The University of Michigan is one of the best public research universities in the United States and a leader in higher education.  

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 $1.86 billion expenditures in FY2023. 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 and scholarship.

The University serves its student body of more than 51,000, retains an eminent faculty of 8,000, and its libraries hold more than 14.8 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 659,000 living alumni around the world.

(Updated October 2023)

At Michigan Medicine, we advance health to serve Michigan and the world. We pursue excellence every day in our five 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, Sparrow Health, University of Michigan Health-West, the Frankel Cardiovascular Center, and the Rogel Cancer Center. U-M Health is ranked best in Michigan by 2023-2024 U.S. News & World Report and the only Michigan hospital on the nation's Honor Roll of Hospitals. The  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 2023--2024. The U-M Medical School is one of the nation's biomedical research powerhouses, with total external research funding of more than $746 million.

More information is available at www.michiganmedicine.org.

(Last updated October 2023)

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 4,251 faculty members teaching 667 medical students, 977 graduate students, 513 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 (905); Research Track (370); and Clinical Track (2,036). Additionally, the School has 353 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 160 physicians annually and is consistently ranked as one of the top institutions in the nation. 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 FY2023, the Medical School received $773.3 million in awards from all external sponsors. Annual federal grant funding awarded to the School's clinical researchers and biomedical scientists reached $656.5 million in FY2023.  Additionally, UMMS is recognized as 13th in medical schools across the nation in NIH grants awarded. In FY2023, Medical School researchers filed 188 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 comprises 44 buildings (including 29 at the North Campus Research Complex), encompassing 4.5 million square feet.

(Updated January 2024)
 

Michigan Institute for Clinical & Health Research (MICHR)

The Michigan Institute for Clinical & Health Research (MICHR) strives to develop and advance translational science - a field of study that aims to identify and overcome long-standing challenges in the translational research pipeline. MICHR examines translational research at a systems level with the goal of generating scientific and operational innovations that reduce translational barriers and improve the efficiency and effectiveness of all translational research. The ultimate goal of translational science is for health solutions to reach all people more quickly. MICHR provides myriad offerings to the research community that are focused on building and educating research teams; designing, funding, and implementing research studies; and disseminating research results. As a hub of innovation and experimentation, MICHR also rigorously evaluates and studies their offerings to ensure they produce the expected outcomes and impact and can be scaled and shared nationally. U-M established MICHR as a centralized resource to transform translational research in 2006, and an NIH Clinical and Translational Science Award (CTSA) has supported MICHR since 2007.

MICHR Facilities and Resources at the North Campus Research Complex: MICHR occupies 12,428 square feet of office, conference, lab, and media production space in a single-story building that is part of the North Campus Research Complex (NCRC). MICHR shares the NCRC with the IRB, administrative offices for the U-M Medical School Office of Research, the clinical trials office of the U-M Comprehensive Cancer Center, and the Innovation Partnerships office, creating a hub for clinical and translational research administration. Housing these resources in close proximity fosters communication, collaboration, and sharing of best practices among these units.

MICHR has software for media development, and a still image camera and digital audio recording device available for digital learning work. In addition, the North Campus Research Complex has a multi-media 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. These resources provide faculty, trainees, and mentors with an enhanced learning and teaching environment while providing a strong learner-support system. 

Office and Meeting Space: In addition to the MICHR resources mentioned above, all team members have individual workstations at MICHR, which include personal computers with access to secure high-speed internet. The MICHR office space also contains secure filing cabinets. Individual space is also available for faculty members who have main offices elsewhere but have effort associated with MICHR projects. To accommodate team meetings, focus groups, and advisory meetings, MICHR’s administrative space includes six shared meeting rooms that accommodate 50 or more persons, a fully equipped training room that accommodates 40 persons, and multiple small meeting rooms that may be used for interviews and short video production. 

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MICHR has many programs that advance translational science:

Behavioral Research Innovation & Support Program: The Behavioral Research Innovation & Support Program (BRISP) provides support, consultation, and training to enhance rigor in conducting behavioral and social science research. BRISP is available to faculty and staff who are new to behavioral research as well as experts who are seeking the latest resources and guidance on conducting behavioral research. BRISP also provides support for career development and advancement of behavioral and social science research professionals through its consultation and training opportunities. BRISP collaborates with a network of units across campus to build a repository of educational resources related to behavioral research conduct. BRISP works closely with units that support clinical trial conduct to tailor processes to optimally support behavioral clinical trials.

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.

