Wittgenstein, in his famous critique of philosophy, noted that the influence of an idea can be such that it alters the way that we see the world. “It is like a pair of glasses on our nose through which we see whatever we look at,” he said. “It never occurs to us to take them off.” This view of the power of an idea suggests that the interpretation of an event, and what response this event calls for, can depend upon (...) the view one has of the world. A person who is naive about medical facts may, for example, interpret chest pain upon exertion as a sign that he is “overdoing it”; were he more medically knowledgeable, the same symptom might be interpreted as a possible indicator of coronary artery disease. The naive interpretation calls for rest; the informed interpretation calls for medical attention as well. (shrink)

The purpose of this chapter is to describe what we see as several important new directions for philosophy of medicine. This recent work (i) takes existing discussions in important and promising new directions, (ii) identifies areas that have not received sufficient and deserved attention to date, and/or (iii) brings together philosophy of medicine with other areas of philosophy (including bioethics, philosophy of psychiatry, and social epistemology). To this end, the next part focuses on what we call the “epistemological turn” in (...) recent work in the philosophy of medicine; the third part addresses new developments in medical research that raise interesting questions for philosophy of medicine; the fourth part is a discussion of philosophical issues within the practice of diagnosis; the fifth part focuses on the recent developments in psychiatric classification and scientific and ethical issues therein, and the final part focuses on the objectivity of medical research. (shrink)

As a consequence of recent changes, health research policies in the United States mandate the inclusion of women and members of racial and ethnic minority groups as experimental subjects in biomedical research. This article analyzes debates that underlie these policies and that concern the medical management of bodies, groups, identities and differences. Much of the uncertainty surrounding these new policies reflects the fact that researchers, physicians, policy makers and health advocates have adopted competing, and often murky, understandings of the nature (...) of sex, gender, racial and ethnic differences, and of the relation of the biological to the social in the manifestation of bodily illness. (shrink)

This paper aims to problematize pregnancy and support the development of a safe alternative method of gestation. Our arguments engage with the health risks of gestation and childbirth, the value assigned to pregnancy, as well as social and medical attitudes toward women’s pain, especially in labor. We claim that the harm caused by pregnancy and childbirth provides a prima facie case in favor of prioritizing research on a method of extra corporeal gestation.

I pose problems for the views that human nature should be the object of study in the social and behavioral sciences and that a concept of human nature is needed to guide research in these sciences. I proceed by outlining three research programs in the social sciences, each of which confronts aspects of human variation. Next, I present Elizabeth Cashdan and Grant Ramsey’s related characterizations of human nature. I go on to argue that the research methodologies they each draw on (...) are more productive resources for social scientists than their competing characterizations of human nature. (shrink)

To judge from the rash of recent law review articles, it is a miracle that research with human subjects in the U.S. continues to draw breath under the asphyxiating heel of the rent-seeking, creativity-stifling, jack-booted bureaucrethics that is the current system of research ethics oversight and review. Institutional Review Boards, sometimes called Research Ethics Committees, have been accused of perpetrating “probably the most widespread violation of the First Amendment in our nation's history,” resulting in a “disaster, not only for academics, (...) but for the whole nation.” One member of the President's Council on Bioethics went so far as to assert, “There has been no greater damage to academic freedom in the United States in my lifetime. And my lifetime encompasses McCarthy and it encompasses political correctness, both.” Locked in the bureaucratic “iron cage” of IRB oversight, critics charge that researchers have been transformed into a vulnerable, exposed population, subject to domination, that has been likened in one case to a kind of “Tuskegee in reverse.”. (shrink)

The Women's Movement has greatly benefitted women in the workplace. What about in their encounters with medicine? This paper reviews the history of physicians’ attitudes toward women and then considers three contemporary areas of medicine in particular: health research relevant to women, health policies, and women's success at working their way into the medical profession. The picture that emerges is somewhat less than rosy. The androcentrism that has been so glaring in the history of medicine has not entirely gone away. (...) Women and their concerns are still considered less important than men's, and women are valued more for what they provide than for who they are themselves. These problems are mostly not the fault of specific physicians or other individuals; they are, rather, systemic problems—the result of social practices and institutions that work together quite impersonally to favor the interests of men over women. Correcting them requires listening to women's voices better than medicine, or bioethics, has so far managed to do. (shrink)

