The goal of synthetic biology is to create artificial organisms. To achieve this it is essential to understand what life is. Metabolism-replacement systems, or (M, R)-systems, constitute a theory of life developed by Robert Rosen, characterized in the statement that organisms are closed to efficient causation, which means that they must themselves produce all the catalysts they need. This theory overlaps in part with other current theories, including autopoiesis, the chemoton, and autocatalytic sets, all of them invoking some idea of (...) closure. A simple model of an (M, R)-system has been implemented in the computer, and behaves in ways that may shed light on the requirements for a prebiotic self-organizing system. In addition to a trivial steady state in which nothing happens, it can establish a non-trivial steady state in which all intermediates have finite concentrations, with their rates of degradation balanced by their rates of synthesis. The system can be regenerated from the set of food components plus a single intermediate, and maintain itself in that state indefinitely, despite continuous degradation. At the very low compartment volumes that may have existed in prebiotic conditions, for example in cavities in minerals, or in micelles formed by simple amphiphiles, statistical fluctuations in the numbers of molecules need to be taken into account. With the stochastic approach there is no non-trivial steady state in strict mathematical terms, because the system will always collapse to the trivial state after sufficient time. However, the average time before collapse is so long for volumes greater than $10^{-19}\;{\textsc{l}}$ (much smaller than the volume of the order of $10^{-15}\;{\textsc{l}}$ for a typical bacterial cell) that for practical purposes the self-maintaining state of non-null concentrations becomes significant, recalling the situation of bistability that is observed in deterministic analysis. In turn, there exists a minimum size below which the self-organizing system cannot maintain itself on chemically relevant time scales. The value of the critical volume depends on the particular concentrations and rate constants assumed, but the principle could apply generally. (shrink)

According to the Argument for Autonomous Mental Disorder, mental disorder can occur in the absence of brain disorder, just as software problems can occur in the absence of hardware problems in a computer. This article argues that the AAMD is unsound. I begin by introducing the “natural dysfunction analysis” of disorder, before outlining the AAMD. I then analyze the necessary conditions for realizer autonomous dysfunction. Building on this, I show that software functions disassociate from hardware functions in a way that (...) mental functions do not disassociate from brain functions. It follows that mental disorders are brain disorders necessarily. (shrink)

Justin Garson has recently advanced a Generalised Selected Effects Theory of biological proper function. According to Garson, his theory spells trouble for the Dysfunction Account of Disorder. This paper argues that Garson’s critique of the Dysfunction Account from the Generalised Theory fails, and that we should reject the Generalised Theory outright. I first show that the Generalised Theory does not, as Garson asserts, imply that neurally selected disorders are not dysfunctional. Rather, it implies that they are both functional and dysfunctional. (...) I argue on this basis that the Generalised Theory yields conflicting functional norms, and we that should reject it outright on these grounds. (shrink)

Metabolic systems are complicated and contain very large numbers of interacting reactions and many internal regulatory mechanisms. This does not prevent the genetic composition of an organism from influencing its behavior, however, nor does it preclude the possibility that some aspects of its behavior may be amenable to simple explanations.

This paper asks when a natural disease kind is truly 'reactive' and when it is merely associated with a corresponding social kind. I begin with a permissive account of real kinds and their structure, distinguishing natural kinds, indifferent kinds and reactive kinds as varieties of real kind characterised by super-explanatory properties. I then situate disease kinds within this framework, arguing that many disease kinds prima facie are both natural and reactive. I proceed to distinguish ‘simple dependence’, ‘secondary dependence’ and ‘essential (...) dependence’ between a natural kind and its classification, and argue that a natural kind is only really reactive, in an important sense, under conditions of essential dependence. On this basis, I offer a principled hypothesis for why psychiatric kinds tend to be more metaphysically unstable than paradigm somatic disease kinds. (shrink)

