Clinical trials litigation: practical realities as seen from the trenches

Litigation involving human clinical research trials has escalated rapidly in the past few years. Whereas these suits raise many important theoretical questions, they also have important practical and human dimensions of which many people are unlikely to be aware until, by some unfortunate turn, they must live the reality. From the vantage of a fairly close view on one recent lawsuit, this article offers some ground-level observations and reflections that, it is hoped, may be of use to people in clinical research who might one day find themselves in a similar position.     

The macroeconomics of Italy: a regional perspective

In this contribution we show that the dualistic nature of the Italian economy has been, and still is, crucial for the design of short- and long-run macroeconomic policies, concerning unemployment, income growth and public finance.We establish the seriousness of the dualistic process of Italian regional development using several approaches. We then considered the regional nature of the Italian unemployment and show that it has profound implications for short- and long-run policies. In particular, we find that an aggregate price–unemployment relationship must be rejected. Different values of equilibrium unemployment rates for the main macro-regions of Italy are found and short-run policy implications discussed. We then consider how this heterogeneity relates to the design of growth-promoting policies.Lastly, we present evidence in favor of the importance of the missing growth of the Italian southern regions for the evolution of the Italian public finance.     

Clinical trials of drugs used off-label in neonates: ethical issues and alternative study designs

The use of drugs for indications unapproved by the Food and Drug Administration (FDA), often called "off label use, "is widespread in children, including neonates. The widespread off-label use of drugs in neonates presents ethical and safety challenges. Since the passage of the Best Pharmaceuticals for Children Act (BPCA) in 2002, both the FDA and National Institutes of Health (NIH) have taken initiatives to facilitate and encourage research to achieve the necessary labeling for drugs routinely used in infants and children. Federal regulations provide broad rules and guidance for the protection of human subjects in research. However, there are ethical issues that a physician may face when designing clinical trials of drugs in neonates that are routinely used off-label and widely believed to be beneficial. We attempt to describe these ethical challenges and provide recommendations, including alternative study designs, to resolve them in an ethical framework that takes into account the Belmont Report, the statement of the World Medical Association (WMA), and federal regulations.     

Enhancing corrections,transforming lives: a Singapore perspective

Abstract

This keynote speech was presented at the SSR-NAI Conference 2017. It explores the changes Singapore Prison Service (SPS) has made through the years and discuss its future developments. The speaker, Desmond Chin Kim Tham, Commissioner of Prisons, examines the Throughcare framework and community involvement program that the SPS has put in place, and describes the future directions of in-care practices and the involvement of community in corrections.     

Adopted foster youths' psychosocial functioning: a longitudinal perspective

Researchers have long debated whether adopted youth manifest disproportionate levels of psychological dysfunction compared with non‐adopted youth. Yet, missing from the debate has been a clear understanding of the specific subgroups of adopted youth who may develop behaviour problems and of the risk factors associated with various vulnerable populations. This longitudinal study examined one subpopulation of adopted youth – former foster children – in order to determine their immediate and long‐term functioning, particularly in comparison with their adopted non‐foster care peers. The central goal of this study was to ascertain the prevalence of behavioural problems in adopted foster youth compared with adopted non‐foster youth and to chart the longitudinal course of their behavioural problems. Participants included adopted foster youth (n = 293) and adopted non‐foster youth (n = 312) from a statewide sample of adopted youth, aged 2–18 years. Data were collected from the adoptive parents at approximately 2, 4 and 8 years after adoption. Adoptive parents rated youths’ functioning with the Behaviour Problems Inventory. According to parental report, a striking number of the foster youth displayed behaviour problems, although the non‐foster care group of children also displayed noteworthy levels of problem behaviours. The rates of behaviour problems in both groups far exceed what is observed in the general population of children.     

