Participant Advocacy and Ombudsman Core provides the key components of the Research Subject Advocate (RSA) program, including the development, maintenance & training on ICTS Site SOP’s as well as on-going training & orientation programs for clinical research coordinators and nursing staff. The core monitors studies . to promote adherence to human subject protection regulations and adoption of operational best practices
The Recruitment Enhancement Core (REC) delivers systematic, data-driven, and strategic support to optimally recruit and retain eligible research participants, as detailed separately in Resources.
The Saint Louis University Center for Health Outcomes Research (SLUCOR) supplements programs available through SLU on health information management (Doisy College of Health Sciences), health management and policy (College of Public Health and Social Justice). Within SLUCOR, work is organized in three sets of activities to inform health care in the translation from patient to policy: education and training, independent research, and consulting. Unique sample data sets include integrated USRDS, Medicare and commercial claims data for US solid organ transplantation, Symphony Health data comprising 10 years of national integrated claims data for ~34M Americans with diabetes, and information from the Missouri Health Initiative, comprising integrated commercial state data (from MO, Southern IL, and KS), PBMs, and Medicare for 6 years. SLUCOR offers a Master’s program in health data science that includes a substantive experience through a capstone project.
The Siteman Biostatistics Shared Resource (SBSR) facility is a shared resource supporting consultation on biostatistics and epidemiology. The core supports cancer research conducted through experimental designs, study monitoring, and data analyses. The faculty and staff utilize efficient methods that reflect ‘best practices’ in biostatistics and epidemiology. Examples of core work include: NIH-funded peer reviewed cancer grants, and pilot and small-scale studies to become part of successful applications for peer-reviewed funding. SBSR offices are located in the Taylor Avenue Building on the east edge of the WUSM campus within the Division of Population Health Sciences, established in 2010. Building on relationships with the SCC and the IPH, the division is a major component of the population health initiative embraced by WUSM leadership. The division also provides a home for the Master of Population Health Sciences (MPHS), a degree program for clinicians who seek training in population-based clinical outcomes research methods. The division also cosponsors the Cell to Society Pathway doctoral training program with the Division of Biology and Biomedical Sciences (DBBS), which provides rigorous training in biology, genomics, epidemiology and biostatistics together to establish new leaders in biological and quantitative population sciences.
The Skandalaris Center for Entrepreneurial Studies was established in 2002 to convey the fundamentals of entrepreneurship to undergraduate and graduate students. In the Fall of 2014, under the direction of the new Managing Director, Emre Toker, the Skandalaris Center changed its name to Skandalaris Center for Interdisciplinary Innovation and Entrepreneurship (SCIIE) and expanded its focus to offer a variety of co-curricular workshops, activities, and competitions to complement the range of classroom education at the individual WU schools. In 2015, the SCIIE Director partnered with the CRTC to offer a 10-hour series of seminars and workshops on I&E thinking on the medical campus to keep up with the student and faculty appetite for additional training. This series was attended by over a hundred participants and, based on extremely positive participant feedback, has been repeated each semester.
The SCIIE offers co-curricular programs to draw students and faculty into the funnel of entrepreneurial activity which provide real-world, practical training opportunities including: pitching ideas at an IdeaBounce® to get feedback and test the market; participating in a three-day intensive Pre-orientation program (for first-year students); working through IDEA LabsTM with Medical School clinicians to develop solutions to every-day problems they experience in practice; attending a series of non-credit workshops that lead from idea generation to business plan development; and taking classes such as The Hatchery, a popular course offered in both the fall and spring semesters through Olin Business School. IdeaBounce® and IDEA LabsTM and described separated under Resources.
The SCIIE hosts several business plan competitions that award funding to support social and commercial new ventures. The innovation and entrepreneurial pathway in these competitions begins with a concept posting to IdeaBounce to provide connection to available resources to prepare the application and identify subsequent deliverables for the competition. The Bear Cub Competition, offering $250,000 awards in three annual cycles, is open to WU faculty, post-docs and graduate students who have previously submitted an invention disclosure to the OTM or who submit an invention disclosure concurrently with their Bear Cub application. Since 2005, the Social Enterprise and Innovation Competition (SEIC) has expanded opportunities for collaboration, innovation and learning supporting SCIIE goals of engaging students and faculty, providing practical training, and funding for the most promising ventures. In its first ten years, the competition has awarded over $1.2 million in cash and in-kind prizes to nearly 50 different mission-based organizations.