Background Generally, there is unanimity about the value of community engagement in health-related research. There is also a growing tendency to view genetics and genomics research (GGR) as a special category of research, the conduct of which including community engagement (CE) as needing additional caution. One of the motivations of this study was to establish how differently if at all, we should think about CE in GGR. Aim To assess the perspectives of genetics and genomics researchers in Uganda on CE (...) in GGR. Method A cross-sectional qualitative study was conducted at Makerere University and Uganda Virus Research Institute. Twenty-five individuals participated, the majority being male (sixteen). Participants included nineteen genetics and genomics researchers (researchers and research coordinators), two CE officers, three nurses and one nursing counsellor. Data were collected using in-depth interviews and analyzed in a thematic manner using NVivo version 12 Plus. Study findings Thirteen of the respondents had conducted CE in their GGR in either a geographical and disease-specific community. Some respondents said CE principles are the same and there is no need for special consideration for CE in GGR. Others gave ethical issues in GGR that require special consideration for CE in such research and these were categorized into six themes: GGR is new to communities, Difficulty in communicating GGR by the researchers, Genes are shared in communities, Cultural sensitivities against GGR, Community attitude toward GGR, Some GGR studies take long to end, and Negotiation of research benefits. Special considerations for CE when conducting GGR were suggested and categorized into seven themes: creating awareness of GGR in communities, obtaining both community acceptance and individual consent, CE team composition, involve communities in solving GGR challenges, prolong CE in some GGR, develop guidelines for CE in GGR, and legal considerations on GGR. Conclusion GGR was characterized by special issues that require special CE considerations for such research. (shrink)

In its concern to evoke in its readership an appropriate response to the challenge posed by the contemporary environmental crisis, the recent papal encyclical Laudato Si': On Care for our Common Home differentiates between the task of human education, on the one hand, and the deeper and more abstract task of motivating the human will for change and action, on the other. What must take place, it asserts, is the creation of nothing less than an ‘ecological citizenship’. To describe how (...) this might be brought about, the encyclical employs the theological language of ‘conversion’. However, the rationale for this suggestion, and the implications it would entail for the way in which educational programmes on the environment might be pursued, is developed only minimally in the encyclical itself. The objective of this article is to take up and develop this hint by offering some philosophical and theological perspectives on the idea of human motivation towards care for the environment, and by exploring the current state of affairs in environmental education in light of it. The article therefore aims to develop the encyclical's brief and unthematized suggestion regarding an ‘ecological citizenship’ in a practical and applied direction.© 2018 Trustees for Roman Catholic Purposes Registered. (shrink)

Cet article présente une analyse du thème de la religion dans l’oeuvre de Bruno Latour. Certains commentateurs affirment que la présence persistante du thème n’est qu’une manifestation de la piété catholique résiduelle de Latour et, ce faisant, mettent en cause l’ontologie pluraliste qu’il défend. M’inscrivant en faux face à ces critiques, je suggère que ce thème a constitué un argument dominant dès les premières étapes de sa carrière. Latour propose deux définitions de la religion. La première, que j’ai nommée « (...) la Religion », a vocation à fermer le monde pluriel. La seconde, que Latour nomme « religion comme mode d’existence », ou [REL], est une expression de ce monde pluriel et, pour cette raison, peut être qualifiée de « rationnelle ». Si on perd de vue cet aspect, on risque de se priver du potentiel de critique de la situation de la modernité séculière que nous offre sa pensée.This paper examines the theme of religion in the work of Bruno Latour. Some critics have suggested that the persistent presence of this theme is an indication of a residual Catholic piety on the part of Latour and hence that it calls into question the pluralist ontology he advocates. However, I will argue that this theme has been a concern from the earliest stages of his career. In fact, Latour identifies two forms of religion as operating in the world. The first, which I will name “Religion,” serves to close down the plurality of the world. The second, which Latour himself names “religion as a mode of existence,” or [REL], is an expression of the plural world, and can be called rational for this reason. If this point is not well understood, the potential of Latour’s work for a critique of the situation of secular modernity risks being missed. (shrink)

