Leveraging Technology Solutions to Automate Informed Consent for Outpatients

Problem: Paper-informed consent 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 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 paper informed consents 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 is to implement electronic informed consent for research participants in the adult oncology, allergy and infectious disease, and diabetes, digestive, and kidney diseases outpatient clinics in a clinical research hospital.

Methods: Pre-implementation surveys were administered to clinicians (n=43) to obtain baseline perceptions on using paper versus electronic consents. The clinicians were then trained remotely on using electronic consent for signatures. Paper consents were replaced with electronic consents for specific protocol studies (n=8), followed by a post-implementation survey to compare clinicians’ preferences and satisfaction.

Preliminary results: Preliminary results show an increase in the mean percentage of confirmed electronic informed consents accessible in the electronic health record within one day of signing by clinicians. However, the results of the project have not yet been completed. The plan will be to discuss the findings for documentation of informed consent, timeframe for accessibility of confirmed consents in the electronic health record, and clinician satisfaction with using electronic informed consent.

Preliminary conclusions: Preliminary conclusions show that replacing paper with electronic informed consent appears to improve documentation. However, the results of the project have not yet been completed, and therefore conclusions cannot be drawn at this time.