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Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations

Published online by Cambridge University Press:  01 January 2021

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  and
Stacey A. Tovino
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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. This article addresses the difficult policy challenge of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 48 , Issue S1: Unregulated Health Research Using Mobile Devices , Spring 2020 , pp. 196 - 226
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

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