University of Michigan
The University of Michigan is one of the best public research universities of the United States and a leader in higher education. It was ranked the No. 1 U.S. public university by QS World University Rankings 2019–2020.
Since 1817, the University has provided a national model of a complex, diverse, and comprehensive public institution of higher learning that supports excellence in research, provides outstanding undergraduate, graduate, and professional education, and demonstrates commitment to service through partnerships and collaborations that extend to the community, region, state, nation, and around the world.
The University's mission directs the institution “to serve the people of Michigan and the world through preeminence in creating, communicating, preserving and applying knowledge, art, and academic values, and in developing leaders and citizens who will challenge the present and enrich the future”.
Permeating all 19 Schools and Colleges, research is central to the University of Michigan’s mission and comprised over $1.62 billion expenditures in 2019. The University of Michigan is a strong advocate of promoting collaboration and interdisciplinary research initiatives that involve faculty and students across the campuses. The University of Michigan Office of Research’s mission is to catalyze, support and safeguard the University’s research.
The University serves its student body of more than 44,000, retains an eminent faculty of 8,000, and its libraries hold more than 15 million volumes. Michigan's excellence in higher education rests on the outstanding quality of its schools and colleges, fourteen of which accept undergraduate students, as well as on national recognition of individual departments and programs and on the many major scholarly and creative contributions of its faculty.
More than 100 of its graduate programs are ranked Top Ten in their fields, indicating remarkable breadth and depth of excellence. Michigan is a national leader in securing private sector support from its friends and alumni; it has more than 611,000 living alumni around the world. The University is governed by an elected Board of Regents, each member of which is elected to an 8-year term (without term limits). Dr. Mark S. Schlissel is President of the University.
(Last updated November 2019)
At Michigan Medicine, we advance health to serve Michigan and the world. We pursue excellence every day in our three hospitals, 125 clinics and home care operations that handle more than 2.3 million outpatient visits a year, as well as educate the next generation of physicians, health professionals and scientists in our U-M Medical School.
Michigan Medicine includes the top ranked U-M Medical School and the University of Michigan Health System, which includes the C.S. Mott Children’s Hospital, Von Voigtlander Women’s Hospital, University Hospital, the Frankel Cardiovascular Center and the Rogel Cancer Center. Michigan Medicine’s adult hospitals were ranked no. 11 in the nation by U.S. News and World Report in 2019-20 and C.S. Mott Children’s Hospital was the only children’s hospital in Michigan nationally ranked in all 10 pediatric specialties analyzed by U.S. News and World Report for 2019-20. The U-M Medical School is one of the nation's biomedical research powerhouses, with total research funding of more than $500 million.
More information is available at www.michiganmedicine.org.
(Last updated November 2019)
U-M Medical School
The University of Michigan Medical School began in the year 1850 with five faculty members, 90 students, and five physicians seeking additional training. The School currently has 3,879 faculty members teaching 795 medical students, 685 graduate students, 591 postdoctoral fellows, and over 1,000 interns and residents, as well as other groups of learners. The Medical School offers three faculty tracks: Instructional Track (955); Research Track (415); and Clinical Track (1,549). Additionally, the School has 256 clinical lecturers/lecturers.
The University has had notable "firsts" in medicine: it was among the first of the state-supported universities to have a medical school (1850), it had the first teaching hospital owned by a university (1869), and it had the first university department of roentgenology (1917). Given these circumstances, teaching and research were early priorities. Medical School alumni include Nobel Prize winners, a former U.S. Surgeon General, leaders of Fortune 500 companies, and faculty at the best educational and research institutions around the world. With 20,600 alumni, the School is second in the nation in the number of alumni who are faculty members at academic institutions across the country. Thousands of University of Michigan Medical School graduates provide the highest quality of care to patients in the United States and throughout the world. Today the Medical School graduates approximately 200 physicians annually and is consistently ranked as one of the top institutions in the nation. In the 2020 U.S. News & World Report's Best Medical Schools rankings, the University of Michigan Medical School placed No. 6 for primary care and No. 16 for research. The Medical School has twenty clinical and nine basic sciences departments, as well as the Unit for Laboratory Animal Medicine. Teaching, research, and clinical care often cross traditional departmental boundaries, particularly in the School's 39 interdisciplinary research centers and institutes, including the Rogel Cancer Center, the Geriatrics Center, the Cardiovascular Center, and the Michigan Institute for Clinical and Health Research (MICHR).
Faculty members lead research efforts in a broad scope of basic and clinical science areas. In FY2019, the Medical School received $646 million in awards from all external sponsors. Annual NIH grant funding awarded to the School's clinical researchers and biomedical scientists reached $552 million in FY2019, which places UMMS 10th of medical schools in the nation in terms of NIH grants awarded. In FY2019, Medical School researchers filed 226 reports of new inventions.
Fast Forward Medical Innovation initiative unifies Medical School efforts to nurture commercialization and entrepreneurship activity in close collaboration with U-M Technology Transfer. The initiative integrates activities of the Office of Research's Business Development group and the MTRAC for Life Sciences commercialization fund with partners across campus, such as the College of Engineering's Center for Entrepreneurship and the U-M Business Engagement Center.
In addition to their work in research and education, faculty in clinical departments provide inpatient and outpatient care within Michigan Medicine, which includes three major hospitals and multiple health centers and outpatient clinics. Medical School's physical plant is comprised of 50 buildings (including 16 at the North Campus Research Complex), encompassing 2.3 million square feet.
