Building a More Connected DSMB: Better Integrating Ethics Review and Safety Monitoring

Data and Safety Monitoring Boards (DSMBs) have become an increasingly common feature of clinical trial oversight, yet a paucity of legal or ethical frameworks govern these Boards’ composition or operation, or their relationship with other actors with monitoring responsibilities. This paper argues that prevailing structural gaps are impeding harmonized systems for monitoring the ongoing ethical acceptability of clinical trials. Particular tensions stem from DSMBs’ sweeping discretion in deciding whether and when to recommend that a trial should be terminated or amended based on safety and efficacy information. This discretion becomes especially challenging in light of DSMBs’ monopoly over emerging trial data, which prevents Institutional Review Boards, sponsors, and investigators from participating in certain pivotal and ethically charged decisions. To address these disconnects, I advocate for strengthened pre-trial and post-trial communication in addition to innovative strategies to support DSMB decision making through the life of a trial.     

Ethical consideration of the research proposal and the informed-consent process: An online survey of researchers and ethics committee members in Thailand

Researchers designing and conducting studies using human data should consider the values and principles of ethical conduct. Research ethics committees (RECs) typically evaluate the ethical acceptability of research proposals. Sometimes, differences arise between how researchers and RECs interpret ethical principles, and how they decide what constitutes ethical conduct. This study aimed to explore the opinions of these two groups about the importance of core ethical issues in the proposal and in the informed-consent process. An anonymous online questionnaire was distributed to a target population in health-related academic/research institutes across Thailand; 219 researchers and 72 REC members participated. Significantly, more REC members than researchers attributed the highest importance to three core ethical considerations – risk/benefit, vulnerability, and confidentiality/privacy. For the informed-consent process, significant differences were found for communication of risks, decision-making authority for consent, process for approaching study participants, and availability of a contact for study deviations/violations. The different ratings indicate differences in the groups’ perspectives on ethical principles, which may affect focal congruence on ethical issues in the proposal. Communication of these findings should help close gaps between REC and researcher perceptions. Further study should investigate how RECs and researchers perceive equivocal ethics terms.     

Perceptions of grandparents who provide auxiliary care: value transmission and child‐rearing practices

A grounded theory qualitative study was developed to explore how grandparents perceive their role as socializing agents. Forty‐two grandparents with grandchildren aged from 6 to 12 years old participated in this study. Data were collected through focus groups, which were conducted until reaching data saturation and analyzed using the constant comparative method. Four general conclusions emerged from the study: (i) grandparents recognized the importance of getting involved in the socialization of grandchildren as supporters of parents' socializing role, and the need to adapt to social changes; (ii) they emphasized traditional value that were perceived in decline, and combination of warmth and involvement were considered the best way to help grandchildren internalize values; (iii) interaction with grandchildren helped grandparents to feel active and useful, increased their life purpose and gave them a second chance to enjoy what they could not with their own children; and (iv) grandparents also accused burden and role ambiguity. These results show the importance of developing family policies that recognize grandparents' socializing role. Also, interventions that promote strategies that enable grandparents to perform their role more successfully and to cope with possible family conflicts should be developed.     

Public Policy and the Effects of Media Violence on Children

Policymakers and the public have been concerned about the effects of media violence on children for decades. Scientific psychological research can be an important source of information for policy, as the goal of science is to separate facts from opinions. This article reviews children's exposure to media violence, describes theories that explain the effects media violence could have, summarizes the research on the effects of media violence exposure, and describes several moderators that can enhance or mitigate those effects. These scientific findings provide useful information for public policy, yet there are many barriers to their use, including misunderstandings of how causality is determined in scientific and public health circles and how large the effects are. Finally, the implications for public policy are discussed, including what has and has not worked in the United States, what other countries and the international community are doing, and where opportunities for new approaches for effective policies may exist.     

Reporting bad results: The ethical responsibility of presenting abused women's parenting practices in a negative light

The purpose of this paper is to present and analyse the ethical dilemmas involved in presenting research findings that describe abused women's parenting practices in a negative light. The study was based on data collected by in‐depth interviews for the purpose of examining the turning point among 20 Israeli abused women who refused to live with violence and took active steps to stop it while staying with the perpetrator. Overall the analysis indicated successful survival stories but the women's parenting practices became questionable. This raised dilemmas as to how to present such findings and what are the ethical implications related to interventions with abused women.     

