SAM has over 30 years of clinical experience, a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. She has served many roles in clinical research, including site study coordinator and manager, sponsor and CRO monitor, quality assurance auditor, risk manager, trainer, and performance management consultant. SAM has held clinical research industry certifications for over 15 years by the Association for Clinical Research Professionals (ACRP). She is a current member of the ACRP Academy Board of Trustees, and Regulatory Affairs Committee (RAC). SAM is a frequent subject matter expert for GCP regulation and speaker at industry conferences. Sam has authored many competency-based curriculums for various clinical research stakeholders.
Melanie Flores CIP, CCRP, Vice President of Compliance, IntegReview
As the Vice President of Compliance, Melanie is responsible for the daily leadership, management and full responsibility for the Company’s compliance program. Melanie has worked in the IRB industry since 1999 and has been with IntegReview since 2001. Prior to leading the Regulatory Compliance Department, her main focus for 9 years was spent providing training to IRB staff and IRB members to ensure compliance with Federal Regulations, ICH Guidelines, IntegReview IRB Standard Operating Procedures and standards of the AAHRPP.
Vincent Miller, Informatics Project Leader: mHealth, Duke Clinical Research Institute 19 + years of research in areas in mobile health, participant engagement and data source integrations. Specializing in identification of research and business objectives paired with informatics solutions for utilization in clinical research data management operations as well as translational or clinical research projects. Prior work includes identification and implementation new technologies including but not limited to econsent, integrations, application development, devices, and remote data acquisition. Actively designing more efficient and effective data management support for all projects.
John Wilbanks, Chief Commons Officer at Sage Bionetworks
John Wilbanks is the Chief Commons Officer at Sage Bionetworks, where he leads the Governance team and the development of open source informed consent systems integrated into Apple’s ResearchKit and the NIH’s AllofUs Research Program. Previously, Wilbanks worked as a legislative aide to Congressman Fortney “Pete” Stark, served as the first assistant director at Harvard’s Berkman Center for Internet & Society, founded and led to acquisition the bioinformatics company Incellico, Inc., and was executive director of the Science Commons project at Creative Commons. In February 2013, in response to a We the People petition that was co-led by Wilbanks and signed by 65,000 people, the U.S. government announced a plan to open up taxpayer-funded research data and make it available for free. Wilbanks holds a B.A. in philosophy from Tulane University and also studied modern letters at the Sorbonne.
Optimizing eConsent for Patient Centricity
MODERATOR - Good morning or good afternoon everyone, depending on where you are joining us from. And welcome to today’s webinar. My name is Eliza Barry from Business Review, and I will be your host for today. It is our pleasure to have CRF Health with us today, who will be presenting today’s webinar, titled Optimizing eConsent for Patient Centricity. Today’s guest speakers are: Sam Sather, MS, BSN, CCRA, CCRC, Regulatory and Quality, CRF Bracket; Melanie Flores, CIP, CCRP, Vice President of Compliance, IntegReview, Vincent Miller, Duke Research Institute Informatics Project Leader, mHealth, Remote Monitoring and Data CA; and John Wilbanks, Chief Commons Officer at Sage Bionetworks. I’d like to welcome you to our platform on 24. You will notice that this webinar is browser based, so if you disconnect for any reason, please just click on the link that you received via email to rejoin the session. In order to ask questions, you can send them in via the question widget. Just type them into the box at the top lefthand corner of your screen and click submit. We will allocate some time at the end of the session to address any questions or thoughts that you may have. Please use the yellow help widget if you require any assistance, and you can move, resize, and maximize any of the windows in front of you to get a better view of the slides. But now, please allow me to welcome Sam.
SAM SATHER - Thank you Eliza. Hi everybody, welcome to the presentation today. I have the honour to facilitate this webinar today with three great subject matter expert speakers. But first just a quick introduction of myself related to the topic today for eConsent and patient centricity. I’ve been in the industry for about 30 years and have had the opportunity to monitor and audit studies that have been utilizing eConsent, but also I’m a subject matter expert for CRF Bracket related to the development of their eConsent solution for the last couple years. And I have my master’s in adult learning theory and related to how people learn and absorb information. So I would like to let each of the speakers introduce themselves related to the topic. Melanie, go ahead.
MELANIE FLORES - Hi, good morning. This is Melanie Flores, and I’m the Vice President of Compliance for IntegReview. And my responsibilities really include the daily leadership, management, and full responsibility of the company’s compliance program. I think how that most relates to informed consent is part of my responsibilities to ensure the highest level of ethical compliance are applied to the informed consent document and the process as a whole, and develop standards for the review and approval of consent by developing standard operating procedures and guidelines for our board members. And I conduct internal audits to ensure compliance, to ensure that those standards continue to be met and maintained. Welcome to the webinar.
SAM SATHER - Thank you, Melanie. And John.
JOHN WILBANKS - Hi everyone, I’m John Wilbanks, I’m the Chief Commons Officer at Sage Bionetworks. We’re a non-profit research organization that tries to use open scientific methods to explore how we can bring some of the technologies and efficiencies we know from software into the sciences. As Chief Commons Officer, my job is to work with the data governance team to design systems and processes that move data in and out of our systems both efficiently and ethically. As part of that, I’ve co-led a lot of work on informed consent design, including work with Apple’s Research Kit, that became incorporated in their baseline open source consent framework for clinical research apps on iPhones, as well as co-leading work at the All of Us Research Program in the US government, which is a million-person-launched, ten-year longitudinal study where we have the award to design informed consent, clinical protocols, and other related systems.
