The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

To judge from the rash of recent law review articles, it is a miracle that research with human subjects in the U.S. continues to draw breath under the asphyxiating heel of the rent-seeking, creativity-stifling, jack-booted bureaucrethics that is the current system of research ethics oversight and review. Institutional Review Boards, sometimes called Research Ethics Committees, have been accused of perpetrating “probably the most widespread violation of the First Amendment in our nation's history,” resulting in a “disaster, not only for academics, (...) but for the whole nation.” One member of the President's Council on Bioethics went so far as to assert, “There has been no greater damage to academic freedom in the United States in my lifetime. And my lifetime encompasses McCarthy and it encompasses political correctness, both.” Locked in the bureaucratic “iron cage” of IRB oversight, critics charge that researchers have been transformed into a vulnerable, exposed population, subject to domination, that has been likened in one case to a kind of “Tuskegee in reverse.”. (shrink)

Before participants can be enrolled in a clinical trial, an institutional review board must determine that the risks that the research poses to participants are ‘reasonable.’ This paper examines the two dominant frameworks for assessing research risks and argues that each approach suffers from significant shortcomings. It then considers what issues must be addressed in order to construct a framework for risk assessment that is grounded in a compelling normative foundation and might provide more operationally precise guidance to the deliberations (...) of various stakeholders. The paper concludes by sketching the outlines of what is referred to as the ‘Integrative Approach’ to risk assessment and by highlighting some of the ways in which this approach may be more promising than current alternatives. (shrink)

An Aristotelian conception of practical ethics can be derived from the account of practical reasoning that Aristotle articulates in his Rhetoric and this has important implications for the way we understand the nature and limits of practical ethics. An important feature of this conception of practical ethics is its responsiveness to the complex ways in which agents form and maintain moral commitments, and this has important implications for the debate concerning methods of ethics in applied ethics. In particular, this feature (...) enables us to understand casuistry, narrative, and principlism as mutually supportive modes of moral inquiry, rather than divergent and mutually exclusive methods of ethics. As a result, an Aristotelian conception of practical ethics clears the conceptual common ground upon which practical ethicists can forge a stable and realistic self-understanding. (shrink)

ABSTRACT:The judgments of conscientious and informed experts play a central role in two elements of clinical equipoise. The first, and most widely discussed, element involves ensuring that no participant in a randomized trial is allocated to a level of treatment that everyone agrees is substandard. The second, and less often discussed, element involves ensuring that trials are likely to generate social value by producing the information necessary to resolve a clinically meaningful uncertainty or disagreement about the relative merits of a (...) set of interventions. The distribution of judgments in expert communities can take many forms, each with important implications for whether a trial satisfies one or both elements of clinical equipoise. In this article we use a graphical approach to represent three ways in which expert community uncertainty can vary: by spread, modality, and skew. Understanding these different distributions of expert judgment has three important implications: it helps to make operational the requirement of social value, it shows that some conditions for initiating studies to promote social value diverge from common assumptions about clinical equipoise, and it has important implications for how trials should be designed and monitored, and what patients should be told during informed consent. (shrink)

: An Aristotelian conception of practical ethics can be derived from the account of practical reasoning that Aristotle articulates in his Rhetoric and this has important implications for the way we understand the nature and limits of practical ethics. An important feature of this conception of practical ethics is its responsiveness to the complex ways in which agents form and maintain moral commitments, and this has important implications for the debate concerning methods of ethics in applied ethics. In particular, this (...) feature enables us to understand casuistry, narrative, and principlism as mutually supportive modes of moral inquiry, rather than divergent and mutually exclusive methods of ethics. As a result, an Aristotelian conception of practical ethics clears the conceptual common ground upon which practical ethicists can forge a stable and realistic self-understanding. (shrink)

Following the conclusion of a period of educational expansion during the last two decades, developing nations are now focusing attention upon adjusting some of those innovations made during the recent period of quantitative expansion. The paper examines how Trinidad and Tobago has responded to the need for adjustments in education provision during the current post‐expansionist period. In particular the paper analyzes Trinidad and Tobago's current reaction to the nation's system of double‐shift schooling, a device instituted during the 1970s as part (...) of Government's strategy for universal secondary education. Arguments both for and against the shift‐system are presented, and Trinidad and Tobago's insistence that the mechanism should be dismantled is critically examined. Explanations for the approach taken by Trinidad and Tobago towards the nation's double‐shift schooling are drawn from two sources: arguments about the state of the nation's economy, and policies regarding approaches to educational development planning in developing nations. (shrink)

