The University of Iowa ICTS was established in 2007 as part of the university’s Clinical and Translational Science Award (CTSA), to be an integrated academic home for clinical and translational science, and to create a catalytic infrastructure for nurturing the broad spectrum of T1 – T4 translational science. The unique overarching academic structure of the ICTS provides a multidisciplinary matrix for facilitating and supporting clinical and translational science throughout the university's colleges as well as University of Iowa Health Care. In addition to NIH funding, the University of Iowa provides substantial investments in support of the goals of the ICTS.  

The ICTS is located in the University of Iowa Health Care’s Medical Center on the University Campus and includes 14,000 square feet of administrative and educational facilities and 20,000 square feet for the Clinical Research Unit. The administrative space houses biomedical informatics staff, study and regulatory coordinators, the operations director, financial administrator, and additional administrative and operational team leadership. The administrative space also includes a conference room equipped with video conferencing capabilities to support administrative meetings, classes, research seminars, and presentations by visiting professors.

The ICTS offers several resources to support innovative clinical and translational investigation. These resources include: 

Biomedical Informatics (BMI) Component

The University of Iowa Institute for Clinical and Translational Science’s Biomedical Informatics Core (BMI) helps in the capture, management and analysis of human subject data. BMI maintains an enterprise data warehouse for research that contains data from electronic medical records linked to a growing number of external data including bio-sample data, genomic data, and cancer registries. Investigators can use tools such as TriNetX to explore this data. BMI provides access to REDCap for collaborative and compliant data capture and management and to UI BioSHARE to manage information about bio-samples. BMI supports multi-institutional medical record data queries via PCORnet and TriNetX and submits data to the National Covid Cohort Collaborative. BMI has a team of developers to assist with custom application development, especially for mobile device applications and for exploring new techniques such as Natural Language Processing (NLP). See our website to learn about consulting and training.

Information Technology Infrastructure

At the center of ICTS’s IT infrastructure is the Biomedical Informatics core (BMI), which provides a number of IT and Informatics services for ICTS and the researchers who work with it. BMI also brokers collaborations with the two Enterprise IT units – UI Information Technology Services (ITS) and Health Care information systems (HCIS) and collaborates with other service units including the College of Medicine Office for Information technology (CCOM IT. Details these IT resources and how ICTS leverages these collaborative and symbiotic services follows.

ICTS Biomedical Informatics (BMI) supports a number of services including custom application hosting, REDCap (data capture and management), ICART (MUSC SPARC based tool for research resource tracking) and TriNetX data tools. BMI operates and enterprise data warehouse for research that provides researchers access to EHR data from UIHC linked to other key data sources. All systems are housed on servers managed in HCIS HIPAA-compliant data centers. BMI serves as the technical data support for UIs participation in research data networks such as PCORNet, TriNetX Research, Sentinel and the National Covid Cohort Collaborative.

UI Information Technology Services (ITS) provides network infrastructure including 10 Gigabit/sec connections to all research buildings and UI Health Care and high-speed connections (up to 100 Gps) to external networks including Internet 2 and BOREAS, a regional optical network. ITS also provides access to high-performance computing clusters which collectively are composed of over 550 compute nodes with more than 6500 processor cores. With the Bioinformatics core facility in the Institute for Human Genetics, ITS operates a web-based suite of computational genetics tools based on Galaxy.

The UIHC’s Health Care Information System (HCIS) has a capital budget of > $15 million, an operational budget of > $55 million, and > 400 staff members to provide technology support for patient care, teaching, and research. Staff members assist investigators with their computer needs, including clinical informatics support, analytics support, IT security services, hardware and application management, storage services, data network and telephony services. The data communication network, which transports information between systems and sites, utilizes numerous redundant Gigabit Ethernet (GEN) backbones. The network supports > 25,000 Users, 33,000 wired clients, 19,000 wireless clients, 4,200 Servers, over 800 applications, 10 Petabytes Storage, 4,950 System Interfaces, 52,000 Communication Ports, 7,490 Pagers, and 4,00 Voalte Phones. UI Health Care has a 10 GB full-duplex connection with the University of Iowa’s network. The University of Iowa participates in Internet2 with a backup connection to the Iowa Communications Network, the State of Iowa’s fiber optic network. HCIS has active, rigorous compliance programs to ensure the security and integrity of sensitive institutional data such as personal health information and has implemented many physical and electronic safeguards and aggressive monitoring and auditing processes to ensure compliance with organizational policies.