SAM SATHER - Great John, thanks. And Vincent.
VINCENT MILLER - Yes, Vincent Miller with Duke Clinical Research Institute. I’ve been in the research field for over 20 years. I’ve done everything from consenting patients to asking questionnaires. I played a part in the early eConsent adoption efforts here at Duke University. I love the fact that we’re taking this patient-centric approach here in discussions. I’m a huge patient advocate. My day-to-day job here is in informatics, I deal with a lot of processes in design, marrying that with technology and research to achieve a certain goal.
SAM SATHER - Great, thanks everybody. Just a quick disclaimer about the speakers and the views and the opinions of us is that they really are our opinions and do not necessarily reflect the official policies or positions of our organizations that we work with. The sponsor of the webinar today is CRF Bracket, and bringing this webinar together. We have a robust solution for eConsent, that we just want to mention today as we go into the webinar. It has three main tools: one is for the design of the eConsent, designing it related to the multimedia and the ways to present the consent. The second is a Trial Consent Participant tool, and this is a web-based tool that presents the eConsent either on a Bring Your Own Device or on someone’s laptop, etc. And then finally, the way to manage and really track the consenting is through the Trial Consent Manager. So thanks for coming onto the webinar today.
So let’s go into the webinar agenda and session objectives for you, and what will the speakers be talking about specifically. We’re going to really touch on first the components of eConsent that support patient centricity, and then go into some best practices that our speakers have learned from working with eConsent, and how can we best support the patient participant. And then finally, how can a patient-centric eConsent, what are some best ways to support recruitment, retention, and compliance. We also will save time for audience Q&A. So, as we go through these sections, it’s really important that you start to enter your questions into the question widget, as we talked first with Eliza, she mentioned in the beginning. That way you’re not spending time entering questions, but we can get to those more quickly. So let’s get started.
We’re going to start the presentation today with a polling. If you can answer the polling on your screen, and please remember to click submit when you’re done. The question is: What is your experience with eConsent? Have you used eConsent for more than five studies, you’ve used it for less than five studies, or you’ve never used eConsent. No matter your role, what do you think is the best answer for you. And we really wanted to get a baseline as we go into the presentation today of really what is the audience experience here. So I’ll give you just a few more moments as we get into the first topic related to eConsent. Thanks for participating in the poll; let’s see what we came up with. Wow, we’ve got 77.4% of the audience have never used eConsent. And then we also have middle, you’ve got less than five studies but you’ve used it. So it’s actually great timing to be able to hopefully influence the idea of really going into the ability to use eConsent for patient centricity. And then we’ve got 1.9% that have used it for five or more studies. Thanks for participating in the poll.
Before we get into that first topic, let’s just set the stage on what patient centricity is. There is a little bit of a debate in the industry of what the definition is. It is of interest and being promoted worldwide to make healthcare, including clinical research and clinical studies, more patient centric, or really support patient centricity. It is really the idea of a dynamic process that we allow the patient to really control the flow of information that comes to them and to really make sure they get the ability to exercise their rights and choices, related to preferences, values, and beliefs. And this is very much a culture shift, it’s a transformational concept. When we think about patient centricity, it is not the same as patient-centric studies or the idea of patient centricity and consent being the same thing. I think the spirit of patient centricity and consent is trying to accomplish the same thing, where we provide the support for everything someone would need to be able to make an informed decision and be supported throughout the process and time on consent. So what’s happened in our industry is, we’ve struggled, and consent has really become quite a legal permission type of event versus a dynamic process. It’s something we obtain instead of something we cultivate and really let the patient drive it. So think about patient centricity as being a process of designing consent around the patient. How can we do that in this industry and do it well. We have been asked to do this as an industry globally, quite a challenge in clinical trials.
The FDA defines eConsent, really, same as paper consent but refers to something that can use electronic systems. And they define it as something that can help us obtain and document the consent process, again not sounding very patient centric. So, how can we take this definition and maybe better support the idea of it being a dynamic process and not just an event. So the last slide before we go into the first objective and topic is, we know there is an increased use of eConsent, you can see by the survey, it’s starting for a lot of you, and some of you have yet to be participants in it. But we know that there’s an increased use. And we just really today are talking about, are we doing it though in a way to best serve the patient.
Let’s get going here with components of eConsent that support patient centricity. I’ll be calling on our speakers to talk about and offer their expertise here. First, Melanie, on this first topic, why don’t you go ahead and chime in form the IRB perspective.