(Last updated November 2019)
Michigan Institute for Clinical & Health Research (MICHR)
The Michigan Institute for Clinical & Health Research (MICHR) strives to enable and enhance clinical and translational research by educating, funding, connecting, and supporting University of Michigan (U-M) investigators. MICHR’s ultimate goal is to accelerate the translation of scientific discoveries, resulting in improved health for local, national, and global communities. MICHR provides U-M researchers with the training, tools, and services necessary to speed discovery of new ways to diagnose, treat, and prevent disease. Specifically, MICHR develops research talent through its predoctoral and postdoctoral education programs; helps investigators launch their ideas through pilot grant funding and consultation; connects researchers with community groups, clinics, practice-based networks, and potential study volunteers; and supports research teams with clinical research management services, including biostatistical design and analysis, study monitoring, project-specific database development, data and study management mentoring, and a fully-equipped and professionally-staffed clinical research unit. U-M established MICHR as a centralized resource to transform translational research in 2006, and a NIH Clinical and Translational Science Award has supported MICHR since 2007.
MICHR Facilities and Resources at the North Campus Research Complex: MICHR occupies 26,000 square feet of office space in a single-story building that is part of the North Campus Research Complex. The MICHR administrative space includes six shared meeting rooms that accommodate 50 or more people, a fully equipped training room that accommodates 40 people, and multiple small meeting rooms that may be used for interviews and short video production. MICHR shares the North Campus Research Complex with the IRB, administrative offices for both U-M’s and the Medical Schools’ Offices of Research, the clinical trials office of the U-M Comprehensive Cancer Center, the U-M Office of Technology Transfer, and the U-M Business Engagement Center, creating a hub for clinical and translational research administration. Housing these resources in such close proximity fosters an unprecedented level of communication, collaboration, and sharing of best practices among these units.
MICHR has many programs that provide research support services to U-M investigators:
Education and Mentoring Group (EMG): MICHR’s Education and Mentoring Group (EMG) provides multidisciplinary education, career development, and mentoring programs for members of clinical and translational research teams across U-M. Offerings include: 1) mentored research programs comprising (1a) the Mentored Clinical Scientists Career Development Program (MICHR K), (1b) the Postdoctoral Translational Scholars Program, (1c) the Pathways to Engagement program for faculty preparing for community engaged research projects, and (1d) a pre-doctoral Summer Immersion program; 2) a Master of Science in Clinical Research program; 3) educational and training initiatives including (3a) clinical trials training for faculty and staff, (3b) mentoring education and training, and also instruction in (3c) scientific writing and (3d) research methods; 4) research and evaluation studies to demonstrate the impact of our competency-based approach to education; and 5) consultation to other U-M units regarding educational initiatives.
EMG Facilities and Resources: EMG has a number of resources that facilitate educational content development and provide faculty, trainees, and mentors with an enhanced learning and teaching environment. Specifically, EMG has multimedia production software; and video, audio, and mixing equipment available for developing scripted video content, e-learning modules, and other digital learning products. In addition, MICHR has a multimedia studio that can accommodate and facilitate webinar production and presentation, remote meeting access, and blended-learning training techniques that combine online and face-to-face instruction.
Pilot Grant Program (PGP): MICHR’s Pilot Grant Program (PGP) offers funding to facilitate and support innovative research across the translational spectrum (bench to bedside, bedside to practice, practice to policy). The PGP currently hosts six different funding mechanisms that are designed to support faculty along their career trajectories from obtaining their first extramural grants all the way to large, team-based initiatives. PGP award amounts range from $5,000 to $100,000. Since inception, the PGP has awarded $23.7 million, and awardees have self-reported $220 million in subsequent funding.
Research Development Core (RDC): MICHR’s Research Development Core (RDC) offers no-cost consultation and grant editing services to investigators during all stages of proposal development. During consultations, the RDC team advises on hypotheses, specific aims, study design, biostatistics, future research directions, and grantsmanship; matches research ideas with funding sources; and suggests potential collaborators and mentors. RDC’s grant editors review proposals and provide edits to strengthen clarity, flow, and grammar. Since 2011, RDC has provided support for 1100 grant proposals and research ideas resulting in $141 million in external funding.
Biostatistics Group: MICHR’s Biostatistics Group offers consultation, collaboration, and mentoring throughout the lifecycle of a study. Services include grant proposal and protocol review, study implementation, and manuscript development. MICHR’s faculty and staff biostatisticians provide expertise in research design, randomization scheme development and implementation, data analysis planning and implementation, data quality assessment, and database review. Initial consultations are free of charge. Biostatisticians will serve as study co-investigators, team statisticians, or statistical analysts for a fee.
Community Engagement (CE) Program: MICHR’s Community Engagement (CE) program provides consultation, education, and funding to support research projects in community and practice-based settings. CE services and funding are available to a broad base of partners, including academics, community members, health providers, and others engaged in collaborative research efforts to improve community and population health. MICHR also maintains strong and active relationships with community partners and organizations state-wide who work together to foster university-community research partnerships and facilitate specific community-engaged research projects.
Participant Recruitment Program: MICHR’s Participant Recruitment Program provides an array of services for research teams needing support to recruit, enroll, and retain participants. The Recruitment Program offers consultations to faculty and other research team members and can conduct recruitment analysis and strategic planning. This includes developing robust recruitment plans, creating timelines, and estimating costs. The Participant Recruitment Program also maintains UMHealthResearch.org, an engaged volunteer registry, which provides research teams with a database of >40,000 individuals interested in research participation as well as a portal where study teams can advertise their studies and give them a place to reside on-line. The database recommends studies to participants on topics of interest to them and recommends participants to research teams based on participants’ responses to health profile questions. The program also offers assistance with the creation of professional quality marketing and advertising materials as well as assists teams with paid targeted social media advertising and community outreach.
