BackgroundThe biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.Main textAny institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that (...) arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context “specification” substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity.ConclusionUnderstanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society. (shrink)

Pitting i-frame policies against s-frame policies inadvertently propagates a false dichotomy that fails to distinguish between effective i-frame policies that directly change behaviors and ineffective education-based i-frame policies that try to change people's hearts and minds. We argue that people's fixation on changing hearts and minds may be an obstacle for behavioral science in policy.

We build on Ainslie's discussion of willpower by highlighting another common misconception in the literature: the conflation of self-control and willpower. In our commentary, we identify this issue and discuss the importance of recognizing willpower not as synonymous with self-control, but rather as a subset of self-control. We describe a set of upstream strategies as more effective alternatives to willpower.

One of the most common policy-related messages that economists present to non-economists is the superiority of cash over in-kind transfers as a policy tool. A good deal of government policy on behalf of the poor consists, of course, of various forms of in-kind assistance, such as medical care or food stamps. However, if we wish to help the poor, the argument goes, in-kind transfers are an inferior way to do so.

The American Journal of Bioethics, Volume 11, Issue 6, Page 25-27, June 2011.

To protect children in research, procedures that are not administered in the medical interests of a child must be restricted. The risk threshold for these procedures is generally measured according to the concept of minimal risk. Minimal risk is often defined according to the risks of “daily life.” But it is not clear whose daily life should serve as the baseline; that is, it is not clear to whom minimal risk should refer. Commentators in research ethics often argue that “minimal (...) risk” should refer to healthy children or the subjects of the research. I argue that neither of these interpretations is successful. I propose a new interpretation in which minimal risk refers to children who are not unduly burdened by their daily lives. I argue that children are not unduly burdened when they fare well, and I defend a substantive goods account of children’s welfare. (shrink)

An argument that anyone can pursue political agency and resistance through photography, even those with flawed or nonexistent citizenship.

Infants are unable to make their own decisions or express their own wishes about medical procedures and treatments. They rely on surrogates to make decisions for them. Who should be the decision-maker when an infant’s biological parents are also minors? In this paper, we analyse a case in which the biological mother is a child. The central questions raised by the case are whether minor parents should make medical decisions on behalf of an infant, and if so, what are the (...) limits to this decision-making authority? In particular, can they refuse treatment that might be considered best for the infant? We examine different ethical arguments to underpin parental decision-making authority; we argue that provided that minor parents are capable of fulfilling their parental duties, they should have a right to make medical decisions for their infant. We then examine the ethical limits to minor parents’ decision-making authority for their children. We argue that the restricted authority that teenagers are granted to make medical decisions for themselves looks very similar to the restricted autonomy of all parents. That is, they are permitted to make choices, but not harmful choices. Like all parents, minor parents must not abuse or neglect their children and must also promote their welfare. They have a moral right to make medical decisions for their infants within the same ‘zone of parental discretion’ that applies to adult parents. We conclude that adult and minor parents should have comparable decision-making authority for their infants. (shrink)

Controlled human infection model (CHIM) studies involve the intentional exposure of healthy research volunteers to infectious agents. These studies contribute to knowledge about the cause or development of disease and to the advancement of vaccine research. But they also raise ethical questions about the kinds of risks that should be permissible and whether limits should be imposed on research risks in CHIM studies. Two possible risk thresholds have been considered for CHIM studies. The first suggests constraining ethically permissible risks according (...) to a minimal risk threshold and the second endorses a higher risk threshold that excludes irreversible or fatal infections. I argue that neither of these thresholds is persuasive and situate questions about risk thresholds in CHIM studies within a broader debate about permissible risks in research. I argue that risks in CHIM studies should be constrained according to limits on research risks that do not offer corresponding benefits in all studies rather than developing a unique risk threshold for CHIM studies. I then propose five recommendations for the ethical assessment of risk in CHIM studies. (shrink)

This book outlines and evaluates the principal strands of critical legal studies, and achieves much more as well.