The SCIIE coordinates more than 50 entrepreneurship courses across campus, including a capstone course — the Hatchery and the Skandalaris Student Venture Fund (SSVF), an MBA student-run, advisor-guided investment fund. Cocurricular programs include IdeaBounce®, Coffee with the Experts, the Olin Cup, the YouthBridge Social Enterprise and Innovation Competition, the Skandalaris Seminar Series, and the Skandalaris Center Internship Program. Through partnership with the Center for Experiential Learning (CEL) in the Olin Business School, the SCIIE supports the CEL Entrepreneurial Consulting Team (CELect) which delivers impact to the St. Louis start-up community. During fall 2014 through spring 2015, 42 students worked with 12 entrepreneurial organizations, including Arch Grants, Hatchbuck, Prosper Women Entrepreneurs, and Sparo Labs.
Since 2009, the Social System Design Lab (SSDL), supported through the WU Brown School, develops and implements systems dynamics and simulation approaches for the improvement of health and human services. The Lab supports an aggressive scientific research agenda with the expectation that it become a place where students, post-graduates, human service professionals, and researchers can engage in collaborations that bridge the divide between disciplines and government, university, and private sectors to accelerate the research and development of organizational innovations. The SSDL provides a unique role in the fields of systems dynamics, social work, and health and human services by unifying and advancing this approach to research, quality improvement, policy, and evaluation. One of the Lab three main objectives is to promote the application of systems dynamics approaches for the improvement of services and policy through collaborations between professionals, communities, governmental, and nongovernmental organizations. Use of these services over the past six years has established bidirectional communication with community groups. In conjunction with the St. Louis City Department of Health, SSDL services helped to identify barriers to initiating breast cancer treatment among lower socioeconomic status women who receive a suspicious diagnosis of breast cancer in community health centers and federally qualified health centers (FQHCs).
The Statistical Genetic Analysis Core (SGAC) capitalizes on existing WU infrastructure in genetics, including the McDonnell Genome Institute (see below), and the Division of Statistical Genomics to provide comprehensive resources to support investigators engaged in genomics research. The SGAC assists investigators by providing statistical genetics input in experimental design, analysis and interpretation through general services such as protocol design, database development, and statistical analytics.
The StL Biogenerator is an evergreen investor that creates, grows, and invests in promising companies and entrepreneurs in the St. Louis region. BioGenerator identifies and de-risks commercially promising innovations and services; advises innovators and entrepreneurs; recruits and supports entrepreneurial talent; makes staged investments grounded in rigorous due diligence; and offers access to lab space and capital equipment. The Biogenerator positions companies to navigate the unique challenges of early-stage bioscience company development. Facility use agreements for WU and SLU have been developed. Externship programs for trainees are available as well as an Entrepreneur in Residence EIR program to support the growth of entrepreneurial talent by identification of experienced professionals with strong backgrounds including management, operating, and scientific expertise.
TigerPlace is an innovative independent living environment built and operated by Americare of Sikeston, MO, in affiliation with the MU Sinclair School of Nursing. TigerPlace provides a unique opportunity in which to develop and evaluate technology in a collaborative setting with researchers drawn from nursing schools, electrical and computer engineering programs, health management and informatics, as well as schools of social work and medicine to improve the quality of life and care of seniors. This unique setting offers an unparalleled environment combining an aging subject population, research infrastructure, and clinical and translational science resources; TigerPlace residents who choose to participate in research projects enjoy helping to develop new technologies to help other seniors “age in place.” Key concerns of TigerPlace residents mirror those expressed by other seniors in Missouri and the United States; they are concerned about maintaining independence and dignity, have at least one chronic illness and some limitations in activities of daily living; their average age is 85. Located near the MU campus, TigerPlace is a 54-unit apartment complex specially planned to promote the independence of older adults. Nurses, physical therapists, occupational therapists, and specialists in environmental design contributed and participated in the building plan. A 23-unit expansion was opened in 2009.
