Informed Consent App for Researchers

FDA says it is making its Covid My Studies app (formerly known as FDA My Studies) available to investigators as a free platform to obtain informed consent from patients for eligible clinical trials when face-to-face contact is not possible or practical due to Covid-19 control measures. An online notice says the agency “is providing this resource after hearing that investigators were having difficulty obtaining informed consent for clinical trials when patients were in isolation rooms in healthcare facilities or could not travel to outpatient clinics.”

The notice says that through the app investigators 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 notice says. “The investigator can then access the signed consent in a secure manner and print it or transfer the file electronically.”