Executive Summary There is a general perception that biomedical research has not given the same attention to the health problems of women that it has given ...

Public health raises critical ethics issues and concerns, making public heath ethics an essential topic for students and public health professionals. The 73 chapters in this volume examine public health ethics across a broad range of public health topics both in the U.S. and globally. It is the first ever comprehensive collection devoted to public health ethics.

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women have been (...) inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

U.S. researchers and scholars often point to two legal factors as significant obstacles to the inclusion of pregnant women in clinical research: the Department of Health and Human Services’ regulatory limitations specific to pregnant women's research participation and the fear of liability for potential harm to children born following a pregnant woman's research participation. This article offers a more nuanced view of the potential legal complexities that can impede research with pregnant women than has previously been reflected in the literature. (...) It reveals new insights into the role of legal professionals throughout the research pathway, from product conception to market, and it highlights a variety of legal factors influencing decision-making that may slow or halt research involving pregnant women. Our conclusion is that closing the evidence gap created by the underrepresentation and exclusion of pregnant women in research will require targeted attention to the role of legal professionals and the legal factors that influence their decisions. (shrink)

Beyond Consent examines the concept of justice, and its application to human subject research, through the different lenses of various research populations: children, the vulnerable sick, captive and convenient populations, women, people of colour, and subjects in international settings. Separate chapters address the evolution of research policies, implications of the concept of justice for the future of human subject research, and the ramifications of this concept throughout the research enterprise.

In lieu of an abstract, here is a brief excerpt of the content:IntroductionAnna Mastroianni (bio) and Jeffrey Kahn (bio)In this issue of the Kennedy Institute of Ethics Journal, we subject the work of the Advisory Committee on Human Radiation Experiments to examination from many angles. Nearly one year has passed since the release of the Committee’s final report and recommendations, and it seems an appropriate time to invite discourse and reflection on the influence and impact of the Committee and (...) its efforts. Our intent is to advance understanding of the Committee and its work, its place in the evolution of bioethics and public policy, as well as the broader legacy of restoring trust in the conduct of human subjects research.In 1993, President Clinton and Secretary of Energy Hazel O’Leary initiated an investigation of America’s involvement in radiation experiments on its citizens during the Cold War. The investigation resulted in the appointment of the Committee in January 1994. Some issues raised by these radiation experiments were brought to the attention of the nation by revelations contained in a Pulitzer Prize-winning series of newspaper stories about plutonium injections carried out by the government on allegedly unsuspecting subjects during the Cold War. The Committee faced a broad mandate, which included piecing together the history of Cold War radiation experiments and human subjects research, as well as recommending remedies for past wrongs and mechanisms to ensure that such wrongs could not be repeated in the future.This issue of the Journal consists of articles and accompanying commentaries on historical, philosophical, policy, and political aspects of the Committee’s work that are important to bioethics. This collection of articles, authored by Committee members, staff, and leading scholars, is designed to paint a picture of the breadth and complexity of the Committee’s efforts and to provide context and to stimulate discussion of significant issues.In the first article, Ruth Faden provides her unique perspective as chair of the Committee. She goes beyond the necessary overview and background of the Committee to reflect on the impact and meaning of the Committee’s work to bioethics and public policy.Much of the Committee’s effort was directed at gathering and uncovering information about the history of Cold War radiation experiments, an endeavor fairly foreign to bioethics but critically important to understanding the context in which to make moral judgments about the past. Jonathan Moreno and Susan Lederer discuss how the Committee’s work changed some of the traditional views of the history of research ethics. The commentary by Allan Brandt and Lara Freidenfelds further illuminates the value of understanding this recovered history. [End Page ix]In making moral judgments about the past, the Committee confronted complex questions about how to assess wrongdoing and the culpability of the government and its agents. Allen Buchanan explains why this was such a difficult but crucial task and how the Committee worked through some of the answers to these questions. His discussion illustrates the challenges to consensus in the committee decision-making process described in Ruth Macklin’s article in this issue on committees and consensus. Tom Beauchamp analyzes the frameworks for making retrospective moral judgments developed by two committees, the Advisory Committee and the University of California at San Francisco Ad Hoc Fact Finding Committee on World War II Human Radiation Experiments, and critiques their applications of the frameworks in the case of the plutonium injection experiments.The Committee recognized that in order to prevent wrongs seen in the past from occurring in the future, it would be necessary to understand the human subjects protections now in place. Nancy Kass and Jeremy Sugarman discuss the results of the Committee’s attempts to measure the operation and effectiveness of the current system for protection of human subjects. Paul Appelbaum comments on the relevance and value of the Committee’s empirical projects to contemporary human subjects research.The Committee’s work, and the products of any commission’s work, must be viewed partly in light of the place of commissions in bioethics scholarship and policymaking. Appointed commissions can have significant impacts on scholarly and public thinking, policymaking, and future direction, and bring high visibility to issues. It is important to realize that the conclusions of the Committee... (shrink)

Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.Public health is primarily concerned with (...) the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions. (shrink)

: During the nearly 10 years since its introduction, preimplantation genetic diagnosis (PGD) has been used predominantly to avoid giving birth to a child with identified genetic disease. Recently, PGD was used by a couple not only to test IVF-created embryos for genetic disease, but also to test for a nondisease trait related to immune compatibility with a child in the family in need of an hematopoetic stem cell transplant. This article describes the case, raises some ethical and policy issues, (...) highlights gaps in U.S. policy, and finally makes some recommendations for addressing advancing genetic and reproductive technologies. (shrink)

This book is a rich blend of analyses by leading experts from various cultures and disciplines. A compact introduction to a complex field, it illustrates biotechnology's profound impact upon the environment and society. Moreover, it underscores the vital relevance of cultural values. This book empowers readers to more critically assess biotechnology's value and effectiveness within both specific cultural and global contexts.

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it (...) is wise to do so, remains to be seen. (shrink)

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it (...) is wise to do so, remains to be seen. (shrink)

At a White House ceremony in October 1995, the Advisory Committee on Human Radiation Experiments presented its Final Report to President Bill Clinton. The 925-page report and the over 2,000 pages of supplemental volumes summarized eighteen months of investigative research, debate, and deliberation on historical and contemporary issues in human subjects research. The Advisory Committee's efforts were aided by unprecedented support from the highest levels of the executive branch, including the heads of eight cabinet-level agencies and their departments' resources. The (...) presidentially appointed committee and its staff delved into long-forgotten Cold Warera government archives, listened to hours of public testimony, interviewed key players in the development of medical therapies and nuclear weapons, and studied ethical issues arising in today's research.In this article we focus on a critical, but narrowly defined, part of the Advisory Committee's Final Report: remedying harms or wrongs to subjects of human radiation experiments conducted or sponsored by the U.S. government between 1944 and 1974. (shrink)

At a White House ceremony in October 1995, the Advisory Committee on Human Radiation Experiments presented its Final Report to President Bill Clinton. The 925-page report and the over 2,000 pages of supplemental volumes summarized eighteen months of investigative research, debate, and deliberation on historical and contemporary issues in human subjects research. The Advisory Committee's efforts were aided by unprecedented support from the highest levels of the executive branch, including the heads of eight cabinet-level agencies and their departments' resources. The (...) presidentially appointed committee and its staff delved into long-forgotten Cold Warera government archives, listened to hours of public testimony, interviewed key players in the development of medical therapies and nuclear weapons, and studied ethical issues arising in today's research.In this article we focus on a critical, but narrowly defined, part of the Advisory Committee's Final Report: remedying harms or wrongs to subjects of human radiation experiments conducted or sponsored by the U.S. government between 1944 and 1974. (shrink)

At its core, public health introduces tensions between individuals' autonomy and the need to account for the perspectives and needs of communities and populations. It further raises social justice issues, including fair allocation of limited resources. This article examines and elaborates on these tensions and their resolutions using specific public health examples. Experiences in the 1980s and 1990s with HIV/AIDS provide a particularly rich collection of issues that brought ethical issues in public health to the public's attention, and in so (...) doing challenged previously held assumptions about the appropriate consideration of individual rights in the context of population health objectives. Lastly, the article examines some of the ethical challenges arising in public health applications of recent science and technology advances, specifically the emerging area of public health genomics and the large scale collection and analysis of health information. (shrink)