MELANIE FLORES - Sure. So we all know what the regulatory definition of informed consent is, but really what we’re talking about today is not just informed consent in the handwritten document, but really facilitating a true informed consent. The term “informed consent" is not just a process of collecting a handwritten signature from a subject or the LAR, but obtaining the subject’s oral or written consent is part of the true process of informed consent. I think that patient centricity as a process of course—we’ve talked about this already—is designing the consent around the patient, really being focused on what they want to know, not what the sponsor or investigator would want to tell them, but what they would want to know as an individual, their values and beliefs, totally focusing on what the patient would want to know on making the decision of whether or not they would truly want to participate in a research study, giving them all of the good and the bad. And when we talk more about the eConsent (and you can go on to my next slide, if you’d like), really went we talk about IRB recommendations and what that entails, I’d like to take these one by one and talk about them. The great thing about EIC is how it really really aids the facilitation of the patient-focused IC process. I think that a lot of individuals, because it’s presented in a way—we talk about the rules of consent, it has to be presented in a way which minimizes coercion and undue influence, it’s provided in a language that’s understood by the subject. We kind of know all of those textbook rules, but when we talk about EIC, the great thing about it, the things that I think are most valuable, is that there are the optional questions at the end. That really makes sure that they really did understand what was presented to them. It wasn’t just read through really quickly and they really didn’t understand it. Or also sometimes people don’t like to ask questions verbally, so if they were able to answer questions and then it would give them correct answers, correct them if they’re wrong, I think that those are ways that really help to facilitate what the important things were that they should have gotten out of the informed consent document. Often there are very interactive interfaces that allow for more visual aids. And with visual aids, a lot of people can read something over and over and over, but they’re not going to really grasp it, their understanding and comprehension is not there. The visual and interactive aids are often the way to go with facilitating a better understanding. And there’s oftentimes a better explanation of scientific terms. We all know that when we’re reading an informed consent, we need to ensure that it’s in lay language. But we also, even some of the simpler terms, there are ways for the eConsent to define some of those things that may be kind of standard for you and I, but they may be able to hover over a commonly known word and have a definition of those items too. So I think all of those things are really well played out in the EIC process in our focus around the patient centered document.
And then if you go on to my next slide. Again, I just want to click on some other things about the e-informed consent. When we’re looking at it, we want to make sure it’s easy to navigate, that it allows the consent to go forward and backward, so if I want to go back I can easily go back to something that I read a few pages back, and then I can stop and continue at any time. Some people’s attention span is not that long and so they may need to take a break, go to the restroom, what have you, and allowing them to come back to the consent as they can. Alternatives, there should always be alternatives for subjects who just can’t do EIC. So you may still have a paper-based copy or you may have somebody there that will assist, especially an elderly population where you want somebody, study personnel to help them go back and forth and make sure they’re understanding, and really just walking them through that process. Because again it’s a process, not just a document. And then a method for remote informed consent. Again, if you’re doing informed consent remotely and that’s for certain types of research projects that would allow for this, ensuring that there is a validation of the subject’s identity, and that the entire consent is just not left up to the system, but there is a way for a dialect—that the investigator is still responsibly that legally effective ICE was obtained. And although it can be delegated to another individual qualified through expertise, it cannot be delegated wholly to an electronic system. And I think that’s it for my portion of this section.
SAM SATHER - Thanks Melanie. I wondered as I was listening to your slides and your presentation, it sounds like there needs to be a lot of choices for the participant, sounds like there could be a lot of differences between what people need.
MELANIE FLORES - Absolutely, I think it has to be tailored per protocol. You may have a very simple protocol, so you could have a simpler form, versus a very complex oncology trial where you need a lot more explanation and a lot more visual aids to break up the content and the length of the document or the content.
SAM SATHER - Thanks. And Vince, you had some good insights on this as well.
VINCE MILLER - Yes, thank you Melanie and Sam. I want to take the opportunity here to kind of explain this slide and touch on some of the points that Melanie just went through, which is that eConsent process, or the consent process, is kind of an agreement, a partnership if you will, between the research project or the endeavor and the participant. In some cases, it could be a patient, but in all cases it’ll be a participant. And it’s important to remember that we’re trying to develop a product or give them a product by which they can easily digest the information, understand the information, take advantage of the opportunity to convey as much information to them as possible so they can make an educated decision about whether or not they want to partner with you. I think with eConsent and some of the options and technologies out there, we really have a chance to kind of give that empowerment to those participants, kind of give them a voice if you will, so that they feel that they’re being heard when they decide that they want to participate, that their answers matter. When we design some of these projects, at least here at the research facility, we take into account a lot of patient experience, we try to make sure that these options were easy to understand, digestible, user friendly, quick, readable, enticing. And I think this image here displays exactly a captive audience. We have a chance, it’s a matter of how you want to present that medium or that conversation for consent with the participant. Utilizing the tablet in this particular case appears to be more enticing than a piece of paper sitting in front of you or waiting in a waiting room for a doctor to come and see you. At the same time, we also gain some advantages with the eConsent process. We are IRB compliant, we are able to create a secure environment. And as Melanie just mentioned, there’s multiple mediums by which we can insert information to appeal to an audience, for an audience that would respond better to video or an audience that responds better to texting and alerting and so forth. There’s multiple mediums by which we can embed technology here, kind of create a partnership where the patient feels like they’re of interest, they know what they’re signing up for. So like I said, I’m pretty excited about where we’re heading in this particular space. I’ll turn it back over to you, Sam.
