Human Subjects Research Enhancements Program

人类受试者研究增强计划

基本信息

批准号：
6777870
负责人：
WENDY A VISSCHER
金额：
$ 14.99万
依托单位：
RESEARCH TRIANGLE INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-09-01 至 2005-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6777870
关键词：
Internet clinical research computer system design /evaluation data management education evaluation /planning ethics health administration health science research support human rights information systems informed consent meeting /conference /symposium training

项目摘要

RTI's mission is "to improve the human condition through objective, innovative, multidisciplinary research, development and technical services, setting the standard for scientific and professional excellence." To fulfill our mission, we must ensure that our research meets the highest ethical standards and that the rights and safety of all of our study participants are protected. RTI has an established human subjects protection program that enjoys the support of upper management and the respect of researchers. This grant will allow us to strengthen our program to keep pace with new issues in the changing human subjects environment. Our grant application consists of three complimentary components: (1) developing a module on human subjects protection to be used for a university-based training in responsible conduct of research, (2) hosting a symposium on human subjects and privacy issues relevant to international research, and (3) the transition of our existing IRB management information system to the intranet to allow for electronic submission of protocols and amendments, automatic generation of approval notices, tracking logs for amendments and adverse events, and ready access by investigators to standard on-line forms. It is important that not only researchers, but also students in various research disciplines, be trained in the ethics and practices of responsible research. The responsible conduct of research (RCR) training module we propose will include information about methods for protecting human subjects that are ethically sound and satisfy the federal regulations. This will be part of a comprehensive RCR curriculum focused on social research and will be developed in collaboration with a consortium of local universities. The international symposium will bring together speakers and attendees from the U.S. and abroad to discuss human subjects and privacy issues relevant to research conducted in other countries. Finally, our computerized IRB management information system (MIS) has been evolving over several years. During the first year of our HSREP grant, we began to augment this system. During the second year, we plan to continue to streamline the system by adapting the MIS, and the IRB forms associated with it, for web-based application. This will significantly streamline our IRB operations, and help our researchers navigate the system efficiently, while still assuring that we operate within all applicable regulations. This will allow the IRB staff to devote more time interacting directly with researchers and giving guidance on specific human subjects issues.

RTI的使命是“通过客观，创新，多学科研究，发展和技术服务改善人类状况，为科学和专业卓越的标准树立标准。”为了履行我们的使命，我们必须确保我们的研究符合最高的道德标准，并且我们所有研究参与者的权利和安全受到保护。 RTI拥有一项既定的人类受试者保护计划，该计划享有高层管理人员的支持和研究人员的尊重。这笔赠款将使我们能够加强计划，以与不断变化的人类主题环境中的新问题保持同步。我们的赠款申请包括三个免费组成部分：（1）开发人类模块受试者的保护用于基于大学的负责任研究培训，（2）主持与国际研究有关的人类受试者和隐私问题研讨会，以及（3）我们现有的IRB管理信息系统过渡到Intranet为了允许提交协议和修正案的电子提交，自动生成批准通知，跟踪修正案和不利事件的日志，以及调查人员准备访问标准的在线表格。重要的是，不仅研究人员，而且在各个研究学科中的学生都需要接受负责任研究的伦理和实践培训。我们建议的负责任的研究（RCR）培训模块将包括有关保护人类受试者的方法的信息并满足联邦法规。这将是专注于社会研究的全面RCR课程的一部分，并将与当地大学的财团合作开发。国际研讨会将召集来自美国和国外的演讲者和与会者，讨论与其他国家进行的研究有关的人类主题和隐私问题。最后，我们计算机化的IRB管理信息系统（MIS）已在几年中不断发展。在我们的HSREP赠款的第一年，我们开始增强该系统。在第二年，我们计划通过调整MIS以及与IRB相关的IRB表格来继续简化系统，以用于基于Web的应用程序。这将大大简化我们的IRB操作，并帮助我们的研究人员有效地浏览系统，同时仍然确保我们在所有适用的法规中运作。这将使IRB员工能够将更多的时间直接与研究人员互动，并就特定人类受试者的问题提供指导。