Ethics guidelines and commentary suggest that a central function of research ethics committees is to assess the scientific merit of the protocols they review. However, some commentators object to this role, and evidence suggests that the assessment of scientific merit is a significant source of confusion and animosity between ethics committees and clinical investigators. In this essay, we argue that ethics committees should assess the scientific value and validity of research protocols and that new decision-making tools are needed to help (...) them do so in a systematic, transparent, and reliable way. We present a novel ethical framework that can assist in this task. (shrink)

Minimal risk is a central concept in the ethical analysis of research with children. It is defined as the risks “. . . ordinarily encountered in daily life . . . .” But the question arises: who is the referent for minimal risk? Commentators in the research ethics literature often answer this question by endorsing one of two possible interpretations: the uniform interpretation or the relative interpretation of minimal risk. We argue that describing the debate over minimal risk as a (...) disagreement between the uniform and the relative interpretation impedes progress on the identification of a justifiable referent for minimal risk. There are two main problems with this approach: constructing the debate over minimal risk as a disagreement between a uniform and a relative interpretation misconstrues the main difference between competing interpretations and neither the uniform nor the relative interpretation identifies one unique and consistent group of children as the referent for minimal risk. We conclude that progress on the debate over minimal risk requires that we abandon the uniform and relative interpretations and address the main moral problem at stake: whether healthy children or the subjects of the research should be the referent for minimal risk. (shrink)

Most agree that clinical research offers one of the best prospects of improving pediatric medicine. Most also agree that children may be exposed to some degree of risk while participating in clinical trials. But the degree of risk that should be permitted and the reasons for which it should be permitted remain controversial. In this paper, I examine a central risk threshold in research with children—the threshold constraining risks that do not offer research subjects the prospect of direct medical benefit. (...) That is, the threshold for research risks undertaken in the interests of deriving valuable knowledge that may benefit future children, but not the research subjects themselves. I examine competing... (shrink)

The inclusion of children in research gives rise to a difficult ethical question: What justifies children's research participation and exposure to research risks when they cannot provide informed consent? This question arises out of the tension between the moral requirement to obtain a subject's informed consent for research participation, on the one hand, and the limited capacity of most children to provide informed consent, on the other. Most agree that children's participation in clinical research can be justified. But the ethical (...) justification for exposing children to research risks in the absence of consent remains unclear. One prevalent group of arguments aims to justify children's risk exposure by appealing to the concept of benefit. I call these ‘benefit arguments’. Prominent versions of this argument defend the idea that broadening our understanding of the notion of benefit to include non-medical benefits helps to justify children's research participation. I argue that existing benefit arguments are not persuasive and raise problems with the strategy of appealing to broader notions of benefit to justify children's exposure to research risk. (shrink)

Ethics has been identified as a central reason for choosing the stepped wedge trial over other kinds of trial designs. The potential advantage of the stepped wedge design is that it provides all arms of the trial with the active intervention over the course of the study. Some groups receive it later than others, but the study intervention is not withheld from any group. This feature of the stepped wedge design seems particularly ethically advantageous in two instances: when the study (...) intervention appears especially likely to be effective and when the consequences of not receiving the intervention may be dire. But despite an increase in the use of the stepped wedge design and appeals to its ethical superiority as the motivation for its selection, there has been limited attention to the stepped wedge trial in the ethics literature. In the following, I examine whether there are persuasive ethical reasons to prefer or to require a stepped wedge trial. I argue that while the stepped wedge design is ethically permissible, it is not morally superior to other kinds of trials. To this end, I examine the ethical justification for providing, withholding, and delaying interventions in research. (shrink)

This article reviews four areas of pediatric research in which we have identified questionable levels of allowable risk, exceeding those foreseen by the Commission. They are the following: the categorization of increasingly risky interventions as minimal risk in a variety of protocols; the increasing number of applications for federal panel review of research not otherwise approvable because of higher projected risk levels; research on asymptomatic at risk children; and the inclusion of children and adolescents in placebo-controlled trials for participants of (...) all ages without performing subgroup analysis. While embracing the imperative to include children in research is an encouraging step towards providing the pediatric population with effective medical care and finally eradicating the therapeutic orphan, we must ensure that this research does not become overly permissive. (shrink)

What is photography? -- Rethinking the political -- The photograph as the source of civil knowledge -- Civil uses of photography.

