The U.S. Federal regulations allow institutional review boards (IRBs) to approve non-beneficial pediatric research when the risks are a minor increase over minimal, provided that the research is likely to develop generalizable knowledge about the subjects' disorder or condition. This “subjects' condition” requirement is quite controversial; commentators have argued for a variety of interpretations. Despite this considerable disagreement in the literature, there have not been any attempts to apply principles of legal interpretation to determine how the subjects' condition requirement should (...) be understood. (shrink)

Assigning a date to Kumārila is notoriously difficult. Kumārila’s dates are usually assigned through a relative chronology of Brahmanical and Buddhist philosophers with whom Kumārila engages or is engaged. This is a precarious method because the dates of these interlocutors are equally unstable. But what if in considering systematic dialogues (_śāstra_) to be the primary medium for interreligious philosophical debate we have missed a source that does engage with Kumārila, and that can be reliably dated? In this article, I turn (...) to a religious group whom, it has been previously thought, did not respond to Kumārila until the eighth century—Jainas—as well as to a genre that is not typically viewed as a site of systematic philosophical dialogue—narrative. I argue that the _Padmacarita_, a Jaina Rāmāyaṇa composed by a Digambara writer called Raviṣeṇa, contains a narrative refutation of Kumārila’s commentary to _Mīmāṃsāsūtra_ 1.1.2. By bringing to light this refutation, and explaining how Raviṣeṇa’s _Padmacarita_ can be reliably dated, I assign Kumārila’s _terminus ante quem_ to the date of the _Padmacarita_’s composition, 676 CE. Finally, I suggest that Raviṣeṇa’s _Padmacarita_ is the earliest extant Jaina text to discuss Kumārila’s claims, and that Jainas used narrative to reflect on Mīmāṃsā before they turned to _śāstra_ as another medium for this dialogue. (shrink)

Preface -- Introduction -- 1. Muslim reformists and the transition to English rule -- 2. The making of the "Indian Arab" and the tale of Sayyid Fadl -- 3. Rahmatullah Kairanwi and the Muslim cosmopolis -- 4. Haji Imdadullah Makki in Mecca -- 5. Nawab Siddiq Hasan Khan and the Muslim cosmopolis -- 6. Maulana Jafer Thanesri and the Muslim ecumene -- Conclusion -- Notes -- Acknowledgments -- Index.

Ali Shariati is typically understood as a theorist of “political Islam.” Yet his theological innovations within what is called “mystical thought” are also worthy of attention. Shariati does not consider mystical thought as an escapist, transcendent paradigm, but as a means to interpret and navigate the socio-political world. Of particular relevance to Shariati is an idea ubiquitous across Islamic mysticism: the transformation of the self. Within Islamic mysticism, there are various iterations of the idea that to become closer to God, (...) one must enact a radical transfiguration of the self, one that occurs simultaneously at the divine and existential registers. For Shariati, this transformation of the self is tied not only to one’s relationship with God, but also to the desire to alter the social realm. This is an ethos that, for Shariati, should infiltrate all aspects of life, material and immaterial, cerebral and social. If one wishes to overturn the status quo, one must cultivate not only a revolutionary subjectivity but a mystically-oriented subjectivity as well, or one that is characterized by constant change and growth. (shrink)

While it is known that reward induces attentional prioritization, it is not clear what effect reward-learning has when associated with stimuli that are not fully perceived. The masked priming paradigm has been extensively used to investigate the indirect impact of brief stimuli on response behavior. Interestingly, the effect of masked primes is observed even when participants choose their responses freely. While classical theories assume this process to be automatic, recent studies have provided evidence for attentional modulations of masked priming effects. (...) Most such studies have manipulated bottom-up or top-down modes of attentional selection, but the role of “newer” forms of attentional control such as reward-learning and selection history remains unclear. In two experiments, with number and arrow primes, we examined whether reward-mediated attentional selection modulates masked priming when responses are chosen freely. In both experiments, we observed that primes associated with high-reward lead to enhanced free-choice priming compared to primes associated with no-reward. The effect was seen on both proportion of choices and response times, and was more evident in the faster responses. In the slower responses, the effect was diminished. Our study adds to the growing literature showing the susceptibility of masked priming to factors related to attention and executive control. (shrink)

It is shown that there are incomparable Σ2 e-degrees a, b such that every e-degree strictly less than a is also less than b.

