IMPROVING HUMAN SUBJECTS PROTECTION

加强对人类受试者的保护

• 批准号: 6591540
• 负责人: Thomas J Moore
• 金额: $ 39.67万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591540
• 关键词: Internet; clinical research; computer assisted instruction; computer data analysis; computer program /software; data management; educational resource design /development; ethics; health science research support; human rights; informed consent; medically underserved population; public health

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).

该财团申请（波士顿大学和波士顿医学中心）的合作伙伴有一个 临床研究中的丰富传统。我们是波士顿的主要医疗保健提供者 种族多样性，提供医学服务的人群以及我们确实重点关注的许多人类研究，这些问题对这些服务不足的患者群体特别重要。人类研究是我们全面研究企业中非常重要的一部分：2001年，授予的新研究赠款中的42％，授予的资金中有55％具有人类的研究部分。人类的研究也以每年10％的速度增长。这种增长使我们目前的系统紧张，以教育研究人员有关人类研究的安全和道德行为，并给IRB委员会带来了巨大负担。我们建议使用此RFA的资金来支持三类的改进类别： 1.）研究教育计划（包括在线每月临床研究公告和测验； HIPAA顾问，以协助我们以一种方式重新研究临床研究活动 与HIPAA的新隐私规则一致；我们的临床研究学员的“ IRB实习”； 我们IRB网站的教育价值的改善；以及知情同意程序和IRB委员会的录像带）。 2.）改进IRB基础架构（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。 所有这些举措的设计，以便该RFA的支持将具有持久的价值，并将使财团的成员（波士顿大学和波士顿医学中心）受益。