HCIS and ITS both contribute similar enterprise services in supporting ICTS. The division of this support is determined by the data involved with a given service or project, with HCIS resources used for clinical data services and databases that utilize EPIC-extracted data and ITS resources used for non-clinical or de-identified data. The similar services provided by HCIS and ITS include:

• Data center services to house servers and storage systems: This includes a new 43,000 square foot data center shared by both HCIS and ITS. This new building – the Information Technology Facility (ITF)- is a LEED certified building, with a severe-weather-resistant structure that includes backup cooling and electrical power systems if the primary systems fail. Physical security access is HIPAA compliant and requires two-factor authentication.
• Server support: Physical and virtual server hosting services are available from HCIS and ITS. These services which can be purchased on a monthly basis or on a project basis; support a number of environments including Windows and Linux Server, MS SQL, PostgreSQL and MySQL databases, and Apache/JAVA and Net hosting environments.
• Data storage services: HCIS and ITS both have a growing array of secure and robust storage services available to campus researchers. HCIS and ITS in conjunction with CCOM provide low cost secure, HIPAA compliant network-based storage including 3TB of backed-up, network storage allocated for each lab. Both ITS and HCIS provide secure cloud-based storage for collaborating inter and intra-institutionally. Large-scale data storage needs are provided by ITS and are offered in conjunction with the High-Performance Computing service.
• Security services: HCIS and ITS share a security office that provides comprehensive security coverage on the University of Iowa campus. Campus users all have a standard MS Active directory ID – the Hawk ID - used for most IT services. Researchers accessing clinical data for research have a second HCIS-managed Active directory ID – the Health care ID. External users may be assigned guest IDs. Both security offices provide security audits and guidance on meeting NIH requirements for IT security.
• Software licensing: Campus researchers have a variety of software tools available to them through the software licensing efforts of HCIS, ITS and CCOM IT. Some of the tools available include Microsoft Office, Adobe Master Collection, EndNote, LaserGene, MatLab, SAS, SPSS GraphPad Pris and Pymol.

Biostatistics, Epidemiology, and Research Design Core (BERD)

BERD serves an essential and multifaceted role within the ICTS, focusing on advancing research by offering comprehensive expertise in study design and statistical analysis. The team comprises experts with deep knowledge in biostatistics, epidemiology, and research design, enabling them to support investigators in developing and refining their studies. At the heart of BERD's mission is its commitment to methodological excellence in health care research. The consultation service is particularly well-established, offering researchers valuable assistance in crafting research protocols, improving methodological planning, and ensuring that their studies are designed to yield reliable and valid results. This support is available in both consultative and collaborative frameworks, tailored to meet the specific needs of each research project. Through their collaborative work with researchers, BERD continually seeks to improve the statistical rigor of analyses, contributing to the advancement of the field. Coordination with the BMI Core during project development ensures greater scientific rigor for studies involving data requests, REDCap, and TriNetX. In addition to providing these critical services, BERD also drives innovation, ensuring that the research conducted across the CTR spectrum is grounded in robust and credible evidence. These innovations are crucial in adapting to the evolving demands of clinical research, with the team pioneering approaches such as adaptive clinical trial designs, which allow for modifications to be made to a trial as it progresses, and comparative effectiveness research, which evaluates the relative effectiveness of different interventions. BERD also offers training opportunities for researchers seeking to further develop their knowledge of design and analysis of clinical and translational research studies across the T1-T4 spectrum. Their work not only enhances individual projects but also contributes to the broader goal of improving health care through the generation of credible, actionable evidence. 

