The protection of research participants is paramount during the course of human research. With this overall goal in mind, national organizations and federal agencies have called for systems improvements to assure overall research participant safety. The DFCI maintains the sole IRB of record for all adult clinical oncology research opened through the Dana-Farber/Harvard Cancer Center, and for pediatric clinical oncology research shared with Children's Hospital of Boston. The DFCI has existing needs in two areas in which self-sustaining programs would enhance patient safety, education and adverse event reporting.
In AIM 1, we propose to develop web-based, written and videotaped educational materials to enhance investigator, study staff, and IIRB member knowledge in multiple areas related to clinical research; and written and videotaped materials to educate potential research participants about the process of clinical research, their rights as study subjects, and the specifics of the proposed clinical protocol.
In AIM 2, we will develop enhanced systems to record and monitor adverse events. The improved adverse event reporting infrastructure will assure that the information is available during the course of the study, as appropriate, to the IRB, administrative staff and review groups responsible for monitoring research participant safety, and to the relevant clinical investigators throughout the Dana-Farber/Harvard Cancer Center. 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. Through education and improved information management, we will enhance our ability to assure the safety of the people who volunteer to participate in clinical research.
| 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 |
