Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia.

Background Rapid Ethical Assessment is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Methods Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health (...) researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. Results In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity, inadequate information, language barriers, cultural differences, undue expectations and power imbalances. About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. Conclusion The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended. (shrink)

Background Currently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis) in southern Ethiopia. Methodology/Principal Findings We adapted (...) a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO) working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent. Conclusions Researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis. (shrink)

_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)

BackgroundThe consent process for a genetic study is challenging when the research is conducted in a group stigmatized because of beliefs that the disease is familial. Podoconiosis, also known as 'mossy foot', is an example of such a disease. It is a condition resulting in swelling of the lower legs among people exposed to red clay soil. It is a very stigmatizing problem in endemic areas of Ethiopia because of the widely held opinion that the disease runs in families and (...) is untreatable. The aim of this study was to explore the impact of social stigma on the process of obtaining consent for a study on the genetics of podoconiosis in Southern Ethiopia.MethodsWe adapted a rapid assessment tool validated in The Gambia. The methodology was qualitative involving focus-group discussions (n = 4) and in-depth interviews (n = 25) with community members, fieldworkers, researchers and staff of the Mossy Foot Treatment and Prevention Association (MFTPA) working on prevention and treatment of podoconiosis.ResultsWe found that patients were afraid of participation in a genetic study for fear the study might aggravate stigmatization by publicizing the familial nature of the disease. The MFTPA was also concerned that discussion about the familial nature of podoconiosis would disappoint patients and would threaten the trust they have in the organization. In addition, participants of the rapid assessment stressed that the genetic study should be approved at family level before prospective participants are approached for consent. Based on this feedback, we developed and implemented a consent process involving community consensus and education of fieldworkers, community members and health workers. In addition, we utilized the experience and established trust of the MFTPA to diminish the perceived risk.ConclusionThe study showed that the consent process developed based on issues highlighted in the rapid assessment facilitated recruitment of participants and increased their confidence that the genetic research would not fuel stigma. Therefore, investigators must seek to assess and address risks of research from prospective participants' perspectives. This involves understanding the issues in the society, the culture, community dialogues and developing a consent process that takes all these into consideration. (shrink)

A global health archive consisting of podoconiosis tissue slides and blocks, was donated to Brighton & Sussex Medical School in 2014. There is little guidance on the socioethical and legal issues surrounding the retrospective use of archived or ‘abandoned’ tissue samples, which poses a number of questions relating to the ethical standing of the archive. There is a great deal of interpretation in the guidelines that are currently in existence; however, modern ethical principles cannot be applied as it is not (...) feasible to either reconsent or retrospectively seek approval. Our research team believed that it was unethical to leave the archive in storage, as this option favours neither researcher nor subjects. Permission was obtained from the Human Tissue Authority and a local ethics board for the tissues to be utilized in on-going research on podoconiosis aetiology. There is a delicate balance between the benefits gained by society relating to the development and progress of scientific research and the risks to the donor regarding the reuse of their tissues. Clearer guidelines should be made available to ensure that researchers are able to reuse tissue archives in contemporary research. (shrink)

An interview with Gail Weiss concerning her interests and influences, especially the body and embodiment.

Lecturer in social foundations of education and women's studies, Victoria College, Australia.

The conflicting positions of the two early eleventh century Yogācāra scholars, Ratnākaraśānti and his critic Jñānaśrīmitra, concerning whether or not consciousness can exist without content are inseparable from their respective understandings of enlightenment. Ratnākaraśānti argues that consciousness can be contentless —and that, for a buddha, it must be. Mental content can be defeated by reasoning and made to disappear by meditative cultivation, and so it is fundamentally distinct from the nature of consciousness, which is never defeated and never ceases. That (...) mental content is thus separable from the nature of consciousness is unimaginable to Jñānaśrīmitra, who argues that all mental content cannot be so defeated, nor can it disappear completely, and who concludes that Ratnākaraśānti’s commitment to this idea can be based on nothing but faith. Contra Jñānaśrīmitra, I will suggest that Ratnākaraśānti’s view is based not only on faith, but is also driven by a certain theory of buddhahood, the implications of which he is committed to working out. Because Ratnākaraśānti’s theory of buddhahood is developed in part in his tantric work, our understanding of his position benefits from our reading it in this context, wherein buddhahood and the most effective techniques for attaining it are explored. (shrink)

