eConsent Best Practices 

Electronic informed consent, also known as electronic consent or eConsent for short, is a digital way of capturing consent to participate in clinical trials and clinical research such as human cohort studies or genomics studies. The word ‘informed’ means that potential participants are aware of what they’re consenting to, which includes how they will participate, as well as any potential risks or benefits, and their right to withdraw consent at any time. 

As a result of our work at Vibrent Health in helping clients design and implement eConsent technology and processes, we’ve managed to learn and adapt some best practices that could be useful to you and your research teams looking to adopt this efficient digital method.  

Differences between eConsent and Paper Consent 

Before we begin to offer eConsent best practices, here are some critical differences between eConsent and paper consent. 

• Accessibility and convenience: Paper consent is usually done in person but can be mailed to participants who are far away from sites or lack appropriate transit. eConsent on the other hand can be completely remote, which creates accessibility and convenience for patients. 
• Record-keeping: Paper consent is prone to data entry errors since it must be manually filed. Even if a digital copy is produced, this requires scanning the paper copy which can be time intensive for study staff scanning every consent form. eConsent is automatically stored and organized for easy tracking, including things like date it was signed, IP addresses, and other information that can be important to establish a compliant audit trail. 
• Flexibility: eConsent is also highly flexible to account for things like sub-studies, different languages, tailored content for different demographics and populations, while paper consent typically possesses far less versatility without creating and managing multiple versions manually. 

Make these vital decisions up front 

In creating eConsent content and processes, you first have to think several steps ahead of simple execution. Here are some vital things to consider up front. 

• Language translation: For one, translation has to come early on in the conversation. How many languages do you want to translate? Will other elements of your study need to be translated? Do you want to consider localization for different sites to account for geographic variations in dialect? 
• State regulations: State laws can create complexity for studies being conducted in many areas of the country. The same goes for international studies – you need competent guidance to ensure you are complying with the legal obligations that states can have. 
• IRB requirements: You will want to gather not just the typical requirements for traditional consent, but the additional specifications that IRBs ask for when creating digital consent. 
• eConsent video script: If you’re going to create a consent video, the trick is to make sure you write the script early on. It will likely change alongside the consent document. Video production can take a long time, so you want to do this up front. 
• Other media: Also consider other media or interactive elements you want to include up front. Think of ways to build trust and give prospective participants an inclusive, informative, easy process. 
• Organization of consent: How will you organize and structure your content? Getting the flow right is important in phase one of your consent creation. 
• Customization for different populations: Like translation, you want to think about the demographics you will target for your study and how you will customize content to fit their general needs and psychology. It may be worth using language to build trust with prospective participants from under-represented groups who may harbor mistrust or distrust of clinical research. 
• Stakeholder engagement: All of this can certainly be overwhelming to a team of researchers who may not know where to find certain information or how to complete some of these list items. Video is a clear example of that. So it’s important to think about the kind of expert stakeholders you need to partner with to get these things done. 

Research and follow state regulations 

State regulations are important to understand up front. Here are some kinds of information that laws typically call for when it comes to digital consent. 

• Patient bill of rights: A patient bill of rights has to be included in consent forms in Illinois and California, for instance. This is because it needs to be clear as to what information research participants have a right to request, and what they are allowed to do. 
• Confidentiality, right to withdraw: States may also require specific language be included around things like confidentiality, the purpose of the study, and a patient’s right to withdraw at any time. California is a great example of this, and they have quite an exhaustive list of what consent forms need to say and how they say it. 
• Legal consent age: There can be variation across states as to what age that research participants can legally consent. Make sure you have a clear picture of this, because the implications of improper consent could have dire consequences on your ability to do research. 

Understandably, interpreting and complying with state regulations can be tricky and perhaps time-intensive. Finding an expert or a team of experts can help you navigate a multi-state consent process with a sense of ease and security. 

Want to partner with eConsent experts?  

Submit the right materials to the IRB 

What are the materials you need to submit to an IRB for eConsent? There is some overlap between traditional and electronic consent, but we want to stress some differences. 