Despite more than a century of research on sexual dysfunction, there has been limited attention to ethical concerns. This is problematic because sex research involves complex ethical questions that generate confusion for ethics review and have not been addressed by ethical guidelines. We analyze two questions. First, does sexual content raise the risk profile of a research protocol? We argue that there is nothing inherent in sexual content that makes a study high risk and that many sexual dysfunction studies involve (...) no more than minimal risk. Second, we ask whether research interventions that involve seeing participants undressed or having physical contact with a research subject are permissible? We argue that these interventions raise an important ethical challenge—they often involve sexual dysfunction researchers engaging in interventions that would not be conducted in their standard practice. To resolve this, we propose an expertise-based account of the permissibility of sexual dysfunction research. (shrink)

Iris Marion Young, On female body experience: “Throwing like a girl” and other essays, New York: Oxford University Press, 2005, reviewed by Ariella Binik.

This thesis is a contribution to the ethical justification for clinical research with children. A research subject’s participation in a trial is usually justified, in part, by informed consent. Informed consent helps to uphold the moral principle of respect for persons. But children’s limited ability to make informed choices gives rise to a problem. It is unclear what, if anything, justifies their participation in research. Some research ethicists propose to resolve this problem by appealing to social utility, proxy consent, arguments (...) explaining why it is permissible to expose children to some harm, and an argument concerning the appropriate balance between research harms and benefits. I argue that each of these is a necessary part of the justification for research with children, but that the argument concerning harms and benefits is under-developed. It relies on the concept of minimal risk, but minimal risk is inadequately justified. I propose an interpretation of minimal risk. I defend the idea that minimal risk should be interpreted according to the risks of daily life. I reject the most prominent defense of daily life, which claims that daily risks are morally relevant because they replace, rather than add to, the risks a child would ordinarily face. Instead, I propose that these risks are part of a reasonable trade-off between personal safety and our ability to pursue meaningful lives. I then examine whose daily life should be captured in the concept of minimal risk. I reject arguments that minimal risk should refer to healthy children or the subjects of the research and propose instead that the referent should be children who are not unduly burdened by their lives. I argue that children are not unduly burdened when they fare well and defend the idea that children fare well when they possess sufficiently high degrees of the substantive goods of childhood. I conclude by analyzing a controversial case study using my interpretation of minimal risk. I draw on this case to argue that my interpretation offers clear guidance for research ethics review and contributes to a determination that is more plausible than its rivals. (shrink)

One of the central problems concerning research with children is the delineation of appropriate levels of risk exposure. In the U.S. Code of Federal Regulations, the "minimal risk" concept serves as an anchoring measure for allowable risk. While the regulations sought to promote a balance between scientific advances and the protection of children's vulnerable status, ambiguities in the language of the regulations and the regulatory definition of "minimal risk" have given rise to a great deal of confusion. Research ethics boards (...) and the medical community espouse a multitude of varying opinions regarding the interpretation and application of the federal regulations with more recent research demonstrating an apparent increase in risk without corresponding benefit in pediatric research. Informed by ethical theory, law, and science, this project analyzes the apparent increase in allowable risk, calls for a reassessment of the concept of "minimal risk," and recommends modifications to the federal regulations. (shrink)

Since the start of the occupation of Palestinian territories in 1967, Israel's domination of the Palestinians has deprived an entire population of any political status or protection. But even decades on, most people speak of this rule—both in everyday political discussion and in legal and academic debates—as temporary, as a state of affairs incidental and external to the Israeli regime. In _The One-State Condition_, Ariella Azoulay and Adi Ophir directly challenge this belief. Looking closely at the history and contemporary (...) formation of the ruling apparatus—the technologies and operations of the Israeli army, the General Security Services, and the legal system imposed in the Occupied Territories—Azoulay and Ophir outline the one-state condition of Israel/Palestine: the grounding principle of Israeli governance is the perpetuation of differential rule over populations of differing status. Israeli citizenship is shaped through the active denial of Palestinian citizenship and civil rights. Though many Israelis, on both political right and left, agree that the occupation constitutes a problem for Israeli democracy, few ultimately admit that Israel is no democracy or question the very structure of the Israeli regime itself. Too frequently ignored are the lasting effects of the deceptive denial of the events of 1948 and 1967, and the ways in which the resulting occupation has reinforced the sweeping militarization and recent racialization of Israeli society. Azoulay and Ophir show that acknowledgment of the one-state _condition_ is not only a prerequisite for considering a one- or two-state _solution_; it is a prerequisite for advancing new ideas to move beyond the trap of this false dilemma. (shrink)