This paper considers Jñānaśrīmitra’s defense of manifestation as the criterion of ultimate existence. In the first section, "Asatkhyāti and Adhyavasāya: making sense of manifestation as the criterion of the real", I show the way that, in response to Ratnākaraśānti’s Nirākāravāda, Jñānaśrīmitra argues for a sharp distinction between manifestation and determination in an effort to establish that the manifestation of something unreal is incoherent. The unreal, he thinks, is only ever determined; it is never manifest to consciousness, properly speaking. In the (...) second section, “To be manifest is to be locked away in a single awareness-event”, I turn to one of the consequences of this view that Jñānaśrīmitra embraces: what manifests is only what appears in a single moment of conscious awareness. In the third section, “The scope of neither-one-nor-many: Jñānaśrīmitra’s Interpretation of PV 3.220–221”, I consider one of the problems this raises: how is it that an appearance with mutually opposed parts manifests in one and the same unitary moment of awareness? Jñānaśrīmitra solves this problem by appealing to the nature of manifestation and its distinction from determination: what is manifest, even if it is variegated, is nondual and indivisible; distinctions arise only on the basis of determination. I trace the details of this solution in the context of his discussion of an important pair of verses from Dharmakīrti. Finally, in the last section, “The marvelous nonduality of variegated awareness-events”, I turn to the surprising buddhological consequences of this solution. (shrink)

Abstract:Ratnākaraśānti (ca. 970–1040) holds three conflicting positions: luminosity (prakāśa) is the ultimately real nature of consciousness; luminosity and appearances (ākāras) are identical; and appearances are false (alīka) because they are targeted by the neither-one-nor-many argument. But why is luminosity not false, too, given its identity with appearances? In response to this worry, Ratnākaraśānti develops a notion of identity (tādātmya) that lets him claim that, although luminosity and appearance are composed of the same stuff, they are not identical in every respect. (...) On the basis of this, he limits the scope of the neither-one-nor-many argument such that it targets appearances but not luminosity. Other philosophers (and possibly Ratnākaraśānti himself) then further limit the argument's scope, showing that it also does not target experiences of pleasure (sukha) and, crucially for their buddhology, the innate bliss (sahajānanda) that characterizes the experience of buddhahood. (shrink)

This essay argues that Merleau-Ponty’s phenomenology of embodiment can be an extremely helpful ally for contemporary feminist theorists, critical race theorists, and disability studies scholars because his work suggests that the gender, race, and ability of bodies are not innate or fixed features of those bodies, much less corporeal indicators of physical, social, psychic, and even moral inferiority, but are themselves dynamic phenomena that have the potential to overturn accepted notions of normalcy, naturalness, and normativity. Taking seriously Merleau-Ponty’s insistence that (...) our bodies are the means by which we directly engage with the world, I suggest, encourages us to be attentive to how an individual’s or group’s gender, race, and bodily abilities differentially affect how their bodies are responded to by other bodies. The responses of others, in turn, directly influences the significance of an individual’s actions within that situation. This essay provides a critical examination of specific feminist philosophers, critical race scholars, and disability theorists who creatively utilize Merleau-Pontian insights to illustrate, and ultimately combat, the insidious ways in which sexism, racism, and “compulsory able-bodiedness”, impoverish the lived experience of both oppressors and the oppressed, largely by predetermining the meaning of their bodily interactions in accordance with institutionalized cultural expectations and norms. (shrink)

