Search tips
Search criteria

Results 1-2 (2)

Clipboard (0)

Select a Filter Below

Year of Publication
Document Types
author:("sauer, Sara")
1.  When the Subject Is More than Just the Subject: Two Case Studies of Family Involvement in Human Subjects Research 
Institutional review boards (IRBs) protect human research subjects by reviewing research to ensure compliance with federal regulations and institutional policies. One of the most important functions of IRBs is to ensure that investigators anticipate, plan for, and minimize risks to subjects. Under certain circumstances, however, participation in research may pose risks to nonsubject family members or other members of a subject’s social network. In the context of a research protocol designed to test an intervention to prevent depression among a population of culturally diverse, urban mothers, we present two case studies of unanticipated problems, which demonstrate how nonsubject family members can either impact, or be impacted by, an individual’s participation in research. The case studies illustrate the incongruence between federal regulations addressing IRB approval of research— which focus specifically on risks to subjects—and regulations on reporting incidents that occur during the conduct of the research, which extend to risks involving “others” as well. The cases also illustrate how risks to “others” can be accentuated in certain cultures where codependent family structures may increase the role that family members play in an individual’s decision to participate in research. The question is raised as to whether this incongruence can inadvertently result in investigators and IRBs under-appreciating the risks that participation in research can pose to nonsubjects.
PMCID: PMC3273779  PMID: 21460585
maternal depression; secondary subjects; family involvement in research
2.  Maternal Depression, Perceptions of Children’s Social Aptitude, and Reported Activity Restriction among former Very Low Birth Weight Infants 
Archives of disease in childhood  2010;95(7):521-525.
Maternal depression is common among mothers of very low birth weight (VLBW) infants. In a cohort of mother-VLBW infant dyads followed to preschool age, we assessed the impact of maternal depression on mothers’ perceptions of their children’s social aptitude, and reported participation in age-appropriate preschool activities.
Longitudinal multivariable analysis of a nationally representative sample of VLBW infants in the United States. Models were adjusted for children’s developmental abilities according to the Bayley Scales of Infant Development, Mental Development Index.
800 VLBW singletons (mean gestational age 28.9 weeks) were analyzed. During the preschool years, depressed mothers perceived their children’s social abilities more negatively than non-depressed mothers. Specifically, they saw their children as less likely to be able to share with others (aOR 0.37, 95% CI 0.14, 0.96), make friends (aOR 0.58 95% CI, 0.35, 0.96), or play independently (aOR 0.30 95% CI, 0.16, 0.58). These negative perceptions were not shared by the children’s preschool teachers. Children of depressed mothers were also less likely to participate in age-appropriate preschool activities (aOR 0.30 95% CI, 0.16, 0.58). Each of these associations either lost significance or were substantially attenuated in a separate population of former healthy term infants.
Among former VLBW infants, maternal depression is associated with negative perceptions of children’s social abilities and decreased participation in preschool activities. Maternal mental health should be considered in ongoing efforts to maximize the social-emotional development of preterm infants.
PMCID: PMC3158425  PMID: 20522473
prematurity; maternal depression; vulnerable child

Results 1-2 (2)