SAM SATHER - Yes, actually Vince and Melanie, one thing that came up from both of you—and Melanie one of your first bubbles in that slide was optional questions. And I’ve seen a lot of different designs of eConsent, and sometimes those questions are optional, sometimes they’re not. And I wonder, we sometimes have the idea that they must read every line of the consent, they must fill out and they must touch every page. That’s kind of how the paper process is, the initialing of every page. So as we go through the presentation, and the audience and you guys think about how it would be related to allowing someone to skip over something and not read the full thing or just do part of something or decide to do the consent in a different platform. You’ve both said that maybe someone likes to text a lot, maybe someone else really doesn’t even know how to use the text function on their phone. But they might be being enrolled in the same study. So think of that as we go through this next topic here.
We talked about eConsent in terms of how it can support patient centricity, but what are some best practices in the actual design of eConsent? And it kind of follows up or attaches to that last question that I asked related to the previous one. So, for the best practices, we’re going to ask John to lead us in this section.
JOHN WILBANKS - Thank you Sam. I’m going to touch on some of what Vincent and Melanie just said actually, because when we start moving towards an electronic presentation of the consent, there’s a bunch of different factors we need to take into consideration. One is that there are a number of studies that demonstrate, both though quantitative eye gaze fixation tracking but also through more qualitative means, that we don’t read the same way on screens, whether those are desktop, laptop, tablet, or phone screens, that we read in print. And indeed, it’s unlikely that people read more than one out of three words on a screen unless they’re really paying close attention. And so it’s not sufficient to simply place a consent document on a screen and let people click okay on it. Which leads to the second problem, which is that we’re conditioned to click okay on legal documents between us and our goals by the clickwrap agreements for software terms of service and privacy policies. So at Sage, what we’ve been working on—Sage Bionetworks, not Sage Therapeutics or Sage Publishing—what we’ve been working on for the last several years are a set of design methods and processes and principles for how to present information relevant to informed consent to a potential participant before we present the actual consent document. So what you see is in a standard UX—which stands for user experience—model, the elements are standardized in the sense that we have an icon, a headline, and a sub-headline. There is a reasonable amount of evidence that these three elements together slow down eye gaze fixation to a level very similar to print. But it does not work if the picture is off-task or too complex, it doesn’t work if there’s too much information in the text on the screen. We do allow participants to go backwards and forwards—so you can go back, you can cancel, you can move forward. And we also allow navigation to a more detailed summary of the concept at a fifth grade level. So these are the kinds of interface elements we’ve got. And we’ve tried to develop what we call drag-and-drop text as well, the idea being you’ve got a standard kind of element for a clinical study. And we mainly work in the observational space, not the interventional trial space. You should be able to reuse these sorts of triptychs of icon/headline/sub-headline in multiple studies without having to regenerate them. Because there’s actually a lot of consistency in these things consent forms talk about, even if there’s not a lot of consistency in the legal text in those forms. So what this does is create essentially an interface to the consent document that’s more likely to be looked at, processed, and understood by a potential participant. Next slide, please.
So what you get when you start to construct these is a linear narrative that lays out the elements of the study. And again, parts of these can be relatively standardized, especially across observational studies on phones, which is a lot of what we do at Sage Bionetworks, which you can also have different structures. So this is a linear narrative from left to right. We’ve been doing work with the Alzheimer’s Disease Research Centers here in the United States on a different kind of interface where we have tiles which you can drop into each of these specific areas—like “research your data” and “impact on your life”—and really go back and review those multiple times, ask questions. We’re looking at various processes where you can do those kinds of elements.
E-consent really creates this capacity for two-way communication in a way that is really interesting. You’ve got that communication in a person-to-person interview of course, but in many of those person-to-person encounters, you don’t have the ability to have all of this information surrounding it, and it doesn’t happen at the participant’s pace, it happens in sort of a negotiated pace of the two together. And so, now I’ll show you just a little bit of data on how this works. Next slide.
So in the All of Us Research Program, which is one-million-person, ten-year longitudinal cohort study that’s being run by the National Institutes of Health here in the US, this is the first time that we’ve been able to really introduce this methodology in a more complex study. We’ve been working with Apple Research kinds of studies. Our method has been introduced in about 50 of those sorts of studies, as well as being added to Apple core open source framework. We’ve also worked with Samsung. But those are really observational one-to-many truly virtual studies, whereas All of Us is a blended study where people can enroll through health provider organizations in person or through a phone or through a computer remotely. And what we do is we go through the user experience where we explain what’s happening in the consent document and then we add a short assessment at the end. The goal of this is not to create a gate that people have to get 100% right; it’s to reinforce the teaching that’s in those screens and videos that we’ve got. So this is a nice sense of do people get the answers right or not. And so this is on about 90,000 people who are residents of the United States, 70% or so represent populations traditionally underrepresented in biomedical research. There’s a classic therapeutic misconception kind question. And so you say, what the purpose of All of Us? Is it to give medical advice and treatment, or is it to help scientists make discoveries about health. This is frequently a question that people don’t get right. We’re not looking for them to say that it’s about medical advice and treatment, but hoping they say it’s about making discoveries. And so this is a graph, the blue bars represent “to help scientists make discoveries about health.” The green bar at the bottom represents the wrong answer, “to give medical advice and treatment.” And the orange bar represents a person who has skipped the question. And so you see from the left, fifth grade, to the right towards advanced degree and others, pretty strong and consistent ability to answer this question correctly at the end of the consent process. And we are now starting to look and say, does that change over time, what does the decay and the retention rate look like. But across education we’re pretty happy with this, we spent a lot of time working on a fifth grade reading level. Next slide?