Clinical Research Management: MICHR’s Clinical Research Management (CRM) Program provides the highest quality operational support for single and multi-center clinical and behavioral 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, with a focus on Investigational New Drug/Investigational Device Exemption (IND/IDE) required monitoring. In addition, CRM provides study teams with consultations focused on data management, quality management, and study management activities, as well as assistance with registration of clinical trials in the ClinicalTrials.gov Protocol Registration and Results System.

Community Engagement Program: MICHR’s Community Engagement (CE) program fosters community-academic partnerships and community-engaged research (CEnR). CE develops, demonstrates, and disseminates strategies promoting translational science and the science of CEnR, and enhances the ability of community-academic partnerships to address community health priorities equitably across the state of Michigan. CE provides consultation, education, and funding to support research projects in community-engaged 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 CEnR projects.

Dissemination & Implementation Science Catalyst: The MICHR Dissemination & Implementation (D&I) Science Catalyst Implementation Science Network (ISN) connects researchers to promote more innovative dissemination and implementation research to close the gap between science and practice and ultimately improve care in our health systems and communities. It offers assistance for investigators pursuing implementation science learning opportunities including learning collaboratives, conferences, course offerings, and examples of career plans, frameworks, measures for K and R grants, and examples of U-M implementation studies. It also promotes novel and competitive implementation science-driven initiatives by providing funding opportunities, toolkits on D&I methods, and hosting forums to share and foster ideas about implementation science. Its efforts to build implementation science capacity in health systems and communities include: MICHR Community Research Studios, U-M BCBS Clinical Quality Collaboratives, Multimodal D&I Curricula, and Michigan Medicine Statewide expansion. The ISN comprises three components: 1) Spark - Leveraging talent to promote implementation science learning opportunities, 2) Seed - Promoting novel and competitive implementation science-driven initiatives, and 3) Spread - Building Implementation Science capacity in health systems and communities.

Education and Mentoring Group: The Education and Mentoring Group (EMG) provides multidisciplinary education, career development, and mentoring programs for 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) Predoctoral T32 training in translational science, (1c) Postdoctoral T32 training in translational science, and (1d) a pre-doctoral Summer Immersion program; 2) educational and training initiatives including (2a) a summer research immersion program to train new clinical research professionals; (2b) clinical trials training for faculty and staff, (2c) mentorship education and training, and also instruction in (2d) scientific writing, (2e) research methods, and (2f) responsible conduct of research; 3) research and evaluation studies to demonstrate the impact of our competency-based approach to education; and 4) consultation to other U-M units regarding educational initiatives. EMG also provides the health community with access to online training resources through the Development, Implementation, and AssessMent Of Novel Training in Domain-based competencies (DIAMOND) portal. DIAMOND is a federated professional development platform that provides just-in-time training resources to clinicians and study team members that is tailored to their needs. Resources on the platform are curated from throughout the CTSA consortium.

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.

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 (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.

Interdisciplinary Research and Team Science Program: MICHR’s Interdisciplinary Research and Team Science Program offers a variety of services to support teams in coordinating and advancing research ideas, securing funding, and elevating team functioning. MICHR offers engaging, 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.

MICHR IND/IDE Investigator Assistance Program: 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.

Network Based Research Unit: MICHR’s Network Based Research Unit (NBRU) facilitates health-related network-based research for U-M by assisting investigators, industry, and patient communities in linking to and designing studies that utilize large-scale research consortia from national Clinical Research Networks (CRN). The CRNs are comprised of the CTSA Trial Innovation Network, the Patient-Centered Outcomes Research Institute’s national Patient-Centered Clinical Research Network (PCORnet®), and the PaTH Clinical Research Network. The MICHR NBRU team fully participates in the PCORnet® Common Data Model (CDM) and supports requested queries, extraction, and data quality on the studies that involve the use of the CDM.  

Patient Partners Program: The goal of the Patient Partners Program is to reimagine the role of individuals with lived experience in health research, and build the capacity of individual patients, family members, caregivers, and researchers to create authentic research partnerships. To achieve this vision, the Patient Partners Program is working with patients to co-design a Patient Partners Academy curriculum. This academy will train faculty and patient partners in strategies that optimally engage patients in research, with the goal of increasing patient leadership in clinical and translational research to ultimately impact health. Patients will learn how to engage in the co-creation of study design, grant applications, study conduct, and dissemination. The Patient Partners Academy will also prepare patients to serve as grant reviewers on study sections and mentors on career development awards. 