Jesudason and Weitz's article examines two public policy debates in California, where both sides of the debate used similar language that had the potential to be detrimental to women. Specifically, they show how anti-abortion crusaders in California used similar language to describe why women's rights should be curtailed as pro-choice advocates use when fighting for more choice and privacy for women's reproductive decisions. This commentary builds upon their article by demonstrating the harm that such co-opting causes to women's rights using (...) the example of sex selective abortion. By examining the legislative history of state and national bills to ban sex-selective abortion, this commentary demonstrates how the anti-abortion lobby has adopted the language of pro-choice advocates quite effectively. Although the framing of this issue as being “woman-protective” is strategic and insincere, such political framing is powerful, as Jesudason and Weitz have noted. Anti-abortion activists have convinced lawmakers in many states that sex-selective abortion is a dire issue in their state and that they must restrict it in order to protect women. In fact, there is no evidence that sex selective abortion is a problem in the United States, yet these frames have been very effective in weakening women's privacy rights. Whenever woman-protective framings are invoked for self-serving purposes, women's rights advocates must work hard to uncover the truth behind these discourses to prevent successful legislative efforts that curtail women's reproductive freedom. (shrink)

Papers presented at the Seminar on Ethics and Aesthetics in Indian Literary Practices, held at Udaipur in Rajasthan, India in 2009; organized by Department of English, Mohanlal Sukhadia University, Udaipur, India.

This essay argues that feminist legal theory offers an important, and underutilized, perspective to examine health law and policy. We use several theoretical frameworks developed by feminist legal theorists including relational autonomy, intersectionality, vulnerability theory, and the feminist critique of the public-private divide to demonstrate the utility of these theories to health law analysis. These frameworks provide insights relevant not only to issues that obviously relate to gender, but also to matters of choice, quality, and access that are less obviously (...) gender-related. We map three key areas of existing scholarship and future inquiry at the intersection of health law and feminist legal theory: patient choice and relational autonomy, patriarchy, power and patient safety, and access to health care and healthy living conditions at the public-private divide. Uniting these areas of inquiry is a nagging question central to the relationship between critical legal scholarship and pragmatic action to combat injustice: Can we use legal rights to achieve our aims even as we recognize them as tainted tools that have propped up oppressive social structures? A feminist agenda for health law and policy must grapple with this dilemma. (shrink)

Evidence suggests a limited contribution to the total research output in leading obstetrics and gynaecology journals by researchers from the developing world. Editorial bias, quality of scientific research produced and language barriers have been attributed as possible causes for this phenomenon. The aim of this study was to understand the prevalence of editorial board members based out of low and lower-middle income countries in leading journals in the field of obstetrics and gynaecology. The top 21 journals in the field of (...) obstetrics and gynaecology were selected based on their impact factor, SCImago ranking and literature search. The composition of the editorial boards of these journals was studied based on World Bank Income Criteria to understand the representation status of researchers from low and lower-middle income countries. A total of 1315 board members make up the editorial composition of leading obstetrics and gynaecology journals. The majority of these editors belong to high-income countries (n = 1148; 87.3%). Low (n = 6; 0.45%) and lower-middle income (n = 55; 4.18%) countries make up for a very minuscule proportion of editorial board members. Only a meagre 9 out of 21 journals have editorial board members from these countries (42.85%). Low and low-middle countries have poor representation in the editorial boards of leading obstetrics and gynaecology journals. Poor representation in research from these countries has grave consequences for a large proportion of the global population and multidisciplinary collaborative efforts must be taken to rapidly change this statistic with immediate effect. (shrink)

The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease , debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical trials. Those engaged in the debate have responded rapidly to a complex and evolving crisis, however, and this debate has not provided much opportunity for in-depth (...) analysis. Additionally, the existing literature on access to unproven therapies has focused on contexts like HIV/AIDS and oncology, which are very different than the Ebola epidemic. In this paper, we examine the ethical issues surrounding access to unproven therapies in the context of the recent Ebola outbreak to yield new insights about this controversial and unsettled issue. We argue first that, in this context, the interests of patients in obtaining access to unproven therapies are not fully aligned.. (shrink)

Brain death, or the determination of death by neurological criteria, has been described as a legal fiction. Legal fictions are devices by which the law treats two analogous things (in this case, biological death and brain death) in the same way so that the law developed for one can also cover the other. Some scholars argue that brain death should be understood as a fiction for two reasons: the way brain death is determined does not actually satisfy legal criteria requiring (...) the permanent cessation of all brain function, and brain death is not consistent with the biological conception of death as involving the irreversible cessation of the functioning of an organism as a whole. Critics counter that the idea that brain death is a legal fiction is deceptive and undemocratic. I will argue that diagnosing brain death as a hidden legal fiction is a helpful way to understand its historical development and current status. For the legal‐fictions approach to be ethically justifiable, however, the fact that brain death is a legal fiction not aligned with the standard biological conception of death must be acknowledged and made transparent. (shrink)

Caring for seriously ill and dying patients plays a key role in the patient-physician story. The emotional experience, while at times gratifying, can also be quite burdensome. In “The Inner Lives o...

