We aim to raise awareness and stimulate dialogue among investigators and research ethics committees regarding ethical issues that arise specifically in the design and conduct of mHealth research involving persons living with HIV/AIDS and substance abuse. Following a brief background discussion of mHealth research in general, we offer a case example to illustrate the characteristics of mHealth research involving people living with HIV/AIDS and substance abuse. With reference to a well-established systematic general ethical framework for biomedical research with human participants, we identify a range of ethical issues that have particular salience for the protection of participants in mHealth research on HIV/AIDS and substance abuse. 1. Introduction In the past decade, mobile phone technology has become nearly ubiquitous in most developed country contexts, crossing socioeconomic boundaries and in some populations displacing traditional landline infrastructure. Similar trends have been noted globally, as current estimates suggest that nearly 6.1 billion mobile subscriptions exist in 2013 [1]. The pervasive growth of this technology has resulted in innovations across sectors of agriculture, education, and even health, focused around a new domain of research and implementation science termed “mHealth” or mobile health. Classical medical information systems and technologies have, for decades, been centered on the highly tethered, facility-based patient record, and other management systems. The advent of mHealth has led both researchers and patients to explore the potential for mobile technologies to improve health outcomes and lower costs by increasing patient engagement, improving provider quality, and optimizing efficiency in health care. mHealth opens new avenues for research insight, as this ubiquitous technology allows much more frequent data collection about participants’ behavior, location, and physiology, sometimes in real time [2]. In the past 5 years, a growing body of mHealth research has emerged, exploring the role of these technologies in improving preventive and curative care. In HIV, a number of research projects have explored how mobile phones can be used to improve adherence to antiretroviral treatment in low-resource settings [3, 4] to provide decision support to frontline health workers [5, 6] and to introduce the benefits of continuous care in places where this was previously impossible. mHealth strategies have been used to improve patient care and self-efficacy by improving adherence to complex antiretroviral regimens, reducing missed
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