Defining Mental Disorder: Jerome Wakefield and His Critics, edited by Denis Forest and Luc Faucher, is essential reading for students and researchers in philosophy of medicine whose work is informed by that of Jerome Wakefield, or the disease debate in general. If you are anything like me, this book will open the door to a new depth of understanding of the harmful dysfunction analysis (HDA) and its methodical underpinnings, and an enriched appreciation of what is at stake in defining medical (...) disorder. To those confident that they understand Wakefield’s view and the surrounding debate, thinking perhaps that they do not need a refresher, I would say: perhaps you do not understand it as well as you think. Defining Mental Disorder provides much more than an overview of previously well-trodden ground. The chapters themselves, and Wakefield’s own detailed responses, help to elucidate a number of methodological nuances and peculiarities that have rarely been covered in such depth before. I was startled to learn how philosophically complex Wakefield’s position actually is, and how shallow my own understanding of it has been. It emerges as a far more nuanced and sophisticated account than I had given it credit for, and one that deserves serious reevaluation. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Medical Tourism:Crossing Borders to Access Health CareHarriet Hutson Gray (bio) and Susan Cartier Poland (bio)Traveling abroad for one's health has a long history for the upper social classes who sought spas, mineral baths, innovative therapies, and the fair climate of the Mediterranean as destinations to improve their health. The newest trend in the first decade of the twenty-first century has the middle class traveling from developed countries to those (...) with emerging economies to avoid treatment delays, prohibitive costs for life-saving procedures, or simply high costs for elective surgery. Others leave to have access to assisted suicide in countries that have legalized it: Belgium, The Netherlands, and Switzerland. This new era of globalization in health care has arrived without the benefit of international standards, government oversight, or ethical and legal review.Howard Staab, a self-employed carpenter from North Carolina, flew to India for his medically necessary heart surgery, scheduled a side trip to the Taj Mahal, and returned home to work in North Carolina. He spent a total of less than $10,000, instead of the $200,000 required from the local hospital (I, Milstein and Smith 2006).At first blush, the outsourcing of medical care to India seems to be a particular solution for a particular problem. However, the particularity of Mr. Staab is not unique. His experience is emblematic of those patients in the United States with a medical need for major and elective procedures, but who also must bear the total cost of these procedures. These middle-class, under-insured Americans go abroad.In tandem with increasingly aggressive marketing campaigns, American hospitals and companies have begun to leverage their connections in Asia to grow the medical tourism business into a major economic force. What are the consequences of this?Several authors point to the effect on the host country's population, particularly the poor, to be pushed farther down the queue to receive adequate, affordable care. Resources are applied to the foreign trade instead of building the local [End Page 193] medical infrastructure. Another potential problem is the obligation of the home-country physician to provide follow-up care. What are the legal ramifications when the procedure was illegal to begin with? Are there opportunities for redress for medical errors?These factors may be converging into a "perfect storm" for health care in the U.S., in which the potential participation of the major insurance companies in promoting offshore care will be the tipping point in the precarious structure that represents the economic currents in health care. Third-party administrators and self-funded employers may be on the cutting edge in 2009 by providing incentives to employees to travel overseas for care.I. Economic ConsiderationsConnell, John. Medical Tourism: Sea, Sun, Sand and... Surgery. Tourism Management 27: 1093–1100, 2006.As evidence of the interest of traditional tour operators in this newer twist on the industry, the author explores medical tourism as an element of the growth of world tourism. In promoting medical tourism, he urges consideration of such issues as the privatization of health care, the foundational role of technology, and uneven access to health resources.Dunn, Philip. Medical Tourism Takes Flight. H and HN: Hospitals and Health Networks: 40–44, November 2007.Writing for U.S. health care executives, Dunn emphasizes that the reality of medical tourism competes with the local medical center for patients and their insurance dollars in a significant way. He examines the possibility that U.S. insurance plans soon may offer to pay for what is currently a cash only business and that the economic impact to the local medical center could be significant or even devastating.Frontiers of Health Services Management [Selected Articles] 24 (2), Winter 2007.In "Managing Healthcare Services in the Global Marketplace" (pp. 3–18), Bruce J. Fried and Dean M. Harris consider legal, ethical, and financial implications of the international workforce. In "Globalization of Health Care" (pp. 19–30), Lynn Schroth and Ruthy Khawahja point out that the transfer of comprehensive management expertise and intellectual property from U.S. medical centers to international sites is driving the success of collaboration between U.S. and foreign health care centers. In "Is... (shrink)

