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

See all articles by Mark A. Rothstein

Mark A. Rothstein

U of Louisville

John Wilbanks

Sage Bionetworks

Laura M. Beskow

Vanderbilt University Medical Center

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 Florida Levin College of Law

Catherine Hammack

Independent

Michelle McGowan

University of Cincinnati

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)

U of Louisville ( email )

3787 Via Vuelta
3787 Via Vuelta
Rancho Santa Fe, CA 92091
United States
15025299381 (Phone)

John Wilbanks

Sage Bionetworks ( email )

1100 Fairview Ave. North
Seattle, WA 98109
United States

Laura M. Beskow

Vanderbilt University Medical Center ( email )

Center for Biomedical Ethics and Society
2525 West End Ave., Suite 400
Nashville, TN 37203
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 Florida Levin College of Law ( email )

P.O. Box 117625
Gainesville, FL 32611-7625
United States

Catherine Hammack

Independent ( email )

Michelle McGowan

University of Cincinnati ( email )

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

Do you have a job opening that you would like to promote on SSRN?

Paper statistics

Downloads
173
Abstract Views
1,773
Rank
367,515
PlumX Metrics