If social, political, and material transformation is to have a lasting impact on individuals and society, it must be integrated within ordinary experience. Refiguring the Ordinary examines the ways in which individuals' bodies, habits, environments, and abilities function as horizons that underpin their understandings of the ordinary. These features of experience, according to Gail Weiss, are never neutral, but are always affected by gender, race, social class, ethnicity, nationality, and perceptions of bodily normality. While no two people will experience (...) the ordinary in exactly the same way, the multiplicities, possibilities, overlaps, and limitations of day-to-day horizons are always intersubjectively constituted. Weiss turns her attention to changing the conditions and experiences of oppression from ordinary to extraordinary. This book is an impressive phenomenological, feminist reading of the complexities of human experience.M. V. Marder, University of Toronto, Feb. 2009. (shrink)

This volume is an introduction to both newer and more established ideas in the growing field of critical phenomenology from a number of disciplinary perspectives.

Philosophy and the Disdain for History: Reflections on Husserl's Ergiinzungsband to the Crisis GAIL SOFFER HUSSERL'S RECENTLY PUBLISHED Erganzungsband to the Cr/s/s' is a highly inti- mate statement, almost a confession, of hope and despair at the end of a philosophical life, a compendium of urgent, world-historical tasks not yet laid to rest. Above all, it abounds in reflections on history. In these, two things are poignantly clear: the late Husserl is completely convinced that history is of the utmost (...) importance to philosophy; he is not certain why. On a superfi- cial interpretation, the reason may seem obvious: Husserl's philosophical proj- ect is founded on the ideal of presuppositionless rational insight, and hence is Cartesian and ahistorical in its essence. The turn to history is to something external, and an implicit admission of the limitations of phenomenology itself, its inability to address the most pressing and meaningful problems of human existence: the crisis in European society and values, the ultimate significance of a man's life, work, and death. For those who would seek external motives for Husserl's turn to history, material is not lacking in this volume. There are moving philosophical discussions -- set in the atemporal phenomenological present tense -- of nationalism, of territoriality and the search for Lebensraum, of racism and xenophobia, of the forced emigration of families to a "no man's land. '' There is an attack on... (shrink)

It is an ancient view, to be found even in Aristotle’s analysis of friendship, that the other is an alter ego, another myself. More recently, this conception has provoked spirited debate within and without the phenomenological tradition. It can be found in a wide variety of texts, from Husserl’s Cartesian Meditations to Thomas Nagel’s “What is it like to be a bat?” The basic position can be summarized as follows. Intentional experiences are subjective, first-person experiences, not objective, third-person experiences.

Existing metasemantic projects presuppose that word- (or sentence-) types are part of the non-semantic base. We propose a new strategy: an endogenous account of word types, that is, one where word types are fixed as part of the metasemantics. On this view, it is the conventions of truthfulness and trust that ground not only the meaning of the words (meaning by convention) but also what the word type is of each particular token utterance (words by convention). The same treatment extends (...) to identifying the populations through which the conventions prevail. We consider whether this proposal leads to new underdetermination challenges for metasemantics, and make a case that it does not. (shrink)

The field of bioethics has evolved over the past half-century, incorporating new domains of inquiry that signal developments in health research, clinical practice, public health in its broadest sense and more recently sensitivity to the interdependence of global health and the environment. These extensions of the reach of bioethics are a welcome response to the growth of global health as a field of vital interest and activity. This paper provides a critical interpretive review of how the term “global health ethics” (...) has been used and defined in the literature to date to identify ethical issues that arise and need to be addressed when deliberating on and working to improve the discourse on ethical issues in health globally. Selected publications were analyzed by year of publication and geographical distribution, journal and field, level of engagement, and ethical framework. Of the literature selected, 151 articles were written by authors in high-income countries, as defined by the World Bank country classifications, 8 articles were written by authors in low- or middle-income countries, and 13 articles were collaborations between authors in HIC and LMIC. All of the articles selected except one from 1977 were published after 1998. Literature on global health ethics spiked considerably from the early 2000s, with the highest number in 2011. One hundred twenty-seven articles identified were published in academic journals, 1 document was an official training document, and 44 were chapters in published books. The dominant journals were the American Journal of Bioethics, Developing World Bioethics, and Bioethics. We coded the articles by level of engagement within the ethical domain at different levels: interpersonal, institutional, international, and structural. The ethical frameworks at use corresponded to four functional categories: those examining practical or narrowly applied ethical questions; those concerned with normative ethics; those examining an issue through a single philosophical tradition; and those comparing and contrasting insights from multiple ethical frameworks. This critical interpretive review is intended to delineate the current contours and revitalize the conversation around the future charge of global health ethics scholarship. (shrink)