In the UK, it has been proposed that alongside the current advice to abstain from alcohol completely in pregnancy, there should be increased screening of pregnant women for alcohol consumption in order to prevent instances of fetal alcohol spectrum disorder. The Scottish Intercollegiate Guidelines Network published guidelines in 2019 recommending that standardised screening questionnaires and associated use of biomarkers should be considered to identify alcohol exposure in pregnancy. This was followed in 2020 by the National Institute for Health and Care (...) Excellence Draft Quality Standard, which recommended that pregnant women should have information on their alcohol consumption recorded throughout their pregnancy and this information transferred to the child’s health records. Most recently, Public Health England has stated that the alcohol intake of all women should be recorded throughout pregnancy, not just at the initial booking appointment and that tools such as blood biomarkers and meconium testing should be researched in order to determine true prevalence rates of alcohol in pregnancy. We argue that this proposed enhanced screening undermines women’s autonomy and their legal right to be sufficiently informed to consent to screening. We argue that there is no evidence that this kind of screening will result in a reduction of fetal harm and there is a danger that undermining the autonomy of women and the trust relationship between women and healthcare professionals may even increase harm to future children. (shrink)

During the past four decades the governance of environmental problems – the definition of issues and their political and practical resolution – has evolved to include a wider range of stakeholders in more extensive open discussions. In the introduction to this issue of Environmental Values on ‘Environment, Policy and Participation’, we outline some features of these recent developments in participatory environmental governance, indicate some key questions that arise, and give an overview of the collection of papers in this special issue.

Utilising empirical ethics analysis, we evaluate the merits of systems proposed to increase deceased organ donation in South Africa. We conclude that SA should maintain its soft opt-in policy, and enhance it with ‘required transplant referral’ in order to maximise donor numbers within an ethically and legally acceptable framework. In SA, as is the case worldwide, the demand for donor organs far exceeds the supply thereof. Currently utilising a soft opt-in system, SA faces the challenge of how to increase donor (...) numbers in a context which is imbued with inequalities in access to healthcare, multiplicitous personal beliefs and practices, distrust of organ transplant and varying levels of education and health literacy. We argue that a hard opt-in, opt-out or mandated consent system would be problematic, and we present empirical data from Gauteng Province illustrating barriers to ethically sound practice in soft consent systems. Ultimately, we argue that in spite of some limitations, a soft opt-in system is most realistic for SA because its implementation does not require extensive public education campaigns at national level, and it does not threaten to further erode trust at a clinical level. However, to circumvent some of the clinical-level barriers identified in our empirical study, we propose a contextually sensitive option for “enabling” soft opt-in through “required transplant referral”. We argue that this system is legally defensible, enhances ethical practice and could also increase donor numbers as it has in many other countries. (shrink)

This reflection item provides an edited account of human rights lawyer Harriet Wistrich’s conversation with Manvir Grewal, Visiting Lecturer and Ph.D. student, and Harriet Samuels, Reader in Law at the University of Westminster. It summarises the exchange which focused on Harriet Wistrich’s career trajectory and the many public interest law cases that she has brought on behalf her clients, mainly women, in both domestic and international forums. It also includes a condensed version of the question and answer (...) session with the audience. Questions included the broader issues around domestic violence, rape, coercive control, sex work and the nature of feminism. (shrink)

Climate science denial is serious. It facilitates political procrastination and brings us ever closer to a world beset by growing food insecurity, heatwaves, floods, storms, fires and extensive los...

