Patient-led medicine, powered by mobile technology like smartphones and wearable fitness trackers, is transforming health research. While these new tools have powerful potential, some of this research is not subject to federal regulations, raising quandaries about how to ensure adherence to independent review, informed consent and privacy standards. A new NIH-funded project, MobileELSI, will develop and disseminate recommendations for the ethical conduct of this emerging research. It's led by Consortium collaborators Mark Rothstein (University of Louisville), Charlisse Caga-anan (National Cancer Institute) and John Wilbanks (Sage Bionetworks); Consortium chair Susan M. Wolf is serving on the Working Group. The Consortium hosted an event, How Patients Are Creating Medicine's Future, in Dec. 2016, featuring four experts in the field; video can be viewed here.
To date, there has been very little study of the ethical and legal issues surrounding unregulated health research performed by "citizen scientists." A three-year grant from the National Institutes of Health will enable a team of 30 researchers from leading research institutions, health technology developers, and patient advocates to consider a wide range of issues, including the various types of mobile health research platforms, the potential applicability of various federal and state laws regulating research, possible models of self-regulation, and specific measures from online consent to integrating privacy protection in health apps.