A Comprehensive Risk Assessment Method for Pediatric Patients Undergoing Research Examinations Using Ionizing Radiation: How We Answered the Institutional Review Board

Abstract

Objective: The objectives of this study are to establish a comprehensive method for radiation dose estimates for the most common imaging examinations performed for research, for internal use of institutional review board (IRB) and radiation safety committees; to provide investigators with relative examination doses so that they may better assess the potential radiation effects and risks for research subjects; and to provide simplified language that investigators can use in consent documents.

Materials and methods: Nineteen common radiation-based examinations used in clinical research at our institution were identified. For each modality (CT, digital radiography, dual-energy x-ray absorptiometry, PET/CT, and nuclear medicine), a comprehensive patient-specific dosimetry method was established. Effective dose was calculated according to average population calculated doses for the following age groups: 0-1, 2-8, 9-13, 14-15, and older than 15 years.

Results: Estimated effective dose values were tabulated and posted on our institutional IRB intranet site for use by IRB and radiation safety committee members and institutional investigators. Relative examination dose levels were compared for all ages and for all examinations. A three-tiered approach to establish consent language for radiation exposure was established for research subjects receiving an effective dose less than 3 mSv, a dose between 3 and 50 mSv, and a dose greater than 50 mSv.

Conclusion: The method to estimate effective dose was tabulated for 19 of the most common ionizing radiation examinations at our institute. These results will act as a resource to help investigators better understand the implications of radiation exposure in research and can assist investigators in protocol development and correct categorization of radiation exposure risk.

Keywords: consent form; institutional review board; patient dose; pediatric radiology; risk analysis.