We elaborate the kind of metaphysical, ontological arguments and positions put forth by Martin and Sugarman in several ways, in an attempt to clarify that it is the assumption of psychological and sociocultural entities as fixed ontological categories that makes psychological—sociocultural dualism problematic, not the necessary distinction it draws between sociocultural and psychological processes. In so doing, we develop an emergent, mutable metaphysics and ontology for psychological and sociocultural processes that emphasizes their dynamic interrelation. We then attempt to articulate (...) and defend a neorealist hermeneutics as a viable epistemological accompaniment to this dynamic, interactionist metaphysics, and to indicate its appropriateness to psychological inquiry in particular. (shrink)

Experiments have suggested that umbilical cord blood stem cells can be used to prevent diseases such as atherosclerosis. This paper discusses ethical issues surrounding such usage such as the uncertainty that individuals at risk of a disease will actually get the disease; issues related to research with children; safety issues; from where these stem cells would be obtained; and whether these usages should be considered as therapies or as physical enhancements.

Television medical dramas frequently depict the practice of medicine and bioethical issues in a strikingly realistic but sometimes inaccurate fashion. Because these shows depict medicine so vividly and are so relevant to the career interests of medical and nursing students, they may affect these students' beliefs, attitudes, and perceptions regarding the practice of medicine and bioethical issues. We conducted a web-based survey of medical and nursing students to determine the medical drama viewing habits and impressions of bioethical issues depicted in (...) them. More than 80% of medical and nursing students watch television medical dramas. Students with more clinical experience tended to have impressions that were more negative than those of students without clinical experience. Furthermore, viewing of television medical dramas is a social event and many students discuss the bioethical issues they observe with friends and family. Television medical dramas may stimulate students to think about and discuss bioethical issues. (shrink)

Introduction While quizzing during informed consent for research to ensure understanding has become commonplace, it is unclear whether the quizzing itself is problematic for potential participants. In this study, we address this issue in a multinational HIV prevention research trial enrolling injection drug users in China and Thailand. Methods Enrolment procedures included an informed consent comprehension quiz. An informed consent survey followed. Results 525 participants completed the informed consent survey (Heng County, China=255, Xinjiang, China=229, Chiang Mai, Thailand=41). Mean age was (...) 33 and mean educational level was 8 yrs. While quizzing was felt to be a good way to determine if a person understands the nature of clinical trial participation (97%) and participants did not generally find the quiz to be problematic, minorities of respondents felt pressured (6%); anxious (5%); bored (5%); minded (5%); and did not find the questions easy (13%). In multivariate analysis, lower educational level was associated with not minding the quizzing (6–10 yrs vs 0–5 yrs: OR=0.27, p=0.03; more than 11 yrs vs 0–5 yrs: OR=0.18, p=0.03). There were also site differences (Heng County vs Xinjiang) in feeling anxious (OR=0.07; p=<0.01), not minding (OR=0.26; p=0.03), being bored (OR=0.25; p=0.01) and not finding the questions easy (OR=0.10; p=<0.01). Conclusions Quizzing during the informed consent process can be problematic for a minority of participants. These problems may be associated with the setting in which research takes place and educational level. Further research is needed to develop, test and implement alternative methods of ensuring comprehension of informed consent. Trial Registration clinicaltrials.gov number NCT00270257. (shrink)

Participants in clinical research sometimes view participation as therapy or exaggerate potential benefits, especially in phase I or phase II trials. We conducted this study to discover what methods might improve cancer patients’ understanding of early-phase clinical trials. We randomly assigned 130 cancer patients from three U.S. medical centers who were considering enrollment in a phase I or phase II cancer trial to receive either a multimedia intervention or a National Cancer Institute pamphlet explaining the trial and its purpose. Intervention (...) participants were 32 times more likely to believe that the trial’s purpose was to examine safety and 60 % less likely to believe they would experience long-term benefit or cure. There was no difference in enrollment decision. However, while patients’ understanding of the trial’s purpose improved and expectations of long-term benefit diminished, half the respondents still believed they would experience long-term benefit or cure from participation. Therefore, we conclude that multimedia interventions such as this one may help oncologists to explain the risks and benefits of early-phase cancer trials in a way that patients can more easily understand, helping them to make more informed decisions about participation. But further research into other factors that influence patients’ beliefs about the outcome of enrollment is needed, both to modify the interventions and to determine how malleable patient beliefs are. (shrink)

Television medical dramas sometimes depict medical professionalism and bioethical issues, but their nature and extent are unclear. The authors systematically analysed the bioethical and professionalism content of one season each of Grey's Anatomy and House M.D., two of the most popular current television medical dramas. The results indicate that these programmes are rife with powerful portrayals of bioethical issues and egregious deviations from the norms of professionalism and contain exemplary depictions of professionalism to a much lesser degree.

