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主办主席圆桌会议以及 IRB 成员和临床研究人员务虚会，进一步加强整个卫生系统的人类受试者保护环境，并加强我们的研究合规性监督计划。来自我们卫生系统内所有医院的适当高层人士（包括一些拥有独立IRB的医院）将召开主席圆桌会议，概述他们在进一步丰富人类受试者保护计划方面的责任。活动结束后，将为所有 IRB 成员和临床研究人员举办为期两天的静修会，让他们了解正确审查和开展研究所需的知识和工具 与人类受试者。这次务虚会将为研究人员和 IRB 成员提供单独的轨道，重点是 GCRC 的利用。为本次活动开发的工具将用于未来的培训和教育，作为持续努力的一部分，协助我们整个卫生系统的研究人员完善他们在人类受试者保护和方案制定方面的技能和知识。将在研究静修处首次举办的“研究路演”将设有多个展位，描绘研究方案从想法的构思到研究计划的诞生的整个过程。这些展位将包括对研究方案的正确制定至关重要的领域的专家，包括适当的科学/医学专业、适当的方案设计、GCRC 的利用以及研究主题倡导者 (RSA) 的作用、IRB 提交和我们的卫生系统内运营独立 IRB 的社区医院之一将通过购买计算机和视听设备来增强其计划，这将使他们的人类受试者保护计划能够满足他们不断增长的研究计划的需求。此外，还将评估当前的研究合规计划，如有必要，将聘请顾问来帮助确定该计划可以改进的领域。在评估和改进该计划的同时，将聘请按日津贴工作人员协助进行审计。购买计算机设备将为合规人员提供高效进行现场审核和撰写合规报告所需的机动性。