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Ultrasound and the IRB
1Vocal Tract Visualization Lab, Biomedical Sciences Department, University of Maryland Dental School, Baltimore, 21201, USA. maepstein@alumni.upenn.edu
Clinical Linguistics & Phonetics
|October 7, 2005
Summary
This guide helps researchers ensure diagnostic B-scan ultrasound in speech studies is minimal risk. It details potential risks to assure Institutional Review Boards (IRBs) and participants of safety.
Area of Science:
- Medical Imaging
- Speech Science
- Biomedical Research
Background:
- Diagnostic ultrasound, specifically B-scan, is increasingly used in speech research.
- Previous studies on fetal ultrasound and tissue effects indicate general safety.
- Professional organizations affirm the safety of diagnostic ultrasound when used prudently.
Purpose of the Study:
- To guide researchers in preparing protocols and consent forms for diagnostic B-scan ultrasound in speech research.
- To provide a clear understanding of the minimal risks associated with this technology.
- To facilitate assurance for Institutional Review Boards (IRBs) and research subjects regarding safety.
Main Methods:
- Review of existing epidemiological and laboratory studies on ultrasound safety.
- Compilation of potential risks associated with diagnostic B-scan ultrasound.
- Development of a framework for communicating risk to IRBs and subjects.
Main Results:
- Diagnostic B-scan ultrasound, when used prudently, is considered minimal risk in speech research.
- Identification of specific risks allows for transparent communication and informed consent.
- Established safety data supports the use of B-scan ultrasound in this context.
Conclusions:
- Researchers can confidently use diagnostic B-scan ultrasound in speech studies by understanding and communicating potential risks.
- This approach ensures ethical research practices and participant safety.
- The paper serves as a resource for IRB submissions and subject education.