Protecting Human Subjects in Research

本次联合申请的合作伙伴（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。我们是波士顿多种族、医疗服务不足人群的主要医疗保健提供者，我们所做的许多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，镰状病、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中非常重要的一部分：2002年，43%的新研究拨款和54%的资助都有人类研究的组成部分。这本书对我们教育临床研究人员关于人类研究的安全和道德行为的努力施加了越来越大的负担，并对我们的IRB委员会施加了巨大的负担。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电脑，并选择并开始安装一个

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).