Human Subjects Research Protections Outreach Project

在人类研究过程中，人类研究对象的保护是至关重要的。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改进的较小机构共享HSR系统改进。DFCI与Dana-Farber/Partner‘s癌症关怀(DF/PCC)的其他成员一起，与新英格兰地区的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)将新开发的高铁工具和教育倡议扩展到其附属的社区医院。在AIM I中，我们将为NAP医院提供进入我们的中央计算机系统的通道，以加快DFIPCC和NAP医院之间的方案信息和不良事件报告的传输。在AIM II中，将向每个国家行动方案医院的调查人员、研究小组成员和IRB管理人员/成员提供教育讲习班、演讲、IRB指导和其他教育资源材料。在AIM III中，我们将提供一名驻扎在DFCI网络办公室的旅行临床研究协调员(CRC)，他将监测每个NAP医院的HSR，以促进制定最新的HSR实践和程序，确定资源需求，以及HSR认证程序。在AIM IV中，为教育潜在的人类研究对象了解HSR并让公众了解更广泛的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的社区医院。当所有各方都理解时，安全就会得到加强 他们在临床研究中的作用和责任，以及何时有工具可用于管理此类研究的所有方面。通过改善我们附属医院的教育和信息管理，我们将增强我们附属机构的能力，以确保在这些地点护理的人体研究对象的安全。我们期望这一方法将提供一种模式，使其他综合性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。

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.