Human Subjects Research Enhancements Program at MUSC

南卡罗来纳州医科大学（MUSC）继续专注于提高其机构审查委员会（IRB）的绩效，该委员会的工作量超过1300个活动协议。在支持的第一年，我们开始开发一系列数据驱动的决策支持工具，以装备IRB和相关的合规活动。在第二年，我们建议：a）继续这一发展，B）启动基于网络的会议工具的开发，和c）与另一个机构的合作伙伴，作为第一步向全州虚拟IRB系统。我们的具体目标是： 1.继续开发和实施一个安全的、符合HIPAA的、基于网络的1RB数据库系统，除了加强对涉及人类受试者的方案、不良事件、招募实践和进展、方案偏离和违反以及方案稽查产生的纠正措施计划结果的审查外，还可以提高与研究者团队互动的质量和效率。 2.开发和实施有助于人类受试者保护问题的平行数据库，例如，生物安全、学术合规（教育、审计）和利益冲突。这些数据库将与新的内部审查委员会数据库连接，建立一系列关系数据库，可查询监督系统的活动和有效性。 3.评价数据库阵列作为IRB决策工具在以下方面的有效性：a）识别需要改进的人类受试者保护领域，以及B）促进旨在实现这些改进的行动计划的实施。 4.与南卡罗来纳州州立大学建立伙伴关系，以加强对这两个机构的人类研究对象的保护。SCSU是一个综合性的，国家支持的，少数民族服务机构和赠地大学，位于南卡罗来纳州奥兰治堡的MUSC 80英里处。除了为合作机构提供直接利益外，从合作伙伴关系的形成中获得的经验将促进与该州其他机构的联系。 如上所述，该提案的长期目标是建立一个基于机构网络的全州虚拟IRB。这样一个系统将把当地的专业知识与全州范围的系统联系起来，以加强对人类受试者的保护和其他研究合规问题，同时保留每个机构处理当地问题的灵活性。

The Medical University of South Carolina (MUSC) continues to focus on enhancing performance of its institutional review boards (IRBs), which carry a caseload of over 1300 active protocols. During the first year of support, we initiated development of a series of data-driven decision support tools to equip the IRBs and associated compliance activities. During the second year, we propose to: a) continue this development, b) initiate development of tools for web-based meetings, and c) partner with another institution as a first step toward a statewide virtual IRB system. Our specific aims are to: 1. Continue the development and implementation of a secure, HIPAA-compliant, web-based 1RB database system that increases the quality and efficiency of interactions with investigator teams in addition to enhancing the review of protocols involving human subjects, adverse events, recruitment practices and progress, protocol deviations and violations, and outcomes of corrective action plans resulting from protocol audits. 2. Develop and implement parallel databases for issues contributing to human subject protection, e.g., biosafety, academic compliance (education, audits), and conflict of interest. These databases will be linked to the new IRB database, creating an array of relational databases that can be queried about oversight system activity and effectiveness. 3. Evaluate the effectiveness of the database array as an IRB decision tool in: a) identifying areas of protection of human subjects that need improvement, and b) facilitating implementation of action plans designed to make those improvements. 4. Establish a partnership with South Carolina State University (SCSU) for enhancement of the protection of human research subjects at both institutions. SCSU, a comprehensive, state-supported, minority-serving institution and land-grant university, is located 80 miles from MUSC in Orangeburg, SC. In addition to providing direct benefits to the partnering institutions, experience gained from formation of the partnership will facilitate linkage with other institutions in the state. As indicated above, the longer-range goal of this proposal is to create a statewide virtual IRB based on a network of institutions. Such a system will link local expertise into a statewide system to enhance protection of human subjects and other research compliance issues while retaining the flexibility of each institution to deal with its local issues.