Advance care planning refers to the process of determining how one wants to be cared for in the event that one is no longer competent to make one's own medical decisions. Some have argued that advance care plans often fail to be normatively binding on caretakers because those plans do not reflect the interests of patients once they enter an incompetent state. In this article, we argue that when the core medical ethical principles of respect for patient autonomy, honest and (...) adequate disclosure of information, institutional transparency, and concern for patient welfare are upheld, a policy that would allow for the disregard of advance care plans is self-defeating. This is because when the four principles are upheld, a patient's willingness to undergo treatment depends critically on the willingness of her caretakers to honor the wishes she has outlined in her advance care plan. A patient who fears that her caretakers will not honor her wishes may choose to avoid medical care so as to limit the influence of her caretakers in the future, which may lead to worse medical outcomes than if she had undergone care. In order to avoid worse medical outcomes and uphold the four core principles, caregivers who are concerned about the future welfare of their patients should focus on improving advance care planning and commit to honoring their patients’ advance care plans. (shrink)

Patient-funded trials are gaining traction as a means of accelerating clinical translation. However, such trials sidestep mechanisms that promote rigor, relevance, efficiency, and fairness. We recommend that funding bodies or research institutions establish mechanisms for merit review of patient-funded trials, and we offer some basic criteria for evaluating PFT protocols.

Advertising by health care institutions has increased steadily in recent years. While direct-to-consumer prescription drug advertising is subject to unique oversight by the Federal Drug Administration, advertisements for health care services are regulated by the Federal Trade Commission and treated no differently from advertisements for consumer goods. In this article, we argue that decisions about pursuing health care services are distinguished by informational asymmetries, high stakes, and patient vulnerabilities, grounding fiduciary responsibilities on the part of health care providers and health (...) care institutions. Using examples, we illustrate how common advertising techniques may mislead patients and compromise fiduciary relationships, thereby posing ethical risks to patients, providers, health care institutions, and society. We conclude by proposing that these risks justify new standards for advertising when considered as part of the moral obligation of health care institutions and suggest that mechanisms currently in place to regulate advertising for prescription pharmaceuticals should be applied to advertising for health care services more broadly. (shrink)

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees personnel, and a government agency member involved in multinational HIV Prevention Trials Network research in emerging economies. Ministries of Health or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can (...) lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply-rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration. (shrink)

I’d like to begin, if I may, by repeating myself. When I spoke at the Institute’s official launch last June, I quoted W.V. Quine’s remark that logic is an old subject, and since 1879 it has been a great one; and I commented that whatever the truth of this, it is undeniably true that philosophy is an old subject and has been a great one since the 5th century BC. The foundation of an institute of philosophy in the University of (...) London has been, in my opinion, a great thing for philosophy and for the University. Our mission is to promote and support philosophy of the highest quality in all its forms, inside and outside the university. With our programmes of events, fellowships and research facilitation, I think we have been carrying out this mission pretty well since our foundation in 2005. But I have already said enough in public about the Institute. Given the occasion, it is appropriate for me to say something instead about philosophy itself. (shrink)

The history of the Institute of Medical Ethics has been well recorded. Accounts of its origins in the London Medical Group were published in an academic paper of 2003,1 in the transcript of a Wellcome Witnesses to Twentieth Century Medicine Seminar in 20072 and in a chapter of the 2009 Cambridge World History of Medical Ethics.3 In 2013, 50 years since the inauguration of its first series of lectures and symposia, the LMG as an organisation no longer exists, but (...) its aspirations and achievements are alive and well, both in the Journal of Medical Ethics and in the IME, now exploring a new phase as a membership organisation. Other papers in this issue will discuss the history and prospects of the Journal and Institute. But the LMG, similar medical groups in all other British medical schools and the Society for the Study of Medical Ethics from which the IME derived also have a significant continuing life in the thinking and practice of many medical and healthcare professionals who participated in their activities, and then in turn on those influenced by their thinking and practice. The LMG, it could be said, is ‘no more’ an organisation ‘Now but a whole climate of opinion’.4A bottom-up evolutionThe first medical students to be involved in the LMG may not have foreseen its influence on their future careers, but many were aware of being part of something new and exciting. One of those with whom the first lecture series was planned was Margaret Lloyd . "The beginning of the LMG in 1963 was an exciting time for medical students in London. As a mature student entering St Mary's Hospital Medical School … ". (shrink)