• Video script: If you are creating video, sending a script is a must. 
• Multimedia and interactive features: Document how interactive features will help increase patient understanding and garner support when needed. 
• Knowledge check questions: Submit your knowledge check questions and answers, along with any branching logic to show how prospective participants will be corrected if they answer each question correctly or incorrectly. 
• Data safeguards: Provide information on data safeguards to explain how you will keep participant data secure and private. 
• Overview of the process: And be sure to describe an overview of how your consent process will work. A good best practice we have observed is submitting a workflow graphic like the one on this slide to show what exactly happens when a participant end-user takes a specific action. 
• Technical information: In addition to data security and privacy, it’s also important to show how the digital infrastructure works. A good example is to explain how digital signatures will be recorded. 
• Risk assessment: Be sure to address questions such as: how will you assess and avoid risks? How will you mitigate them when they happen? How will you collect and store data? 
• Digital support: Another really important thing to explain is how you will support participants in the process should they become lost or confused. However,  any automated or digital support should not replace meaningful interaction with study staff. This is because it’s so important to build trust directly with participants as well as digitally. 

Read our blog IRB Approval for eConsent: What to Include in Your Protocol for a more in-depth look at what you need to submit to institutional review boards for digital consent. 

Integrate intuitive communication tools and processes 

Another best practice for eConsent is to consider integrating intuitive communication tools and processes that make eConsent an easier process for people who want to participate in your study. 

• Encourage participation/interaction: You can also use communication tools like reminders and bi-directional messaging so that participants are encouraged to reach out to study staff. 
• Send reminders: You can use communication tools to segment participants based on whether they have completed their consent, or completed certain surveys. This is great for reminding participants to complete consent and other study milestones. 
• Self-service portal: one way you can do this is by creating a comprehensive self-service portal where participants can go online to sign, view, and withdraw consent at any time, change their communication preferences so they are notified in the manner they want to be, a dashboard where they can view the items they’ve completed in the study to show their progress, and to offer them a way to easily schedule appointments with research staff. 
• Communication preferences: If participants have access to a portal that allows them to indicate their communication method of preference, they will receive a reminder via that method such as email, SMS, or an in-app notification. 

Follow eConsent video best practices 

• As a result of our time at Vibrent Health creating many consent videos for our collaborators, we have learned many best practices you can incorporate when creating them for your studies. 
• Plan ahead: Get your script written and then approved by the IRB. Get on board with a video team early so they have enough time to create it before your study starts. 
• Optimize length: As far as length, eConsent videos that are three minutes or less tend to be the right amount of time. Three minutes or less ensures optimal comprehensibility without sacrificing some detail. 
• Consider visuals: You want to consider your visuals carefully. Animation can quickly show how participation in the study works, and it can easily explain complex concepts. 
• Don’t use stock video: We caution against using stock video because it’s often too vague and doesn’t always convey what you want to participants. Animated video is often a better choice to illustrate complex topics in a way that is easy to understand for a non-scientific audience. 
• Be efficient: Make sure your visuals are created to make your script length an optimal length. The key is to use visuals for efficiency and avoid too much language. 
• Represent diversity: Visuals should always be representative of the populations you aim to recruit, and also account for underrepresented groups as well. 
• Use text: Closed captioning and translations (when applicable) help participants to follow along with the video and optimize comprehension. 
• Assess your audio: Narrators of videos should have a friendly, informational tone, and be representative of the communities you want to recruit and engage for your study. 
• Write for your audience: Use specific messaging that resonates with your target population and diverse populations. The script itself should help cultivate a delightful, informative experience, and to do that, we recommend gaining as much feedback as you can from people who aren’t necessarily involved in your study. 
• Be flexible and accessible: Always be mindful that not everyone can view the video, so you will want to plan accordingly. If participants can’t or don’t want to view the video, give them the option to read the transcript instead as a requirement of completing the consent process. 
• Ensure comprehension with knowledge checks: Knowledge checks are the hallmark of great eConsent because they ensure that participants understand what they are agreeing to. But it needs to be done right. 
• Define objectives: Getting clear on what you want participants to learn up front can easily help you formulate your questions. 
• Vary question types: In order to keep participants engaged during the knowledge check, use a variety of question types to make it interesting. 
• Be clear and concise: Make sure questions are clear and concise to avoid confusion and reduce the likelihood of incorrect responses. 
• Focus on important concepts: You want to make sure the knowledge check focuses on the right concepts that are key to understanding the study consent. 
• Provide immediate feedback: Knowledge checks should be able to provide immediate feedback to patients as to whether they successfully answered the question or not. 
• Optimize difficulty: Make sure that the knowledge check you create is in the ‘goldilocks zone’ between so difficult that few prospects pass, and so easy that it doesn’t adequately check participant knowledge. 
• Randomize questions: While not entirely necessary, we suggest randomizing questions to avoid logical progression of questions, and to keep it interesting. 
• Time limit: Consider creating a time limit if you want to ensure patients are not cheating or to motivate them to finish the knowledge check quickly. 
• Test it out: We always recommend pilot testing the knowledge check to be sure it works. 
• Adjust as needed: As your consent process and language evolves, you can evaluate how your needs for the knowledge check changes and update it accordingly. 

