Ultrasound and the IRB.
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.
Epstein
Melissa A
MA
Vocal Tract Visualization Lab, Biomedical Sciences Department, University of Maryland Dental School, Baltimore, 21201, USA. maepstein@alumni.upenn.edu
D035843:Biomedical Research; D026724:Ethical Review; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000592:standards*; D018570:Risk Assessment; D013066:Speech-Language Pathology / Q000941:ethics*; D014463:Ultrasonography / Q000941:ethics* / Q000592:standards