Most informed consent forms are not patient focused and do not support the needs of the study participant! Use of electronic consent can help improve the current paper document approach, but there is more to it than just replacing paper with a multi-media eConsent. What does it take to make eConsent patient centric?
Patient centricity related to informed consent focuses on better understanding how people absorb information to make an informed decision about participating in a study, and also supporting them throughout the trial. Sure, eConsent can give a better user experience than paper and better support sites and sponsors related to compliance, tracking, monitoring and knowledge testing, but these do not directly relate to patient centricity. We are missing the mark and opportunity to really improve consent. Data shows that with patient centricity we have better recruitment, retention, and better data!
Come to this presentation and hear from the experts as they share their data and expertise on how to best support patient centricity through eConsent. You will learn what aspects of eConsent are essential for supporting this. Better yet, come learn from the experts on what are best practices for the design, process, and presentation of electronic informed consent. You will be surprised as to what matters most as they answer key questions like:
• What multimedia components really matter and how should they best be designed?
• Where do we best use text within eConsent?
• How do we get our team members to value a patient centric approach to improving consent?
Presented by
Sandra “SAM†Sather, MS, BSN, CCRA, CCRC,
Regulatory and Quality, CRF Bracket
SAM has over 30 years of clinical experience, a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. She has served many roles in clinical research, including site study coordinator and manager, sponsor and CRO monitor, quality assurance auditor, risk manager, trainer, and performance management consultant. SAM has held clinical research industry certifications for over 15 years by the Association for Clinical Research Professionals (ACRP). She is a current member of the ACRP Academy Board of Trustees, and Regulatory Affairs Committee (RAC). SAM is a frequent subject matter expert for GCP regulation and speaker at industry conferences. Sam has authored many competency-based curriculums for various clinical research stakeholders.
Melanie Flores CIP, CCRP,
Vice President of Compliance, IntegReview
As the Vice President of Compliance, Melanie is responsible for the daily leadership, management and full responsibility for the Company’s compliance program. Melanie has worked in the IRB industry since 1999 and has been with IntegReview since 2001. Prior to leading the Regulatory Compliance Department, her main focus for 9 years was spent providing training to IRB staff and IRB members to ensure compliance with Federal Regulations, ICH Guidelines, IntegReview IRB Standard Operating Procedures and standards of the AAHRPP.
Vincent Miller,
Duke Clinical Research Institute, Informatics Project Leader: mHealth, remote monitoring and data ca
19 + years of research in areas in mobile health, participant engagement and data source integrations. Specializing in identification of research and business objectives paired with informatics solutions for utilization in clinical research data management operations as well as translational or clinical research projects. Prior work includes identification and implementation new technologies including but not limited to econsent, integrations, application development, devices, and remote data acquisition. Actively designing more efficient and effective data management support for all projects.
John Wilbanks,
Chief Commons Officer at Sage Bionetworks
John Wilbanks is the Chief Commons Officer at Sage Bionetworks, where he leads the Governance team and the development of open source informed consent systems integrated into Apple’s ResearchKit and the NIH’s AllofUs Research Program. Previously, Wilbanks worked as a legislative aide to Congressman Fortney “Pete†Stark, served as the first assistant director at Harvard’s Berkman Center for Internet & Society, founded and led to acquisition the bioinformatics company Incellico, Inc., and was executive director of the Science Commons project at Creative Commons. In February 2013, in response to a We the People petition that was co-led by Wilbanks and signed by 65,000 people, the U.S. government announced a plan to open up taxpayer-funded research data and make it available for free. Wilbanks holds a B.A. in philosophy from Tulane University and also studied modern letters at the Sorbonne.
