Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations.
PMID: 32342752 ·
Mark A Rothstein, John T Wilbanks, Laura M Beskow, Kathleen M Brelsford, Kyle B Brothers, Megan Doerr, Barbara J Evans, Catherine M Hammack-Aviran, Michelle L McGowan, Stacey A Tovino
Abstract
Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device
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