SF424 (R&R) Application Guide for NIH and Other PHS agencies
Other Project Information:Facilities & Other Resources
This information is used to assess the capability of the organizational resources available to perform the effort proposed. Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical and Other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work. Provide any information describing the Other Resources available to the project (e.g., machine shop, electronic shop) and the extent to which they would be available to the project. Source: PHS SF 424 (R&R) Forms Version C Application Guide
MSU- General Information
The nation’s pioneer land-grant university, Michigan State University (MSU) is recognized internationally as a top research university. Located in East Lansing, MSU encompasses a 5,200-acre campus with 2,100 acres in existing or planned development, 538 buildings, including 95 academic buildings. These, as well eight medical campuses distributed throughout the state are supported by over 5,100 faculty and academic staff, with >38,000 undergraduates, and >11, 000 graduate and professional students enrolled in the 17 degree-granting colleges at MSU.
MSU is listed among the top 50 universities in the world based on research performance, including publications and citations based on rankings compiled at the University of Western Australia. Michigan State’s global standing as a top-notch research and teaching institution continues to improve. The World University Rankings by Times Higher Education, a London-based publication ranks MSU 82, up one spot from last year. Michigan State University is among the top 100 universities in the world, according to a new set of rankings from U.S. News & World Report. According to the rankings, which list the top 500 universities in the world, MSU is tied for 75th with the Netherlands’ Leiden University. This is the first time U.S. News & World Report has rated universities on a global scale. It used a new set of criteria, with a heavy emphasis on the schools’ research prowess. For example, The Institute for Scientific Information included 27 MSU faculty members on its most recent list of "Highly Cited" researchers. Individuals on the list are among the top 250 researchers worldwide in their respective fields in terms of the number of citations to research published and represent about half of 1 percent of all researchers in the sciences and social sciences.
Funding for externally sponsored programs comes primarily from federal agencies, state agencies, industry associations and foundations, with ~$528 million in external funding in 2013-14. As a result, MSU is a member of the prestigious Association of American Universities, a group of only 60 U.S. and two Canadian universities widely regarded as among the top research-intensive institutions in North America.
MSU is the only university in the country with on-campus medical schools graduating allopathic (MD) and osteopathic (DO) physicians, as well as veterinarians (DVM), that each also produce dual- degreed, PhD graduates as well. The College of Nursing is also one of the top research Nursing Colleges in the country. Significant research infrastructure exists to support the research and training efforts underway within each of these colleges.
Basic and T0 level research has been foundational to the successes of the 4 health and medical colleges as they jointly benefit by sharing several distinguished basic sciences departments and their research faculty. These include research faculty in the departments of Physiology, Biochemistry & Molecular Biology, Microbiology and Molecular Genetics, Pharmacology and Toxicology, as well as Epidemiology and others, each again shared with other Colleges including Engineering (COE), the College of Natural Sciences (CNS), and the College of Agriculture and Natural Resources (CANR).
As but one example of several, the College of Natural Science at Michigan State University is home to 27 departments and programs in the biological, physical and mathematical sciences. The college averages $28 M in research expenditures annually while providing world-class educational opportunities to more than 5,000 undergraduate majors and nearly 1,000 graduate students.
MSU- Community Setting:
The concept of “clinical and translational science” implies that extensive interaction with communities will take place for its implementation. The AgriculturalCollege of the State of Michigan, precursor of MichiganStateUniversity, was chartered in 1855 as the nation’s first land-grant institution of higher education. The outreach mission of the University was expanded by the Hatch and Smith-Lever Acts creating a series of Agricultural Experiment Stations and the Cooperative Extension Service, with missions of Outreach and Service to the residents of Michigan. Implementation of this mission at MSU led to establishment of the MSU Extension Service (MSUE) with branches in all of the 83 Counties of Michigan.
For 45 years, MSU, through its distributed Health Campuses, has been educating medical students and nurses in the communities of the State of Michigan. MSU’s three human health sciences colleges (Human Medicine, Osteopathic Medicine and Nursing) have an education system where students begin study in East Lansing or Grand Rapids and move to community health campuses to complete clinical training. Over 50% of the graduates from these colleges remain in the state for postgraduate training and clinical practice, often in primary care, many in underserved regions of the state. These and other strengths, including over 5,000 clinical faculty statewide, have established MSU as a national leader in community-based medical education. MSU recognized early the opportunity to build on its dual foundations namely the MSUE and the three human health sciences colleges, and in 2008 created the MSU Clinical and Translational Sciences Institute (MSU-CTSI).
