This interview with media anthropologist, Rebecca L. Stein, conducted by Noa Levin and Andrew Fisher in Spring 2023, takes her recent book Screenshots: State Violence on Camera in Israel and Palestine (2021) as its starting point in order to explore issues of state violence and the militarization of social media in Israel/Palestine. This book marks the culmination of a decade-long research project into the camera dreams introduced by digital imaging technologies and the fraught histories of their disillusionment. Stein (...) discusses the way her research has critically conceptualized the recent history of hopes invested in the digital image in this geopolitical context, by the occupier as much as the occupied, and charts the failures and mistakes, obstructions and appropriations that characterize the conflicted visual cultures of Israel/Palestine. (shrink)

Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase (...) 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules. (shrink)

Book reviewed in this article: To Do No Harm: DES and the Dilemmas of Modern Medicine. By Roberta J. Apfel and Susan M. Fisher.

In phase I clinical trials, healthy volunteers are dosed with investigational drugs and subjected to blood draws and other bodily monitoring procedures. In exchange, they are paid. Healthy volunteers are, in a very direct sense, selling access to their bodies for pharmaceutical companies and their associates to run drugs through. In his ethnographic study of socalled professional guinea pigs, Roberto Abadie writes, "Paid volunteers are well aware of the demand for an idealized, perfectly healthy volunteer. They also realize that their (...) body is a valued commodity in clinical trials research". It is perhaps surprising, then, that commodification is little discussed in the bioethics literature on phase I... (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

The article "Picking and Choosing Among Phase I Trials", written by Jill A. Fisher, Torin Monahan and Rebecca L. Walker, was originally published Online First without Open Access. After publication in volume 16, issue 4, page 535-549 the author decided to opt for Open Choice and to make the article an Open Access publication.

Background The ethical use both of human and non-human animals in research is predicated on the assumption that it is of a high quality and its projected benefits are more significant than the risks and harms imposed on subjects. Yet questions remain about whether and how IRBs and IACUCs should consider the scientific value of proposed research studies.Methods We draw upon 45 interviews with IRB and IACUC members and researchers with oversight experience about their perceptions of their own roles in (...) reviewing the quality and value of scientific protocols. Interview transcripts were memoed to highlight specific findings, which were then used to identify key themes through an iterative process.Results IRB and IACUC members expressed broad trust in the need for and value of research, and they often assumed that protocols had social value or that prior review, especially when associated with funding, affirmed both the rigor and merit of those protocols. Some oversight members also took an explicit stance against scientific review by stating that such review is not within the regulatory mandates governing their parts in the oversight system. Yet other interviewees expressed uneasiness about the current paradigm for evaluating the quality and overall value of science, suggesting that IRB and IACUC members perceive gaps in the oversight systems.Conclusions These findings reveal many similarities in how IRB and IACUC members understand the roles and limitations of their respective oversight committees. We conclude with a discussion of how the lack of a clear mandate regarding scientific review within US federal regulations may undermine ethical engagement of whether human and animal research is scientifically justified, resulting in a “mission lapse” wherein no organizational body is clearly responsible for ensuring that the research being conducted has the potential to advance science and benefit society. (shrink)

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of (...) the adverse events they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity. (shrink)

Attention is vital to success in all aspects of life (Erickson, Thiessen, Godwin, Dickerson, & Fisher, 2015; Meck & Benson, 2002), hence it is important to identify biomarkers of later attentional problems early enough to intervene. Our objective was to determine if any of 11 genes (APOE, BDNF, HTR4, CHRNA4, COMT, DRD4, IGF2, MAOA, SLC5A7, SLC6A3, and SNAP25) predicted the trajectory of attentional development within the same group of children between infancy and childhood. We recruited followup participants from children (...) who participated as infants in visual attention studies and used a similar task at both time points. Using multilevel modeling, we associated changes in the participant’s position in the distribution of scores in infancy to his/her position in childhood with genetic markers on each of 11 genes. While all 11 genes predicted reaction time (RT) residual scores, only MAOA had a significant interaction including time point. We conclude that the MAOA SNP rs1137070 is useful in predicting which girls are likely to develop slower RTs on an attention task between infancy and childhood. This early identification is likely to be helpful in early intervention. (shrink)

Book reviewed in this article: To Do No Harm: DES and the Dilemmas of Modern Medicine. By Roberta J. Apfel and Susan M. Fisher.

