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FDA Provides Free eConsent Platform for Eligible Clinical Trials During COVID-19

On Friday, May 29, the FDA announced that its previously developed FDA MyStudies app is now 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.”

To utilize the eConsent app, investigators provide their IRB-approved consent forms to the designated COVID MyStudies support team for upload to the app. The investigator can then, in a secure manner, transmit the consent form electronically to the subject/LAR, obtain an electronic signature, and distribute signed copies of the form to the study team and the participant. Ongoing technical support for the app will be provided by Harvard Pilgrim Health Care Institute and funded as resources allow by the FDA.

The COVID-19 pandemic has created myriad challenges to conducting clinical trials, including that of obtaining informed consent—a process typically conducted in a face-to-face interaction between research subject and research staff. Stakeholders across the research enterprise have had to modify processes to accommodate participants’ physical separation (whether enforced or voluntary) from staff.

Guidance from the FDA as well as Advarra’s Coronavirus Guidance FAQ  have encouraged the use of electronic methods of transmitting the consent document to the subject and obtaining their signature. While these electronic tools have facilitated some aspects of the process, there have remained inefficiencies (for example, printing out a consent form and photo-documenting the signature) that create time delays and privacy concerns.

Investigators who are interested in using the COVID MyStudies app can request more information by contacting CDERMedicalPolicy-RealWorldEvidence@fda.hhs.gov.

Advarra is committed to supporting the research community through the current crisis and provides a free eLearning module to help sites and institutions determine a plan for restarting research.

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