US FDA offers draft guidance on electronic informed consent

Industry seems poised to push more towards the use of eIC​ as subjects get more comfortable with technology, and as the technology advances and keep patients better informed, track more data and shave off some of the time of a trial. Last summer, the FDA also updated what it expects in regards to informed consent​ in general.

In this latest document unveiled Monday, the agency makes it clear from the forefront that informed consent should not just be a patient’s signature and that eIC refers to using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent.

“To many, the term informed consent is mistakenly viewed as synonymous with obtaining a handwritten signature from the subject or the subject’s legally authorized representative (LAR) on a written informed consent form​,” the FDA says. “FDA believes that obtaining a subject’s oral or written informed consent is only part of the consent process. Informed consent involves providing a potential subject with adequate information about the research to allow for an informed decision about the subject’s voluntary participation in the clinical investigation.”​

Dr Lindsay McNair, chief medical officer of contract service organization WIRB-Copernicus Group, told Outsourcing-Pharma.com that the draft wasn’t too surprising though it “does clearly reinforce that the practices and requirements that apply to the 'traditional' process of informed consent still apply when the consent uses electronic technology​.

“In particular, I’m pleased to see that the guidance reinforces the idea that informed consent is a process, and not a document, and to see the reminder that even an electronic-based process should have a mechanism for allowing potential participants the opportunity to ask questions.  It’s also encouraging to see the confirmation that eIC can be used in the assent process for children, as I think the video and graphic capabilities of the electronic platforms are a great fit for providing understandable information to children, and perhaps others with impaired capacity."​

Electronic Documentation​

If any or all of the informed consent process occurs at a remote location, the agency says, then all interactive responses by subjects, witnesses, or other involved parties “should be documented electronically using software systems to ensure that responses cannot be altered​.”

In addition, if the consent process is not personally witnessed by study personnel, the technology “should include a method to ensure that the person signing the informed consent is the subject who will be participating in the research study. Whether the eIC is obtained from the subject on-site or remotely, the subject should have the opportunity to ask questions and receive answers prior to signing the eIC to participate in the study​.”

This may be accomplished by in-person discussions with study personnel or by using a combination of electronic messaging, telephone calls, videoconferencing, or a live chat with a remotely located clinical investigator or appropriately delegated study personnel.

McNair added: "The guidance does add some new information on obtaining consent when the participant is not at the clinical site, what would need to be available as documentation during an FDA audit for a study, and some clarification about the processes of electronic signature (that the FDA does not mandate a specific method).  It also provides particular instruction for IRBs in the review of eIC, which are consistent with our current processes​."

Data security and privacy are also important points for the agency, which recommends using programs that may be enhanced by including questions at the end of each section of the eIC interview process that help assess the subject’s understanding and awareness of the informed consent materials. 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.

Researchers also need to be cognizant of people who are less comfortable with new technology, the FDA says, noting that because some subjects “may have difficulty navigating or using electronic systems because of, for example, lack of familiarity, poor eye sight, or impaired motor skills, steps should be taken to ensure that the eIC process is appropriate for these subjects. The eIC must be presented in a manner that minimizes the possibility of coercion or undue influence regarding the subject’s decision to participate in a study​.”