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. (shrink)

The market can produce skewed information about investigational products awaiting FDA approval. But the FDA rarely steps in to correct such misleading information, despite statutory authority to do so. This article evaluates a recommendation by the FDA Transparency Working Group that FDA more clearly signal when and how it will correct misleading information about investigational products, and why such a recommendation is particularly important after the 21st Century Cures Act.

Originally edited by Timothy Stoltzfus Jost, this text examines how different countries around the world approach the same challenges in health care law and ethics: how to finance care for as many people as possible; how to ensure quality care; how to best secure patients' rights; how to regulate abortion, end of life decision making, and assisted reproduction; and how to manage infectious diseases, tobacco use, and human subject research. The new edition considers a broader array of countries, particularly from (...) Asia, Latin America, Africa, and the Middle East. (shrink)