Simultaneously accommodating imaging for day-to-day clinical care and clinical research
trials can be a daunting task for a medical center. Failing to meet the imaging guidelines imposed by a clinical trial will result in additional effort for staff, and can jeopardize the integrity of the research, cause patient removal from the trial, and tarnish the reputation of the institution.
Medical centers with large portfolios of clinical research are likely to see their local radiology departments overburdened with the unique imaging requirements of clinical trial patients. Instead of focusing on routine patient care
, the radiology department must also ensure the integrity of the clinical trial's imaging–a substantial task even for trials with relatively simple requirements.
Our experience handling these issues at the University of Chicago led us to create an office dedicated to the management and administration of research-related imaging: a Human Imaging Research Office, or HIRO. The sole purpose of this office is to ensure that all research-related imaging at the institution is performed in compliance with research protocols, institutional review board requirements and regulations under the Health Insurance Portability and Accountability Act.
The creation of a HIRO at our institution has enabled us to better accommodate the numerous imaging demands that accompany clinical research. Personnel are knowledgeable in the conduct of clinical trials and familiar with the details and logistics of clinical and research imaging. Delegating these responsibilities to a dedicated office alleviates the burden on radiology department personnel and the local researcher's team.
With the increased use of medical imaging in clinical research, the complexity of research will only grow. Medical centers that wish to participate in this type of research will need to make appropriate investments in their imaging infrastructure. At the University of Chicago, this required the addition of dedicated staff and resources; however, smaller institutions may be able to do so with intelligent restructuring of current resources. Such an office helps reduce overall institutional liability by ensuring a medical center's adherence to research requirements and HIPAA regulations.
In an effort to improve research integrity, this service-oriented model should become the de facto standard among all institutions conducting clinical research, since it will improve the efficiency, accuracy and overall experience among researchers, imaging scientists and personnel, clinical trial sponsors, and most importantly, patients.Samuel Armato III, Ph.D., is an associate professor in the Department of Radiology at the University of Chicago. Nicholas Gruszauskas, Ph.D., is technical director of the University of Chicago's Human Imaging Research Office.