Sécurité des patients et développement des recherches : de la loi Bertrand à la loi Jardé

The legislator has successively adopted two laws amending deeply the legal framework of research. The first one is the law “Bertrand” no. 2011-2012 of 29 December 2011 on strengthening the safety of the drug and health products, which emphasizes the need for transparency of links of interest and opens wider opportunities for using post-marketing authorization trials. The second one is the law “Jardé” no. 2012-300 of March 5, 2012 on researches involving the human person, reforming all the rules governing researches and which establishes a national commission of researches involving the human person. If the first one is a clear move towards strengthening the protection of patients in research, it is possible to be more reserved about the effects of the latter, which seems more oriented towards an easing of constraints on researchers.     

Responsabilité médicale et expertise : de la loi du Talion à la loi Kouchner

Despite the appearance from the Mesopotamian era of medical responsibility, an apparent impunity of the doctor will be in place until the 19th century. In France, it will be necessary to wait for the Napoleonic codes of 1804 and 1810 in order to clearly dissociate the civil and criminal responsibilities of the doctor. If liability for fault remains the rule in medical matters today, the concept of liability without fault introduced by the industrial revolution and the legislation on industrial accidents was taken up by the Kouchner law of 2002. It definitively opens the way to a statutory and legal compensation for non-faulty medical accidents under national solidarity via the National Office for Compensation for Medical Accidents (ONIAM) and the Conciliation and Compensation Commissions (CCI). Expertise in medical liability is now the backbone of the victim compensation process. It guides the magistrate in the recognition of faulty or non-faulty medical liability and helps him to set the amount of compensation allocated with regard to bodily injury.     

Le développement d’un outil de mesure des comportements inadaptés au travail auprès de directions d’établissements scolaires du Québec

This study focuses on developing a measuring tool for unsuitable behaviour in the workplace. The tool has been developed from school principals. To do so, exploratory factor analyses have been conducted. Data have been collected from 232 senior staff members from school facilities across Quebec. Participants were invited to answer an online questionnaire. The results obtained help to classify inappropriate work behaviour into one factor. In addition to its theoretical value, this research brings several significant contributions to practice.     

Développement des collectifs de travail et développement de la sécurité : une étude sur les décisions à risque en anesthésie

This article highlights the collective dimensions of risk management for patients before an anesthesia. After a phase of observation of real activity, interviews were conducted with 20 anesthetists from two French hospitals. The analysis reveals interindividual diversity in practices. This diversity is explained by the inclusion, in decisions, of knowledge about “distributed” skills in the team and about local “shared practice”. The results establish a link between the site where the anesthetists are working and the choice of an anesthetic technique. They also show that the positioning of anesthetist vis-à-vis the “shared practice” is significantly related to their seniority in the profession. These results open perspectives for research and intervention for the joint development of collective work and safety.     

Le procès pénal du Mediator® et ses implications concernant les différents ordres de juridiction

The long-awaited judgment issued about the Mediator case by the 31st criminal court of the Tribunal de grande instance de Paris will not be the last one. The public prosecutor, as well as Servier and some of the victims have called for the appeal. Nevertheless, the number of victims reflects the extent of damage caused by this medicine. The complexity of the procedure highlights the specificities of the civil and administrative jurisdictions, as well as the transactional process. The purpose is to study the main points related to this articulation.     

Développement conceptuel de la notion d’énergie relative à des objets inanimés et animés chez les élèves de dix à 17 ans

The objective of this work is to study the concept of energy in case where animates and inanimates objects interact. We questioned pupils between 10 and 17 years old with regard to the existence of energy in inanimates and energy consumption by animates. Our results show that pupils use a small number of coherent conceptions dependent on the context. These conceptions develop differently for inanimate and animate objects. In the case of inanimates, some evolution is observed, while for animates the concept evolves slowly. In general, the materialist character of energy, its confusion with force and its attribution, in preference, to animates are among the naive conceptions which constrain the scientific understanding of energy.     

Les bases du développement de la psychologie communautaire en Europe

Community psychology was born in the USA during the sixties, in a context of poverty, social reforms and deinstitutionalisation. In Europe, because of government policies (dictatorships in Spain, Portugal…) and the orientation of Psychology Institutes, community psychology developed lately. On the other hand, there has been for a long time experiments of alternative care to the hospitalization which are based on the same principles (the experiment of Basaglia in Italy, the district policy in France…). Since the eighties, there are also much more courses in European universities. Finally, the creation of the European Network Community Psychology (ENCP) in 2005 illustrates the expansion of community psychology in Europe. In this article, we will reexamine the various medical and social policies in Italy, in France, in the United Kingdom, and in the other countries of Europe which supported the establishment of Community Psychology.     