This is the same question, but broken down by race and ethnicity. And so what again you see is this really strong consistency of the kinds of answers that we’re looking for across both education and now across race and ethnicity. Because part of the mandate of the program is to oversample underrepresented groups. And it’s really important because some of these populations justifiably do not trust the United States government and the biomedical research enterprise because of the history of exploitation. And so the clarity of the consent interface, the clarity of this presentation method, appears to have given us a really good head start on building a better consenting relationship with the people who enroll in the study. So we have multiple questions, we see very similar patterns across three out of the four core questions we use. The question where we get the most diversity in a negative sense—like people getting the question wrong—was about whether or not privacy was guaranteed, which is of course a very important element of any study that has an electronic or a mobile component. So we’re not beginning to rewrite that question, and we’ll begin running a very small set of ABC tests to see which of those questions are the easiest for our participants to understand, and which of the elements or educational process we need to revisit and look at that. We’re also running a randomized controlled trial with the Geisinger Health system here in the United States, to look for equipoise between this kind of eConsent methodology and an individual in person with a paper document. And we hope to have data to publish on that in 2019.
And so the takeaway from this is that the design best practices are to actually recognize eConsent as a design priority, a first class design priority, and that there are these open source methods. As a non-profit, everything we do at Sage Bionetworks is free. You can come and grab the icons, you can grab the design templates and documents. You can even grab implemented clinical protocols from our research kit studies. And we’re in the process of publishing the same kind of information out of the All of Us Research Program to help people who would like to use these kinds of methods bootstrap very quickly and prevent any enclosure of this as a method. We don’t think of this as a product as much as simply a way of doing things. And part of our mission is to make it as cheap and easy for everyone out there to pick up these methods, use them, and then feed back the kinds of innovations that they create out of them. And Sam, with that I’ll pass it back to you.
SAM SATHER - Thanks John, so much. Great great information. And it sounds like some really good best practices to help the industry. Then also I know Vince has had some interesting lessons learned about some best practices related to eConsent.
VINCE MILLER - Yes, Sam, I’ll pick up where John left off. I love this slide, because I personally worked with a number of clinics and sites and project teams as they navigated the early adoption process of eConsent. There’s a number of—I wouldn’t say barriers—but a number of things that we should factor in as we design an eConsent solution for a particular project or a particular need, one of those being—I know it says WiFi access at clinics, but what I’m trying to convey there is one clinic is not the same as another clinic, or one environment is not the same as another environment. You need to plan for the environment by which you will be consenting your participants. And take a look at the environment. I encourage you to go over—if it’s a multi-site project or if you’re actually going to be enrolling at different locations and so forth, go take a look and see what type of functionality is there so that you’re better able to leverage the technology and the medium by which you want to convey the information. There may be additional pieces of information at that particular site or location that you were unaware of. And you designed your entire project around WiFi access and then you go to a clinic and realize there is none. Same thing with the options for consumption of the information. Here we have videos consent; there’s a process to making a video consent. There’s an IRB approval process that goes along with it, and you want to make sure that you’re conveying the information appropriately. So you want to have a standardized structured way by which you have that medium—in this particular case, a video consent—to prove. And then you can plan ahead as well. There are tremendous advantages with technology. We’re talking about data security. We can plan against data loss. We can also do our best in terms of process and design to make sure that if a device malfunctions or if something shuts down that our data is still secure and preserved so that when we’re able to rectify the situation we didn’t actually lose any data. And then obviously if you’re going out into the public domain, you may want to put some sort of trackers on your device to prevent loss. I mean they do tend to get up and walk away from time to time, and having that particular foresight to know that, okay, this could occur could be advantageous to you in the long run. Obviously we’re dealing with technology software updates, things that you want to consider if your project is going to go for longer than, say, a year or two, you probably want to plan for software updates and making sure that your devices are still compatible with the software that you intend to use. And then what most people don’t realize is that at some point in time, most of these studies end, and they don’t plan for that end. Instead they just assume that they can shut everything off. If you’re on a public domain and you’re recruiting patients, you’re not seeing them face to face, that can be a little bit more cumbersome than most people think. So I would advise most to plan ahead and say, okay, this is our process for shutting down. And test it out. Validation, production environments, creating those simulations can be very very advantageous.
SAM SATHER - Great thanks Vince. And Melanie.