Implications of Male and Female Same-Gender Dyads

ABSTRACT

A sample of 222 Swedish social services officers were surveyed in regard to their opinions on a fictitious case addressing the needs of a same-gender client. The 49-question survey was statistically analyzed through a comparison of female and male same-gender dyads. The findings suggest that gender is an important factor in assessment, and this seems to be influenced by the gender of the client, the gender of the assessor, and how the problem area or situation of the client is “gendered.” Also, same-gender dyads tend to strengthen stereotypical expectations of men and women as clients and influence what forms of assistance are offered to the client. The male same-gender dyad tends to reduce the likelihood of assistance being offered, while the female same-gender dyad increased it. These results suggest that assessments are based upon stereotypical beliefs about men and women rather than being focused directly on individual differences and needs. Further research is recommended that incorporates a number of more refined “gendered” problem areas and situations and how these assessments can affect social work practice.     

Age limits for participation in child protection court proceedings in Sweden

According to the UN Convention on the Rights of the Child and Swedish legislation, children have the right to participate in child protection proceedings. The aim of this paper is to describe and analyse the notion of age and maturity in child protection proceedings in order to elucidate how these aspects could influence children's rights to participate. We focus on the view of three groups of actors involved in child protection proceedings in Sweden—social workers, lawyers, and laypersons in social welfare boards and administrative courts—and on how children's age and maturity should be taken into consideration in decisions on their participation in court. The analysis is based on survey data. The study found that social workers, laypersons, and lawyers have different views on when children are old enough to have the right to litigate in court. Additionally, there is no consensus on how the maturity of the child can be assessed to inform the decision about participation. More discussion is needed about what competences a child needs to participate in court and to what extent this right should be limited by their age. Importantly, courts and decision‐making proceedings can be made more child friendly.     

The documented layer of children's rights in care order decision‐making

The recognition of children as rights holders is a true challenge for any policy and practice that involves children, but it is even more so for making decisions about taking children into care. This article departs from the view that when children are perceived as bearers of rights, this should also be reflected in the institutional documents of decision‐making. That is why the documented layer of decisions about taking a child into care is examined here. The empirical data consist of documents of hearings (prehearing and hearing reports) in which children (33) are asked to give their view about a proposed care order and placement in Finland. The documented layers of involving children as rights holders are divided into two types: a minimalist type and a more individualised, thorough and detailed type. The former type represents children as rights holders in a routinised manner, whereas the latter one treats them in a particularised manner: how this particular child in this particular hearing received and gave information and on what grounds her/his view rested. As the documents may have some controversial implications, the recording of children as rights holders should not be treated as an isolated and technical issue.     

Parents' perceptions of contact with the Norwegian Child Welfare Services

Listening to the opinions of service users is important in research. This study explored how parents cognitively and emotionally perceive contact with the Norwegian Child Welfare Services (CWS). It also compared the reports of parents recently referred to the CWS with reports of more experienced users. A content analysis was conducted on open‐ended survey responses from parents (n = 697). This study fills a gap in the literature on how parents perceive contact with the CWS and what they see as important factors when judging this contact. The findings showed that 40.6% of the parents reported exclusively positive experiences, 30.7% of the parents reported solely negative experiences, while 24% of the parents described both positive and negative experiences. The content of the positive and negative experiences were related to characteristics of the child welfare workers, the quality of the relationship, the help offered and the parent's feelings of insecurity and fear. New CWS users tended to view the contact as more positive than the more experienced ones. Practical implications are presented.     

What might Normalisation Process Theory bring to policy implementation studies? Learning lessons and uncovering questions through a case study of the profound implementation failure of a new policing policy

