I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

Background Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards and regulators trying to implement the criterion. Main text This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the (...) ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. Conclusion The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment. (shrink)

The article reviews different antitheodicies in response to Toby Betenson’s article “Anti-Theodicy”. Antitheodicies involve rejecting the position that God or meaning exist only, if evils have justifying morally sufficient reasons. The article builds on Betenson’s division into moral and conceptual antitheodicies and his characterization of antitheodicies as a metacritique of the problem of evil. Moral antitheodicies are problematic, as they do not address the key conceptual issues and might end up in question-begging or moralism. Dissolving the problem of evil requires (...) a conceptual antitheodicy that exposes its presuppositions as speculative metaphysics. Religious conceptual antitheodicies help to focus on different ways of sense-making that do not fall into theodicism. (shrink)

Peer disagreement presents religious believers, agnostics, and skeptics alike with an epistemological problem: how can confidence in any religious claims (including their negations) be epistemically justified? There seem to be rational, well-informed adherents among a variety of mutually incompatible religious and non-religious perspectives, and so the problem of disagreement arises acutely in the religious domain. In this paper, we show that the transformative nature of religious experience and identity poses more than just this traditional, epistemic problem of conflicting religious beliefs. (...) In encountering one another, believers, agnostics, and skeptics confront not just different beliefs, but different ways of being a person. -/- To transition between religious belief and skepticism is not just to adopt a different set of beliefs, but to transform into a different version of oneself. We argue that the transformative nature of religious identity intensifies the problem of pluralism by adding a new dimension to religious disagreement, for there are principled reasons to think we can lack epistemic and affective access to our potential religious, agnostic, or skeptical selves. Yet, access to these selves seems to be required for the purposes of decision-making that is to be both rational and authentic. Finally, we reflect on the relationship between the transformative problem of religious disagreement and what it shows about the epistemic status of religious conversion and de-conversion, in which one disagrees with one’s own (transformed) self. (shrink)

Research on the capacity to understand others’ minds has tended to focus on representations of beliefs, which are widely taken to be among the most central and basic theory of mind representations. Representations of knowledge, by contrast, have received comparatively little attention and have often been understood as depending on prior representations of belief. After all, how could one represent someone as knowing something if one doesn't even represent them as believing it? Drawing on a wide range of methods across (...) cognitive science, we ask whether belief or knowledge is the more basic kind of representation. The evidence indicates that non-human primates attribute knowledge but not belief, that knowledge representations arise earlier in human development than belief representations, that the capacity to represent knowledge may remain intact in patient populations even when belief representation is disrupted, that knowledge attributions are likely automatic, and that explicit knowledge attributions are made more quickly than equivalent belief attributions. Critically, the theory of mind representations uncovered by these various methods exhibit a set of signature features clearly indicative of knowledge: they are not modality-specific, they are factive, they are not just true belief, and they allow for representations of egocentric ignorance. We argue that these signature features elucidate the primary function of knowledge representation: facilitating learning from others about the external world. This suggests a new way of understanding theory of mind—one that is focused on understanding others’ minds in relation to the actual world, rather than independent from it. (shrink)

Review of Graeme Laurie, Genetic Privacy: A Challenge to Medico-Legal Norms.

Elämä on nähty merkittävänä aiheena Bergsonin filosofiassa. Elämän filosofinen merkitys Bergsonilla ilmenee selvästi hänen pääteoksessaan L'évolution créatrice (Luova evoluutio, 1907), jossa hän keskittyy inhimillisten tietokykyjen evolutiivisen alkuperän rekonstruointiin ja tieto-opillisiin seurauksiin. Bergsonin mukaan biologia tarjoaa filosofialle tietokykyjen kehitysteoreettisen näkökulman, ja filosofia metafysiikkana täsmentää biologialle sopivaa epistemologiaa. Tässä artikkelissa esittelen Bergsonin filosofisen teorian biologian ja epistemologian vastavuoroisesta suhteesta. Aloitan epistemologian, tieteen ja metafysiikan välisen suhteen selventämisellä Bergsonin teoriassa. Sen jälkeen esittelen, kuinka Bergson näkee tietokykyjen kehittymisen olennaisena osana eläinten yleistä kehityshistoriaa. Analysoimalla (...) eläinkunnan kognitiivisten kykyjen kahta taipumusta, älykkyyttä (intelligence) ja vaistoa (instinct), Bergson kehittää näkemyksen metafysiikasta, jonka avulla on mahdollista selvittää epistemologian ja biologian keskinäistä riippuvuutta ja vastavuoroisuutta. Lopuksi valaisen tätä vastavuoroisuutta Bergsonin analyysilla käsitteellisen tiedon muodostumisesta. (shrink)

Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, Health and (...) Policy-relevant Ethics in Singapore Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AI-assisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data. (shrink)

O desempenho das empresas tem sido estudado sob diferentes perspectivas teóricas, que, em geral a utilizam indicadores econômico-financeiros. Essa abordagem sofre constantes críticas por não contemplar aspectos estratégicos, que podem fornecer informações acerca de vantagem competitiva obtida pela empresa. Fatores macroeconômicos também tendem a impactar de maneira indireta os diferentes setores. Além disso, os setores sofrem esses impactos macroeconômicos conforme o nível de exposição deste às oscilações macroeconômicas. Assim este trabalho buscou analisar como as dimensões de desempenho se relacionam com (...) retorno, para cada setor da bolsa de valores. Para a análise, utilizou-se a modelagem de equações estruturais a partir do software Smart-PLS. Foram utilizados dados do Economática para 82 empresas listadas em 6 setores da B3 no período entre 2011 e 2018. Os resultados indicam que diferentes indicadores compõe os construtos para cada setor analisado, indicando que o retorno tem associações diferentes em cada setor. O construto econômico-financeiro apresenta uma relação positiva na explicação dos retornos para os diferentes setores. Já o construto estratégico relacionou-se positivamente apenas no setor de Materiais Básicos. A dimensão macroeconômica apresentou resultados que evidenciam uma relação negativa com os retornos no período analisado. Assim pode-se apontar que o retorno de cada setor é explicado por diferentes informações, sugerindo que o investidor deve observar critérios específicos de cada setor. Os indicadores macroeconômicos foram similares para os setores analisados, contudo o impacto significativo não pode ser verificado para todos os setores, indicando que existem níveis de exposição diferentes para os setores. Ainda, foram evidenciados tanto efeitos diretos quanto indiretos dos indicadores macroeconômicos sobre o retorno. (shrink)

Review of Graeme Laurie, Genetic Privacy.

Is the societal-level of analysis sufficient today to understand the values of those in the global workforce? Or are individual-level analyses more appropriate for assessing the influence of values on ethical behaviors across country workforces? Using multi-level analyses for a 48-society sample, we test the utility of both the societal-level and individual-level dimensions of collectivism and individualism values for predicting ethical behaviors of business professionals. Our values-based behavioral analysis indicates that values at the individual-level make a more significant contribution to (...) explaining variance in ethical behaviors than do values at the societal-level. Implicitly, our findings question the soundness of using societal-level values measures. Implications for international business research are discussed. (shrink)

It is important for the theory of knowledge to understand the factors involved in the generation of the capacities of knowledge. In the history of modern philosophy, knowledge is generally held to originate in either one or two sources, and the debates about these sources between philosophers have concerned their existence, or legitimacy. Furthermore, some philosophers have advocated scepticism about the human capacity to understand the origins of knowledge altogether. However, the developmental aspects of knowledge have received relatively little attention (...) both by past philosophers and in current philosophical discussions. This dissertation provides a historical approach to this developmental problem of knowledge by interpreting the developmental theories of knowledge of Maine de Biran (1766–1824) and Henri Bergson (18591941) from the perspective of a theory of the ‘generative factors of knowledge.’ It first studies the philosophies of Maine de Biran and Bergson separately and then brings together and compares the metaphilosophical aims drawn from these philosophers. The dissertation’s novel analysis, provided by its theory and structure, has far-reaching consequences. From a wide point of view, it fills in considerable scholarly gaps and provides great opportunities for future research in the study of the history of philosophy. From more specific points of view, it provides its most decisive contributions in such metaphysical and epistemological topics as the nature of causality, self-generated activity, the role of effort in knowing and learning, the complementary relationship between philosophy and science, and the non-conceptual basis of knowledge. (shrink)

