University of Michigan
The University of Michigan is one of the best public research universities in the United States and a leader in higher education. It was ranked the No. 1 U.S. public university by QS World University Rankings, 2022.
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 $1.58 billion expenditures in FY2021. 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 47,000, retains an eminent faculty of 8,000, and its libraries hold more than 14.5 million volumes. Michigan's excellence in higher education rests on the outstanding quality of its schools and colleges, fifteen of which accept undergraduate students, as well as on the 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 according to US News & World Reports, 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 630,000 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). Mary Sue Coleman, Ph.D., is the President of the University.
(Last updated January 2022)
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 2.6 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 2021-2022 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 2021-2022. The U-M Medical School is one of the nation's biomedical research powerhouses, with total external research funding of more than $750 million.
More information is available at www.michiganmedicine.org.
(Last updated April 2022)
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 3,040 faculty members teaching 785 medical students, 685 graduate students, 540 postdoctoral fellows, and over 1,300 interns and residents, as well as other groups of learners. The Medical School offers three faculty tracks: Tenure Track (896); Research Track (348); and Clinical Track (1,370). Additionally, the School has 426 clinical instructors/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 over 20,000 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 2022 U.S. News & World Report's Best Medical Schools rankings, the University of Michigan Medical School placed No. 15 for primary care and No. 15 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 50+ 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 FY2021, the Medical School received $750 million in awards from all external sponsors. Annual federal grant funding awarded to the School's clinical researchers and biomedical scientists reached $540 million in FY2021. Additionally, UMMS is recognized as 13th in medical schools across the nation in NIH grants awarded. In FY2021, Medical School researchers filed 204 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’s Innovation Partnerships office, which handles technology transfer issues. 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 April 2022)
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 U-M’s 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, Faculty Development, Precision Health, 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 between 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) postdoctoral translational science training, and (1c) a pre-doctoral Summer Research 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) translational research training workshops for clinicians engaged in research projects, and (3c) mentoring education and training, as well as instruction in (3d) scientific writing, (3e) research methods, and (3f) responsible conduct of research; 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: The EMG has experience in the multimedia learning environment and can provide guidance to study teams regarding development of digital learning products. Our team of education experts can provide advice in the development of webinars, e-learning modules, and virtual learning and instruction.
Pilot Grant Program (PGP): MICHR’s Pilot Grant Program (PGP) offers funding to facilitate and support innovative research across the translational spectrum. The specific funding mechanisms are continually evolving to align with emerging needs and priorities. Since inception, the PGP has awarded $28 million, and awardees have self-reported $382 million in subsequent funding and 700 publications.
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 and comments to strengthen clarity, flow, and grammar. Since 2011, RDC has provided support for 1200 grant proposals and research ideas resulting in $198 million in extramural funding.
Interdisciplinary Research and Team Science: MICHR’s Interdisciplinary Research and Team Science Program offers a variety of services to support teams in coordinating and advancing research ideas and securing funding. MICHR offers engaging and facilitated Research Jams to help cross-disciplinary teams surface and prioritize shared research ideas; develop pilot projects; identify audiences and value propositions; and respond to funding opportunity announcements. For teams pursuing large-scale grants, MICHR provides strategic and personalized advice, proposal management, numerous resources and tailored templates, and grant editing.
Biostatistics Program: MICHR’s Biostatistics Program offers consultation, collaboration, and mentoring throughout the lifecycle of a study. Services include study implementation, and abstract and manuscript development. MICHR’s faculty and staff biostatisticians provide expertise in randomization scheme development and implementation, development and implementation of statistical analysis plans, data quality assessment, and database review. Biostatisticians will serve as study co-investigators, team statisticians, or statistical analysts.
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 that work together to foster university-community research partnerships and facilitate specific community-engaged research projects.
Participant Recruitment (PR) Program: MICHR’s Participant Recruitment (PR) Program provides an array of services for research teams needing support to recruit, enroll, and retain participants. PR 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. PR also maintains UMHealthResearch.org, an engaged volunteer registry, which provides research teams with a database of >70,000 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, and 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 electronic medical records. 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 that 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 tens of thousands of 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) Program 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 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 consultations 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.
