In this paper, we examine the case of psychedelic medicine for Alzheimer’s disease and related dementias (AD/ADRD). These “mind-altering” drugs are not currently offered as treatments to persons with AD/ADRD, though there is growing interest in their use to treat underlying causes and associated psychiatric symptoms. We present a research agenda for examining the ethics of psychedelic medicine and research involving persons living with AD/ADRD, and offer preliminary analyses of six ethical issues: the impact of psychedelics on autonomy and consent; (...) the impact of “ego dissolution” on persons experiencing a pathology of self; how psychedelics might impact caregiving; the potential exploitation of patient desperation; institutional review boards’ orientation to psychedelic research; and methods to mitigate inequity. These ethical issues are magnified for AD/ADRD but bear broader relevance to psychedelic medicine and research in other clinical populations. (shrink)

To ensure that the information resulting from research is relevant to patients, the Patient‐Centered Outcomes Research Institute eschews the “traditional health research” paradigm, in which investigators drive all aspects of research, in favor of one in which patients assume the role of research partner. If we accept the premise that patient engagement can offer fresh perspectives that shape research in valuable ways, then at least two important sets of questions present themselves. First, how are patients being engaged—and how should they (...) be engaged? Second, which patients are being engaged—and which patients should be? This set has received relatively less attention, and the neglect is surprising, given that the “who” question is conceptually prior to the question of “how.”This article focuses attention on the “who” of patient engagement in research. First, we provide background on the rationale for patient engagement, underscoring the importance of ensuring the representativeness of engaged patients. Second, we present what little is known about patients engaged in PCORI‐funded research. Third, we identify and discuss the ethical implications of ways in which current practices of patient identification and recruitment may lead to a lack of representativeness. These practices include reliance on the well‐connected and well‐informed, reliance on patients who are not well trained or well‐informed, and reliance on patient advocacy organizations. Finally, we consider several strategies for addressing these pitfalls in order to maximize the positive goals of patient engagement. Patient engagement is intended to address the inability of researchers, funders, and others to fully represent patient views and priorities, but without sufficient attention, the patients selected for this role may still leave important gaps. (shrink)

"The Renaissance in Scotland" contains original essays on the following topics of cultural history: literature; manuscripts and printed books; libraries; law; ...

In May 2011, the clinical ethics group of the Center for Ethics at Washington Hospital Center launched a 40-hour, three and one-half day Clinical Ethics Immersion Course. Created to address gaps in training in the practice of clinical ethics, the course is for those who now practice clinical ethics and for those who teach bioethics but who do not, or who rarely, have the opportunity to be in a clinical setting. “Immersion” refers to a high-intensity clinical ethics experience in a (...) busy, urban, acute care hospital. During the Immersion Course, participants join clinical ethicists on working rounds in intensive care units and trauma service. Participants engage in a videotaped role-play conversation with an actor. Each simulated session reflects a practical, realistic clinical ethics case consultation scenario. Participants also review patients’ charts, and have small group discussions on selected clinical ethics topics. As ethics consultation requests come into the center, Immersion Course participants accompany clinical ethicists on consultations. Specific to this pilot, because participants’ evaluations and course faculty impressions were positive, the Center for Ethics will conduct the course twice each year. We look forward to improving the pilot and establishing the Immersion Course as one step towards addressing the gap in training opportunities in clinical ethics. (shrink)

In May 2011, the clinical ethics group of the Center for Ethics at Washington Hospital Center launched a 40-hour, three and one-half day Clinical Ethics Immersion Course. Created to address gaps in training in the practice of clinical ethics, the course is for those who now practice clinical ethics and for those who teach bioethics but who do not, or who rarely, have the opportunity to be in a clinical setting. “Immersion” refers to a high-intensity clinical ethics experience in a (...) busy, urban, acute care hospital. During the Immersion Course, participants join clinical ethicists on working rounds in intensive care units and trauma service. Participants engage in a videotaped role-play conversation with an actor. Each simulated session reflects a practical, realistic clinical ethics case consultation scenario. Participants also review patients’ charts, and have small group discussions on selected clinical ethics topics. As ethics consultation requests come into the center, Immersion Course participants accompany clinical ethicists on consultations.Specific to this pilot, because participants’ evaluations and course faculty impressions were positive, the Center for Ethics will conduct the course twice each year. We look forward to improving the pilot and establishing the Immersion Course as one step towards addressing the gap in training opportunities in clinical ethics. (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)

This paper presents the behavioral interview model that we developed to formalize our hiring practices when we, most recently, needed to hire a new clinical ethicist to join our staff at the Center for Ethics at Washington Hospital Center.

