The US Food and Drug Administration (FDA) have developed a new app which provides a suitable way of obtaining informed consent in an electronic format for both investigators and subjects.
In a guidance recently published by the FDA regarding conduct of clinical trials of medical products during the COVID-19, they encouraged investigators to consider electronic methods of obtaining informed consent, and discussing methods for remote informed consent procedures.
The FDA MyStudies app has been developed in line with social distancing guidelines in place due to the pandemic. “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.”
To use the COVID MyStudies app, investigators should 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 email. Investigators will then receive contact information to provide the relevant informed consent documents to the COVID MyStudies app team. The documents are then added to the app and investigators can review the consent documents for completeness and accuracy in the app, before making them available to prospective trial participants.
Informed consent can be sent to the subject or authorised representative, who will receive an electronic copy after signing. The investigator can then securely access the consent electronically and generate a printed copy. It must be noted that all informed consent documents and the process for obtaining consent must still go through institutional review board review and approval.
Additionally, the app gives investigators the option to incorporate branding specific to a clinical trial. It also lets subjects provide data that can be linked to traditional clinical trials, real-world trials, observational studies, and registries.
The app can be found on Google Play and Apple Store. For more information, click here.