By Tina Caruana, MSc, MBA, Medrio Subject Matter Expert – eClinical Solutions (Digital and Decentralized Trials)
The concept of eConsent is not new, but it’s only recently become more mainstream. You might think of eConsent evolving along the same kind of timeline as the telephone. As a concept, eConsent has been around for nearly two decades, but in the same way that only a few people had telephones early on and an operator had to connect the parties to speak, eConsent has grown in use and efficiency from its earliest days. Even before COVID, companies were beginning to use the technology more often. In fact, the FDA published its eConsent guidance[1] in 2016, which indicates that there was already significant momentum around its use.
Recent research by the Tufts Center for the Study of Drug Development (CSDD) looked at eConsent use among biopharmaceutical companies and CROs. It found[2] that prior to the pandemic, about 41% of respondents used eConsent in their clinical trials, while 65% use eConsent now, and an additional 37% plan to use it in the future—meaning that nearly everyone in the industry is either already using eConsent or planning to soon.
Yet, despite the growing uptake of eConsent, the possibilities of digital consent are only beginning to be explored. For example, few companies use multimedia elements, such as video or images, in their eConsent forms. Right now, eConsent tools are a bit like PDAs just before the smartphone was introduced. A Blackberry could perform useful functions like receiving and sending emails, but connecting to the internet for research could have been more convenient at best. Similarly, eConsent, while very useful for collecting signatures to document consent, actually has an immense potential to do much more.
Why the Hesitation?
Although it is still being determined why the use of multimedia in eConsent remains low, there are a few reasons why Sponsors and CROs may be reluctant to implement these elements.
One question that research is only now starting to unravel is whether or not employing multimedia elements will improve comprehension, lower drop-out rates, or offer other meaningful benefits to participants or researchers. Currently, the evidence points to[3] interactive informed consent helping participants understand[4] what they agree to.
Change management may also present tricky problems in large, complex research organizations. Regardless of the field of study, standard operating procedures are a crucial element in how consent forms are developed. Making changes to the process, including onboarding and using new vendors such as graphic design, multimedia or technology firms, can challenge established practices and may limit the adoption of novel eConsent technologies in some companies.
Furthermore, some sponsors may need clarification about how their institutional review boards (IRBs) will react to the inclusion of multimedia elements in eConsent. Concerns about potentially more complex review requirements or delays in IRB review timelines may limit the broader use of multimedia in eConsent.
However, despite these potential challenges, internal change management efforts across sponsors and CROs to enhance the uptake of clinical trial innovations are making an impact. When paired with the growing acceptance of novel approaches by regulators and IRBs alike, it reduces the perceived or real barriers to the use of multimedia elements in eConsent, allowing electronic consenting to become a more mainstream practice within clinical trials.
The Most Beneficial Multimedia Elements for eConsent
Although “multimedia” may bring flashy technology to mind, many common digital tools are multimedia elements and can be employed, possibly with a great impact. For example, if a trial includes participants who are visually impaired, multimedia can allow these participants to enlarge the font size, or to listen to an audio version of the consent form, so they can hear the text being read to them, in lieu of, or as they are viewing the electronic consent form.
Embedded dictionaries, glossaries and definitions[5] are also multimedia elements and can be very useful in eConsent forms, which are often dense, technical documents. When readers can hover over a word for a definition or click on a word to learn more about a topic, comprehension is very likely improved.
Other multimedia elements give participants tools to ensure they understand what they are reading and consenting to, such as free text fields where readers can make notes or a highlighting function that lets them mark areas of concern or questions, which also serve to facilitate discussion with research staff.
Embedded interactive quizzes, either as the section stops or at the end of the consent form, can improve comprehension.5 One group of researchers tested[6] this and found that participants better understood procedures and risks through the combination of an introductory video and standard consent language, followed by an interactive quiz.
These types of multimedia tools can help to address the problem of literacy. In the United States,[7] 54% of adults between the ages of 16 and 74 lack proficiency in reading, essentially reading below the equivalent of a sixth-grade level.
Along with basic literacy, eConsent forms need to be written with health literacy in mind. The CDC defines[8] personal health literacy as “the degree to which individuals have the ability to find, understand, and use the information and services to inform health-related decisions and actions for themselves and others.” Using multimedia tools in eConsent can help improve the health literacy[9] of participants. However, it’s crucial to ensure that the content is appropriate for the general literacy level of the target audience regardless of how it’s delivered—via paper, a digital representation, or eConsent with multimedia elements.
