Responding to industry concerns about the use of electronic Informed Consent (eIC) in regulated clinical trials, the FDA has issued a draft guidance that opens the door to the use of podcasts, “biological recognition devices” and other electronic media to improve understanding of trial participation.
The draft guidance document, Use of Electronic Informed Consent in Clinical Investigations, addresses the clinical research community’s interest in using computer-based technology to provide critical information about a trial, questions that evaluate participants’ comprehension and documentation of their consent.
Unlike traditional paper consent forms, which often can be long and difficult to understand, eIC can include graphics, audio and visual aids, podcasts, interactive web sites and “biological recognition devices” [biosensors] to capture and convey information to complete the Informed Consent process.
“When Informed Consent is required, the use of electronic (including digital) signatures is permitted, provided the electronic signature is in compliance with applicable FDA regulations,” the guidance states. “In such cases, the electronic signature is considered by FDA to be trustworthy, reliable and generally equivalent to handwritten signatures executed on paper.”
The guidance, written in question and answer format, also says questions from participants should be answered in an in-person discussion with study personnel or through a combination of electronic messaging, telephone, videoconference or live chat with a clinical investigator or appropriately delegated study personnel.
“Overall, the draft guidance is a good step in the right direction,” said Lindsay McNair, M.D., chief medical officer at WIRB-Copernicus Group. “It acknowledges the increasing interest in e-Informed Consent as a process and not just a document and makes that point in a couple of places by specifying that there has to be a mechanism by which participants can ask questions. This process is a conversation—not an information dump.”
As for how to measure a participant’s understanding of the information being presented, the FDA says if a computer program is used, it should be appropriate for the intended audience and take into consideration the patient’s age, language and comprehension level.
“In addition, programs may be enhanced to include questions at the end of each section of the electronic Informed Consent interview process that help assess the subject’s understanding and awareness of the Informed Consent materials,” the guidance states. “These and other tests may be used to verify comprehension of key study elements before the subject signs the informed consent to enter the study.”
The guidance also addresses the requirements for pediatric patients and the IRB’s role in determining adequate provisions for soliciting assent from children and how that assent is determined.
IRBs also must review and approve the eIC and any amendments to it. Also, in certain circumstances, CDER and CBER may request submission of the Informed Consent for review; for example, when a known clinical toxicity is linked with the study drug or class of drugs, or when the study population is in a particularly vulnerable situation.
McNair said she was glad to see questions about pediatric trials and the need for more videos for children, as well as consent concerns for adults with impaired capacities such as neurological disorders.
She acknowledged an eIC does add more work to an IRB review; her company routinely reviews story boards and scripts before a video is produced.
“It doesn’t add a lot of time, but good communications is required to make sure they coordinate in a timely manner,” said McNair.
“We are delighted with this FDA document, as it provides guidance on what is permitted in Informed Consent without changing the regulations,” said Gareth Milborrow, M.D., head of clinical development at Firecrest, Icon’s clinical technology division, which provides investigator training and support systems.
The best part, he said, was remote access—allowing potential trial participants to make enrollment decisions at home with family members and friends and to gain information about the trial remotely before committing to join a trial. He also welcomed the focus on improving information absorption and operational efficiencies with electronic technology.
“This improves decision making in a major way, so when patients come to the clinic they are well prepared,” he said.
The FDA guidance is designed to harmonize its regulatory requirements with Health and Human Services’ Office of Human Research Protection. Milborrow said he hopes the European Medicines Agency follows this guidance.
Comments on the draft guidance are due by May 7.
“We are seeing more pilot studies from sponsors where they run one or two electronic informed consent trials, but it’s been a slow uptake in the last couple of years,” said McNair. “However, with this guidance, we will see more e-Informed Consents coming.”
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