Health research is increasingly conducted on mobile devices by unregulated researchers. A new National Institutes of Health-funded project, Mobile ELSI (Ethical, Legal and Social Implications) is developing recommendations for the ethical conduct of this emerging research.
“We are looking at various issues of research ethics raised by this new type of research,” says Mark A. Rothstein, JD, principal investigator of Mobile ELSI.
Unregulated researchers — those who are not subject to the Common Rule or FDA regulations — include:
• independent researchers who do not receive federal funding;
• “citizen scientists;”
• patient advocacy organizations, which increasingly sponsor or even perform their own research;
• research use of data collected for another purpose, such as health app data.
“The grant is for three years, and we are approaching the midpoint in our study,” reports Rothstein, founding director of the University of Louisville’s Institute for Bioethics, Health Policy, and Law, and author of a paper on this topic.1 Ethical issues include:
• lack of external oversight from IRBs;
• online recruitment and inducements to participate;
• informed consent;
• confidentiality and security of sensitive information;
• return of results.
“The next — and most difficult — step will be to analyze numerous potential recommendations and then decide which policies and practices to propose,” says Rothstein.
The overarching goal is to bring this new and largely overlooked form of research to the attention of stakeholders and policymakers. “We believe there is little likelihood that laws will be amended to regulate previously unregulated research,” says Rothstein. Self-regulation is a more realistic outcome.
Anyone can now obtain genomic testing online, laboratory analyses without a physician’s orders, electronic health records with longitudinal data, and connections with a network of similarly affected individuals. “These factors enable research by nontraditional researchers,” says Rothstein. “The theoretical capacity exists for unregulated researchers to attempt biomedical research.”
Citizen science research also is facilitated by commonly available software that can be used on mobile devices. Notably, nontraditional research participants often include individuals with disorders for which there are no effective standard therapies. “This is a vulnerable population,” says Rothstein. “In some cases, they are willing to trust people without questioning their credentials, experience, or acumen.”
This raises the possibility that individuals will stop taking medications based on dubious medical evidence or will try dangerous, unproven therapies.
“We want to try to figure out how we can protect the welfare of nontraditional research participants without impeding or stifling the creativity of nontraditional researchers,” says Rothstein.
1. Rothstein MA, Wilbanks JT, Brothers KB. Citizen science on your smartphone: An ELSI Research Agenda. J Law Med Ethics 2015; 43(4):897-903.
• Mark A. Rothstein, JD, Institute for Bioethics, Health Policy and Law, University of Louisville. Phone: (501) 852-4982. Email: firstname.lastname@example.org.