Participant Recruitment Program: MICHR’s Participant Recruitment (PR) Program provides a variety of services for research teams in need of support to recruit, enroll, and retain participants. PR offers consultations to assist with recruitment analysis and strategic planning, development of robust recruitment plans and timelines, and cost estimation. PR also offers assistance with the creation of professional quality marketing and advertising materials and with paid targeted social media advertising and community outreach. PR maintains the engaged volunteer registry, UMHealthResearch, which provides research teams with a database of >92,000 individuals interested in research participation and a portal through which they can advertise their studies. The tool recommends studies to participants based on topics of interest, medical conditions, and participants’ responses to health profile questions. 

Pilot Grant Program: MICHR’s Pilot Grant Program offers funding for projects that propose addressing a common cause of inefficiency or failure in research projects at any stage of translation. The goal of pilot projects is to create scientific, operational, financial, or administrative innovations that will increase the efficiency and effectiveness of translational research, ultimately improving human health. 

Research Development Core: MICHR’s Research Development Core (RDC) offers no-cost consultation and grant editing services to investigators during all stages of research ideation and 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. 

Translational Innovation Program: Through a blend of human-centered design, meaningful experimentation, and systems thinking, MICHR's Translational Innovation Program (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 co-create human-centered service designs, patient- and community-centered health services, easy-to-use digital products for health interventions, and systems that promote connection and collaboration.

The Institute for Healthcare Policy and Innovation (IHPI) is the nation’s largest university-based community of health services researchers, uniting more than 650 University of Michigan (U-M) faculty members to solve complex and timely challenges within healthcare policy and practice. The U-M Board of Regents approved the creation of IHPI in May 2011. 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 fields such as medicine, public health, nursing, social work, public policy, engineering, business, dentistry, law, information, pharmacy, social sciences, and more. IHPI also encompasses 32 collaborating health services research-focused centers and programs at U-M, many of which predate the Institute and originally provided the collective momentum to establish it.

Mission, Vision, and Strategic Priorities

Mission
Foster innovative, interdisciplinary research to inform policies and practices that advance the equity, quality, safety, and affordability of healthcare, and improve health for individuals, families, and communities.

Vision 
The IHPI community strives to improve health and well-being throughout Michigan, our nation, and the world through collaborative research and learning, rigorous evidence, robust communication, and policy engagement.

Values

Scientific excellence: Foster high-quality, rigorous research to produce credible evidence for improving health and healthcare delivery.

Policy relevance: Promote research with the greatest potential to inform policies that impact health and healthcare. 

Interdisciplinarity: Cultivate effective collaboration across disciplines, within and beyond the University, applying collective knowledge to address the most challenging problems in health and healthcare.

Integrity: Fulfill the highest ethical standards for independent, impartial research.

Innovation: Encourage creative ways of thinking, problem-solving, and collaborating to catalyze novel health services research.

IHPI’s Strategic Priorities include the areas of aging and Medicare; child and adolescent health; climate change and health; COVID-19; healthcare delivery and financing; health equity and disparities; Medicaid; mental and behavioral health; opioid and substance use; prevention and population health; healthcare quality, safety, and value; telehealth and health information technology; and women's health. Developing the next generation of healthcare leaders and scientists is another key focus of IHPI. As such, the Institute provides support to early-stage investigators through mentorship from senior scientists, connections with experts in innovative methodological and analytical approaches, and regular seminars and workshops to 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 help catalyze and enhance the research impact of IHPI members. IHPI’s Data and Methods Hub can facilitate access to data resources and provide analytical and methodological support. IHPI’s Communications and Policy Engagement teams collectively provide tools and advice for IHPI members to create a greater impact on health policy and healthcare delivery through their research. These teams help communicate research findings 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, with a special focus on early-career faculty members. The Institute is one of six sites for the National Clinician Scholars Program, which trains clinicians as change agents driving policy-relevant research and partnerships to improve health and healthcare.

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. The IHPI footprint includes nearly 90,000 square feet of physical space within NCRC, including dedicated workspace for more than 600 IHPI members, staff, and trainees. Meeting spaces are equipped with cutting-edge information-sharing technologies and are available for use by all IHPI members regardless of where their primary office is located. IHPI administration supports several collaborative workspaces for IHPI members and encourages them to use these spaces for limited-duration projects. Flexible workspace for faculty not housed at NCRC is also available. Finally, IHPI organizes many formal and informal networking opportunities, both at NCRC and across campus, to develop and enhance research collaborations around common interests and connect IHPI members to the Institute’s many services and programs.

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. In addition, many of IHPI’s collaborating centers and programs, including the Susan B. Meister Child Health Evaluation and Research Center (CHEAR), the Center for Healthcare Outcomes & Policy (CHOP), and the Center for Bioethics and Social Sciences in Medicine (CBSSM), also have office space at NCRC.