Translational Innovation Program (TIP): MICHR's Translational Innovation Program (TIP) provides an innovation infrastructure that helps research teams systematically, sustainably, and consistently fast-track innovation with a focus on translation. Through a blend of human-centered design, meaningful experimentation, and systems thinking, TIP actively catalyzes diverse projects that bring together multiple stakeholders, including researchers, community members, technologists, and domain experts. Through services that range from one-off consultations to in-depth partnerships, TIP has helped research teams produce grant proposals featuring human-centered design methodology, patient- and community-centered health services, easy-to-use digital products for health interventions, and services and systems that promote connection and collaboration.
Michigan Clinical Research Unit (MCRU): The Michigan Clinical Research Unit (MCRU) provides the resources and infrastructure necessary to conduct human clinical research protocols at Michigan Medicine. MCRU’s clinical core services and physical facilities provide investigators access to clinical research resources and lab personnel. MRCU also provides MCRU2U, a mobile research service for clinical study teams. The mobile team supports simple protocol-specific services such as blood draws and ECGs throughout Michigan Medicine’s campus, at participants’ homes, and at other locations within an hour of the Michigan Medicine campus.
MCRU Facilities and Resources: The main performance site for MCRU is in Michigan Medicine’s Medical School’s Cardiovascular Center (CVC) located at the center of the Medical Campus. The MCRU facility occupies approximately 7400 square feet of space, including research-only outpatient examination rooms, research-only extended stay beds in private rooms, and administrative offices. This location also houses a research exercise physiology area, a procedure room, clinical workspace, a medical preparation and storage room, a patient/subject intake area, equipment storage space, clean holding rooms, a principal investigator and study coordinator workroom, a staff locker room, a metabolic kitchen, a specimen processing laboratory, a patient waiting area, and a common dining area.
MCRU’s Outpatient Clinical Research Unit is located in the Domino’s Farms extension approximately four miles from the medical campus in northeast Ann Arbor. This unit houses four exam rooms. All aspects of the unit are compliant with the Joint Commission on Accreditation of Healthcare Organizations. Shared space includes a waiting room, patient carrels, a patient intake area, an equipment room, a patient food preparation room, a staff kitchen, patient showers, and handicap accessible bathrooms. A 140 square-foot wet laboratory is contiguous with the patient facility. The lab contains one tabletop centrifuge, a computer with internet connection for follow-up on patient laboratory values, a label printer for blood draws, and supplies for drawing blood and preparing aliquots for storage. The laboratory also contains a small specimen refrigerator, one -80° specimen freezer, and one -30° specimen freezer.
(Last updated April 2022)
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 670 University of Michigan (U-M) faculty members to solve complex and timely challenges across healthcare policy and practice. IHPI members represent diverse disciplines across 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 31 U-M health services research-focused 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 and approaches), and impact (public and private partnerships).
IHPI’s strategic research and policy priorities are focused in the areas of aging and Medicare; child and adolescent health; COVID-19; healthcare delivery and financing; health equity and disparities; Medicaid; mental and behavioral health; opioid and substance use; prevention and population health; quality, safety, and value; telehealth and health IT; and women's health. Developing the next generation of healthcare leaders and scientists is another core focus of IHPI. 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 strengthen 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 healthcare.
Core Services and Programs: The Institute offers several core services and programs to enhance the research and dissemination capacity of all IHPI members. The expert staff of IHPI’s Data and Methods Hub can facilitate access to data resources and provide analytical and methodological support. IHPI’s Policy Engagement team can provide strategies and tools to help translate members’ research findings for policy audiences, develop targeted dissemination plans to share research findings and expertise, and facilitate connections with key stakeholders. IHPI’s Communications team can assist with developing dissemination tools to communicate research results, including issue briefs and visual abstracts, to help members reach those who would benefit most from their work, including the media, policymakers, and the public. IHPI also offers an array of Education and Training programs to support ongoing professional development. A more detailed description of IHPI member resources is available here.
