The continuous stream of new information regarding COVID-19 has forced the U.S. Food and Drug Administration (FDA) to reevaluate and amend its guidance for researchers as they conduct clinical trials during the pandemic.
Recent guidance updates focus on informed consent in light of the public health emergency, adding information about electronic signatures for informed consent for clinical trials.
“[We recognize] that the COVID-19 public health emergency may impact the conduct of clinical trials of medical products,” the FDA said in their announcement of the guidance updates. “[P]rotocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 public health control measures.”
Regarding informed consent, the FDA outlines how researchers might obtain consent from patients, specifically in isolation or if travel restrictions prevent the patient from traveling to a clinical trial site. “If the technology is available, electronic methods of obtaining informed consent should be considered,” the administration said. One such technology would be the FDA’s COVID MyStudies App, which enables investigators to obtain informed consent securely from patients when face-to-face contact is not possible or practical due to COVID-19 public health measures.
Should it not be possible to obtain informed consent electronically, the FDA says “methods of obtaining informed consent other than a face-to-face consent interview may still be acceptable if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the legally authorized representative of the subject.”
For example, the investigator may send the consent form through email, with the consent interview being conducted with the patient over the phone. Following the interview, the patient can return the signed and dated form to the investigator a number of specified ways, either through a secure email account, mailing it directly to the clinical investigator, or by bringing in the consent form to their next visit to the clinical site.
“Where it is not feasible for investigators to receive the signed consent form prior to beginning study-related procedures, the investigators should have the subject or legally authorized representative confirm verbally during the consent interview that the subject or legally authorized representative has signed and dated the form,” the FDA said. “In addition, the overseeing Institutional Review Board (IRB) must review and approve the planned informed consent process.”
Despite the investigator needing to go through the IRB with their proposed informed consent process, the FDA also recently outlined guidance clarifying the conditions under which the administration will consider sponsor and investigator requests for waivers from full IRB review. The guidance—in effect only for the duration of the public health emergency—says the agency will grant a waiver if an IRB chairperson or other designated IRB member approves the individual use before treatment begins.