An analysis of the concept of identity may be seen as a possible key to the understanding of the mechanisms for the maintenance of social order in liberal democracies. The maintenance of a social-cultural balance necessitates forms of identification which are institutionalized within categorization built upon a sharp inclination towards scientism. In the oscillation between images of Identity and Identification, the subject is captured by the complexities of signification. This paper will display a series of argumentative claims regarding the fundamental (...) role of education governed by scientism as a rhetorical game which diverts signs into signals. (shrink)

The point of departure of Berger and Mohr’s Another Way of Telling is what they call the discovery that ‘photographs did not work as we had been taught’. Since their book was written, the same feeling of ‘discovery’ has been expressed in other writings on photography. Often, these ‘discoveries’ have been linked with the way ‘ordinary’ people have been using photography. This paper addresses this recurrence and asks what are the discursive conditions under which this understanding of photography has been (...) perceived as a ‘discovery’ whenever it has surfaced in the last 30 years. The paper analyzes the conceptual grid within the hegemonic discourse on photography that has contributed enormously to the marginalization of this new understanding of photography — the common opposition between the ‘aesthetic’ and the ‘political’, and accordingly between two seemingly contradictory judgments: ‘this is too political’; ‘this is too aesthetic’. These judgments, applied frequently to photographs taken in zones of ‘regime-made disaster’, usually differ and sometimes completely prevent the possible encounter with the photographed people who, through the photograph, are co-present with the spectators in the event of viewing the photograph. (shrink)

Many interpretations have been put forward for Walter Benjamin's short essay “On the Concept of History” (Benjamin 2003), an aphoristic text written in 1940 in Paris under the Nazi occupation. Most...

Questions of how we claim to know the things that we know and whose claims to knowledge are treated as authoritative are inescapable in reaching legal judgments. I want to illustrate this generalization by referring to a pair of hypothetical self-defense cases that, I argue, require fact finders to judge both how “accurately” each defendant understood the situation in which he found himself and how accurately policymakers can assess the consequences of alternative legal rules.The first case I will deal with (...) is one in which the defendant shoots and kills her sleeping husband. The husband had physically abused her over a long period. While the defendant will of course acknowledge that she was in no immediate danger at the moment she killed the man, her preliminary claim is that she needed to act self-defensively at that moment for fear that she subsequently would be incapable of defending herself against life-threatening attacks that she was convinced would inevitably be made.The second case is one in which a white defendant shoots and kills a black teenager who has confronted him on the subway, in a situation in which the teenager’s “threats” were ambiguous. The shooting victim had brandished no weapon and made no physical contact with the defendant, but he had “asked” the defendant for money and, in the defendant’s mind, displayed a generally threatening demeanor. I will presuppose that this defendant—unlike Bernhard Goetz, the defendant in the notorious New York subway vigilante case on which I partly base this hypothetical model—overtly acknowledges that the race of the victim played a substantial role in his assessment of the danger of the situation. Mark Kelman, professor of law at Stanford University, is the author of A Guide to Critical Legal Studies as well as a number of articles on law and economics, taxation, criminal law, and legal theory. (shrink)

This article examines the question of allegory in Vico. While there have been some attempts to read the New Science as an allegory, little attention has been paid to what Vico himself meant by the term ‘allegory’. In fact, Vico complicates things by referring to two types of allegory: the philosophical allegory and the true poetic allegory. While the former term refers to the mode of signification of the age of man or the third age, the latter term has to (...) do with the poetic characters that Vico ascribes to the divine or first age. Vico further emphasizes the difference between the two types of allegory by calling (or translating) the true poetic allegory “diversiloquium.” Through a careful reading of this unusual translation of the term ‘allegory’, this inquiry suggests a surprising relation between the mode of signification of poetic characters (allegory) and Vico’s philosophy of history. (shrink)

This article examines the question of allegory in Vico. While there have been some attempts to read the New Science as an allegory, little attention has been paid to what Vico himself meant by the term ‘allegory’. In fact, Vico complicates things by referring to two types of allegory: the philosophical allegory and the true poetic allegory. While the former term refers to the mode of signification of the age of man or the third age, the latter term has to (...) do with the poetic characters that Vico ascribes to the divine or first age. Vico further emphasizes the difference between the two types of allegory by calling (or translating) the true poetic allegory “diversiloquium.” Through a careful reading of this unusual translation of the term ‘allegory’, this inquiry suggests a surprising relation between the mode of signification of poetic characters (allegory) and Vico’s philosophy of history. (shrink)