Collaboration to Enhance Human Subjects Protections

合作加强人类受试者保护

• 批准号: 6779010
• 负责人: CAMILLE NEBEKER
• 金额: $ 10万
• 依托单位: SAN DIEGO 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 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6779010
• 关键词: Internet; biomedical equipment purchase; computer assisted instruction; computer system design /evaluation; computers; educational resource design /development; ethics; experimental designs; handbook; health science research support; interdisciplinary collaboration; patient safety /medical error; training

This proposal describes a plan to utilize short-term interim support to support three goals. First, we propose to enhance the oversight of human subjects protections within the twenty-three campus California State University system by developing a web-based training that focuses on ethical issues unique to research conducted in the social and behavioral sciences. The training will target research investigators as well as IRB members. Once developed, this training will be available to each campus and will be updated as needed to respond to current ethical issues. In addition, SDSU plans to develop a standardized guidance and procedure manual for each institution to use in strengthening their human subjects protection program. This manual will provide the framework for each institution to implement a human subjects protection program that is compliant with federal regulations, yet can be modified as needed in response to specific institutional requirements. SDSU is the only CSU campus eligible for the interim support provided through the HSREP. Second, our proposal requests funding to purchase computer equipment to complement the software developed through our initial award. Specifically, equipment will be purchased to support IRB members in the review of web-based protocol applications. Document scanning equipment will also be purchased to support the transition from a manual submission system to a web-based system. Third, to reduce the burden to both investigators and human subjects that results when multiple institutions are involved in oversight of a research protocol, we will collaborate with UCSD to develop an electronic process to support IRB submission and review when multiple institutions have oversight. We will partner with institutions in the region that are not eligible for this interim support and who engage in collaborative research. It is expected the end product will 1- improve communications between regional IRB's; 2- allow for one protocol submission, by the investigator; and 3- allow for expansion to include other institutions that are involved in collaborative research.

该提案描述了一项计划利用短期临时支持以支持三个目标的计划。首先，我们建议通过开发一种基于网络的培训，重点介绍社会和行为科学领域进行的研究所特有的道德问题，以增强对二十三个加州州立大学系统中人类受试者保护的监督。该培训将针对研究研究人员和IRB成员。一旦开发，该培训将用于每个校园，并会根据需要进行更新以应对当前的道德问题。此外，SDSU计划为每个机构使用标准化的指导和程序手册来加强其人类受试者保护计划。本手册将为每个机构提供符合联邦法规的人类对象保护计划的框架，但可以根据需要进行修改 机构要求。 SDSU是唯一有资格获得通过HSREP提供的临时支持的CSU校园。其次，我们的建议要求资金购买计算机设备，以补充通过我们的初始奖励开发的软件。具体而言，将购买设备以支持IRB成员在审查基于Web的协议应用程序中。还将购买文档扫描设备，以支持从手动提交系统到基于Web的系统的过渡。第三，为了减轻调查人员和人类受试者的负担，这些负担是在多个机构涉及研究协议监督时导致的，我们将与UCSD合作开发电子过程，以支持IRB提交并审查多个机构的监督。我们将与该地区的机构合作，这些机构不符合这种临时支持并从事合作研究的人。预计最终产品将1-改善区域IRB之间的通信； 2-允许 对于一个协议提交，调查员； 3-允许扩展包括参与协作研究所涉及的其他机构。