How are drugs approved? Part 2: ethical foundations of clinical research

In the United States, the U.S. Food and Drug Administration (FDA) evaluates and approves drugs through a process that includes clinical research. The purpose of clinical research is to diminish uncertainty by acquiring knowledge. For drug development, the goal is to approve drugs that are safe and effective. Because of the uncertainty, however, participation in clinical research entails some degree of risk. Ethical principles provide the framework on which studies can be designed and conducted and which appropriately balance benefits and risks for research participants. As part of a broad overview of the drug development process, this article reviews the ethical foundations of clinical research.     

How are drugs approved? Part 3. The stages of drug development

The first article of this series on the drug development process described the historical evolution of the U.S. Food and Drug Administration (FDA), and last month's article reviewed the ethical foundations of clinical research. Before a new drug is marketed, a sequence of preclinical investigations and three phases of clinical studies are conducted. This drug development process involves the FDA, pharmaceutical companies (sponsors), clinical investigators, and institutional review boards. This article further describes this aspect of the drug development process.     

Alternative Food Networks and the Labor of Food Provisioning: A Third Shift?

Scholars have increasingly examined the sphere of consumption in alternative food networks (AFNs). However, research has largely overlooked women's experiences as food provisioners. This is problematic, as AFNs prescribe practices that could be expanding women's food provisioning labor. This article addresses this gap in the literature by examining how the physical labor of food provisioning varies for women engaged in AFNs relative to those not engaged in AFNs, and how diverse AFNs as well as socioeconomic status (SES) influence the labor of food provisioning for women engaged in AFNs. Using data from the 2012 Ohio Survey of Food, Agriculture and Environmental Issues, I demonstrate that women engaged in AFNs, relative to women not engaged in AFNs, exert more physical labor in food provisioning, that prioritizing local food systems involves more physical labor than prioritizing organic foods, and that women with lower household incomes who prioritize organic foods exert greater physical labor in food provisioning than women with higher incomes who prioritize organic foods. I conclude by arguing that women who prioritize local food systems are engaging in a third shift and that greater attention should be paid to the role of SES in shaping women's experiences as food provisioners in AFNs.     

How consistent are perceptions of inequality?

Despite recent empirical evidence on the importance of perceived inequality, its analysis is still underexplored. In this paper we study whether unobserved perceptions of inequality are reflected in observed individual opinions in a consistent fashion. Inconsistency is relevant to ealuate the level of agreement that individuals share with respect to different domains of inequality.Using the wave from the 2009 International Social Survey Program in the US, we show that inequality is a complicated concept prone to inconsistencies and propose a testing procedure to an empirical appraisal. We find that inconsistencies exist though they may not extend to all the domains of inequality. This inconsistency also emerges by analyzing the relation between unobserved perceptions and political treatment suggesting the hypothesis that inconsistency may be associated with a set of relevant political preferences.     

How are employees of the nonprofit sector motivated? A research need

This article reviews research on motivation of employees in the nonprofit sector, with a major emphasis on the motivation of teachers and hospital nursing staff. Although both areas are widely researched in the nonprofit sector, empirical motivation research conducted in schools and hospitals is certainly not extensive. Nevertheless, based on these limited research findings, we derive potential hypotheses for future research in schools and hospitals.     

Understanding the mobility chances of children from working-class backgrounds in Britain: How important are cognitive ability and locus of control?

Research in social stratification has shown that children from working-class backgrounds tend to obtain substantially lower levels of educational attainment and lower labor market positions than children from higher social class backgrounds. However, we still know relatively little about the micro-level processes that account for this empirical regularity. Our study examines the roles of two individual-level characteristics—cognitive ability and locus of control—in mediating the effect of individuals’ parental class background on their educational attainment and social class position in Britain. We find that cognitive ability mediates only about 35% of the total parental class effect on educational attainment and only about 20% of the total parental class effect on respondents’ social class position, net of their educational attainment. These findings contradict existing claims that differences in the life chances of children from different social class backgrounds are largely due to differences in cognitive ability. Moreover, we find that although individuals’ locus of control plays some role in mediating the parental class effect, its role is substantially smaller than the mediating role of cognitive ability. We measure individuals’ social class positions at different points in their careers—at labor market entry and at occupational maturity—and find that the mediating roles of cognitive ability and locus of control are remarkably stable across individuals’ working lives.     

