The Division of Epidemiology, Statistics and Prevention Research (hereafter, Division) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has established an internal committee, the Biospecimen Repository Access and Data Sharing Committee (BRADSC), to oversee the repository access and data sharing program. The BRADS Committee will evaluate submitted proposals for biospecimens in terms of their relevance of the study question to current research;adequacy of the study design to address the question;feasibility and appropriateness of the source study and material for conducting the new study;appropriateness of the assay, including evidence that the analyte is stable under prolonged storage;and experience of the investigators in conducting similar studies. Access to Division resources is announced on the Division website. Announcements and current proposal guidelines are available under the Research link at http://despr.nichd.nih.gov, and interested researchers should consult the Division website for resources available, the most recent guidelines for proposal submission and evaluation, and cost schedules. Procedures may vary depending on the age and nature of the samples and original institutional review board (IRB) approval, although the general outline of the procedures should remain the same. Cost schedules may vary depending on the nature and complexity of the request. The specimens and ancillary data that are currently available under this program are those from the national Collaborative Perinatal Project (CPP, 1959-1966), the Norway-Alabama Fetal Growth Study (1986-1988), the Vaginal Infections and Prematurity Study (VIP, 1984-1989), the Calcium for Preeclampsia Prevention Trial (CPEP, 1992-1997), and the Longitudinal Study of Vaginal Flora (FLORA, 1999-2002). Other collections will be made available through this mechanism in a timely fashion. The approximate number of samples available for CPP: 198,389 serum, 36,215 cord bloods;Norway-Alabama Fetal Growth Study: 14,408 serum from Alabama, 11,817 serum from Norway;VIP: 30,067 serum;CPEP: 14,429 serum, 14,331 urine;and FLORA: 13,551 serum and vaginal washes, 3,569 periodontal swabs. Multiple aliquots are available for most samples. New collections are entered into the repository for recently completed (BioCycle, LIFE Study, ENDO Study, EAGeR Trail) and ongoing studies (NEXT Study, Diabetes and Women's Health, Fetal Growth, FAZST Trial).

Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
2013
Total Cost
$195,604
Indirect Cost
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