Using community-centered research to transform a complex genomic consent process

Informed consent is intended to help people make knowledgeable, voluntary decisions about research participation. In practice, long and complex consent documents can leave participants satisfied with the process while still misunderstanding important information.

For the Personalized Medicine Research Project, our challenge was to redesign consent for a population-based genomic biobank without sacrificing comprehension, ethical integrity, human connection, or participant trust.

Project Overview

My role
Research design, literature review, data collection, analysis, UX and usability research, and lead manuscript development

Organization
Marshfield Clinic Research Foundation Biomedical Informatics Research Center

Program
Personalized Medicine Research Project, a population-based DNA biobank

Team
Biomedical informatics researchers, genetic researchers, research coordinators, education specialists, software developers, project management, community advisors, and usability professionals

Methods

Consent-process observation
Simulated consent sessions
Workflow analysis
Community advisory focus groups
Hybrid focus groups with hands-on technology evaluation
Formal task-based usability testing
System Usability Scale
Readability analysis
Comprehension assessment
Video recording and qualitative analysis
Iterative prototype development

Research participation

12 simulated consent sessions
11 Community Advisory Group participants
10 hybrid focus-group participants
9 formal usability-test participants

The Context & Challenge

Consent was being delivered, but important information was not always understood

Genomic research introduces unusually complex consent questions. Participants must understand not only what will happen during enrollment, but also how their DNA and health information may be stored and used over time.

Previous research with Personalized Medicine Research Project participants found that many understood the overall purpose of the study but remained uncertain or incorrect about important details, including:

How long participation would continue
Whether DNA would be stored
Whether participants would receive personal study results
How genetic information might be used
What risks and benefits were associated with participation

The problem extended beyond this individual program. Research across clinical studies had shown that participants often reported being satisfied and well informed while demonstrating poor understanding or recall.

A computer-based consent experience offered several potential advantages:

Consistent delivery of essential information
Self-paced learning
Optional access to additional detail
Multimedia explanations
Built-in comprehension checks
Standardized documentation
Reduced variation between consent sessions

However, digitization also introduced significant risks. A computer could make the experience feel impersonal, undermine trust, create accessibility barriers, or simply reproduce the complexity of the paper document on a screen.

The strategic question was:

How might we use technology to make genomic research consent clearer and more consistent while preserving the human support required for an informed, voluntary decision?

Project goals

The team set out to:

Understand how the existing consent process worked in practice.
Identify where technology could support or replace parts of the process—and where human involvement remained essential.
Involve community members in decisions about content, format, hardware, tone, and interaction.
Develop and evaluate a computer-based consent prototype.
Determine whether representative participants could complete the experience and correctly answer comprehension questions.
Create a more consistent and scalable consent process without weakening ethical safeguards or participant trust.

Research & Insights

Studying the real consent experience before designing its replacement

We began by examining the existing consent process rather than immediately translating the paper form into a digital interface.

Twelve simulated consent sessions were conducted: six with employees and six with community participants. The sessions were video-recorded and digitally captured so the team could examine:

What the research coordinator explained beyond the written document
Where participants asked questions
Which concepts required additional clarification
Which sections were covered too quickly
How long consent took
Where human judgment and interaction added value
Which frequently asked questions should be incorporated into the digital experience

The average simulated consent took approximately 20.8 minutes, ranging from about 13 to 28.5 minutes.

Participants identified several areas that were sometimes covered too quickly, including study participation, laws protecting genetic information, study duration, and emergency care. They also wanted more natural opportunities to ask questions instead of feeling that they had to interrupt the coordinator.

Key insight 1: Digitizing the form was not the same as redesigning the experience

The existing paper document was written at approximately an 8.4-grade reading level and contained long sentences averaging 20.4 words.

Through observation and annotation, the team identified the information the coordinator actually emphasized during verbal consent. This became the basis for a computer-based script written at approximately a 7.6-grade reading level, with sentences averaging 12.2 words.

The objective was not simply to shorten the material. It was to create a clearer structure that preserved required information while making key concepts easier to process.

