The Importance of the Preservation of the Ethical Principle of Equipoise in the Design of Clinical Trials: Relative Impact of the Methodological Quality Domains on the Treatment Effect in Randomized Controlled Trials

Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."     

Overcoming liability concerns in vaccine trials involving pregnant women

Without the protection of vaccines, the health of pregnant women may be compromised. But assessing the safety and efficacy of vaccines in pregnancy requires research in pregnancy. Furthermore, vaccinating women while they are pregnant may convey immunity to the fetus in utero, but assessing this possible benefit of maternal immunization also requires research. This article argues that one factor inhibiting vaccine research involving pregnant women is that vaccine manufacturers fear incurring liability if they fund such research. We argue that vaccine research in pregnancy can be ethical, and we explore some methods for overcoming vaccine manufacturers' fear of liability.     

On the coase theorem and coalitional stability: the principle of equal relative concession

The Coase theorem is argued to be incompatible with bargaining set stability due to a tension between the grand coalition and sub-coalitions. We provide a counter-intuitive argument to demonstrate that the Coase theorem may be in complete consonance with bargaining set stability. We establish that an uncertainty concerning the formation of sub-coalitions will explain such compatibility: each agent fears that others may `gang up' against him and this fear forces the agents to negotiate. The grand coalition emerges from the negotiations if each agent uses the principle of equal relative sacrifice to determine the actual allocation. We also establish the rational basis for the choice of the principle of equal relative concession by the negotiating agents. Hence we argue that the Coase theorem will be valid even if there are stable sub-coalitions.     

The rhetoric versus the reality: a critical perspective on practice with fathers in child care and protection work

Within social work training and practice there is a firm emphasis on anti-discriminatory practice. At the same time, however, fathers are often marginalized or ignored in child protection practice. In suggesting a framework for practice we argue that it is essential to address the anomaly between the rhetoric and the reality of such practice if we are to provide a coherent child protection service. This paper addresses the limitations of current models of practice and traces the theoretical strands that influence them. It is essential that social work practitioners understand the role terms they use and the aim of engaging fathers. By beginning to unravel the differences between role and gender and unpicking the diverse (but overlapping) dimensions of fatherhood, it is contended that there is no definitive, dominant discourse regarding fatherhood in the same way as there is about motherhood. However, in conceptually recognizing these roles it is suggested that intervention can be planned in a way that explicates the specific aim of engaging men.     

The inclusion of minority groups in clinical trials: problems of under representation and under reporting of data

Objective: To evaluate the representation of minority groups in randomized control trials (RCTs), and the frequency with which this information is reported. Study Design: Reviewers collected data on the racial/ethnic composition of study samples from all RCTs published in six leading medical journals in 1999. Results: Of the 280 RCTs, most (204, 71.3%) provided no information on the race/ethnicity of participants. Of the 89 U.S.-based RCTs, 50 (56.1%) reported their minority distribution. Relative to other trials, those funded by the National Institute of Health (NIH) (n = 52) were more likely to report race/ethnicity data (55.8% vs. 23.7%; x2 = 20.9, p <_0.001) and to include nonwhite participants (13.5 % vs. 12.5%; x2=22.7, p<_0.001). Conclusion: Minority groups are currently under-represented in clinical trials. Information on the race and ethnicity of clinical trial participants is currently underreported in six leading medical journals. Reporting of minority group information was significantly better only in NIH funded trials, which also were more likely to include nonwhite participants. This suggests that mandatory reporting policies may have a positive effect on both reporting and representation.     

