Abstract 5946: Universal consent for biospecimens: A novel electronic/video consent

Abstract

Abstract Background: Developing innovative, efficient and institutionally scalable bio-specimen consent for remnant tissue that meets the NIH consent guidelines for genomic and molecular analysis is essential for precision medicine efforts in cancer. Solutions in this arena need to satisfy the needs of patients, researchers, ethicists, IRB and compliance leadership, while fitting as seamlessly as possible into existing clinical workflows. Methods: UCLA developed a video-application kiosk-based approach for providing universal consent to repurpose clinical remnant bio-specimen for research. The process was designed to be self-service, comprehensive yet fast (mean shorter than 5 minute for completion). The consent additionally asked the patient if they were willing to be contacted directly for future research projects. This approach was piloted with 474 patients who were coming in for routine services in laboratory medicine, radiology, oncology, and hospital admissions. Of the pilot population, 175 individuals had targeted surveys to evaluate drivers for opting-in or opting-out of the consent for allowing the collection and use of their remnant tissue for research. The cognitive survey was online and presented immediately after the consent process was completed. Results: The opt-in rate for the pilot was 90.7%, and 56% agreed to direct contact for future research. Only 7% needed help navigating the online consent process. Of the subgroup of pilot population who completed the targeted survey, there was no difference between individuals who opted in and out regarding ease of use, of the consent application with about 75% stating it provided mostly or very useful information, 90% stating it was mostly or very easy to understand, and 85% stating they trusted the information. However, there were significant differences between those that opted-in and opted-out in their beliefs concerning usefulness of tissue, trusting researchers, importance of contributing to science and privacy risk with those opting in strongly supporting these beliefs (>90%) compared to those that opted out (<40%), p<0.001. Conclusions: Video-application approach for allowing individuals to consent for remnant specimens to be collected and used for research, including cancer research, can be efficient, patient-centric and meet the NIH requirements. This method could increase the availability of blood and tissue for cancer research and should be tested for scalability as an enterprise solution. Citation Format: Arash Naeim, Neil Wenger, Antonia Petruse, Liliana Sanchez, Azita Sharif, Sarah Dry. Universal consent for biospecimens: A novel electronic/video consent [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 5946. doi:10.1158/1538-7445.AM2017-5946