Novel Method for Bilirubin Quantification: Computational and In Vitro Validation; Lack of Regulation of Minority Data Inclusion in FDA Clinical Trials

Haiz, Gabriella, School of Engineering and Applied Science, University of Virginia
Forelle, MC, Engineering and Society, University of Virginia
Helmke, Brian, Biomedical Engineering, University of Virginia
Guilford, William, Biomedical Engineering, University of Virgina

My STS research paper, and the topic explored, were constructed from the motivation of my Capstone project. My Capstone project sought to address an inequity in healthcare: creating a non-invasive measurement device for bilirubin, also known as bilirubinometers, in infants that is skin-tone inclusive. Currently, non-invasive bilirubinometers are only effective on light-skinned patients, causing an over prescription for phototherapy treatment. My STS research paper considered what political factors led to the allowance of biased medical products to be brought to market, specifically why there are no strict regulations on the inclusion of minority data in clinical trials. The STS research paper addressed the broader implications of the lack of inclusion of minority data in clinical trials, while my Capstone project related to one specific device that was produced from a lack of regulatory power concerning demographic data. Holistically, both projects informed the other with the Capstone project supplementing technical evidence of a larger, more systematic issue that my STS research paper addressed.

BS (Bachelor of Science)
Bilirubin, FDA, PDE, Inclusion

School of Engineering and Applied Science

Bachelor of Science in Biomedical Engineering

Technical Advisor: William Guilford, Ph.D., Brian Helmke, Ph.D.

STS Advisor: MC Forelle, Ph.D.

Technical Team Members: Mark Provost, William Adu-Jamfi, Kaitlyn Hixson

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