MELANIE FLORES - Yes, so I’ll just chime in. Thanks, Vince and John, for all of the information, it was great. Just on the IRB review perspective, whichever platform you choose, when it comes for IRB review, what we're going to be looking for is, we’re going to look for if you’re signatures, we’re going to look for Part 11 compliance documentation ensuring the data security. We’re going to need both electronic forms as well as the paper. If we need to make modifications, we typically will track it on the paper document. And let me tell you, the companies are getting better and they’re getting faster at making these quick fixes and changes to the electronic format so that it can be finalized and ready to use. Videos and web-based presentations that are included as part of the consent process, we’re going to want to see those. Anything that’s web-based and you provide links to, we actually need something that we can save forever, because as you know, links change. So we want to make sure that we have all of that documentation. So again, it kind of goes with that last point there, if the ICF includes hyperlinks to convey information, we want to print that out and make sure it’s included, because if you’re looking at it later, and again those hyperlinks don’t work, then you really don’t know what the IRB had reviewed and approved. And then, if you use the optional questions, I know that we had talked a little bit about optional question earlier and Sam had some points. I just wanted to say, if you use the optional questions, we’d like to see those questions that you’re going to be using to gauge subjects’ understanding. And the thing is that you have to realize that some people don’t have the education and some people just aren’t good test takers. That is a common thing. And so it’s really not a pass/fail type of thing, it’s just another way to really ensure that they’ve understood those key factors of the informed consent. So making sure that again when we’re talking about the patient-centered, patient-focused, thinking about what they really needed to know, and if they read it and they didn’t get anything out of it, then enforcing those things through questions is a great way of facilitating understanding. And that’s it for me at this time.
SAM SATHER - And Melanie, I had a question related to the IRB. Say we have some optional questions, or say that we take some of the information, like from John’s study, looking at what people skip questions and things like that. Maybe those folks are skipping questions when they’re the ones we really would like to answer because we can identify when they don’t understand. So the idea that, say a research site is able to have a patient come in, based on their demographics they put them in, and the consent based on data we know about certain demographics or races or whatever it is, then it creates their experience based on what we know about that, is that really not ethical? Do you know what I mean? Would that be something we could envision in the future?
MELANIE FLORES - Sure, what we’ve always done is, it’s either all or none. You don’t really separate a population. You look at the study itself, and even if somebody could pass it with flying colors because it’s a study in graduate students, and so how do you know the they’re all going to be able to answer the question. But when you’re going into a different population, I think it’s more study based and not necessarily population based, if you will, because again you can’t—it’s important not to discriminate of course. But then just looking at the study as a whole and saying, these are the things that we want them to get out of it, we want to make sure people understand this is so important. And so by putting the question—and the thing is, it’s not allowing it to be skipped, having them answer it no matter what. That way, if they do get it wrong, then you’ve pushed the correct information back to them and say, sorry that’s incorrect, this is what you need to know. And so I think it’s really just honing in and trying to get them to understand the really important aspects of whether or not they should participate.
SAM SATHER - What do you think, John, that question I asked, did that spark any thoughts?
JOHN WILBANKS - I think a lot of it depends on the study. So in the stuff that we’ve done, we’ve done both ways. We’ve had the quiz questions be required to be gotten right. So in some of the studies we’ve done that are closer to particularly neurodegenerative or cognitive decline where we think it’s really important to get the questions right or have a caregiver help get the questions right, whereas in some of the other studies we’ve done like all of us, we prioritize participant autonomy over summative evaluation where you have to get everything right; a formative evaluation is one where the evaluation itself is part of the teaching process. And so we can say, John, you got four out of four questions wrong, are you sure you want to move forward or would you like to go back and review more information? And so in some cases we prioritize autonomy, in which we don’t require people to get all the questions right. And then in some cases we prioritize a summative evaluation. For us it depends on the study. We built up the toolkit, I’ll make it available through the process, that sort of walks through how we go through that decision process. But there’s not like a right answer. There’s just a heuristic to work through.
SAM SATHER - Great. And when you read a lot about patient centricity and the formative and summative type of approaches, it is important to understand, and there has to be quite a bit of education across different roles, I would think, for the future. So great. I wanted to ask that question because it makes us think what we must and what is really a must not, and really maybe challenge ourselves when we’re enforcing things that may not be patient centric.
The last part, and I want to make sure we keep about 10 minutes left for questions. So this next section, let’s focus on eConsent related to patient centricity, what are anything else that we would like to say that supports recruitment, retention, and compliance, these million dollar things that we’d like to improve and haven’t been that successful in the industry, so maybe with patient centricity. So Vince, you’ve got a case study that you talked about earlier with us as speakers.
VINCE MILLER - Thanks Sam. So I think this slide here kind of embodies a successful use case that we did here at Duke University maybe about two to four years ago, whereby we originally started out—if everybody can follow that blue line—that was our original protocol and design. We were trying to basically enroll 7500 patients in a statin trial. Our thought process was that it was going to take us about nine months to do that, and that we would need about 175 sites to possibly enroll those 7500 patients across those nine months. About a month and a half or two months in, we decided actually—see the red line over there—that we were going to utilize eConsent as our offering. That enabled us to get our sites up faster, and allowed a faster startup time and quicker movement in terms of the study process. We realized that we actually kind of hit the nail on the head and we enrolled like gangbusters basically over the next five months, hit our quota, we actually only were able to activate 150 sites. But it’s a great example where all of a sudden you’re meeting the needs of the participants in a place and venue by which they can consume the information, digest the information, and then agree whether or not they want to participate. The responses and feedback was phenomenal. We actually gave them a couple options to consume the information. One was the video consent option, and the other was basically a digital rendering of the paper consent. So the participant within their eConsent module could decide which way they wanted to consume the information. And as you can see it’s quite successful. We actually ended up enrolling 7000 consenters and 58 patients, and had a little bit of trouble shutting it down, so telling everybody we’d done our job and were three months early.
