Protecting Human Subjects in Research

该联盟申请的合作伙伴（波士顿大学和波士顿医学中心）在临床研究方面有着丰富的传统。我们是波士顿种族多样、医疗服务不足的人口的主要医疗保健提供者，我们所做的大部分人类研究都集中在对这些患者群体特别重要的问题上（例如，镰刀病、艾滋病毒/艾滋病、药物滥用等）。人类研究也是我们整个研究事业的一个非常重要的部分：在2002年，43%的新的研究赠款和54%的拨款都有人类研究部分。这一卷已经给我们的临床研究人员关于人体研究的安全和道德行为的教育工作带来了越来越大的负担，也给我们的IRB委员会带来了巨大的负担。利用RFA第一年的资金，我们开发了新的研究教育机会，为我们的IRB行政办公室购买了新的计算机，并选择并开始安装 新的IRB管理软件系统（BRAAN，在贝勒医学院开发）。利用目前RFA提供的资金，我们希望保持这一势头，重点关注四个领域： 1.）通过完成在线临床研究时事通讯项目和实施临床研究重新认证考试（在线时事通讯的一个组成部分），改善我们所有参与人类研究的人员的人类研究教育。 2.通过最终实施新的IRB管理软件（BRAAN）来改善IRB基础设施，并为我们的研究人员提供软件培训计划，以帮助他们转换到新的无纸化IRB系统。 3.）第三章为我们的IRB委员会成员提供笔记本电脑和宽带互联网接入，他们需要足够的设备来在线进行所有IRB审查。 4.）通过改善非英语使用者的访问，促进我们临床研究中受试者的种族多样性，这些人占我们患者社区的很大一部分，但目前遇到各种语言相关障碍。 所有这些举措都是为了使外地住房储备金的支助具有持久的价值。这些举措也将使联盟的两个成员（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, medicallyunderserved population and much of the human research that we do focuses on problems that are particularly important to these patient groups (e.g., sickle disease, HIV/Aids, substance abuse, etc.). Human research is also a very important portion of our total research enterprise: in 2002, 43% of new research grants awarded and 54% of the funding awarded had a human research component. This volume has placed an increasing burden on our efforts to educate our clinical researchers about the safe and ethical conduct of human research and has placed an enormous burden on our IRB committees. With the funds from year one of the RFA, we have developed new research education opportunities, purchased new computers for our IRB administrative office, and have selected and are beginning to install a new IRB management software system (BRAAN, developed at Baylor School of Medicine). With the funds from this current RFA, we would like to maintain this momentum, focusing on four areas: 1.) To improve human research education for all of our personnel involved in human research by completing the online clinical research newsletter project and by instituting a clinical research re-certification examination (a component of the online newsletter). 2.To improve IRB infrastructure by finalizing the implementation of new IRB management software (BRAAN) and to offer a software-training program to our investigators to help them covert to the new paperless IRB system. 3.) To provide laptop computers and broadband internet access for our IRB Committee members who need adequate equipment to do all of their IRB reviews online. 4.) To promote more ethnic diversity among the subjects in our clinical studies by improving access for non-English speakers, who comprise a large portion of our patient community but who currently encounter a variety of language-related barriers. All of these initiatives are designed so that the support from this RFA will have lasting value. The initiatives will also benefit both members of the consortium (Boston University and Boston Medical Center).