The field of bioethics has evolved over the past half-century, incorporating new domains of inquiry that signal developments in health research, clinical practice, public health in its broadest sense and more recently sensitivity to the interdependence of global health and the environment. These extensions of the reach of bioethics are a welcome response to the growth of global health as a field of vital interest and activity. This paper provides a critical interpretive review of how the term “global health ethics” (...) has been used and defined in the literature to date to identify ethical issues that arise and need to be addressed when deliberating on and working to improve the discourse on ethical issues in health globally. Selected publications were analyzed by year of publication and geographical distribution, journal and field, level of engagement, and ethical framework. Of the literature selected, 151 articles were written by authors in high-income countries, as defined by the World Bank country classifications, 8 articles were written by authors in low- or middle-income countries, and 13 articles were collaborations between authors in HIC and LMIC. All of the articles selected except one from 1977 were published after 1998. Literature on global health ethics spiked considerably from the early 2000s, with the highest number in 2011. One hundred twenty-seven articles identified were published in academic journals, 1 document was an official training document, and 44 were chapters in published books. The dominant journals were the American Journal of Bioethics, Developing World Bioethics, and Bioethics. We coded the articles by level of engagement within the ethical domain at different levels: interpersonal, institutional, international, and structural. The ethical frameworks at use corresponded to four functional categories: those examining practical or narrowly applied ethical questions; those concerned with normative ethics; those examining an issue through a single philosophical tradition; and those comparing and contrasting insights from multiple ethical frameworks. This critical interpretive review is intended to delineate the current contours and revitalize the conversation around the future charge of global health ethics scholarship. (shrink)

How are we to think and act constructively in the face of today’s environmental and political catastrophes? Gail Stenstad finds inspiring answers in the thought of German philosopher Martin Heidegger. Rather than simply describing or explaining Heidegger’s transformative way of thinking, Stenstad’s writing enacts it, bringing new insight into contemporary environmental, political, and personal issues. Readers come to understand some of Heidegger’s most challenging concepts through experiencing them. This is a truly creative scholarly work that invites all readers to (...) carry Heidegger’s transformative thinking into their own areas of deep concern. (shrink)

This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be permitted (...) access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

I distinguish between two senses in which feminists have argued that the knower is social: 1. situated or socially positioned and 2. interdependent. I argue that these two aspects of the knower work in cooperation with each other in a way that can produce willful hermeneutical ignorance, a type of epistemic injustice absent from Miranda Fricker's Epistemic Injustice. Analyzing the limitations of Fricker's analysis of the trial of Tom Robinson in Harper Lee's To Kill a Mockingbird with attention to the (...) way in which situatedness and interdependence work in tandem, I develop an understanding of willful hermeneutical ignorance, which occurs when dominantly situated knowers refuse to acknowledge epistemic tools developed from the experienced world of those situated marginally. Such refusals allow dominantly situated knowers to misunderstand, misinterpret, and/or ignore whole parts of the world. (shrink)

