Human Subjects Research Protection Improvement Plan

人类受试者研究保护改进计划

• 批准号: 6778022
• 负责人: JEFFREY H SILVERSTEIN
• 金额: $ 25万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 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 2006-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6778022
• 关键词: clinical research; computer program /software; health science research support; health services research tag; human data; human rights; informatics; information systems; informed consent; patient safety /medical error; training

The goals of this continuation proposal are 1) to expand the computer based system that was proposed last year to encompass components beyond those previously included and 2) to collaborate with four institutions that conduct human subjects research, none of which were previously funded by the S 07 program. In addition to serving as an instrument for an investigator's development and submission of applications to the IRB, IRB office management and tracking of all appli cations, adverse events, and advert isements, a tool for monitoring the education of IRB members, staff and investigators and a means for preparing agendas and minutes, the expanded system will incorporate the following additional components that are highly relevant to the protection of hum an research subjects: a) conflicts of interest; b) the new requirements of the Health Insurance Portability and Accountability Act (HIPAA); c) biosafety considerations; and d) pharmacy information required for all drugs utilized in protocols that include human subjects. Furthermore, access to the computer based system will be expanded beyond the investigators, IRB members and staff to incorporate access to staff of the Grants and Contracts Offices and access to relevant components of the IRB application by designated individuals in the General Clinic al Research Center (GCRC) incl uding the Research Subject Advocate (RSA), the MSSM Conflicts of Interest in Research Committee, the Bios afety Officer and Biosafety Committee, the Research Pharmacy and the MSSM Compliance Officer. The collaboration with the external institutions will include integrating the needs of those institutions relative to human subjects research into the computer system and sharing the product that is devel oped with these institutions. The collaborating institutions will include Elmhurst Hospital Center, Queens Medical Center (both part of the Health and Hospital Corporation of New York City), the Jewish Home and Hospital of New York and the Bronx Veteran's Administration Medical Center. The expanded access to the computer system and the unique, rapidly available searchable system for adverse events that will be provided to the MSSM GCRC RSA and Biosafety Committee are considered particularly important elements of the proposed software that will greatly enhance the ability of the MSSM IRB and its collaborating instituti ons to protect human research subjects.

该延续提案的目标是 1) 扩展去年提出的基于计算机的系统，以包含先前包含的组件之外的组件，以及 2) 与四个进行人类受试者研究的机构合作，这些机构以前都没有得到 S 资助。 07 计划。除了作为研究者向 IRB 制定和提交申请、IRB 办公室管理和跟踪所有申请、不良事件和广告的工具之外，还可以作为监测 IRB 成员、工作人员和研究者教育的工具，以及准备议程的手段和 分钟，扩展后的系统将纳入以下与保护人类和研究对象高度相关的附加组件： a) 利益冲突； b) 健康保险流通与责任法案 (HIPAA) 的新要求； c) 生物安全考虑； d) 包括人类受试者在内的方案中使用的所有药物所需的药房信息。此外，对基于计算机的系统的访问将扩展到研究者、IRB 成员和工作人员之外，以纳入对拨款和合同办公室工作人员的访问以及普通临床研究中心指定个人对 IRB 应用程序相关组件的访问（ GCRC）包括研究对象 倡导者 (RSA)、MSSM 研究利益冲突委员会、Bios 安全官和生物安全委员会、研究药房和 MSSM 合规官。与外部机构的合作将包括将这些机构与人类受试者研究相关的需求整合到计算机系统中，并共享与这些机构开发的产品。合作机构将包括埃尔姆赫斯特医院中心、皇后医疗中心（均为纽约市健康和医院公司的一部分）、纽约犹太之家和医院以及布朗克斯退伍军人管理局医疗中心。对计算机系统的扩展访问以及独特的、快速的 将提供给 MSSM GCRC RSA 和生物安全委员会的不良事件可用搜索系统被认为是拟议软件的特别重要元素，将大大增强 MSSM IRB 及其合作机构保护人类研究对象的能力。