The Tissue Procurement Core (TPC) facilitates the collection, processing, storage, and molecular analysis of biospecimens from participants enrolled in clinical and translational research studies. ICTS investigators may utilize the core to assist in the prospective collection and processing of human blood and tissue specimens associated with clinical trials, and may also search for and request previously collected biospecimens for translational and correlative research studies.
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TPC maintains the WUSM Biospecimen Navigator (WBN), a comprehensive catalog of research biospecimens collected across the WUSM scientific community. The TPC also assists investigators in designing and executing studies focused on genomic and molecular (e.g. proteomic and lipidomic) analyses of study participant biospecimens. Through close alignment with the CBMI, researchers can have highly integrated access to clinical, pathology, and molecular data associated with each study participant biospecimen(s).
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The TPC occupies 3,000 SF of newly constructed laboratory space on the fifth floor of the BJCIH and an additional 2,800 SF of newly renovated space for off-site biospecimen storage, 3 blocks east of the main laboratory. The BJCIH facility consists of 2300 SF of laboratory space, and 400 sq. ft. of temperature monitored storage space for ultralow mechanical freezers (-80°C), refrigerated storage (4°C) and liquid nitrogen (LN2) vapor storage (-196°C), as well as 300 SF office space. The off-site biospecimen storage facility houses temperature monitored refrigerated, ultralow mechanical freezer, and LN2 vapor storage that is supplied by a bulk-feed LN2 and manifold system. Both facilities are monitored with restricted access limited to TPC Staff and institutional security. The TPC is also located down the hall from the Pathology and Immunology Digital Imaging Center (DIC). Through this combined clinical and research shared resource, whole slide imaging, file storage, and image sharing is available for investigators on a fee for service basis using the Aperio ScanScope XT scanner and Imagescope and Spectrum data management and image analysis software. The main laboratory is equipped with standard instrumentation for blood processing, histology, and nucleic acid isolation and quality assurance.
The Translational Cardiovascular Biobank and Repository (TCBR) was established for the acquisition, utilization and storage of integrated human cardiovascular tissues and clinical data for detailed phenotypic and genotypic analyses. Specimens are obtained using standardized, validated procedures and clinical data can be referenced along with electrophysiological, structural and biochemical for genomic, epigenetic and somatic analyses. Consultation services provided by the TCBR include study form creation, generalized procedures for the creation of tissue biobanks or data repositories, and detailed services for investigators planning to utilize human cardiac tissue and/or clinical data in their research projects. Pediatric cardiovascular tissues facilitate discovery into genetic and epigenetic mechanisms underlying congenital heart and vascular defects, through support provided by the CDI. Experimental data, integrated with clinical information in an accessible database, enables collaborative efforts among basic, translational and clinical researchers to facilitate the timely application of novel research findings to the clinic.
The Undiagnosed Mendelian Disorders Clinic at St. Louis Children’s Hospital (SLCH) specializes in the evaluation of children and adults with severe and complex medical conditions for which a diagnosis has not been made by traditional testing methods (physical exam, imaging studies, metabolic evaluation, single gene testing or chromosomal microarray analysis). Following evaluation, testing recommendations are discussed with the family with counseling regarding the benefits and risks of the test. Clinical exome sequencing, offered through the Division of Medical Genetics and Genomic Medicine of SLCH, examines the majority of coding regions simultaneously to provide a diagnosis. The Clinic provides precision medicine resources to determine diagnosis and subsequent treatment options for affected individuals and their families.
An array of –Omics resources are available through the Saint Louis University Vaccine Trial and Innovation Unit (VTEU) within their central facilities in support of clinical studies and trials. SLU Omics Core investigators will provide expert consultation on 1) timing of sample collection, 2) methods of sample collection, 3) optimal sample storage and shipping conditions, 4) optimal experimental platforms for generation of Omics data, 5) cost-effectiveness of different Omics platforms, and 6) any other issues that arise regarding the planning, preparation or analysis of Omics data. Omics resources available to ICTS members include:
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Lipidomics: comprehensive analysis and quantitation of the structure and function of lipids and their interactions with other lipids, proteins and metabolites within the cell or organism at the membrane or mediator level. This unit offers a range of GC equipment for detection, including electron impact and chemical ionization sources for mass spectrometry and two Thermo Electron Surveyor LC and Quantum Ultra triple quadrupole electrospray ionization mass spectrometers for lipidomic studies.