Gambling Behavior of Student-Athletes and a Student Cohort: What are the Odds?

This study investigated the prevalence of gambling, gambling related NCAA violations, and disordered gambling in student-athletes (n = 736) with a comparison cohort of students (n = 1,071) at four universities. Student-athletes reported similar rates of gambling frequency, use of a bookmaker, and disordered gambling as students. After accounting for demographic differences, student-athletes were less likely to engage in sports wagering than students. Several risk factors for disordered gambling were identified, including being male and reporting at least one parent with a history of gambling problems. These findings suggest that problems associated with gambling are a university-wide issue with student-athletes meriting additional attention because of implications for the integrity of intercollegiate sports. Improved prevention and intervention efforts for collegiate gambling are recommended.     

Social images of residential care: How children,youth and residential care institutions are portrayed?

The literature suggests that residential care for children and youth is associated with a negative social image harmful to their wellbeing. However, the social images of children and youth in residential care and of the residential care institutions have received no systematic study. The current study seeks to examine the social images associated with children and youth in residential care and the respective care institutions in Portugal. The sample of 176 participants in the present study was comprised of individuals with and without professional contact with children and youth in residential care. Participants responded to an open-ended questionnaire requesting attributes and characteristics of children and youth living in residential care as well as attributes associated with residential care institutions. The data collected were analysed through Discriminant Analyses, Z Tests and Multiple Correspondence Analyses. Results show that children and youth are primarily described with negative attributes (e.g., sad, rebellious, deprived, lonely) while residential care institutions are mainly described with positive attributes (e.g., cosy, secure, affectionate, comfortable). Results also show that the social images of children and youth in care and the respective care institutions are heterogeneous and present different profiles. Finally, there will be a discussion of the implications of these results for practice, namely the importance of raising awareness about existing biased social images and how to deconstruct them.     

How sorry are you? Intensified apologies and the mediating role of perceived remorse in corporate crisis communication

This article reports the results of a between-subject experiment investigating the direct and indirect effects of intensified apologies on purchase intent. The study adopts a linguistic approach to apologies and operationalizes them based on Blum-Kulka and Olshtain’s (1984) apology framework. The study compares the effectiveness of a simple apology (‘We’re sorry’) to four intensified apologies which - in addition to expression of remorse - contain one of the following apology strategies: a) intensification through adverbials, b) admission of guilt, c) offer of repair or d) promise of forbearance. In addition, the study examines the role of perceived remorse as a mediating factor between intensified apologies and purchase intent. Intensified apologies containing adverbials and offer of repair are found to have a positive effect on perceived remorse which, in turn, leads to higher purchase intent. The experiment is the first one in the field of corporate crisis communication to examine the mediating role of perceived remorse in intensified apologies.     

Refusing to Listen: Are We Failing the Needs of People with Alcohol and Drug Problems?

This paper argues that social work education in the UK has persistently failed to equip its social workers with the knowledge to work effectively with people with alcohol and drug problems. In spite of continuing criticism of the profession's unwillingness or inability to engage with substance use issues, social work education has failed to respond to the calls for better training on this subject, even when specific guidance has been issued about course content. This results in a failure to meet the needs of our service users as well as social work staff who remain frustrated at their inability to intervene. The paper explores the historical and current debate about social work training in relation to alcohol and drugs and identifies the barriers to its inclusion in qualifying and post‐qualifying (PQ) curricula. Finally it offers a strategy for improving social work training as well as an overview of programme content requirements.     

Parental unemployment and children's educational attainment: How big is the role of aspirations?