Normalisation Process Theory (NPT), used nationally and internationally to explore implementation within health services research, is used for the first time within policing to understand profound policy implementation failure and to generate broader discussion of policy implementation theory. The policy in question (Police to Primary Care [P2PC]) was an intervention designed to notify GPs when women are assessed by police as at high risk of future domestic abuse. Designed to improve interagency communication, it took place amidst radical organisational change. Using qualitative interviews with domestic abuse specialist and frontline officers, this paper addresses how NPT helps to explain the (non)implementation of P2PC, how such an analysis differs from other policy implementation approaches, and what this means for our understandings of policy implementation more broadly. NPT proved useful in understanding mechanisms leading to (non)implementation of the intervention: fuzzy alignment with existing practice, faulty communication of purpose, and inattention to discretionary implementation spaces. It helped us understand why the intervention came to be invisible. Dwarfed by its organisational context, made institutionally hard to read by a lack of formal protocols, and given restricted view to police officers, it was compromised by a failure to instigate systems of organisational learning. More broadly, NPT helped reveal practices intersecting top‐down and bottom‐up implementation theory. The paper concludes by asking how NPT and theories of street‐level bureaucracy might be better used in tandem and, particularly, how this might help explorations of policy implementation where human actors are joined by technological actors in interpreting and making policy in vivo.     

The limits of inequality: Public support for social policy across rich democracies

Does public opinion react to inequality, and if so, how? The social harms caused by increasing inequality should cause public opinion to ramp up demand for social welfare protections. However, the public may react to inequality differently depending on institutional context. Using ISSP and WID data (1980?2006), we tested these claims. In liberal institutional contexts (mostly English‐speaking), increasing income inequality predicted higher support for state provision of social welfare. In coordinated and universalist contexts (mostly of Europe), increasing inequality predicted less support. Historically higher income concentration predicted less public support, providing an account of the large variation in inequality within the respective liberal and coordinated contexts. The results suggest opinions in liberal societies – especially with higher historical inequality – reached the limits of inequality, reacting negatively; whereas in coordinated/universalist societies – especially with lower historical inequality – opinions moved positively, as if desiring more inequality.     

Promoting child protection, welfare and healing: the case for developing best practice

This paper presents a 'best practice perspective' on child and family work. This involves moving beyond the 'deficit perspective' which dominates how the literature examines practice negatively in terms of what is not being done well to one which sets out best practice positively as a model for learning and developing systems and practice competencies. The paper focuses specifically on the meanings and development of best practice in family support in the context of child protection work. This involves work that is not only sensitive to achieving child protection and empowering practice in the context of power differences, but which meets the challenges of engaging therapeutically with and ultimately helping (often resistant) service users. The paper argues that issues of trauma and healing, and self-actualization more broadly, need to move to the centre of how family support and child protection are theorized and done. The aim should be to promote child protec-tion, welfare and healing through the development of egalitarian relationships in what Giddens calls the 'democratic family'.     

Teaching and learning communication with children and young people: developing the qualifying social work curriculum in a changing policy context

Twenty years after survey evidence showed that UK social work students could complete their training without having learnt about or worked with children, new research suggests little has changed. There is still no guarantee that any student on qualification will have been taught about or assessed in communication skills with children and young people. This is despite the claim that the pre‐registration award provides teaching and assessment in core generic skills as a foundation for the development of specialist practice roles in agencies. In fact, as this paper shows, a common understanding of what counts as effective communication with children has yet to be consolidated in social work practice and research. This has impeded the process of curriculum development. Divergent expectations about what counts as social work communication with children in a changing policy context may be exacerbating long‐standing uncertainties about how genericism and specialism should be linked in professional education and training. In exploring these issues, this paper seeks to clear the way for the renewed effort that is now required if this aspect of curriculum development is to be effective.     

社会学与伦理学的争执:涂尔干的道德科学

要把握社会学的根本问题,对其基本思维方式进行辩护和反思,我们应将它置于它曾经努力挣脱的学科体系中,并把它视为对现代伦理学的一种回应。本文通过检讨涂尔干和列维-布留尔的道德科学对伦理学的两点批评来触及社会学的基本主张。针对伦理学把自己理解为一门立法科学的定位,社会学强调只有从对道德事实的实证研究入手,才能为人们的社会生活提供有效的规范。针对伦理学把实现人的本性作为道德的目的的观点,社会学主张从社会功能出发来界定道德。可以从这场争论中看到社会学如何试图通过对经验现实,特别是非西方民族的宗教和社会形态中的合理性的把握,突破西方人文主义传统的典范地位,进而为人们构想现代社会和道德提供不同的思想资源。     

A Capability Approach to Unemployed Young People's Voice and Agency in the Development and Implementation of Employment Activation Policies

