FDA Released Free Electronic Informed Consent Tool but Will Anyone Use it?
[Thursday, June 4, 2020]

This week FDA re-released a free tool for electronic informed consent to be used in clinical trials as an alternate to conventional paper-based informed consents. This is to help investigators obtain informed consent during the pandemic. But the tool seems to be of very limited functionality. It is hard to know if being free is a sufficient incentive for sponsors to switch to electronic informed consent when every other aspect of the trial is hard to implement as well. This free FDA tool has been available since November 2018; it was renamed from “FDA MyStudies” to “COVID MyStudies”. The app downloaded for Apple or Android formats provides some very basic functionalities. The cost of an App or electronic tool for use in clinical trials is a small fraction of the overall cost of conducting the clinical trial. Most sponsors who use electronic tools do so for convenience and overall money savings due to automation. To be clear, the COVID MyStudies app is not a true e-consent tool but facilitates sending the informed consent document to the patient who can then electronically sign it and get an electronic copy. The investigator also can access the signed consent and save or print it. To the patient, the consent form is available as a screen-readable PDF file. So, besides the ease of being able to read the consent on their screens, it is not obvious what other advantages the App offers. For example, how different would it be for the investigator or sponsor to simply email the consent form to the patient for review and signatures. On the other hand, true e-consent forms convert the consent form into series of smaller pieces for the participants to review making it easier to review the content, includes assessment of understanding measures, and does not require the need to keep paper copies. The FDA MyStudies app can be used to capture several pieces of data, additional to the informed consent, but the “COVID MyStudies” version seems to be limited to informed consent only. The app is another effort by FDA to support ongoing clinical trial activities during the pandemic, but the informed consent app falls short on that promise. Switching from conventional consent to electronic informed consent is a major change for a sponsor; having a free tool could provide one reason in favor of the switch for the undecided, but higher functionality rules. While industry-funded commercial trials may not switch easily, the academic research clinical trials may take up the use of this app mostly for financial reasons. It would be interesting to see how many commercial sponsors use this app in their clinical trials or if it becomes another less used or known tool like “FDA MyStudies”.