Promoting an Environment of Compliance

促进合规环境

• 批准号: 6777246
• 负责人: Jacqueline Altman
• 金额: $ 20万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 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 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6777246
• 关键词: behavioral /social science research tag; biomedical equipment purchase; computers; education evaluation /planning; experimental designs; health care personnel education; health care policy; health care service evaluation; health science research support; health services research tag; patient safety /medical error; training; training aid

The objectives of this proposal are to further strengthen the human subjects protections environment throughout the Health System by hosting a Chairs' Roundtable and a retreat for IRB members and clinical researchers, and to enhance our program for research compliance oversight. Appropriate high-level individuals from all the hospitals within our health system, including some with independent IRBs, will be convened for a Chair's Roundtable to outline their responsibilities in further enriching the program for human subjects protections. Following this event, a two-day retreat will be held for all IRB members and clinical researchers to expose them to the knowledge and tools necessary to properly review and conduct research with human subjects. The retreat will feature separate tracks for researchers and IRB members, with emphasis placed on the utilization of the GCRC. The tools developed for this event will then be used for future training and education as part of an ongoing effort to assist the researchers throughout our health system in refining their skills and knowledge in human subjects protections and protocol development. A "Research Road Show" to be debuted at the Research Retreat will feature a number of booths that depict the life of a research protocol from the conception of an idea to the birth of a research plan. These booths will include individuals who are specialists in the areas crucial to the proper development of a research protocol, including the appropriate scientific/medical specialties, proper protocol design, GCRC utilization and the role of the research subject advocate (RSA), IRB submission and process, statistical design, regulations, ethics, etc. One of the community hospitals within our health system that operates a separate IRB will have their program enhanced through the purchase of computer and audiovisual equipment, which will allow their human subjects protections program to meet the demands of their growing research program. Additionally, the current program for research compliance will be evaluated and, if necessary, a consultant will be hired to help determine the areas where the program can be improved. Per diem staff will be hired to assist in the conduct of audits while this program is being evaluated and improved. The purchase of computer equipment will provide the compliance staff with the mobility that is necessary for efficiently conducting on-site audits and for writing compliance reports.

该提案的目标是通过举办椅子的圆桌会议和IRB成员和临床研究人员的务虚会，进一步增强整个卫生系统的人类受试者的环境，并增强我们的研究合规性监督计划。来自我们卫生系统中所有医院的适当高级个人，包括具有独立IRB的一些医院，将召集主席的圆桌会议，以概述其责任，以进一步丰富针对人类受试者的保护计划。在此活动之后，将为所有IRB成员和临床研究人员举行为期两天的务虚会，以使他们了解正确审查和进行研究所需的知识和工具 与人类主题。该务虚会为研究人员和IRB成员提供单独的曲目，重点放在GCRC的利用率上。然后，为本活动开发的工具将用于将来的培训和教育，这是一项持续努力的一部分，以帮助整个卫生系统的研究人员在人类受试者保护和协议开发方面的技能和知识。将在研究度假胜地首次亮相的“研究路展”将有许多摊位，这些摊位描绘了从想法的概念到研究计划的诞生的研究协议的生活。这些摊位将包括在适当开发研究方案至关重要的领域中的专家，包括适当的科学/医学专业，适当的协议设计，GCRC利用以及研究主题倡导者（RSA）的作用（RSA），IRB提交和过程，统计学，法规，法规，伦理学等，在我们的健康系统中，他们可以在我们的健康系统中进行操作，以使其在我们的健康系统中进行操作。将允许其人类对象保护计划满足其不断增长的研究计划的需求。此外，将评估当前的研究合规计划，并在必要时聘请顾问来帮助确定可以改进该计划的领域。在评估和改进该计划时，将雇用DIEM员工来协助进行审计。购买计算机设备将为合规人员提供有效进行现场审核和编写合规报告所需的机动性。