ICTS Clinical Research Unit

The CRU is a 20,000 square foot state-of-the-art facility for inpatient and outpatient studies that has 22 exam and consultation rooms, a seven-bay infusion suite, three procedure rooms, a specimen processing laboratory, one inpatient bed, a Climate Change chamber, and a dedicated staff of nurses, respiratory therapist, lab technicians, bionutrition manager, and research specialist. A specialized facility, the Human Brain Lab includes an acoustically and electrically shielded Faraday cage for detailed neuroelectrophysiology research monitoring. This unique facility was designed for research on refractory epilepsy but also is used for a broad range of research on human brain function. The CRU also houses a unique Research Clinic for the patients of Dr. Michael Shy with heritable peripheral neuropathies. The clinic, which is designated as the Center of Excellence by the Charcot-Marie-Tooth Association, provides routine care, supports research protocols, and serves as a model for establishing other rare disease clinics. The CRU also houses the annual Wellstone Clinic, which is a Centers of Excellence program in the Muscular Dystrophy Specialized Research Center (MDSRC) established by the National Institutes of Health (NIH) in 2003, in honor of the late Senator Paul D. Wellstone of Minnesota. The clinic is conducted annually in the CRU by Dr. Katherine Mathews who focuses on dystroglycanopathies in adult and pediatric patients. 

Early Phase Trials Unit: The Early Phase Unit in the CRU can accommodate inpatient and outpatient studies. The unit is staffed by infusion-trained nurses who provide services in a designated infusion suite, as well as in other areas of the hospital when it is not feasible or convenient to move patients to the CRU. The unit supports both investigator-initiated and industry-initiated trials and offers (1) safety monitoring with close physician and nursing oversight; (2) comprehensive drug administration capabilities; and (3) performance of pharmacokinetic and pharmacodynamic analyses in conjunction with clinical pharmacology faculty in the College of Pharmacy. 

Mobile nursing services were established to support clinical research in inpatient areas and UI offsite areas with a goal of expanding and supporting clinical research services within and outside the main campus.

ICTS Phenotyping Laboratories: The CRU also includes an analytical laboratory for assaying biological markers that are not assessed by the hospital laboratory and several other specialized phenotyping labs.

• The ICTS Human Brain Research Laboratory (Director, Dr. M. Howard) includes an acoustically and electrically shielded room for detailed neuroelectrophysiology research monitoring. This unique facility was designed to analyze neurosurgically treated refractory epilepsy but is now being used to investigate a broad range of studies analyzing human brain functions.
• The ICTS Bionutrition Body Composition Laboratory: the BOD POD body composition tracking system is an air displacement plethysmograph which uses whole-body densitometry to determine body composition (body fat and fat-free mass). The BOD POD is a complete system with a dedicated computer system, the ability to measure thoracic gas volume, estimated resting metabolic rate.
• The ICTS Cardiovascular Physiology Laboratory (Director, Dr. G. Pierce) tests regional blood flow, small blood vessel function, systemic hemodynamics, and sympathetic neural recordings. Analytical techniques include plethysmography, laser Doppler probing, infrared oxygenation, pneumotrace strain gauge, impedance cardiography, and nerve recordings with variety of stressors.
• The ICTS Pulmonary Physiology Laboratory (Director, Director, Dr. A. Comellas) includes a pulmonary function and exercise testing facility and a human exposure chamber equipped for exposure delivery, and monitoring. Services include pulmonary functions (Spirometry, Diffusion Capacity, whole body plethysmography, airway resistance, bronchial provocation, nitrogen washout, single breath nitrogen elimination, maximum respiratory pressures), cardiopulmonary exercise testing, methacholine challenge, sputum induction, and exhaled nitric oxide analysis. Bronchoscopy services and equipment are also performed within the CRU in the procedure suite.
• The ICTS Bone Density Laboratory (Director, Dr. J. Schlechte) uses dual-energy x-ray absorptiometry (DEXA) and peripheral quantitative computerized tomography (PQCT) to measure bone density.

Engagement, Integration, and Implementation (EII) Core

Mobile Technology Lab

The Mobile Technology Lab currently supports a remote bi-directional data-collection platform that is flexible and easy to use.

The platform can support the delivery of short surveys and collect responses. It can also support the bi-directional transfer of photos as well as short audio and video files. Finally, the platform can collect data from remote sensors and send messages based on sensor readings.

Our current platform is designed to support pilot and exploratory studies and is ideal for collecting preliminary data for proposals or small studies. In addition, our platform can be customized to support larger, externally funded projects, including multi-center projects.