This paper is a counter to the view that names are always predicates with the same extension as a metalinguistic predicate with the form “is a thing called “N”” (the Predicate View). The Predicate View is in opposition to the Referential View of names. In this paper, I undermine one argument for the Predicate View. The Predicate View’s adherents take examples of uses of names that have the surface appearance of a predicate and generalise from these to treat uses of (...) names that do not have the surface appearance of a predicate. They show that the Predicate View can provide a unified account of these two uses and assume that the Referential account cannot. I propose an alternative view of names, the Polysemy View. This view allows one to resist the pressure to generalise from the cases with the surface appearance of predicates to all uses of names while nevertheless providing connections between the uses. On the Polysemy View names are not, in their core use, metalinguistic predicates. Names are predominantly referring expressions but they also freelance as metalinguistic predicates on occasion. They have a double life. This double life is possible because of the pragmatic and conventional connections between the two aspects of that life. My main aim in this paper is to show that the Predicate View is not the only view that can give a good account of apparently predicative uses of names. In addition, I offer some inconclusive reasons to prefer the Polysemy View over the Predicate View. My paper assumes a background framework that the Predicate and Referentialist Views share and I do not attempt to justify that framework. I ignore many other views of names (notably descriptivist views and relevance theoretic views) in order to focus on the debate between these two opponents. (shrink)

The present book is true to its title. A collection of articles that stems from a symposium of the same name at the University of Hamburg in 2017, the authors here bring different perspectives to bear on the philosophical and historical relations between Buddhism and scepticism. Though this is relatively well-trodden ground, the insightful studies here shed new light on the matter. We find historical studies of the possible links between Pyrrhonism and Buddhism ; a defense of Nāgārjuna's philosophical scepticism (...) as of the Pyrrhonian variety ; considerations of the role of sceptical doubt in less expected places, such as in Dharmakīrti's and Vasubandhu's... (shrink)

Access to human biospecimens is widely regarded as essential to the progress of medical research, and in particular, to the success of “personalized medicine.” Understanding the influence of genetic variation on human health and disease requires that researchers conduct genetic and other studies on thousands of human specimens. Over the past decade, human “biobanks” — vast collections of human biospecimens — have proliferated both in the United States and internationally. These biobanks are subject to a heterogeneous mix of standards that (...) govern the collection and use of biospecimens. (shrink)

This book opens the door to the effects of intellectual, educational, and economic colonization of young children throughout the world. Using a postcolonial lens on current educational practices, the authors hope to lift those practices out of reproducing traditional power structures and push our thinking beyond the adult/child dichotomy into new possibilities for the lives that are created with children.

Since the first draft of the human genome was published in 2001, DNA sequencing technology has advanced at a remarkable pace. Launched in 1990, the Human Genome Project sought to sequence all three billion base pairs of the haploid human genome, an endeavor that took more than a decade and cost nearly three billion dollars. The subsequent development of so-called “next generation” sequencing methods has raised the possibility that real-time, affordable genome sequencing will soon be widely available. Currently, NGS methods (...) can be used to sequence up to 60 billion base pairs per day. Whole-genome sequencing costs an estimated $5,000-10,000, with that number predicted to fall to $1000 in the near future.In the past few years, the availability of high-throughput NGS methods has led to a proliferation of potential and actual clinical applications for NGS. NGS therefore has the potential to usher in the long-awaited era of personalized medicine. (shrink)

Large-scale sequencing tests, including whole-exome and whole-genome sequencing, are rapidly moving into clinical use. Sequencing is already being used clinically to identify therapeutic opportunities for cancer patients who have run out of conventional treatment options, to help diagnose children with puzzling neurodevelopmental conditions, and to clarify appropriate drug choices and dosing in individuals. To evaluate and support clinical applications of these technologies, the National Human Genome Research Institute and National Cancer Institute have funded studies on clinical and research sequencing under (...) the Clinical Sequencing Exploratory Research program as well as studies on return of results. Most of these studies use sequencing in real-world clinical settings and collect data on both the application of sequencing and the impact of receiving genomic findings on study participants. They are occurring in the context of controversy over how to obtain consent for exome and genome sequencing. (shrink)

This editorial critically engages with the understanding of openness by attending to how notions of presence and absence come bundled together as part of efforts to make open. This is particularly evident in contemporary discourse around data production, dissemination, and use. We highlight how the preoccupations with making data present can be usefully analyzed and understood by tracing the related concerns around what is missing, unavailable, or invisible, which unvaryingly but often implicitly accompany debates about data and openness.

