Protocol for student replication of published research

Subpart D of the Common Rule establishes 4 categories of research that may be conducted on children. One category, 45 CFR 46.406, permits research posing a minor increase over minimal risk and no prospect of direct benefit but expected to yield vital knowledge about the subjects' disorder or condition. To include other children in research posing a minor increase over minimal risk and no prospect of direct benefit requires federal review and approval of the Secretary of Health and Human Services under 45 CFR 46.407. It is widely held that children generally should not be exposed to more than minimal risk in research without the prospect of direct benefit. To justify deviating from this norm, as 406 allows, two claims must be true: (1) When there is vital knowledge to be gained from studying children, it is permissible to expose some children to a minor increase over minimal risk with no prospect of direct benefit; (2) It is permissible for locally reviewed and approved research to expose only children with the disorder or condition under investigation to greater risk with no prospect of direct benefit. The justification for (1) appears to be grounded in the magnitude of benefit to society combined with the need to study children. This article demonstrates that, even if the necessity and magnitude of benefit to society justify exposing children to increased risk, the decision to categorically restrict participation in such research to children with the disorder or condition under investigation (unless the study is federally reviewed and approved) is not justified. Subpart D should be revised.     

Pediatric research posing a minor increase over minimal risk and no prospect of direct benefit: challenging 45 CFR 46.406

Subpart D of the Common Rule establishes 4 categories of research that may be conducted on children. One category, 45 CFR 46.406, permits research posing a minor increase over minimal risk and no prospect of direct benefit but expected to yield vital knowledge about the subjects' disorder or condition. To include other children in research posing a minor increase over minimal risk and no prospect of direct benefit requires federal review and approval of the Secretary of Health and Human Services under 45 CFR 46.407. It is widely held that children generally should not be exposed to more than minimal risk in research without the prospect of direct benefit. To justify deviating from this norm, as 406 allows, two claims must be true: (1) When there is vital knowledge to be gained from studying children, it is permissible to expose some children to a minor increase over minimal risk with no prospect of direct benefit; (2) It is permissible for locally reviewed and approved research to expose only children with the disorder or condition under investigation to greater risk with no prospect of direct benefit. The justification for (1) appears to be grounded in the magnitude of benefit to society combined with the need to study children. This article demonstrates that, even if the necessity and magnitude of benefit to society justify exposing children to increased risk, the decision to categorically restrict participation in such research to children with the disorder or condition under investigation (unless the study is federally reviewed and approved) is not justified. Subpart D should be revised.     

Public Service Quality Improvements: A Case for Exemption from IRB Review of Public Administration Research

Should the exemption from Institutional Review Board (IRB) evaluations currently in place for quality improvements research be extended to public administration research that addresses questions of improving the quality of public service delivery? As a means to both reduce the level of disdain held by a group of social science researchers for IRBs and to reduce the cost of review for minimal risk studies, I argue here that much of the current public administration research should also be exempted from normal processes of review by IRBs on the basis of their similarity to Quality Improvements (QI) research, a category of studies already granted exemption. This argument dovetails provisions currently in place for studies of public service and public benefit, but reframes these exemptions in the language of “quality improvements,” which may be a more comfortable language for IRBs concerned to demonstrate compliance for review of all fields. To expedite this argument into the practices of IRBs, I included a checklist that researchers could use to self-identify their studies as QI, not research as such.     

Transitioning to stepfamily life: the influence of closeness with biological parents and stepparents on children's stress

Family transitions, such as stepfamily formation, can be a source of stress for adults and children. Yet, the stepfamily literature lacks a focus on factors that influence child stress levels while transitioning to stepfamily life. Using a social support perspective, the purpose of this study was to assess the independent and additive influence of closeness with three common parental figures on retrospective reports of stress experienced by children during stepfamily formation. A sample of 1139 emerging adults from a retrospective, US‐based national quota sample, the Stepfamily Experiences Project, was analysed. Results indicated that parental relationships have independent, not combined, effects on stress. More specifically, we found that greater closeness with resident stepparents and resident biological parents was associated with less stress in children, whereas greater closeness with non‐resident biological parents was associated with slightly greater levels of stress. These findings reflect (i) the primacy of residential relationships in children's stress reduction; (ii) the benefit of parental relationships to children as sources of social support during stressful family transitions; and (iii) the potential for children to experience stressful loyalty binds during stepfamily formation. Implications for social work practice, limitations and future directions for research are discussed.     

