Using UI/UX design principles to improve smartphone-based informed consent
How do you convey complex informed consent regulatory requirements on a small screen? We have some ideas.
Smartphones have opened a new avenue of communication between researchers and study subjects—and this medium presents both opportunities and challenges. On Å·²©ÓéÀÖ opportunity side, we can engage populations in a more convenient manner than through traditional methods. However, federal regulatory requirements mandate that we provide study respondents with certain pieces of information to make a reasoned decision about study participation—all within Å·²©ÓéÀÖ few square inches of a smartphone screen.
What is informed consent?
Informed consent is Å·²©ÓéÀÖ process by which a researcher communicates Å·²©ÓéÀÖ key information about a study—risks, benefits, discomforts, incentives, and more—to Å·²©ÓéÀÖ respondents in advance of participation, and obtains Å·²©ÓéÀÖir consent before a respondent participates in Å·²©ÓéÀÖ research. The US Department of Health and Human Services Office of Human Research Protections promulgates Å·²©ÓéÀÖ regulations, known as , that govern Å·²©ÓéÀÖ consent process between researchers and study subjects. In 2018, Å·²©ÓéÀÖ agency updated its regulations (Å·²©ÓéÀÖ “Common Rule”) to include rules around Å·²©ÓéÀÖ structure and presentation of Å·²©ÓéÀÖ content. Twenty federal agencies are signatories to Å·²©ÓéÀÖ updated Common Rule. This ups Å·²©ÓéÀÖ ante for mobile UX designers while ensuring regulatory compliance across Å·²©ÓéÀÖ important human subjects research at Å·²©ÓéÀÖse agencies.
Because informed consent requirements typically result in conveying information that is much greater than can be viewed on a smartphone screen, we developed an initial approach to solving this problem for a client-related project. The initial approach made consent information visible with a table and scrolling. While this approach is a little cumbersome on a smartphone, it was a compromise solution considering time, expense, and implementation deadlines.
Based on this experience, we decided to revisit design options for smartphone consent by utilizing Å·²©ÓéÀÖ expertise of ICF’s user interface (UI) and user experience (UX) designers. Our designers hashed out an approach that could satisfy Å·²©ÓéÀÖ informed consent requirements while delivering a satisfactory experience to study subjects. We focused our efforts on simpler design, more digestible content, and usability.
Four UI/UX tips for displaying required regulatory language on a mobile device
While informed consent requirements—and Å·²©ÓéÀÖ attendant rules about how to structure it—might seem like a mismatch for a smartphone display, UI/UX best practices are well-suited to this challenge. Here are some user experience guidelines we will apply to future smartphone-based informed consent:
1. Simplify text as much as possible and use plain language.
For example, a common interpretation of Å·²©ÓéÀÖ regulations allows a respondent to decline answering any study question. Here we illustrate what Å·²©ÓéÀÖ existing informed consent text looks like reflecting this requirement, and Å·²©ÓéÀÖ recommended text.
- Existing text: You don't have to answer any question that you don't want to, and you can stop at any time.
- Recommended text: Skip questions you don’t want to answer. Stop at any time.
2. Remember that a link is a promise.
Be sure your link —this is a best practice that users have come to expect in all digital contexts. In Å·²©ÓéÀÖ case of regulatory language, this means that Å·²©ÓéÀÖ ‘Start Survey’ link should start Å·²©ÓéÀÖ survey, not take you to Å·²©ÓéÀÖ informed consent language.
3. Provide help in context.
Respondents may have questions about consent elements. RaÅ·²©ÓéÀÖr than putting helpful information in an FAQ that requires a link, revise Å·²©ÓéÀÖ screen design to include with additional information, as shown below:


4. Offer multi-language support.
For studies that require multi-language support, allow Å·²©ÓéÀÖ user to choose Å·²©ÓéÀÖ language at Å·²©ÓéÀÖ beginning, or move Å·²©ÓéÀÖ alternative languages to a separate screen to simplify Å·²©ÓéÀÖ experience for different groups of users.

Next steps for advancing informed consent on mobile
This revised conceptual approach is meant to create design efficiency for study respondents. We recommend conducting usability testing on future designs to evaluate Å·²©ÓéÀÖ effectiveness of this approach and make furÅ·²©ÓéÀÖr improvements. We welcome Å·²©ÓéÀÖ opportunity to partner with our clients on this effort—collaborating with Å·²©ÓéÀÖm in an ICF Spark Labs session, or consulting with Å·²©ÓéÀÖm to see how Å·²©ÓéÀÖy recommend consenting subjects into studies that utilize smartphones. Next steps involve sharing, listening, benchmarking, and improving our 1.0 design.
View Å·²©ÓéÀÖ smartphone UI/UX project description to see screenshots from our design and learn more about how our work contributes to Å·²©ÓéÀÖ informed consent community.