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.