The Therapeutic Misconception: A Threat to Valid Parental Consent for Pediatric Neuroimaging Research

Neuroimaging research has brought major advances to child health and well-being. However, because of the vulnerabilities associated with neurological and developmental conditions, the parental need for hope, and the expectation of parents that new medical advances can benefit their child, pediatric neuroimaging research presents significant challenges to the general problem of consent in the context of research involving children. A particular challenge in this domain is created by the presence of therapeutic misconception on the part of parents and other key research stakeholders. This article reviews the concept of therapeutic misconception and its role in pediatric neuroimaging research. It argues that this misconception can compromise consent given by parents for the involvement of their children in research as healthy controls or as persons with neurological and developmental conditions. The article further contends that therapeutic misconception can undermine the research ethics review process for proposed and ongoing neuroimaging studies. Against this backdrop, the article concludes with recommendations for mitigating the effects of therapeutic misconception in pediatric neuroimaging research.     

The therapeutic misconception: a threat to valid parental consent for pediatric neuroimaging research

Neuroimaging research has brought major advances to child health and wellbeing. However, because of the vulnerabilities associated with neurological and developmental conditions, the parental need for hope, and the expectation of parents that new medical advances can benefit their child, pediatric neuroimaging research presents significant challenges to the general problem of consent in the context of research involving children. A particular challenge in this domain is created by the presence of therapeutic misconception on the part of parents and other key research stakeholders. This article revierws the concept of therapeutic misconception and its role in pediatric neuroimaging research. It argues that this misconception can compromise consent given by parents for the involvement of their children in research as healthy controls or as persons with neurological and developmental conditions. The article further contends that therapeutic misconception can undermine the research ethics review process for proposed and ongoing neuroimaging studies. Against this backdrop, the article concludes with recommendations for mitigating the effects of therapeutic misconception in pediatric neuroimaging research.     

Self-reported mental health problems and post-traumatic growth among children in Pakistan care homes

ABSTRACT

Children in care experience multiple risk factors, particularly in low-income countries such as Pakistan. The aim was to establish rates of mental health problems and their relationship with posttraumatic growth, as reported by 132 children aged 9–19 years, living in three care homes in Pakistan. Children reported high rates of posttraumatic stress (70.45%) and common mental health symptoms (43.94%) within the clinical range, but also high levels of posttraumatic growth. These findings highlight the high levels of mental health needs among children in residential care, as well as the importance of understanding factors that promote their posttraumatic growth and resilience.     

The therapeutic misconception,beneficence, and respect

In order to provide benefits to society, human medical trials must place subjects at risk of harm. This activity is thought to be justified in part by the consent of the subjects involved. But, studies have shown that most such consents are based on a therapeutic misconception (TM); the false belief of subjects that their researchers will act as their personal physicians (seeking their benefit and protecting them from harm), rather than placing them at risk of harm for the good of others. Toleration by researchers of the TM in their subjects is a form of “informational manipulation”; that renders consent procedures disrespectful to subject autonomy. Consent obtained from subjects who labor under a TM is neither voluntary nor informed; as long as they have not been disabused of the TM, the action they take in enrolling in a trial is not the one they intend nor is it autonomously chosen. Changes in consent procedures should be adopted to ensure that all subjects are aware inter alia that (a) the health interests of future patients (as well as the researchers’ and their sponsors’ financial interests) may be more important to researchers than the interest of a subject in his or her health, and (b) normal subjects neither understand nor believe this when told. Close attention to the response of prospective subjects to this information should allow for the exclusion of all but the truly altruistic. However, the result of conscientious implementation of such policies would likely be that human medical research could no longer be conducted on more than a minimal level.     

The therapeutic misconception,beneficence, and respect

In order to provide benefits to society, human medical trials must place subjects at risk of harm. This activity is thought to be justified in part by the consent of the subjects involved. But, studies have shown that most such consents are based on a therapeutic misconception (TM); the false belief of subjects that their researchers will act as their personal physicians (seeking their benefit and protecting them from harm), rather than placing them at risk of harm for the good of others. Toleration by researchers of the TM in their subjects is a form of "informational manipulation" that renders consent procedures disrespectful to subject autonomy. Consent obtained from subjects who labor under a TM is neither voluntary nor informed; as long as they have not been disabused of the TM, the action they take in enrolling in a trial is not the one they intend nor is it autonomously chosen. Changes in consent procedures should be adopted to ensure that all subjects are aware inter alia that (a) the health interests of future patients (as well as the researchers' and their sponsors' financial interests) may be more important to researchers than the interest of a subject in his or her health, and (b) normal subjects neither understand nor believe this when told. Close attention to the response of prospective subjects to this information should allow for the exclusion of all but the truly altruistic. However, the result of conscientious implementation of such policies would likely be that human medical research could no longer be conducted on more than a minimal level.     

