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Free eConsent App June 5, 2020

Posted by Michael Hamrell in Uncategorized.

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.





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