Community Reach and Population Diversity:MSU’s four health sciences colleges are intimately connected with urban and rural populations of Michigan, as well as with professionals delivering health care to these communities. MSU-CTSI will employ MSU’s existing teaching and hospital networks (Table 1) in the statewide Zones of Research Engagement to implement its clinical and translational science mission (Grand Rapids, Flint, Midland, Detroit area, Lansing, Traverse City region, and Marquette region). The population potentially impacted by MSU-CTSI includes approximately 4.7 million people and is quite diverse, as noted in Table 2.
Clinical and Translational Sciences Institute (MSU-CTSI)
In August 2008, the Michigan State University established theClinical and Translational Sciences Institute (MSU-CTSI), recruited a Director for the Institute, consolidated existing infrastructure resources, and invested new funds to support the CTSI mission. The MSU Office of Clinical Research (OCR) and the Biomedical Research Informatics Core (BRIC), two independently reporting units, became divisions within the CTSI at that time. MSU-CTSI is strongly linked to the leadership of MSU, and its Colleges and its external partners. The goal of the MSU-CTSI is to develop clinical and translational research infrastructure to the benefit of the communities and investigators in the MSU partner network, and ideally to expand this network by linking with CTSA recipients across the nation.All MSU faculty members or members of partner institutions involved in clinical and translational research and/or teaching may participate in and derive support from the MSU-CTSI. Faculty members and other participants retain their departmental and college affiliations, but the MSU-CTSI adds sustainability and organization to the interdisciplinary and collaborative nature and relevance of clinical and translational research.
MSU-CTSI serves as the multi-disciplinary infrastructure to support MSU clinical and translational research. CTSI is directed by Dr. Andrea Amalfitano, DO, Ph.D, Osteopathic Heritage Foundation Professor, who took on this role in August of 2013. His background in medical practice, genetics research, and clinical research has provided new expertise into an already diverse group. The Director of MSU-CTSI reports directly to the Office of Dr. Stephen Hsu, the Vice President for Research and Graduate Studies, (OVPRGS) who reports directly to the President’s office of MSU, Dr. Lou Anna K. Simon. MSU-CTSI is supported by general fund dollars through the OVPRGS.Investigators engage the support of MSU-CTSI from numerous origins including the human health colleges, basic biomedical disciplines, the social sciences, the College of Veterinary Medicine, and the community.
MSU-CTSI and the divisions of OCR and BRICare located West Fee Hall at MSU Main Campus in East Lansing. The space accommodates approximately 40 individuals in 6,731 square feet of recently remodeled space. The space has 4 conference rooms, 8 areas of cubicle space with 6 stations each organized on the perimeter of an open common area, and 11 private office suites located on the perimeter of the space. In addition Translational Research Support Facility (TRSF) space in West Fee Hall is currently available in support of clinical research projects. Plans are underway to relocate and expand the TRSF in 2015. The layout of the MSU-CTSI space is below.
Office of Clinical Research Division (OCR): The Office of Clinical Research was established in 2006 to serve the need for enhanced support of clinical and translational research, and to expedite the research administration process. OCR has as its mission to assist researchers with the development, implementation, management, and completion of industry- and government-funded clinical research conducted through MSU and community partners. OCR offers clinical research support services to investigators including feasibility assessment, subject recruitment planning, clinical research coordination, regulatory support, connection to external resources, and access to the local Translational Research Support Facility (TRSF) resources. Serving as the ‘Researcher Advocate’, OCR helps faculty and staff navigate the MSU clinical research environment and facilitates use of tools such as ResearchMatch, StudySearch, and eagle-i. ResearchMatch is a national web-based volunteer registry that connects people interested in participating in research, with researchers looking for participants. StudySearch is an online tool that serves as a central repository of local research studies that are open to enrollment through MSU. Eagle-i provides researchers access to discover needed core laboratory services, reagents, animals, specimens, etc. that are available on campus and nationally. OCR currently serves as the point of contact for linking investigators (both locally and in the community) to existing MSU scientists, research support, and community network resources.
Translational Research Support Facility: The MSU-CTSI TRSF currently consists of two well-equipped outpatient exam rooms, several separate areas for interviewing and study monitoring, secured space for record and drug storage, several blood collection areas, and a specimen processing laboratory. Exam room equipment includes infusion chairs, ECG machines, and other various equipment needed to complete physical examinations. The specimen processing laboratory equipment includes multiple benchtop centrifuges (refrigerated and portable) and multiple temperature-monitored refrigerators and freezers for drug sample storage. The TRSF and staff are a registered vaccination clinic through the Michigan Care Improvement Registry. Plans are underway for a major expansion of space and services for 2015 to accommodate the increased need for research-dedicated clinic space, as well as to better meet the needs of research participants.