Many enzymes are inhibited by their own substrates, leading to velocity curves that rise to a maximum and then descend as the substrate concentration increases. Substrate inhibition is often regarded as a biochemical oddity and experimental annoyance. We show, using several case studies, that substrate inhibition often has important biological functions. In each case we discuss, the biological significance is different. Substrate inhibition of tyrosine hydroxylase results in a steady synthesis of dopamine despite large fluctuations in tyrosine due to meals. (...) Substrate inhibition of acetylcholinesterase enhances the neural signal and allows rapid signal termination. Substrate inhibition of phosphofructokinase ensures that resources are not devoted to manufacturing ATP when it is plentiful. In folate metabolism, substrate inhibition maintains reactions rates in the face of substantial folate deprivation. Substrate inhibition of DNA methyltransferase serves to faithfully copy DNA methylation patterns when cells divide while preventing de novo methylation of methyl‐free promoter regions. (shrink)

This study provides a global perspective on citations of articles published in ten business ethics journals between 1999 and 2012 and establishes three findings. First, the results indicate that Journal of Business Ethics and Business and Society are the two top business ethics journals based on the distribution of normalized citations received. Second, although North America, particularly the US, remains the top producer of business ethics research, it has been surpassed by Europe in terms of weighted normalized research citations received (...) in 2012, implying a potential diminishing global role of US influence in business ethics research over time. Third, the top-ranked US institutions have reduced their business ethics research impact in recent years, while the European institutions have sharply increased theirs. (shrink)

Three questions arising from Aggleton & Brown's target article are addressed. (1) Is there any benefit to considering the effects of partial lesions of the anterior thalamic nuclei (AT)? (2) Do the AT have a separate role in the proposed extended hippocampal system? (3) Should perirhinal cortex function be restricted to familiarity judgements?

What role does language play during attention allocation in perceiving and remembering events? We recorded adults‟ eye movements as they studied animated motion events for a later recognition task. We compared native speakers of two languages that use different means of expressing motion (Greek and English). In Experiment 1, eye movements revealed that, when event encoding was made difficult by requiring a concurrent task that did not involve language (tapping), participants spent extra time studying what their language treats as the (...) details of the event. This „linguistic encoding‟ effect was eliminated both when event encoding was made easier (no concurrent task) and when the concurrent task required the use of language (counting aloud). In Experiment 2, under conditions of a delayed concurrent task of counting aloud, participants used language covertly just prior to engaging in the additional task. Together, the results indicate that language can be optionally recruited for encoding events, especially under conditions of high cognitive load. Yet, these effects are malleable and flexible and do not appear to shape core biases in event perception and memory. (shrink)

Williams Syndrome is a developmental disorder that is characterized by cardiovascular problems, particular facial features and several typical behavioral and neurological abnormalities. In Williams Syndrome patients, a heterozygous deletion is present of a region on chromosome 7q11.23 (the Williams Syndrome critical region), which spans approximately 20 genes. Two of these genes encode proteins that regulate dynamic aspects of the cytoskeleton of the cell, either via the actin filament system (LIM kinase 1, or LIMK1), or through the microtubule network (cytoplasmic linker (...) protein of 115 kDa, or CLIP‐115). The recent findings that knockout mice lacking LIMK1 or CLIP‐115 have distinct neurological and behavioural phenotypes, indicates that cytoskeletal defects might play a role in the development of neurological symptoms in Williams Syndrome patients. In this review, we discuss the properties of LIMK and CLIP family proteins, their function in the regulation of the actin and microtubule cytoskeletal systems, respectively, and the relationship with neurodevelopmental aspects of Williams Syndrome. BioEssays 26:141–150, 2004. © 2004 Wiley Periodicals, Inc. (shrink)

