Human Subjects Research Enhancements Program at MUSC

南卡罗来纳医科大学(MUSC)继续把重点放在提高其机构审查委员会(IRBs)的绩效上，这些委员会有1300多项有效方案。在支助的第一年，我们开始开发一系列以数据为导向的决策支持工具，以装备综合资源中心和相关的遵约活动。在第二年，我们建议：a)继续这一发展，b)开始开发基于网络的会议工具，c)与另一个机构合作，作为迈向全州虚拟IRB系统的第一步。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，该系统除了加强对涉及人体受试者、不良事件、招聘做法和进展、方案偏差和违规以及方案审计所产生的纠正行动计划结果的方案的审查外，还提高了与调查小组互动的质量和效率。 2.为生物安全、学术合规(教育、审计)和利益冲突等有助于人类主体保护的问题开发和实施并行数据库。这些数据库将与新的内部审查机构数据库相连接，创建一组可查询监督系统活动和有效性的关系数据库。 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)确定需要改进的保护人类主体的领域；b)促进执行旨在作出这些改进的行动计划。 4.与南卡罗来纳州立大学(南卡罗来纳州立大学)建立伙伴关系，以加强对两所大学人类研究对象的保护。南加州州立大学是一所综合性的、国家支持的、为少数族裔服务的机构和土地赠与大学，距离南卡罗来纳州奥兰治堡的南加州大学80英里。除了为合作机构提供直接利益外，从建立伙伴关系中获得的经验还将促进与该州其他机构的联系。 如上所述，这项提议的较长期目标是在机构网络的基础上创建一个全州范围的虚拟IRB。这一系统将把当地的专门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其当地问题的灵活性。

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.