IMPROVING HUMAN SUBJECTS PROTECTION

该联盟应用程序的合作伙伴(波士顿大学和波士顿医疗中心)拥有 在临床研究方面有丰富的传统。我们是波士顿的主要医疗保健提供者 种族多元化，医疗服务不足的人群，以及我们所做的大部分人类研究，都集中在对这些服务不足的患者群体特别重要的问题上。人类研究是我们整个研究事业中非常重要的一部分：2001年，42%的新获得的研究资助和55%的资助都是人类研究的组成部分。人类研究也在以每年10%以上的速度增长。这种增长使我们目前教育调查人员了解人类研究的安全和道德行为的系统变得紧张，并给我们的IRB委员会带来了巨大的负担。我们建议使用这一RFA的资金来支持三大类改进： 1)研究教育计划(包括每月在线临床研究简报和测验；HIPAA顾问帮助我们以以下方式重新设计我们的临床研究活动 符合HIPAA的新隐私规则；为我们的临床研究实习生提供“IRB实习”； 提高我们IRB网站的教育价值；以及知情同意程序和IRB委员会实际运作的录像带)。 2.)改善IRB基础设施(IRB管理软件和IRB的升级 计算机和其他硬件)。 3.)几个旨在改善临床研究教育和IRB功能的试点项目。 所有这些计划的设计都是为了使来自RFA的支持具有持久的价值，并将使财团的两个成员(波士顿大学和波士顿医疗中心)受益。

The partners in this consortium application (Boston University and Boston Medical Center) have a rich tradition in clinical research. We are the major healthcare provider for Boston's ethnically-diverse, medically-underserved population, and much of the human research that we do focuses on problems that are particularly important to these under-served patient groups. Human research is a very important portion of our total research enterprise: in 2001,42% of new research grants awarded and 55% of the funding awarded had a human research component. Human research is also growing at a rate of greater than 10% per year. This growth has strained our current systems for educating investigators about the safe and ethical conduct of human research and has placed an enormous burden on our IRB committees. We propose to use the funds from this RFA to support three broad categories of improvements: 1.) Research education programs (including an on-line monthly clinical research bulletin and quiz; a HIPAA consultant to assist us in re-engineering our clinical research activities in a way that is consistent with HIPAA's new privacy rule; an "IRB Internship" for our clinical research trainees; improvements in the educational value of our IRB website; and videotapes of the informed consent process and IRB committees in action). 2.) Improvements in IRB infrastructure (both IRB management software and upgrades of the IRB computers and other hardware). 3.) Several pilot projects aimed at improving clinical research education and IRB function. All of these initiatives are designed so that the support from this RFA will have lasting value and will benefit both members of the consortium (Boston University and Boston Medical Center).