By Rachele Peterson (Director, Healthcare Provider Organization Engagement) | December 17, 2020
In my many years leading participant recruitment in health research, one of the most common questions I’m asked is, “How do you enable eConsent for health research?” Having led recruitment for a large healthcare partner of the National Institutes of Health’s All of Us Research Program – a national initiative that endeavors to recruit a diverse one-million-person cohort – I’ve seen first-hand the rapid adoption of eConsent and its ability to spur greater participant engagement.
It’s surprising to see eConsent still underused by many research organizations, when its impact can be so beneficial to participants. Using our experience in All of Us — a massive digital health research undertaking scaled to 430,000+ diverse participants across all 50 states in multiple languages including 790,000 eConsents over a four-year period — I’ll share seven best practices to help you adopt or strengthen electronic informed consent in your large or small health research studies.
In health research, informed consent is not a document to be read once, signed, then set aside. The process of informed consent is an ongoing experience between researchers and participants for the duration of their involvement in your protocol. When your consent process achieves the objective of participants’ full understanding of their agreement and the “why” and “how” they will be involved in your research, you are successfully accomplishing informedness. This ongoing state is a clear determining factor in long-term commitment and retention.
Virtual platforms leverage the conversational nature of information sharing, build in specific workflows based on eligibility criteria and populations, and create a customized experience that engages and educates participants during their decision to provide consent. They also ensure standardization of information sharing – reducing the burden on your best research coordinator in the case they forget to review an essential protocol element or your newest research assistant who is still learning the nuances of the schedule of events. If you’re considering adopting or strengthening eConsent, consider using a virtual platform to make the process more straightforward.
Include upfront questions based on your inclusion and exclusion criteria. For different consent versions based on responses, enable multiple branching workflows, so the right version is presented to the right participant at the right time. Make sure you follow consent and HIPAA regulations that can vary state to state. Requirements for different state-based rules can be programmed to reflect bills of rights, expiration dates, witness requirements and more.
Eight seconds. That’s the average human attention span. Still here? Good! We learn best in bits of information at a time. “Chunking” breaks down content into manageable segments that participants can more easily understand. For instance, in eConsent, the required elements of informed consent are broken down whereby each part of the experience is a different chunk.
Think of your favorite story. Do you prefer to read the book or watch the movie? Your diverse participants differ in their learning styles also. The best part of eConsent is the opportunity to used mixed methods to share information. For example, this can entail presenting short screens of written content followed by informational videos with closed captioning. Alternating these formats as you present the chunked information is best practice for educating participants with different learning styles.
A general rule in research is to target information to a fifth- to eighth-grade reading level. Ideally, you should also accommodate multiple languages, such as Spanish. When you translate, fit the language not just for literal but also cultural fluency.
A quiz is a great way to double check – and reinforce – the key concepts related to the research to which participants are consenting. For weighty decisions or protocols involving genetic research, provide a decision support tool. This tool helps participants better sort the pros and cons of their personal decision, such as whether to choose to get DNA results. Most importantly, it achieves the richer understanding that will boost your participant retention and engagement rates.
Virtual platforms make eConsent documentation user-friendly. For starters, they’ll present the long form for the participant’s review and signature. They will also record the participant’s electronic signature and the date, and immediately generate and email a PDF to the participant. The participant can access their signed consents at any time. These platforms also handle version control, so there are no out-of-date, printed paper consent forms laying around, ensuring that the newest consent version can be easily uploaded as soon as it is IRB-approved, and reducing deviations.
When new information becomes available and additional consent is needed, make sure that it can be provided to the participant quickly and easily in their account.
eConsent is a valuable tool that not only creates workflow efficiencies for research organizations but also enhances the experience for your participants. Bring your informed consent process to the level of today’s virtual research environment. Use a trusted virtual platform to streamline eConsent and help you achieve the participant trust and informedness that helps you retain your cohort and achieve your research outcomes. Vibrent Health is the Participant Technology Systems Center (PTSC) for the NIH All of Us Research Program and provides the digital health research platform for eConsent, data collection and participant engagement. Vibrent’s team brings deep expertise in all aspects of eConsent creation, delivery and ongoing management using digital health solutions.