Authors: Annie B. Friedrich, PhD, Erin D. Solomon, PhD, Jessica Mozersky, PhD, & James M. DuBois, DSc, PhD

Author affiliation (all authors): Bioethics Research Center, Washington University School of Medicine, St. Louis, MO, USA

With funding from the National Institutes of Health, our team at Washington University School of Medicine developed an online toolkit, ConsentTools.org, to make consent processes in clinical trials more effective and efficient. It shares information, resources, brief videos, and tools to help clinical research professionals implement several evidence-informed consent practices. These include:

• Using plain language
• Using appropriate formatting
• Assessing for understanding

Randomized controlled trials demonstrated that using these practices can increase participants’ understanding and appreciation of consent information.[1, 2] In this blog post, we explore how to adapt these practices when using eConsent in clinical trials.

eConsent

The traditional paper-based informed consent process is usually conducted in person with research personnel and potential participants or their representatives. However, the COVID-19 pandemic led to a rapid shift towards remote electronic informed consent (eConsent) because in-person consent was not feasible or safe in many cases.

Broadly understood, eConsent involves using electronic devices (i.e. computer, tablet, phone) to provide study information to a potential subject or legally authorized representative and to obtain documentation of consent.[3-5] The benefits of eConsent include: 

• Enabling consent when face-to-face consent is not possible
• More convenient for researchers and participants
• Increased enrollment potential, including recruitment and enrollment of under-represented populations [3, 6]

Generally, there are two types of eConsent: 1) researcher-assisted eConsent, or 2) self-administered eConsent without research personnel. Researcher-assisted eConsent usually involves a live discussion between the potential research participant and a member of the study team. This discussion often occurs remotely. For example, research team members may use video conferencing to share their screen and walk participants through an electronic consent form. When using this type of eConsent, participants can have their questions answered immediately when going through the consent documents. Research personnel can also direct attention to the most relevant information for decision making, while using multimedia components to enhance understanding and engagement. Researcher-assisted eConsent can be used for a variety of studies, from minimal risk to higher risk.

Self-administered eConsent (also referred to as “app-mediated” or “mobile-mediated consent”) is conducted entirely by the research participant without study personnel present. For example, participants might use a mobile phone consent app to allow researchers to track their daily exercise. This model of eConsent is convenient for both participants and researchers, as additional clinic visits to complete the consent process can be eliminated.[7] Participants can also move through the consent process at their own pace, which may help facilitate understanding and voluntariness. While self-administered eConsent is most commonly used in minimal risk trials such as requests for review of one’s electronic health record, biobanking, or similarly minimal risk research, self-administered eConsent may be appropriate in other studies, as well.  

Evidence-Informed Practices for eConsent

Given the advantages of eConsent, its broader use will likely continue beyond the pandemic. Thus, we wish to explore how researchers can incorporate evidence-informed practices when designing their eConsent processes (see Table 1). We developed ConsentTools.org to help clinical research professionals understand and adopt three evidence-informed practices for consent in clinical trials. Below and in Table 1, we detail how to adapt these practices for eConsent.

Using Plain Language

Participants prefer and achieve higher levels of understanding with consent forms that use clear language at an appropriate reading level.[1] However, research suggests that formatting and plain language are not widely used in consent forms.[8, 9] When writing your eConsent, make sure to use active voice and simple words, define technical terms, and avoid jargon. Use hover-over definitions when possible, and use short paragraphs that contain only one topic.

Using Appropriate Formatting and Web Design Formatting and web design are also important elements of a successful eConsent.[10] Because participants may physically process text differently on a screen than they do on paper (skimming, reading only parts of the webpage, etc.), make sure your eConsent is formatted properly for electronic display so that participants can read and understand the consent. In particular, use responsive web design with html, which will adapt the font size to fit the

reader’s screen. Try to avoid using pdf documents, because they do not adapt easily to smaller screens. Also consider using bullet points and increased white space to improve understanding. 

Assessing for Understanding

Lastly, it is important to assess for understanding when using eConsent. Providers and participants often overestimate patient comprehension of informed consent information.[11] If you are using researcher-assisted eConsent, check for understanding throughout and allow time for questions. You may also consider using a validated assessment like the University of California Brief Assessment of Capacity to Consent (UBACC) to determine understanding and appreciation of information, even if not face-to-face [2].

