In 2015, Academic & Research Computing (ARC) began working on a custom eConsent platform built upon REDCap, a popular web-based data capture system that already had a strong research presence at BIDMC. At that time, there were few options for obtaining consent remotely; those that did exist generally lacked key features such as document versioning. The Covid-19 pandemic added urgency and impetus to the project.
This system, built with input from the IRB and Human Subjects Protection Office, needed only a few tweaks to become compliant with Title 21 CFR Part 11 government regulations. These are the Federal Drug Administration’s (FDA) specifications for electronic records and electronic signatures. Compliance with 21 Part 11 is needed for FDA regulated drug and device trials. Though there are BIDMC research studies that require formal consent but don’t require 21 Part 11 Compliance, there are compelling reasons to have a single, standard system for eConsent. It eases the overhead of administration, it is easier for the users, and it simplifies the training needed. In 2022-2023, the system underwent a validation process for FDA 21 Part 11 compliance. All studies using the BILH eConsent system are compliant with 21 Part 11 when used according to the guidelines in this document.