What is electronic informed consent?
Informed Consent is a voluntary agreement to participate in research. Clinical research professionals know that the informed consent process is more than just a signature on a form; it is a process of information exchange that may include: providing subject recruitment materials, verbal instructions, question/answer sessions, time for the patient to read the form individually or with family members, and measures of subject understanding. This is all in addition to actually signing the informed consent document.
Traditionally, paper-based consent has been the method through which researchers conducted and documented the informed consent process. Electronic consent forms often use tablets or computers as the medium for communicating information and seeking consent from the patient.
How do we ensure the electronic informed consent process is adequate?
FDA’s requirements for electronic records/electronic signatures, informed consent, and IRBs are set forth in 21 CFR Parts 11, 50, and 56, respectively. The Department of Health and Human Services (HHS) also has requirements regarding the protection of human subjects which are set forth in 45 CFR Part 46, often referred to as The Common Rule. The information presented to the subject, processes used for obtaining informed consent, and documentation of the electronic informed consent (eIC) must meet the requirements of these and any other applicable regulations. If the study is conducted or supported by HHS and involves an FDA-regulated product, the study is subject to both 45 CFR Part 46 and 21 CFR Parts 50 and 56, meaning that both sets of regulations must be followed. Where the regulations differ, the regulations that offer the greater protection to human subjects should be followed.
FDA regulations governing the conduct of clinical trials describe good clinical practices (GCPs) for studies with human subjects. For studies that must comply with the FDA regulations, the informed consent documents should meet the requirements of 21 CFR 50.20 and contain the information required by each of the eight basic elements of 21 CFR 50.25(a), and each of the six elements of 21 CFR 50.25(b) that is appropriate to the study. These regulations apply to electronic consent forms just as they do for paper-based consents.
Institutional Review Boards (IRBs) or Ethics Committees (ECs) have the final authority for ensuring the adequacy of the information in the informed consent document. The IRB will evaluate both the planned consent process and the procedures for documenting informed consent to ensure that adequate informed consent is obtained from subjects.
IRBs, clinical investigators, and research sponsors all share responsibility for ensuring that the informed consent process is adequate. Thus, rather than an endpoint, the consent document should be the basis for a meaningful exchange between the investigator and the subject.
How can electronic signatures be used to document eIC?
FDA regulations found at 21 CFR part 11 set forth the criteria under which FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to a handwritten signature executed on paper (see 21 CFR 11.1(a)). In order to be considered equivalent to full handwritten signatures, electronic signatures must comply with all applicable requirements under 21 CFR part 11. The electronic system must also capture and record the date that the subject or subject’s LAR provides consent (see 21 CFR 50.27(a)).
Finalized FDA guidance on Electronic Informed Consent (eIC):
- The eIC must contain all elements of informed consent required by HHS and/or FDA regulations (45 CFR 46.116 and 21 CFR 50.25).
- Inform the subjects of approximately how long the eIC process will take and what information will be presented to them to ensure that the eIC is presented appropriately and that subjects will have enough time to dedicate to the eIC process.
- Keep the process simple, any eIC should be easy to navigate.
- An eIC may be used to either supplement or replace paper-based informed consent processes in order to best address the subject’s needs throughout the course of the study.
- Whether part or all of the eIC process takes place on-site or remotely, the responsibility for obtaining informed consent remains with the investigator and the study personnel to which the responsibility has been delegated. (The investigator cannot delegate authority to obtain informed consent to the electronic system.)
- The investigator should have methods in place to ensure that the eIC process allows subjects the opportunity to consider whether or not to participate and to ask questions about the study before signing the consent.
- The eIC may use interactive electronic-based technology, which may include diagrams, images, graphics, videos, and narration to assist the subject in understanding the material.
- Electronic signatures based on biometrics must be designed to ensure that they cannot be used by anyone other than their genuine owners (21 CFR 11.200(b)).
In a previous blog, the question was asked, “How quickly do you think this (electronic informed consent) will be implemented, if at all”?
Electronic technologies are being viewed as an increasingly popular and an effective tool in many aspects of human subject research. Healthcare providers and research organizations are now adopting an electronic way of providing information and capturing informed consent in certain situations. The FDA acknowledges the increasing trends towards electronic media for consenting processes in the research community and published the guidance to provide its current thinking on the topic. The choice to use eIC is up to researchers, and depends on the study, patient population, sponsor, and IRB/EC whether it is an appropriate and affordable choice. As with most transitions in this industry, it is likely to take time, but as more researchers become familiar and comfortable with eIC, the more widespread it will become. It is also important to remember that technology will continue to evolve, leading to new questions for research professionals and the FDA to explore to ensure the continued protection of human subjects in research.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.