Electronic Informed Consent
Is the use of Electronic Informed Consent Forms approved by the regulatory authority?
This is a frequently asked question (FAQ) in the last few weeks as Research Teams devise alternate means of consenting participants remotely for both continuing exemption trials and upcoming COVID-19 vaccine and testing trials.
ICH E6R2 Good Clinical Practices (November 2016) accepts electronic records (2.10, 8.1) as a means of documentation. Health Canada formally adopted this guideline in May 2017, and have been ‘generally accepting’ of e-IC. That is, as long as ALL ICH and Division 5 regulatory requirements are met.
By interpretation, the electronic IC system you are using or planning to use must:
- be formally validated and further validated into the environment to which it has been placed
- feature a validated internal or linked signature authentication component
- contain all of the elements that comprise a paper informed consent system
- have SOP(s) on the e-administration of e-IC
- have e-IC training module for Administrators
- feature instructions for participants at an appropriate reading level with explanation that it is the equivalent of a handwritten signature on paper
- be accessible and usable by all participants in the study
- be achievable in an original format (for 25 years)
- contain an audit trail to document any changes or updates made
- control for Access and passwords
- be remotely or directly accessible for audit, monitoring and inspection
The e-IC areas that are often found deficient are: lack of detailed processes and records for user and participant training, missing controls for password and access, missing validated signature authentication features, and most concerning missing consents for all versions and for all participants in the clinical trial.
In applying the regulations to the implementation of e-consenting during the COVID-19 pandemic, my best advice is: document well, and most importantly ensure that all participants are consented before they start in a clinical trial (by alternative means if the e-IC is not feasible) and with each version change of the informed consent.
- For more information, please contact Jean Smart.