For more information, please visit the IHPI website.

(Updated November 2023)

Fast Forward Medical Innovation (FFMI)

With 249 invention disclosures in 2023, 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 January 2024)
 

The Central Biorepository (CBR), a unit of the University of Michigan Medical School Office of Research, is a 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 records 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 3,000-square-foot freezer storage space and 2,000-square-foot wet lab. Access to the labs is controlled, where the entrance to the wet lab and the freezer facility is badged entry only. The CBR has a current capacity of more than 1,200,000 biological samples in 2 ml tubes across 15 upright -80°C freezers and 13 LN2 vapor phase storage units. The CBR space can support up to 23 additional cryogenic storage freezers and 27 -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.

(Updated October 2023)

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 (5). As of October 2023, 12 members of the faculty are diplomates of the American College of Laboratory Animal Medicine (ACLAM), 1 faculty members is a diplomate 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.

(Updated October 2023)

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.

(Updated January 2023)

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 October 2023)

The mission of the University of Michigan (U-M) Rogel Cancer Center (Rogel) is to reduce the burden of cancer and advance health equity through transdisciplinary collaboration in research, education, patient care and community outreach. The vision is to be a leader in prevention, early diagnosis, optimal treatment and care for all at risk of or affected by cancer.

Rogel has a distinguished history of excellence and impact in research, education, clinical care, and outreach and service. Founded in 1986 by Dr. Max Wicha as the U-M matrix cancer center, Rogel received National Cancer Institute (NCI) designation in 1988 and “comprehensive” status in 1991. Rogel is led today by Eric Fearon, MD, PhD, named Director in September 2016. The center has grown to over 330 core grant members with over $120 million per year in direct cost research support. In federal fiscal year 2022, the U-M ranked sixth 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 ninth in the nation among all medical schools in NCI funding. The Center provides an organizational framework to promote transdisciplinary cancer research through the development of well-funded basic, translational, clinical, and prevention programs and the development of shared resources. The Cancer Center’s six Research Programs includes three basic programs – Signaling and Tumor Microenvironment, Cancer Genetics, and Developmental Therapeutics; one basic/clinical/translational program – Cancer Hematopoiesis and Immunology; one clinical/translational program – Translational and Clinical Research; and Cancer Control and Population Science. To advance these efforts, Rogel supports 13 Shared Resources and two developing Shared Resources: Cancer Data Science; Cell and Tissue Imaging; Experimental Irradiation; Flow Cytometry; Health Communications; Immune Monitoring; Pharmacokinetics; Preclinical Molecular Imaging; Structure and Drug Screening; Tissue and Molecular Pathology; Transgenic Animal Models; Proteomics; Single Cell Spatial Analysis; Epigenetics and Epigenomics (developing); and Liquid Biopsy (developing).

The Rogel Cancer Center occupies a dedicated Cancer Center Building encompassing >95,000 sq ft of research space (with 5,000 sq ft for an animal facility), and 125,000 sq ft of clinical space comprised of many outpatient clinics and infusion space. A Phase I unit offers first-in-human trials with an adjacent translational research laboratory. The Rogel Cancer Center also 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). Rogel’s Community Outreach and Training and Education personnel are also located at NCRC. Rogel has an additional >8,000 sq ft of space in the University Hospital South building for O-CTSU clinic coordination and research nursing staff operations.

(Updated January 2023)

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.

1. 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.
2. 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.
3. 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.
4. 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.
5. Heart, Vessel, Blood CTSU enhances performance of cardiovascular, coagulation, and nonmalignant hematologic clinical trials across the lifespan of acute and chronic disease.
6. 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.
7. 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

OnCore
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.

eReg
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)

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 January 2023)

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 January 2023)

Established by the Michigan Medicine Office of Research in 2013, DOCTR aims to accelerate clinical and translational research at U-M by: 1) provisioning access to robust, validated clinical, genetic, socioeconomic, biosensor, and other types of patient health data; and 2) serving as an honest broker between sensitive patient data and our diverse research community.

Data Access

Researchers at U-M can access data by various means:

• Self-Service: Investigator-friendly tools, such as DataDirect and EMERSE, to find eligible cohorts as well as create one’s own datasets for secure download and analyses.  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; patient socioeconomic information based on geolocation data, and patient-reported outcome measures/surveys.  
• Custom Data Extract:  For complex data needs, DOCTR has 4 data analysts, technically trained in query development such as SQL, who partner closely with researchers to create custom data extracts for researchers. There is a $60/hour recharge rate for custom pulls.  

