Author:
Rothstein Mark A.,Wilbanks John T.,Beskow Laura M.,Brelsford Kathleen M.,Brothers Kyle B.,Doerr Megan,Evans Barbara J.,Hammack-Aviran Catherine M.,McGowan Michelle L.,Tovino Stacey A.
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.
Publisher
Cambridge University Press (CUP)
Subject
Health Policy,General Medicine,Issues, ethics and legal aspects
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2. 244. Id., at pt. 812.
3. 203. See Tovino, supra note 180 (surveying state data breach, security, and privacy statutes).
4. 232. “Statement from FDA Commissioner Scott Gottlieb, M.D., and Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D., on Agency Efforts to Work with Tech Industry to Spur Innovation in Digital Health,” available at (last visited March 11, 2020); Food and Drug Administration, “Digital Health Innovation Action Plan,” available at (last visited March 11, 2020).
Cited by
27 articles.
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