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

On 29 May 2020 the FDA announced the availability of the free COVID MyStudies Application (App) for obtaining informed consent remotely.

The FDA 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.

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