MICHR Informatics Program: MICHR's Informatics team consists of staff who have specialized knowledge and experience in clinical research systems and processes. Informatics develops, implements, and supports informatics software for clinical research investigators and currently provides researchers with several web-based systems. For example, REDCap (Research Electronic Data Capture), is a secure web-based application designed to support electronic data capture for clinical research studies. REDCap provides an intuitive interface for data entry, audit trails, automated export and import procedures, and advanced features such as branching logic and calculated fields. In addition, Informatics has developed EMERSE (Electronic Medical Record Search Engine), which provides a self-service web-based tool for authorized users to search clinical notes from our electronic medical record. Users can input their own terms or phrases and get results within seconds. The clinical notes include admission, discharge, and progress notes, as well as ambulatory care notes and notes from radiology, pathology, and other reports going back to 1998. Also, MICHR Informatics has developed UMHealthResearch.org (UMHR), a public website which allows participants to search for studies using various parameters and express interest in the studies that fit them. These volunteer participants create personal accounts with self-reported demographic and health information, and researchers create digital postings that describe their study and eligibility criteria. A matching algorithm continuously runs to link eligible volunteers with studies open for recruitment. UMHR currently has >42,000 registered volunteers interested in clinical research.
MICHR IND/IDE Investigator Assistance Program (MIAP): The MICHR IND/IDE Investigator Assistance Program (MIAP) provides comprehensive regulatory support, guidance, and education services to investigators involved in Food and Drug Administration (FDA) regulated clinical research. MIAP's primary focus is providing regulatory assistance to sponsor-investigators of drugs, biologics, and medical devices. This includes Investigational New Drug (IND) and Investigational Device Exemption (IDE) services such as: regulatory needs assessments; exemption rationale development; assistance with FDA meeting preparation; assistance with IND and IDE application submissions, including protocol and informed consent development; assistance with regulatory compliance, document preparation, and FDA contact and correspondence; sponsor investigator training; and ongoing study assistance, including safety reporting, FDA annual report preparation, protocol amendments, and IND/IDE closeout.
Clinical Research Management (CRM): MICHR’s Clinical Research Management (CRM) group provides the highest quality operational and regulatory support for single and multi-center clinical studies in accordance with Standard Operating Procedures, Good Clinical Practice, and appropriate regulatory requirements. The CRM team includes Certified Clinical Research Professionals with experience in both clinical research and project management. CRM can staff can be engaged to design project databases built for efficient collection, management, and analysis of research data. CRM also provides study monitoring services for clinical trials, including IND/IDE required monitoring. Services include site initiation, interim, and close-out visits; pre- and post-audit reviews; and NIH/DoD preparation visits. In addition, CRM provides study teams with mentoring focused on data management and study management activities, as well as assistance with registration of clinical trials in the ClinicalTrials.gov Protocol Registration and Results System.
(Last updated January 2020)
Institute for Healthcare Policy & Innovation (IHPI)
Overview: The Institute for Healthcare Policy and Innovation (IHPI) is the nation’s largest university-based group of health services researchers, uniting more than 600 University of Michigan (U-M) faculty members across diverse disciplines to solve complex and timely healthcare policy and practice challenges. IHPI members represent 15 U-M schools and colleges on the main Ann Arbor campus, and several academic units on U-M’s Flint and Dearborn campuses. The Institute strategically aligns broad expertise across such fields as medicine, public health, nursing, social work, public policy, engineering, business, dentistry, law, information, pharmacy, social sciences, and more. IHPI also encompasses 24 health services research-focused U-M centers and programs, many of which predate the Institute and originally provided the collective momentum to establish it. The U-M Board of Regents approved the creation of IHPI in May 2011.
Mission, Vision, and Strategic Priorities: The Institute’s mission is to enhance the health and well-being of local, national, and global populations through innovative, interdisciplinary health services research. The Institute strives to inform public and private efforts to optimize the quality, safety, equity, and affordability of healthcare services through: Collaboration (Intellectual Synergies), Evidence (Novel Research Ideas & Approaches), and Impact (Public & Private Partnerships).
IHPI’s strategic priorities include the areas of healthcare reform, opioid policy, healthy aging, health equity, Medicaid policy, value in healthcare, healthcare safety, and precision health. Another core focus of IHPI is developing the next generation of healthcare leaders and scientists. As such, the Institute provides strong support to early stage investigators through mentorship from senior scientists; forging connections with experts in innovative methodological and analytical approaches; and offering regular seminars and workshops to share state-of-the-science evidence within health services research and help build research, policy engagement, and leadership skills. The Institute is also one of six host sites for the National Clinician Scholars Program, which trains clinicians as change agents driving policy-relevant research and partnerships to improve health and health care.
Leadership and Governance: The Institute is led by Director John Z. Ayanian, M.D., M.P.P., and Managing Director Gail Campanella, M.B.A. IHPI’s Institute Leadership Team assists the Director and Managing Director in decision-making on matters related to: scientific direction; policy; education and training; budget; recruitment; membership criteria, approvals and engagement; and Institute governance. A National Advisory Board, consisting of local, national, and internationally recognized leaders with demonstrated expertise in the areas of healthcare delivery, public policy, research, education, business, and philanthropy, assists the Institute in achieving and monitoring its mission and goals. IHPI’s Early Career Faculty Advisory Council advises Institute leadership on how to best leverage its resources to promote the success of early career faculty and accelerate the impact of their research.
