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)

Peterson, Karlawish, and Largent’s “Supported Decision Making with People at the Margins of Autonomy” brings welcome attention to the rights of people with cognitive impairment and provides...

Friesen et al. (2023) describe barriers to research in patient populations that have been historically labeled as vulnerable and, as a result, are under-represented in research due to the Instituti...

Research Ethics, Volume 18, Issue 1, Page 64-83, January 2022. Automated, wearable cameras can benefit health-related research by capturing accurate and objective information about individuals’ daily experiences. However, wearable cameras present unique privacy- and confidentiality-related risks due to the possibility of the images capturing identifying or sensitive information from participants and third parties. Although best practice guidelines for ethical research with wearable cameras have been published, limited information exists on the risks of studies using wearable cameras. The aim of this (...) literature review was to survey risks related to using wearable cameras, and precautions taken to reduce those risks, as reported in empirical research. Forty-five publications, comprising 36 independent studies, were reviewed, and findings revealed that participants’ primary concerns with using wearable cameras included physical inconvenience and discomfort in certain situations. None of the studies reviewed reported any serious adverse events. Although it is possible that reported findings do not include all risks experienced by participants in research with wearable cameras, our findings suggest a low level of risk to participants. However, it is important that investigators adopt recommended precautions, which can promote autonomy and reduce risks, including participant discomfort. (shrink)

The emergence of innovative neuroimaging technologies, particularly highly portable magnetic resonance imaging (pMRI), has the potential to spawn a transformative era in neuroscience research. Resourced academic institutional review boards (IRBs) with experience overseeing traditional MRI have a special role to play in ethical governance of pMRI research and should facilitate the collaborative development of nuanced and culturally sensitive guidelines and educational resources for pMRI protocols. This paper explores the ethical challenges of pMRI in neuroscience research and the dynamic leadership role (...) that IRBs should play to promote ethical oversight of emerging pMRI research. (shrink)