Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations
J.L. Med & Ethics, 48(Supp. 1) 2020
31 Pages Posted: 21 Nov 2019 Last revised: 30 Apr 2020
Date Written: November 11, 2019
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.
Keywords: Citizen Science, Common Rule, FDA, IRB, IRBs, Mobile Devices, NIH, Research Ethics
JEL Classification: K31, K32
Suggested Citation: Suggested Citation