Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. (...) A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)

The theory of space-time developed in Kant’s Critique of Pure Reason and his Metaphysical Foundations of Natural Science is connected to Leonhard Euler’s proof of invariance under Galilean transformations in the “On Motion in General” of the latter’s 1736 Analytical Mechanics. It is argued that Kant, by using the Principle of Relativity that is the output of Euler’s proof as an input to his own proof of the kinematic parallelogram law, makes essential use of absolute simultaneity. This is why, in (...) the Transcendental Aesthetic, he observes that “our theory of time explains as much a priori knowledge as the general theory of motion displays.” In conclusion, it is shown that the same proof-method, under a different definition of simultaneity, leads to the parallelogram law of the “Kinematic Part” of Einstein’s 1905 “On the Electrodynamics of Moving Bodies”. (shrink)

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of the (...) standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

This article draws attention to the limited amount of scholarship on what constitutes fairness and equity in resource allocation to health research by individual funders. It identifies three key decisions of ethical significance about resource allocation that research funders make regularly and calls for prioritizing scholarship on those topics – namely, how health resources should be fairly apportioned amongst public health and health care delivery versus health research, how health research resources should be fairly allocated between health problems experienced domestically (...) versus other health problems typically experienced by disadvantaged populations outside the funder's country, and how domestic and non-domestic health research funding should be further apportioned to different areas, e.g. types of research and recipients. These three topics should be priorities for bioethics research because their outcomes have a substantial bearing on the achievement of health justice. The proposed agenda aims to move discussion on the ethics of health research funding beyond its current focus on the mismatch between worldwide basic and clinical research investment and the global burden of disease. Individual funders’ decision-making on whether and to what extent to allocate resources to non-domestic health research, health systems research, research on the social determinants of health, capacity development, and recipients in certain countries should also be the focus of ethical scrutiny. (shrink)

This book offers a new interpretation of Hermann von Helmholtz's work on the epistemology of geometry. A detailed analysis of the philosophical arguments of Helmholtz's Erhaltung der Kraft shows that he took physical theories to be constrained by a regulative ideal. They must render nature "completely comprehensible", which implies that all physical magnitudes must be relations among empirically given phenomena. This conviction eventually forced Helmholtz to explain how geometry itself could be so construed. Hyder shows how Helmholtz answered this (...) question by drawing on the theory of magnitudes developed in his research on the colour-space. He argues against the dominant interpretation of Helmholtz's work by suggesting that for the latter, it is less the inductive character of geometry that makes it empirical, and rather the regulative requirement that the system of natural science be empirically closed. (shrink)

Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss include the (...) nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board and research ethics committee review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies. (shrink)

Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss include the (...) nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board and research ethics committee review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies. (shrink)

With developed country governments and high resource institutions engaging in research in low- and middle-income countries, we argue that these entities have a moral obligation to help build and strengthen research infrastructure and capacity so local scientists and institutions can adequately conduct studies to understand and resolve the health burdens in low and middle income countries. We explore the moral justifications and motivations behind engaging in research capacity strengthening in the health sector in LMIC at multiple levels. In highlighting these (...) issues, this paper aims to initiate a global discourse around why capacity development in LMIC has a moral basis at the individual, institutional and system levels. (shrink)

In establishing unexpected cross-connections between physics, the theory of perception, and logic, Hyder also makes a valuable contribution to the history of ...

203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers.

Negotiation between two individuals is a common task that typically involves two goals: maximize individual outcomes and obtain an agreement. However, research on the simplest negotiation tasks demonstrates that although naive subjects can be induced to improve their performance, they are often no more likely to achieve fully optimal solutions. The present study tested the prediction that a decrease in a particular type of argumentative behavior, substantiation, would result in an increase in optimal agreements. As substantiation behaviors depend primarily on (...) supplied content of the negotiation task, it was also predicted that substantiation behavior would be reduced by curtailing the content. A 2 × 2 experimental design was employed, where both negotiation tactics (list of tactics present versus absent) and negotiation task content (high versus low) were varied to determine the processes leading beyond solution improvement to solution optimality. Sixty‐one dyads engaged in a two‐party, four‐issue negotiation task. All negotiations were videotaped and analyzed. Although the list of negotiation tactics resulted in improved performance, only the content manipulation resulted in a significant increase in dyads achieving optimal solutions. Analyses of the coded protocols indicated that the key difference in achieving optimality was a reduction in persistent substantiation‐related operators (substantiation, along with single‐issue preferences and procedures) and an increase in a complex macro‐operator, multi‐issue offers that reduced the problem space, facilitating the search for optimality. (shrink)

