FEB 5, 2020
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 the 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 the few square inches of a smartphone screen.

What is informed consent?

Informed consent is the process by which a researcher communicates the key information about a study—risks, benefits, discomforts, incentives, and more—to the respondents in advance of participation, and obtains their consent before a respondent participates in the research. The US Department of Health and Human Services Office of Human Research Protections promulgates the regulations, known as §45 CFR 46, that govern the consent process between researchers and study subjects. In 2018, the agency updated its regulations (the “Common Rule”) to include rules around the structure and presentation of the content. Twenty federal agencies are signatories to the updated Common Rule. This ups the ante for mobile UX designers while ensuring regulatory compliance across the important human subjects research at these 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 the expertise of ICF’s user interface (UI) and user experience (UX) designers. Our designers hashed out an approach that could satisfy the informed consent requirements while delivering a satisfactory experience to study subjects. We focused our efforts on simpler design, more digestible content, and usability.