Strengthening oversight of human subjects research

加强对人体受试者研究的监督

• 批准号: 6779025
• 负责人: ROBERT D MORRIS
• 金额: $ 10万
• 依托单位: GEORGIA STATE UNIVERSITY
• 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 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6779025
• 关键词: Internet; clinical research; computer program /software; computer system design /evaluation; data management; educational resource design /development; ethics; health science research support; human rights; information systems; informed consent; method development

This proposal is requesting short-term interim support for five institutional activities that will have a significant impact in strengthening the oversight of human subjects research at Georgia State University and its partnering institutions. The five activities, which will be sustained after expiration of the award, are as follows: (1) To continue working with the consultants who reviewed the Georgia State University IRB program during the first year of this award to address the several deficiencies identified in that review. (2) To enhance the infrastructure/technology for tracking and managing human subjects protocols by implementing the IRBWISE human subjects web-based IRB management and tracking tool. (3) To develop a system that will ensure privacy, security of data storage, and confidentiality of research conducted on the Internet by implementing the eListen web-based interface that can be used to design, submit and analyze an electronic survey or data collection instrument. (4) To develop a program for strengthening the audit and oversight of IRB approved protocols. The compliance specialists from the four partnering universities have agreed to form a pool of reviewers that will audit each other's institutions currently active and continuing review protocols. (5) To enhance the oversight of human subjects research at the University System of Georgia institutions that currently have limited compliance support infrastructure by making the online training in social and behavioral sciences research available to all the schools requiting training materials for their researchers. Together, these five activities will significantly improve the quality of the systems that protect the tights and welfare of individuals who participate in research conducted by Georgia State University and our partnering institutions researchers. The outcomes of these activities will become embedded in each institution's conduct of research with human subjects ensuring they are sustained after the award period ends. The goal is to ensure that when researchers conduct research using human participants, they do so using the highest ethical standards.

该提案要求为五项机构活动提供短期临时支持，这些活动将对加强格鲁吉亚州立大学及其伙伴机构的人类受试者研究监督产生重大影响。这五项活动，这将是在该奖项到期后持续，如下：（1）继续与顾问谁审查了格鲁吉亚州立大学IRB程序在本奖项的第一年，以解决在审查中发现的几个不足之处。(2)通过实施IRBWISE人类受试者基于网络的IRB管理和跟踪工具，增强跟踪和管理人类受试者方案的基础设施/技术。(3)开发一个系统，以确保隐私，数据存储的安全性和在互联网上进行的研究的机密性， 实施eListen基于网络的界面，可用于设计、提交和分析电子调查或数据收集工具。(4)制定一项计划，以加强对IRB批准的方案的稽查和监督。来自四所伙伴大学的合规专家已同意组成一个审查员库，对彼此机构目前正在进行的和正在进行的审查议定书进行审计。(5)为了加强对格鲁吉亚大学系统机构人类受试者研究的监督，这些机构目前的合规支持基础设施有限， 行为科学研究提供给所有学校要求培训材料，为他们的研究人员。总之，这五项活动将显着提高系统的质量，保护谁参加由格鲁吉亚州立大学和我们的合作机构研究人员进行的研究的个人的权利和福利。这些活动的成果将嵌入每个机构对人类受试者的研究中，以确保在奖励期结束后能够持续下去。其目标是确保当研究人员使用人类参与者进行研究时，他们使用最高的道德标准进行研究。 标准