FDA Provides Free Method to Obtain Informed Consent Electronically for Eligible Clinical Trials During the COVID-19 Public Health Emergency

FDA Provides Free Method to Obtain Informed Consent Electronically for Eligible Clinical Trials During the COVID-19 Public Health Emergency 

The U.S. Food and Drug Administration is making its previously developed FDA MyStudies app available 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 is providing this resource after hearing that investigators were having difficulties obtaining informed consent for clinical trials when patients were in isolation rooms in health care facilities or could not travel to outpatient clinics.

FDA MyStudies is now referred to as COVID MyStudies in the Apple App and Google Play stores. The display name that appears underneath its icon after it has been downloaded is COVID19. 

Through the COVID MyStudies app, 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.

Obtaining informed consent remotely can help make sure clinical trials are not unnecessarily delayed during the COVID-19 public health emergency. Methods for obtaining informed consent remotely were discussed in a recent FDA guidance, Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The guidance encouraged investigators to consider using electronic methods of obtaining informed consent if possible.

Harvard Pilgrim Health Care Institute, which operates the Sentinel and Catalyst systems on behalf of the agency, will provide the technical assistance required for the COVID MyStudies app. To facilitate free use of the app during the public health emergency, FDA intends to fund this assistance as resources permit.  Before using the COVID MyStudies app, investigators will provide their informed consent documents to the COVID MyStudies team to be added to the app. They will then have a chance to review all informed consent documentation within the app before incorporating it into their trials. There is also an opportunity for investigators to incorporate clinical trial-specific branding within the app.  Regardless of whether they use the COVID MyStudies app, investigators must comply with applicable requirements for IRB review and approval of the informed consent document and process.

Investigators interested in using the COVID MyStudies app should contact the CDER Real-World Evidence Program at CDERMedicalPolicy-RealWorldEvidence@fda.hhs.gov and reference their pre-IND or IND numbers if applicable. FDA plans to prioritize requests to use the app, taking into account agency resources.