Space, Facilities, and Intellectual Environment: IHPI’s administrative home at U-M’s North Campus Research Complex (NCRC) provides a centralized venue and robust resources to convene researchers – physically and virtually – to respond to vital questions within healthcare policy and practice. The IHPI footprint, which provides nearly 88,000 square feet of contiguous physical space within NCRC, offers cutting-edge information-sharing technologies as well as informal and formal meeting and working space to facilitate multidisciplinary interactions. More than 400 IHPI members, staff, and trainees are located in IHPI space at NCRC. In addition to dedicated workspace, IHPI administration supports several collaborative work spaces for IHPI members, and encourages researchers to use these spaces for limited duration projects. Flexible workspace for faculty not housed at NCRC is also provided.
Faculty and research staff from the VA’s Center for Clinical Medicine Research are also co-housed in VA-controlled space within the IHPI footprint, providing valuable collaborative opportunities. Likewise, many coordinating centers for the U-M Health System’s Collaborative Quality Initiatives, which work collaboratively with healthcare providers throughout Michigan to collect, analyze, and share data to guide quality improvement, are co-housed at NCRC, with a majority led by IHPI members. IHPI also organizes many formal and informal networking opportunities, both at NCRC and across campus, for faculty members to enhance and develop research collaborations around common interests and connect to the many services and programs offered to IHPI members.
Core Services and Programs: The Institute offers several core services and programs to support and enhance the research and dissemination capacity of all IHPI members. IHPI’s Data and Methods Hub facilitates access to data resources and provides expert analytical and methodological support. IHPI’s Communications and Policy Engagement and External Relations teams help communicate research results to policymakers, the media, and the public, and facilitate connections between IHPI researchers and these stakeholders. IHPI also offers an array of education and training programs to support ongoing professional development.
John Z. Ayanian, M.D., M.P.P., Director
The University of Michigan
North Campus Research Complex
2800 Plymouth Road
Ann Arbor, MI 48109-2800
(Last updated February 2020)
Fast Forward Medical Innovation (FFMI)
Fast Forward Medical Innovation (FFMI): Significance With 422 invention disclosures and 160 issued patents in 2015, U-M has tremendous potential to create a positive impact on human health and society. To facilitate the translation of discoveries to impact, the Fast Forward Medical Innovation (FFMI) program was established in 2014 to accelerate the transformation of biomedical innovations into patient and health impact. While the number of academic medical center innovation programs around the nation is growing, FFMI remains unique in its integration of 1) product development funding and mentorship through an “Innovation Navigator” Program, 2) industry engagement via a business development team, and 3) innovation and commercialization education. The combination of these strategically integrated programs enables FFMI to build and nurture a culture supportive of biomedical innovation with the goal of accelerating new products coming to market as well as to catalyze clinical-translational scientists to think differently about their research.
FFMI’s Four Key Strategies:
FFMI Funding & Mentorship programs provide milestone-driven innovation, commercialization funding, and expert mentorship. FFMI offers consultation for multistage technology development, funding, and mentorship for successful commercialization of biomedical discoveries, across U-M campus and also as a statewide biomedical Innovation Hub. Fast Forward Medical Innovation offers researchers a number of funding opportunities to help advance biomedical research projects. From the statewide MTRAC for Life Sciences Innovation Hub to U-M internal funds, resources, and personalized funding consultations, FFMI gives researchers valuable guidance and support as they navigate the path to successful commercialization.
FFMI Commercialization Education: Programs Accelerating Commercialization Education (PACE) Whether you’re a med student, fellow, clinician, or seasoned researcher, PACE from Fast Forward Medical Innovation offers a broad spectrum of innovation and commercialization educational opportunities. PACE provides valuable mentorship and will give you a deep, real-world understanding of strategy and tactics helping you gain valuable insight into successfully translating your research to market.
FFMI Business Development Every day, stakeholders across healthcare are forming novel partnerships in an effort to accelerate new technologies to market. Fast Forward Medical Innovation Business Development team members are alliance managers, building and executing successful relationships between U-M Medical School researchers and their potential corporate partners. By using creative partnering methods, including precompetitive consortia, sponsored research, and co-development, the team connects collaborators and works with them to navigate the system and take translational research to a successful outcome.
FFMI Statewide Innovation Hub The Michigan Translational Research and Commercialization for Life Sciences Innovation Hub is a statewide program supporting translational research projects in life sciences with high commercial potential, with the ultimate goal of positively impacting human health. Innovators from all schools at the University of Michigan, other institutions of higher education, non-profit research centers, and hospital systems across Michigan are eligible to submit projects for funding consideration. The program offers early-stage funding opportunities through Mi-Kickstart, and Mi-TRAC is our funding program for mid-stage commercialization projects. MTRAC for Life Sciences Innovation Hub/Mi-TRAC/Mi-Kickstart have awarded millions of dollars in funding since launch. CLICK HERE to see our Project Awards.
The MTRAC for Life Sciences Innovation Hub is co-managed by the U-M Medical School’s Fast Forward Medical Innovation Program and U-M Tech Transfer. It has an operating budget of $4.05M, with half of the funds coming from the State of Michigan’s Michigan Strategic Fund (MSF) and the remainder coming from participating institutions. The program reinforces the commitment of the MSF, the Michigan Economic Development Corporation, and the U-M to entrepreneurship as a dynamic catalyst for economic growth, allowing for greater collaboration and ultimately increasing the number of start-ups, jobs, industry licenses, and investment for Michigan.
(Last updated October 2019)
Central Biorepository (CRB)
The Central Biorepository (CBR), a unit of the University of Michigan Medical School Office of Research, is state-of-the-art research infrastructure with a mission to facilitate discovery and improve healthcare outcomes by providing high-quality, highly annotated biospecimens donated for basic, clinical and translational research. The CBR meets and exceeds biospecimen best practices described by the International Society for Biological and Environmental Repositories and is accredited by the College of American Pathologists (CAP) Biorepository Accreditation Program.