In lieu of an abstract, here is a brief excerpt of the content:Breathing TogetherRebecca L. Walkowitz (bio)For the first seven years of my career, I taught a very large lecture course once, and sometimes twice, a year in a graded auditorium filled seat-to-seat with as many as 350 undergraduates. The course focused on a cluster of themes that linked art and violence–how art resists violence, how art animates violence, how art expresses violence, how violence spurs art– and traced those themes (...) through the history of British fiction from Joyce, Woolf, and Forster through Barker, Burgess, Ishiguro, and Rushdie. I loved teaching that class. I loved and was sometimes terrified and almost always invigorated by being in that room with those students. Needless to say, no one wore masks. Far from it.I remember the feel of the crowded, anonymous, yet intimate room. Intimate, because a group of 20 or 30 very avid students occupied the first few rows, and I came to value and recognize their attentive faces. I could hear their little sounds as they scratched out notes, adjusted their laptops, whispered to each other, and rustled papers. Intimate, because I was standing at my full, not very substantial height on a stage, and they were looking up at my body and listening to my voice for 50 minutes twice a week. And intimate, in another sense, because they would sometimes forget that we were there together live and behave in ways that I have never experienced in a smaller classroom. One day, two students in the last row, which in the slanted auditorium was directly level with my elevated gaze, spent most of the lecture kissing ardently. I was impressed by their enthusiasm and by the duration of their embrace. At the end of the lecture, I quick-stepped up the aisle to remind them: this is not TV; we are here together. I smiled while I said it, and they apologized for distracting me. I smile as I think about it now.During the COVID lockdown, I missed the embodied experience of large gatherings, including large lectures. The Zoom classroom, for all its affordances, can't replicate the accidental encounters, the risk and energy of embodied presentation, the warmth of individual eye contact, and the shoulder experiences of the class period: what happens in the time just before and the time just after the actual class takes place. The shoulder experiences are truly precious, as any seasoned teacher knows, because [End Page 258] they allow us to shift the scale of encounter up and down, and they allow us to interact in spontaneous and less formal ways than we do when the entire class is gathered as one. Close up and informally, we are more likely to use our faces and our hands: smiling, nodding, tilting, waving, and pressing our palms together to say thank you.There is a kind of social intimacy and a kind of social violence that can only be illustrated in a very large group, and I appreciated my lecture for allowing me to experience that. The most terrifying day of my class each semester was the day I spoke about– and performed!–the shock of involuntary, inchoate expression in E. M. Forster's A Room with a View. Like other Bloomsbury artists, Forster was committed to ushering out traditional ideas of self-restraint and maturity and ushering in greater communication between men and women, between social classes, and between ages about sexuality, desire, and the experiences of the body. The word of the day was "play": life needed more play, more honesty, more curiosity, and less seriousness, less decorum, and less lying to ourselves and others.What does this look like in the classroom? On the day in question, we would talk about the scenes in the novel in which characters are criticized for disruptive actions they cannot or do not control, such as fainting, laughing, bleeding, getting carried away, or expressing sounds in addition to words. I would explain that there are two problems with these actions: they are accidental or unintentional, and they involve an unexpected, unregulated expression of the body in public. Even worse, the actions take place in what our grandparents used to call "mixed... (shrink)

Contemporary moral psychology has focused on the notion of a universal moral sense, robust to individual and cultural differences. Yet recent evidence has revealed individual differences in the psychological processes for moral judgment: controlled cognition, mental-state reasoning, and emotional responding. We discuss this evidence and its relation to cross-cultural diversity in morality.