The “dead-donor rule” states that, in any case of vital organ donation, the potential donor should be determined to be dead before transplantation occurs. In many countries around the world, neurological criteria can be used to legally determine death (also referred to as brain death). Nevertheless, there is considerable controversy in the bioethics literature over whether brain death is the equivalent of biological death. This international legal review demonstrates that there is considerable variability in how different jurisdictions have evolved to (...) justify the legal status of brain death and its relationship to the dead-donor rule.In this article, we chose to review approaches that are representative of many different jurisdictions—the United States takes an approach similar to that of many European countries; the United Kingdom’s approach is followed by Canada, India, and influences many other Commonwealth countries; Islamic jurisprudence is applicable to several different national laws; the Israeli approach is similar to many Western countries, but incorporates noteworthy modifications; and Japan’s relatively idiosyncratic approach has received some attention in the literature. Illuminating these different justifications may help develop respectful policies regarding organ donation within countries with diverse populations and allow for more informed debate about brain death and the deaddonor rule. (shrink)

Many guidelines for international research require that studies be responsive to host community health needs or health priorities. Although responsiveness possesses great intuitive and rhetorical appeal, existing conceptions are confusing and difficult to apply. Not only are there few examples of what research the responsiveness requirement permits and what it rejects, but its application can lead to contradictory results. Because of the practical difficulties in applying responsiveness and the danger that misapplying responsiveness could harm the interests of developing countries, we (...) argue that responsiveness should be refocused in three ways: in terms of (1) who enforces it, (2) under what standard, and (3) in what cases. We conclude that responsiveness should be applied by host country officials at the policy level with the exercise of judgment when externally funded research threatens to displace scarce local resources. (shrink)

This book turns critical feminist scrutiny on national climate policies in India and examines what transition might really mean for marginalized groups in the country. -/- A vision of “just transitions” is increasingly being used by activists and groups to ensure that pathways towards sustainable futures are equitable and inclusive. Exploring this concept, this volume provides a feminist study of what it would take to ensure just transitions in India where gender, in relation to its interesting dimensions of power, is (...) at the centre of analysis. With case studies on climate mitigation and adaptation from different parts of India, the book brings together academics, practitioners and policymakers who provide commentary on sectors including agriculture, forestry and renewables. Overall, the book has relevance far beyond India’s borders, as India’s attempt to deal with its diverse population makes it a key litmus test for countries seeking to transition against a backdrop of inequality both in the Global North and South. -/- This volume will be of great interest to students and scholars of climate policy, gender studies, sustainable development and development studies more broadly. (shrink)

Drawing on a six-year national study, _Community Organizing for Stronger Schools_ offers a richly textured analysis of community organizing for school reform. The authors examine the role of organizing in building social and political capital and improving educational outcomes for students in some of the nation’s most challenged school districts. In cities across America, community organizations are taking up the cause of public school reform. Their efforts are radically transforming the role of young people, parents, and community members in public (...) education. As the results of their campaigns become more visible, community groups are igniting interest and gaining support among education reform advocates, policy makers, and private foundations. The authors delineate the strategic choices and organizational characteristics that foster successful initiatives and consider how community organizing can support increased civic engagement and sustained educational reform. Finally, they discuss the challenges facing this burgeoning field in a new era of American politics. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 22-23, June 2011.

The Common Rule creates a division of moral labor in research. It implies that investigators and sponsors can outsource their ethical obligations to IRBs and participants, thereby fostering a culture of compliance, rather than one of responsibility. The proposed revisions to the Common Rule are likely to exacerbate this problem. To harness the expressive power of the law, I propose the Common Rule be revised to include the ethical responsibilities of investigators and sponsors.

Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides (...) antiretroviral treatment and care. Assuming the Institutional Review Board raises no objections to this plan, should the research team consider their ethical obligations to participants fulfilled? If the investigator and sponsor were to consult the Common Rule, they would find little to suggest that there are any further ethical issues to address. (shrink)

There is limited guidance on how to assess the ethical acceptability of research risks that extend beyond research participants to third parties (or “research bystanders”). Community or stakeholder engagement has been proposed as one way to address potential harms to community members, including bystanders. Despite widespread agreement on the importance of community engagement in biomedical research, this umbrella term includes many different goals and approaches, agreement on which is ethically required or recommended for a particular context. We analyse the case (...) of a potential Zika virus human challenge trial to assess whether and how community engagement can help promote the ethical acceptability of research posing risks to bystanders. We conclude that, in addition to having intrinsic value, community engagement can improve the identification of bystander risks, effective approaches to minimizing them, and transparency about bystander risks for host communities. (shrink)

A core tenet of research ethics is that risks assumed by research participants are reasonable, balanced, and minimized in relation to benefit to the individual and to society. It is also generally accepted that people who cannot give their own informed consent ought only to be exposed to low risks in research, unless there is a compensating potential for direct benefit.However, there is no consensus on whether individuals should be able to voluntarily consent to high net risk in research—or, in (...) other words, to research that is not justified by direct benefits to the individual and must be justified by benefits to others in society. The Belmont Report—perhaps the most canonical document in research ethics—does not... (shrink)

The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of (...) children's research decision making should be based on the principles of respect for autonomy and nonmaleficence. These principles imply that the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research. (shrink)

Clinical research with children generates special ethical concern, raising the need for additional protections beyond those for research with competent adults. Most guidelines permit research with children when it offers a prospect of direct benefit, or poses minimal risk. Unlike many other guidelines, the U.S. federal regulations also allow institutional review boards to approve pediatric research that does not offer a prospect of direct benefit when the risks are no greater than a minor increase over minimal risk. To approve research (...) in this category, IRBs must find that two additional conditions obtain:1). The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; and 2). The intervention or procedure is likely to yield generalizable knowledge about the subjects disorder or condition which is of vital importance for the understanding or amelioration of the subjects disorder or condition. (shrink)

The American Journal of Bioethics, Volume 12, Issue 7, Page 53-54, July 2012.

Our purpose in this essay is twofold: to explore John Deely’s “semiotic” or “contextualized animal” as also a “contextualizing animal”, one that not only responds in context but one that changes first the context so as later to change itself—as all living things do; and to explore how this context-shifting “semiotic animal” has caused to emerge the very “signs upon which”, as Deely writes, “the whole of life depends”. Environmental ethics are inseparable from personal ethics, then, because (1) we are (...) in fact ourselves environments for others, (2) we carry models of our environments within us (our genetic / ontogenetic selves), and (3) even our free will (the basis of ethical choice) is an “environmental” phenomenon, as Martin Heisenberg argues in Nature (14 May 2009: 164–165) and as Deely writes in Semiotic Animal: “signs do not fall strictly among the things objectified by perceptions of sense but act prior to that perception to enable it to reconstruct the physical environment along objective lines that are meaningful to the species” (Semiotic Animal: A Postmodern Definition of Human Being Transcending Patriarchy and Feminism [2010]: 119). (shrink)

Coronavirus disease 2019 is a fast-developing viral pandemic spreading across the globe. Due to lack of availability of proven medicines against COVID-19, physicians have resorted to treatments through large trials of investigational drugs with poor evidence or those used for similar diseases. Large trials randomize 100–500+ patients at multiple hospitals in different countries to either receive these drugs or standard treatment. In order to expedite the process, some regulatory agencies had also given permission to use drugs approved for other diseases, (...) despite a lack of evidence of efficacy in COVID-19. In this review, we highlight the potential ethical issues that should be addressed during the use of investigational drugs with little prior evidence as a treatment options during a pandemic. We discuss the impact of design of randomized clinical trials using LOTUS trial as an example and that of off-label use of drugs like chloroquine/hydroxychloroquine on the safety of patients during COVID-19. We conclude that the adaptive randomized clinical trial designs offer a flexible and efficient approach, enabling patients to quickly switch to successful treatments, while minimizing the number of patients on standard of care. Randomized clinical trial design should consider blinding of investigators and only representative patients who can provide consent should be included. We also conclude the emergency approvals of drugs should be carefully issued and off-label use should be restricted in pandemics. Streamlined regulatory guidelines for emergency drug use in a pandemic can also help in providing benefit and minimizing harm to patients in the future. (shrink)

Volume 19, Issue 10, October 2019, Page 99-101.

