In a new target article published in the American Journal of Bioethics, faculty at the Center for Bioethics at Harvard Medical School collaborated with the McLean Hospital Institute for Technology in Psychiatry (ITP) and an interdisciplinary expert working group to develop the first guidance for return of results in digital phenotyping research in psychiatry. 

Psychiatric research is rapidly adopting digital tools such as smart phones, wearables, text messaging, and social media to gain individualized patient data and better understand how real-time digital interventions could improve mental health outcomes. 

“These new tools have awesome potential,” said Center faculty member Francis Shen, “but big data digital phenotyping research also raises many big ethical and legal challenges.” One of the most immediate challenges is the lack of guidelines for when and how to share individual and group research results, as well as incidental findings, with participants.

To address this challenge, Center for Bioethics faculty members Benjamin Silverman, MD, Francis Shen, JD, PhD, Barbara Bierer, MD, Melissa Abraham, PhD, Ingrid Holm, MD, MPH, and Gabriel Lázaro-Muñoz, PhD, JD, together with McLean Hospital faculty members Justin Baker, Scott Rauch, Laura Germine and Ipsit Vahia, and additional experts from HMS, Harvard-affiliated hospitals, and leading institutions nationally created a novel, comprehensive framework specific to the ethical, legal, and social implications of returning individual research results in digital phenotyping research.

Center faculty member Benjamin Silverman, who also serves as Senior IRB Chair for Mass General Brigham, noted that "the framework we provide in this article addresses a critical unmet need for psychiatric research as it greatly expands its use of digital tools." The work was supported by a Bioethics Supplement from the National Institute of Mental Health (NIMH) of the National Institutes of Health (NIH) under Award Number 1U01MH116925-01 (Baker, PI).