The repository is populated through CBR partnerships with investigators, departments, centers, and institutes that collect biospecimen resources for their own research and commit to sharing samples for additional, approved research uses. Michigan Medicine patients enrolled in CBR programs provide consent for broad use of biospecimens, as well as controlled access to clinical data contained within the electronic health record.
Biorepository processes are included in a quality management system (QMS) to ensure maintenance of specimen integrity for the duration of the storage. The QMS includes version-controlled standardized operating procedures, scheduled and documented equipment calibration and maintenance, internal audit procedures, information systems backups, and personnel training programs with competency testing. Sample chain of custody is secured and tracked throughout the life cycle of the biospecimen using barcodes and a commercially available laboratory information management system (LIMS) tailored to meet UMMS needs. Frozen samples are stored in monitored and alarmed liquid nitrogen vapor phase cryogenic freezers and -80°C mechanical freezers. Liquid nitrogen is supplied on-demand from an external bulk-tank and plumbed into each storage unit, including the -80°Cs, where it serves as a back-up cooling mechanism. Mechanical freezers, temperature-monitoring devices and other key equipment are connected to the emergency power grid, powered by two diesel-fired generators. Biorepository services also include sample aliquotting, DNA and RNA isolation, nucleic acid quantification, and sample distribution management.
The CBR LIMS securely integrates with a research data warehouse containing detailed clinical information sourced from the electronic health record. This connection allows U-M scientists to interrogate the biorepository and discover samples of interest from a research-specific, clinically defined cohort of individuals. Access to biospecimens and associated data is subject to regulatory and steering committee approval.
The CBR and lab occupies 4,200 square feet, comprising a 2,200-square-foot freezer storage space and 2,000-square-foot wet lab. Access to the labs is controlled, where entrance to the wet lab requires a key code and the freezer facility is badged-entry only. The CBR has current capacity for up to 1,200,000 biological samples in 2 ml tubes. There are eight upright -80°C freezers and eight LN2 vapor phase storage units, each configured for 46,565 and 65,610 2mL cryovials, respectively. The CBR has space for up to 10 additional cryogenic storage freezers or 10 -80°C freezers, or a combination thereof.
Freezers, refrigerators, ambient temperatures, and laboratory humidity are monitored via NIST-calibrated sensors connected to a 900 MHz, web-based monitoring system, called TempTrak. Use of the biorepository and its service is on a fee-for-service recharge basis.
(Last updated October 2019)
Unit for Laboratory Animal Medicine (ULAM)
Animal husbandry will be provided by the staff of the Unit for Laboratory Animal Medicine (ULAM) under the guidance of supervisors who are certified by the American Association for Laboratory Animal Science (AALAS). Veterinary care will be provided by ULAM faculty members (11) and veterinary residents (8). As of January 2017, eleven members of the faculty are diplomats of the American College of Laboratory Animal Medicine (ACLAM). The University of Michigan is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC, Intl) and the animal care and use program conforms to the standards of “The Guide for the Care and Use of Laboratory Animals,” Revised 2011. The program includes required inspections of animal facilities, review of all funded projects for humane use of animals, and the appropriate use of surgical anesthesia, analgesics, and tranquilizers. The University of Michigan has filed an assurance statement on these matters with the Office of Laboratory Animal Welfare (OLAW).
(Last updated November 2019)
Biomedical Research Core Facilities (BRCF)
The Biomedical Research Core Facilities (BRCF) are a collection of campus-wide laboratories used for developing and providing state-of-the-art resources to facilitate biomedical research. These facilities are available on a fee-for-service basis to the University of Michigan biomedical research community. Cores include:
- Advanced Genomics Core
- Bioinformatics Core
- Biomedical Research Store
- Epigenomics Core
- Flow Cytometry Core
- Metabolomics Core
- Microscopy Core
- Proteomics Core
- Transgenic Animal Model Core
- Vector Core
Core Facilities aim to ensure access to new biomedical research services and costly instrumentation for a wide variety of investigators, avoiding duplication of expense and effort. Cores also offer highly trained personnel to carry out the procedures for investigators, increasing efficiency and quality control in coordinating services for multiple users.
In addition, Core Facilities sponsor relevant mini-courses, technical symposia, etc. as a training function for university investigators and implement new shared services as needed. As part of this effort, Core Facilities coordinate applications for externally funded instrumentation grants to purchase equipment.
To help streamline core processes, the BRCF uses a single portal for investigators to request services from core facilities. MiCores is a scheduling, billing and reporting system that is fully integrated into the University of Michigan financial system. From the initial request through billing to data reporting and performance metrics, both internal and external clients have access to MiCores.
The instrumentation used in Core Facilities is sophisticated and costly; with the analytical techniques and operations highly specialized. Instrumentation is regularly being upgraded to keep pace with the rapid advance in biomedical research. It is virtually impossible for individual laboratories to afford such a broad array of facilities and technical expertise. This is where the BRCF can help support your efforts in biomedical research.
Medical Science Research Building (MSRB) II
1150 W. Medical Center Drive, C560
Ann Arbor, MI 48109-5613
For more information, please visit the Facilities' website at:
(Last updated November 2019)
Institutional Review Boards of the University of Michigan Medical School (IRBMED)
The Institutional Review Boards of the Medical School (IRBMED) are charged with the oversight of human subjects research conducted by Medical School faculty, students, and staff at Michigan Medicine facilities or sites. Additionally, IRBMED has oversight of all UM studies subject to Food & Drug Administration (FDA) regulations. The purpose of an IRB is to protect the rights and welfare of human subjects in research. Guiding this process is the application of federal regulations, state laws, university policies, and ethical principles, particularly those articulated in the Belmont Report.
