试验、登记和病例对照研究设计、实施和执行数据分析，以及监管、后勤和信息支持。 除了这些活动，最相关的这一建议，埃姆斯已担任国家癌症研究所（NCI）中央机构审查委员会（CIRB）的运营办公室超过10年。在这个角色中，Emmes支持了一个由近2000个机构组成的复杂网络和由四个CIRB审查的数百个协议。Emmes为实施NCI中央机构审查委员会做出了重大贡献，同时支持旨在减少多中心试验行政负担的信息学。埃姆斯在确保人类研究保护计划认证协会方面发挥了重要作用。（AAHRPP）NCI CIRB的认证，包括CIRB从其原始的便利审查模式过渡到独立的中央IRB模式。埃姆斯还成功地将CIRB的范围从两个扩大到四个，并于2015年建立了最新的CIRB。 此外，自2016年初IRB成立以来，Emmes一直为NIH的All of Us研究计划提供支持。埃姆斯利用其与NCI CIRB和埃姆斯自己的人类受试者保护专家团队的经验，以支持我们所有的IRB，因为它已经在过去两年的发展。这给了埃姆斯独特的经验，在启动一个新的单一的IRB支持一个新成立的和动态的NIH资助的研究计划。 因此，我们的工作人员在与本项目最相关的活动中接受过培训并经验丰富：管理IRB会议并为IRB会议提供行政和监管支持;项目、项目和会议管理;遵守管理人类受试者研究保护的联邦法规;执行和报告质量控制流程;制定和管理时间表以优化项目绩效。 NHLBI数据科学IRB项目的成功取决于合作伙伴对所述需求提供快速灵活响应的能力，为IRB对新数据访问请求和方案的审查提供高水平的支持和定制，这些请求和方案提出了利用NIH数据共享中存储的心脏，肺，血液和睡眠（HLBS）相关数据集的研究，预测问题并与NHLBI工作人员合作解决问题，并提供符合NHLBI和Emmes高标准的服务和技术产品。了解到该项目需要NHLBI数据科学IRB的支持，而不是根据自己的时间表，政策和程序提供商业IRB服务，Emmes预计该项目将与NHLBI工作人员和NHLBI数据科学IRB成员高度合作，以确保政策，程序的定制和IRB运营基础设施的开发，以最好地满足该计划的需求。这是一个服务埃姆斯是唯一定位提供。 Emmes与其他潜在合作伙伴的区别在于我们多年来作为NCI CIRB运营办公室和All of Us IRB运营办公室的支持，我们专注于支持科学研究，并结合试点项目和新举措的速度和灵活性，以及我们的员工协作定义和实施复杂工作的能力。 在支持NCI CIRB和All of Us IRB运营的过程中，Emmes招募、培训并保留了一支技术熟练、经验丰富的专业团队，他们在IRB支持、集中IRB审查、项目管理、项目协调、NIH倡议和NIH优先事项方面具有特殊的专业知识。该团队与NCI、NIH的All of Us研究计划以及依赖这些中央IRB作为IRB或记录的机构建立了牢固的工作关系，并希望与NHLBI数据科学IRB建立同样牢固的关系。