IRB ADMINISTRATION AND MANAGEMENT: A Paperless Approach

IRB 行政和管理：无纸化方法

• 批准号: 6591180
• 负责人: GAIL S HABICHT
• 金额: $ 15万
• 依托单位: STATE UNIVERSITY NEW YORK STONY BROOK
• 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 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591180
• 关键词: automated health care system; behavioral /social science research tag; clinical research; computer assisted patient care; health care policy; health care service evaluation; health science research; health science research support; health services research tag; information systems; patient care management; patient care planning; patient safety /medical error

This application is in response to NIH's invitation to apply for one-time funds for the improvement of the processes that insure the protection of human subjects in research. The responsibility for this compliance function resides in the Office of the Vice President for Research. The management of internal IRB functions has depended on a substantial level of administrative computerization for over 15 years, The objective of this project is to extend the computerization to the investigator community to enhance the review process of projects involving human subjects. While the administrative data system maintains project attributes, the current review of human subjects project applications is completely paper-based. Paper proposals and supporting documents are provided to the Compliance office which then duplicates the information to IRB members by paper. The data system stores and maintains records of summary actions and dates, but the supporting documents themselves, including amendments and adverse event reports are filed in paper format. In recognition of the fact that virtually all of the paper received by the Compliance Office has been in a computer compatible format during the preparation stages, we seek to eliminate the need for reduction of the materials to paper for both the review process itself and archiving. We have investigated and evaluated several alternatives that enable such elimination and propose to implement a system which will in a short time remove entirely the paper basis of the review of projects involving human subjects. We believe that such an initiative will improve both the efficiency and depth of the review and monitoring of projects involving human subjects.

本申请是为了响应NIH的邀请，申请一次性资金，以改善确保保护人类受试者的研究过程。该合规职能由研究副总裁办公室负责。内部IRB职能的管理依赖于超过15年的行政计算机化水平，本项目的目标是将计算机化扩展到研究者群体，以加强涉及人类受试者的项目的审查过程。虽然行政数据系统保持项目属性，但目前对人类受试者项目申请的审查完全是基于纸张的。向合规办公室提供纸质提案和支持文件，合规办公室随后将纸质信息复制给IRB成员。数据系统存储并维护汇总措施和日期的记录，但支持性文件本身（包括修正案和不良事件报告）以纸质格式存档。考虑到合规办公室收到的几乎所有文件在编写阶段都采用了与计算机兼容的格式，我们力求消除将材料缩减为纸张的必要，以供审查过程本身和存档之用。我们已经调查和评估了几种替代方案，使这种消除，并建议实施一个系统，将在很短的时间内完全消除审查涉及人类受试者的项目的纸张基础。 我们认为，这一举措将提高审查和监测涉及人体的项目的效率和深度。