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 90,000 square feet of physical space within NCRC, offers cutting-edge information-sharing technologies as well as informal and formal meeting and workspace to facilitate multidisciplinary interactions. More than 600 IHPI members, staff, and trainees are located in IHPI space at NCRC. In addition to dedicated workspace, IHPI administration supports several collaborative workspaces 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. Finally, IHPI 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.
Faculty and research staff from the VA’s Center for Clinical Management Research are also co-housed in VA-controlled space within the IHPI footprint, providing valuable collaborative opportunities. Likewise, the Collaborative Quality Initiatives (CQIs), which work in concert with healthcare providers and organizations throughout Michigan to collect, analyze, and share data to guide quality improvement, maintain dedicated space at NCRC, as the majority of the 20+ Michigan CQIs are led by IHPI members. Support for the CQIs is provided by Blue Cross Blue Shield of Michigan and Blue Care Network.
For more information, please visit the IHPI website.
(Last updated March 2022)
Fast Forward Medical Innovation (FFMI)
Fast Forward Medical Innovation (FFMI): Significance With 204 invention disclosures in 2021, 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. U-M internal funds, resources, and personalized funding consultations by 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.
(Last updated March 2022)
Central Biorepository (CBR)
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, or as part of a consortium, 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 (LN2) vapor phase cryogenic freezers and -80°C mechanical freezers. Liquid nitrogen is supplied on-demand from an external bulk-tank and plumbed into each cryogenic storage unit. Mechanical freezers are protected against compressor failures through hookups to compressed CO2. Mechanical freezers, temperature-monitoring devices and other key equipment are connected to the emergency power grid, powered by two diesel-fired generators. Biorepository services include sample aliquoting, DNA and RNA isolation, nucleic acid quantification, PBMC isolation and preservation, and sample distribution management.
The CBR LIMS securely integrates with a research data warehouse containing detailed clinical information sourced from the electronic health record of Michigan Medicine patient-participants. This connection allows U-M scientists to interrogate the biorepository and discover samples of interest from a research-specific, clinically defined cohort of individuals. When samples are collected as part of a consortium, singular subject identifiers are used across data systems to link participant and sample data. 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 and the freezer facility is badged entry only. The CBR has current capacity for up to 1,100,000 biological samples in 2 ml tubes across eight upright -80°C freezers and 11 LN2 vapor phase storage units, each configured for 46,565 and 65,610 2mL cryovials, respectively. Existing CBR space can support up to 9 additional cryogenic storage freezers, 10 -80°C freezers, or a combination thereof. An expansion of the CBR footprint (to be completed by July 2022) will add additional ultralow and cryogenic storage capacity. In total, the CBR will have infrastructure to support 23 cryogenic LN2 vapor phase freezers and 27 -80°C ultralow mechanical freezers.
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.
(Updated March 2022)
Unit for Laboratory Animal Medicine (ULAM)
Animal husbandry will be provided by Unit for Laboratory Animal Medicine (ULAM) staff 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 (12) and veterinary residents (8). As of November 2021, 10 members of the faculty are diplomates of the American College of Laboratory Animal Medicine (ACLAM), 2 faculty members are diplomates of the American College of Veterinary Pathology (ACVP), and 1 faculty member is a diplomate of the American College of Veterinary Surgery (ACVS). Veterinarians are available during regular business hours, and are on-call after hours, on weekends, and holidays. Directions for obtaining emergency veterinary care are posted throughout the vivarium and on the Program website.
The University of Michigan is accredited by AAALAC International, and the Animal Care & Use Program conforms to the standards outlined in the Guide for the Care and Use of Laboratory Animals (NRC 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 an approved assurance statement on file with the Office of Laboratory Animal Welfare (OLAW) regarding these matters.
(Last updated November 2021)
Biomedical Research Core Facilities (BRCF)
Biomedical Research Core Facilities (BRCF) are campus-wide laboratories that develop and provide state-of-the-art scientific resources to enable biomedical research.
The BRCF was formed in 1986, offering centralized access to research services, shared equipment and the expertise of biomedical researchers/investigators to support research projects. Our mission is that we believe in serving you, advancing health, and paving the way for great discoveries in biomedical research at the University of Michigan and beyond.