This investigation addresses the hypothesis that negative affect is associated with decreased ability to shift attention to a new focus. Thirty-nine participants completed a covert attentional orienting task and then viewed a distressing film clip. Mood was measured by self-report at the beginning and end of the session. Correlations between attentional orienting performance and self-reported mood indicated that participants with greater response time costs on invalidly cued trials reported more negative affect in response to the film. These results support the (...) hypothesis that negative affect is associated with a slowness to disengage attention. (shrink)

Some writers claim that ethicists involved in assessing future technologies like nanotechnology and human enhancement devote too much time to debating issues that may or may not arise, at the expense of addressing more urgent, current issues. This practice has been claimed to squander the scarce and valuable resource of ethical concern. I assess this view, and consider some alternatives to ‘speculative ethics’ that have been put forward. I argue that attempting to restrict ethical debate so as to avoid considering (...) unacceptably speculative scenarios would not only leave scientific progress devoid of ethical guidance, but would also rule out some of our most important ethical projects. I conclude that the issue of speculation is a red herring: what is most important is not that ethicists concentrate on current issues or those that are most likely to arise; but that ethicists, scientists, and others focus on maximising what is most valuable. (shrink)

Translational science is a 21st century mission. Government officials and industry leaders are making huge investments in an attempt to transform more basic science discoveries into therapeutic applications. Scientists and policymakers express great excitement about the medical advances that could come with the current bench-to-bedside campaign.A key step in translational science is the move from animal and other preclinical studies to initial human testing. Researchers ability to predict human effects is limited, and first-in-human tests present significant uncertainty. Participants in this (...) form of research face risks and can experience serious, even lethal, harm. Well-known incidents involving Jolee Mohr and Jesse Gelsinger, as well as subjects in the 2006 study of the investigational agent TGN1412, show the dangers that can arise in early human research.The bench-to-bedside campaign will need many volunteers to participate in early human testing. Investigators and regulators must not allow the policy enthusiasm for translational science to overshadow the commitment to protect human subjects. Participants in exploratory research are diverse and as a group lack characteristics usually associated with vulnerable populations, such as impaired decisional ability or economic or educational disadvantage. (shrink)

We consider the current debate between bioconservatives and their chief opponents — whom we dub bioliberals — about the moral acceptability of human enhancement and the policy implications of moral debates about enhancement. We argue that this debate has reached an impasse, largely because bioconservatives hold that we should honour intuitions about the special value of being human, even if we cannot identify reasons to ground those intuitions. We argue that although intuitions are often a reliable guide to belief and (...) action, there are circumstances in which they are not reliable. Intuitions — including intuitions about enhancement — are subject to various cognitive biases rendering them unreliable in some circumstances. We argue that many bioconservative intuitions about enhancement are examples of such unreliable intuitions. Given this, it is unrealistic of bioconservatives to expect others to rely on their unexamined intuitions. Furthermore, refusing to engage in debates about the reasons and values that underpin their intuitions about enhancement will have the effect of making bioconservative voices less relevant in policy debates about enhancement than they would otherwise be. (shrink)

Under current U.S. law, physicians may prescribe drugs and devices in situations not covered on the label approved by the Food and Drug Administration. Those supporting this system say that requiring FDA approval for off-label uses would unnecessarily impede the delivery of benefits to patients. Patients do benefit from off-label prescribing that is supported by sound scientific and medical evidence. In the absence of such evidence, however, off-label prescribing can expose patients to risky and ineffective treatments. The medical community and (...) federal authorities should more actively promote patients' interests in receiving beneficial off-label treatments. To exercise responsible self-regulation, members of the medical community must determine whether available evidence justifies specific off-label uses and must promote information-gathering when the evidence is inadequate. Physicians should also discuss with patients the uncertainties accompanying off-label uses. Federal authorities should more closely monitor the effects of off-label prescribing and adopt other measures to reduce harm and enhance benefits produced by off-label prescribing. (shrink)