SAM SATHER - Cool, wonderful. And I know, Melanie, you’ve got some comments and also a case study as well.
MELANIE FLORES - Yes, just real quickly I’ll go through this because I know we’re running out of time, and you are more than welcome to ask questions at the end. So I just want to hone in that we all know it’s our duty to ensure the protection of the rights, safety, and welfare of human subjects. And I think that by employing the latest technology, we can really kick everything up a notch and ensure and really focus in on their rights to be included, their rights to have a voice, and really focusing on the patient. And I think with the Common Rule changes that are coming up next month, I think that we’re all looking at consent a little differently, and I think that the eConsent process is really one of those ways that aids us in facilitating a better consent. And so there’s just a few other bullets there. It helps to facilitate the subject’s comprehension, and the information presented during the informed consent process. We want to make sure that the general information and the assurance that you are compliant is better in eConsent. And if you’ll go to my case study, I just go over to this section, you can always look back at the information. That one last bullet on that previous slide, I did put in there that you need to make sure that everything is available during an FDA inspection. It is part of their—they want to be able to see it as well, see all the information, so ensuring that you keep all versions etc. of the informed consent and any methods that are used.
With the case study that I was talking about, it was really done in a standard of care kind of practice. But it really shows that in this particular, it was a study but it was a study in standard of care. So they evaluated the documentation of informed consent for two common prostate operations that used current conventional paper-based consent forms and then replaced them with the new standardized electronic consent. And a total of 204 consents were available for review, and the study showed that conventional non-standard consent forms had significant deficiencies and errors. The new system of electronic informed consent is standardized, it’s legible and understandable, and it assists providers in fully informing patients about the treatment, risks, benefits, and alternative therapies, thereby supporting ethical and legal standards and improving the quality of healthcare. And I think this could be very easily transferred into the research community, and I do think we’re moving towards that. I think that the companies are getting faster, because that’s really important to get the information modified and updated as quickly as possible, especially if there are safety-related changes. And I think that a lot of the companies have jumped that hurdle of they’re able to implement those modifications very quickly. So I think we’re on the right track.
SAM SATHER - Great. And I hope that continues, especially if we’re going to be giving patients more choices. You might have a different types of presentations as an IRB to review, I imagine. Like Vince’s study. I thought it was really interesting that they’d really choose which way they wanted to go through the consent. And it seems very successful. So before we get into the Q&A—and actually we’re right on time and doing really well on that, so not to rush this section at all and the speakers— if you had a crystal ball, what does the future hold related to eConsent and patient centricity? Melanie, kick it off from the IRB perspective. What does the future hold, do you think?
MELANIE FLORES - Well, I think if we continue to involve patients more in developing the informed consent, then I can see that translating and developing protocols that are also more patient focused. I hope that more and more companies put patients’ needs into their science. And I like the catchphrase, “no decision about me without me.” To me, that’s really what patient centricity is all about.
SAM SATHER - Excellent, I agree. And John?
JOHN WILBANKS - I mean, I think crystal ball, I would just get people away from thinking that putting the document on the screen with an okay button is enough. That’s the first barrier. You look at the number of people who have never done an eConsent, that’s frequently the first jump people make. So if I could crystal ball I would get people to go right past that into thinking that they’ve got to do some design.
SAM SATHER - Awesome, thank you. And Vince?
VINCE MILLER - I like that John. Actually I’m going to push that a little bit further and I’m going to say I see a world where research and technology kind of mesh, being a seamless experience for the participant, one in which they feel empowered and that they’re being heard.
SAM SATHER - Great. I’m jumping on that one too, for the idea that it’s more of a personalized experience. I had someone about five years ago say to me, oh eventually we’re going to have a consent per person. And I thought, oh my gosh the poor IRB that would have to do that. But I don’t think they meant per person individual paper consent, more of a personalized experience to really help them absorb the information and make the best decision and also for them to influence their experience. So, awesome today, thank you so much, everyone. I’m going to hand it back over to our host, Eliza, to start our Q&A.
[0:49:52 Q&A SECTION BEGINS]
MODERATOR - Thank you so much. Okay, so it’s now time for the Q&A section. The first question of today is:
I would expect that the larger IRBs are familiar with reviewing or approving eConsent, but what about small local or institutional IRBs? Are they receptive, familiar with eConsenting?
MELANIE FLORES - I think that some of the institutional IRBs or the local IRBs, sometimes they have less resources. Not always, I mean some are larger than some of the commercial IRBs. But in the smaller sector, I just think that they need to—there is not a real problem with the review of it. I don’t think that the review is difficult, I just think that they might not have the policies and procedures to ensure the regulatory compliance. So I think that it’s just a matter of helping them. I know that I’m a big advocate for helping the smaller IRBs, I know when I attend PRIM&R I’m always there trying to assist people in streamlining their processes, and I’d be more than happy to talk to anybody who had questions about that and maybe developing a process for the review. So if you’d like to reach out to me, feel free to. And I think that other IRBs can all review them.
SAM SATHER - Yes, I do think that the policies and procedures, even outside the US, how is this going to impact how we do our day to day is really the first hurdle. But Vince, do you want to chime in on anything else about this question, from your perspective?