The IRBMED is composed of six distinct boards (A1, A2, B1, B2, C1, C2) of approximately 120 members. Some researchers may need to cede IRB oversight to an external IRB. UM is a signatory to the SMART IRB master reliance agreement which facilitates the establishment of IRB reliance arrangements with external institutions. UM also has master reliance agreements with the Central Institutional Review Board for the National Cancer Institute (NCI CIRB) and two commercial IRBs, Advarra and Western IRB (WIRB). Faculty and students outside of the Medical School and Michigan Medicine may need to apply to the Health Sciences and Behavioral Sciences IRB (IRB-HSBS).
IRBMED offers presentations on topics important to researchers conducting human subjects research, invites special speakers to present to the UM community, and provides workshops on IRBMED processes throughout the year and upon request. In addition to the IRBMED offerings, UM offers other research education opportunities. Workshops cover both context issues (e.g., regulations, special considerations, writing a consent form) and technical issues (e.g., application completion and submission).
(Last updated October 2019)
Rogel Cancer Center (RCC)
Under the leadership of Dr. Max Wicha, MD, the University of Michigan Rogel Cancer Center was established by the University Board of Regents in May, 1986. Dr. Eric Fearon, MD, PhD, was named Director in September 2016. The center (which has received consistent NCI core funding and was awarded the “comprehensive” status in 1991) has grown to over 300 core grant members with over $110 million per year in direct cost research support. In federal fiscal year 2018, the University of Michigan Rogel Cancer Center ranked #7 in the nation among all organizations classified within domestic higher education in National Cancer Institute (NCI) funding and the University of Michigan Medical School ranked #6 in the nation among all medical schools in National Cancer Institute (NCI) funding. The research and training missions of the Center are carried out in four basic science programs (Cancer Genetics, Cancer Biology, Developmental Therapeutics, and Cancer Hematopoiesis and Immunology), a clinical research program (Translational and Clinical Research), and two cancer control and population sciences programs (Cancer Epidemiology & Prevention, and Health Behavior & Outcomes).
In May 1997, the Cancer Center moved into the new nine-story $88 million Cancer Center Building, occupying roughly 90,000 sq ft of research space, 5,000 sq ft for an animal facility, and 125,000 sq ft of clinical space which houses many of the Center’s outpatient clinics as well as infusion space. A Phase I unit was added in 2008 to offer first-in-human trials with an adjacent translational research laboratory. The Rogel Cancer Center has over 70,000 sq ft in the North Campus Research Complex (NCRC) which houses shared core facilities, basic science, translational, and behavioral sciences researchers and laboratories, and the Oncology Clinical Trials Support Unit (CTSU), which has more than 125 FTEs providing pre-/post award financial management, regulatory, data management, multisite coordination and IT support for therapeutic and select non-therapeutic cancer clinical trials across all tumor types. NCRC also houses the Cancer Center’s Community Outreach Program, Education Program and the Research Administration Finance Unit.
In addition to its support of basic science, clinical research and population science research programs, the Rogel Cancer Center also provides support to a wide variety of state-of-the-art shared resource (core) facilities including: Biostatistics Analytics & Bioinformatics, Experimental Irradiation, Flow Cytometry, Immune Monitoring, Cell & Tissue Imaging, Pharmacokinetics, Structure & Drug Screening, Preclinical Imaging & Computational Analysis, Tissue & Molecular Pathology, Transgenic Animal Models, Health Communications and two developing shared resources: Proteomics, Single Cell Analysis.
Rogel Cancer Center Shared Equipment
- Milli-Q water systems
- Milli-Q water filtration systems are located in autoclave rooms 3126, 4126, 6126, and 7126
- Xray Film Developer
- An Xray film developer is located in the west side dark room 6132
- Digital Gel Imaging Systems
- BioRad Chemidocs are located in east side equipment rooms 4400 and 6400
- High Speed Centrifuges
- Lynx 4000 centrifuges are located in equipment rooms 4132 and 7132
- Liquid Scintillation Counter
- LS-6500 Standard Vial Counter is located in room 3135
- Sterilizers and Dishwashers – 3126, 4126, 6126, and 7126
- A free door-to-door dishwashing service is also available by signing up via firstname.lastname@example.org
- Ethidium Bromide Gel Imaging
- Alpha Imager Gel Docs are located on floors 3400, 4400, and 7400
- UVP Gel Studio Touch is located in room 6400
- Shaker Incubators
- New Brunswick Innova 4300 – 4132, 7132
- Backup -20 – 7401
- Backup -80 – 3416, 7401
- Speed Vacs
- Savant Integrated SpeedVac – 6th floor west cold room, 6125
(Last updated October 2019)
Clinical Trials Support Office (CTSO)
The Clinical Trials Support Office (CTSO) is the central hub for the seven trans-departmental Clinical Trials Support Units (CTSUs), providing enterprise-wide leadership, standards, policies, and a common infrastructure for clinical research at Michigan Medicine.
The CTSUs were developed to ensure timely activation and efficient execution of clinical research at Michigan Medicine. Recognizing that institutional resources with deep expertise are already available in several units, the CTSUs partner with these units to strategically shepherd clinical research as the administrative process continues to be streamlined. Leveraging resources such as the Michigan Institute for Clinical & Health Research (MICHR) and the Medical School Regulatory Affairs team provides Study Teams with comprehensive and robust support without duplicating effort.