In Byron, Shelley, and Goethe’s Faust, author Ben Hewitt has provided us with a carefully done and convincing study. Given this, it would have been interesting to see Hewitt’s effort to integrate Mary Shelley’s work into his narrative. Apart from any similarities between Faust and Frankenstein, it bears remembering that Goethe himself remained unconvinced by efforts to clearly demarcate works as “tragic” or “epic”; a fact that becomes especially clear in the number of works he’d devoted to rewriting (...) the story of Prometheus. One cannot help but wish that Hewitt had considered the connection between these works and Shelley’s own “Modern Prometheus” in juxtaposition to his reading of P.B. Shelley’s Prometheus Unbound, for this would have made for an especially good ending to Hewitt’s story. Wayne Deakin’s consideration of Hegel and the English Romantic Tradition does indeed close with a brief consideration of Mary Shelley’s Prometheus, but this comes only at the end of a much longer set of considerations. In this book Deakin adopts a similar strategy as that of Hewitt, namely, foregoing any historical recovery of Hegel’s direct influence on the English Romantics—in Deakin’s case, Coleridge, Wordsworth, and P.B. Shelley—to focus instead on a reading of key poetic works in concert with their Hegelian framework. This reading essentially flows from Deakin’s effort to rethink Hegel’s relatively early notion of self-consciousness through his late lectures on aesthetics. For Deakin, this leads to “aesthetic recognition”; a situating of the self in relation to the world that remains in tension so far as the subject’s drive for autonomy will automatically be humbled by its reception of and to alterity—be that other “Nature” or other subject. (shrink)

The London Institution, established in the City of London in 1807, was devoted, as its full title proclaimed, to the 'advancement of Literature and the Diffusion of Useful Knowledge'. With its extensive lecture programme, splendid reference library, reading rooms, laboratory and other amenities, it provided for its members a scientific and cultural centre, modelled on the highly successful and fashionable Royal Institution in London's West End. Among its scientific activities, chemistry long maintained a leading role, in terms (...) of both the sheer volume and variety of its presentations, and the high standing of its lecturers; they included Faraday, Playfair, Hofmann, Roscoe, Odling, Norman Lockyer, Meldola, and Sir William Ramsay, as well as other visiting lecturers, specially selected for their ability to present their subject in an interesting and attractive fashion to a wider lay public. The laboratory of the Institution, although limited in size and facilities, was the scene of instruction in practical chemistry, and between 1863 and 1884 attained the reputation of a significant centre of chemical research during the successive tenure of the professorship in chemistry by J. A. Wanklyn and H. E. Armstrong. Their publications, appearing under the device 'From the Laboratory of the London Institution', were a frequent feature of the leading chemical periodicals. Thus, within its many-sided activities, the Institution promoted significantly the public appreciation of the function of chemistry, as a contributor both to pure knowledge, and to technical and economic progress. It achieved this in an environment of influential City merchants, manufacturers and financiers and doubtless led to beneficient, if unrecorded, consequences. It was only towards the close of the nineteenth century, when the universities had become increasingly concerned with the systematic study of the discipline, that chemistry lost its direct impact in the London Institution, but continued to maintain a presence within its cultural framework. (shrink)

From March 1841 until the end of 1845, W. R. Grove held the post of Professor of Experimental Philosophy at the London Institution. No previous study of the Institution has dealt in detail with the period of Grove's tenure of this, the first professorship. Here, by reference to the various manuscripts and publications of the Institution, and to Grove's papers and correspondence, it is possible to describe the background to Grove's appointment and the achievements of his term of office.

This paper attempts to suggest the changing organisation of scientific culture and scientific institutions in London in the approximate period 1790–1820. A preliminary survey of the varieties of science in the city is followed by a treatment of one instance of informal association, the Askesian Society of 1796–1807. The intention is to provide a significant amount of data in an extra-institutional manner, and to illustrate a possible relationship between scientific culture and scientific advance. It is hoped that the essay (...) might provide a starting-point for subsequent treatments of group science in urban contexts during this phase of England's history. (shrink)

This paper is both an exercise in historical recovery in that it details some of the events surrounding the founding of the City and Guilds of London Institute and describes the way in which the Institute set about the building and running of two of its colleges, the City and Guilds Technical College, Finsbury, and the Central Institution in South Kensington and an attempt to interpret the above material in terms of various forms of association within the City Corporation (...) and the guilds. Collectively the City and the guilds made an effort to come to terms with a modernizing world through the means of providing scientific and technical education. The guilds wanted to remain important even though traditional apprenticeship was dying out. In joining in a new venture to provide technical education for young people it was necessary to maintain an order in which the City's presence was clear and apparent. This paper will show how such an order was achieved and, in so doing, it shows something more generally of the relationship of tradition and rhetoric to institution building. (shrink)