Development,Feasibility, and Piloting of a Novel Natural Mentoring Intervention for Older Youth in Foster Care

Aging out of foster care is associated with deleterious emerging adulthood outcomes. The enduring presence of a caring adult, such as a natural mentor, can improve outcomes for emancipating foster youth. Caring Adults ‘R’ Everywhere (C.A.R.E.) is a novel, child welfare-based intervention designed to facilitate natural mentor relationships among aging-out youth. Our aims were to test the feasibility of implementing C.A.R.E. and the feasibility of conducting a randomized controlled study with older foster youth. Twenty-four foster youth aged 18–20.5 years were recruited and randomly assigned to the intervention (n = 12) or control groups (n = 12). Ten natural mentors were identified and contacted for participation in the intervention and study. Process-oriented qualitative data and quantitative pre- and postintervention outcome data were collected and analyzed. Utilizing a controlled rigorous design, the findings highlight the positive experience of both the intervention youth and their natural mentors with C.A.R.E. Overall, results support the continued refinement, delivery, and rigorous testing of C.A.R.E. with great promise for programmatically supporting natural mentor relationships among youth aging out of foster care.     

Are interventions supporting separated parents father inclusive? Insights and challenges from a review of programme implementation and impact

This paper reviews divorce‐related parenting programmes, assessing the extent to which fathers are included and whether father inclusion influences outcomes. The paper also discusses limitations of the research evidence and implications for future intervention and evaluation design. Thirteen programmes met the criteria in the review period 2005–2012 but only four had been evaluated using randomized control trials or with independent measures from mothers and fathers. Analysis of these four programmes shows modest evidence of reduced couple‐conflict, improved coparenting and some evidence of improved child outcomes. Key issues raised are the need for improving the quantity and quality of demographic data about fathers; the importance of incorporating analysis by gender of parent into evaluation design and the value of developing and routinely using father‐related indicators to measure programme impact on men's parenting, fathering and co‐parental relationships.     

Intentional exposure studies of environmental agents on human subjects: assessing benefits and risks

In this article, I assess the benefits and risks of studies that intentionally expose research subjects to environmental agents. I describe these types of studies, identify their benefits and risks, compare them to other research methods that can be used to investigate the relationship between environmental exposures and disease, and discuss some issues related to research design and risk minimization. I argue that the benefits of intentional environmental exposure studies outweigh the risks when 1) the knowledge gained is likely to improve our understanding of the relationship between environmental exposure and disease, 2) this knowledge cannot be obtained by other methods, 3) the experiments are well designed, 4) the subjects will receive some benefits, such as medical evaluations, 5) risks are minimized, and 6) the risks to human subjects are less than those encountered in a typical Phase I drug study. Only in rare circumstances (i.e., when an intentional environmental exposure study is needed to implement an important environmental or public health intervention or regulation) may such studies expose research subjects to risks as high as those encountered in a typical Phase I drug trail.     

Social work with youth in social withdrawal: in-home and beyond-home intervention modalities

This article discusses the characteristics and the process of in-home and beyond-home social work intervention with young people suffering from social withdrawal in the form of chronic self-seclusion at home. These young people are characterized by their socially avoidant behaviour and are deprived of the enjoyment of legitimate social status as a student, worker or trainee. As a way of confronting this problem, ‘start where the client is’ – an age-old social work intervention principle – can be read in a literal sense, i.e. taking home as a secure place for rapport-building and initial intervention with the clients to pave the way for further intervention beyond the home setting, both online and offline. Drawing on qualitative interviews with youth clients and social workers, it is argued that adopting a flexible, informal and tailor-made approach to working with youth in silent and invisible disengagement from the rest of society has to take into consideration spatial, relational and organizational dimensions of intervention modalities and possibilities if the goal of youth reengagement is to be achieved.     

Intentional Exposure Studies of Environmental Agents on Human Subjects: Assessing Benefits and Risks∗

In this article, I assess the benefits and risks of studies that intentionally expose research subjects to environmental agents. I describe these types of studies, identify their benefits and risks, compare them to other research methods that can be used to investigate the relationship between environmental exposures and disease, and discuss some issues related to research design and risk minimization. I argue that the benefits of intentional environmental exposure studies outweigh the risks when 1) the knowledge gained is likely to improve our understanding of the relationship between environmental exposure and disease, 2) this knowledge cannot be obtained by other methods, 3) the experiments are well designed, 4) the subjects will receive some benefits, such as medical evaluations, 5) risks are minimized, and 6) the risks to human subjects are less than those encountered in a typical Phase I drug study. Only in rare circumstances (i.e., when an intentional environmental exposure study is needed to implement an important environmental or public health intervention or regulation) may such studies expose research subjects to risks as high as those encountered in a typical Phase I drug trail.     

