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

PMID: 32342752 · 2020

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ZeitschriftThe Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics

Jahr2020

PMID32342752

Zusammenfassung

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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