A book review on Riku Juti's book "Johdatus Metafysiikkaan" (An Introduction to Metaphysics).

Laurie Paul (2014, 2015) argues that, when it comes to many of your most significant life-changing decisions, the principles of rational choice are silent. That is because, in these cases, you anticipate that one of your choice options would yield a transformative experience. We argue that the best way to make sense of transformative decisions is to see them as ones in which you anticipate awareness growth. You do not merely lack knowledge about which possible outcome will arise from (...) a transformative option; you lack knowledge about what are the possible outcomes. We indicate how principles of rational choice can be extended to cases of anticipated awareness growth. (shrink)

This article offers a novel solution to the problem of material constitution: by including non-concrete objects among the parts of material objects, we can avoid having a statue and its constituent piece of clay composed of all the same proper parts. Non-concrete objects—objects that aren’t concrete, but possibly are—have been used in defense of the claim that everything necessarily exists. But the account offered shows that non-concreta are independently useful in other domains as well. The resulting view falls under a (...) ‘nonmaterial partist’ class of views that includes, in particular, Laurie Paul’s and Kathrin Koslicki’s constitution views; ones where material objects have properties or structures as parts respectively. The article gives reasons for preferring the non-concretist solution over these other non-material partist views and defends it against objections. (shrink)

[A comment paper on Tuomas Tahko's book An Introduction to Metametaphysics (CUP, 2016).] Pyrin tässä artikkelissa selvittämään, missä määrin Tuomas Tahkon kirjan An Introduction to Metametaphysics luvussa 9 esittämä käsitys tieteen ja metafysiikan suhteesta tuo selvyyttä metafysiikan luonteeseen itsenäisenä tutkimusalana. Analyyttinen metafysiikka on joutunut viimeisten viidentoista vuoden aikana kasvavan kritiikin kohteeksi. James Ladymanin (2012) mukaan viime aikoina suosittu käsitys metafyysisen teorian valinnasta teoreettisten hyveiden perusteella kohtaa niin sanotun vahvan globaalin alimääräytyneisyyden ongelman. Tahko pyrkii vastaamaan näihin huoliin esittämällä synteesiin E.J. Lowen (...) metafysiikkakäsityksen ja Laurie Paulin (2002) esittämien ideoiden välillä. Argumentoin, että Tahkon vastaus on sikäli puutteellinen, että se jättää avoimeksi kysymyksen parhaan ontologisen kategoriajärjestelmän valinnasta. Teen ehdotuksia siitä, miten voimme välttää alimääräytyneisyyshuolen myös tässä tapauksessa. (shrink)

In this article, I respond to Laury Naranch’s and Mary Caputi’s discussion of my book Power and Feminist Agency in Capitalism (2017). In response to Naranch, I clarify how the political subject-in-outline translates into collective political action through the figure of the Chicana working-class woman. I also explain why the proletariat, more so than the precariat, implies a radical political imaginary if we rethink this concept in the context of my idea of the political subject-in-outline. I also clarify that my (...) chapters on Marx expose how Adorno and Marx have problematic imaginations of the working-class woman, which counter their otherwise radical imaginary. In response to Caputi, I clarify the meaning of capitalism in my book and underline that we need a rigorous critique of capitalism to counter the rise of the Far Right. I also explain why the fluid subject does not have agency and why the subject-in-outline is a better way to theorize transformative feminist agency. I also clarify that my conception of feminist political subjectivity does not assume a privileged vantage point outside power structures. (shrink)