The cost‐effectiveness of UK parenting programmes for preventing children's behaviour problems – a review of the evidence

Parenting programmes are widely used in the UK, promoted in policy documents as a cost‐effective way for children's services to address behaviour problems and thereby the longer‐term costs associated with conduct disorders, particularly antisocial behaviour and criminality. To explore whether these programmes are a cost‐effective component of family intervention, this paper examines evidence from cost‐effectiveness studies based on randomized controlled trials, modelling studies estimating longer‐term costs and outcomes, and studies estimating costs of UK parenting programmes, including evidence from routine practice. Findings indicate that parenting programmes have the potential to be cost‐saving in the long term; however, gaps in the evidence include: lack of follow‐up of families who drop out of programmes, absence of control groups in longer‐term follow‐ups, and little information about costs and effects of programmes in routine practice. The size of savings resulting from implementation of effective parenting programmes will depend on the extent to which families likely to be most costly to society attend and experience lasting benefit.     

Victim Evaluations of Face-to-Face Restorative Justice Conferences: A Quasi-Experimental Analysis

One major goal of face-to-face restorative justice (RJ) is to help heal the psychological harm suffered by crime victims ( Braithwaite, 2002 ). Substantial evidence from randomized controlled trials (RCTs) has shown that this can be accomplished ( Strang, 2002 ) and more trials are underway ( Sherman & Strang, 2004 ). These outcomes are even more clearly, if less rigorously, demonstrated through retrospective interviews of victims about their feelings before and after RJ took place. We review the responses of victims ( N = 210) who participated in trials in Canberra (Australia) and in London, Thames Valley, and Northumbria (UK). Despite substantial variations in offense types, social contexts, nation and race, before-after changes revealed by qualitative and quantitative data are all in the same beneficial direction.     

Causes of ambiguity aversion: Known versus unknown preferences

Ambiguity aversion appears to have subtle psychological causes. Curley, Yates, and Abrams found that the fear of negative evaluation by others (FNE) increases ambiguity aversion. This paper introduces a design in which preferences can be private information of individuals, so that FNE can be avoided entirely. Thus, we can completely control for FNE and other social factors, and can determine exactly to what extent ambiguity aversion is driven by such social factors. In our experiment ambiguity aversion, while appearing as commonly found in the presence of FNE, disappears entirely if FNE is eliminated. Implications are discussed.      

Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia

The review of clinical trials with human participants in Malaysia is governed by a decentralized control system. The clinical trial protocols are reviewed by 13 registered research ethics committees (RECs) in Malaysia. A governmental body, the National Pharmaceutical Control Bureau, is responsible for the inspection and oversight of these registered RECs to ensure that they comply with the regulatory requirements. However, this study highlights that each REC in Malaysia has a different standard operating procedure and ethical review process. Other procedural challenges identified include inadequate membership, poor mechanism for research monitoring after ethical approval, and insufficient resources. Establishments of a national standard of REC and a central ethics committee are suggested to ensure procedural compliance in the oversight of clinical trials in Malaysia. While there is a growing concern that procedural compliance may not have a direct impact on the protection of human subjects, our key point is that an ethical review system compliant with the national standards could serve as a strong framework to support and enhance the ethical quality of decision-making and judgement. We believe that being aware of how influential procedural compliance can be would help committees improve the ethical quality of their research review.     