The archive can take many forms but all are marked by a connective sequence: archive, memory, the past, narrative. The author explores this sequence through an account of her engagement with four different types of archive, constructing a phenomenology of the archive which highlights the promises and seductions offered to the researcher. Postmodern questioning may throw in doubt older conceptions, whereby the archive is used to legitimate knowledge claims about the past of a nomological nature. However, in a context where (...) intellectuals become interpreters rather than legislators, the role of the archive as repository of inert meanings is strengthened rather than weakened; using the archive helps us to understand the dialectical nature of the relationship between past and present and our own positioning within this. (shrink)

All authors in this symposium use a food regime perspective to ask questions about the present which—as these articles demonstrate—have several possible answers. History suggests a time perspective of 25–40 year cycles so far—a food regime 1870–1914, an experimental and chaotic era 1914–1947, and a food regime 1947–1973. It has been less than 40 years since 1973, when food regime analysts agree that a contested and experimental period began. There is no consensus on whether it has already ended or how (...) it might issue into a new food regime. The conversation is more fruitful than the conclusions. I intend these comments as an invitation to join in. (shrink)

This paper presents four arguments in favour of respecting Ulysses Contracts in the case of individuals who suffer with severe chronic episodic mental illnesses, and who have experienced spiralling and relapse before. First, competence comes in degrees. As such, even if a person meets the usual standard for competence at the point when they wish to refuse treatment, they may still be less competent than they were when they signed the Ulysses Contract. As such, even if competent at time 1 (...) and time 2, there can still be a disparity between the levels of competence at each time. Second, Ulysses Contracts are important to protect people’s most meaningful concerns. Third, on the approach defended, the restrictions to people’s liberty would be temporary, and would be consistent with soft paternalism, rather than hard paternalism: the contracts would be designed in such a way that individuals would be free to change their minds, and to change or cancel their Ulysses Contracts later. Finally, even if one rejects the equivalence thesis, this is still consistent with the claim that, in particular cases, it can be as wrong to allow a harm as to do a harm. Nevertheless, controversies remain. This paper also highlights several safeguards to minimise risks. Ultimately, we argue that people who are vulnerable to spiralling deserve a way to protect their autonomy as far as possible, using Ulysses Contracts when necessary. (shrink)

In the mid-twentieth century, Jérome Gaïth drew attention to the possible influence of Plotinus’ Enneads VI 8 (39) on Gregory of Nyssa’s theory of Divine will. In this treatise, despite being aware of the inappropriateness of all language to describe the One, Plotinus ascribes to it the classical traits of human action: will, freedom, self-determination, though raised to an absolute degree. In the present study we will analyse the reception and transformation of this theory in Nyssen and its anthropological corollaries, (...) in which he extends the virtuality of human freedom to an ontological level. Resumen: A mediados del siglo XX, Jérome Gaïth señalaba la posible influencia de Enéadas VI 8 (39) de Plotino sobre la teoría de la voluntad divina de Gregorio de Nisa. En ese tratado, a pesar de ser consciente de la impropiedad de todo lenguaje para describir lo Uno, Plotino le atribuye los clásicos distintivos del obrar humano: voluntad, libertad, autodeterminación, aunque elevados al grado absoluto. En el presente estudio analizaremos la recepción y transformación de esta teoría en el Niseno y sus corolarios antropológicos, en los que extiende la virtualidad de la libertad humana al plano ontológico. (shrink)