The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research

One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this article, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process. The fact that IRB risk/benefit decision-making involves intuition need not imply that it is hopelessly subjective or biased, however, since there are strategies that IRBs can employ to improve their decisions, such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to guide the evaluation of harms and benefits, and engaging in moral reasoning concerning the acceptability of risks.     

Active emotion regulation mediates links between shyness and social adjustment in preschool

Shyness is characterized by the experience of heightened fear, anxiety, and social‐evaluative concerns in social situations and is associated with increased risk for social adjustment difficulties. Previous research suggests that shy children have difficulty regulating negative emotions, such as anger and disappointment, which contributes to problems interacting with others. However, it remains unclear precisely which strategies are involved among these associations. Accordingly, the goal of this study was to explore the mediating role of emotion regulation strategies in the links between young children’s shyness and social adjustment at preschool. Participants were 248 preschool children aged 2.5–5 years. Parents rated children’s shyness and emotion regulation strategies in the context of anger and fear. Early childhood educators assessed indices of social adjustment 4 months later. Among the results, active regulation mediated associations between shyness and subsequent prosocial and socially withdrawn behaviors. Child gender further moderated these linkages, such that the model predicting socially withdrawn behavior was stronger among boys. These results expand on our understanding of emotion regulation strategies in shy children’s early socio‐emotional development.     

Children and young people with a hidden disability: an examination of the social work role

Summary There has been little research attention paid to the natureand extent of social work intervention with children and youngpeople with invisible impairments. The recent study describedhere found that children and young people with a hidden andstigmatizing impairment received a social work service whichwas at a minimal level. The children and young people were affectedby physically induced incontinence, and described how they facedan environment which created particular tensions. Their parentsconcurred with this overall picture and reported unmet needs.Recommendations are made about social services input, but itis recognized that the level of social services interventionavailable to these families may, in part, be a reflection ofa low priority assigned to disabled children generally. It isargued that, although such an assignment is a common picturein recent research about social services provision to disabledchildren, a change in priorities is needed which recognizesthe importance of coherent support to disabled children as ameans of improving their environment and thereby reducing families'stress levels and the likelihood of abuse or rejection.     

Participation and health – a research review of child participation in planning and decision‐making

Effective child participation in child protection proceedings has proved difficult to achieve in Norway. Although participation is in principle accepted as a human right and something of benefit to children, when children's health is at stake there is a tendency to view participation in decision‐making processes by children as potentially disruptive to their well‐being. The purpose of this study is to review the research evidence for effects, positive or negative, of participation on health outcomes for children in care. A scoping review of major health and social work research databases was undertaken. Searches in five databases yielded 1830 studies of which 21 were finally included in this review. Studies were included if a relationship between health and participation was evident from the data presented, even if this was not the main objective in the study at hand. We conclude that when participation is successful, it may have beneficial side effects. Chief among these are that participation may improve children's safety, increase the success of care arrangements and increase feelings of well‐being for children involved. Evidence for long‐term effects of successful or failed participation attempts on subsequent health outcomes is however largely absent.     

Waivers of parental consent for sexual minority youth

ABSTRACT

The Society for Adolescent Health and Medicine emphasizes the need for research to focus on the health outcomes of sexual minority youth (i.e., lesbian, gay, bisexual, transgender, queer). However, sexual minority youth (SMY) are often less willing to participate in research studies where parental consent is required due to potential victimization and discrimination. This is a major concern given that more research is needed to understand the health needs of this population, especially in terms of suicide, substance use, and HIV prevention. The National Suicide Prevention Strategy classifies SMY as a high-risk group, emphasizing the need to explore suicide risks (along with other health outcomes) among this group. However, this high-risk classification also increases the safeguards necessary to conduct research with this population. Many researchers have argued for waivers of parental consent, but such waivers present with several ethical implications. This article discusses ethical principles, risks, benefits, safeguards, and potential alternative approaches to waivers of parental consent for SMY. We conclude by emphasizing the need for policy changes to allow parental consent waivers for research targeting SMY.     

Preschool and Academic School Readiness Among Young Children of Asian and Hispanic Immigrant Mothers

ABSTRACT

Preschool is an important developmental context for children of immigrants that can help them succeed in later life. In this study, we examine the association between preschool and academic school readiness among young children of Asian or Hispanic immigrant mothers. A secondary data analysis was conducted using data (n ≈ 1,550) collected in the Early Childhood Longitudinal Study-Birth Cohort. Results show that attending preschool (mostly prekindergarten or other center-based care) was associated with better academic school readiness at the year of participation among children of both Asian and Hispanic immigrant mothers; such beneficial associations were found at kindergarten entry among Asian children, but not Hispanic children. Furthermore, more-pronounced beneficial influences of preschool on academic school readiness were found at the year of participation among children of home language mothers in both groups, but such more-pronounced benefits were gone at kindergarten entry in both groups. These findings suggest that the differences between the two groups in maintaining the benefits from preschool may be associated with different home environments. Future research is needed to look specifically at the mechanisms of how attending preschool is related to academic school readiness among children of immigrants.     

