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 I V, 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.
| Hoffner, Brianna; Bauer-Wu, Susan; Hitchcock-Bryan, Suzanne et al. (2012) ""Entering a Clinical Trial: Is it Right for You?"": a randomized study of The Clinical Trials Video and its impact on the informed consent process. Cancer 118:1877-83 |