: This paper discusses the origins of two key notions in Foucault's work up to and including The Archaeology of Knowledge. The first of these notions is the notion of "archaeology" itself, a form of historical investigation of knowledge that is distinguished from the mere history of ideas in part by its unearthing what Foucault calls "historical a prioris". Both notions, I argue, are derived from Husserlian phenomenology. But both are modified by Foucault in the light of Jean Cavaillès's critique (...) of Husserl's theory of science. On Husserl's view, we demand that propositions holding of scientific objects be intersubjective and invariant, but this demand conflicts with our immediate experience, which is essentially bound to a subject's perspective. Thus the mathematical and physical sciences must utilise formal languages to fix these truths independently of the thoughts of a particular subject. This necessary procedure leads to the sedimentation of these formal systems: we forget their source in the concrete experiences of individuals, and use them as purely technical means. The technique of reactivating the intentional acts in which sedimented formal systems originated is thus, in Fink's terminology, an archaeological method. Foucault and Cavaillès retain the general outlines of this archaeology of the sciences, but they reject its appeal to conscious acts of meaning, to what Cavaillès calls "the philosophy of consciousness". I conclude by discussing the implicit difficulties in the "linguistic transcendentalism" proposed as an alternative by these French critics of Husserl. (shrink)

Dieter Henrich ‘s “Notion of a Deduction” (1989), opened up approaches to both Deductions in terms of legal as opposed to syllogistic reasoning. Since the CpR is shot through with juridical metaphors and analogies, many points of connection suggest themselves. In this paper, I extend and modify Henrich’s approach, in order to extract a particular logic of evidence. I argue that the three syntheses of the A-Deduction correspond to parts of a deductive procedure, and that their names have been chosen (...) to indicate this connection to the reader. Nonetheless, the principal aim of the paper is not to develop and defend these historiographical claims, but to explicate the structure of the logic of evidence in question and link it to Kant’s intended refutation of Hume. Since the procedures Kant describes are part of the law of evidence of many nations and are equally well at work in contemporary information-theory, a precise reconstruction can map directly onto contemporary problems in philosophy, physics, and informatics, without any loss of historical accuracy. (shrink)

I analyze the two main theses of Helmholtz's "The Applicability of the Axioms to the Physical World," in which he argued that the axioms of Euclidean geometry are not, as his neo-Kantian opponents had argued, binding on any experience of the external world. This required two argumentative steps: 1) a new account of the structure of our representations which was consistent both with the experience of our (for him) Euclidean world and with experience of a non-Euclidean one, and 2) a (...) demonstration of why geometric propositions are essentially connected to material and temporal aspects of experience. The effect of Helmholtz's discussion is to throw into relief an intermediate category of metrological objects--objects which are required for the properly theoretical activity of doing physical science (in this sense, a priori requirements for doing science), all while being recognizably contingent aspects of experience. (shrink)

Parmenides’ Poem on Nature contains a proof that the world could not have come into being in time, because no explanation could be given for why it would do so at a given time. This same proof reappears in the Leibniz-Clarke Correspondence, where it is directed against Newtonian absolute time. Newtonians, Leibniz explains, believe that time is homogeneous and absolute, but this makes it inexplicable how God could have chosen to create the world on a given day. Similarly, in his (...) correspondence with Schrödinger in the 1930s, Einstein suggests that certain quantum mechanical occurrences, such as the spontaneous decay of a radioactive atom, are absurd, because they cannot be assigned a definite location in time. In Schrödinger’s version of Einstein’s argument, we must say that the cat dies twice: first, inside the box; yet, second, when we open the box. But both accounts cannot be true. Since each of the authors discussed was aware of the approach of his predecessors, they share a structure. In this article, I develop a unified account of all three. (shrink)

The Johns Hopkins‐Fogarty African Bioethics Training Program (FABTP) has offered a fully‐funded, one‐year, non‐degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub‐Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of its trainees.Our data (...) show that since 2001, the 28 former FABTP trainees have authored or co‐authored 105 new bioethics‐related publications; were awarded 33 bioethics‐related grants; played key roles on 78 bioethics‐related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post‐training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

In this lengthy book, Daniel Sutherland proposes to rectify our long neglect of Kant's theory of mathematics by means of both historical and systematic analyses. This is a worthy undertaking, since the scope and significance of that theory were lost from view during the twentieth century.

