Testing drugs in pediatric populations: The FDA mandate

On November 27, 1998 the Food and Drug Administration (FDA) issued a new rule requiring that drugs and biological products be tested in pediatric populations. Since voluntary testing in pediatric populations had not resulted in a significant increase in pediatric labeling of drugs, stronger measures were needed to ensure that infants and children would receive the benefits of properly tested drugs and biologies. The mandate for pediatric testing raises a core ethical question: How should the need for validated treatments that benefit children as a group be weighed against the obligation to protect individual child subjects of research? The preamble to the new rule claims that adherence to Department of Health and Human Services (DHHS) and American Academy of Pediatrics (AAP) guidelines will provide adequate protection to individual subjects. Yet the special protections provided to children in these guidelines are not required by the new FDA rule, and have never been obligatory for research that is regulated by the FDA. While the new rule does not necessitate or encourage violation of these standards, the rule does not pay adequate attention to them nor clarify what role they should play in IRB review of protocols under FDA regulation.     

Cross-sectoral collaboration working with perinatal women who use substances: outcomes and lessons from HerWay Home

ABSTRACT

HerWay Home is a multi-service drop-in and outreach program women for with substance use issues and who also may be affected by mental illness, trauma, and/or violence. Philosophical foundations of the program include harm reduction and being relationship-based and trauma-informed. This article presents the program’s evaluation findings related to cross-sectoral service collaborations and outcomes for service partners as well as for women and families, including prevention of children going into care. For service partners, HerWay Home provided peace of mind, knowing that vulnerable women’s needs would be met and also led to increased understanding about substance-using women and best practice approaches.     

A Theoretical Perspective on Coping With Stigma

Stigmatized people have a vast array of responses to stressors resulting from their devalued social status, including emotional, cognitive, biological, and behavioral responses. This article uses existing theory and research on general stress and coping responses to describe responses to stigma-related stressors and to discuss the adaptiveness of these responses.     

South Asian immigrants' experience of child protection services: are we recognizing strengths and resilience?

Ethno‐racial minority families who come in contact with child protection services face unique challenges that include different ideas about appropriate child rearing practices, possibly different definitions of child maltreatment, the possibility of racial biases and service provision that does not address their particular needs. Ethno‐racial minority immigrants encounter additional barriers to services associated with the challenges of settlement in a new cultural environment. Although considerable research has explored these issues, knowledge of the experiences of ethno‐racial families who have been in contact with child protection is limited. The current paper provides insights from a qualitative study that explored the experiences of one ethno‐racial group (South Asians) in Canada. Findings suggest a variety of reasons that families come into contact with the child protection system, and the characteristics of the sample highlight their difficult financial and employment circumstances. Themes include participants' desire to be better informed about the reasons for child protection involvement and about what they can expect from the worker and the agency. They also identified a wish for services that not only recognize their cultural diversity but also respond to the needs of the whole family. In‐home services were especially appreciated. The findings reveal the resilience and personal agency among participants that can be enhanced through strength‐based approaches to practice. Helping others, establishing community networks and developing needed services were avenues of resilience identified.     

Actuarial risk assessment in child protective services: Construction methodology and performance criteria

Purpose

To prevent the recurrence of child maltreatment, actuarial risk assessment can help child protective services (CPS) workers make more accurate and consistent decisions. However, there are few published articles describing construction methodologies and performance criteria to evaluate how well actuarial risk assessments perform in CPS. This article describes methodology to construct and revise an actuarial risk assessment, reviews criteria to evaluate the performance of actuarial tools, and applies a methodology and performance criteria in one state.

Methods

The sample included 6832 families who were followed for two years to determine whether they were re-reported and re-substantiated for maltreatment.

Results

Both the adopted and the revised tools had adequate separation and good predictive accuracy for all families and for the state's three largest ethnic/racial groups (White, Latino, and African American). The adopted tool classified relatively few families in the low-risk category; the revised tool distributed families across risk categories.

Conclusions

The revised tool classified more families as low-risk, allowing CPS to allocate more resources to higher-risk families, but at the cost of more false negatives.