jump to navigation

Free eConsent App June 5, 2020

Posted by Michael Hamrell in Uncategorized.
trackback

The U.S. Food and Drug Administration (FDA) is offering its FDA MyStudies app to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials, when face-to-face contact is not possible or practical due to COVID-19 control measures. The agency said it “is providing this resource after hearing that investigators were having difficulties obtaining informed consent for clinical trials when patients were in isolation rooms in healthcare facilities or could not travel to outpatient clinics.”

Through the App (available as iOS or Android), the investigator can send the informed consent document electronically to the patient or his or her legally authorized representative. Once the patient or representative has signed the form, he or she will receive an electronic copy. The investigator can then access the signed consent in a secure manner and print it or transfer the file electronically.  To facilitate free use of the app during the public health emergency, FDA intends to fund this assistance as resources permit.

 

 

Comments»

No comments yet — be the first.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: