Leveraging Technology Solutions to Automate Informed Consent in a Clinical Research Hospital

Abstract

Problem: Paper informed consent (PIC) forms are associated with incomplete and or inaccurate information such as missing signatures and incorrect patient identification. The Food and Drug Administration’s Bioresearch Monitoring Program audit for the 2019 fiscal year lists failure to obtain informed consent (IC) requirements as one of the most common violations (2%) by clinical investigators in clinical trials. In a selected practice site, approximately 440 (2%) out of 25,000 PICs were returned by the medical records department to clinicians in 2019 due to incomplete and or inaccurate information. This resulted in significant delays in the start of clinical trials, incurring additional time and effort for participants and clinicians to correct and or re-consent. Purpose: The purpose of this quality improvement project was to implement electronic informed consent (EIC) for research participants in the adult oncology, infectious disease, and digestive diseases outpatient clinics in a clinical research hospital. Methods: Pre and post implementation surveys were administered to clinicians (n = 43) to obtain baseline perceptions, and compare preferences and satisfaction with using PIC versus EIC. The clinicians were trained on using EIC for signatures, then EIC was implemented and tracked for eight specific protocol studies. Results: The average confirmed IC available in the electronic health record (EHR) within one day of signing by clinicians for all three clinics increased from 52.5% (pre) to 61.3% (post). EIC use increased by 20%, and returned consents decreased from an average of 2.2% to 0.6%. Clinician preference to use EIC over PIC increased from 44.8% to 57.1%, Fisher’s Exact Test = 0.5256, 2-sided, p > .05. Conclusions: Replacing PIC with EIC was preferred by clinicians, improved documentation of consent, and decreased the time for consent availability in the EHR. The implications for practice are that automating informed consent is associated with improved consenting processes and supports remote workflows.