Invisible Hand accounts of the operations of the competitive market are often thought to have two implications for morality as it confronts economic life. First, explanations of agents economic activities eschew constitutive appeal to moral notions; and second, such moralism is pernicious insofar as it tends to undermine the operations of a socially valuable social process. This is the Mandevillean Conceit. The Conceit rests on an avarice-only reading of the profit-motive that is mistaken. The avarice-only reading is not the only (...) way of characterising the profit-motive, and there are some positive grounds for thinking the benefits of profit pursuit are better attributed to the "lucrephile", and not the avarice-only "lucrepath". (shrink)

Human microbiome research makes causal connections between entire microbial communities and a wide array of traits that range from physiological diseases to psychological states. To evaluate these causal claims, we first examine a well-known single-microbe causal explanation: of Helicobacter pylori causing ulcers. This apparently straightforward causal explanation is not so simple, however. It does not achieve a key explanatory standard in microbiology, of Koch’s postulates, which rely on manipulations of single-microorganism cultures to infer causal relationships to disease. When Koch’s postulates (...) are framed by an interventionist causal framework, it is clearer what the H. pylori explanation achieves and where its explanatory strengths lie. After assessing this ‘simple’, single-microbe case, we apply the interventionist framework to two key areas of microbiome research, in which obesity and mental health states are purportedly explained by microbiomes. Despite the experimental data available, interventionist criteria for explanation show that many of the causal claims generated by microbiome research are weak or misleading. We focus on the stability, specificity and proportionality of proposed microbiome causal explanations, and evaluate how effectively these dimensions of causal explanation are achieved in some promising avenues of research. We suggest some conceptual and explanatory strategies to improve how causal claims about microbiomes are made. (shrink)

Human microbiome research makes causal connections between entire microbial communities and a wide array of traits that range from physiological diseases to psychological states. To evaluate these causal claims, we first examine a well-known single-microbe causal explanation: of Helicobacter pylori causing ulcers. This apparently straightforward causal explanation is not so simple, however. It does not achieve a key explanatory standard in microbiology, of Koch’s postulates, which rely on manipulations of single-microorganism cultures to infer causal relationships to disease. When Koch’s postulates (...) are framed by an interventionist causal framework, it is clearer what the H. pylori explanation achieves and where its explanatory strengths lie. After assessing this ‘simple’, single-microbe case, we apply the interventionist framework to two key areas of microbiome research, in which obesity and mental health states are purportedly explained by microbiomes. Despite the experimental data available, interventionist criteria for explanation show that many of the causal claims generated by microbiome research are weak or misleading. We focus on the stability, specificity and proportionality of proposed microbiome causal explanations, and evaluate how effectively these dimensions of causal explanation are achieved in some promising avenues of research. We suggest some conceptual and explanatory strategies to improve how causal claims about microbiomes are made. (shrink)