Research using human embryonic stem cells raises an array of complex ethical issues, including, but by no means limited to, the moral status of developing human life. Unfortunately much of the public discussion fails to take into account this complexity. Advocacy for liberal and conservative positions on human embryonic stem cell research can be simplistic and misleading. Ethical concepts such as truth-telling, scientific integrity, and social justice should be part of the debate over federal support for human embryonic stem cell (...) research. Moreover, the debate should be conducted in accord with principles of deliberative democracy, including respect for people holding competing views. (shrink)

Is it conceptually possible for one person to ‘remember’ the experiences of another person? Many philosophical discussions of personal identity suppose that this is possible. For example, some philosophers believe that our personal identity through time consists in the continuation of our mental lives, including the holding of memories over time. However, since a person’s memories are necessarily memories of her own experiences, a definition of personal identity in terms of memory risks circularity. To avoid this, we must invoke the (...) concept of ‘quasi-memory’. From my quasi-memory of doing x, I cannot infer that I did x; but I can infer that somebody did x. It is then a further question as to whether the person who did x is me, the answer to which will depend upon what we believe personal identity to consist in. Quasi-memory, then, allows us to separate the concept of memory from the concept of personal identity. (shrink)

The biomedical literature and popular media are full of upbeat reports about the health benefits we can expect from medical innovations using nanotechnology. Some particularly enthusiastic reports portray nanotechnology as one of the innovations that will lead to a significantly extended human life span. Extreme enthusiasts predict that nanotechnology “will ultimately enable us to redesign and rebuild, molecule by molecule, our bodies and brains….”Nanomaterials have special characteristics that could contribute to improved patient care. But the same characteristics that make nanotechnology (...) promising also present risks to humans exposed to nanomaterials. A failure to appreciate these risks could jeopardize the research effort. As others have pointed out, if nanomedical interventions produce unexpected human harm, a loss of public and government support for nanomedicine is likely to follow.Like other forms of medical innovation, novel nanomedical interventions require human testing to evaluate their safety and effectiveness. (shrink)

The year 2014 brought a new development in the bioethics “laboratory of the states.” Five states adopted “right to try” laws intended to promote terminally ill patients' access to investigational drugs. Many more state legislatures are now considering such laws. The campaign for right to try laws is the latest move in an ongoing effort to give seriously ill patients access to drugs whose safety and effectiveness remain largely unknown. Although scientists and policy‐makers oppose the right to try approach, it (...) has proven quite popular among state legislators and the public. (shrink)

The deceased's prior consent to posthumous reproduction is a common requirement in many common law jurisdictions. This paper critically evaluates four arguments advanced to justify the presumption against consent. It is argued that, in situations where death is caused by sudden trauma, not only is there inadequate justification for the presumption against consent, but there are good reasons to reverse the presumption. The article concludes that the precondition of prior consent may be inappropriate in these situations.

Realist ideology critique (RIC) is a strand of political realism recently developed in response to concerns that realism is biased toward the status quo. RIC aims to debunk an individual's belief that a social institution is legitimate by revealing that the belief is caused by that very same institution. Despite its growing prominence, RIC has received little critical attention. In this article, I buck this trend. First, I improve on contemporary accounts of RIC by clarifying its status and the role (...) of motivated reasoning. Second, I show that realist ideology critics face a dilemma: either their account makes deeply implausible epistemological assumptions, or they temper its epistemology at the expense of rendering it toothless. I argue for each horn in turn before revealing the dilemma to be a false one by making a novel distinction between varying strengths of RIC based on their underlying epistemological assumptions. I propose Moder-ate RIC as a solution: upon discovering that one reason for your belief that a social institution is legitimate is likely malignantly epistemically circular, the belief should undergo further epistemic testing. I respond to three potential objections and suggest that Moderate RIC would make a fruitful addition to political theorists' methodological toolkit. (shrink)

This introduction provides an overview to a special issue on Critical Healing, which draws on queer theory, disability studies, postcolonial theory, and literary studies to theorize productive engagements between the clinical and cultural aspects of biomedical knowledge and practice. The essays in this issue historicize and theorize diagnosis, particularly diagnosis that impacts trans health and sexuality, homosexuality, and HIV/AIDS transmission. The essays also address racialization, disability, and colonialism through discussions of fiction, film, theoretical memoir, and comics, as well as biomedical (...) discourse and knowledge. (shrink)

By acquiring an understanding of the cultural meaning of deafness and acting as a bridge to resources and opportunities, clinicians.