Global health research partnerships are increasingly taking the form of consortia of institutions from high-income countries and low- and middle-income countries that undertake programs of research. These partnerships differ from collaborations that carry out single projects in the multiplicity of their goals, scope of their activities, and nature of their management. Although such consortia typically aim to reduce health disparities between and within countries, what is required for them to do so has not been clearly defined. This article takes a (...) conceptual approach to explore how the governance of transnational global health research consortia should be structured to advance health equity. To do so, it applies an account called shared health governance to derive procedural and substantive guidance. A checklist based on this guidance is proposed to assist research consortia determine where their governance practices strongly promote equity and where they may fall short. (shrink)

This book is a collection of essays on Husserl's _Crisis of European Sciences_ by leading philosophers of science and scholars of Husserl. Published and ignored under the Nazi dictatorship, Husserl's last work has never received the attention its author's prominence demands. In the _Crisis_, Husserl considers the gap that has grown between the "life-world" of everyday human experience and the world of mathematical science. He argues that the two have become disconnected because we misunderstand our own scientific past—we confuse mathematical (...) idealities with concrete reality and thereby undermine the validity of our immediate experience. The philosopher's foundational work in the theory of intentionality is relevant to contemporary discussions of _qualia_, naive science, and the fact-value distinction. The scholars included in this volume consider Husserl's diagnosis of this "crisis" and his proposed solution. Topics addressed include Husserl's late philosophy, the relation between scientific and everyday objects and "worlds," the history of Greek and Galilean science, the philosophy of history, and Husserl's influence on Foucault. (shrink)

There has been growing consensus to develop relevant guidance to improve the ethical review of global health policy and systems research and address the current absence of formal ethics guidance.

The Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has offered a fully-funded, one-year, non-degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub-Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of its trainees.Our data (...) show that since 2001, the 28 former FABTP trainees have authored or co-authored 105 new bioethics-related publications; were awarded 33 bioethics-related grants; played key roles on 78 bioethics-related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post-training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

Scholarship focusing on how international research can contribute to justice in global health has primarily explored requirements for the conduct of clinical trials. Yet health systems research in low- and middle-income countries has increasingly been identified as vital to the reduction of health disparities between and within countries. This paper expands an existing ethical framework based on the health capability paradigm – research for health justice – to externally-funded health systems research in LMICs. It argues that a specific form of (...) health systems research in LMICs is required if the enterprise is to advance global health equity. “Research for health justice” requirements for priority setting, research capacity strengthening, and post-study benefits in health systems research are derived in light of the field's distinctive characteristics. Specific obligations are established for external research actors, including governments, funders, sponsors, and investigators. How these framework requirements differ from those for international clinical research is discussed. (shrink)

Isis, Vol. 105, No. 2 (June 2014) , pp. 432-434.

The paper by Lynch et al. raises interesting ethical questions regarding whether and how much SARS-CoV-2 Human Challenge Studies participants should be paid. We appreciate the timely e...

ArgumentHermann von Helmholtz’s distinction between “pure intuitive” and “physical” geometry must be counted as the most influential of his many contributions to the philosophy of science. In a series of papers from the 1860s and 70s, Helmholtz argued against Kant’s claim that our knowledge of Euclidean geometry was an a priori condition for empirical knowledge. He claimed that geometrical propositions could be meaningful only if they were taken to concern the behaviors of physical bodies used in measurement, from which it (...) followed that it was posterior to our acquaintance with this behavior. This paper argues that Helmholtz’s understanding of geometry was fundamentally shaped by his work in sense-physiology, above all on the continuum of colors. For in the course of that research, Helmholtz was forced to realize that the color-space had no inherent metrical structure. The latter was a product of axiomatic definitions of color-addition and the empirical results of such additions. Helmholtz’s development of these views is explained with detailed reference to the competing work of the mathematician Hermann Grassmann and that of the young James Clerk Maxwell. It is this separation between 1) essential properties of a continuum, 2) supplementary axioms concerning distance-measurement, and 3) the behaviors of the physical apparatus used to realize the axioms, which is definitive of Helmholtz’s arguments concerning geometry. (shrink)

A translation of the Introduction to Hermann Cohen's 1883 work The Principle of the Infinitesimal Method and Its History.

The increase in the volume of research conducted in Low and Middle Income Countries (LMIC), has brought a renewed international focus on processes for ethical conduct of research. Several programs have been initiated to strengthen the capacity for research ethics in LMIC. However, most such programs focus on individual training or development of ethics review committees. The objective of this paper is to present an approach to institutional capacity assessment in research ethics and application of this approach in the form (...) of a case study from an institution in Africa. (shrink)

