Biospecimen Repository - Division of Epidemiology, Statistics & Prevention Res.

生物样本库 - 流行病学、统计学部

• 批准号: 8351270
• 负责人: Germaine Louis
• 金额: $ 10万
• 依托单位: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8351270
• 关键词: Address; Age; Alabama; Aliquot; Biological Assay; Calcium; Child; Child health care; Collection; Communities; Consult; Data; Data Set; Epidemiology; Evaluation; Fetal Growth; Guidelines; Human Development; Infection; Institutes; Institutional Review Boards; Link; Longitudinal Studies; Nature; Norway; Perinatal; Policies; Pre-Eclampsia; Prevention; Prevention Research; Procedures; Qualifying; Research; Research Design; Research Personnel; Resources; Sampling; Schedule; Serum; Source; Specimen; Swab; Umbilical Cord Blood; United States National Institutes of Health; Urine; Vagina; cost; data sharing; experience; interest; premature; programs; repository; statistics; web site

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. In brief, 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: 12,404 serum and vaginal washes, 3,197 periodontal swabs. Multiple aliquots are available for most samples.

Eunice Kennedy Shriver国家儿童健康和人类发展研究所（NICHD）的流行病学、统计学和预防研究部（以下简称“部”）成立了一个内部委员会，即生物标本储存库访问和数据共享委员会（BRADSC），以监督储存库访问和数据共享计划。简言之，BRAS委员会将评估提交的生物样本提案，包括研究问题与当前研究的相关性;研究设计是否足以解决问题;进行新研究的源研究和材料的可行性和适当性;分析方法的适当性，包括分析物在长期储存下稳定的证据;以及研究者进行类似研究的经验。 可在统计司网站上查阅统计司的资源。公告和现行提案准则可在http://despr.nichd.nih.gov的研究链接下查阅，感兴趣的研究人员应查阅该司网站，了解可用资源、提案提交和评估的最新准则以及费用表。 程序可能会因样本的年龄和性质以及原始机构审查委员会（IRB）的批准而有所不同，但程序的一般概述应保持不变。费用表可能因请求的性质和复杂性而异。 目前在该计划下可用的标本和辅助数据来自国家围产期合作项目（CPP，1959-1966），挪威-阿拉巴马州胎儿生长研究（1986-1988），阴道感染和早产研究（VIP，1984-1989）、钙用于先兆子痫预防试验（CPEP，1992-1997）和阴道植物群的纵向研究（FLORA，1999-2002）。 其他收藏品将通过这一机制及时提供。 CPP可用样本的大致数量：198，389份血清，36，215份脐带血;挪威-亚拉巴马胎儿生长研究：14，408份来自亚拉巴马的血清，11，817份来自挪威的血清; VIP：30，067份血清; CPEP：14，429份血清，14，331份尿液;以及植物群：12，404份血清和阴道冲洗液，3，197份牙周拭子。 大多数样品可获得多个等分试样。