Effectiveness of the International Child Development Programme: Results from a randomized controlled trial

This study aimed to evaluate the effectiveness of the International Child Development Programme (ICDP), a group-based parenting programme used internationally and implemented nationally in Norway. We used a cluster randomized controlled trial in which 81 groups were randomly assigned to either the intervention or waitlist control condition after the baseline data collection. A total of 590 parents completed at least one of three questionnaires (administrated before and after ICDP and 4 months after completing the intervention). Primary outcomes included parental self-efficacy, parental emotion sensitivity and positive involvement with their child. Secondary outcomes included parents' perceptions of their relationship with the child, child-rearing conflicts and the child's psychosocial health. We found significant effects favouring the intervention arm following the intervention and at follow-up on two primary outcomes (parental self-efficacy and emotion sensitivity). For the secondary outcomes, we found a significant reduction in child-rearing conflict at the 4-month follow-up, increased closeness to the child, reduced child internalizing difficulties and increased prosocial behaviour immediately following the intervention. However, ICDP seems to have limited effects on parent-reported changes in children. We conclude that ICDP as a universal preventive programme offered to parents in groups can be effective in strengthening parental self-efficacy and improving parental emotion sensitivity.     

Newcomb's many problems

Newcomb's paradox rests on two arguments one appealing to the principle of maximizing expected utility and one appealing to dominance in order to generate conflicting recommendations in certain kinds of choice situations. In my essay, I argue that the applications of the principle of maximizing expected utility and of the dominance principle are both fallacious and that the specification of the decision problem is too indeterminate to render a verdict between the two options considered. I also show that if Nozick's case for invoking the dominance principle is taken seriously, it leads to contradictions.     

Religiosity and the political economy of the Salem witch trials

Salem Village, both before and through the witchcraft trials, was a religion-based community, allowing its minister to exert a level of political–economic control over its citizens. During the height of the witchcraft episode, there was an increased demand for ministerial services (salvation) in the Salem area. Recent research has argued that the minister used the witchcraft episode to maintain and build upon personal and corporate wealth. In the years after the witchcraft trials changes were made in the business and legal environment of the surrounding New England region. By transitioning to a more neutral rules system with a larger area of consensus for the system, Salem and the rest of the New England transitioned from the 17th Century traditional, religion-based community to a more rules-based, pro-business one in the 18th Century.     

Overcoming Liability Concerns in Vaccine Trials Involving Pregnant Women

Without the protection of vaccines, the health of pregnant women may be compromised. But assessing the safety and efficacy of vaccines in pregnancy requires research in pregnancy. Furthermore, vaccinating women while they are pregnant may convey immunity to the fetus in utero, but assessing this possible benefit of maternal immunization also requires research. This article argues that one factor inhibiting vaccine research involving pregnant women is that vaccine manufacturers fear incurring liability if they fund such research. We argue that vaccine research in pregnancy can be ethical, and we explore some methods for overcoming vaccine manufacturers' fear of liability.     

The individual rationality of maintaining a sense of justice

Let us say that an individual possesses aprincipled preference if she prefers satisfying her preferences without violating the principles of justice governing her community to satisfying her preferences by violating these principles. Although living among possessors of principled preferences benefits individuals, maintaining such a preference is individually costly. Further, individuals can benefit from others possessing principled preferences without themselves possessing one. In this paper, I argue that occupying a choice situation which mirrors key aspects of our own situation, maximizing rationality requires individuals to develop and maintain principled preferences.To establish that maintaining a principled preference is individually rational for the occupants of such a choice situation, I define a range of individual strategies for them, model their choice of individual strategies as a game, and argue that this game involves an equilibrium in which all of its participants would choose to develop and maintain a principled preference.     

Culturally Based Intervention Development: The Case of Latino Families Dealing With Schizophrenia

OBJECTIVES: This article describes the process of developing a culturally based family intervention for Spanish-speaking Latino families with a relative diagnosed with schizophrenia. METHOD: Our iterative intervention development process was guided by a cultural exchange framework and based on findings from an ethnographic study. We piloted this multifamily group 16-session intervention with 59 Latino families in a randomized control trial. Data were collected on family- and client-level outcomes, and poststudy focus groups were conducted with intervention participants. RESULTS: Preliminary evidence indicates that the intervention is effective by increasing illness knowledge and reducing family burden. CONCLUSIONS: This work can provide a model for how to integrate cultural factors into psychosocial services and enhance interventions in real-world settings for culturally diverse populations.