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)

Most moral theorists agree that it is one thing to believe that someone has slighted you and another to resent her for the insult; one thing to believe that someone did you a favor and another to feel gratitude toward her for her kindness. While all of these ways of responding to another's conduct are forms of moral appraisal, the reactive attitudes are said to 'go beyond' beliefs in some way. We think this claim is adequately explained only when we (...) take seriously the fact that reactive attitudes are emotions. In this paper, we appeal to insights of the emotions literature to highlight one key way in which reactive attitudes go beyond beliefs: beliefs about a person and her morally significant conduct merely ascribe to the person the property of having performed a morally significant action, while reactive attitudes are ways of experiencing that person as having performed a morally significant action. We then suggest that appreciating this is a crucial first step toward understanding why reactive emotions play roles in our practices around responsibility that beliefs do not. (shrink)

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. (shrink)

The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare of human research participants. Evaluation and measurement of how IRBs satisfy this purpose and other important goals are open questions that demand empirical research. Research on IRBs, and the Human Research Protection Programs (HRPPs) of which they are often a part, is necessary to inform evidence-based practices, policies, and approaches to quality improvement in human research protections. However, to date, HRPP and IRB engagement in empirical (...) research about their own activities and performance has been limited. To promote engagement of HRPPs and IRBs in self-reflective research on HRPP and IRB quality and effectiveness, barriers to their participation need to be addressed. These include: extensive workloads, limited information technology systems, and few universally accepted or consistently measured metrics for HRPP/irb quality and effectiveness. Additionally, institutional leaders may have concerns about confidentiality. Professional norms around the value of participating in this type of research are lacking. Lastly, obtaining external funding for research on IRBs and HRPPs is challenging. As a group of HRPP professionals and researchers actively involved in a research consortium focused on IRB quality and effectiveness, we identify potential levers for supporting and encouraging HRPP and IRB engagement in research on quality and effectiveness. We maintain that this research should be informed by the core principles of patient- and community-engaged research, in which members and key stakeholders of the community to be studied are included as key informants and members of the research team. This ensures that relevant questions are asked and that data are interpreted to produce meaningful recommendations. As such, we offer several ways to increase the participation of HRPP professionals in research as participants, as data sharers, and as investigators. (shrink)

To date, 1.7 million US military service personnel have been deployed to Iraq and Afghanistan. Of those, one in five are suffering from diagnosable combat-stress related psychological injuries including Posttraumatic Stress Disorder (PTSD). All indications are that the mental health toll of the current conflicts on US troops and the medical systems that care for them will only increase. Against this backdrop, research suggesting that the common class of drugs known as beta-blockers might prevent the onset of PTSD is drawing (...) much interest. I urge caution against accepting too quickly the use of beta-blockers for dealing with the psychological injuries that combat experiences can wreak. Beta-blockers are thought to work by disrupting the formation of emotionally disturbing memories that typically occur in the wake of traumatic events and that in some people manifest as PTSD. Focusing on a single dimension of soldiers' experience in combat, namely, their perpetration of other-directed violence, I argue that some of the emotional memories blunted by beta-blockers play important roles in the recovery of moral aspects of soldiers' selves damaged by experiences of combat violence — specifically, in the achievement of a state of grace— and, therefore, that the use of beta-blockers may come with distinct moral costs. (shrink)

It is now a commonplace that emotions are not mere sensations but, rather, conceptually contentful states. In trying to expand on this insight, however, most theoretical approaches to emotions neglect central intuitions about what emotions are like. We therefore need a methodological shift in our thinking about emotions away from the standard accounts' attempts to reduce them to other mental states and toward an exploration of the distinctive work emotions do. I show that emotions' distinctive function is to engage us (...) with both objective and personal values. Attention to emotions' work reveals that it is precisely their “unruliness” that allows them to play meaningful roles in our lives. (shrink)

it has recently been discovered that propranolol — a beta-blocker traditionally used to treat cardiac arrhythmias and hypertension — might disrupt the formation of the emotionally disturbing memories that typically occur in the wake of traumatic events and consequently prevent the onset of trauma-induced psychological injuries such as Posttraumatic Stress Disorder. One context in which the use of propranolol is generating interest in both the popufor and scientific press is sexual violence. Nevertheless, feminists have so far not weighed in on (...) propranolol. I suggest that the time is ripe for a careful feminist analysis of the moral and political implications of propranolol use in the context of sexual violence. In this paper, I map the feminist issues potentially raised by providing propranolol to victims of sexual assault, focusing in particufor on the compatibility of propranolol use and avaüability with an understanding of the social and systematic dimensions of rape s harms. I do not deliver a final verdict on propranolol; in fact, I show that we do not yet have enough information about propranolol's effects to do so. Rather, 1 provide a feminist framework for evaluating the possibilities and penis opened up by therapeutic memory manipuktion in the context of sexual violence against women. (shrink)

The Belmont Report’s three foundational ethical principles—respect for persons, beneficence, and justice—have shaped regulation, practice, and our collective thinking about research with human beings in the United States for over 40 years. While it has proven remarkably adaptable, Belmont’s framework is a product of a specific time and historical context. Both the research enterprise and society at large have changed in significant ways since its creation. For example, the last four decades have seen a general democratization of knowledge production, increasing (...) skepticism of authority and expertise, and growing demands that institutions of power be more transparent about their activities so they can be better held to account. Within the research enterprise, the emergence of community engaged- and patient-centered research reflects these changes. This chapter examines the application of Belmont’s framework to stakeholder-engaged research, both illuminating its flexibilities and identifying its limitations, in terms of the values, norms, and expectations that are central to stakeholder-engaged research but unaccounted for by Belmont. (shrink)

The National Institutes of Health (NIH) invests over $37 billion per year in support of research to improve human health. All research funded by NIH that involves human subjects is subject to regulatory oversight, requiring institutions to staff and manage Institutional Review Boards (IRBs). IRB members, chairs, and the many associated human subjects protections oversight professionals who support the work of the IRB must navigate complex federal regulations issued by multiple agencies. This book is the industry standard reference work for (...) the research oversight community, providing comprehensive, understandable interpretations of the regulations, clear descriptions of the ethical principles on which the regulations are based, and practical best-practices guidelines for effectively implementing regulatory oversight. (shrink)

Biomedical and behavioral research is a complex, multidisciplinary, and highly varied enterprise with but a single goal: to produce and disseminate knowledge about the causes, effects, prevention, diagnosis, and treatment of human illnesses and impairments. Success requires public trust in the process. When that trust has been shaken (or worse), the response has been to establish offices to exercise oversight of the various actors and to require them to adhere to regulations that specify, with various levels of detail, what they (...) may or may not do.The two regulatory frameworks examined in this report by Barbara Bierer and Mark Barnes began separately, provoked by different scandals and abuses of public trust. (shrink)