Human Subject Enhancement Program

人类受试者增强计划

• 批准号: 6591479
• 负责人: Daniel Michael Dorsa
• 金额: $ 25万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-10 至 2003-09-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591479
• 关键词: computer system design /evaluation; experimental designs; health science research analysis /evaluation; health science research support; information dissemination; information systems; online computer; patient safety /medical error

The specific aim of this project is to enhance human subjects safety by improving efficiency and oversight of electronically tracking and managing human subjects protocols and associated reports and regulatory documents. OHSU includes four schools (Medicine, Nursing, Dentistry, Science & Engineering), two hospitals, numerous primary care and specialty clinics, research institutes and centers and community service programs. Competitive funding awards have more than quadrupled at OHSU during the last decade--from $49 million in 1991 to almost $217 million in 2001. OHSU ranks 29th out of 483 higher education institutions that receive research grants from NIH. The commitment of OHSU to growth in research includes a strong focus on clinical research. The OHSU GCRC is in its 36 thyear of funding, currently at $4.2 million annually. The OHSU Cancer Institute (OCI) was designated a NCI clinical cancer center in 1996 and, during this past year, received over $71 million in funding for 320 projects. OHSU's strategic plan positions the institution on a course that will create a world-class research organization in Oregon. OHSU has also embarked on The Oregon Opporttmity, a $500 million investment initiative. OHSU's current research infrastructure is strained given the current rate of annual increases in extramural fimding and will be challenged to an even larger extent as the institution implements its Oregon Opportunity initiative. This rate of growth has strained the research compliance infrastructure for protocols that are conducted on the main campus and provided even greater challenges for those conducted at off-campus locations. At this point, OHSU has not fully utilized technological advantages for handling protection of human subjects. The IRB, the GCRC, the OCI and some investigators each have their own databases to track the administrative status of human research projects. Information is not shared between the databases and the ultimate source of information is in paper files. A large amount of communication (memos, email and telephone) is necessary to ensure that only the latest approved versions of consent forms, protocols, etc. are being used. OHSU proposes to contract with a vendor to help develop an electronic research compliance system that will allow the creation, submittal, and review of all applicable human subjects research documentation, including but not limited to protocols, consent forms, directly entered adverse event and protocol deviation reports, and institutional information currently transmitted via paper forms. Having this information in electronic form will allow OHSU to more readily share the most up-to-date information about a human subjects research study between the various institutional participants including the investigators and their staffs, the IRB, the Research Subject Advocate/GCRC, the OCI, and other institutional administrative offices. There are many advantages to making the review process of human subjects research electronic. One important example is providing the investigator with the capability of entering and submitting adverse event report information on-line. Capturing the data electronically is critical for tracking adverse events in real time. The system will be able to be set up so that notifications of the adverse event report submittal could be sent almost instantaneously to all other parties that might be impacted by the report. The development of an electronic research compliance system described in this application will greatly increase the likelihood of success in creating the desired seamless, electronic interface between oversight committees and the research centers.

该项目的具体目的是通过提高对人类受试者的电子跟踪和管理的效率和监督，加强受试者的安全，以及相关的报告和管理文件。OHSU包括四所学校(医学、护理、牙科、科学和工程)、两家医院、许多初级保健和专科诊所、研究 研究所和中心以及社区服务计划。在过去的十年里，OHSU的竞争性资金奖励增加了四倍多--从1991年的4900万美元增加到2001年的近2.17亿美元。在获得NIH研究资助的483所高等教育机构中，OHSU排名第29位。OHSU对研究增长的承诺包括对以下方面的强烈关注 临床研究。OHSU GCRC已进入第36个资助年头，目前为每年420万美元.OHSU癌症研究所(OCI)于1996年被指定为NCI临床癌症中心，在过去的一年中，该研究所为320个项目获得了超过7100万美元的资金。OHSU的战略计划将该机构定位为将在俄勒冈州创建世界级研究机构的课程。俄勒冈州立大学还启动了俄勒冈Opporttmity项目，这是一项5亿美元的投资计划。鉴于目前校外活动的年增长率，OHSU目前的研究基础设施紧张，随着该机构实施俄勒冈州机会计划，将受到更大程度的挑战。这种增长速度使在主园区进行的协议的研究合规性基础设施变得紧张，并给在校外地点进行的协议带来了更大的挑战。 在这一点上，OHSU还没有充分利用技术优势来处理对人类主体的保护。IRB、GCRC、保监处和一些调查人员各自都有自己的数据库来跟踪人类研究项目的行政状况。信息不在数据库之间共享，信息的最终来源是纸质文件。有必要进行大量的沟通(备忘录、电子邮件和电话)，以确保只使用最新批准版本的同意书、协议等。OHSU建议与供应商签订合同，帮助开发一个电子研究合规系统，该系统将允许创建、提交和审查所有适用的人类受试者研究文件，包括但不限于方案、同意书、直接输入的不良事件和方案偏差报告，以及目前通过纸质表格传输的机构信息。拥有电子形式的这些信息将使OHSU能够更容易地在不同的机构参与者之间分享关于人类受试者研究的最新信息，包括调查人员及其工作人员、IRB、研究对象倡导者/GCRC、保监处和其他机构行政办公室。将人类受试者研究的审查过程电子化有许多好处。一个重要的例子是向调查员提供在线输入和提交不良事件报告信息的能力。以电子方式捕获数据对于实时跟踪不良事件至关重要。将能够设置该系统，以便将提交不良事件报告的通知几乎立即发送给可能受该报告影响的所有其他方。这个 开发本申请中描述的电子研究合规系统将大大增加在监督委员会和研究中心之间创建所需的无缝电子接口的成功可能性。