Longitudinal study of informed consent in innovative therapy research: experience and provisional recommendations from a multicenter trial of intracerebral grafting.

BACKGROUND: There is an urgent need to assess and improve the consent process in clinical trials of innovative therapies for neurodegenerative disorders. METHODS: We performed a longitudinal study of the consent of Huntington's disease patients during the Multicenter Fetal Cell Intracerebral Grafting Trial in Huntington's Disease (MIG-HD) in France and Belgium. Patients and their proxies completed a consent questionnaire at inclusion, before signing the consent form and after one year of follow-up, before randomization and transplantation. The questionnaire explored understanding of the protocol, satisfaction with the information delivered, reasons for participating in the trial and expectations regarding the transplant. Forty-six Huntington's disease patients and 27 proxies completed the questionnaire at inclusion, and 27 Huntington's disease patients and 16 proxies one year later. RESULTS: The comprehension score was high and similar for Huntington's disease patients and proxies at inclusion (72.6% vs 77.8%; P > 0.1) but only decreased in HD patients after one year. The information satisfaction score was high (73.5% vs 66.5%; P > 0.1) and correlated with understanding in both patients and proxies. The motivation and expectation profiles were similar in patients and proxies and remained unchanged after one year. CONCLUSIONS: Cognitively impaired patients with Huntington's disease were capable of consenting to participation in this trial. This consent procedure has presumably strengthened their understanding and should be proposed before signing the consent form in future gene or cell therapy trials for neurodegenerative disorders. Because of the potential cognitive decline, proxies should be designated as provisional surrogate decision-makers, even in competent patients

The meta-crisis of secular capitalism

The current global economic crisis concerns the way in which contemporary capitalism has turned to financialisation as a double cure for both a falling rate of profit and a deficiency of demand. Although this turning is by no means unprecedented, policies of financialisation have depressed demand (in part as a result of the long-term stagnation of average wages) while at the same time not proving adequate to restore profits and growth. This paper argues that the current crisis is less the ‘normal’ one that has to do with a constitutive need to balance growth of abstract wealth with demand for concrete commodities. Rather, it marks a meta-crisis of capitalism that is to do with the difficulties of sustaining abstract growth as such. This meta-crisis is the tendency at once to abstract from the real economy of productive activities and to reduce everything to its bare materiality. By contrast with a market economy that binds material value to symbolic meaning, a capitalist economy tends to separate matter from symbol and reduce materiality to calculable numbers representing ‘wealth’. Such a conception of wealth rests on the aggregation of abstract numbers that cuts out all the relational goods and the ‘commons’ on which shared prosperity depends

Ethical principles in machine learning and artificial intelligence: cases from the field and possible ways forward

Decision-making on numerous aspects of our daily lives is being outsourced to machine-learning algorithms and artificial intelligence (AI), motivated by speed and efficiency in the decision process. Machine learning (ML) approaches - one of the typologies of algorithms underpinning artificial intelligence - are typically developed as black boxes. The implication is that ML code scripts are rarely scrutinised; interpretability is usually sacrificed in favour of usability and effectiveness. Room for improvement in practices associated with programme development have also been flagged along other dimensions, including inter alia fairness, accuracy, accountability, and transparency. In this contribution, the production of guidelines and dedicated documents around these themes is discussed. The following applications of AI-driven decision making are outlined: a) Risk assessment in the criminal justice system, and b) autonomous vehicles, highlighting points of friction across ethical principles. Possible ways forward towards the implementation of governance on AI are finally examined

Dunno if you've any plans for the future: medical student indirect questioning in simulated oncology interviews

<p>Abstract</p> <p>Background</p> <p>This exploratory study investigated the motives of medical students (N = 63) for using indirect questions of the type <it>I don't know if </it>[you have already heard about chemotherapies], <it>I don't know how </it>[you are], or <it>I don't know what </it>[you do for a living] in simulated patient interviews during a communication skills course.</p> <p>Methods</p> <p><it>I don't know </it>questions (IDK-Qs) were observed during the initial evaluation of students' communication skills; they were systematically identified through video screening and subjected to a qualitative content and discourse analysis considering their context, their content, their intent and their effect on the simulated patients. To evaluate the specificity of medical students' IDK-Qs, the data were compared with a data set of oncologists (N = 31) conducting simulated patient interviews in the context of a Communication Skills Training (CST).</p> <p>Results</p> <p>During the interviews, 41.3% of the students asked 1-6 IDK-Qs. The IDK-Qs were attributed to three content categories: medical/treatment questions (N = 24); lifestyle/psychosocial questions (N = 18); and "inviting questions" questions (N = 11). Most of the IDK-Qs had an exploratory function (46/53), with simulated patients providing detailed responses or asking for more information (36/53). IDK-Qs were rare in the oncologist sample compared to the student sample (5 vs. 53 occurrences).</p> <p>Conclusions</p> <p>IDK-Qs showed a question design difference between medical students and oncologists in simulated patient interviews. Among other reasons for this difference, the possible function of IDK-Qs as a protective linguistic strategy and marker for psychological discomfort is discussed.</p

