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Consensus Statement on Ethical & Safety Practices for Conducting Digital Monitoring Studies with People at Risk of
Matthew K Nock1, Evan M Kleiman1, Melissa Abraham1
1Department of Psychology, Harvard University, Cambridge, Massachusetts (Nock, Bentley, Castro-Ramirez, Lee, Millner, Mou, Rankin); Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts (Nock, Abraham, Bentley, Huffman, Mou); Franciscan Children's, Boston, Massachusetts (Nock, Buonopane, Millner); Department of Psychology, Rutgers University, New Brunswick, New Jersey (Kleiman); Department of Clinical Research, Massachusetts General Hospital, Research Ethics Consultation Unit, Boston, Massachusetts (Abraham); Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (Brent); Department of Counseling and Clinical Psychology, Teachers College, Columbia University, New York, New York (Cha); Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan (Dempsey); National Suicide Prevention Lifeline, vibrant Emotional Health, New York, New York (Draper); Department of Psychology, Old Dominion University, Norfolk, Virginia (Glenn); American Foundation for Suicide Prevention, New York, New York (Harkavy-Friedman); Department of Psychiatry, McLean Hospital, Belmont, Massachusetts (Hollander, Wheelis); Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts (Onnela); Massachusetts Institute of Technology, MIT Media Lab, Cambridge, Massachusetts (Picard); Harvard University, Office of the General Counsel, Cambridge, Massachusetts (Quay); Department of IRB Administration, Harvard University, Cambridge, Massachusetts (Sewards); Department of Psychiatry, Beth Israel Deaconess Medical Center, Boston, Massachusetts (Torous); University of Washington, Behavioral Research and Therapy Clinics, Seattle, Washington (Whiteside); National Institute of Mental Health, Office of Clinical Research, Bethesda, Maryland (Siegel, Ordóñez); National Institute of Mental Health, Special Advisor to the Director on Suicide Research, Bethesda, Maryland (Pearson). National Suicide Prevention.
Objective:
Digital monitoring technologies (e.g., smart-phones and wearable devices) provide unprecedented opportunities to study potentially harmful behaviors such as suicide, violence, and alcohol/substance use in real-time. 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.
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