Research Coordinator Core

Regulatory Core

The ICTS Regulatory Core helps investigators navigate the regulatory requirements process by collaborating with researchers to work directly with the IRB and other regulatory agencies. The ICTS Regulatory Core provides training, services, education, and other resources to anyone at the University of Iowa that is conducting research. 

The ICTS Regulatory Core can support researchers in the following areas:

• Early Regulatory Development: Interaction to develop regulatory plan. This can include sIRB assistance prior to grant submission, FDA IND/IDE consultation or submission, feasibility visits with sponsors, assistance with protocol and Data Safety Monitoring Board creation, and clinicaltrials.gov consultation or submission.
• Regulatory Submissions and Maintenance: We can prepare, submit, and maintain HawkIRB, commercial IRB, and sIRB submissions. We can also assist investigators, coordinators, and study staff in their submissions.
• Education and Training: We can provide individual or group regulatory education and training to researchers and study staff or study groups.
• FDA Inspections: The ICTS Regulatory Core can be a resource to researches and study staff when preparing for an FDA inspection or preparing and implementing responses to the FDA inspection.

Workforce Development

The primary goal of the ICTS Workforce Development Core is to train motivated and talented scholars, community members, and research professionals for careers and engagement in translational science. ICTS delivers educational offerings that are designed to be customizable across our workforce audience. Some of our education programs are broadly applicable to our workforce population, while others are targeted to a specific audience(s).

K12 Program

The NIH K12 Career Development Award is designed to identify and train outstanding junior faculty campus-wide who seek a career in clinical and translational research. K12 awardees are guaranteed 75% protected time to devote to their training and research activities. In addition to K awardees, the ICTS also maintains a cohort of Translational Science Scholars. These translational science scholars join the cohort of K12 scholars and participate in the Critical Thinking courses facilitated by the ICTS as well as an eight-week mentoring academy and monthly K-Club discussions.

Master of Science in Translational Biomedicine

ICTS administers the Master of Science in Translational Biomedicine, available to post-doctoral fellows and junior faculty with an appointment at the University of Iowa. The M.S. program is designed to teach students how to move biomedical discoveries into clinical applications and beyond. It is tailored for individuals who have completed training in one area of biomedicine and wish to apply their expertise to the T1-T4 research spectrum.

Academy for Research Professionals

Research is also supported by the Academy for Research Professionals and the Clinical Lecture Series, focused on training and continuing education for research support staff. Topics include Good Clinical Practice, research ethics, handling of biological specimens, and standard clinical research protocols.

Team Science Training

Team Science trainings are integrated into the Masters in Translational Biomedicine as well as our Pilot Grant Program.

Iowa Mentoring Academy

ICTS is leading an initiative at the University of Iowa to implement the Iowa Mentoring Academy (IMA). The IMA offers at least one training session per semester, serving faculty as well as graduate and post-doctoral scholars. The curriculum is based on the Entering Mentoring program and addresses the new National Institute of General Medical Sciences (NIGMS) guidelines regarding the preparation of mentors involved in training grants. Upon the completion of mentor training (attending at least six of the eight-hour long sessions), participants receive letters of recognition.  

Undergraduate Certificate in Clinical and Translational Science (CCTS)

Aimed at introducing undergraduates to the field of translational science, this undergraduate certificate provides educational enrichment and an increased awareness of expanding opportunities in translational science, a discipline focused on moving biomedical discovery into application in the healthcare arena. Participation in the innovative CCTS program provides motivated undergraduates an opportunity to connect their research activities to translational science and begin their training in this important discipline.

Clinical Trials Investigator Training Program

To help junior investigators develop and execute excellent clinical trials, ICTS developed the Clinical Trials Investigator Training Program. The program provides PIs with resources and skills they need to develop their ideas into functional clinical trials. The program aims to provide participants with as much hands-on support as possible while in class with support from experts in regulatory, clinical research, bioinformatics, and study design. Participants are eligible for ICTS services to support ongoing development and grant submission of their trial.

Beginning and Early Stage Translational Research Program (BEST)

The BEST Research Program is a summer mentored training experience wherein undergraduate participants join a member of a translational research team to increase their skills and understanding in translational science. In this program, participants are paid full-time employees for a ten-week period of the summer, receiving educational programming in addition to their time in the lab.