In his recent work exploring the role of science in democratic societies Kitcher claims that scientists ought to have a prominent role in setting the agenda for and limits to research. Against the backdrop of the claim that the proper limits of scientific inquiry is John Stuart Mill’s Harm Principle , he identifies the limits of inquiry as the point where the outcomes of research could cause harm to already vulnerable populations. Nonetheless, Kitcher argues against explicit limitations on unscrupulous research (...) on the grounds that restrictions would exacerbate underlying social problems. I show that Kitcher’s argument in favor of dissuading inquiry through conventional standards is problematic and falls prey to the same critique he offers in opposition to official bans. I expand the conversation of limiting scientific research by recognizing that the actions that count as ‘science’ are located in the space between ‘thinking’ and ‘doing’. In this space, we often attempt to balance freedom of research, as scientific speech, against the disparate impact citizens might experience in light of such research. I end by exploring if such disparate impact justifies limiting research, within the context of the United States, under Title VII of the Civil Rights Act of 1964 or under international human rights standards more generally. (shrink)

Subpart B of 45 Code of Federal Regulations Part 46 (CFR) identifies the criteria according to which research involving pregnant women, human fetuses, and neonates can be conducted ethically in the United States. As such, pregnant women and fetuses fall into a category requiring “additional protections,” often referred to as “vulnerable populations.” The CFR does not define vulnerability, but merely gives examples of vulnerable groups by pointing to different categories of potential research subjects needing additional protections. In this paper, I (...) assess critically the role of this categorization of pregnant women involved in research as “vulnerable,” both as separate entities and in combination with the fetuses they carry. In particular, I do three things: (1) demonstrate that pregnant women qua pregnancy are either not “vulnerable” according to any meaningful definition of that term or that such vulnerability is irrelevant to her status as a research participant; (2) argue that while a fetus may be vulnerable in terms of dependency, this categorization does not equate to the vulnerability of the pregnant woman; and (3) suggest that any vulnerability that appends to women is precisely the result of federal regulations and dubious public perceptions about pregnant women. I conclude by demonstrating how this erroneous characterization of pregnant women as “vulnerable” and its associated protections have not only impeded vital research for pregnant women and their fetuses, but have also negatively affected the inclusion of all women in clinical research. (shrink)

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

This article develops an account of distributive epistemic justice in the production of scientific knowledge. We identify four requirements: (a) science should produce the knowledge citizens need in order to reason about the common good, their individual good and pursuit thereof; (b) science should produce the knowledge those serving the public need to pursue justice effectively; (c) science should be organized in such a way that it does not aid the wilful manufacturing of ignorance; and (d) when making decisions about (...) epistemic risks, scientists should make sure that there aren’t social groups or weighty interests that are neglected. After discussing these requirements, we examine the relationship between discriminatory and distributive epistemic injustice in science and argue that they often compound each other. (shrink)

Advancements in novel neurotechnologies, such as brain computer interfaces and neuromodulatory devices such as deep brain stimulators, will have profound implications for society and human rights. While these technologies are improving the diagnosis and treatment of mental and neurological diseases, they can also alter individual agency and estrange those using neurotechnologies from their sense of self, challenging basic notions of what it means to be human. As an international coalition of interdisciplinary scholars and practitioners, we examine these challenges and make (...) recommendations to mitigate negative consequences that could arise from the unregulated development or application of novel neurotechnologies. We explore potential ethical challenges in four key areas: identity and agency, privacy, bias, and enhancement. To address them, we propose democratic and inclusive summits to establish globally-coordinated ethical and societal guidelines for neurotechnology development and application, new measures, including “Neurorights,” for data privacy, security, and consent to empower neurotechnology users’ control over their data, new methods of identifying and preventing bias, and the adoption of public guidelines for safe and equitable distribution of neurotechnological devices. (shrink)

Recent guidelines from the US National Institutes of Health (NIH) mandate the inclusion of adequate numbers of women in clinical trials. Ought such standards to apply internationally? Walzer's theory of justice is brought to bear on the problem, the first use of the theory in research ethics, and it argues for broad application of the principle of adequate representation. A number of practical conclusions for research ethics committees (RECs) are outlined. Eligibility criteria in clinical trials ought to be justified by (...) trial designers. Research ethics committees ought to question criteria that seem to exclude unnecessarily women from research participation. The issue of adequate representation should be construed broadly, so as to include consideration of the representation of the elderly, persons with HIV, mental illness and substance abuse disorders in clinical research. (shrink)