Our Cores include:
- Advanced Genomics Core
- Bioinformatics Core
- Biomedical Research Store
- Epigenomics Core
- Flow Cytometry Core
- Metabolomics Core
- Microscopy Core
- Proteomics & Peptide Synthesis Core
- Transgenic Animal Model Core
- Vector Core
Core Facilities aim to ensure centralized access to some of the latest instrumentation and services for investigators, avoiding the duplication of institutional expense and effort. Core instrumentation is regularly being upgraded to keep pace with the rapid advance in biomedical research. Cores have highly trained staff to carry out investigator projects, as well as access to workshops and training opportunities, increasing efficiency and quality control in coordinating services for multiple users. We are a fee-for-service provider, offering these services at a reasonable cost.
The BRCF uses MiCores as 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.
For more information, please visit the BRCF website at:
(Last updated March 2022)
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 U-M studies subject to Food & Drug Administration (FDA) regulations. The purpose of an IRB is to ensure the protection of the rights and welfare of human subjects in research. The IRB performs this task by applying federal regulations, state laws, university policies, and ethical principles, particularly those articulated in the Belmont Report (beneficence, respect for persons, and justice).
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. U-M is a signatory to the SMART IRB master reliance agreement which facilitates the establishment of IRB reliance arrangements with external institutions. U-M 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 U-M community, and provides workshops on IRBMED processes throughout the year and upon request. In addition to the IRBMED offerings, U-M 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 March 2022)
Rogel Cancer Center (RCC)
Under the leadership of Max Wicha, MD, the University of Michigan (U-M) Rogel Cancer Center (Rogel) was established by the University Board of Regents in May 1986. Eric Fearon, MD, PhD, was named Director in September 2016. The center (which has received consistent NCI core funding and was awarded “comprehensive” status in 1991) has grown to over 325 core grant members with nearly $120 million per year in direct cost research support. In federal fiscal year 2021, the U-M ranked third 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 seventh in the nation among all medical schools in NCI funding. The research and training missions of the Center are carried out in three basic science programs (Signaling and Tumor Microenvironment, Cancer Biology and Developmental Therapeutics, two clinical research programs (Cancer Hematopoiesis and Immunology and Translational and Clinical Research), and a cancer control and population sciences program (Cancer Control and Population Sciences).
In May 1997, the Cancer Center moved into the new nine-story $88 million Cancer Center Building, occupying >95,000 sq ft of research space, including 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 65,000 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 majority of Rogel’s Oncology Clinical Trials Support Unit (O-CTSU) personnel (pre-/post award financial management, regulatory, data management, multisite coordination and IT support). NCRC also houses Rogel’s Community Outreach and Training and Education personnel. Rogel also has >8,000 sq ft of space in the University Hospital South building, which houses our O-CTSU clinic coordination and research nursing staff.
In addition to its support of basic science, clinical research and population science research programs, Rogel also provides support to a wide variety of state-of-the-art Shared Resources (SRs), including: Cancer Data Science, Cell & Tissue Imaging, Experimental Irradiation, Flow Cytometry, Health Communications, Immune Monitoring, Pharmacokinetics, Preclinical Molecular Imaging, Proteomics, Single Cell Spatial Analysis, Structure & Drug Screening, Tissue & Molecular Pathology, Transgenic Animal Models, and two developing shared resources: Epigenetics and Epigenomics and Liquid Biopsy.
(Last updated March 2022)
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.
The Advarra eReg product is a compliant tool for managing all required regulatory documents for human subjects research. eReg integrates with the existing U-M OnCore CTMS, manages document owners and expiration dates, routes documents for signature or other notifications, and is 21 CFR Part 11 compliant for electronic signatures. eReg can share documents across multiple protocols and allows secure access for study sponsor monitoring.
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:
- RN Nursing
- Clinical Support
- Laboratory Processing
- MCRU Space
- 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 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, study teams, and partner units to keep studies on track. 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 March 2022)
Calendar Review & Analysis Office (CRAO)
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 facilitate the building and completion of the billing grid (calendar) which will interface with MiChart, review required core documents for alignment with Medicare and University policies, and provide clinical research billing analysts who will audit and work to have clinical research billing errors corrected.
(Last updated March 2022)
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)