Psychological Distress Experienced by Parents of Young Children With Congenital Heart Defects: A Comprehensive Review of Literature

ABSTRACT

The purpose of this study was to examine the existing research on the psychological distress experienced by parents whose young children (between the ages of 0 and 5 years old) have a congenital heart defect (CHD). A more detailed understanding of the distress experienced by these parents, including stress associated with the child's age, the severity of the child's diagnosis, and parent characteristics, is vital as it would allow for more targeted and individualized support for this population to enhance parental coping strategies and increase the likelihood of more positive parent–child interactions. This review of 25 studies contributes to the parenting stress literature by focusing on parents of young children and categorizing studies by publication characteristics, research methodology, and findings. The research clearly demonstrates that parents report a great deal of stress throughout the continuum of their child's health care experience. Recommendations for future research and practice implications, such as developing a stress vulnerability model specific to parenting children with CHD, clarifying the role between interdisciplinary team members regarding provision of psychosocial support to parents, and referring parents to specific community-based ongoing social support services, are presented.     

The contribution of mother-father-child interactions to children's emotion narratives

Parents' sensitivity during interactions with their children has been associated with children's emotion narratives elicited using story completion tasks, but almost all of this research focused on mothers and was based on a dyadic, parent-child focus. The goal of the present study was to expand this research by studying triadic, mother-father-child interactions and their associations with children's narratives. Seventy-one families with their 4.5-year-old children were observed in the Lausanne Trilogue Play (LTP) procedure to assess Family Cooperation, and children were administered the MacArthur Story-Stem Battery (MSSB) to assess Coherence, Parental Representations, and Engagement with the task. Regression analyses indicated that controlling for children's Narrative Competence and Effortful Control, children who were part of more cooperative family interactions produced narratives that were more coherent, and they were more engaged during the task. No associations were found with children's representations of parents. Directions for future studies as well as clinical implications are discussed.     

Factors associated with provider self‐efficacy in delivery of evidence‐based programs for children,youth, and families

Investments in training real‐world behavioral health providers in evidence‐based programs (EBPs) can be costly; thus, it is important to understand which providers may be more or less likely to implement such approaches after training. Provider self‐efficacy is associated with implementation of EBPs, but research on factors associated with provider self‐efficacy is less common. An exploratory, cross‐sectional, quantitative survey examined factors associated with provider self‐efficacy among 150 real‐world service providers who reported delivering EBPs to children, youth, or families in one U.S. state. Factors found to be associated with higher self‐efficacy included profession, workplace support, and extent of training received; difficulty engaging families was associated with lower self‐efficacy. Self‐efficacy was found to be associated with program use but not fidelity. Several organization‐level variables were identified as both facilitators and barriers to implementation of EBPs. Implications for research and practice are discussed.     

Central ethical dilemmas in research involving children

We are obligated to protect individual child subjects of research, yet it is also necessary to investigate the safety and efficacy of medical treatments that benefit children as a class. The federal regulations on research with children have provided ethical guidance since 1983, but divergent interpretations persist. Since varying interpretations can lead to confusion and abuses, efforts are underway to clarify the criteria. Clarity is needed to protect individual child subjects from harm while enabling ethical research to proceed. The "pediatric rule" and the "pediatric exclusivity" incentive are important policy initiatives for promoting sound research on the medical treatment of children.     

Exuberance,attention bias,and externalizing behaviors in Chinese preschoolers: A longitudinal study

Exuberance, a temperament type influenced by approach motivation, has been found to be associated with maladaptive behaviors such as more externalizing behaviors in early childhood. A possible mechanism underlying it is children's selective attention to environmental cues. However, few studies have investigated the effect of attention bias on the relation between exuberance and externalizing behaviors. This longitudinal study examined the association of temperamental exuberance (as assessed by behavioral observation and parental report) at 3 years old with attention bias to reward and punishment (as assessed by a spatial cueing task) and teachers' reports of externalizing behaviors at 5 years old in 153 Chinese preschool‐age children. As predicted, externalizing behaviors were positively predicted by exuberance and attention bias to reward. However, novel findings were that attention bias to punishment moderated the relation between exuberance and externalizing behaviors, such that exuberant children showed an increased risk of externalizing behaviors when they did not have high punishment bias. The results highlight attention bias to punishment as an important factor for the development of behavioral problems in exuberant children.