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

J.L. Med & Ethics, 48(Supp. 1) 2020

79 Pages Posted: 21 Nov 2019

See all articles by Mark A. Rothstein

Mark A. Rothstein

University of Louisville - Institute for Bioethics, Health Policy, and Law; University of Louisville - Louis D. Brandeis School of Law

John Wilbanks

Sage Bionetworks

Laura M. Beskow

Duke University - Institute for Genome Sciences & Policy

Kathleen Brelsford

Vanderbilt University - Center for Biomedical Ethics and Society

Kyle Brothers

University of Louisville - School of Medicine

Megan Doerr

Sage Bionetworks

Barbara J. Evans

University of Houston Law Center

Catherine Hammack

Independent

Michelle McGowan

affiliation not provided to SSRN

Stacey A. Tovino

University of Nevada, Las Vegas, William S. Boyd School of Law

Date Written: November 11, 2019

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.

Keywords: Citizen Science, Common Rule, FDA, IRB, IRBs, Mobile Devices, NIH, Research Ethics

JEL Classification: K31, K32

Suggested Citation

Rothstein, Mark A. and Wilbanks, John and Beskow, Laura M. and Brelsford, Kathleen and Brothers, Kyle and Doerr, Megan and Evans, Barbara J. and Hammack, Catherine and McGowan, Michelle and Tovino, Stacey Ann, Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations (November 11, 2019). J.L. Med & Ethics, 48(Supp. 1) 2020. Available at SSRN: https://ssrn.com/abstract=3485023

Mark A. Rothstein (Contact Author)

University of Louisville - Institute for Bioethics, Health Policy, and Law ( email )

Louisville, KY 40202
United States

HOME PAGE: http://www.louisville.edu/bioethics

University of Louisville - Louis D. Brandeis School of Law ( email )

Wilson W. Wyatt Hall
Louisville, KY 40292
United States

John Wilbanks

Sage Bionetworks ( email )

1100 Fairview Ave. North
Seattle, WA 98109
United States

Laura M. Beskow

Duke University - Institute for Genome Sciences & Policy ( email )

240 North Building
Box 90141
Durham, CA 27708
United States

Kathleen Brelsford

Vanderbilt University - Center for Biomedical Ethics and Society ( email )

2525 West End Avenue
Suite 400
Nashville, TN 37203
United States

Kyle Brothers

University of Louisville - School of Medicine ( email )

550 South Jackson Street
Louisville, KY 40202
United States

Megan Doerr

Sage Bionetworks ( email )

1100 Fairview Ave. N.
Mailstop M1-C108
Seattle, WA 98109
United States

Barbara J. Evans

University of Houston Law Center ( email )

4604 Calhoun Road
Houston, TX 77204-6060
United States
713-743-2993 (Phone)

Catherine Hammack

Independent ( email )

No Address Available

Michelle McGowan

affiliation not provided to SSRN

Stacey Ann Tovino

University of Nevada, Las Vegas, William S. Boyd School of Law ( email )

4505 South Maryland Parkway
Box 451003
Las Vegas, NV 89154
United States

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