: In the last two decades, scientists, government officials, and science policy experts have expressed concerns about the increasing role of financial interests in research. Many believe that these interests are undermining research by causing bias and error, suppression of results, and even outright fraud. This paper seeks to shed some light on this view by (1) explicating the concept research bias, (2) describing some ways that financial interests can cause research biases, and (3) discussing some strategies for mitigating or (...) managing the influence of financial interests. These strategies include (a) using government funds to counter-balance privately funded research, (b) increasing public input into government funding decisions, (c) disclosing and managing conflicts of interest in research, (d) auditing data, (e) expanding access to data. Since it is neither possible nor desirable to eliminate financial interests from research, the wisest policy is to manage and counter-balance these interests for the good of science and society. (shrink)

Epistemic trust is an unacknowledged feature of medical knowledge. Claims of medical knowledge made by physicians, patients, and others require epistemic trust. And yet, it would be foolish to define all epistemic trust as epistemically responsible. Accordingly, I use a routine example in medical practice to illustrate how epistemically responsible trust in medicine is trust in epistemically responsible individuals. I go on to illustrate how certain areas of current medical practice of medicine fall short of adequately distinguishing reliable and unreliable (...) processes because of a failure to systematically evaluate health outcomes. I conclude by articulating the devastating obstacles to the consilience assumption, which takes intellectual character as the standard for epistemic responsibility. (shrink)

In a White House ceremony on May 16, 1997, President Clinton issued an apology on behalf of the nation for the Tuskegee Syphilis Study, a forty-year research project in which African-American men were deceived and denied treatment in order to document the natural course of syphilis. Reflection on this occasion can give us pause to take pride in the progress made toward more ethical research with humans. The President's apology is perhaps the most public of a number of recent events (...) representing a renewed attention to ethics in research with human participants. Alongside it stand the efforts of treatment activists for people with acquired immune deficiency syndrome and the revelations of the human radiation experiments. In 1995, President Clinton called for the creation of the National Bioethics Advisory Commission, which was charged with a host of projects aimed at investigating the organization and function of the federal system for overseeing human subjects research in the United States, and giving guidance on specific forms of research. (shrink)

Feminist science studies scholars have documented the historical and cultural contingency of scientific knowledge production. It follows that political and social activism has impacted the practice of science today; however, little has been done to examine the current cultures of science in light of feminist critiques and activism. In this article, I argue that, although critiques have changed the cultures of science both directly and indirectly, fundamental epistemological questions have largely been ignored and neutralized through these policy reforms. I provide (...) an auto-ethnography of my doctoral work in a neuroscience program to a) demonstrate how the culture of science has incorporated critiques into its practices and b) identify how we might use these changes in scientific practices to advance feminist science agendas. I critically analyze three areas in current scientific practice in which I see obstacles and opportunities: 1) research ethics, 2) diversity of research subjects and scientists, and 3) identification of a project's significance for funding. I argue that an understanding of the complicated and changing cultures of science is necessary for future feminist interventions into the sciences that directly challenge science's claim to epistemic authority. (shrink)

Several years ago, the University of Minnesota hosted a lecture by Alan Milstein, a Philadelphia attorney specializing in clinical trial litigation. Milstein, who does not mince words, insisted on calling research studies “experiments.” “Don't call it a study,” Milstein said. “Don't call it a clinical trial. Call it what it is. It's an experiment.” Milstein's comments made me wonder: when was the last time I heard an ongoing research study described as a “human experiment”? The phrase is now almost always (...) associated with abuses. Asking a prospective subject to sign up for a medical experiment would probably get roughly the same response as asking him or her to sign up for a police interrogation. It wasn't always this way. In the early days of American bioethics, scholars used the word “experimentation” in the same neutral way that they later began to use “research study” and “clinical trial.”. (shrink)

There is significant evidence that the health needs of women and minorities have been neglected by a medical research community whose agendas and protocols tend to focus on more advantaged segments of society. In response, the National Institutes of Health and Food and Drug Administration in the United States have recently issued new policies aimed at increasing the utilization of women in clinical studies. As well, the U.S. Congress passed the NIH Revitalization Act of 1993, which specifically mandates increased inclusion (...) of women and racial and ethnic groups in clinical studies. On the face of it, such gender and race-specific policies would appear to be morally problematic because traditionally ethics opposes the use of sex or race as legitimate criteria for distributions of benefits or burdens in social policies. Hence, these policies pose some significant moral questions. Feminist ethics provides us with a framework for evaluating such policies because of its readiness to recognize that socially and politically significant factors such as sex and race are morally relevant in setting public policy. Of course, feminist ethics does not simply endorse all appeals to sex and race but only the policies in which attention to such factors will contribute to social justice. In this essay, I Identify some of the Important ethical questions that a feminist ethics perspective raises about research policies devised to promote the Inclusion of women in clinical studies. (shrink)