In the UK, current approaches to employment activation are primarily concerned with rapid labour market entry, with jobseekers compelled to engage in activities or be sanctioned. The Capability Approach (CA) has been proposed as an alternative framework to measure successful employment activation. It is concerned with what people can do rather than what they actually do, together with their substantive freedom of choice. In applying the CA, attention is drawn to the need for jobseekers to have a voice in the design and implementation of employment activation programmes. Drawing on in‐depth qualitative research, this article uses the CA to explore the voice and agency of unemployed young people (aged 16–24) in the development and implementation of employment activation policies. It analyses how far, and in what ways, young people's ideas, experiences and voices are included in policy development and implementation. Reflections and conclusions are made about how the policy discourse which has stressed the importance of centring services on the needs of users is reflected in employment activation policy.     

The microphysics of accountability

How is it possible to deploy the law to create and perform accountability? To answer this question, I address the argumentative function of the law in order to legitimize genetic medicine. Using interview data, I will in particular elaborate on how medical experts strive to convince interviewing social scientists that their own professional action is above all ethical reproach. For this purpose, medical experts capitalize on the law in specific ways. It is the aim of this article to expound exactly how this happens during qualitative research interviews. The analysis of the interview data is informed by the works of Sheila Jasanoff and Michel Foucault. The former provides an instructive conceptual background for demonstrating how the law serves as an important element of accountability practices. The latter is known for his plea not to understand the law in repressive terms. Accordingly, the law does not prohibit specific medical practices, but in a specific sense it rather makes medical practice socially robust. Based on qualitative analysis of interview data, I conclude that referring to the law allows experts of genetic medicine to evade engaging with ethical and social aspects of their work. The law was rhetorically utilized to bring a discussion on such issues to a communicative closure. For that purpose, the existence of the law was presented as proof that undesirable practices would not be possible and consequently further discussions of the matter would be unnecessary. The law allows medical experts to transfer ethical problems to other places and actors and also to promote their professional interests.     

Making Sense of Inequalities: How Do Clinical Commissioning Groups in England Understand their New Role?

This research explored how newly forming clinical commissioning groups (CCGs) were beginning to think about their new ‘duty’ to tackle health inequalities (HIs), as outlined in UK health policy. The concept of ‘sensemaking’ (Weick 1995) was used to illustrate the influences on CCGs’ interpretations of the policy. Three CCGs in the North of England were recruited, and qualitative methods, including interviews, observations and document analysis, were used to collect data, over a period from January 2012 to December 2012. The tangibility of central policy objectives is important in providing clear guidance and direction to organizations trying to tackle large scale policy agendas such as HIs. At a local level, both individual and collective organizational histories and wider relationships were influential on the way CCGs understood the problem of HIs and how they decided to try to tackle the issue locally. The research highlights what influences local level relationships and what factors need to be considered when trying to interpret and implement national policy at a local level.     

Longing to belong: children in residential care and their experiences of peer relationships at school and in the children's home

Resilience literature has stressed the potential of both children's educational experiences and their friendships to act as protective factors against adversity. However, less is known about how children living with adversity navigate these ‘everyday’ aspects of social terrain and the particular challenges that they face. This paper explores the meaning and experience of peer relationships to one group of children living in residential care in Ireland. Drawing on a larger study of school and care, it explores data gathered from 16 children, aged 8 to 18, who were living in eight different children's homes on the east coast of Ireland. The findings suggest that the children were acutely aware of their ‘care’ status and developed a number of strategies to manage this identity in school. It appears that more often than not, children described being left to their own devises to manage friendships and peer relationships. Thus, despite being a crucial source of both stress and support, peer relationships did not appear to be regarded as an issue that adults should be involved with. This raises questions for practice about what children should be supported with and the way in which peer relationships are potentially overlooked by social work, residential and school staff.     

In Conclusion: Current Themes in Bereavement and Widowhood Research

A number of important themes and controversies emerged from the preceding papers. These include (a) what kinds of losses lead to grief; (b) how long grief lasts; (c) how to conceptualize "recovery," (d) the nature of "normal" grief; (e) whether bereavement has lasting effects on health; and (f) what characteristics of the individual, the relationship, or the nature of the death create a greater risk for poor outcome of bereavement. Consideration of these issues should help develop more effective strategies for intervention with sufferers, and social policies sensitive to the needs of those at greatest risk.