Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary

Authors

• Laura M. Beskow
• Catherine Hammack-Aviran, Belmont University College of LawFollow
• Kathleen M. Brelsford
• P Pearl O'Rourke

Document Type

Article

Publication Date

2020

Abstract

This study explores expert perspectives on oversight mechanisms for unregulated mobile health (mHealth) research conducted outside traditional regulatory frameworks. Through qualitative interviews with stakeholders including patient advocates, researchers, regulators, and technology developers, the authors examine concerns surrounding ethical protections in research utilizing data from mobile applications and devices. Participants highlighted risks associated with inadequate study design, lack of informed consent, and insufficient safeguards for participant privacy and autonomy. Experts proposed a range of potential oversight mechanisms, including voluntary ethical review processes, industry standards, and expanded institutional policies. The findings underscore the growing ethical challenges posed by nontraditional research environments and emphasize the need for adaptable oversight structures that protect participants while fostering innovation in digital health research.

Recommended Citation

Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary, 48 J. L. Med. Ethics S.1: 136-46 (2020) (with Laura Beskow, Kathleen Brelsford, & Pearl O’Rourke).