Sensibilité développementale théorique et empirique des items de la Batterie d’Évaluation Cognitive et Socio-émotionnelle (BECS) pour l’évaluation du développement psychologique de très jeunes enfants au développement typique

The Social and Cognitive Evaluation Battery (SCEB) is an instrument specifically created for the examination of pre-school and school-aged children with autism and intellectual disability and recommended by the French High Health Authority (HAS, 2010, 2011, 2012, 2018). The SCEB explores 16 functional abilities, in both cognitive and socio-emotional areas and allows the calculation of domains and areas developmental levels and heterogeneity indices for the global, cognitive and socio-emotional areas. Each of the 16 domains of the SCEB includes behavioral items hierarchized into 4 developmental levels corresponding to 4 age periods (level 1: 4–8 months; level 2: 8–12 months; level 3: 12–18 months; level 4: 18–24 months). The child's assessment provides a profile of the 16 levels of cognitive and socio-emotional development that can be interpreted within the framework of Piaget's (1977) and Fisher's (1980) theory. The study tests the developmental sensitivity of level scores and their adjustment to chronological ages and developmental ages assessed with the Brunet-Lézine Scale for 65 young typical developmental French children aged from 4 months to 24 months. The results show high sensitivity of scores and satisfactory adjustment to chronological and developmental age differences. Normative benchmarks are also given for indices of heterogeneity of development profiles, heterogeneity that decreases with age. Thus, the scores are interpretable in reference to theoretical models and can be used for the study of all developmental characteristics in infant and toddlers’ children with and without neurodevelopmental disorder.     

Conflit d’intérêts et déontologies : l’échec des déontologies existantes et l’improbable (?) succès de la loi

The increasing frequency with which health scandals have come to light since the 1980s has uncovered a great deal of unlawful behavior, both in the pharmaceutical industry and the medical profession, as well as in the world of “experts” (or researchers), along with journalists and specialist media companies. These types of behavior have accumulated and combined to inhibit any reaction from government, thus preventing health policy from playing its role. The State has its share of responsibility in this failure, for having been unable to conserve the impartiality and effectiveness of its administrative actions: it must acknowledge this, which is a whole other problem. However, in the case in point, it is obvious that those texts which must have been breached to allow these health scandals to occur are almost exclusively the result of professional self-regulation, with a wide range of diverse legal values: ethics for the health professions, journalistic ethics, charters between the pharmaceutical industry and media companies, alongside scientific ethical charters. These texts are the result of regulations generated by the professions themselves, drafted to counteract conflicts of interest. The sheer number of cases highlights the failure of these self-regulatory measures, leading to legislation targeting the problem, in particular that of December 29, 2011, which strengthened monitoring in terms of conflicts of interest and penalties against those placing themselves in a conflict of interest situation. Will this legislation, in direct response to the so-called Mediator^® case, be able to succeed where self-regulation failed, swept away as it was by financial considerations? The arbitrations that characterized the drafting of this legislation and the resulting complexity, which affects the decrees, seem to promise many difficulties, particularly due to the scarcity of resources the authorities have to enforce it.     

Méthode d’évaluation des risques psychosociaux auprès de travailleurs déficients intellectuels

While current regulation imposes to take into account psychosocial risks, their evaluation among workers with intellectual disabilities is still lacking. In order to develop an adapted tool, a language skills test was combined with the perception of work situations. Then, an ergonomic analysis was used to confirm the answers to the questionnaire. In a second phase of the study, the questionnaire was tested among a sample of 85 workers with intellectual disabilities. Data collected attested the relevance of this tool by accurately revealing workers’ feelings about their working environment. This study constitutes a first step in the psychosocial risk assessment process for workers with intellectual disabilities.     

Le rôle médiateur de la réflexivité et du climat entre la distance de pouvoir et l’efficacité d’une équipe de travail

In this study, we investigate the mediating role of reflexivity (West, 1996) and climate to innovation (Anderson & West, 1998) between power distances and effectiveness of work teams of engineers training. Regression analysis (Baron & Kenny, 1986) reveals a total mediation of climate and a partial mediation of reflexivity. These results are discussed from a practical perspective.     

Comment les parents,les enseignants et les cliniciens évaluent les troubles du comportement externalisé du jeune enfant ? Étude de la variabilité des jugements évaluatifs et de son impact sur le développement de l’enfant

Present study aims at refining assessment of preschoolers’ behavior. Data was provided with questionnaires and observation on 118 preschoolers when recruited and 12 months later by their parents, their teachers and clinicians. The results confirmed high variations in informants’ ratings as well as negative effects of such variations regarding later child's development. The results imply the need for a multi-informant and multi-method assessment of preschoolers’ disruptive behavior. The implications of our findings for clinical purpose are discussed.