When it comes to eConsent, there are a lot of things that health researchers get wrong. Using digital methods in health and clinical research involves many areas of expertise beyond understanding the area of research that study teams operate within as well as the various procedural guidelines that many institutions recommend. It also involves understanding and adopting digital best practices to prevent potential participants from dropping out too early. This is especially true of eConsent. Here are some reasons why your potential participants may not be completing consent in your studies.
Your website or digital experience is not participant-friendly
These days, people who participate in digitally-enabled health research are subject to many types of experiences online. Shopping apps, online dating, accessing their medical records, scheduling appointments, and ordering food are just some of the many ways people are using their smartphones and computers to engage digitally with various products and services. Whether you know it or not, your research interests in engaging potential participants are competing with these digital experiences. And most if not many of these experiences are fine-tuned for optimal user experience. Is your digital research experience on par with these experiences?
Potential participants may be put off from engaging with your consent materials if your website portrays a potentially frustrating or lackluster user experience. It could be stale, uninspiring graphics, or clunky writing, or a lack of buttons that call your prospects to specific actions—like signing up for the study. In a recent research paper, we showed that by creating a website with good user experience, we were able to convert 20.9 percent of vistiors into consenting participants.
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Your website and accompanying study materials may not be mobile-friendly. Or your study may not provide clear details on who to reach out to on your research team to ask questions. All of these can cause your recruits to abandon your study immediately and not look back.
So it’s important to consider how your messaging and the design of your digital recruitment materials and study materials reflects the modern user experience that many people expect. Any inkling that your website looks or feels outdated to the average research participant could be enough to reflect poorly on your study and discourage enrollment and completion of consent materials.
Your consent form is too complicated or unclear
Often, research teams are more focused on writing materials and consent documentation that serve their interests. They focus on conforming to state rules around consent, and for explaining the study in the way that they, as researchers, understand. But writing materials based on a researcher’s understanding of their research is quite different than writing study materials that reflect the average participant’s understanding of what that research might entail.
To that end, it’s important to take the time to write and rewrite consent materials to adapt them for an audience who may lack health literacy. When in doubt, it’s always helpful to consult a focus group or an advisory board of patients or people who may participate in your study as it relates to your target population and demographics. A test audience, however small, can tell you if your materials are too hard to understand. If you can rewrite your consent documents so that potential participants can more easily get what you are studying and how you will conduct your research, it’s less likely that you will lose prospects to unclear or complicated explanations. You’ll suffer less abandonment at point of consent.
Your consent process takes too much time
It’s easy to see that any process that seems too lengthy or complex may compel people to abandon the consent process early. If a prospective participant has to read and sign multiple documents, or if there are too many steps in the process, you can easily turn them off from the study.
There may be a way to either break the process into simpler steps, or to do away with unnecessary tasks or information. The key is to avoid redundant information wherever possible. Do you repeat information? Is there a way to reduce the repetition? In terms of breaking the process down, have you considered paginating your consent form? Digital health research platforms like Vibrent’s allow for the breaking down of information into smaller pages, hence the term ‘pagination’. This is especially important for being able to have potential participants digest your consent form in bits and pieces. And doing so allows for people to focus on key information and retain it more easily.
Participants need to be reminded
Sometimes life gets in the way. If a potential participant is consenting remotely for your study and gets interrupted, they should be able to easily return to the process. But what if they forget? Digital health research has evolved to the point where it’s easy to monitor who has completed consent after initial enrollment, and who hasn’t.
For that matter, being able to remind prospects that they have yet to complete the consent process is a powerful tool for avoiding non-completion or total study attrition. It’s easy in this modern digital world for people to quickly lose interest in participating in a study. But in having the ability to send out reminders via text message or email to complete a consent form, it’s more likely that you can retain participants at this initial step. Even more important is fruther in the study when you are collecting data on these consented participants. If they forget to complete a survey, you can easily remind them. Being able to remind participants of an uncompleted milestone helps to foster engagement—whether it’s in the consent process or beyond.
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You aren’t incorporating best practices for diversity recruitment and engagement
When it comes to digital health research, the opportunity to recruit diverse participants across ethnicity, race, age, and other demographics is plentiful. However, you stand to lose recruits when information is not presented in a way that addresses various demographics’ general concerns. For one, privacy and confidentiality can be of utmost concern to many participant demographics where trust is key to engaging these populations. It’s also important to use graphics and imagery that are representative of the diverse demographics you wish to recruit and consent for your studies. For example, a consent video, when showing how research will be conducted, should depict an ethnically diverse sample of participants in its animations.
Technology is also a factor when it comes to consenting a diverse group of participants. People who are socioeconomically disadvantaged lack access to broadband internet and are more often using their smartphones to engage with digital health studies. For aging populations, many are not specifically comfortable with technology, and may benefit from versatile approaches like a computer-assisted telephone interview tool that consents them over the phone.
You aren’t incorporating other eConsent best practices
There are a number of other considerations that research teams need to be aware of when they create their electronic informed consent process and content. Planning up front and engaging your IRB early on are two important factors to make sure that you create consent content that is adherent to things like state regulations, and according to the standards that your institution considers heavily.
Video consent and digital consent call for numerous best practices to follow aside from just writing for your audience and breaking up your content into digestible fragments.
Overall, digital health research needs to be reflective of the modern digital age. EConsent has to adapt to modern best practices for user experience and in its messaging so that it can be clearly understood by a wide range of participants who may lack health literacy. You also need to be able to address values that different patient populations tend to hold as it relates to things like privacy and confidentiality. And above all, you need to meet participants where they’re at as it relates to technology—otherwise they won’t be able to participate.
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