eConsent Done Right: A Powerful Tool to Build Trust and Diversity in Research  - Vibrent
Blog | April 04, 2022

eConsent Done Right: A Powerful Tool to Build Trust and Diversity in Research 

By Praduman “PJ” Jain, CEO & Founder

Researchers use a variety of tools and techniques to reach out and recruit diverse participants to their studies. But the best recruitment campaign does little good if potential participants encounter a stack of informed consent legalese that overwhelms with information instead of building trust and understanding. It can feel like entering a confusing and frustrating labyrinth after crossing the welcome mat. 

Decentralized eConsent technology can change that. eConsent can improve the informed consent process and help researchers overcome some of the barriers to recruiting and retaining diverse participants for their studies. 

But it has to be done right. 

Towards diversity in health research 

Participation from diverse communities is an essential ingredient for quality health research. Researchers can’t know if their results are applicable to all people unless their participant population reflects the general population.  

Unfortunately, many studies fall short in this regard. Racial and ethnic minorities make up more than 35 percent of the population but account for about 10 percent of health research participants—even though minorities often have higher rates of many diseases. Other people left out of research include older people, sexual and gender minorities, and residents of rural areas. 

Overcoming historical distrust 

People who are left out of medical research are often people who feel excluded from society in other ways, including the health care system. Negative experiences in seeking care as well as past instances of exploitation of minorities in medical research (Tuskegee syphilis study) breed mistrust and form another barrier to participation. 

Participating in research involves personal sacrifice and commitment. People who sign up for a clinical trial give their time and personal information to further medical research. They want reassurance that these valuable assets will contribute to a greater good and not be misused. 

Informed consent’s role in establishing trust 

The informed consent process should address concerns with clear and complete information about what data is being collected, how it will be stored, who will have access to it, and how it will be used — along with any associated risks and responsibilities. After all, participants aren’t likely to sign up for a study if they don’t know what the research involves or what researchers will be doing with the information collected. Is the treatment risky? Will their information be kept private or shared with employers or insurers? All of that should be explained in the informed consent process. 

This essence of informed consent in health research can get lost in jargon and inconsistent delivery. The most ethical and noble goals can be quickly obscured by a wall of incomprehensible terminology or unanswered questions.  

A participant-centric approach to informed consent 

eConsent is not about a single document, to be read or reviewed once and then set aside. It’s about clear and effective communication presented in a way that encourages understanding and absorption. It’s about giving participants choices, allowing them to ask questions or repeat certain information. It’s about starting an ongoing conversation.  

It’s about earning and building trust. 

And it can be especially effective when trying to reach diverse populations.  Studies show that participants from diverse backgrounds express more satisfaction with eConsent over paper consent processes.  

What does “done right” mean when it comes to eConsent?  

  • Engaging, professional presentation: Let’s face it, the informed consent process can be onerous. People are more likely to stick with it if the information is presented accurately in a way that is appealing.  
  • Multiple media—especially video: When information is presented by various methods—written, video with closed captions, etc.—it helps accommodate different learning styles, languages and platforms to ensure accessibility and understanding. Professional-level quality video – and portrayals that represent the participants – can help participants connect with the content. Researchers can use video tool kits which are less costly than starting from scratch to tell their own stories by modifying generic video scripts and animated scenes to connect with potential study participants.  
  • Standardized yet customizable: No two people are exactly alike. eConsent done right recognizes those differences while still presenting information in a standardized, non-biased way. Based on the participant’s answers, eConsent allows for multiple branching workflows and walks participants through the information that pertains to their situation. It also helps ensure that study developers follow state and federal rules to obtain legally, effective and meaningful informed consent. 
  • Clear navigation on various devices: When participants can choose how and when they access the information, they feel more relaxed and comfortable and can focus more on making an informed choice. 
  • “Chunked” information in plain language: Research involves complex issues; breaking the content down into manageable bites at a 5th– to 8th-grade reading level allows participants to digest it at their own pace.  
  • Built-in knowledge reinforcement: Consent should build on and reinforce key concepts. Users should be able to repeat sections, as necessary. Built-in knowledge checks foster feelings of support and mastery that increase user confidence in the process. 
  • Support for key decisions: Signing up for a research study involves a series of choices, some more complicated than others. eConsent should include a decision support tool to work through the pros and cons of difficult decisions, such as whether to get DNA results.  
  • Accessible records: The eConsent process should record participant answers as well as signatures, and participants and researchers should have access to review the forms they have signed at any time. They should be able to go back and re-read, even change their mind about some aspects. 
  • Adaptable to a shifting landscape: Research studies must evolve and adapt to changing circumstances—we just saw that with the pandemic when many studies had to pivot or change strategies in response to the public health emergency. When eConsent is online and cloud-based, researchers can quickly amend forms, request reconsent and adapt to unforeseen circumstances. eConsent thereby reinforces consent as a process that continues to evolve as the study evolves.  

The All of Us Use Case

The National Institutes of Health All of Us Research Program has made informed and decentralized eConsent a centerpiece of its multifaceted approach to participant recruitment and retention. With a goal of enrolling one million people living in the US, All of Us recruits participants in nationwide, both online and through trusted local partner organizations.  While there may be different requirements for informed consent based on geographic location, target population and other factors, eConsent ensures that research staff follow protocols and local laws while also presenting information in different languages and formats to meet individual participant needs.   Participants can stop and start as they want, go at their own pace and repeat certain parts. At any time, participants can initiate a conversation and ask questions via online chat, telephone or an in-person appointment with staff. Because eConsent automatizes some of the informed consent process, study staff report that it frees up their time to focus on building relationships and establishing ongoing dialogs in which participants ask more meaningful questions—which paves the way for better retention.   Using the eConsent process, All of Us has recruited 481,000 participants nationwide between May 2017 and August 2021. More than 50 percent of participants who completed the initial steps of the protocol identify as racial and ethnic minorities; more than 80 percent are from populations considered “underrepresented in biomedical research.”  As the use of eConsent grows along with the prevalence of digital health research, we will continue to see giant steps towards greater diversity in research, towards the goal of health equity and better health outcomes for all. 

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