When payment is offered for controlled human infection model research, ethical concerns may be heightened due to unfamiliarity with this study design as well as perceptions—and misperceptions—regarding risk. Against this backdrop, we commend Grimwade et al 1 for their careful handling of the relevant issues, coupling empirical and conceptual approaches. We agree with foundational elements of the authors’ analysis, including the acceptability of payment for research risk.1 However, in our view, it is preferable to treat payment for risk as a (...) discretionary incentive to achieve adequate recruitment and retention, rather than compensation owed as a matter of fairness. Grimwade et al 1 note that although their ‘Payment for Risk Model’ was ‘created specifically in the context of CHIM research, it has the potential to inform payment in other areas of medical research.’ We agree and would go further: we do not need a special payment framework for CHIMs because there is nothing so novel about them compared with other types of research as to demand a distinct approach. Any successful payment framework must address the following ethical issues: preserving informed consent ; treating participants fairly ; encouraging adequate recruitment and retention; avoiding deception by participants; and preserving public trust.2 Some of these issues may have particular salience in the context of CHIMs, but this study design does not demand consideration of entirely distinct ethical factors when evaluating offers of payment.2 We also agree with Grimwade et al 1 about several other key points.2 Given the burdens involved and …. (shrink)

Liberation theology is in retreat. Once orthodox Catholics, starting with Pope John Paul II, recognized liberation theology's cultural challenge, they effectively countered it. They insisted on a traditional Catholic hierarchy of values. They undercut liberation theology's appeal by taking back key words and precepts that liberationists tried to appropriate. The Magisterium's sensus fidei included practical steps to demonstrate the weakness of liberation theology's hold, especially on poor people. Orthodox Catholics thus used the theological and practical weapons that the Church always (...) had at her disposal. The response of many liberation theologians has been to change some of liberation theology's precepts. (shrink)

Background Meaningfully evaluating the quality of institutional review boards (IRBs) and human research protection programs (HRPPs) is a long-recognized challenge. To be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), organizations must demonstrate that they measure and improve HRPP “quality, effectiveness, and efficiency” (QEE). We sought to learn how AAHRPP-accredited organizations interpret and satisfy this standard, in order to assess strengths, weaknesses, and gaps in current approaches and to inform recommendations for improvement.Methods We conducted 3 (...) small-group interviews with a total of 19 participant representatives of accredited organizations at the 2019 AAHRPP annual meeting. Participants were eligible if they had familiarity with their organization’s approach to satisfying the relevant QEE standard.Results Participants reported lacking clear definitions for HRPP quality or effectiveness but described various approaches to assessing QEE, typically focused on turnaround time, compliance, and researcher satisfaction. Evaluation of IRB members was described as relatively superficial and information regarding research subject experience was not reported as central to QEE assessment, although participants described several efforts to improve consideration of patient, subject, and community perspectives in IRB review. Participants also described efforts to educate and build relationships with key stakeholders as important features of a high-quality HRPP. While generally satisfied with their approaches, participants expressed concern about resource and time constraints that pushed them to be reactive and automatic about QEE, rather than proactive and critical.Conclusions The relevant AAHRPP accreditation standard may obscure critical gaps in defining and measuring QEE elements. We recommend that AAHRPP: (1) offer a definition of QEE or require accredited organizations to provide their own, to help clarify the rationale and goals behind assessment and improvement efforts, and (2) require accredited organizations to establish QEE objectives and measures focused on participant outcomes and deliberative quality during protocol review. (shrink)

Human microbiome research makes causal connections between entire microbial communities and a wide array of traits that range from physiological diseases to psychological states. To evaluate these causal claims, we first examine a well-known single-microbe causal explanation: of Helicobacter pylori causing ulcers. This apparently straightforward causal explanation is not so simple, however. It does not achieve a key explanatory standard in microbiology, of Koch’s postulates, which rely on manipulations of single-microorganism cultures to infer causal relationships to disease. When Koch’s postulates (...) are framed by an interventionist causal framework, it is clearer what the H. pylori explanation achieves and where its explanatory strengths lie. After assessing this ‘simple’, single-microbe case, we apply the interventionist framework to two key areas of microbiome research, in which obesity and mental health states are purportedly explained by microbiomes. Despite the experimental data available, interventionist criteria for explanation show that many of the causal claims generated by microbiome research are weak or misleading. We focus on the stability, specificity and proportionality of proposed microbiome causal explanations, and evaluate how effectively these dimensions of causal explanation are achieved in some promising avenues of research. We suggest some conceptual and explanatory strategies to improve how causal claims about microbiomes are made. (shrink)

