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. eConsent provides organizations with an efficient and streamlined way to garner consent from study participants. Removing this barrier can help improve engagement and deeper the pool of potential participants.
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Let’s look at seven best practices to help you adopt or strengthen electronic informed consent in your large or small health research studies.
Full participant informedness can lead to higher commitment and retention
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 streamline the complexity of eConsent
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.
Here are some ways to more effectively implement eConsent in your research organization:
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Rachele Peterson Rachele Peterson is Director, Clinical Research at Vibrent Health. Rachele has more than 15 years of experience in clinical research and research administration, bringing to Vibrent firsthand knowledge and understanding of the needs of investigators and research teams. Most recently, she was the Executive Director and Principal Investigator of the All of Us […]
- Assess participant eligibility
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.
- “Chunk” information for participants into easy-to-understand segments
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.
- Accommodate different participant learning styles
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.
- Use “easy” language that is tailored to your participants
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.
- Use knowledge check to ensure a participant’s understanding and full informedness
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.
- Make documentation easy for your participants
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.
- Commit to consent over the duration of the project
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.
Photo: Elena Lukyanova, Getty Images
Rachele Peterson is Director, Clinical Research at Vibrent Health. Rachele has more than 15 years of experience in clinical research and research administration, bringing to Vibrent firsthand knowledge and understanding of the needs of investigators and research teams. Most recently, she was the Executive Director and Principal Investigator of the All of Us Research Program at the University of Arizona and Banner Health where she led award management, milestone adherence, relationship stewardship, communications, research compliance and fiscal management. Rachele successfully harmonized 130 research staff across 14 enrollment sites in two states to ensure program goals and milestones were achieved using standardized operations, enrolling over 38,500 participants from diverse communities. Rachele is the primary leader engaging with Healthcare Provider Organizations in the All of Us Research Program, guiding cross-functional and strategic efforts to position and manage the Participant Technology Systems Center needs around policy development, customer support and engagement, and quality improvement. She identifies opportunities for Vibrent platform offerings and builds industry-academic relationships. As a lifelong learner focused on continuous improvement and innovation, Rachele holds a Master of Science in clinical research management from Arizona State University and is presently completing an Executive MBA at her alma mater. She has a Bachelor of Arts in public policy analysis from University of North Carolina at Chapel Hill. She maintains two professional, national certifications as a Certified Research Administrator and Certified Clinical Research Professional.
