FDA Offers Free eConsent App to Advance Remote Trials

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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.”

FDA MyStudies is labeled 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 on “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 institutional review board (IRB) review and approval of the informed consent document and process.

Separately, the FDA published a June 2 guidance on “IRB Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators.”

“FDA is issuing this guidance because of the substantial increase in the number of requests by physicians seeking to treat their patients with investigational drugs under the agency’s individual patient expanded access (EA) pathway during the COVID-19 public health emergency,” the agency said. The agency also is aware that IRBs seek clarity regarding the key factors and procedures to consider when they review requests for individual patient EA—including reviews conducted by a single member of the IRB—to fulfill obligations under 21 CFR Part 56 in the Code of Federal Regulations.

The recommendations in the guidance address establishing procedures for single IRB member review in response to physician waiver requests for exemption from full IRB review, as well as factors to consider when assessing benefits and risks for a particular patient being treated under the EA pathway.

Edited by Michael Causey