Clinical Trials Support Units
The seven Clinical Trial Support Units are business units that partner with investigators and their teams to ensure the timely and efficient activation and execution of clinical trials. The CTSUs are thematically aligned based on research foci. These local units provide comprehensive support to study teams, offering high-quality and efficient service in support of a mix of clinical trials. The CTSUs provide a professional environment of expert personnel accessible to all investigators, especially early-career faculty.
- Acute, Critical Care, Surgery & Transplant CTSU provides infrastructure to study time-sensitive, unscheduled clinical interventions in the emergency medical services system, emergency department, critical care unit, transplant, or studies conducted in an acute hospital setting.
- Ambulatory & Chronic Disease CTSU is the home for all chronic, non-ICU diseases in the non-ICU adult population (excluding cancer and cardiovascular disease). These diseases constitute the majority of clinical trials in the ambulatory Internal Medicine divisions and the Department of Ophthalmology & Visual Sciences (rheumatology, endocrinology, pulmonary medicine, geriatrics, nephrology, and gastroenterology) which account for a large number of the ambulatory trials within Michigan Medicine.
- Behavior, Function, and Pain CTSU represents investigators who conduct trials that involve behavioral interventions or behavioral or biomedical trials intended to impact the following types of outcomes: health behaviors (physical activity, self-management), psychological states (e.g. mood, anxiety), maladaptive behaviors (e.g. substance use, eating disorders), physical function (e.g. recovery from stroke, rehabilitation therapies), psychosocial function, or pain.
- Children’s CTSU specializes in clinical trials for pediatric subjects. The unique needs of children and their families are the focus of this CTSU. The CCTSU provides enhanced support to a variety of pediatric clinical trials, including but not limited to pediatric disciplines such as hematology/ oncology, intensive care, nephrology, neurology, and endocrinology.
- Heart, Vessel, Blood CTSU enhances performance of cardiovascular, coagulation, and nonmalignant hematologic clinical trials across the lifespan of acute and chronic disease.
- Neurosciences and Sensory CTSU is a multidisciplinary, multi-departmental CTSU that aims to provide a full range of services for investigators with clinical trials related to the skin or nervous system. The CTSU is open to all faculty within the departments of Neurology, Neurosurgery and Dermatology, along with faculty outside these departments who find a natural fit with the CTSU theme.
- Oncology CTSU serves as the centralized core facility of all oncology clinical research trials conducted by investigators at the University of Michigan Rogel Cancer Center and the Michigan Medicine community.
Clinical Trials Management System
All clinical research being serviced by a CTSU will be managed in OnCore, an enterprise Clinical Trials Management System. OnCore allows for automated standard interfaces with MiChart, which helps reduce duplicate data entry and integrates clinical research billing for increased efficiency and accuracy. OnCore provides complete subject and financial management for all clinical trials at Michigan Medicine.
Clinical Trials Support Office Services
Michigan Clinical Research Unit (MCRU) provides clinical staff, resources, and infrastructure that are necessary to conduct adult and pediatric human clinical research protocols at the University of Michigan. The main performance site is located at Michigan Medicine within the Cardiovascular Center (CVC). The Domino's Farms extension is located in northeast Ann Arbor, approximately four miles from the hospital.
MCRU offers the following services:
- Clinical Support Services
- Specimen Core & Processing Lab
- Mobile Clinical Research Team (MCRU2U)
- Study Team Storage Management
Clinical Research Study Coordinator Support provides investigators with team members who are already on staff and fully trained. All CTSU study coordinators are Good Clinical Practice (GCP) trained, and many coordinators have obtained or are working towards becoming either Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certified. The study coordinator services span the entire scope of clinical trial study coordination but are also available for specific tasks for studies. Available activity assistance includes:
- IRB Submission
- Identifying, screening, consenting, and enrolling subjects
- Database support (collecting and managing data)
- Collecting, packing, and shipping specimens
- Data entry – case report forms
- Reporting adverse and serious adverse events
- Liaising with sponsors, departments, and participants
The CTSU study coordinator services offer a model in which our study coordinator effort is recharged to the sponsor or study budget. Using a study coordinator from the pool can provide continuity during study team turnover and cushion faculty from carrying full personnel expenses when they only need fractional support.
Clinical Research Science Coordinator is a role with roots in the science liaison role from industry. This service offers a great resource to study teams in clinical research who can help with infrastructure logistics, and serve as a mentor and guide for early-career investigators and staff.
Teams understand the bi-directional associations between research questions, outcome measures, and data management strategies, and how these factors intersect with resources, the welfare of participants, and the ever-changing regulatory landscape. Services available are:
- Support in creating study protocols or documents
- Consultation in designing studies in accordance with Good Clinical Practice (GCP) standards
- Creating fidelity or data management plans
- Resources for collecting physical activity data
Portfolio Manager Support assists study teams with any pre-award activity challenges on the path to facilitate timely study activation. The portfolio manager tracks the project in its lifecycle, offers a line of communication between the CTSU and study teams, and keeps studies on track. The Portfolio manager offers regulatory support in preparation of the IRB application, amendments, and consent forms. Assistance is also offered in working with strategic partners including Michigan Institute for Clinical & Health Research (MICHR), Office of Research and Sponsored Projects (ORSP), Institutional Review Boards (IRBMED), Research Pharmacy, and more.
Financial Support is provided to all study teams that require a billing calendar. Pre-/Post-Award financial support includes, but are not limited to:
- Billing calendar creation (pre-award)
- Budget preparation and negotiation (pre-award)
- Contracting support (pre-award)
- Account reconciliation (post-award)
- Milestone tracking (post-award)
- Invoicing (post-award)
- Reporting (post-award)
(Last updated June 2020)
Calendar Review & Analysis Office (CRAO)
The Clinical Research Calendar Review & Analysis Office (CRAO) assists principal investigators and study teams conducting clinical research by providing analysts and support specialists who can provide guidance on the billing calendar, required core documents, our Michigan Budget Enrollment Calendar Tool (MBECT) and even clinical research billing analysts who will audit and work to have clinical research billing errors corrected.
