Improved Electronic Work Process/Data Systems

约翰霍普金斯大学致力于保护人类研究对象。这一承诺始于全面的义务教育和培训我们的教师，学生和工作人员的研究人员谁进行人类受试者的研究。它继续发展一个全面的计划，以支持我们的机构审查委员会（IRB）和我们参与人类受试者研究的研究人员。该大学共有8个IRB，2003年9月将扩大到9个：5个在医学院，2个在公共卫生学院（2003年9月成为3个），1个在艺术和科学学院。这些委员会监督大约3,500个协议， 超过5万人参与。在过去的一年中，我们继续对我们的整个人类受试者保护计划进行了深入的审查，包括我们IRB的政策、程序、实践和支持系统。基于我们获得的见解以及我们申请认证的意图，我们制定了继续开发支持我们保护人类受试者所需的改进电子工作流程和数据系统的目标。 因此，我们希望将这笔赠款集中用于以下具体目标：1.将IRB方案提交和审查流程转换为无纸化电子工作流程系统，以提高方案提交和审查流程的及时性和一致性，成为方案状态沟通的来源，确保人类受试者保护计划始终符合联邦法规以及机构程序和政策，改善对已批准研究的监测，并确保IRB记录准确。2.计划并开始开发交互式研究受试者登记系统，为研究者、临床医生、IRB和合规工作人员提供有关受试者、方案和受试者经历的非研究临床事件的信息;从而改善临床护理，确保研究者和IRB了解潜在不良事件，提供关于研究性研究资助的研究患者护理以及受试者指定的隐私授权的数据。

The Johns Hopkins University is deeply committed to the protection of human research subjects. This commitment begins with comprehensive compulsory education and training of our faculty, student, and staff researchers who conduct human subjects research. It continues with the development of a comprehensive program to support our institutional review boards (IRBs) and our investigators involved in human subjects research. The University has a total of eight IRBs which will be expanded to nine in September 2003: five in the School of Medicine, two in the School of Public Health (becoming three in September 2003) and one in the School of Arts and Sciences. These boards oversee approximately 3,500 protocols that directly involve more than 50,000 human participants. During the past year, we have continued an intensive review of our entire human subjects protection program, including the policies, procedures, practices and support systems of our IRBs. Based on the insights that we have gained, and our intent to apply for accreditation, we have formulated the goal of continuing the development of improved electronic work process and data systems needed to support our protection of human subjects. Accordingly, we wish to focus this grant on the following specific aims: 1. To convert the IRB protocol submission and review processes to paperless electronic work process systems that will enhance the timeliness and consistency of the protocol submission and review process, be a source of protocol status communication, assure consistent human subjects protection program compliance with federal regulations and institutional procedures and policies, improve the monitoring of approved studies and assure accurate records for our IRBs. 2. To plan and begin development of an interactive research subject registry that could provide investigators, clinicians, IRBs and compliance staff with information about the subjects, protocols and non-study clinical events experienced by the subjects; thereby improving clinical care, assuring investigator and IRB knowledge of potential adverse events, providing data on what research patient care is funded by the research study and what privacy authorization has been specified by the subject.