The triumph was the most prestigious accolade a politician and general could receive in republican Rome. After a brief review of the role played by the triumph in republican political culture, this article analyzes the severe limits Augustus placed on triumphal parades after 19 BC, which then became very rare celebrations. It is argued that Augustus aimed at and almost succeeded in eliminating traditional triumphal celebrations completely during his lifetime, by using a combination of refusing them for himself and his (...) relatives and of rewarding his legates who fought under his auspices with ornamenta triumphalia and an honorific statue in the Forum of Augustus. Subsequently, the elimination of the triumph would have been one natural result of the limit placed on further imperial expansion recommended by Augustus in his will, a policy his successors chose not to follow. Tiberius, however, was unwilling to conform to this new order and retired from public life to Rhodes the year after celebrating a triumph in 7 BC, the first such celebration since 19 BC. Tiberius' two triumphs and the senate's repeated offers of further triumphs to Augustus himself represented a different vision of the role triumphal celebration should take in a restored res publica and an ongoing challenge to the princeps. (shrink)

To mark International Women’s Day the Research Group for Law, Gender and Sexuality at Westminster Law School held an evening conversation on 10 March 2016 on Women and Asylum. Speakers working in different areas of the asylum system shared their insights and experiences with an audience of staff, students, activists and other visitors. Harriet Samuels chaired the conversation and the speakers were Princess Chine Onyeukwu, Debora Singer, Priya Solanki and Zoe Harper. This article is an edited extract from the (...) transcript of the presentations and wide-ranging discussion, including the question and answer session. The discussion focused on the different steps in the refugee determination process and considered, in particular, the gendering of credibility and how women’s perceived lack of credibility has a significant impact on determinations and processes. (shrink)

The prior issue of Krisis (42:1) published Critical Naturalism: A Manifesto, with the aim to instigate a debate of the issues raised in this manifesto – the necessary re-thinking of the role (and the concept) of nature in critical theory in relation to questions of ecology, health, and inequality. Since Krisis considers itself a place for philosophical debates that take contemporary struggles as starting point, it issued an open call and solicited responses to the manifesto. This is one of the (...) sixteen selected responses, which augment, specify, or question the assumptions and arguments of the manifesto. (shrink)

Sabellianism, the doctrine that the Persons of the Trinity are roles that a single divine being plays either simultaneously or successively, is commonly thought to entail that the Father is the Son. I argue that there is at least one version of Sabellianism that does not have this result and meets the requirements for a minimally decent doctrine of the Trinity insofar as it affirms that each Person of the Trinity is God and that the Trinity of Persons is God (...) while maintaining monotheism without undermining the distinctness of Persons. (shrink)

The world’s first living donor liver transplant from an HIV-positive mother to her HIV-negative child, performed by our team in Johannesburg, South Africa in 2017, was necessitated by disease profile and health system challenges. In our country, we have a major shortage of donor organs, which compels us to consider innovative solutions to save lives. Simultaneously, the transition of the HIV pandemic, from a death sentence to a chronic illness with excellent survival on treatment required us to rethink our policies (...) regarding HIV infection and living donor liver transplantation. Although HIV infection in the donor is internationally considered an absolute contraindication for transplant to an HIV-negative recipient, there have been a very small number of unintentional transplants from HIV-positive deceased donors to HIV-negative recipients. These transplant recipients do well on antiretroviral medication and their graft survival is not compromised. We have had a number of HIV-positive parents in our setting express a desire to be living liver donors for their critically ill children. Declining these parents as living donors has become increasingly unjustifiable given the very small deceased donor pool in SA; and because many of these parents are virally suppressed and would otherwise fulfil our eligibility criteria as living donors. This paper discusses the evolution of HIV and transplantation in SA, highlights some of the primary ethical considerations for us when embarking on this case and considers the new ethical issues that have arisen since we undertook this transplant. (shrink)

