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)

This collection brings together fourteen contributions by authors from around the globe. Each of the contributions engages with questions about how local and global bioethical issues are made to be comparable, in the hope of redressing basic needs and demands for justice. These works demonstrate the significant conceptual contributions that can be made through feminists' attention to debates in a range of interrelated fields, especially as they formulate appropriate responses to developments in medical technology, global economics, population shifts, and poverty.

In her short story “Stable Strategies for Middle Management,” Eileen Gunn imagines a future in which Margaret, an office worker, seeks radical genetic enhancements intended to help her secure the middle-management job she wants. One source of the story’s tension and dark humor is dramatic irony: readers can see that the enhancements Margaret buys stand little chance of making her life go better for her; enhancing is, for Margaret, probably a prudential mistake. This paper argues that our positions in (...) the real world are sufficiently similar to Margaret’s position in Gunn’s fictional world that we should take this story seriously as grounding an argument from analogy for the conclusion that radical genetic enhancements are, for us, probably a prudential mistake. The paper then defends this method. When the question at hand is one of speculative ethics, there is no method better fit to the purpose than argument from analogy to speculative fiction. (shrink)

Katerina Kolozova is a Macedonian philosopher whose publications from last two decades aim to analyze various topics using François Laruelle’s “non-philosophy” or “non-standard philosophy.” Non-philosophy could be roughly described as radicalized deconstruction: Laruelle claims that not everything can be grasped by a philosophy: for Laruelle, “philosophy is too serious an affair to be left to the philosophers alone.”1 Non-philosophy opposes the “principle of sufficient philosophy” through which philosophy determines and decides what is real. According to Laruelle, the ultimate limit of (...) philosophical thought and its self-proclaimed sufficiency lies in its inherent tendency to close itself in a transcendental system of autofetishist conceptions, which presume that one can grasp the Real (“The Real is neither capable of being known or even ‘thought,’ but can be described in axioms. [...] Even ‘immanence’ only serves to name the Real which tolerates nothing but axiomatic descriptions or formulations.”) by a philosophical thought, or that the Real could be mediated only through human thought. Laruelle criticizes this tendency of philosophy, which is usually expressing itself through the structure of “philosophical Decision.” (“To philosophize is to decide Reality and the thoughts that result from this, i.e. to believe to be able to order them in the universal order of the Principle of Reason [Logos].”) Katerina Kolozova use Laruelle’s non-philosophy to explore more explicitly political topics. In the Cut Of Th e Real (2014), she criticized certain dogmatism of poststructuralist philosophy and feminist theory, namely their symptomatic rejection of the Real and the One. In Toward a Radical Metaphysics of Socialism (2015) and The Lived Revolution (2016) Kolozova presented a rereading of Marx, whose work she found relevant for the critique of speculative philosophical dimension of the capitalist economy, embodied in the 2008 global finance crisis, and in the latter book, she explored the possibility of a new political solidarity, based on “bodies in pain.” Kolozova doesn’t call to philosophically reconstruct Marx’s thought for the current situation, but she goes back to Marx with the help of Laruelle’s non-Marxism, contrary to the usual approach of Marxist philosophers, who often try to create certain philosophical system of Marx’s work. Together with Eileen A. Joy, Kolozova edited the anthology After the “Speculative Turn” (2016), which addressed recent realist and materialist tendencies in feminist philosophy. In her most recent book, Capitalism’s Holocaust of Animals (2019), Kolozova aimed to explore broader philosophical foundations of neoliberal capitalism, and its dealing with nonhuman animals and their suffering. According to Kolozova, “We have to start by coming to terms with what we did to the animals in the constitutive act of philosophy and via proxy to all those dehumanised that belong to the species of man ‘by courtesy’ only.” . (shrink)