Children exposed to parental unemployment have been found to lag behind in school, but research has struggled to pin down the underlying explanation. One hypothesis is that parental unemployment may dampen children's aspirations to do well and go far in school. Yet, few studies on parental unemployment have relied on actual measures of children's aspirations or devised a formal analysis of this mechanism. Using the UK Household Longitudinal Study (Waves 1–12, N = 1067), I investigate the role of educational aspirations in children's General Certificate of Secondary Education (GCSE) attainment. I compare adolescents exposed to parental unemployment before or only after the typical age at which GCSE exams are taken. In adjusted models, children exposed to parental unemployment before their GCSEs are around 6 percentage points less likely to attain any GCSE qualification by age 17. On average, children have high educational aspirations, although intentions to enrol in college or university are relatively lower among children exposed to an early spell of parental unemployment. Nevertheless, a hypothetical intervention setting these aspirations to the same level for all children only accounts for a modest portion of the educational penalty tied to an early spell of parental unemployment. Several sensitivity and robustness tests support this conclusion. This note seeks to stimulate more research on the mechanisms underpinning the intergenerational effects of unemployment. Findings cast doubts on the idea that children's aspirations, the target of broader policy discourse and interventions, are a crucial part of the equation.     

Return Migration and Transnationalism: How Are the Two Connected?

Return migration and migrant transnationalism are key phenomena in research on international migration. Here we examine how the two are connected. The article introduces a special section and draws partly upon this selection of papers and partly upon the broader literature. First, we argue that there is often a blurred boundary between mobility as a transnational practice, for instance in the form of return visits, and purportedly permanent or long‐term return migration. Second, we examine the effects of transnationalism on return migration intentions and experiences. Third, we explore how migration trajectories, involving various forms of ‘return’ moves, create different forms of transnationalism. Examples include the ‘reverse transnational’ practices of returnees and the ‘residual transnationalism’ of migrants who have had an unsuccessful return experience and decided to settle permanently abroad. We end by considering how both return migration and transnationalism exist in the interplay between the personal and the social.     

Adoption and the Race Factor: How Important is It?

As of 1997 federal law prohibits a state from delaying or denying adoption on the basis of race, color, or national origin. This article reports the major research findings, going back over 25 years, pertaining to transracial adoptions. The findings show that transracial adoptions serve the children's best interest and are consistent with the recently enacted federal law.     

Patterns of delayed marriage: how special are the Irish?

"This paper deals with delayed marriage and singlehood among the Irish as a focus for the study of the persistence of ethnic characteristics. Patterns of delayed marriage in Ireland in the nineteenth and twentieth centuries are reviewed, and evidence is also presented that Irish persons in other countries (especially in the United States) continue to show significantly higher rates of singlehood and postponed marriage than persons of other nationality groups. Discussion includes how delayed marriage became common in Ireland during the past 150 years and what may be involved in the apparent persistence of this pattern today in Ireland and among the Irish in other countries."     

How are you doing? Patient evaluations of nursing actions

1. Quality of patient care can be enhanced if we know what nursing actions psychiatric patients perceive as helpful. Previous research has focused on perceptions of patients on medical-surgical units. 2. Patients diagnosed with bipolar disorder tended to see nursing actions as more helpful and performed more frequently than patients diagnosed with substance abuse. 3. Although positive feedback was identified as one of the most helpful nursing actions, it was rated only average in frequency of performance. 4. Even patients who had histories of long hospitalization did not want nursing staff to do things for them that they could do for themselves. Nurses need to focus on teaching self-care skills rather than "doing for" the patient.     

How Can the Process of Parental Alienation and the Alienator Be Effectively Treated?

This article discusses primarily approaches or methods in dealing with a parent who alienates a child against another parent due to the hostility developed following divorce and separation. The basic vision or aims for combating parents in conflict are delineated. This is followed by the importance of being aware of the problems resulting in parental alienation (PA). To overcome PA an orderly set of stages from soft options to severe strategies are presented, with reasons for the use of the more severe method being provided. Finally, there is an appeal to the family courts and its judges to consider seriously the conclusions reached by one expert witness in how to combat PA by considering first and foremost the short- and long-term needs of the child and secondarily the alienated parent.