CRAO collaborates with strategic partners across campus, creating billing calendars for all clinical trials that have billable items and services. The staff works with study teams to ensure consistency across the protocol process, including the billing calendar, budget, informed consent, contracts, and more.
(Last updated January 2020)
Data Office for Clinical & Translational Research (DOCTR)
Established by the Michigan Medicine Office of Research in 2013, DOCTR aims to accelerate translational research at U-M by: 1) provisioning access to actionable clinical and genetic data, and 2) serving as an honest broker. Access to data includes investigator-friendly self-serve tools, such as DataDirect, to find eligible cohorts as well as create one’s own datasets for secure download. These self-serve tools search a robust enterprise data warehouse with more than 15 years of clinical data (eg: vital signs, medications, diagnoses, labs) for 4 million unique patients. In addition to clinical data, the tools also allow for exploration of available biospecimens, genetic SNP data from the Michigan Genomics Initiative (MGI), critical care waveform data; and patient reported outcomes. For complex data needs, DOCTR SQL analysts create custom data extracts for researchers that are de-identified, limited datasets, or minimal direct identifiers based on IRB-approval.
Honest Broker services under DOCTR ensure a highly secure conduit between protected patient information and the research end user. Services are designed to operationalize IRB and Compliance policies, including assistance with data sharing both internally, as well as with external institutions; identifying secure storage options; linking disparate datasets with a coded identifier methodology; keeping the key for encrypted data identifiers; and auditing services.
Technical support and Information Technology Services
Medical School, IHPI and DOCTR technical support
IHPI, the Data Office for Clinical & Translational Research (DOCTR), and Precision Health Initiative have the necessary servers, firewalls, and other computer hardware and software needed to manage large volumes of data with appropriate data security. All IHPI, Medical School, and School of Public Health offices are connected to local area networks (LANs). These LANs are connected by state-of-the-art fiber optic wiring to the University’s backbone and to the Internet. This allows for rapid communication between the workstations in the staff offices and the secure databases maintained in the space occupied by members of IHPI. Dr. Waljee and Dr. Brummett’s computers are equipped with an Intel Core® i3, a dual core processor clocked at 3.30 GHz, 8 GB of RAM, 500 GB of internal Hard Drive space, and a 64-bit Windows® 7 operating system. Our computer is connected to the Medical School’s Medical Center Information Technology LANs and is equipped with necessary research software including Microsoft Office®, Internet Explorer®, Stata®, SAS®, S-plus®, Oracle®, and other statistical software and database packages.
- Data Security. Managing data security is mandatory given that a single integrated system manages the data from multiple clinical settings. Data access must be controlled. Managing data access will be performed with a User ID and password. User ID and passwords are required to access any systems database application or any applications that run inside the firewall. All assignments of user ID and passwords will be managed by a coordinator. User IDs for investigators are deactivated when not used for 3 months. Before accessing secured applications and data through the internet or intranet, each user will be required to login using their assigned user ID and password. Group files will be maintained to control access to directories, applications, and data. The user ID must be a member of the group file in order to access the group’s data or application. The groups are assigned roles to the data and applications (e.g. viewing authority to a protocol document, adding and updating patient data, etc.). To get to specific secured directories, applications, and data, the user ID and password are verified at a folder and application level, thus, members are restricted to viewing only applications and data that pertain to their role in the study. Study data applications will be run on secure socket layers. Files can be downloaded where applicable, but cannot be directly updated on the server. The mini-server is an application that redirects requests from outside the firewall to inside the firewall. No application is directly run outside the firewall. The mini-server redirects the application requests and directs the output back to the client workstation. The Health Information Technology and Services (HITS) at the University of Michigan performs the necessary backups of the system for disaster recovery. The process used for performing backups is as follows: full backups of the file servers are performed weekly, incremental backups are performed nightly, backup tapes are stored at an offsite location, tapes are kept for up to 3 months, at which time they are rotated, a history is kept of all changes made to the electronic forms. This history includes who made the changes to any data on any form.
- Data transfer. Data for the proposed supplemental studies are already collected, and the clinical, genetic, and pharmacy data are currently all separated for purposes of data security. To further ensure data/PHI security, data files will be encrypted and sent via a secure web file service developed at the University of Michigan, MiShare (https://mishare.med.umich.edu). MiShare is a secure collaborative file transfer system provided by Medical Center Information Technology (MCIT) at the University of Michigan. The MiShare infrastructure provides a method approved by the UMHS Compliance Office for UMHS personnel, non-UMHS business partners, and researchers to securely transfer files, including files that contain electronic Protected Health Information (ePHI), protected research data, or other sensitive information. Files are encrypted while being uploaded or downloaded, and are encrypted while they are on the MiShare server. Files are available for download for 5 days after they are sent. Files are deleted from the system after 5 days to enhance data security.
- Data linking. The clinical (electronic health records, patient reported outcome measures), genetic, and pharmacy (prescription drug monitoring program and Surescripts) data are currently all separated for purposes of data security. Cleaned and coded datasets will be securely sent to the Data Office for Clinical & Translational Research (DOCTR) where they will be linked with the pharmacy data. These datasets will be assigned an encryption identification number and stripped of direct patient identifiers, which will also be assigned to the corresponding genetic data housed in the School of Public Health. Limited protected health information will be included to allow for analyses, including dates of service. The clinical, pharmacy and genetic data will then be linked for analyses.
(Last updated June 2020)