IRBs Are Scrutinizing Digital Tools for Informed Consent
Compared to paper-based informed consent, a multimedia digital tool resulted in higher satisfaction, was perceived as easier to use, gave more people the ability to complete the consent independently, and was perceived as taking less time to complete the consent process, according to the results of a recent study.1
Researchers asked 25 study participants to complete the informed consent process using the tool on an iPad, and 25 did so with traditional paper forms. Both groups showed high comprehension. When study protocols include digital informed consent, though, there are some important considerations for IRBs. One is the quality of the subject-investigator interaction should not depend on a good internet connection, a certain kind of computer, or familiarity with software commands.
“There should be equal opportunity for all subjects to have the best consent process,” says Gianna McMillan, DBe, acting graduate director and program administrator of the Bioethics Institute at Loyola Marymount University.
Another potential drawback is the need for added technical support. “If something goes wrong, who will fix it? What timing constraints would be involved?” asks Sue Logsdon, MS, CIP, an IRB administrator at the University of Nebraska Medical Center.
Researchers must manage different versions of the tool and ensure all research personnel own the correct version. Data security is another worry, considering the risk of cyberattacks. “Is the technology compatible with what’s allowed in the institution?” Logsdon asks.
If researchers manage to overcome all these obstacles, electronic tools can make the consent process much more efficient. For multisite studies, it allows for a standardized consent process across all study sites. “It increases the potential for better understanding of the study by the subjects, particularly for complex trials,” Logsdon adds.
IRBs should ask these questions: Is the use of digital tools appropriate for the type of research or subject population? What are the risks and benefits of using digital tools in this particular study? If the digital consent tool is a requirement for all subjects, how will researchers handle subjects who are visually challenged, who lack access to technology, or who are non-English-speaking? Do the digital tools enhance the consent process as a whole?
Generally, IRBs probably would be receptive to digital tools, says Logsdon, as “anything that can be done to help the consent process is a plus.”
Digital tools do not negate the need for discussions about risks and benefits. “There should still be a conversation between the researcher and the subject,” Logsdon says.
Recently, the University of Nebraska’s IRB approved a study protocol with a website-based consent process. Participants go through the consent process by completing an interactive quiz. If questions are answered incorrectly, the potential subject cannot move forward with the consent process unless the quiz is repeated with all questions answered correctly. Participants also can rewatch a slide presentation, and are encouraged to contact the research team if anything is unclear.
For any study protocol including digital consent tools, Logsdon says IRBs want to be sure videos do not downplay the risks involved. “An example of something the IRB is likely to question would be a quiz that asks questions only on the potential benefits or compensation associated with the study, before addressing the potential risks of the research,” Logsdon says.
If it is a simple study, putting lots of time and effort into digital consent tools may not be feasible — or necessary. “For a more complex trial, with subjects with a very serious disease, it makes more sense to include tools that are going to help subjects understand the research better,” Logsdon offers. “You want to try to make that 30-page consent form easier for somebody to understand.”
When planning a digital consent process, researchers should consider what multimedia will best help the specific study population understand the consent information (e.g., attention-check questions or interactive elements).
“Consider how to verify the participant actually looked at or listened to all the content, instead of skipping past important information,” advises Elicia Preslan, MS, CIP, IRB operations QA/QI manager of Virginia Commonwealth University’s Human Research Protection Program.
Investigators still need to be in contact with participants, so consider whether participants can ask questions. “The digital platform should have a way to hand off a participant to a member of the study team if they have questions or don’t understand something,” Preslan says.
For example, participants could click a button to pause the consent process, which then opens a chat box or prompts the participant to call a staff member.
Finally, consider the how the process tools could be developed in a cost-efficient manner. Options range from a simple PowerPoint presentation with audio-recorded narration to sophisticated apps or websites. However, consent signature requirements do place restrictions on what tools can be used.
“But minimal risk studies can, in many cases, qualify for a waiver of the consent signature,” Preslan says. “This allows a lot more creativity and use of lower-cost tools.”
Still, digital tools for informed consent can be costly for researchers to develop. “This is a potential drawback if the study has inadequate funding,” Logsdon cautions.
Basic components of a consent process can be developed in template form, but specific explanations must be created for each study. “I do not think requirements for paper-based information will ever go away, so multimedia formats will always be an add-on,” McMillan says. “It will be an extra expense that a sponsor, institution, or investigator must agree to assume.”
- Abujarad F, Peduzzi P, Mun S, et al. Comparing a multimedia digital informed consent tool with traditional paper-based methods: Randomized controlled trial. JMIR Form Res 2021;5:e20458.
Compared to paper-based informed consent, a multimedia digital tool resulted in higher satisfaction, was perceived as easier to use, gave more people the ability to complete the consent independently, and was perceived as taking less time to complete the consent process, according to the results of a recent study.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.