When using self-administered eConsent, consider incorporating attention checks. For example, ask participants to respond to a simple quiz question at different points when reading the consent form. Doing so may help ensure participant understand, and it creates “cognitive friction” so that participants cannot simply “click through” the consent form without reading it.[12]

Further Considerations When Implementing Evidence-Informed Practices in eConsent

It is appropriate to use evidence-informed practices when preparing the entire informed consent document. However, IRBs and sponsors often require the use of templates that can reduce clinical trialists’ ability to edit consent forms. For this reason, we recommend focusing on rigorously implementing evidence-informed practices in the key information section of informed consent documents. This is because the key information “must be organized and presented in a way that facilitates comprehension.”[13] Moreover, they supplement rather than replace consent forms. In general, IRBs are more willing to allow modifications to this section.

Once your form is designed for electronic use, many questions will arise regarding implementation.

• Does my IRB recommend or require a specific eConsent vendor (REDCap, Doxy.me, etc.)? What guidance does my IRB provide?
• How will I protect patient privacy and confidentiality? Is my eConsent HIPAA compliant?
• Will various populations have access to this eConsent, including rural, minority, or elderly populations? How can I address barriers that might hinder eConsent, such as internet connectivity or device issues?[14]
• Will participants be offered an alternative consent document (e.g., a hard copy) if they prefer?
• Will I assess understanding of consent information? If so, how?
• Can I use this eConsent model with a Legally Authorized Representative (LAR)?

We recommend that clinical trialists address these questions as they prepare their IRB applications.

Conclusion

For more information on implementing evidence-informed consent practices in both paper-based and electronic consent formats, visit our toolkit at ConsentTools.org. Here you will find short instructional videos, a sample assessment of participant understanding, and templates with sample language and references you could include on an IRB application to explain why you have adopted these practices. We invite you to check out the toolkit and provide your feedback.

Table 1. Evidence-Informed Practices for eConsent

References

Kim, E.J. and S.H. Kim, Simplification Improves Understanding of Informed Consent Information in Clinical Trials Regardless of Health Literacy Level. Clinical Trials, 2015. 12(3): p. 232-6.

2.         Jeste, D.V., et al., A New Brief Instrument for Assessing Decisional Capacity for Clinical Research. Archives of General Psychiatry, 2007. 64(8): p. 966-74.

3.         Skelton, E., et al., Electronic Consenting for Conducting Research Remotely: A Review of Rurrent Practice and Key Recommendations for Using e-Consenting. International Journal of Medical Informatics, 2020. 143: p. 104271.

4.         De Sutter, E., et al., Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review. Journal of Medical Internet Research, 2020. 22(10): p. e19129.

5.         US Food and Drug Administration (FDA). Use of Electronic Informed Consent: Questions and Answers. Guidance for Institutional Review Boards, Investigators, and Sponsors. 2016. Accessed 1 December 2021; Available from: https://www.fda.gov/media/116850/download.

6.         Bobb, M.R., et al., Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial. Academic Emergency Medicine, 2016. 23(7): p. 759-765.

7.         Vanaken, H.I. and S.N. Masand, Awareness and Collaboration Across Stakeholder Groups Important for eConsent Achieving Value-Driven Adoption. Theraputic Innovation and Regulatory Science, 2019. 53(6): p. 724-735.

8.         Paasche-Orlow, M.K., et al., Readability of Consent Form Templates: A Second Look. IRB: a Review of Human Subjects Research, 2013. 35(4): p. 12-19.

9.         Solomon, E.D., et al., Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials. Journal of Empirical Research on Human Research Ethics, 2022. 17(1-2): p. 177-192.

10.       Campbell, F.A., et al., The Effect of Format Modifications and Reading Comprehension on Recall of Informed Consent Information by Low-Income Parents: A Comparison of Print, Video, and Computer-Based Presentations. Patient Education and Counseling, 2004. 53(2): p. 205-216.

11.       Montalvo, W. and E. Larson, Participant Comprehension of Research for Which They Volunteer: A Systematic Review. Journal of Nursing Scholarship, 2014. 46(6): p. 423-31.

12.       Wilbanks, J., Design Issues in E-Consent. Journal of Law, Medicine, and Ethics, 2018. 46(1): p. 110-118.

13.       U. S. Department of Health Human Services, Office for Human Research Protections, and Office of the Assistant Secretary for Health, Subpart A of 45 CFR 46 : Basic HHS Policy for Protection of Human Subjects (As revised on January 19, 2017, and amended on January 22, 2018 and June 19, 2018). 2018.

14.       Simon, C.M., et al., Perspectives on Electronic Informed Consent From Patients Underrepresented in Research in the United States: A Focus Group Study. Journal of Empirical Research on Human Research Ethics, 2018. 13(4): p. 338-348.

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