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Human Subjects Research Protections Outreach Project

人类受试者研究保护外展项目

基本信息

批准号：
6777806
负责人：
Barrett J. Rollins
金额：
$ 25万
依托单位：
DANA-FARBER CANCER INST
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-09-01 至 2007-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6777806
关键词：
Internet clinical research data management educational resource design /development health science research support health services research tag human data information dissemination information systems patient safety /medical error training videotape /videodisc

项目摘要

The prote(_tion of human research subjects is paramount during the course of human research. With this overall goal in mind, the Human Subjects Research (HSR) Enhancements Program has called upon large academic research centers to share HSR systems improvements with smaller institutions that lack the resources to make such enhancements on their own. Together with the other members of the Dana-Farber/Partner's Cancer Care (DF/PCC), the DFCI has established affiliations with 13 community-based hospitals throughout the New England area. The DFCI now seeks to extend newly developed HSR tools and educational initiatives to its affiliated community-based hospitals through the Network Affiliate Program (NAP). In AIM I, we will provide the NAP hospitals with access to our centralized computer systems to speed the transmission of protocol information and adverse event reports between the DFIPCC and the NAP hospitals. In AIM II, educational workshops, presentations, IRB mentoring and other educational resource materials will be offered to investigators, study team members and IRB administrators/members at each of the NAP hospital. In AIM III, we will provide a traveling Clinical Research Coordinator (CRC), based in the Network Office of the DFCI, who will monitor HSR at each NAP hospital to facilitate the development of up-to-date HSR practices and procedures, the identification of resource needs, and the process of HSR accreditation. In AIM IV, resources developed to educate potential Human Research Subjects about HSR and to inform the public about clinical trials at the more extensive Dana-Farber/Harvard Cancer Center will be extended to these affiliated community-based hospitals. Safety is enhanced when all parties understand their roles and responsibilities during clinical research, and when tools are available to manage all aspects of such studies. By improving education and information management at our affiliated hospitals, we will enhance the ability of our affiliated institutions to assure the safety of human research subjects cared for at these sites. We expect that this approach will provide a model whereby other Comprehensive Cancer Centers can extend their systems and expertise to smaller affiliated institutions.

在人类研究过程中，保护人类研究对象是至关重要的。考虑到这一总体目标，人类受试者研究（HSR）增强计划呼吁大型学术研究中心与缺乏资源自行进行此类增强的小型机构共享HSR系统改进。与丹娜法伯/合作伙伴的癌症护理（DF/PCC）的其他成员一起，DFCI已与整个新英格兰地区的13家社区医院建立了联系。DFCI现在寻求通过网络附属计划（NAP）将新开发的HSR工具和教育计划扩展到其附属的社区医院。在AIM I中，我们将为NAP医院提供访问我们的中央计算机系统的权限，以加快DFIPCC和NAP医院之间的协议信息和不良事件报告的传输。在AIM II中，将向每个NAP医院的研究者、研究团队成员和IRB管理员/成员提供教育研讨会、演示文稿、IRB指导和其他教育资源材料。在AIM III中，我们将在DFCI的网络办公室提供一名旅行临床研究协调员（CRC），他将在每个NAP医院监测HSR，以促进最新HSR实践和程序的发展，确定资源需求以及HSR认证过程。在AIM IV中，为教育潜在的人类研究受试者了解HSR并向公众宣传更广泛的Dana-Farber/哈佛癌症中心的临床试验而开发的资源将扩展到这些附属社区医院。当所有各方都了解时，安全性得到提高他们在临床研究中的角色和职责，以及何时可以使用工具来管理此类研究的所有方面。通过改善附属医院的教育和信息管理，我们将提高附属机构的能力，以确保在这些研究中心接受治疗的人类研究受试者的安全。我们希望这种方法将提供一种模式，使其他综合癌症中心可以将其系统和专业知识扩展到较小的附属机构。