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Abstract
The purpose of this paper is to assist researchers in writing their research protocols and subject consent forms so that both the Institutional Review Board (IRB) and subjects are assured of the minimal risk associated with diagnostic B‐scan ultrasound as it is used in speech research. There have been numerous epidemiological studies on fetal ultrasound and laboratory studies on the effects of ultrasound on various types of tissue, and the American Institute of Ultrasound in Medicine and the World Federation for Ultrasound in Medicine and Biology have concluded that B‐scan diagnostic ultrasound procedures are safe if conducted in a prudent manner. To this end, this paper will present a list of potential risks associated with diagnostic ultrasound so that researchers can explain to the IRB and subjects why diagnostic ultrasound, and B‐scan in particular, is minimal risk.
Acknowledgments
The author would like to thank Stan Barnett, Suzanne Boyce, Christy Holland, Maureen Stone and an anonymous reviewer for their assistance and comments. This research was supported in part NIDCD/NIH Grant R01 01758 and NIDCR/NIH Grant T32 DE07309.
Notes
In clinical practice there are two types of ultrasound procedures: diagnostic and therapeutic/surgical. B‐scan ultrasound imaging is a type of diagnostic ultrasound. Therapeutic or surgical ultrasound may be used to heat up muscle tissue or destroy tissues including tumors. Diagnostic ultrasound operates at much lower intensities than surgical or therapeutic ultrasound.