Returning Individual Research Results from Digital Phenotyping in Psychiatry.

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.

Responding to the Call to Meaningfully Assess Institutional Review Board Effectiveness.

This Viewpoint discusses the difficult task of creating a stakeholder-driven, evidence-based approach to assessing institutional review board effectiveness beyond regulatory compliance.

Clarifying the Ethics and Oversight of Chimeric Research.

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human-nonhuman chimeric research. Led by bioethics researchers working closely with an interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human-nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics' previous focus on human-centered questions about the ethics of "humanization" and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less-siloed governance and oversight and more-comprehensive public communication.

Should Participants in Clinical Trials Be Able to Withdraw from Passive Follow-Up?

A research participant's right to withdraw from all research procedures is widely accepted, but there can be justifiable limits to a participant's exercise of autonomy to withdraw from some procedures. Clinical outcomes trials depend on complete subject follow-up for accurate assessment of the safety and efficacy of investigational therapies. Subjects' refusal to complete follow-up, even through passive medical record review, can cause failure to detect safety signals, inaccurate estimation of efficacy, or lack of acceptance of trial results, which alters the study's benefit-risk ratio. Allowing participant refusal of follow-up data collection therefore creates tension between respect for persons and beneficence. With minimal risk study procedures that can help preserve trial benefit, such as passive data collection, we argue that the importance of upholding the principle of beneficence outweighs individual autonomy concerns. Furthermore, a consent process that prospectively informs participants of mandatory passive follow-up is ethically justified and optimizes the balance between autonomy and beneficence.