The pressing and universally relevant issue of euthanasia is debated in this volume. Euthanasia has become increasingly contentious as populations age, and medical and scientific advances continue to transform and extend life. Euthanasia - Choice and Death examines the key philosophical arguments that have underpinned thinking and practice up till now: the centrality of choice to our notion of the human being, and the challenge of changes to our concept of death in the face of medical, scientific and technological advances. (...) Gail Tulloch develops a conception of dignity that does not depend on religious assumptions and can promote a broad ethical consensus in a liberal democracy. Examination of landmark cases and the approaches adopted by key countries - the U.S.A., the U.K., the Netherlands, and Australia - ground the book. (shrink)

The human papillomavirus is the most common sexually transmitted infection worldwide. In the United States, more than six million people are infected each year. Although most HPV infections are benign, two strains of HPV cause 70 percent of cervical cancer cases. Two other strains of HPV are associated with 90 percent of genital warts cases.In June 2006, the Food and Drug Administration approved the first vaccine against HPV. Sold as Gardasil, the quadrivalent vaccine is intended to prevent four strains of (...) HPV associated with cervical cancer, precancerous genital lesions, and genital warts. Following FDA approval, the national Advisory Committee on Immunization Practices recommended routine vaccination for girls ages 11-12 with three doses of quadrivalent HPV vaccine. Thereafter, state legislatures around the country engaged in an intense effort to pass laws mandating vaccination of young girls against HPV. This activity was spurred in part by an intense lobbying campaign by Merck, the manufacturer of the vaccine. (shrink)

ABSTRACT This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be (...) permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

This article explores the development of a novel biomedical research organism, and its potential to remake the species and spaces of translational medicine. The humanized mouse is a complex experimental object in which mice, rendered immunodeficient through genetic alteration, are engrafted with human stem cells in the hope of reconstituting a human immune system for biomedical research and drug testing. These chimeric organisms have yet to garner the same commentary from social scientists as other human–animal hybrid forms. Yet, they are (...) rapidly being positioned as central to translational medicine in immunological research and pharmaceutical development. This article explores the complex relations between species and spaces they seek to enact. Humanizing mice simultaneously moves these animal forms towards the intimate geographies of corporeal equivalence with humans and the expansive geographies of translational research. These multiple trajectories are achieved by the way humanized mice function as both uncertain ‘epistemic things’ and as expansive ‘collaborative things’, articulating mouse genetics with other research, notably stem cell science. In the context of post-genomics, their indeterminacy is critical to their collaborative value; their expansive potential follows as much from their biological openness as from specific expectations. Yet, these new research organisms have both accumulative and disruptive capacities, for there are patterns of interference between these trajectories, remaking boundaries between experimental practices and clinical contexts. (shrink)

To provide effective care physicians must attend, not just to medical issues, but also to the social determinants of health — racial factors, food insecurity, housing instability, transportation barriers and beyond. Social determinants also include a largely underrecognized dimension: legal vulnerabilities such as rental evictions and debt adjudications. Yet rarely do medical trainees have an opportunity to witness legal vulnerabilities, firsthand.

This article considers some of the ways in which ‘the black woman’ as both representation and embodied, sentient being is rendered visible and invisible, and to link these to the multiple and competing ways in which she is ‘present’. The issues are engaged through three distinct but overlapping conceptualisations of ‘presence’. ‘Presence’ as conceived (and highly contested) in performance studies; ‘presence’ as conceived and worked with in psychoanalysis; and ‘presence’ as decolonising political praxis among Indigenous communities. I use these conceptualisations (...) of presence to consider the various ways in which the black woman as figure and as embodied/sentient subject has been made present/absent in different discursive registers. I also explore what is foreclosed and how this is itself linked to legacies of colonial ‘worlding’. I end with consideration of alternative modes of black women's presence and how this offers a resource for new modes of sociality. (shrink)