Enhancement of UCSF Human Subjects Protection Program

加强加州大学旧金山分校人类受试者保护计划

• 批准号: 6591996
• 负责人: REGIS B KELLY
• 金额: $ 25万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 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 2003-09-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591996
• 关键词: Internet; clinical research; computer assisted instruction; computer program /software; computer system design /evaluation; education evaluation /planning; educational resource design /development; health care policy; health related legal; health science research support; human rights; information systems; informed consent

The ultimate goal of this award is to improve the University of California, San Francisco's (UCSF) protections for human subjects. The challenges of expanding activity in human subjects research, an increasingly complex regulatory environment, and limited resources have hampered our ability to keep our educational programs, policies and infrastructure up to date. To address this, programs are proposed that will increase researchers' knowledge, reduce unnecessary correspondence and revision due to lack of knowledge, allow more efficient review and processing of applications, ensure that regulatory and ethical questions are addressed more clearly and completely, revise processes to incorporate recent changes in regulations and guidelines, and allow more detailed and accurate tracking. Specifically,(1) New educational modules will be developed which will improve the ability of the Committee on Human Research (CHR), UCSF's IRB, to deliver training; (2) all existing guidelines and policies will be updated, posted to the CHR web site, and made available as small brochures and booklets; and (3) a fully on-line application process will be developed that allows researchers to submit protocols electronically, correlates protocol types to training requirements, tracks adverse events, and tracks other compliance-related data. These activities will result in a reduction of time spent on routine submission, review, and tracking procedures and allow researchers and IRB members to focus on more substantive subject protection issues. IRB review letters will give less attention to correcting routine omissions and greater attention to larger issues. In order to assess the effectiveness of these activities, samples of letters will be evaluated before and after the grant period to see if the type of content has shifted. Process metrics will be tracked on IRB review cycles and other operational issues. Sample research records will be evaluated for the consistent use of IRB-approved consent forms. Feedback from knowledgeable faculty and staff who are aware of consent processes and subject satisfaction in multiple studies will be sought.

该奖项的最终目标是改善加州大学弗朗西斯科分校（UCSF）对人类受试者的保护。人类受试者研究活动的扩大，日益复杂的监管环境和有限的资源的挑战阻碍了我们保持我们的教育计划，政策和基础设施的能力。为了解决这个问题，提出了一些方案，这些方案将增加研究人员的知识，减少由于缺乏知识而造成的不必要的通信和修改，允许更有效地审查和处理申请，确保更清楚和完整地解决监管和伦理问题，修改流程以纳入法规的最新变化， 并允许更详细和准确的跟踪。具体而言，（1）将开发新的教育模块，以提高加州大学旧金山分校的IRB（人类研究委员会）提供培训的能力;（2）将更新所有现有的指导方针和政策，张贴在人类研究委员会的网站上，并以小册子和小册子的形式提供;以及（3）将开发一个完全在线的申请过程，允许研究人员以电子方式提交方案，将方案类型与培训要求相关联，跟踪不良事件，并跟踪其他与合规性相关的数据。 这些活动将减少常规提交、审查和跟踪程序所花费的时间，并使研究人员和IRB成员能够专注于更实质性的受试者保护问题。IRB审查函将较少关注纠正常规遗漏，而更多关注更大的问题。 为了评估这些活动的有效性，将在资助期前后对信件样本进行评估，以确定内容类型是否发生了变化。将根据IRB审查周期和其他操作问题跟踪过程指标。将评价样本研究记录是否一致使用IRB批准的知情同意书。将寻求了解多项研究中知情同意过程和受试者满意度的知识渊博的教职员工的反馈。