Potential Risks of Ecological Momentary Assessment Among Persons Who Inject Drugs.

BACKGROUND: Ecological momentary assessment (EMA)-which often involves brief surveys delivered via mobile technology-has transformed our understanding of the individual and contextual micro-processes associated with legal and illicit drug use. However, little empirical research has focused on participant's perspective on the probability and magnitude of potential risks in EMA studies. OBJECTIVES: To garner participant perspectives on potential risks common to EMA studies of illicit drug use. METHODS: We interviewed 38 persons who inject drugs living in San Diego (CA) and Philadelphia (PA), United States. They completed simulations of an EMA tool and then underwent a semi-structured interview that systematically explored domains of risk considered within the proposed revisions to the Federal Policy for the Protection of Human Subjects or the "Common Rule." Interviews were transcribed verbatim and coded systematically to explore psychological, physical, social, legal, and informational risks from participation. RESULTS: Participants perceived most risks to be minimal. Some indicated that repetitive questioning about mood or drug use could cause psychological (i.e., anxiety) or behavioral risks (i.e., drug use relapse). Ironically, the questions that were viewed as risky were considered motivational to engage in healthy behaviors. The most cited risks were legal and social risks stemming from participant concerns about data collection and security. IMPORTANCE: Improving our understanding of these issues is an essential first step to protect human participants in future EMA research. We provide a brief set of recommendations that can aid in the design and ethics review of the future EMA protocol with substance using populations.