People use language to communicate their perceptions and conceptions of the world, and underlying this communication is the linguistic system that interacts with the human perceptual and conceptual machinery. This is supported by research on sentence comprehension among adults. This chapter examines theories of sentence processing in children and adults. It comments on a study John Trueswell et al. in which they demonstrated that five-year-old children appeared to be unable to use contextual cues to resolve ambiguity in sentences such as (...) “Put the frog on the napkin into the box.” Trueswell et al. explained this finding by arguing that children have limited working memory capacity that prevents them from using information from the context to disambiguate linguistic input. The chapter first discusses real-time sentence processing in adults before presenting a developmental account of sentence comprehension. It then considers the so-called Kindergarten-path Effect along with referential scenes, definite reference, and restrictive modifiers. It also looks at the effects of discourse and pragmatics on parsing by children and concludes with a discussion of the development of attention in children. (shrink)

Objective Ethical standards state research participation must be voluntary and free of coercion and undue influence, but what if a third party appears to engage in research-relevant coercion, without the researchers’ knowledge? This case study describes this type of situation and its resolution. Methods We are engaged in a randomized clinical trial evaluating pedestrian safety with 7- and 8- years old. Depending on children's rate of learning, families receive up to $1275 for their time. We recently learned a third-party “talent (...) agency,” a firm placing children in modeling and acting jobs, was referring families to our research with the expectation that families would share 20% of study reimbursements. Results We sensed clear impropriety, but identified no ethical violations on our part as researchers. Once paid a study reimbursement, participants can spend funds how they wish. We were concerned, however, that the third-party was exploitatively coercing families to participate. Conclusions We pursued four avenues to resolve the issue. First, we documented the situation to our university Institutional Review Board. Second, we contacted the talent agency and requested they stop referring families to our research. They agreed. Third, we retained children engaged in our study who were referred from the talent agency; removing them partway through the clinical trial could impact study results. In doing so, we explained that we were unaware of the talent agency referral and that they were not obligated by us to offer a portion of the study reimbursement to the talent agency. Last, we asked newly enrolled families about their referral source. (shrink)

Patronizing the Public is the first detailed and comprehensive examination of how American philanthropy has transformed culture, communication, and the humanities. Drawing on an impressive range of archival and secondary sources, the chapters in the volume shed light on philanthropic foundations have shaped numerous fields, including film, television, radio, journalism, drama, local history, museums, as well as art and the humanities in general.

RationaleSurrogates of critically ill patients often have inaccurate expectations about prognosis. Yet there is little research on how intensive care unit clinicians should discuss prognosis, and existing expert opinion-based recommendations give only general guidance that has not been validated with surrogate decision makers.ObjectiveTo determine the perspectives of key stakeholders regarding how prognostic information should be conveyed in critical illness.MethodsThis was a multicenter study at three academic medical centers in California, Pennsylvania, and Washington. One hundred eighteen key stakeholders completed in-depth semistructured (...) interviews. Participants included 47 surrogates of adult patients with acute respiratory distress syndrome; 45 clinicians working in study ICUs, including physicians, nurses, social workers, and spiritual care providers; and 26 experts in health communication, decision science, ethics, family-centered care, geriatrics, healthcare disparities, palliative care, psychology, psychiatry, and critical care.Measurements and main resultsThere was broad support among surrogates for existing expert recommendations, including truthful prognostic disclosure, emotional support, tailoring the disclosure strategy to each family's needs, and checking for understanding. In addition, stakeholders offered suggestions that add specificity to existing recommendations, including: In addition to conveying prognostic estimates, clinicians should help families "see the prognosis for themselves" by showing families radiographic images and explaining the clinical significance of physical manifestations of severe disease at the bedside. Many physicians did not support using numeric estimates to convey prognosis to families, whereas many surrogates, clinicians from other disciplines, and experts believed numbers could be helpful. Clinicians should conceptualize prognostic communication as an iterative process that begins with a preliminary mention of the possibility of death early in the ICU stay and becomes more detailed as the clinical situation develops. Although prognostic information should be initially disclosed by physicians, other members of the multidisciplinary team-nurses, social workers, and spiritual care providers-should be given explicit role responsibilities to reinforce physicians' prognostications and help families process a poor prognosis emotionally.ConclusionsFamily members, clinicians, and experts identified specific communication behaviors that clinicians should use to discuss prognosis in the critical care setting. These findings extend existing opinion-based recommendations and should guide interventions to improve communication about prognosis in ICUs. (shrink)