Ultimately, eConsent must be designed with a fit-for-trial[10] purpose in mind, utilizing multimedia elements that are geared toward a study’s patient population (i.e., region, age, therapeutic area, culture) and their learning preferences.
Looking Into the Future
In 2007, no one could have predicted the value that the smartphone would hold in society in 2023. In the same way, it’s equally impossible to predict how eConsent will continue to revolutionize the decentralization of trials in the coming years or how it will continue to evolve as a tool. However, some changes seem likely.
One area likely to change is enhanced in-app communication between participants and study staff, such as enabling participants to directly communicate with study coordinators as they work through an eConsent form. Overall, communication and consent form comprehension could be greatly enhanced if participants could type a question into a free-text field or highlight a line or paragraph directly within the text. Then, the study staff would be able to answer the participant’s question directly within the eConsent application. This is not yet a common feature of eConsent.
Another likely change is for additional information to be made available outside the consent form, perhaps within an accompanying participant portal. Having videos, graphics, or other supplementary study information available for those participants who would like extra details is a way to enhance patient education and increase engagement.
Finally, making the connections among various digital elements of a study seamless and simple is becoming increasingly necessary. Study coordinators are being asked to adopt more and more digital tools to conduct decentralized trials. This has led to a critical need for integration within systems and platforms to streamline site staff and participant use of core eClinical technologies, including eConsent, ePRO, EDC, RTSM, and CTMS.
Even now, as most people own a smartphone and use them in all kinds of ways, their utility continues to grow. The same will certainly be true for multimedia elements within eConsent, particularly as multimedia continues to grow outside the world of clinical trials. Participants will come to expect video, embedded glossaries, and easy-to-access trial information. Medrio is here to help sponsors and CROs provide those elements and more.
References:
[1] U.S. Department of Health and Human Services & Food and Drug Administration. (2016). Use of electronic informed consent questions and answers. Food and Drug Administration.
[2] Lamberti, M.A., Smith, Z., Dirks, A., Caruana, T., Mitchell, T., & Getz, K.A. (2022, July). The impact of decentralized and hybrid trials on sponsor and CRO collaborations. Applied Clinical Trials. Retrieved January 4, 2023.
[3] Gesualdo, F., Daverio, M., Palazzani, L., Dimitriou, D., Diez-Domingo, J., Fons-Martinez, J., Jackson, S., Vignally, P., Rizzo, C., & Tozzi, A. E. (2021). Digital tools in the informed consent process: a systematic review. BMC medical ethics, 22(1), 18. Retrieved January 31, 2023.
[4] Glaser J, Nouri S, Fernandez A, et al. (2020). Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review. Medical Decision Making. 2020;40(2):119-143. Retrieved January 31, 2023.
[5] De Sutter, E., Zaçe, D., Boccia, S., Di Pietro, M. L., Geerts, D., Borry, P., & Huys, I. (2020). Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review. Journal of medical Internet research, 22(10), e19129. Retrieved January 31, 2023.
[6] Rowbotham, M. C., Astin, J., Greene, K. & Cummings, S. R. (2013, March 6). Interactive informed consent: randomized comparison with paper consents. PLOS One, 8(3), article e58603. Retrieved January 31, 2023.
[7] Barbara Bush Foundation for Family Literacy, (2019). Literacy Gap Map. Barbara Bush Foundation for Family Literacy. Retrieved January 31, 2023.
[8] CDC, (2022, February 2). What is Health Literacy? Centers for Disease Control and Prevention. Retrieved January 31, 2023.
[9] Bader, M., Zheng, L., Rao, D., Shiyanbola, O., Myers, L., Davis, T., O’Leary, C., McKee, M., Wolf, M., & Assaf, A. R. (2022). Towards a more patient-centered clinical trial process: A systematic review of interventions incorporating health literacy best practices. Contemporary clinical trials, 116, 106733. Retrieved January 31, 2023.
[10] Vanaken, H. & Masand, S.N. (2019). Awareness and Collaboration Across Stakeholder Groups Important for eConsent Achieving Value-Driven Adoption. Ther Innov Regul Sci 53, 724–735. Retrieved January 31, 2023.