Recurrent, low-frequency coding variants contributing to colorectal cancer in the Swedish population

<div><p>Genome-wide association studies (GWAS) have identified dozens of common genetic variants associated with risk of colorectal cancer (CRC). However, the majority of CRC heritability remains unclear. In order to discover low-frequency, high-risk CRC susceptibility variants in Swedish population, we genotyped 1 515 CRC patients enriched for familial cases, and 12 108 controls. Case/control association analysis suggested eight novel variants associated with CRC risk (OR 2.0–17.6, p-value < 2.0E-07), comprised of seven coding variants in genes <i>RAB11FIP5</i>, <i>POTEA</i>, <i>COL27A1</i>, <i>MUC5B</i>, <i>PSMA8</i>, <i>MYH7B</i>, and <i>PABPC1L</i> as well as one variant downstream of <i>NEU1</i> gene. We also confirmed 27 out of 30 risk variants previously reported from GWAS in CRC with a mixed European population background. This study identified rare, coding sequence variants associated with CRC risk through analysis in a relatively homogeneous population. The segregation data suggest a complex mode of inheritance in seemingly dominant pedigrees.</p></div

Individual Liberty and the Importance of the Concept of the People

UID/FIL/00183/2013Through publically agreed laws that correspond to a common set of public restrictions, the ‘people as a sovereign body’ serves to protect against violations of individual liberty and despotic power. Where no such common body exists, individuals are deprived of this protection. In such cases, individuals must obey without liberty, while those in power command under a state of license. Neoliberal theorists maintain that any common personality, with its corresponding set of public and arbitrary positive and negative restrictions on liberty, undermines individual liberty. Neoliberal theory only allows for private restrictions on liberty. Against these neoliberal assumptions, we argue that rejecting public restrictions on liberty does not promote individual liberty. To the 1᢫ ᢬ ᢭ ᢮ 1 contrary, it creates conditions in which free individuals become servile and political inequality becomes entrenched, where citizens are divided into those who obey and those who command. Tracing the consequences of neoliberalism, we argue that unless we take seriously both the people as a political category and the right to equal and reciprocal coercion, individual liberty will be at risk. We also argue that neoliberalism ultimately leads to the total exclusion of certain citizens under the veil of full liberty. With the vanishing of the people’s will comes the utter disappearance of certain citizens, who live in the spontaneous society as if they were stateless or lawless persons. To better understand the connections between the rejection of the concept of the people, private restrictions on liberty and the fostering of the servile citizen, this paper considers the political philosophy of Hayek and Nozick. It also considers key ideas from Locke and Kant—theorists who, despite the differences between their philosophical perspectives, and despite the fact that they both provided crucial inspiration for Hayek’s political economy and Nozick’s libertarianism, stressed the protective role of the people with regard to individual liberty.publishersversionpublishe

Russia’s Legal Transitions: Marxist Theory, Neoclassical Economics and the Rule of Law

We review the role of economic theory in shaping the process of legal change in Russia during the two transitions it experienced during the course of the twentieth century: the transition to a socialist economy organised along the lines of state ownership of the means of production in the 1920s, and the transition to a market economy which occurred after the fall of the Soviet Union in the 1990s. Despite differences in methodology and in policy implications, Marxist theory, dominant in the 1920s, and neoclassical economics, dominant in the 1990s, offered a similarly reductive account of law as subservient to wider economic forces. In both cases, the subordinate place accorded to law undermined the transition process. Although path dependence and history are frequently invoked to explain the limited development of the rule of law in Russia during the 1990s, policy choices driven by a deterministic conception of law and economics also played a role.This is the author accepted manuscript. The final version is available from Springer via http://dx.doi.org/10.1007/s40803-015-0012-

What’s new with numbers? Sociological approaches to the study of quantification

Calculation and quantification have been critical features of modern societies, closely linked to science, markets, and administration. In the past thirty years, the pace, purpose, and scope of quantification have greatly expanded, and there has been a corresponding increase in scholarship on quantification. We offer an assessment of the widely dispersed literature on quantification across four domains where quantification and quantification scholarship have particularly flourished: administration, democratic rule, economics, and personal life. In doing so, we seek to stimulate more cross-disciplinary debate and exchange. We caution against unifying accounts of quantification and highlight the importance of tracking quantification across different sites in order to appreciate its essential ambiguity and conduct more systematic investigations of interactions between different quantification regimes