As knowledge increases about the human genome,prenatal genetic testing will become cheaper,safer and more comprehensive. It is likelythat there will be a great deal of support formaking prenatal testing for a wide range ofgenetic disorders a routine part of antenatalcare. Such routine testing is necessarilycoercive in nature and does not involve thesame standard of consent as is required inother health care settings. This paper askswhether this level of coercion is ethicallyjustifiable in this case, or whether pregnantwomen have a right to (...) remain in ignorance ofthe genetic make-up of the fetus they arecarrying. While information gained by genetictesting may be useful for pregnant women whenmaking decisions about their pregnancy, it doesnot prevent harm to future children. It isargued that as this kind of testing providesinformation in the interests of the pregnantwomen and not in the interests of any futurechild, the same standards of consent that arenormally required for genetic testing should berequired in this instance. (shrink)

We review a recent paper in Genome Research by Guantes et al. showing that nuclear gene expression is influenced by the bioenergetic status of the mitochondria. The amount of energy that mitochondria make available for gene expression varies considerably. It depends on: the energetic demands of the tissue; the mitochondrial DNA (mtDNA) mutant load; the number of mitochondria; stressors present in the cell. Hence, when failing mitochondria place the cell in energy crisis there are major effects on gene expression affecting (...) the risk of degenerative diseases, cancer and ageing. In 2015 the UK parliament approved a change in the regulation of IVF techniques, allowing “Mitochondrial replacement therapy” to become a reproductive choice for women at risk of transmitting mitochondrial disease to their children. This is the first time that this technique will be available. Therefore understanding the interaction between mitochondria and the nucleus has never been more important. (shrink)

In this issue, Paul Menzel and M. Colette Chandler‐Cramer propose a novel advance directive. Besides giving competent people the opportunity to refuse future life‐prolonging medical interventions, they say, advance directives should give people the opportunity to refuse ordinary food and water if they later experience severe dementia.This proposal is both appealing and unsettling. It is appealing because it offers some relief to people seeking to avoid the prolonged decline and extreme incapacity they have witnessed in relatives and friends with advanced (...) dementia. But does it sufficiently protect patients? Menzel and Chandler‐Cramer want to empower competent persons to impose potential discomfort and distress on a later self who cannot understand the reasons for that choice. In this situation, the price of respecting autonomy is paid by a frail incapacitated patient who has no idea why food and water are no longer offered to her. (shrink)

Marine interstitial environments are teeming with an extraordinary diversity of coexisting microeukaryotic lineages collectively called “meiofauna.” Interstitial habitats are broadly distributed across the planet, and the complex physical features of these environments have persisted, much like they exist today, throughout the history of eukaryotes, if not longer. Although our general understanding of the biological diversity in these environments is relatively poor, compelling examples of developmental heterochrony (e.g., pedomorphosis) and convergent evolution appear to be widespread among meiofauna. Therefore, an improved understanding (...) of meiofaunal biodiversity is expected to provide some of the deepest insights into the following themes in evolutionary biology: (i) the origins of novel body plans, (ii) macroevolutionary patterns of miniaturization, and (iii) the intersection of evolution and community assembly – e.g., “community convergence” involving distantly related lineages that span the tree of eukaryotes. (shrink)

In this book, Andreas Serafim sets out to investigate the use of religious discourse, by which he means any reference to religious ideas, beliefs, and attitudes in public speaking contexts in classical Athens. Like Gunther Martin (Divine Talk: Religious Argumentation in Demosthenes, 2009), Serafim examines religion primarily as a tool for persuasion, but he differentiates himself from Martin’s book by offering a more comprehensive study: he aims to take into account all extant speeches from t...