Key insight 2: The community wanted simplicity, not multimedia for its own sake

Two focus groups with 11 members of the project’s Community Advisory Group explored willingness to adopt computer-based consent and reactions to possible features.

Participants consistently asked the team to:

Keep the experience simple and concise
Remove unnecessary “fluff”
Present clear, standardized summary points
Allow people to choose when they wanted more detail
Use a real and trusted person as the narrator
Avoid distracting music, sound effects, cartoons, and unnecessary animation
Preserve opportunities to ask questions
Integrate electronic signatures into the digital process
Avoid overwhelming participants with duplicate paper materials

This challenged the assumption that a more engaging digital experience required more media. Participants valued clarity, seriousness, choice, and credibility more than visual novelty.

Key insight 3: Trust depended on how the technology represented people

Community advisors preferred the principal investigator as the primary on-screen “personality” rather than an actor or animated character.

A recognizable research leader created continuity between the project, its public communication, and the consent experience. The decision also reinforced authenticity: the person explaining the study was accountable for the research rather than simply performing a script.

The interface therefore needed to communicate not only information but institutional and interpersonal trust.

Key insight 4: Comprehension checks needed to teach, not judge

Community members initially reacted negatively to proposed quiz questions because they did not want consent to feel like a test.

Their perspective changed when the questions were reframed as reinforcement. Participants recommended placing questions after relevant sections and immediately providing the correct answer.

The final experience included seven true-or-false and multiple-choice comprehension checks designed to:

Reinforce essential concepts
Help participants recognize missed information
Encourage closer attention
Give the research team a more visible indication of understanding

Key insight 5: Hardware shaped accessibility and acceptance

Two hybrid focus groups allowed 10 community participants to try consent and training examples on three hardware options:

Touch-screen kiosks
Ruggedized touch screens
Tablet computers

Participants generally preferred the kiosk because it offered:

A larger, easier-to-read screen
Direct finger-based interaction
A stable physical setup
The ability to sit while completing the experience

Participants who had limited confidence with computers still found direct touch interaction approachable. Hardware selection was therefore treated as part of experience strategy rather than a downstream technology decision.

Key insight 6: Standardization and human support were complementary

Research revealed that neither an entirely human nor an entirely automated experience was ideal.

A research coordinator could answer questions, recognize uncertainty, and help someone become comfortable with unfamiliar technology. The computer could deliver essential information consistently, let participants proceed at their own pace, and make supplemental information available on demand.

The strongest model combined both:

Use technology for consistency, pacing, reinforcement, and documentation. Preserve people for trust, judgment, clarification, and ethical support.

The Strategic Process

1. Map the existing consent workflow

The team observed and recorded simulated consent sessions to understand the complete service—not only the paper document.

We identified:

What information was standardized
What depended on the coordinator
Where questions naturally occurred
Which information needed further explanation
Which tasks could be supported by technology
Where a person needed to remain available

This established a grounded basis for deciding what to automate and what to preserve.

2. Build community participation into strategic decisions

Community members contributed before the final interface was developed.

Focus-group discussions informed decisions about:

Content length and depth
Multimedia use
Narrator selection
Comprehension checks
Electronic signatures
Help and reference materials
Compensation choices
Tone and professionalism

The community was not asked simply to approve a finished concept. Its feedback shaped the experience model.

3. Test the technology before committing to a platform

Hybrid focus groups combined hands-on trials with moderated discussion. Participants compared multiple devices and interaction models before the team selected a touch-screen kiosk.

This allowed usability, comfort, readability, hygiene, privacy, and physical accessibility concerns to influence the hardware strategy.

4. Translate findings into a working prototype

The team developed a computer-based experience that included:

A trusted human narrator
Spoken explanations supported by concise on-screen text
Self-paced progression
Optional FAQs and additional information
Seven embedded comprehension checks
A call button for human assistance
Electronic signatures
A printed copy of the completed consent
Clear and consistent navigation

The prototype complemented rather than eliminated the research coordinator. The coordinator introduced the experience, helped participants become comfortable with the technology, remained available for questions, and completed the final consent steps.