As part of a larger research study, we present model language for disclosing financial interests in clinical research to potential research participants, and we describe the empirical basis and theoretical assumptions used in developing the language. The empirical process for creating appropriate disclosure language resulted in a generic disclosure statement for cases in which no risk to participants’ welfare or the scientific integrity of the research is expected, and nine more specific disclosure statements for cases in which some risk is (...) expected. The disclosure statements are not meant to be canonical, but were instead designed to reflect the typical situations in which disclosure of financial interest might be considered by an institutional review board or conflict of interest committee. Individual institutions could modify key phrases to suit their purposes, and others could use the language in future empirical work on informed consent to better refine the options for disclosing financial interests in clinical research. (shrink)

Pragmatic clinical trials offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question, yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as?pragmatic clinical trial collateral findings,? (...) or?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice. (shrink)

Many medical ethicists accept the thesis that there is no moral difference between withholding and withdrawing life-sustaining therapy. In this paper, we offer an interesting counterexample which shows that this thesis is not always true. Withholding is distinguished from withdrawing by the simple fact that therapy must have already been initiated in order to speak coherently about withdrawal. Provided that there is a genuine need and that therapy is biomedically effective, the historical fact that therapy has been initiated entails a (...) claim to continue therapy that cannot be attributed to patients who have not yet received therapy. This intrinsic difference between withholding and withdrawing therapy is of moral importance. In many instances, patients will waive this claim. But when one considers withdrawing therapy from one patient to help another in a setting of scarce resources, this intrinsic moral difference comes into sharp focus. In an era of shrinking medical resources, this difference cannot be ignored. (shrink)

Book reviewed in this article: Wrong Medicine. By Lawrence J. Schneiderman and Nancy S. Jecker.

The considerable attention to financial interests in clinical research has focused mostly on academic medical centers, even though the majority of clinical research is conducted in community practice settings. To fill this gap, this article maps the practices and policies in 73 community hospitals and several hundred specialized facilities around the country for reviewing clinical investigators’ financial relationships with research sponsors. Community hospitals face a substantially different mix of issues than academic medical centers do because their physician researchers are usually (...) not employees, and more of their studies are later-phase, multicenter trials. Accordingly, community physicians stand to benefit personally from per capita payments, but they tend to have less direct influence over research findings when compared with their academic peers. These and other contrasts require separate guidance for community-based organizations that takes into account their particular needs, circumstances, and institutional capacities. (shrink)

This paper argues that Sulmasy and Sugarman have not succeeded in showing a moral difference between withholding and withdrawing treatment. In particular, they have misunderstood historical entitlement theory, which does not automatically prefer a first occupant by just acquisition.

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)

In contemporary forms of psychoanalysis, particularly intersubjective systems theory, the turn towards contextualism has permitted the development of new ways of thinking and practicing that have dispensed with the notion of isolated individuality. For many who embrace this "post-subjectivist" way of thinking and practicing, the recognition that all human experience is fundamentally immersed in the world makes the question of individuality seem confusing, even anachronistic. Yet the challenge of individuality remains an important and pressing issue for contemporary theory and practice; (...) many clinicians are left to wonder about the role of "individual" experience and how to approach it conceptually or clinically. This volume of original essays gives the problem of individuality its due, without losing sight of the importance of contextualized experience. Drawing on a variety of disciplinary backgrounds - philosophical, developmental, biological, and neuroscientific - the contributors address the tension that exists between individuality and the emergence of contextualism as a dominant mode of psychoanalytic theory and practice, thereby providing unique insights into the role and place of individuality both in and out of the clinical setting. Ultimately, these essays demonstrate that individuality, no matter how it may be defined, always occurs within a contextual web that forms the basis of human experience. _Contributors:_ William J. Coburn, Philip Cushman, James L. Fosshage, Roger Frie, Frank M. Lachmann, Jack Martin, Donna Orange, Robert D. Stolorow, Jeff Sugarman. (shrink)

In this insightful set of essays, the concept of the psychological humanities is defined and explored. A clear rationale is provided for its necessity in the study and understanding of the individual and identity in a discipline that is largely occupied by empirical studies that report aggregated data and its analysis. Contributors to this volume are leading scholars in theoretical psychology who believe that psychology must be about persons and their lives. In these essays, they draw from a variety of (...) disciplines that include art, literature, life writing, and history to make a case for the psychological humanities. A final chapter provides a critical commentary on the value of the psychological humanities. It is argued that psychology must draw on the knowledge and practices of the humanities, as well as the sciences and social sciences, in order to attain a greater understanding of personhood. This book is aimed at upper level undergraduate and postgraduate students and scholars of psychology, particularly theoretical psychology, philosophy of the mind, and those from a humanities background interested in exploring the concept of the psychological humanities. (shrink)