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.

Data Curation

While some researchers prefer access to raw, uncleaned data for analyses, other researchers require pre-calculated, nationally agreed upon views of data, such as computable phenotypes.  Examples of pre-defined data definitions, such as starting cohorts include: primary care patients, surgical patients, patients with type 2 diabetes, patients with heart failure, etc. 

Other examples of data curation are mapping of U-M data from MiChart to national standards for participating in national research networks, and centrally published code for re-use.

Data Sharing

Regulatory experts on the DOCTR team facilitate external sharing of patient data in 3 critical ways:

1. Sharing between U-M investigators and collaborating academic centers:  The DOCTR team facilitates research between institutions by conducting a HIPAA review of which data elements will be shared and what the IRB allows.
2. Sharing between U-M investigators and industry:  The DOCTR office staffs the Human Data and Biospecimen Release Committee which evaluates patient data and/or tissue going to a commercial partner.  The two key priorities for this activity are 1) ensuring that patients whose data or specimens are to be transferred have explicitly consented; and that value is recovered and reinvested in research activities at the University of Michigan.  

Data Privacy

Managing patient privacy and data security are at the foundation of all DOCTR services.  Data provided to researchers meets the “Minimum Necessary Standard” of the privacy rule – ie, datasets contain only the minimal number of patient identifiers required to perform analyses.  

For self-serve tools, DOCTR established an interface with the IRB application on the backend of DataDirect such that the tool only allows the types of data which have been explicitly approved by the IRB.  Direct patient identifiers (name, address, medical record number) require an additional level of permissions.  

Finally, the DOCTR guides investigators on what secure storage options are allowable; performs linkage of disparate datasets with a coded identifier methodology; maintains the key for encrypted data identifiers; and regularly performs auditing services.
Additional information is available at the DOCTR webpage.

(Last updated April 2022)

Health Information & Technology Services (HITS)

Health Information & Technology Services (HITS) is Michigan Medicine’s central resource for IT, serving University of Michigan Health and the University of Michigan Medical School. HITS provides exceptional technology products, services, and support, along with institutional expertise related to IT strategy, security, infrastructure, and resource management.

Within HITS, three divisions support the vast Michigan Medicine mission. Business IT focuses on administrative technology solutions to support shared services across the enterprise, including Finance, HR, and Compliance. Clinical and Revenue Cycle IT supports clinical systems, medical devices, and MiChart, Michigan Medicine’s EHR. Finally, the Academic IT team focuses exclusively on supporting the education and research communities.

Below are highlights of specific services for research and education with additional details provided in the IT Resource Guide for Research and Education.

Research and Education Consultations
We can help you understand and leverage Michigan Medicine’s IT resources prior to grant submission or starting your project. We have a variety of consults available with our Academic IT teams to help you with your IT needs.

Applications and Software 
Provides access, guidance, and support for research and education software and applications.

Clinical Research Information Systems
Provides Michigan Medicine researchers with support for clinical trials and clinical research  when using OnCore and MiChart for research purposes. Partners with the Office of Research, Clinical Trials Support Office and Units and MiChart Clinical Leadership to ensure patients and providers are aware of clinical trial enrollment, have compliant research billing and successfully carry out research studies at the University of Michigan Health.

Scientific Programming  
Consider the HITS scientific programming team to streamline your research.  This is a recharge service available for Michigan Medicine researchers.  Consult with us to discuss how our services can support your current project or be written into a future grant.

Biospecimen Management + Freezer Monitoring

TempTrak is a system used to monitor the temperature status of equipment such as refrigerators and freezers. It provides alters to keep you informed of current state of mission critical equipment.

Research Application Hosting

Host custom and vendor applications in an IA assured self-service containerized environment.  We can work with you to move your research applications into a modern secure environment maintained by HITS.

Devices & Computing  
Provides technical end-user support, consulting, access, and training for campus clusters (Great Lakes, Armis 2) and other HPC research platforms as well as support for specialized hardware, systems and hosting services that are key to your research but unable to run CoreImage.

Michigan Medicine Research Computing Investments

The Michigan Medicine Research Computing Investments (MMRCI) offered by Michigan Medicine Health Information Technology Services (HITS) further expands upon the UMRCP program for Michigan Medicine researchers. MMRCI offers increased storage limits, increased core hour credits, additional cost sharing on core hours invested, and more!

Data & Storage 
Provides a variety of storage solutions and related services such as custom data integration and automation to meet research and education needs. 

Need help and don’t know where to start?  Visit the Michigan Medicine Help Center to engage with HITS. 

(Last updated October 2023)