Background Diversity in Institutional Review Board (IRB) membership is important for both intrinsic and instrumental reasons, including fairness, promoting trust, improving decision quality, and responding to systemic racism. Yet U.S. IRBs remain racially and ethnically homogeneous, even as gender diversity has improved. Little is known about IRB chairpersons’ perspectives on membership diversity and barriers to increasing it, as well as current institutional efforts to promote diversity, equity, and inclusion (DEI) within IRB membership.Methods We surveyed IRB chairpersons leading U.S. boards registered (...) with the Office for Human Research Protections. Here, we focus exclusively on responses from a subset of 388 chairpersons of IRBs at universities and academic medical centers (AMCs).Results Board chairs were predominantly white and evenly split between men and women. Only about half reported that their boards had at least one member who is Black or African American (51%), Asian (56%), or Hispanic (48%), with 85% of university/AMC boards comprised entirely (15%) or mostly (70%) of white members. Most IRB chairpersons (64%) reported satisfaction with the current diversity of their membership. Participants largely agreed that considering diversity in the selection of IRB members is important (91%), including to improve the quality of IRB deliberation (80%), with an emphasis on racial/ethnic (85%) and gender diversity (74%). Most participants (80%) reported some type of active DEI effort regarding board membership at their university/AMC and just over half (57%) expressed satisfaction with these efforts.Conclusions Our national survey found that although university/AMC IRB chairpersons report valuing diversity in board membership, it may be lacking in key areas. Going forward, it will be important to specify clear reasons for diversity in the IRB context, as well to establish targets for acceptable levels of board diversity and to match DEI efforts to those targets. (shrink)

The peer commentaries on our Target Article, “Promoting Ethical Payment in Human Infection Challenge Studies,” offer a number of insights that will help advance the co...

Philosophers debate the death of philosophy as much as they debate the death of God. Kant claimed responsibility for both philosophy's beginning and end, while Heidegger argued it concluded with Nietzsche. In the twentieth century, figures as diverse as John Austin and Richard Rorty have proclaimed philosophy's end, with some even calling for the advent of "postphilosophy." In an effort to make sense of these conflicting positions—which often say as much about the philosopher as his subject—Isabelle Thomas-Fogiel undertakes the first (...) systematic treatment of "the end of philosophy," while also recasting the history of western thought itself. Thomas-Fogiel begins with postphilosophical claims such as scientism, which she reveals to be self-refuting, for they subsume philosophy into the branches of the natural sciences. She discovers similar issues in Rorty's skepticism and strands of continental thought. Revisiting the work of late-nineteenth and early-twentieth-century philosophers, when the split between analytical and continental philosophy began, Thomas-Fogiel finds both traditions followed the same path—the road of reference—which ultimately led to self-contradiction. This phenomenon, whether valorized or condemned, has been understood as the death of philosophy. Tracing this pattern from Quine to Rorty, from Heidegger to Levinas and Habermas, Thomas-Fogiel reveals the self-contradiction at the core of their claims while also carving an alternative path through self-reference. Trained under the French philosopher Bernard Bourgeois, she remakes philosophy in exciting new ways for the twenty-first century. (shrink)

As genomic science has evolved, so have policy and practice debates about how to describe and evaluate the ways in which genomic information is treated for individuals, institutions, and society. The term genetic exceptionalism, describing the concept that genetic information is special or unique, and specifically different from other kinds of medical information, has been utilized widely, but often counterproductively in these debates. We offer genomic contextualism as a new term to frame the characteristics of genomic science in the debates. (...) Using stasis theory to draw out the important connection between definitional issues and resulting policies, we argue that the framework of genomic contextualism is better suited to evaluating genomics and its policy-relevant features to arrive at more productive discussion and resolve policy debates. (shrink)

To prepare for potential human infection challenge studies involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SAR...

We argue that two main accounts of hypocrisy— the deception-based and the moral-non-seriousness-based account—fail to capture a specific kind of hypocrite who is morally serious and sincere "all the way down." The kind of hypocrisy exemplified by this hypocrite is irreducible to deception, self-deception or a lack of moral seriousness. We call this elusive and peculiar kind of hypocrisy, pure hypocrisy. We articulate the characteristics of pure hypocrisy and describe the moral psychology of two kinds of pure hypocrites.

