Table 2.

Key considerations and recommended practices for electronic informed consent (eIC) approaches

Operational Considerations	Regulatory Considerations	Recommended Practices for Research Teams and Institutional Reviewer Boards (IRBs)
Presenting an eIC experience to the IRB	IRBs must be able to assess all aspects of an informed consent (IC) process, including any dynamic or interactive features, and their review should include: • All informational materials including written materials, videos, and web-based presentations, an individual will receive or view during the eIC process. • Any optional questions asked or methods used to gauge the comprehension of key study elements and the usability of eIC materials to ensure they are easy to navigate. • Hyperlinked content to ensure study-related information there is accurate and appropriate.	Suggested approaches for assessing interactive features include having research teams provide: • Hyperlinks to the draft eIC materials so the IRB can experience the interactive features as participants, or • Screenshots of each eIC screen with annotations describing the interactive features and actions that can be taken from the page (e.g., clicking on a hyperlink will define highlighted terms or show details about a study procedure) and indicate allowed navigation between screens, or • A video demo that records the IC experience/content, which can be uploaded and archived within an electronic IRB system. This last approach requires the study team to create the video, which can be time-consuming and require specific expertise.
Tracking changes to the IC	If a copy of the IC provided to participants includes one or more hyperlinks to information, then the hyperlinks should be maintained and information accessible to participants until the study is complete.	To track revisions requested by the IRB or future updates, IRBs might consider having research teams create and maintain one or more of the following: • A text document to accompany any visual presentation and within which changes in IC content and presentation can be tracked. Any websites or information accessed within the IC by hyperlink should be captured as well, such as by creating PDF versions or screenshots of them. • A log of changes to the IC that captures both content and format changes. This log would identify the version date of the IC, when the IRB approved it, and the changes incorporated into that version. • Webpages that capture the content and features of each version of the IC approved by the IRB. Several solutions exist to archive public and nonpublic websites.
Providing participants with a copy of the IC	Federal regulations require IC to be documented via a written, IRB-approved IC form unless the IRB waives the requirement either to obtain IC or documentation of IC. The Common Rule a) defines written as including information provided in electronic format (45 CFR 46.102(m)) and b) requires a “written copy” be given to the person signing the IC document (45 CFR 46.117(a)). OHRP/FDA guidance states that if the eIC uses hyperlinks or other websites or podcasts to convey information specifically related to the research, then the information in the hyperlinks should be included in any printed paper copy provided.	Research teams can provide participants with a summary that highlights key information about the research study and, which participants can either print either in tangible form or save electronically for easy reference. The summary should include a link to all IC materials.
Retaining records	All IRB-approved eIC versions, including copies of each eIC version signed by individual participants, must be maintained in compliance with applicable regulations; federal regulations require IRBs to maintain documentation for at least 3 years after a study’s closure. Sponsor or institutional requirements might require researchers to retain documents for longer.	IRBs should ensure a document retention plan is in place, both for their and research team records related to eIC. The research team should provide its standard operating procedure or describe its record retention as part of the IRB application. Procedures should consider a backup plan in case hyperlinks within a document or linked information cease to exist, to ensure a participant has ongoing access to it or an auditor can see the same information the IRB and participants viewed.
Documentation of informed consent, including electronic signature	If an IRB requires documentation of informed consent and the research is FDA-regulated research, the electronic system must comply with Part 11 requirements and capture and record the date that the participant or participant’s LAR provides consent. Both the FDA and the Common Rule regulations permit IRBs to waive documentation of IC when the research involves no more than minimal risk and involves no procedures for which written consent is normally required outside of the research context.	IRBs can assist study teams by helping them identify the relevant regulations that apply to their studies and providing flexibility regarding when and how written IC is obtained, as appropriate. For example, IRBs should identify for research teams which eIC systems they can use that are Part 11 compliant for research that is FDA-regulated as well as acceptable methods for capturing an electronic signature, based on FDA guidance, including Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency). If a study is not FDA-regulated, IRBs should not require research teams to use Part 11 compliant systems and permit a broader range of signature options (e.g., REDCap that is not Part 11 compliant), so that alternate approaches to eIC can be explored that allow more flexibility in terms of how an electronic signature can be captured. In the case of minimal risk research, IRBs should consider waivers of documentation of IC (as well as waivers of HIPAA authorization), when possible, regardless of whether the research is FDA-regulated.