Biomedical Research Informatics Core Division (BRIC):BRIC was established by MSU in 2001 as part of the University’s commitment to strengthen informatics and research IT support for clinical and translational researchers. The unit provides pre-award consultations and assistance with data management plans and budget, as well as post award support to investigators for a variety of data capture, data security, and study management services. BRIC provides strong support for observational studies for both internal and external investigators, working closely with data analysis collaborators and the investigator’s team members.
BRIC provides best-in-class informatics support of the operation and administration of the MSU-CTSI. This includes research information databases and web sites to provide information and to foster communication among MSU clinical and translational investigators. BRIC provides a risk-based security management system focused on the confidentiality, availability and integrity of data. It has an active program to insure compliance with HIPAA and other federal and state laws and regulations as they pertain to data matters. BRIC reduces barriers to the initiation of new research projects while maintaining high standards of clinical research informatics by providing access to scalable and affordable informatics tools for pilot or early stage research; eliminating cost barriers to high level informatics by offering no or nominal charge licenses to new investigators or seasoned investigators beginning internally funded new lines of research; providing training and support to assure implementation of systems relatively trouble free; using informatics solutions to reduce technical obstacles to research initiation.Faculty and staff of the Biomedical Informatics Core (BRIC) help ensure that data are accessed under safe and compliant conditions.
Consortium of Academic Programs in Clinical Research (CoAPCR):MSU-CTSI and the Program in Public Health represent MSU as a member of CoAPCR. CoAPCR is comprised ofglobal educational institutions offering academic credit in all areas of clinical research, regulatory affairs, and clinical data management. In addition, a supporting membership is available to organizations that are stakeholders of students graduating from clinical research academic programs, and to other organizations that are related to the clinical research enterprise, dedicated to enhancing the quality and safety of the clinical research enterprise through education and training. CoAPCR facilitates the development of high-quality educational programs encompassing all areas of clinical research that are based in academic credit-granting institutions. CoAPcR, as a member of the Joint Task Force for Clinical Trial Competency (JTFCTC), produced the 8 domains of the harmonized core competencies for the clinical research professional. CoAPCR’s mission is to 1) provide a medium for communication among educators of clinical research professionals, 2) encourage and support the development and maintenance of academically based clinical research educational programs to meet the needs of the clinical research community, 3) foster inter-institutional articulation among educational institutions, clinical institutions, professional associations, and industry, 4) initiate and/or support research and studies relating to the educational, manpower and service needs of clinical research professionals.
Institutional Partners of the MSU-CTSI:
MSU is unique among American universities by having 4 health colleges (3 human, 1 animal science school): CHM, COM, CON, and CVM. These colleges were established with major missions to train community-based clinicians, whose primary focus is the care of patients/animals in the communities of Michigan. For clinical education and training, CHM, COM and CON partner with regional hospitals across Michigan. After training, these health care professionals continue to serve in smaller cities, towns and rural underserved areas. The basic sciences education and research at these colleges are based at MSU’s central campus in East Lansing.
CHM In addition to 4-year medical schools in East Lansing and Grand Rapids, the CHM uniquely provides students with comprehensive training in clinical settings that most closely parallel the environment in which many physicians practice. During the third and fourth year of the CHM program (Block III), students complete a series of required and elective clerkships at one of MSU’s seven community-based program sites, located in Flint, Grand Rapids, Kalamazoo, Lansing, Saginaw, Traverse City and the Upper Peninsula. Each community program is aligned with area hospitals and outpatient facilities that join MSU in creating a rich educational environment for students. Several sites have residency programs in various specialties, as well as fellowship programs (cardiology, hematology/oncology, endocrinology, infectious disease),
The CHM MD/PhD programs are well-integrated training programs that combines medical training (MD) with outstanding graduate training, leading to PhDs in areas of biomedical research (East Lansing, Grand Rapids). Community Associate Deans for education and research live in their respective communities, but meet regularly as a group and thus are a potential link to research conducted in each of the communities. Although most community health campuses have research offices that assist investigators to perform and present their research, all do not have access to needed resources, particularly statistics and bioinformatics, and few have NIH funding or mentors.
COM was the first college of osteopathic medicine at a major university in the US, and for the 14th year, the MSU College of Osteopathic Medicine was named as one of the nation’s top colleges for educating primary care physicians by U.S. News & World Report’s annual rankings of the best graduate schools. MSU was the first osteopathic school to offer the “DO/PhD” dual-degree program. COM’s Statewide Campus System comprises 30 hospitals; education directors in each hospital communicate directly with one another several times a year. With this leadership position, and the maturation of the Osteopathic profession, COM is actively growing its focus and investment in clinical and translational research, a transformation that is strongly assisted by the MSU-CTSI.