Human Subjects Research Enhancements Program

Wistar研究所的研究人员主要关注基础生物医学科学问题;然而，他们中的大多数人在研究中使用人体材料，有些人直接参与临床试验。近年来，随着微阵列技术在基因组和蛋白质组学分析方面的发展，研究人员越来越多地使用大量人体组织来筛选疾病相关基因和蛋白质。这一趋势增加了对研究所的需求，即培训研究人员了解与人体材料使用有关的法规，并管理样本的流入，以确保患者隐私得到保护。为了实现这些目标，本提案概述了基于计算机和内联网的基础设施的开发，用于：i）培训研究人员和支持人员在研究中使用人体材料; ii）IRB协议处理和相关信息管理; iii）研究人员使用的人体材料的去识别化和隔离受保护的健康信息。本报告所述的目标是在一年内完成的。

Researchers at The Wistar Institute are primarily focused on questions of basic biomedical science; however, most of them use human materials in their research and some are directly involved in clinical trials. Recent advances in genomic and proteomic analysis using microarray technology are increasing the use of large numbers of human tissues by researchers for screening for disease related genes and proteins. This trend is increasing the demand on the institute to train researchers concerning the regulations that relate to the use of human materials and to manage the influx of samples to ensure that patient privacy is protected. To accomplish these ends, this proposal outlines the development of a computer and intranet based infrastructure for: i) training of researchers and support personnel concerning the use of human materials in research; ii) IRB protocol processing and management of related information; and iii) de-identification of human materials used by researchers and sequester protected health information. The objectives outlined herein are designed to be accomplished within one year.