Governance models for the oversight of human embryonic stem cell research have been proposed which mirror in large part familiar oversight mechanisms for research with human subjects and non-human animals. While such models are in principle readily endorsable, there are a set of concerns related to their implementation — such as ensuring that an elaborated informed consent process and conducting long-term monitoring of research subjects are tenable — which suggest areas where gathering data may facilitate more appropriate oversight. In addition, (...) it is unclear whether a new governance model based at individual institutions are sufficient to address the ethical issues inherent to this research. Regardless, some of the concerns that have arisen in considering the appropriate governance of stem cell research, particularly the important translational pathway of innovation in contrast to staged research, transparency and publication, and social justice, may be useful in science and translational research more broadly. (shrink)

: In light of information uncovered about human radiation experiments conducted during the Cold War, an important charge for the Advisory Committee on Human Radiation Experiments was to assess the current state of protections for human research subjects. This assessment was designed to enhance the Committee's ability to make informed recommendations for the improvement of future policies and practices for the protection of research subjects. The Committee's examination of current protections revealed great improvement over those from the past, yet some (...) problems remain. Although the data collected by the Committee highlight specific areas in need of attention, the Committee's work should be viewed in part as the beginning of a series of ongoing assessments of the adequacy and effectiveness of the protections afforded to human subjects. (shrink)

Clinicians have good moral and professional reasons to contribute to pragmatic clinical trials (PCTs). We argue that clinicians have a defeasible duty to participate in this research that takes place in usual care settings and does not involve substantive deviation from their ordinary care practices. However, a variety of countervailing reasons may excuse clinicians from this duty in particular cases. Yet because there is a moral default in favor of participating, clinicians who wish to opt out of this research must (...) justify their refusal. Reasons to refuse include that the trial is badly designed in some way, that the trial activities will violate the clinician’s conscience, or that the trial will impose excessive burdens on the clinician. (shrink)

The author describes and examines Ian Hacking’s approach to historical ontology and its application to psychological description. Historical ontology is concerned with the study of phenomena that come in and out of being. Phenomena under psychological description not only are historical, but also are particularly susceptible to what Hacking calls dynamic nominalism. Dynamic nominalism characterizes the ways our descriptive practices of naming interact with things named. More precisely, in describing ourselves psychologically, we humans are uniquely capable of reacting to such (...) self-descriptions in ways that can constitute or reconstitute a relation with ourselves. Humans come to define and act toward themselves under psychological descriptions and, in the process, form and alter the kinds of persons they are. Furthermore, it is suggested that an indispensible precondition of historical ontology, and all that is entailed by it, is a uniquely human agency that not only is responsive to psychological descriptions, but also is self-interpreting and self-determining. The author concludes with some impressions about historical ontology and psychological description and their implications for psychology. 2012 APA, all rights reserved). (shrink)

John Macmurray's philosophy of "the form of the personal" is examined with particular interest in his emphasis on persons as agents, his account of psychological development, his claim that our self-awareness as persons is acquired from the mutuality of personal relations, and his important contribution in placing personhood at the center of inquiries into the human condition. Subsequently, it is argued that the reality of psychologically capable personhood so construed is irreducible to physical, biological, or social categories frequently deemed by (...) psychologists as more fundamental and, further, that psychological capacities and their development are best understood in terms of the personal. 2012 APA, all rights reserved). (shrink)

There is considerable confusion regarding the ethical appropriateness of using incentives in research with human subjects. Previous work on determining whether incentives are unethical considers them as a form of undue influence or coercive offer. We understand the ethical issue of undue influence as an issue, not of coercion, but of corruption of judgment. By doing so we find that, for the most part, the use of incentives to recruit and retain research subjects is innocuous. But there are some instances (...) where it is not. Specifically, incentives become problematic when conjoined with the following factors, singly or in combination with one another: where the subject is in a dependency relationship with the researcher, where the risks are particularly high, where the research is degrading, where the participant will only consent if the incentive is relatively large because the participant's aversion to the study is strong, and where the aversion is a principled one. The factors we have identified and the kinds of judgments they require differ substantially from those considered crucial in most previous discussions of the ethics of employing incentives in research with human subjects. (shrink)