Create an easy, gratifying participant experience 

How do you create an easy, gratifying experience for participants? Here are some best practices to follow. 

• Think like a participant: Find out what demographics in your population tend to value, and find ways to speak to those values in your consent process and content. 
• Address fear/mistrust: You want to be sure to address fear and lack of trust when possible. One way you can do this in your recruitment and consent materials is by incorporating testimonials from actual trial participants. This is especially helpful for underrepresented groups who may harbor a lack of trust in clinical research. 
• Consider structure/design: Consider how your information is delivered by being deliberate in your design. Do you want to paginate portions of your consent to break up your content? Or do you want to incorporate it in one page for a continuous scroll? Will participants be using mobile or consenting primarily by tablet in-clinic? 
• Leverage primacy/recency effects: Make sure you take advantage of the primacy and recency effects, which basically means you present the most important information first and last, but not in the middle, because the beginning and end is where people retain the most information. 
• Summarize: A brief summary, especially with bullet points, is a great tool for ensuring clarity and comprehensibility of the consent. 
• Optimize detail: You want to consider how much detail you want to convey, and when brevity is more important. 
• Revise: Remember to think about ways to revise your consent. Can you cut elements out? Can you shorten it in some way? What will the typical participant need to understand? 
• Test your audience: Interviewing participants and researchers can help you to see if the consent process and content actually makes sense to them. 
• Think of the total experience: Being able to seamlessly flow prospects from initial recruitment into consent and study participation is part and parcel of a great participant experience. This is because it really should be that easy for participants. Having a participant portal for self-service that patients can navigate to from your study recruitment website makes this very easy. 

Don’t neglect participant engagement after consent 

eConsent is just the tip of the iceberg when it comes to engagement. Remember to follow these rules beyond the initial consent process with participants. 

• Keep them engaged: You want to find ways to keep participants engaged using regular touchpoints, especially in long studies. 
• Plan for reconsent/dynamic consent: It’s always a good idea to plan for reconsent, or to consider ongoing or dynamic consent. This means putting language in your consent that takes into account the possibilities of follow-up studies or sub-studies that come with your protocol design. 
• Seek consent for recontact: If you plan on possibly contacting patients for reconsent or ongoing consent, we highly encourage you to prime participant expectations in the initial consent so that they are not surprised when they are being given additional forms to complete, or the consent language or process has changed in a dramatic way. 

Conclusion 

eConsent continues to gain adoption and as a result has made an increasing impact on how participants engage with research studies. But we think there’s more to it that simply just doing it, and we’ve learned a lot of important lessons. There are far more nuances beyond this quick guide to eConsent. 

Want to partner with eConsent experts?  

Summary of best practices for eConsent 

• It’s important to think about stakeholders to bring in for things like video, IRB submission, state regulations and so forth. Making key decisions up front is key to ensuring a successful consent in the end. 
• Find out which states you will be consenting patients in so that you can fulfill the legal requirements for each one. 
• Compile the right materials to submit to your IRB, including the nitty gritty of how your digital consent works and how it ensures comprehension. 
• Think of intuitive ways and tools to communicate to participants so that you’re able to keep them engaged. 
• Be deliberate and plan ahead for your consent video, and think about how the video can best convey the information to foster informedness. 
• Create and test your knowledge checks to be sure they aren’t too difficult or too easy, and so that they are engaging. 
• You need to think like a participant and incorporate the right functionality and tools into your eConsent content and process so that it’s a gratifying, easy experience. 
• And remember, don’t neglect engagement after consent. Build in language that allows for reconsent or dynamic consent if you need to, and let participants know if consent for follow up studies may be required in the future.