Consensus Statement on Ethical & Safety Practices for Conducting Digital Monitoring Studies with People at Risk of Suicide and Related Behaviors

Abstract

Objective: Digital monitoring technologies (e.g., smartphones and wearable devices) provide unprecedented opportunities to study potentially harmful behaviors such as suicide, violence, and alcohol/substance use in realtime. The use of these new technologies has the potential to significantly advance the understanding, prediction, and prevention of these behaviors. However, such technologies also introduce myriad ethical and safety concerns, such as deciding when and how to intervene if a participant's responses indicate elevated risk during the study?Methods: We used a modified Delphi process to develop a consensus among a diverse panel of experts on the ethical and safety practices for conducting digital monitoring studies with those at risk for suicide and related behaviors. Twenty-four experts including scientists, clinicians, ethicists, legal experts, and those with lived experience provided input into an iterative, multi-stage survey, and discussion process.Results: Consensus was reached on multiple aspects of such studies, including: inclusion criteria, informed consent elements, technical and safety procedures, data review practices during the study, responding to various levels of participant risk in real-time, and data and safety monitoring.Conclusions: This consensus statement provides guidance for researchers, funding agencies, and institutional review boards regarding expert views on current best practices for conducting digital monitoring studies with those at risk for suicide-with relevance to the study of a range of other potentially harmful behaviors (e.g., alcohol/substance use and violence). This statement also highlights areas in which more data are needed before consensus can be reached regarding best ethical and safety practices for digital monitoring studies.

SIMON: A Digital Protocol to Monitor and Predict Suicidal Ideation

“…This study follows ethical and safety guidelines, such as those put forward by Nock and others ( 69 ). In accordance with these guidelines, participants will not be excluded on the basis of elevated risk of suicide, participants will be elaborately informed before participation on all suggested elements (e.g., whether responses will trigger intervention actions; providing participants with information about who will have access to their data), and recommended technical and safety procedures are in place (e.g., figuring out what to do when technology fails, and providing participants with standardized informations on items of data-collection).…”

Opening the Black Box of Daily Life in Nonsuicidal Self-injury Research: With Great Opportunity Comes Great Responsibility

“…The first consensus statement on ethical and safety procedures for real-time monitoring studies with individuals at risk of suicide has emerged recently [ 109 ]. The recommendations include collecting contact information for participants and a close contact, completing a safety plan at study enrollment, monitoring responses at least once per day, and in the event of a participant being at imminent risk of suicide, for a researcher to contact them.…”

“…In this regard, contacting the participant’s clinician may be better. However, no consensus was reached regarding whether the researcher should contact a participant’s clinician in the event of high or imminent suicide risk [ 109 ]. The logistical challenges of actively monitoring participants’ responses and potentially intervening should not be underestimated, especially for large studies where multiple participants may require intervention simultaneously.…”

Effective Strategies for Crowd-Powered Cognitive Reappraisal Systems: A Field Deployment of the Flip*Doubt Web Application for Mental Health

“…For these reasons, a recent consensus statement from domain experts recommends not to exclude such individuals or remove them from research against their will, and provides additional guidance for working with potentially suicidal participants [65]. Given this, how can we best balance risks to all involved, including participants, moderators, therapists, and even researchers, whose mental health can be seriously compromised while working in this domain [99]?…”