In rapidly evolving medical fields where the standard of care or prevention changes frequently, guidelines are increasingly likely to conflict with what participants receive in research. Although guidelines typically set the standard of care, there are some cases in which research can justifiably deviate from guidelines. When guidelines conflict with research, an ethical issue only arises if guidelines are rigorous and should be followed. Next, it is important that the cumulative evidence and the conclusions reached by the guidelines do not (...) eliminate the need for further research. Even when guidelines are rigorous and the study still asks an important question, we argue that there may be good reasons for deviations in three cases: (1) when research poses no greater net risk than the standard of care; (2) when there is a continued need for additional evidence, for example, when subpopulations are not covered by the guidelines; and (3) less frequently, when clinical practice guidelines can be justified by the evidence, but practitioners disagree about the guidelines, and the guidelines are not consistently followed as a result. We suggest that procedural protections may be especially useful in deciding when studies in the third category can proceed. (shrink)

In many regions around the world, those at highest risk for acquiring HIV are young adults and adolescents. Young men who have sex with men in the USA are the group at greatest risk for HIV acquisition, particularly if they are part of a racial or ethnic minority group.1 Adolescent girls and young women have the highest incidence rates of any demographic subgroup in sub-Saharan Africa.2 To reverse the global AIDS pandemic’s toll on these high-risk groups, it is important to (...) deploy the most effective HIV prevention tools to young MSM in the USA, to adolescent girls and young women in sub-Saharan Africa, and to any other adolescents and young adults at high risk for HIV as products are proven to be safe and efficacious. Although prevention interventions with proven efficacy, such as oral pre-exposure prophylaxis, are available,3–8 they have not been sufficient to stem the tide and an expanded prevention toolkit is urgently needed to serve these populations. The field of HIV prevention continues to identify promising leads in the development of new biomedical prevention products, either delivering antiviral drug topically or systemically. The dapivirine ring has been shown to provide modest protection and is currently being tested in open label studies while injectable cabotegravir is being tested in a large efficacy trial for preventing HIV acquisition. Advances in the field of HIV prevention mean that scientists and regulators must plan for how they will bring prevention tools to populations at high risk for HIV as they conduct efficacy and effectiveness trials. For instance, safety data from younger age groups can also be used in combination with efficacy data from adult studies, where appropriate, as bridging studies to expand labelling to younger ages. If these …. (shrink)

BackgroundTo assess ethical concerns associated with participation in a financial incentive programme to help adolescents with type 1 diabetes improve diabetes self-management.MethodsFocus groups with 46 adolescents with type 1 diabetes ages 12–17 and 38 of their parents were conducted in the Seattle, Washington metropolitan area. Semistructured focus group guides addressed ethical concerns related to the use of FI to promote change in diabetes self-management. Qualitative data were analysed and emergent themes identified.ResultsWe identified three themes related to the ethical issues adolescents (...) and parents anticipated with FI programme participation. First, FI programmes may variably change pressure and conflict in different families in ways that are not necessarily problematic. Second, the pressure to share FIs in some families and how FI payments are structured may lead to unfairness in some cases. Third, some adolescents may be likely to fabricate information in any circumstances, not simply because of FIs, but this could compromise the integrity of FI programmes relying on measures that cannot be externally verified.ConclusionsMany adolescents with type 1 diabetes and their parents see positive potential of FIs to help adolescents improve their self-management. However, ethical concerns about unfairness, potentially harmful increases in conflict/pressure and dishonesty should be addressed in the design and evaluation of FI programmes. (shrink)

This essay exposes how recent attempts at lethal injection reform have involved unethical and illegal research on prisoners. States are varying the doses and types of drugs used, developing methods designed for non-medical professionals to administer medical procedures, and gathering data or making provisions for the gathering of data to learn from executions gone wrong. When individual prisoners are executed under these conditions, states are conducting research on them. Conducting research or experimentation on prisoners in the process of reform is (...) problematic because it violates ethical frameworks and state laws. The Supreme Court has recently taken up the challenge of elucidating the standard for determining the constitutionality of lethal injection. If the Court suggests an approach to lethal injection reform that is akin to some of the more thoughtful and cautious approaches other courts have proposed, the Court's decision may also contravene state laws or ethical precepts regarding research with prisoners. Thus, this paper provides important limitations on the kinds of reform that may be permissible and outlines the open questions that must be addressed before it can be determined whether the risks and uncertainties involved in lethal injection can be remedied. (shrink)

A published case report of an infant who inadvertently developed remission of HIV viral expression has prompted research to determine if this observation is reproducible and can offer a potentially novel clinical approach to inducing sustained viral remission of HIV.Typically HIV-infected mothers receive antiretroviral therapy before delivery and infants receive between one and three drugs at “low doses” for prevention. In the case report, the mother delivered before she could receive ART. The infant was placed on a three-drug approach with (...) “higher” doses by her doctor than are typically used for treatment. When HIV infection was confirmed, the three-drug regimen was continued. For most.. (shrink)