Human Subjects Research Enhancements Program at MUSC

MUSC 人类受试者研究增强计划

• 批准号: 6591528
• 负责人: John R Raymond
• 金额: $ 15万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 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/6591528
• 关键词: Internet; biomedical registry /referral center; computer data analysis; computer program /software; computer system design /evaluation; computer system hardware; health insurance; health science research support; human rights; informatics; information systems; informed consent

In this application, the Medical University of South Carolina (MUSC) focuses on performance enhancements of its system for protecting human subjects in research, including three IRBs that carry a caseload of more than 1,300 active protocols. Funds are requested for technical services, hardware and software to construct, test and implement an array of databases for use as a decision support system by the IRB and related MUSC activities (biosafety, academic compliance [education, audits], conflict of interest). Our specific aims are to: 1. Develop and implement a secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant, Web-based IRB database system that increases the quality and efficiency of all interactions with human research teams and the review of research protocols (new, continuing, amendments), adverse events, recruitment practices and progress, protocol deviations and violations, and outcomes of corrective action plans resulting from protocol audits. 2. Develop and implement a set of secure, HIPAA-compliant parallel databases for other university activities contributing to human subjects protection. Parallel databases for university biosafety, academic compliance [education, audits], and conflict of interest activities will be linked to the new IRB database, creating an array of relational databases that can be queried to answer specific questions about oversight system activity. 3. Evaluate the effectiveness of the relational database array as an IRB decision support system in: (a) identifying areas of protection of human subjects that need improvement, and (b) facilitating the development, implementation and evaluation of action plans designed to make those improvements. The objective is to increase the quality and efficiency of procedures to protect human subjects in research protocols.The database array will enable identification of areas that need improvement, facilitate evaluation of action plans designed to effect those improvements, and provide data that can be used locally (with distribution to PIs, IRB members, university administration) and nationally in conjunction with other institutions to enhance the protection of human subjects.

在此应用中，南卡罗来纳医科大学 (MUSC) 重点关注其系统的性能增强，以保护研究中的人类受试者，其中包括三个 IRB，其负载超过 1,300 个活动协议。需要资金用于技术服务、硬件和软件，以构建、测试和实施一系列数据库，用作 IRB 和相关 MUSC 活动（生物安全、 学术合规性[教育、审计]、利益冲突）。我们的具体目标是： 1. 开发并实施一个安全、符合健康保险流通和责任法案 (HIPAA) 的基于 Web 的 IRB 数据库系统，该系统可提高与人类研究团队的所有互动以及研究方案审查（新的、持续的、修正案）、不良事件、招募实践和进展、方案偏差和违规行为以及方案审计产生的纠正行动计划的结果。 2. 开发并实施一套安全、符合 HIPAA 的并行数据库，用于有助于人类受试者保护的其他大学活动。大学生物安全、学术合规性[教育、审计]和利益冲突活动的并行数据库将链接到新的IRB数据库，创建一系列关系数据库，可以查询这些数据库来回答有关监督系统活动的具体问题。 3. 评估关系数据库阵列作为 IRB 决策支持系统在以下方面的有效性：(a) 确定需要改进的人类受试者保护领域，以及 (b) 促进旨在实现这些目标的行动计划的制定、实施和评估改进。 目标是提高研究方案中保护人类受试者的程序的质量和效率。数据库阵列将能够识别需要改进的领域，促进对旨在实现这些改进的行动计划的评估，并提供可在本地使用的数据（分发给 PI、IRB 成员、大学行政部门）并在全国范围内与其他机构合作，以加强对人类受试者的保护。