Sr. Clinical Research Quality Assurance Analyst | Human Research Protection Program University of Minnesota Saint Paul, Minnesota
Background: An investigator self-audit tool to assess compliance with REDCap eConsent requirements was designed and implemented by the HRPP QA program. The self-audit was part of a CAPA plan requested by the UMN Office of Internal Audit, four years after the pandemic had urgently necessitated remote consent.
Program
Description: The goal was for researchers to assess compliance with eConsent requirements. Success was measured by self-audits completed and if non-compliance was reported to the IRB. The self-audit screened for studies that were enrolling, was limited to one consent form per study, and was conducted in REDCap.
Self-audit questions included: 1. Was the “Consented by” form signed by the person obtaining consent? 2. Was a copy of the “Consented by” form emailed to participants? 3. Is the REDCap eConsent form aligned with the IRB-approved consent form? Researchers were instructed to compare the two forms using “Compare Files” in Adobe Acrobat. 4. Do the IRB-approved consent form and the REDCap eConsent form have version dates/numbers? 5. Do the version dates/numbers match?
Researchers received a response immediately and by email summarizing if no action was needed, action was required (reportable to the IRB), and/or action was recommended (not reportable to the IRB).
Program
Assessment: The purpose of the self-audit was to walk researchers through a method of assessing their own eConsent process to evaluate whether it was consistent with what the IRB approved. Researchers participated fully in the self-audit and commented that, in the process, they learned about eConsent requirements and how to assess their own compliance, and identified errors previously missed. The self-audit had a high response rate and provided insight into the level and type of non-compliance. Those who reported eConsent noncompliance to the IRB were required to include corrective and preventive actions.
In total, 186 studies were eligible for the REDCap eConsent self-audit; 184 researchers responded (99%) and two did not. Of the 184 studies, 98 (53%) were still consenting new participants and were therefore required to complete the entire self-audit. Of the 98 studies, there were 22 (22%) reports of non-compliance submitted to the IRB with a total of 48 corrective and preventive actions taken or planned. The other 76 studies (78%) indicated compliance with eConsent requirements.
Limitations: Limitations to design and implementation of the self-audit project included the need for REDCap expertise and institutional REDCap support. The eConsent self-audit was a survey project and internal validity does not apply.
Discussion: Because of the pandemic, remote consent is now a well-established option for obtaining consent. Although HRPP QA auditors evaluate eConsent compliance during routine audits, the self-audit captured studies using eConsent that would not have been selected for a routine audit. The eConsent self-audit provides QA with an audit tool that can be used on an ongoing basis. After positive feedback and requests from the research community, QA uploaded a public version of the self-audit for voluntary use by the research community on the HRPP QA website. Most importantly, researchers were willing to participate in and learn from the eConsent self-audit process.
