Informed consent is key to study success. It ensures that prospective participants understand the risks and benefits of being involved in a study. But traditional approaches to consent place a high burden on prospects. Long, complex documents with esoteric jargon can be daunting to laypeople, and it’s difficult to know how many prospects abandon a study at the point of consent out of frustration or confusion.
More and more, electronic consent (eConsent) has replaced the traditional paper-based methods. This can reduce time that clinical research staff must spend to get clients informed and enrolled. Now, many trial sponsors are utilizing videos to speed up the process even further.
Suzy Graham, MHA, PMP, one of Vibrent Health’s Project Managers, helps researchers to put together their programs and to make sure that they get the most out of Vibrent’s technology platform and their collaborative services. One of these services Vibrent offers is creating eConsent videos to help streamline enrollment activities for research teams and maximize their resources.
We sat down with Graham to talk about how video consent helps researchers and participants alike, and the best practices to follow when creating videos for the consent process.
Vibrent: First, why should research teams consider creating a video for eConsent? Is there a time or scenario where the traditional consent process isn’t ideal?
Graham: I believe all research teams can find substantial benefits and value from creating a video for their programs or study. Especially those that seek to scale quickly and effectively. An engaging and informative video is an incredible recruitment tool. And participants will be able to quickly understand the value of their participation in your research program.
In an increasingly remote and digital world, traditional consent methods can slow down your participant recruitment and study progress. A concise video easily explains what the participant or prospect is committing to. The participant is normally expected to read and understand lengthy consent documents. This can be burdensome and time consuming, and may deter registration. I highly recommend a video for decentralized research programs. With video consent, the value of your program can be communicated no matter where you are located. And it can convey a meaningful message about your research to viewers everywhere.
Vibrent: What are the advantages to informed consent videos for research teams?
Graham: There has been a positive response from the teams I work with, because the videos have helped them save time in consenting participants. Normally, like in the Mount Sinai Million study, you have researchers going from room to room to convince patients to enroll and to explain to them how the study will work. That process of explaining to patients the elements of a study that they’re consenting to can take anywhere from 20-30 minutes. But with a consent video, they could easily cut that time in half and reduce duplication of effort from teams, by allowing participants to view a short video.
Because of the ability to use dynamic visuals to explain complex concepts, we find that participants are coming out of the consent process with a deeper understanding of what they’re signing up for. This can help to reduce dropout rates, since participants are going into the study with better comprehension of what to expect.
In pediatric studies, we’ve noticed that having a consent video is really helpful for childrens’ comprehension of the trial. It also eases their uncertainty about the study and what it entails. Parents or guardians will still act as the signatory and consent to their child’s participation. But it’s important to make sure your younger participants themselves know they are contributing to valuable research.
Vibrent: How long do consent videos usually need to be?
Graham: We’ve seen video consent take as long as four minutes. But most videos we’ve created for research studies tend to span between two and a half to three minutes’ run time. The length can vary depending on the complexity of the study, the concepts or terminology it entails, what researchers want participants to know, what the IRB wants participants to understand to enroll in a study, and the average level of comprehension of the study population. Among other factors.
With video, it’s standard practice to create videos less than three minutes to reduce drop-off rates of viewership. But video consent is still a novel concept in health research. So we’ll be interested to see how longer run times of videos affect consent rates and overall study engagement.
Vibrent: What is the process for creating an eConsent video?
Graham: We start off by getting a script from the research team. From there, we storyboard the script to get a feel for what the video will look like visually. This is before creating animations, adding background music and voice overs, and putting the video together. After that, the animation process begins. The client is given many opportunities to review, edit, and approve their video throughout the creation process. We try to use animations and illustrations to explain complex concepts. This is to show and tell the participants what will take place during the study and how their participation contributes.
Vibrent: How do state regulations affect the creation of video consent?
Graham: There’s usually little to no variation. In California and Illinois, a patient bill of rights needs to be delivered to participants as part of the consent process. Videos can be created to acknowledge that participants in these states will be given this supplemental information.
Vibrent: What are some best practices to creating consent videos?
Graham: Well for one, animation tends to better explain and illustrate complex concepts quickly. And it’s more efficient from a cost perspective. It doesn’t make sense for consent videos to shoot live action footage to show what the study does. That’s a much more costly and time-intensive process.
And purchasing stock video sequences is not efficient. These video clips tend to be too generic to explain the ins and outs of a particular study. So stock video provides no value to participants’ ultimate understanding of what’s taking place. Think of a stock video clip of a doctor with a stethoscope talking to a patient in an office. Or two lab workers talking over lab results. What value would that provide to potential participants?
As a project manager, I always want to emphasize that an eConsent video script needs to be ready as early as possible. As we begin collaborating, having the script in place is so important. This ensures that the video is ready to go-live on your patient enrollment website on day 1 of the study. Video is so often a ‘waterfall’ process. This is where one element of the project needs to be completed before you can move to the next. Video production takes place over a 1-month period in tandem with other study deployment and implementation activities.
Vibrent: How do you create video for specific populations?
It’s important to create video that is appropriate for the populations that you want to enroll in your study. You need to make sure that the script language makes sense to, for instance, an elderly population when recruiting for a 95+ age group. I’m pleasantly surprised with our SuperAgers collaboration. The study looks at one of the oldest cohorts on the planet. And that video has been an incredibly effective tool in the consent process.
If you are recruiting children, make sure your video is suitable for a limited understanding of basic scientific concepts. If the study is recruiting for diversity across ethnicity, race, and culture, you need to depict participants from these different backgrounds. This way, your audience can easily identify with the content being presented to them.
Preparing your video for translation into multiple languages is particularly important if you plan to engage non-English speaking participants in your study. Research teams should create the translated script alongside the English script.
Vibrent: How do you write an eConsent video script?
You need to make sure you can break down complex medical research concepts into easily digestible language. This is true across populations, as these terms can be baffling even to people with a high-level education. You have to do your best to write the consent video script at a reading level for everyone. Our team has had a lot of success in helping researchers do this.
Researchers don’t usually know how to write video scripts. It’s important to realize that a video script is written according to a sequence of shots. Not all the language needs to be descriptive of what’s going on in the visual element of the eConsent video. The two should complement each other, and ideally play off each other’s strengths. If you look at any well-made film or video, it describes more to viewers in less time than text would. That is ultimately what we’re doing by creating a consent video. Visuals shorten the time it takes for participants to understand the research and where they fit into it. Remember to ask yourself, “What will visually tell the story about my trial? What needs to be verbally explained?” This goes a long way in writing a script that achieves its aim.
Vibrent: What is the main takeaway when considering video for eConsent?
Graham: I can understand that for many researchers, creating an eConsent video sounds like another task among many when trying out new ways to conduct their studies. But when done with the right team, the right focus, and in tandem with other innovative methods, you can engage patients in a meaningful way that will ultimately save time for all parties concerned. And you help increase consent rates.
Above all, I want to stress that as researchers, you are ambassadors to health research. So by providing a delightful and informative experience for participants, you are making it easier for researchers around the world to advance their aims and contribute to greater population health.
Vibrent’s Digital Health Research Services team includes researchers and specialists with diverse expertise to help our collaborators with all stages of the research life cycle, and one of those skill sets is eConsent design. Our team also includes experts in IRB consulting, survey methodology, protocol workflow collaborative design, brand and logo design, diversity / UBR strategies, communication strategies, data collection, and custom analytics.
If you want to learn more about our team, or are interested in collaborating, request a pilot so we can begin discussions about your research aims.
