Strengthening oversight of human subjects research

这项提议要求为五项机构活动提供短期临时支助，这些活动将对加强佐治亚州立大学及其伙伴机构对人体研究的监督产生重大影响。在该奖项到期后将继续开展的五项活动如下：(1)在本奖项的第一年，继续与审查佐治亚州立大学IRB项目的顾问合作，以解决审查中发现的几个不足之处。(2)通过实施IRBWISE人类受试者网上IRB管理和跟踪工具，加强跟踪和管理人类受试者协议的基础设施/技术。(3)发展一套系统，以确保在互联网上进行的研究的私隐、资料储存的安全和保密。 实现eListen基于Web的界面，该界面可用于设计、提交和分析电子调查或数据收集仪器。(4)制定一项计划，加强对IRB批准的协议的审计和监督。来自四所合作大学的合规专家已同意组成一个审查员池，将对彼此的机构目前活跃的和持续的审查协议进行审计。(5)加强对目前合规支助基础设施有限的佐治亚州大学系统的人类受试者研究的监督，方法是在社会和教育领域开展在线培训 向所有学校提供行为科学研究，要求为他们的研究人员提供培训材料。总之，这五项活动将显著提高保护个人紧身衣和福利的系统的质量，这些个人参与了佐治亚州立大学和我们的合作机构研究人员进行的研究。这些活动的结果将纳入每个机构与人类受试者进行的研究中，以确保在获奖期结束后继续进行这些研究。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 标准。

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.