In March, PRIM&R hosted the webinar Electronic Informed Consent: Ethical, Regulatory, and Practical Implications. Presented by Cheryl Grandinetti, PharmD, a health science policy analyst at the FDA, and Christian Simon, PhD, a bioethicist at the University of Iowa who conducts research on electronic informed consent (eIC), this webinar helped attendees understand the definition of eIC, grasp its regulatory requirements and context for using it in FDA-regulated clinical trials, better anticipate the challenges and benefits associated with eIC, and recognize how investigators and IRBs can promote its ethical and effective use. The presenters were joined by additional panelists Leonard Sacks, MD from the FDA and David Klein, PhD and Helen Schartz, PhD, JD from the University of Iowa for an interactive question and answer session at the conclusion of the webinar. After the webinar, the speakers from the two institutions answered attendee questions that time didn’t permit us to answer live. We’re pleased to share those answers with the readers of Ampersand.
Q: Can the FDA presenters comment on the tension or implications of using optional assessment questions for understanding and the investigator’s responsibility to ensure that legally effective informed consent is obtained? Will the results of the assessment be evidence of whether the investigator met his or her responsibility?
FDA: If used, the questions to gauge the subject’s understanding of key study elements should be used as a tool to highlight areas where the subject might need further explanation and discussion before signing the informed consent to enter the study. The results of the assessment (e.g., whether the subject was able to answer the optional questions correctly) are not intended to be used to determine whether the investigator met his or her responsibility under 21 CFR part 50.
Q: In reference to providing copies of the IC to subjects, how much of the electronic consent materials need to be provided to the subjects? For example, if the eIC is a video chat, is the investigator expected to provide a transcript of the chat? If graphics and interactive questions are part of an eIC, is the expectation that those will also be part of the copy provided to the subject?
FDA: The subject should be provided a signed copy of the materials that the subject views during the informed consent process, including graphics and interactive questions. The copy provided to the subject can be paper or electronic and may be provided on an electronic storage device or via email. If the copy provided includes one or more hyperlinks to information on the internet, the hyperlinks should be maintained and information should be accessible until study completion. Note that if the eIC uses hyperlinks or other websites or podcasts to convey information specifically related to the research, the information in these hyperlinks should be included in any printed paper copy, if one is provided.
In addition, while live video chat may be used to answer a subject’s questions about the contents of the electronic informed consent; it would not be appropriate to obtain and document informed consent only through the use of a live video chat with an investigator. Like traditional paper consent, investigators are not required to document any questions or discussions with the subject about the electronic informed consent materials. The investigator would not be expected to provide a transcript of the video chat to the study subject.
Q: Has the panel come across any tools or approaches to help determine if a subject is able to consent or not? If so, are there any tools available to confirm that the legally authorized representative (LAR) is truly able to provide legally effective informed consent?
FDA: An independent, qualified professional may be chosen to assess consent capacity of prospective subjects, documenting elements of capacity (such as understanding information, showing evidence of choice, showing rational reasoning, understanding the nature of the situation, and showing reasonable understanding of outcome of choice).
In the United States, the legal authority governing who may serve as a LAR is determined by state and local law. We recommend contacting legal counsel for advice on this topic.
Q: How would eIC be modified for non-English-speaking potential subjects? Is the platform used in the Iowa study available in multiple languages?
FDA: IRBs and investigators must ensure that the information given to prospective subjects is in language understandable to the subjects or their LARs (21 CFR 50.20), and meet all of the required elements (21 CFR 50.25). Understandable means the information presented to prospective subjects or their LARs is in a language and at a level they can comprehend, including an explanation of scientific and medical terms.
Note: The IRB must review and approve all English and non-English language versions of the eIC and paper informed consent documents (long form or short form with written summary) that are to be used by investigators to document the informed consent of subjects (21 CFR 50.27(a) and 21 CFR 56.111(a)(4) and (5)). When reviewing proposed informed consent procedures involving translation of written and oral information that is to be presented to subjects, the FDA recommends that the IRB review, and, if appropriate, approve procedures for ensuring that the translations will be prepared by a qualified individual or entity.
University of Iowa: For the English-language version of an informed consent document, much of the effort to convert it to an electronic version similar to the ones we have used is from chunking/segmenting the text so that it can be shown in a slideshow format and from locating appropriate graphics. Usually the results of this effort can be applied straightforwardly to additional languages, assuming the consent document has already been translated. After that, the main distinction between the different electronic versions is in translation of the interface, such as button names and headings, and the audio narration of the text. If you add interactive questions as we have done, the questions also need to be translated and narrated. A developer with little to no knowledge of the non-English language should be able to create the non-English version without much trouble, as long as someone proficient in the language proofreads the final version. Narrators can be trained to record the narration fairly easily and editing the audio into appropriate segments does not take complex audio skills. Also, it would be a good idea to get some feedback, such as a usability study, from the target population on the non-English version along with the English version. One other issue, which is likely to be minor, is that it is possible that a non-English population may need to have somewhat different graphics that conform to their expectations. However, a medical center with a diverse population that requires translations of informed consent documents would likely already show that diversity in the graphics of the English electronic version.
We are using English and Spanish versions of a consent document in our current study at one site. We are doing Spanish-language focus groups and usability studies in addition to our English-language efforts. The results of these studies are transcribed (for all languages) and translated into English. We are working with local Iowa people as well as people at the remote site to complete the translations and audio narration.
PRIM&R would like to thank our speakers for sharing their expertise!
The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you would like to purchase the webinar for group viewing, please download the order form (PDF) and send it to email@example.com.