The ArgumentWritten as one book, Science, Technology and Society in Seventeenth-Century England has become two. One book, treating Puritanism and science, has since become “The Merton Thesis.” The other, treating shifts of interest among the sciences and problem choice within the sciences, has been less consequential. This paper proposes that neglect of one part of the monograph has skewed readers' understanding of the whole. Society and culture contributed to institutionalization of science and the directions it took, neither one exclusively. Four (...) aspects of the neglected chapters are examined: their theoretical underpinnings, the conceptions providing foundations for this part specifically and for the monograph as a whole; their comparative neglect, attributed partly to the absence of a cognitive constituency for their claims; the problem of problem choice in science in Merton's work; and the Merton monograph and later social constructionism:their differences and affinities. (shrink)

This essay responds to Donna J. Haraway's (2016) provocation to ‘stay with the trouble’ of learning to live well with nonhumans as kin, through practice-based approaches to learning to care for nonhuman others. The cases examine the promotion of care for trees through mobile game apps for forest conservation, and kinship relations with city farm animals in Kentish Town, London. The cases are analysed with a view to how they articulate care practices as a means of making kin. Two concepts (...) are proposed, ‘learning from’ and ‘facing’ the Other, which are thickened through discussions of how caring takes place in each case in relation to a particular category of nonhuman other: animated tree and urban farm animal. Thus while attendant to situations of care involving a specific nonhuman subject, the cases also broker thinking on learning from and facing (the) other kinds of trees and animals, and the interspecies dynamics of which they are a part. The intersectional implications of the practice sites and participants are elaborated, to complexify and affirm situated but also reflexive approaches to caring. In doing this, the authors attend to their own positionalities, seeking to diversify Western-based ecofeminist engagements with caring, while asking what their research can do for the nonhuman other. They formulate and apply a collaborative methodological approach to the case studies, developed through cultivating attentiveness to the nonhuman subject of research. The authors consider in particular how attentiveness to the nonhuman other can facilitate practices of knowing that further a non-anthropocentric and non-innocent ethic of caring. By further interconnecting situations of caring for nonhuman animals and plants, the authors advocate for practices of care that antagonise how species boundaries are drawn and explore the implications for learning to care for nonhumans as kin. (shrink)

Carte Blanche is the alarming tale of how the right of Americans to say "no" to risky medical research is eroding at a time when we are racing to produce a vaccine and treatments for Covid-19. This medical right that we have long taken for granted was first sacrificed on the altar of military expediency in 1990 when the Department of Defense asked for and received from the FDA a waiver that permitted it to force an experimental anthrax vaccine on (...) the ranks of ground troops headed for the Persian Gulf. Since then, the military has pressed ahead to impose nonconsensual testing of the blood substitute PolyHeme in civilian urbanities, quietly enrolling more than 20,000 non-consenting subjects since 2005. Most Americans think that their right to give or withhold consent is protected by law, but the passing in 1996 of modifications to the Code of Federal Regulations, such as statute CFR 21 50.24, now permit investigators to conduct research with trauma victims without their consent or event their knowledge. More than a dozen studies since have used the 1996 loophole to recruit large numbers of subjects without their knowledge. The erosion of consent is the result of a U.S. medical-research system that has proven again and again that it cannot be trusted. (shrink)

It is the researcher's responsibility to provide accurate, complete, and unbiased verbal and written information yet, as this essay discusses, challenges to meaningful research consent abound in the communication between researcher and subject. This discussion of these challenges is far from exhaustive, but it will flag some of the potholes that researchers must anticipate on the sometimes rocky road to eliciting meaningful consent. These include, but are not limited to, inadequate scientific literacy, poorly written consent forms, and even the deployment (...) of scientific terms and seductive acronyms like CURE and MIRACL. Studies with acronyms, for example, enroll five times as many patients as those without, are more likely to be published by prestigious journals, and have higher Jadad methodologic quality scores although they are no more likely to conclude with positive findings. Other barriers to researcher-subject communication include: widely differing beliefs and customs, semiotics, socioeconomic status, iatrophobia, and dramatically different histories of treatment in the medical-research arena. (shrink)