Is open-mindedness a moral virtue? Surprisingly, this question has not received much attention from philosophers. In this paper, we fill this lacuna by arguing that there are good grounds for thinking that it is. In particular, we show that the extant account of open-mindedness as a moral virtue faces an objection that appears to show that exercising the character trait may not be virtuous. To offset this objection, we argue that a much stronger argument can be made for the case (...) that open-mindedness is a moral virtue by appealing to the notion of moral understanding. Specifically, we provide a new rationale as to why we should exercise open-mindedness and offer several arguments to allay the concern that doing so can at times cause us to be in an epistemically and morally weaker position. (shrink)

Recently, scholars have looked more closely at the philosophical importance of the imaginative and literary aspects of Plato's writing, and have begun to appreciate the methods of ancient philosophers and commentators who studied Plato. This study brings together leading philosophical and literary scholars to investigate these new-old approaches.

A history of injustices to diverse groups of human subjects in medical research has resulted in concerted efforts by U.S. policymakers in the second half of the twentieth century to provide greater protection for future subjects. However, in the context of patient populations demanding better therapies, potential medical advances, and greater attention to issues of social justice, Kahn, Mastroianni, and Sugarman set out to reconceptualize the principle of justice in human subjects research to address these urgent concerns. In BeyondConsent, (...) Kahn and colleagues advance a framework of justice in terms of access to participation in research, instead of protection. Their worthy cause, developed out of collaboration on the White House Advisory Committee on Human Radiation Experiments, aims to demonstrate how previously unaddressed notions of justice now require greater consideration in research. Specifically, they emphasize how fairness requires a greater distribution of risks and benefits, and that The volume does not report new research findings but rather draws on multidisciplinary approaches, including law, medicine, philosophy, history, and health policy, to argue that justice must go beyond informed consent. The editors posit that this challenge to protectionism is necessary given the heightened urgency for patients to benefit from investigational therapies although they incur increased risks. (shrink)

This paper traces the intellectual trajectories of the first stand-alone theories of action, understood as both axiologically neutral and quasi-scientific from a methodological point of view. I argue that the rise of action theory of this kind corresponds to a particular moment of dissatisfaction within Western thought, and as such, it tells us far more about the history of philosophy than the subject itself. I conclude by explaining why subsequent failures to provide an acceptable theory of action are not accidental. (...) On the contrary, such failures owe themselves probably to the fact that formulating a theory of action is neither propitious nor useful. Thus, the most valuable lesson we can learn from philosophical desires for a theory of action is that we should take co-action as the starting point in our normative investigations, rather than positing action simpliciter as a problem to solve. That is, we should move away from propounding a theory of action, and instead focus on a paradigm shift, whereby we move away from a representational, towards a co-actional, model of action. (shrink)

This paper argues that the function of moral education in the biomedical context should be exactly the same as in a general, philosophical framework: it should not provide ready-to-use kits of moral principles; rather, it must show the history, epistemology and conceptual structure of moral theories that would enable those who have to make decisions to be as informed and as responsible as possible. If this complexity cannot be attained, an incomplete product—i.e. bioethics or bioethical principles—should not be seen as (...) a viable substitute. This theoretical position is subsequently illustrated by a case study involving research ethics committees. It is argued that within these committees, that are carefully formed multidisciplinary bodies, what makes competent decision-making possible is not a bioethical theory, nor even a sound philosophical ethics, but the dynamics of the discussion of a number of experts coming from different disciplines. This multidisciplinary expertise is necessary and sufficient to undertake the challenges of complex decisions in the biomedical context. (shrink)