Many think doing animal ethics demands we see moral humanism as a speciesist prejudice of the kind found with sexism and racism. The only serious case for this rests on the Argument from Marginal Cases. We find that argument to the point, but show that properly understood it supports humanism. Understanding why it does this lets us see how we ought to go on in animal ethics.

Volume 19, Issue 9, September 2019, Page 1-4.

This paper presents the behavioral interview model that we developed to formalize our hiring practices when we, most recently, needed to hire a new clinical ethicist to join our staff at the Center for Ethics at Washington Hospital Center.

This article brings out certain philosophical difficulties in Lacan’s account of the mirror stage, the initial moment of the subject’s development. For Lacan, the “original organization of the forms of the ego” is “precipitated” in an infant’s self-recognition in a mirror image; this event is explicitly prior to any social interactions. A Hegelian objection to the Lacanian account argues that social interaction and recognition of others by infants are necessary prerequisites for infants’ capacity to recognize themselves in a mirror image. (...) Thus mutual recognition with another, rather than self-recognition in a mirror, is what makes possible subsequent ego-formation and self-consciousness. This intersubjective critique suggests that many of the psychoanalytic consequences that Lacan derives from the mirror stage (e.g., alienation, narcissism, and aggressivity) may need to be rethought. (shrink)

The central thesis of Foucault's Critical Ethics is that Foucault's account of power does not foreclose the possibility of ethics; on the contrary, it provides a framework within which ethics becomes possible. Tracing the evolution of Foucault's analysis of power from his early articulations of disciplinary power to his theorizations of biopower and governmentality, Richard A. Lynch shows how Foucault's ethical project emerged through two interwoven trajectories: analysis of classical practices of the care of the self, and engaged practice (...) in and reflection upon the limits of sexuality and the development of friendship in gay communities. These strands of experience and inquiry allowed Foucault to develop contrasting yet interwoven aspects of his ethics; they also underscored how ethic practice emerges within and from contexts of power relations. The gay community's response to AIDS and its parallels with the feminist ethics of care serve to illustrate the resources of a Foucauldian ethics—a fundamentally critical attitude, with substantive (but revisable) values and norms grounded in a practice of freedom. (shrink)

Minimalists generally see themselves as engaged in a descriptive project. They maintain that they can explain everything we want to say about truth without appealing to anything other than the T-schema, i.e., the idea that the proposition that p is true iff p. I argue that despite recent claims to the contrary, minimalists cannot explain one important belief many people have about truth, namely, that truth is good. If that is so, then minimalism, and possibly deflationism as a whole, must (...) be rejected or recast as a profoundly revisionary project. (shrink)

Volume 19, Issue 6, June 2019, Page 64-66.

Gene–environment covariance is the phenomenon whereby genetic differences bias variation in developmental environment, and is particularly problematic for assigning genetic and environmental causation in a heritability analysis. The interpretation of these cases has differed amongst biologists and philosophers, leading some to reject the utility of heritability estimates altogether. This paper examines the factors that influence causal reasoning when G–E covariance is present, leading to interpretive disagreement between scholars. It argues that the causal intuitions elicited are influenced by concepts of agency (...) and blame-worthiness, and are intimately tied with the conceptual understanding of the phenotype under investigation. By considering a phenotype-specific approach, I provide an account as to why causal ascriptions can differ depending on the interpreter. Phenotypes like intelligence, which have been the primary focus of this debate, are more likely to spark disagreement for the interpretation of G–E covariance cases because the concept and ideas about its ‘normal development’ relatively ill-defined and are a subject of debate. I contend that philosophical disagreement about causal attributions in G–E covariance cases are in essence disagreements regarding how a phenotype should be defined and understood. This moves the debate from one of an ontological flavour concerning objective causal claims, to one concerning the conceptual, normative and semantic dependencies. (shrink)