Citation

Rothstein MA, Wilbanks JT, Beskow LM, Brelsford KM, Brothers KB, Doerr M, Evans BJ, Hammack-Aviran CM, McGowan ML, Tovino SA. J. Law Med. Ethics 2020; 48(Suppl 1): 196-226.

Affiliation

Mark A. Rothstein, J.D., is Herbert F. Boehl Chair of Law and Medicine and Director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine. John T. Wilbanks is Chief Commons Officer of Sage Bionetworks. Laura M. Beskow, M.P.H., Ph.D., is Professor and Ann Geddes Stahlman Chair in Medical Ethics at the Center for Biomedical Ethics and Society, Vanderbilt University Medical Center Kathleen M. Brelsford, Ph.D., M.P.H., is Research Assistant Professor at the Center for Biomedical Ethics and Society, Vanderbilt University Medical Center. Kyle B. Brothers, M.D., Ph.D., is Endowed Chair of Pediatric Clinical and Translational Research, University of Louisville School of Medicine. Megan Doerr, M.S., L.G.C., is Principal Scientist, Governance at Sage Bionetworks. Barbara J. Evans, J.D., Ph.D., is Mary Ann and Lawrence E. Faust Professor of Law, Professor of Electrical and Computer Engineering, and Director of the Center for Biotechnology and Law, University of Houston. Catherine M. Hammack-Aviran, M.A., J.D., is Associate in Health Policy at the Center for Biomedical Ethics and Society, Vanderbilt University Medical Center. Michelle L. McGowan, Ph.D., is Associate Professor, Department of Pediatrics and Department of Women's, Gender, and Sexuality Studies, Cincinnati Children's Hospital Medical Center. Stacey A. Tovino, J.D., Ph.D., is Judge Jack and Lulu Lehman Professor of Law at the William S. Boyd School of Law, University of Nevada-Las Vegas.

Copyright

(Copyright © 2020, American Society of Law, Medicine and Ethics, Publisher John Wiley and Sons)

DOI

10.1177/1073110520917047

PMID

32342752

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.

Language: en