Human Subjects Research Protections Outreach Project

在人类研究的过程中，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的小型机构分享HSR系统的改进。与丹娜-法伯/合作伙伴癌症护理（DF/PCC）的其他成员一起，DFCI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）将新开发的高铁工具和教育举措推广到其附属的社区医院。在AIM I项目中，我们将向国家计划医院提供使用我们的中央计算机系统的机会，以加快方案信息和不良事件报告在DFIPCC和国家计划医院之间的传输。在AIM II中，将向每个NAP医院的调查员、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，我们将在DFCI网络办公室提供一名巡回临床研究协调员（CRC），他将在每个NAP医院监测高铁，以促进最新高铁实践和程序的发展，确定资源需求，以及高铁认证过程。在AIM IV中，开发用于教育潜在人类研究对象有关HSR的资源，并向公众介绍在更广泛的丹娜-法伯/哈佛癌症中心进行的临床试验，将扩展到这些附属社区医院。当各方都理解时，安全就会得到加强

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.