Infusing research integrity principles and practices into a regional master's degree-intensive university: a case study

The need for institutions of higher education to advance research and scholarly integrity across graduate degree programs involves a strong commitment from each institution to develop a comprehensive approach for promoting responsible conduct of research (RCR). In response to this need, one master's-intensive regional university implemented a three-tier model project (focusing, developing, and evaluating/sustaining) for infusing research integrity principles and practices while promoting RCR. Components of the model and implementation strategies are presented as a case study analysis. Implications of the model for promoting the RCR are projected relative to graduate programs focused on applied research.     

Societal reactions to sexually abusive adolescents: a Swedish perspective

It is urgent to detect and appropriately treat young sex offenders (YSOs) to prevent continued sexual offending into adulthood. We studied the presence of two significant factors in YSO treatment, i.e. interagency cooperation and specific focus on offending behaviours among social services, mental health, and law enforcement professionals involved with identified YSOs. The sample consisted of a subset of all 56 YSOs subjected to forensic psychiatric assessment (FPA) in Sweden between 1988 and 1995. These sixteen individuals were known by the authorities for sexually abusive behaviours already before committing the sex offence leading to FPA. Both interagency cooperation and professional focus on offending behaviours per se were rare. Thus existing interventions for YSOs in a well-developed social welfare state failed to prevent further sexual offending. We suggest that empirically based individual-oriented models for the prevention of criminal recidivism among YSOs should supplement general social welfare policies and non-specific interventions.     

The crying infant: understandable only in a multidisciplinary perspective

The parents' perception of how much their infant cries does not always correspond to the objective amount. The purpose of this study was to examine the correlation between the parents' perception of the infants' crying and the objective amount of crying and to explore the factors of conceivable importance to the perception of infant crying as well as to the measurable amount of crying. The group studied consisted of 122 infants and their parents. According to the mothers' perception — responses to a questionnaire — 86 of these were non-crying and 36 crying infants. According to the mothers, 22 non-crying infants cried as much as or more than those who were considered as crying. Nine categorized by their mothers as crying infants cried less than those categorized as non-crying. Thus, there was a mismatch between subjective and objective crying and non-crying. One factor found to be relevant for the mother's experience of the infant's crying was the explanations the parents gave about crying in their infant. Objective crying differed significantly between the families who had 0–1 siblings and those who had two siblings or more. Correlated with objective crying were the father's age, the father's perception of his wife's recent delivery and the mother's emotional feelings recorded in diaries during the observation weeks. Correlated with subjective crying in the infant were pain relief during delivery and the mother's emotional feelings.     

Social policy and health: transition countries in a comparative perspective

T. Ferrarini, O. Sjöberg. Social policy and health: transition countries in a comparative perspective Int J Soc Welfare 2010: ??: ??–??© 2010 The Author(s), Journal compilation © 2010 Blackwell Publishing Ltd and International Journal of Social Welfare. This article analyses the development and design of unemployment insurance and family policy benefits and their links to health outcomes in Estonia, Poland, the Slovak Republic, Slovenia, the Czech Republic and Hungary from the mid‐1990s. Comparing these six transition countries with long‐standing welfare democracies reveals important similarities and differences in policy and health. Unemployment benefit schemes resemble corporatist schemes in important respects, however, with lower coverage and average benefits. Subjective wellbeing is also comparatively low among both employed and unemployed in the transition countries. Several transition countries have mixed family policy strategies that simultaneously support dual‐earner families and traditional gender roles. One clear exception is Slovenia, which has a highly developed dual‐earner support. Family policy generosity is related to lower rates of poverty, infant mortality and child injuries. The article demonstrates the fruitfulness of institutional analyses of the link between social policy and population health in a broader welfare state context.     

Religion and coping in older adults: a social work perspective

Religion is an important coping resource for many older adults. This paper briefly describes social work's religious roots, makes a distinction between religion and spirituality for older adults, and presents empirical data showing how older adults employ religious strategies to cope with life challenge. The study reports on religious coping in an available sample of 79 European American and African American older adults residing in urban community dwellings. Implications suggest how social workers and others may support religious coping.