Over the past few decades, there has been increasing attention focused on the ethics of health research, particularly in low- and middle-income countries. Despite the increasing focus on the literature addressing human protection, community engagement, appropriate consent procedures and ways to mitigate concerns around exploitation, there has been little discussion about how the duration of the research engagement may affect the ethical design and implementation of studies. In other words, what are the unique ethical challenges when researchers engage with host (...) communities for longer periods (10 years or more), and what special considerations does this time commitment generate when applying ethical principles to these kinds of studies? This article begins to outline key areas of ethical concern that arise during long-term, sustained research activities with communities in low-resource settings. Through a review of the literature and consultations with experts in health systems, we identified the following key themes: fair benefits and long-term beneficence; community autonomy, consultation and consent; impacts on local health systems; economic impacts of research participation; ethical review processes; and institutional processes and oversight within research organizations. We hope that this preliminary exploration will stimulate further dialogue and help inform ethical guidance around long-term research engagements in the developing world. (shrink)

Irecall vividly my initial excitement at the accomplishments of the Human Genome Project. That excitement was short-lived and diminished steadily over the next decade as I came to realize that the HGP was just another nail to be hit by the metaphoric hammer of genome-sequencing technology. To this day, I see this trend in many other spheres of public health and biomedical science. I take responsibility for using this same approach of "hammer" and "nail" in my own research program, where (...) I use complex systems modeling to address pressing public health issues, such as adverse birth outcomes, food insecurity, and the opioid epidemic. But I am slowly yet surely shifting my ways by explicitly and slowly... (shrink)

The dissertation analyzes the theory of "logical space" developed by Ludwig Wittgenstein in his Tractatus Logico-Philosophicus, I show how this idea represents a development of arguments first put forward by Hermann von Helmholtz, the physicist and physiologist. Helmholtz--instead of honouring Kant's distinction between on the one hand time and space, and, on the other, empirical qualia --stretched the Kantian spatial manifold to cover the other qualia as well: the qualia are also organized in manifolds; and this new, extended manifold is (...) the "space" of all possible human experience. He explained this a priori mesh as being a consequence of the physiological constitution of our bodies, and the physical constitution of the world in which they are situated. The subject is enclosed in an inner world whose structure is the network of possible sensation; outside of her is a world of unknown complexity; and separating the two is what Heinrich Hertz called the "no-man's-land" of sense-physiology, a border zone regulating all traffic between the two realms, common to both, yet proper to neither. ;Wittgenstein, in his Tractatus, adapted the picture-theories of Helmholtz and Hertz to his analysis of logic. He too was confronted with the problem of defining a field of possible experience, of possible facts: his analysis of Russell's and Frege's logical theories had led him to the conclusion that the fundamental properties of logic could not be accounted for without assuming such an a priori space. Thus he assimilated Russell's types to the dimensions of a manifold, the elements of which were his Sachverhalte, or elementary facts. The truth-functions of our logic are defined on top of this space: it is the basis on which all symbolic systems, including those of the natural sciences, are erected. (shrink)

Global health research partnerships are increasingly taking the form of consortia. Recent scholarship has proposed what features of governance may be necessary for these consortia to advance justice in global health. That guidance purports three elements of global health research consortia are essential — their research priorities, research capacity development strategies, research translation strategies — and should be structured to promote the health of the worst-off globally. This paper adopted a reflective equilibrium approach, testing the proposed ethical guidance against the (...) experience of a global health research consortium with equity objectives. Case study research was performed with Future Health Systems, a health systems research consortium funded over two phases. Data on FHS Phase-2 were gathered through in-depth interviews with steering committee members and junior researchers and collection of consortium-related documents. Thematic analysis of the data for consistency with the proposed guidance generated recommendations for how the guidance might be better articulated and identified areas where it could usefully be expanded. Factors facilitating FHS alignment with the ethical guidance were also identified, including early engagement and partnership with low and middle-income country stakeholders, the learning developed during FHS Phase-1, and aspects of the grant program funding it. (shrink)

This is a case study of top management in a Swedish pulp industry at Skutskär. After decades of proactive response to change, starting in 1976 the pulp industry experienced a rapid and significant restructuring. In 1992, and after a prolonged hold on local investments, came a large‐scale investment with major labor reductions, which created a local crisis. The aim of this study is to analyze how top managers of a local business plant perceive and explain their citizenship relationship to the (...) community of the company town during a transition period from 1976 to 2007. Our study shows that too much reliance on top management cost reduction requirements and not caring, or underscoring, local social concerns created gaps and local stakeholder distrust. We discuss how prolonged distrust of the company to bear social responsibility ended up in a broken relationship between the company and the local community. Our case indicates at least two problems that must be handled for successful corporate citizenship. First, the traditional control‐oriented management view is too narrow and not adjusted to today's citizenship reality, including how to handle corporate social responsibility. Second, we can see a possibility where the conceived needs on a global corporate level may lead to situations to obscure local needs and consequences. (shrink)