Nebeker C. (2020). mHealth research applied to regulated and unregulated behavioral health sciences. The Journal of Law, Medicine & Ethics. 48(1): 49-59. doi: 10.1177/1073110520917029
Digital and mobile health (mHealth) technology has advanced behavioral research beyond what current regulations and guidelines can support, both for biomedical researchers and for citizen scientists (i.e., individuals without research training using mHealth for self-tracking and self-experimentation). Citizen scientists conduct research without regulatory or ethical frameworks, raising the question of whether guidelines are needed. Even among regulated academic research organizations, both researchers and the institutional review boards (IRBs) who evaluate the ethical implications of research projects often lack knowledge about the technologies involved and the types of potentially sensitive data these technologies produce. This leads to inaccurate and inconsistent assessment of the probability and magnitude of harm to participants. Both researchers and IRB members must become more knowledgeable about these technologies. The author also suggests applying the Ethical, Legal/Regulatory, and Social Implications (ELSI) framework to the Belmont/Menlo principles (respect for persons, beneficence, justice, and respect for law and public interest) when designing mHealth research studies. Analysis of these combined principles and framework would lead researchers to consider whether potential participants have access to the information needed to make an informed choice to participate (respect for persons), whether study risks are reasonable in relation to potential knowledge gained (beneficence), whether distribution of participation burden is fair (justice), and whether the study complies with relevant laws and demonstrates accountability and transparency (respect for law and public interest). The author urges digital health researchers to collaborate to advance the development of ethical principles and responsible practices and recommends prioritizing funding of research on the ethical dimensions of unregulated mHealth.