The Cancer Disparities Research Network (CDRN) is an NCI-funded regional partnership spanning the Northeastern portion of the U.S. from the Dakotas to the eastern seaboard with a southern border of Iowa, Illinois, Indiana, eastward to New Jersey. CDRN, utilizing a community-engaged research approach seeks to improve participation of underrepresented populations in clinical trials and biospecimen research. The work described below, spearheaded by CDRN's clinical trials and biospecimen science arm was originally funded by Biospecimen Management Project (BMaP) initiative. We detail the development of a tool intended to facilitate dialogue and enhance the consent process between trial recruiters and potential research participants. We conducted a series of meetings across our region with biospecimen/biobanking experts, community engaged researchers, community partners, and cancer center administrators regarding barriers to improving clinical trial and biospecimen research. The informed consent process was identified as a major factor in limiting participation of underrepresented populations in research. The communication tool was developed after an extensive literature review of existing tools and collection of region-wide pilot data from community focus group reflections on a biospecimen research education module. CDRN partners participated in 10 iterations of this tool prior to cognitive testing with participants and recruiters. The tool consists of a deck of cards that seeks to optimize the conversation around research participation. Cards are organized into three sections: Part 1: basic research information; Part 2: trial-specific details; Part 3: research participants' rights. Based on the literature, this tool introduces research and clinical trial participation and seeks to solicit feedback on the following concepts: 1) understanding of research, 2) importance of informed consent, 3) meaning of your signature, 4) understanding of biobanking research and biological samples, 5) randomization, 6) healthy participants within research, 7) withdrawal from a study, and 8) understanding access to personal health information. We will present data on the tool's development and cognitive testing amongst African American, Latino, and White potential research participants as well as clinical trial recruiters. This tool has the potential to improve communication at the point of trial recruitment. We envision that this tool will increase potential research subjects understanding of research and thus increase study participation by honoring the principles of valid informed consent.

Citation Format: Samantha Torres, Erika de la Riva, Chirisse Taylor, Marla Clayman, Melissa Simon. The development of a culturally appropriate informed consent communication tool. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr A10. doi:10.1158/1538-7755.DISP13-A10