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Mobile Research Applications and State Research Laws

Published online by Cambridge University Press:  01 January 2021

Stacey A. Tovino
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Abstract

This article assesses the protections provided by state research laws for participants in mobile application (mobile app) mediated health research conducted by independent scientists, citizen scientists, and patient researchers. Prior scholarship in this area focuses on the lack of application of: (1) federal regulations governing research conducted or funded by one of sixteen signatory federal departments and agencies (the Common Rule); and (2) separate federal regulations promulgated by the Food and Drug Administration applicable to research conducted in anticipation of a submission to the FDA for approval of a drug or medical device. This article builds on this prior scholarship by carefully examining state research laws and suggesting ways in which these laws could be improved to better protect participants of mobile appmediated research conducted by independent scientists, citizen scientists, and patient researchers.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 48 , Issue S1: Unregulated Health Research Using Mobile Devices , Spring 2020 , pp. 82 - 86
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

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References

The current list of 16 Common Rule Departments and Agencies and their regulations are as follows: Department of Homeland Security, 6 C.F.R. Pt. 46; Department of Agriculture, 7 C.F.R. Pt. 1c; Department of Energy, 10 C.F.R. Pt. 745; National Aeronautics and Space Administration, 14 C.F.R. Pt. 1230; Department of Commerce, 15 C.F.R. Pt. 27; Social Security Administration, 20 C.F.R. Pt. 431; Agency for International Development, 22 C.F.R. Pt. 225; Department of Housing and Urban Development, 24 C.F.R. Pt. 60; Department of Labor, 29 C.F.R. Pt. 21; Department of Defense, 32 C.F.R. Pt. 219; Department of Education, 34 C.F.R. Pt. 97; Department of Veterans Affairs, 38 C.F.R. Pt. 16; Environmental Protection Agency, 40 C.F.R. Pt. 26; Department of Health and Human Services, 45 C.F.R. Pt. 46; National Science Foundation, 45 C.F.R. Pt. 690; Department of Transportation, 49 C.F.R. Pt. 11.Google Scholar
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