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Regulatory Focus™ > News Articles > 2020 > 6 > FDA’s MyStudies app provides platform for electronic informed consent

FDA’s MyStudies app provides platform for electronic informed consent

Posted 01 June 2020 | By Kari Oakes 

FDA’s MyStudies app provides platform for electronic informed consent


An app developed by the US Food and Drug Administration (FDA) provides a way to obtain informed consent for clinical trials in a format easily accessed by both investigators and participants.
 
The app, FDA MyStudies, can now be found as COVID MyStudies in both the Google Play and Apple App stores. In addition to providing a mechanism for securing informed consent from prospective clinical trial participants, the app also gives investigators the option to incorporate branding specific to a clinical trial.
 
“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,” noted the FDA. The FDA is funding free access to the app “as resources permit.”
 
Informed consent can be sent to the patient or an authorized representative, who receives an electronic copy after signing. The investigator can securely access the consent electronically and can also generate a printed copy. All informed consent documents and the process for obtaining consent must still go through institutional review board review and approval.
 
The FDA recently published guidance regarding conduct of clinical trials of medical products during the COVID-19 public health emergency. In the guidance, the agency encouraged investigators to “consider using electronic methods of obtaining informed consent if possible,” discussing methods that can be used for remote informed consent procedures.

RELATED ARTICLES FDA updates guidance on clinical trials amid COVID-19, Regulatory Focus 13 May 2020; Electronic platforms for submission of clinical trial information, Regulatory Focus 14 May 2020
 
Harvard Pilgrim Health Care Institute is providing technical assistance for the app; that organization is already operating the Sentinel and Catalyst data monitoring and reporting systems on the FDA’s behalf.
 
To use the COVID MyStudies app, investigators first contact FDA by email at CDERMEdicalPolicy-RealWorldEvidence@fda.gov. If a pre-IND or IND number is available, it should be included in the preliminary contact email.
 
Investigators will then receive contact information to provide the relevant informed consent documents to the COVID MyStudies team. The documents are then added to the app; investigators can review the consent documents for completeness and accuracy by viewing them within the app before making them available to prospective trial participants. “FDA plans to prioritize requests to use the app, taking into account agency resources,” said the agency.
 
The app can be found as COVID MyStudies in both the Google Play and Apple App stores. The FDA’s MyStudies app had been freely available as a GitHub download only.
 
Mystudies also provides a secure data storage environment that supports storage partitioning, a feature useful for an organization that is running multiple clinical trials and for multi-site trials and platform-based trials. MyStudies code is open source and has been released for Apple and Android frameworks. Technical information about the app can be found on the FDA’s website.
 

Tags: coronavirus, FDA, US

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