Reducing Regulatory Risk with eConsent Part 5/5



Informed Consent is a cornerstone of research upon which we ensure human subject protection and data integrity; for many years the use of a paper based process has been the industry default. Electronic Informed Consent (eIC) seeks to revolutionize the process due to its ability to improve consent compliance, validate participant comprehension and provide an accurate audit trail of the development, use and amendments.

Most FDA citations related to informed consent are due to poor consent practice, many times due to the use of an outdated consent form, improper completion of the paper document and/or inability to provide the subject materials to enhance their understanding of the undertaking of study participation. Using an eIC solution can address and prevent many of these regulatory findings i.e. by automatic version control in which only the latest version of an informed consent is available to the study participants. Completion errors can also be reduced by having completion monitoring and control that prevents moving further into the consent until the necessary fields are appropriately completed. Including user rights and credentialing that linksto the delegation log at the site can eliminate the wrong person from obtaining consent. The newly released joint FDA/OHRP eIC guidance outlines many of the benefits of the use of eConsent and proposes it as an aid to the current process and not only as a replacement. There is a lot of flexibility in the implementation of an eIC solution.

SAM Sather, discusses the impact of informed consent regulatory risks and how electronic Informed Consent (eConsent) technology holds the power to minimize and, in some cases, eliminate them in this short CRF Health’s video:

Be sure to check out our blog for the other parts in the series!

Thank you!

-The Clinical Pathways Team