5. Conduct formal task-based usability testing

Nine representative community participants between the ages of 48 and 78 completed simulated consent using the touch-screen kiosk.

A usability analyst introduced the study and observed the session. The research coordinator initially remained in the room and was then available through a call button while the participant independently completed the experience.

Evaluation included:

Successful completion
Observed usability issues
Participant comments
Electronic-signature completion
Responses to seven comprehension questions
System Usability Scale results
A post-session interview

Every documented usability issue was compiled with a recommendation and addressed in development of the improved interface.

6. Connect usability with ethical quality

Success was not defined solely by whether participants reached the end of the interface.

The evaluation considered whether the experience:

Communicated required information clearly
Supported correct comprehension
Preserved voluntary decision-making
Allowed participants to ask questions
Maintained human accountability
Worked for people with limited computer confidence
Delivered information consistently across participants

This positioned usability as a contributor to ethical research practice rather than only a measure of interface convenience.

The Outcome & Impact

Strong usability and comprehension results

Formal evaluation produced several encouraging outcomes:

91.11/100 average System Usability Scale score
All nine participants completed the computer-based consent
All seven comprehension questions were answered correctly by every participant
No participant experienced difficulty entering an electronic signature
Participants with little touch-screen experience found the interface easy to use
Participants described the questions as clear and understandable
The digital script reduced the estimated reading level from 8.4 to 7.6
Average sentence length was reduced from 20.4 to 12.2 words

A community-informed experience was implemented

The work moved beyond a research prototype. The resulting computer-based consent was put into use for consenting Personalized Medicine Research Project participants on touch-screen devices.

That implementation demonstrated the operational value of the strategy:

More consistent presentation of required information
Self-paced access to content
Embedded comprehension reinforcement
Standardized electronic signatures
Continued access to a human research coordinator
A repeatable consent model for a large population-based research program

Product and service improvements

Community and usability findings directly influenced:

Hardware selection
Content hierarchy
Reading level
Sentence length
Narrator choice
Use of multimedia
Navigation and interaction
Comprehension-check placement
Electronic-signature handling
Availability of human assistance
Printed reference materials
Participant compensation options

Strategic value

The project demonstrated that community participation could improve both the usability and acceptability of a complex genomic consent process.

It also established a broader design principle for regulated and high-trust experiences:

Standardization should not require dehumanization, and human support should not require inconsistency.

The resulting hybrid model used technology where it added structure and consistency while retaining human involvement where trust, judgment, and clarification were essential.

What the study did not claim

This proof-of-concept study did not establish long-term retention of consent information, compare recruitment rates against the traditional process, or measure financial return.

The sample was small, and the study did not control for medical literacy or reading ability. Some participants may also have had previous exposure to the Personalized Medicine Research Project.

The demonstrated impact was:

Successful development and implementation of a community-informed consent experience
Strong usability among representative participants
Correct responses to all embedded comprehension questions
Identification and resolution of observed usability problems
A foundation for evaluating comprehension and retention at greater scale

What I Took Forward

This project changed how I think about digital transformation in healthcare and research.

The most responsible solution was not to automate the entire consent process. It was to determine which parts benefited from technology and which parts still required a person.

Technology offered consistency, pacing, access to detail, comprehension reinforcement, and documentation. People provided context, trust, judgment, and the ability to respond to individual uncertainty.

The work reinforced another principle that continues to shape my design-strategy practice:

When an experience involves a consequential decision, comprehension and trust are product outcomes.

A successful digital consent experience does more than capture a signature. It helps a person understand the choice, recognize its implications, ask questions, and make a decision that is genuinely informed.

Capabilities Demonstrated

Publication

Mahnke AN, Plasek JM, Hoffman DG, et al. “A Rural Community’s Involvement in the Design and Usability Testing of a Computer-Based Informed Consent Process for the Personalized Medicine Research Project.” American Journal of Medical Genetics Part A. 2014;164A:129–140. doi: 10.1002/ajmg.a.36220.

Designing Informed Consent People Could Understand and Trust