Women’s access to health and medicine in developed countries has been characterized by a range of inconsistent inclusions and exclusions. Health policy has been asymmetrically interested in women’s reproductive capacities and has sought to regulate, control, and manage aspects of women’s reproductive decision making in a manner unwitnessed in relation to men’s reproductive health and reproductive decision making. In other areas, research that addresses health concerns that affect both men and women sometimes is designed so as not to yield data (...) relating to the ways in which women’s physiology and gendered location may affect their experience of the condition and its response to treatment, despite a literature on the significance of sex and gender differences in health research. This paper draws on the situation in Australia to explore the ethical significance of these inconsistencies as failing the ideals of high-quality medical research and evidenced-based health care. (shrink)

Clinicians and policy makers the world over are embracing evidence-based medicine. The promise of EBM is to use summaries of research evidence to determine which healthcare interventions are effective and which are not, so that patients may benefit from effective interventions and be protected from useless or harmful ones. EBM provides an ostensibly rational and objective means of deciding whether or not an intervention should be provided on the basis of its effectiveness, in theory leading to fair and effective healthcare (...) for all. In this paper I closely examine these claims from the perspective of healthcare for women, using relevant examples. I argue that the current processes of evidence-based medicine contain a number of biases against women. These biases occur in the production of the research that informs evidence-based medicine, in the methods used to analyse and synthesise the evidence, and in the application of EBM through the use of guidelines. Finally, the biomedical model of health that underpins most of the medical research used by EBM ignores the social and political context which contributes so much to the ill-health of women. (shrink)

The analysis presented here lays out the ethical warrants for requiring community oversight of health research conducted in international settings. It reviews the inadequacies with the current standards of individual informed consent and research ethics committee review, and then, shows how a broader population-based public health perspective raises new demands on justice involving due consideration of the rights, harms and benefits to the community as a whole. As developed here, an ethical standard that requires community oversight of health research is (...) justified on three principled grounds: respect for community autonomy and their right to self-determination; due consideration of the consequences of the research for the community as a whole; and, a more complete understanding of human autonomy. The paper concludes with practical recommendations regarding the composition of Community Advisory Boards to ensure that they have legitimate decision-making authority in diverse socio-cultural contexts. (shrink)

Medical Research Council, Capetown, South Africa Nasheen Naidoo Medical Research Council, Capetown, South Africa Shamagonam James Medical Research Council, Durban, South Africa Priscilla Reddy Medical Research Council, Capetown, South Africa * Corresponding author: 306 Arnold House, School of Public Health & Health Sciences, University of Massachusetts, Amherst, MA 01003, USA. Tel.: (413) 545 1005; Email: Buchanan{at}schoolph.umass.edu ' + u + '@' + d + ' '//--> . Abstract The analysis presented here lays out the ethical warrants for requiring community oversight (...) of health research conducted in international settings. It reviews the inadequacies with the current standards of individual informed consent and research ethics committee review, and then, shows how a broader population-based public health perspective raises new demands on justice involving due consideration of the rights, harms and benefits to the community as a whole. As developed here, an ethical standard that requires community oversight of health research is justified on three principled grounds: respect for community autonomy and their right to self-determination; due consideration of the consequences of the research for the community as a whole; and, a more complete understanding of human autonomy. The paper concludes with practical recommendations regarding the composition of Community Advisory Boards to ensure that they have legitimate decision-making authority in diverse socio-cultural contexts. CiteULike Connotea Del.icio.us What's this? (shrink)

