The University of Chicago's Human Imaging Research Office has a long and storied history. We've outlined some of its major milestones below.

Why Create a Human Imaging Research Office?

Clinical imaging infrastructure is designed to accommodate consistent, standard-of-care imaging examinations. Many research studies and clinical trials, however, have unique imaging constraints that may differ substantially from those for standard clinical purposes and, thus, burden the established infrastructure. These constraints are often present even when imaging is not the focus of the study but is simply being used to asses an endpoint – groups often wish to standardize their study’s imaging across all participating sites. These constraints often include:

• Specialized scan parameters -- the use of specific imaging equipment (i.e., equipment that has passed the sponsor’s QA process) and protocols (i.e., slice spacing and thickness, anatomic positioning, etc.).
• Unique scan interpretation guidelines -- the use of standard scan assessment paradigms such as RECIST or alternate paradigms (such as mRECIST, irRECIST, iwCLL, PCWG2, RANO, etc.), the need for volumetric measurements of organs or tumors, or the need for experimental 2-D measurements (distance or thickness measurements, etc.).

• Specific image processing and de-identification requirements -- the removal of specific Protected Health Information (e.g., patient name and medical record number), the insertion of study-specific identifiers (e.g., subject ID number and time point) into the DICOM headers of the image files, and the delivery of image data via physical or electronic methods.

The complex infrastructure for standard-of-care imaging is typically stressed by the unique technical, administrative, and compliance needs of a research protocol.

At The University of Chicago Medicine and Biological Sciences there are literally hundreds of clinical trials and research studies in progress simultaneously at any given time, and many of them involve the use of some form of medical imaging. Ensuring the compliance of the scans, their interpretation, and the resulting image data with their research protocols and all applicable regulations was only becoming more arduous, and leaving the issues to the responsibility of the individual investigators was becoming less and less feasible. Consequently, a unified solution to the many imaging demands and challenges presented by clinical research was needed. The Human Imaging Research Office was created to directly address these challenges at The University of Chicago.

The HIRO Begins

The Human Imaging Research Office (HIRO) was created in early 2009 as an initiative of the Biological Science Division's Imaging Research Institute. The Imaging Research Institute intended the HIRO to be the facilitator for clinical trials and research protocols that require the use of medical imaging or radiology resources. In this regard, the HIRO's goal was to standardize the process for utilizing these resources for research purposes and to make this process more efficient and accurate. The IRI appointed Samuel Armato, Ph.D., Associate Professor of Radiology, as the HIRO's first Faculty Director.

The HIRO began as a two-person office: a research imaging coordinator and a data manager. As its responsibilities grew and the number of studies it assisted increased, a technical director and an image distribution specialist were hired. With the addition of some part-time professional staff -- software developers and a research radiologist -- it reached its current level of staffing in 2011.

The HIRO has been dedicated to providing University of Chicago investigators and research staff with the tools and resources they need to ensure their research imaging is performed in a compliant manner. It launched its first full-service website in late 2010 with a plethora of information related to research imaging at the University as well as tools that allowed investigators to request image data for their research projects. A completely redesigned website with more tools and changes driven by feedback from HIRO users was launched in early 2015.

In 2010 the HIRO became a reviewing member of the University of Chicago Comprehensive Cancer Center's Clinical Trials Review Committee (CTRC). This relationship enabled the HIRO to provide critical logistical support to dozens of cutting-edge clinical trials and clinical research studies. In an effort to enhance community participation in all research-related imaging matters and to increase the overall satisfaction and utility of its services, the HIRO formed its Faculty Oversight Committee and its Clinical Operations Committee in late 2013.

In mid-2011 the University received an NIH Shared Instrument Grant to build a large storage system for research-related image data. Initially termed a "Research PACS," this system, now designated the "Biomedical Image Repository" or BMIR, will provide the University's biomedical research community with a professionally maintained and organized storage system for all types of image data. The HIRO is leading the development of the BMIR, and the initial hardware for the system was installed in early 2013. The BMIR is a joint project between the HIRO and the University's Center for Research Informatics.

The HIRO has supported dozens of clinical trials at our institution that are sponsored by numerous different companies, including: AbbVie, AstraZeneca, Astrellas, Bayer, Biogen, Boston Scientific, Bristol-Myers Squibb, Hoffman-La Roche, Genentech, Genzyme, Gilead, GlaxoSmithKline, InCyte, Janssen, MedImmune, Medtronic, Merck, Novartis, Pfizer, Pharmacyclics, and Sanofi Aventis. The HIRO has also supported clinical trials at our institution that are sponsored by cooperative groups like ACOSOG, ACRIN, Alliance, CALGB, COG, ECOG, GOG, NCI, and RTOG.

The HIRO is first and foremost a service-oriented office, and it was one of the first such offices at an academic medical center in the United States. As such, the HIRO has published articles and given a number of presentations on its infrastructure and the impact it has had on the University's research imaging workflow. For a list of the HIRO's various presentations and publications, please click here.