More than 25 years into the HIV epidemic, in excess of 2 million new infections continue to occur each year. HIV prevention research is crucial for groups at heightened risk for HIV, but the design and conduct of HIV prevention research with vulnerable populations worldwide raises considerable ethical challenges. The HIV Prevention Trials Network (HPTN) is a global collaborative network that conducts clinical and behavioural studies on non-vaccine interventions to reduce the transmission of HIV. In 2003, the HPTN developed ethical (...) guidance to enhance the responsible conduct of its research activities and as a distinctive contribution to global research ethics. In what follows, the developments that motivated the drafting of a revised ethics document in 2009 are described, including the process by which that revision took place and some of the key differences between the HPTN ethics guidance and other relevant guidelines in the field. (shrink)

The Wiley Handbook of Theoretical and Philosophical Psychology presents a comprehensive exploration of the wide range of methodological approaches utilized in the contemporary field of theoretical and philosophical psychology. The Wiley Handbook of Theoretical and Philosophical Psychology presents a comprehensive exploration of the wide range of methodological approaches utilized in the contemporary field of theoretical and philosophical psychology. Gathers together for the first time all the approaches and methods that define scholarly practice in theoretical and philosophical psychology Chapters explore various (...) philosophical and conceptual approaches, historical approaches, narrative approaches to the nature of human conduct, mixed-method studies of psychology and psychological inquiry, and various theoretical bases of contemporary psychotherapeutic practices Features contributions from ten Past Presidents of the Society of Theoretical and Philosophical Psychology, along with several Past Presidents of other relevant societies. (shrink)

It is widely assumed that informing prospective subjects about the risks and possible benefits of research not only protects their rights as autonomous decisionmakers, but also empowers them to protect their own interests. Yet interviews with patient‐subjects conducted under the auspices of the Advisory Committee on Human Radiation Experiments suggest this is not always the case. Patient‐subjects often trust their physician to guide them through decisions on research participation. Clinicians, investigators, and IRBs must assure that such trust is not misplaced.

? The research reported here was conducted while the author was employed by the Farming?ton Trust Research Unit in Oxford and was entirely financed by them. Appreciation is expressed to the Director of Education for the County of Oxfordshire, to the headmasters, teachers and pupils for their cooperation in making this study possible. The services of the Oxford University Computing Centre were generously made available. Valuable assistance in revising earlier drafts of this paper was rendered by Robert N. Rapoport and (...) Alfred Yates. (shrink)

The long-standing overarching policy governing research with human subjects conducted and supported by most federal agencies and departments in the United States, known as the Common Rule, has recently been revised, with most requirements slated to become effective in 2018. Although there are multiple alterations to the current regulations, some of the most significant changes aim to enhance consent for research. While some of the particular provisions in this regard will be easy to apply and promise to help meet this (...) goal, others may be more challenging to implement despite their intuitive appeal. In this article, I examine some of the provisions in the revised Common Rule that relate to consent: new required consent elements; the goal of comprehension in the consent process; consent forms; and broad consent. By raising issues about these provisions now and suggesting possible ways to overcome their potential shortfalls, the hope is that future efforts can be taken to help clarify and appropriately implement them. (shrink)

Consequence is at the heart of logic, and an account of consequence offers a vital tool in the evaluation of arguments. This text presents what the authors term as 'logical pluralism' arguing that the notion of logical consequence doesn't pin down one deductive consequence relation; it allows for many of them.

Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from (...) considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency. (shrink)

Empirical research in bioethics can be defined as the application of research methods in the social sciences to the direct examination of issues in [bioethics]. As such, empirical work is a form of descriptive ethics, focused on describing a particular state of affairs that has some moral or ethical relevance. For example, empirical research can help to describe cultural beliefs about the appropriateness of providing health-related information, such as the diagnosis of a life-threatening illness, which informs deliberations about the extent (...) to which it is morally important for clinicians to provide comprehensive information to patients in different cultural contexts. Similarly, empirical research can delineate popular attitudes and experiences related to contentious issues such as abortion, cloning, stem-cell research, and physician-assisted suicide to enlighten discussions and policy formulations regarding them. (shrink)

Empirical research in bioethics can be defined as the application of research methods in the social sciences to the direct examination of issues in [bioethics]. As such, empirical work is a form of descriptive ethics, focused on describing a particular state of affairs that has some moral or ethical relevance. For example, empirical research can help to describe cultural beliefs about the appropriateness of providing health-related information, such as the diagnosis of a life-threatening illness, which informs deliberations about the extent (...) to which it is morally important for clinicians to provide comprehensive information to patients in different cultural contexts. Similarly, empirical research can delineate popular attitudes and experiences related to contentious issues such as abortion, cloning, stem-cell research, and physician-assisted suicide to enlighten discussions and policy formulations regarding them. (shrink)