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.
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.
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.
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.
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?
The All of Us Use CaseThe 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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