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Returning Individual Research Results from Digital Phenotyping in Psychiatry.

Shen FX, Baum ML, Martinez-Martin N, Miner AS, Abraham M, Brownstein CA, Cortez N, Evans BJ, Germine LT, Glahn DC, Grady C, Holm IA, Hurley EA, Kimble S, Lázaro-Muñoz G, Leary K, Marks M, Monette PJ, Onnela JP, O'Rourke PP, Rauch SL, Shachar C, Sen S, Vahia I, Vassy JL, Baker JT, Bierer BE, Silverman BC. Returning Individual Research Results from Digital Phenotyping in Psychiatry. The American journal of bioethics : AJOB. 2023 May 8; 1-22.

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Abstract:

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants'' locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant''s real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas.




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