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Metabolomics: in depth analysis of complex mixtures of small molecular metabolites as a molecular snapshot of cell or organismal physiology in response to pathological processes or genetic modification. This unit offers separation as well as detection methodology.
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Proteomics: comprehensive analysis of the entire complement of proteins, including modification, produced by the organism from a variety of clinical specimens to understand abundance, protein variations and their interacting partners in a network to understand cellular processes in health and disease. This unit uses MALDI-QIT-TOF MS/MS for protein identification and LC-MS/MS on Agilent 6550 Q-TOF to identify signature peptides.
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Transcriptomics: examines the expression level of mRNASs within a given cell or population through expression profiling to determine the type and concentration of mRNA moieties. The unit assays quality through Agilent BioAnalysis for defined QC parameters and uses a combination of DNA microarrays and RNA-Seq approaches for transcriptome profiling. An Ion Torrent Proton sequencer is available, using AmpliseqTM technology (Life Technologies).
The Women and Infants Health Specimen Consortium (WIHSC) assists researchers with the collection of high-quality data and biospecimens related to pregnancy and health of women and infants. A core facility within WUSM, the WIHSC was created in 2008 to advance excellence in the study of women’s and infants health. WIHSC obtains patient consent; collects, processes and stores specimens; and helps researchers select and obtain previously banked specimens based on a comprehensive database of outcomes metrics. The consortium now provides specimens to many academic departments at WUSM, including Pediatrics, Microbiology, Obstetrics and Gynecology, Pathology, Internal Medicine and Developmental Biology. Many sub-studies using WIHSC specimens and data involve multidisciplinary collaboration from the departments involved in WIHSC.
WIHSC enrolls subjects from several clinics at the Medical School Campus, including BJH and is a major provider of obstetrical services to underserved populations in the City of St. Louis, as well as the sole provider of perinatal (high risk obstetrics) and prenatal diagnosis services within the city. WIHSC also enrolls from the Assisted Reproductive Technologies (ART) program offered in the Division of Reproductive Endocrinology and Infertility. ART performs the largest number of in vitro fertilization cycles in the St. Louis area. Patients represent a broad range of socioeconomic groups since roughly half are from Illinois and have mandated fertility/in vitro fertilization (IVF) insurance coverage, and the other half, from Missouri, are often self-pay patients. WIHSC serves as a partner and honest broker, distributing biospecimens and data to researchers focused on women and infant health, disease, fertility and pregnancy. With the ability to consent patients and collect specimens throughout pregnancy – and 24/7 on labor and delivery – WIHSC helps researchers overcome barriers to accessing the tissue, fluid and other samples necessary for women and infants health research.
In 2010 and under the auspices of the Institute of Public Health, the Washington University Network for Dissemination and Implementation Research (WUNDIR) was formed as an informal network of researchers with a common interest in dissemination and implementation science in a variety of different settings and sectors (mental health services, public health, diabetes, acute care, emergency medicine, obesity, cancer, tobacco). Over 80 WUNDIR members attend six half day meetings throughout the year, alternating between the Danforth and Medical School campuses. Meetings provide updated D&I resources, collaborative options for trans-disciplinary research, and a forum to provide peer critique of papers and grant proposals (from concept to full submission).
Washington University Pediatric and Adolescent Ambulatory Research Consortium (WU PAARC) is a practice-based research network of community pediatricians in St. Louis and surrounding areas that initiates and conducts research studies and collaborates with other investigators to design and implement studies in the community setting. Community practitioners provide input to identify study questions and ensure that network studies are relevant to clinical practice and feasible to complete in the office setting. The network was established in 2002 with an infrastructure development grant from the Agency of Healthcare Research and Quality (R21 HS13530-01), and is affiliated with WUSM Department of Pediatrics. Currently WU PAARC includes about 78 pediatricians and 6 pediatric nurse practitioners (PNPs) from 36 practices (see map). These providers care for about 160,000 children who are demographically diverse and representative of the local community. WU PAARC is part of the CCHPR, a core of the ICTS that is supported in part by a NIH CTSA. The director and staff are located in the Patient Oriented Research Unit, comprising 22,100 SF on the 10th floor of the Northwest Tower.
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