Researcher-Assisted eConsent -

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 (not face-to-face). For example, research team members may use video conferencing to share their screen and walk participants through an electronic consent form.

Key benefits of this type of eConsent include:

Participants can have their questions answered immediately
Research personnel can direct attention to the most relevant information for decision making
Multimedia components can be used to enhance understanding and engagement

Evidence-Informed Practices for eConsent

Evidence-informed practices for researcher-assisted eConsent include:

Using plain language
Using appropriate formatting and web design
Assessing for understanding

See the table for how to incorporate these practices into your eConsent model.

Evidence-Informed Practices for Informed Consent	Application to eConsent
Plain Language	Use active voice and simple words, define technical terms, and avoid jargon Use hover-over definitions, when possible Use short paragraphs that contain only 1 topic Sentences should be short and simple (20 words or less)
Formatting and Web Design	Limit the number of fonts per website Use sans serif for body text and a highly readable font size Use bullets to help the reader digest the information quickly Use headers to organize information Use bold for emphasis instead of underlining or italics Use ragged right margins to create more white space Don’t use all caps
Assess for Understanding	Check for understanding throughout Allow time for questions Use a validated assessment (like the UBACC) to determine understanding and appreciation of information, even if not face to face

Key Considerations

1. Focus on the key information section
  - Consider focusing on evidence-informed practices for 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” (45 CFR 46).
    - - As a result, IRBs are often more likely to allow modifications to this section.
      - However, the evidence-informed practices apply to the entire informed consent document and where possible, should be used throughout.
1. Keep in mind the difference between electronic and hard-copy formats
  - 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.
Questions to ask when designing and implementing your researcher-assisted eConsent include:
- - Does my IRB recommend or require a specific eConsent vendor? What guidance does my IRB provide?
  - How will I protect patient privacy and confidentiality? Is my eConsent HIPAA compliant?
  - Does my eConsent follow evidence-informed practices for plain language, formatting, and web-based communication?
  - 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?
  - Will participants be offered an alternative consent document (e.g., a hard copy) if they prefer?
  - How will I assess for understanding of consent information?
  - Can I use this eConsent model with a Legally Authorized Representative (LAR)?

Helpful Resources

Topic	Resource	Brief Description
Overview of eConsent	De Sutter, E., Zace, 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. J Med Internet Res, 22(10), e19129. PMID:33030440	This systematic review provides recommendations to guide implementation of eConsent for six domains: format; impact on understanding; acceptability; security and trust; storage; and content.
	Chen, C., Lee, P. I., Pain, K. J., Delgado, D., Cole, C. L., & Campion, T. R., Jr. (2020). Replacing paper informed consent with electronic informed consent for research in academic medical centers: A scoping review. AMIA Joint Summits on Translational Science, 80–88. PMID: 32477626	This review article collated existing studies of eConsent into five categories: 1) ethical, legal, and social issues, 2) user interface/user experience considerations, 3) comparing to paper consent, 4) enterprise scalability, and 5) feasibility of changes to the eConsent process.
	Skelton, E., Drey, N., Rutherford, M., Ayers, S., & Malamateniou, C. (2020). Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting. Int J Med Inform, 143, 104271. PMID: 32979650	This article offers practical recommendations and best practices for researchers in five primary domains: 1) accessibility and user-friendliness of eConsent; 2) user engagement and comprehension; 3) customizability to participant preferences and demographics; 4) data security; and 5) impact on research teams.
Ethical, Practical, and Design Concerns	Welch, B. M., Marshall, E., Qanungo, S., Aziz, A., Laken, M., Lenert, L., & Obeid, J. (2016). Teleconsent: A novel approach to obtain informed consent for research. Contemporary Clinical Trials Communications, 3, 74-79. PMID: 27822565	This article notes the benefits of teleconsent and provides a detailed method for designing, preparing, and conducting teleconsent.
Participant Experiences and Empirical Data	Simon, C. M., Schartz, H. A., Rosenthal, G. E., Eisenstein, E. L., & Klein, D. W. (2018). Perspectives on electronic informed consent from patients underrepresented in research in the United States: A focus group study. J Empir Res Hum Res Ethics, 13(4), 338-348. PMID: 29790410	In this study, the authors conducted focus groups with underrepresented patients in research to understand their preferences for a paper versus eConsent. Overall, participants found eConsent easier to use, more interesting, and better for understanding. Some minority and rural participants raised concerns, and these population-specific issues are important to consider when designing a study.
	Bunnell, B. E., Sprague, G., Qanungo, S., Nichols, M., Magruder, K., Lauzon, S., . . . Welch, B. M. (2020). An Exploration of Useful Telemedicine-Based Resources for Clinical Research. Telemed J E Health, 26(1), 51-65. PMID: 30785853	In this survey of individuals associated with leading, planning, or conducting clinical research trials, the authors report the greatest opportunities and challenges for teleconsent.
Web-Based Resources	Sage Bionetworks Toolkit	Practical guide with tips and examples for designing and implementing your eConsent.
	TransCelerate BioPharma, Inc. 2017	Practical design and implementation guide for various eConsent models.
	HHS Electronic Informed Consent Guidance	Q&A on eConsent from the Office of Human Research Protections.

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