Journal of Law, Medicine and Ethics 48 (S1):196-226 (2020)

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.
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DOI 10.1177/1073110520917047
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References found in this work BETA

Design Issues in E-Consent.John Wilbanks - 2018 - Journal of Law, Medicine and Ethics 46 (1):110-118.
Defining and Describing Benefit Appropriately in Clinical Trials.Nancy M. P. King - 2000 - Journal of Law, Medicine and Ethics 28 (4):332-343.

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Citations of this work BETA

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There Oughta Be a Law: When Does(N’T) the U.S. Common Rule Apply?Michelle N. Meyer - 2020 - Journal of Law, Medicine and Ethics 48 (S1):60-73.

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