Different kinds of collectives help to coordinate between individuals and social groups to solve distribution problems, supply goods and services, and enable individuals to live fulfilling lives. Collectives, as part of the process of socialization, contribute to the normalization of behaviors, and consequently, structure our ability to be self-reflective autonomous agents. Contemporary philosophy of action models characterize collective action as the product of individuals who have the proper motivations to perform cooperative activities (bottom-up); or they begin with the social-level phenomena (...) and explain this in terms of individual actions and the mental states that motivate them (top-down). One general goal of this project is to show how and why both of these approaches through focusing solely on the individuals involved fail to capture and account for important types of group actions: those of economic group agents. Group agents, one kind of organized collective, are unique in that they have the potential to develop group-level decision-making processes that result in the capacity of the group to engage in practical reasoning. Because of this capacity, group agents can be stable and respond to reason--capacities we would not expect from other kinds of collectives. Inasmuch as we value the possibility of influencing the reflexive dynamics that perpetuate social institutions, understanding the range of organization structures and their agential capacities will open up the possibility of altering the course of those dynamics toward more just systems of organization. Understanding what kinds of group agents currently operate within the systems of organizations that make up social institutions is the first step in determining how to move toward developing group agents that are also moral agents. By analyzing how different systems of constraint--inside and outside the firm--inform one another to influence the possibility of design and the group's possibilities for action, I use Christian List and Philip Pettit's account of group agency as a springboard to develop a more adequate account of how structure influences and constrains the possibilities of economic group agents in non-idealized circumstances (i.e. this world, with our history). My chapters include 1) a taxonomy of organization structures and an analysis of how a narrow conception of organization structure in jurisprudence can lead to systems of constraint that limit the rights and freedoms of individuals even as it seeks to extend them, 2) an evaluation of the popular accounts of collective action (cf. Raimo Tuomela, 1997; Michael Bratman, 1993, 1997, 2009; and Christian List and Philip Pettit, 2011) that could be made to accommodate the actions of certain kinds of economic associations, 3) an exploration of the standards of evaluation that influence these powerful group agents, and how these standards limit the economic group agent's capacity to engage in moral reasoning, and 4) an analysis of the group agent's reasoning capacity and the internal mode of interaction between group agent and group members that perpetuate group agency. I argue that we can understand group agents that have the capacity to be moral agents as the products of a particular kind of decision-making process within an organization's structure. The decision-making process, together with the organization structure and group member support, produces and sustains judgments and actions at the level of the group that cannot be reduced to the beliefs and actions of particular members. In this way, the group displays a systematic unity of actions based on its own judgments. That is, the group exhibits agency. Moral group agents exhibit more than practical reasoning; they also demonstrate the capacity for critical reflection upon the ends they pursue. Member buy-in promotes a tight connection between group members and their role in bringing about and sustaining group agency, and is the foundation of the group agent. Without a holistic organization structure, a member's personal identities could undermine group aims, thereby undermining group agency. Group moral agency, I argue, begins with promoting an organizational way of life conducive to collective flourishing and respect for members. (shrink)

Bioethicists, like many other academics, have a tendency to try to make things general and simpler by eliminating context. Particulars, such as race, economic class, and gender, often seem to be lost in this ocean of generality and abstraction. But in losing them, we are neglecting the analysis of serious moral problems and, with it, the possibility of offering some kind of solution to such problems. This article argues that particulars do matter very much. We will focus ourattention here on (...) gender. We will argue that ignoring questions of gender when evaluating genetic technologies is seriously problematic because it might lead to further injustices against women. Proceeding with a noncontextual understanding of genetic technologies will likely disregard the unjust ways in which the health care system treats women, as well as the ways in which genetic technologies impose extra burdens on them. (shrink)

Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some (...) of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs. (shrink)

Procedures for the selection of subjects for participation in randomized clinical trials--usually formalized as eligibility criteria in the study protocol--have both scientific and ethical implications. In this thesis, I undertake an examination of eligibility criteria at three stages in the genesis and dissemination of medical knowledge: clinical trial protocol, interpretation by investigators, and reporting of study results.In the first chapter, ethical issues in subject selection are reviewed and the main study questions are presented. In the second chapter, the results of (...) an examination of eligibility criteria in two sets of clinical trials, one sponsored by the NSABP, the other sponsored by POG, covering a twenty-year time span are presented. The POG trials had far fewer eligibility criteria than the NSABP studies, suggesting that large numbers of criteria may not be necessary for high quality research. In the third chapter, the impact of subjective eligibility criteria on enrollment and investigator uncertainty is explored. Subjective criteria were associated with more variable enrollment decisions and greater uncertainty. Such criteria represent a threat to the validity, conduct and interpretation of trials and, therefore, should only be included when carefully justified. The fourth chapter examines the accuracy of the reporting of eligibility criteria in sets of corresponding study protocol, methods paper, journal article, and Clinical Alert. Important information is lost at each step in the dissemination of study results. Unnecessary criteria ought to be dropped at a trial's inception; all other criteria must be reported faithfully. The fifth chapter attempts to provide a comprehensive philosophical account of just selection procedures for clinical research using the political philosophy of Michael Walzer. The sixth, and last, chapter, discusses explanatory and pragmatic approaches to clinical trial design, overlapping scientific and ethical concerns related to eligibility criteria, and questions for further study. (shrink)