VINCE MILLER - Yes, so similar to what Melanie was just saying, my experience has been with smaller local institutional IRBs, you have an opportunity there—we’re using that word a lot today—you have an opportunity there to navigate that process with them and show them the functionality, show off the pros for utilizing eConsent. I think sometimes it’s just more of an adoptive hurdle, and then understanding what we can do with the technology, as opposed to we’re not going to do it because there’s a compliance issue. A lot of the compliance issues and regulatory hurdles we can navigate with the technology. So it’s really more of a can I explain this to you, let me sit down with you, or let me give you a copy of the video consent with the script, or let me give you a copy of the text message conversation that may occur, so that you’re comfortable in understanding what’s being displayed and then thereby maybe become more comfortable with the process that we’re offering.
SAM SATHER - I think let’s go to the next question.
MODERATOR - Okay, so the next question of today is:
Would just using logical marketing and verbalization that is patient centric to let the patient be aware of a trial that coincides with their physical element allow the patient to feel in control from the beginning?
SAM SATHER - Anyone want to grab this one?
VINCE MILLER - I’ll go again. I love where this one is heading. In my opinion, yes. I think you can find a way to appeal to a participant market that they are interested in. In other words, if it’s a stroke patient population, and you have a stroke research study or information or educational information about strokes, that they would be interested in, I think the next step would be obviously servicing that information so that they can then decide whether or not they want to participate in something or they would like more information about something. So I think that’s kind of where we’re heading. The ability to kind of social network, crowd surf, and figure out what I am interested in or what a population might be interested in, and then giving them the opportunity to sign up or engage in a partnership with them.
MODERATOR - That’s great thank you.
SAM SATHER - Thanks Eliza, let’s go to the next one.
MODERATOR - Okay, so the next question today is:
Are there any particular types of studies or indications where eConsent would not be advisable, and why?
MELANIE FLORES - I can take this question. I think the quick answer is no, and the reason why I say no is because it can be—you can absolutely use eConsent because you’re not replacing the actual consent process. You’re still going to have dialogue, there’s still going to be discussion. So depending on what type of study it is, the whole process doesn’t have to change. And you can modify the eConsent to fit the needs of any type of research study. I hope that answers that question. Does anybody else have any other insight on this one?
SAM SATHER - I totally agree with that. I think when we first were—and even if you look at TransCelerate’s recommendations, etc. it’s more operational where you should start instead of where it would benefit patients. It really could benefit patients at any type of study, any level. You have to operationally look at if it’s something that’s easy to plug and play or is it something that is very expensive, and can you reuse it. I love John’s idea of reusing templates and reusing things that you’ve designed. Because it is true, we repeat a lot. And then reusing what you learned really worked well.
MODERATOR - That’s great, thank you. Okay, so the next question we have today is:
Can you talk about the relationship between eConsent and the trust of the participant? You mentioned that eConsent gives people a voice. Can you elaborate how so?
VINCE MILLER - I think I’m interested in that, so I’ll take that one. For the participant, as I mentioned before, I started off maybe 20 years ago doing paper consent. And sometimes meeting that participant in a manner by which they feel that they were having a conversation or a digestible conversation so that they’re informed and able to make that decision, it empowers that patient to feel like they’re actually being heard. So in other words, if they have questions about a conversation that we may be having about the consent process and so forth, if I can convey that through technology with a simple choice of I’d rather read the screen or I’d rather look at a video consent, or John mentioned an interactive consent where we’re having almost a text message conversation of what I’m interested in and what my questions are, all of a sudden—in my experience—the patient feels like they’re being heard. And that’s what kind of gives them their voice, where they’re saying, great, I don’t want to sit here and listen to you talk to me on over 20 pages of a consent. Let me point out to you the things that I have concerns about, and that way I feel like I actually have a voice as to what’s going on. I’m an equal participant.
SAM SATHER - Absolutely. And then think about the interaction. I think what happens a lot is there is a conversation well done between the site and the patient, and then they had them maybe this big document or maybe it’s before. But it becomes almost like when you’re signing terms and conditions on the internet, many people don’t read them. And if you don’t really feel warm and fuzzy after, you just all of a sudden had this great talk, and then all of a sudden you see these 25 pages. So it’s interactive and you’re actually learning about what the patient needs, so it helps even the interaction more for the site.
I think we have time for another question.
MODERATOR - Okay, so this final question that we have time today to answer is:
Do you track the responses to the optional questions that the patient answers? And if they get it wrong, is this addressed and somehow recorded?
JOHN WILBANKS - I’m happy to take that one at least first. So we do in our studies track the responses to the questions. The questions are not optional. Everyone—you can skip them; I guess they’re optional in that sense. But in the vast majority of people attempt to answer the questions. And so we do record those answers in studies where we use them as a teaching tool. We note them to the participant if they get them wrong or right. If they get them wrong, we tell them what the correct answer is and why and record that. But in those cases we allow them to move forward after we present them and offer them the chance to go back. And in studies that involve people with neurodegeneration or cognitive decline, we explore them simply pushing people back to the relevant piece of content so that they can then reattempt the question. But there’s not an established best practice on exactly what to do here.
SAM SATHER - Yes, and actually from the system standpoint, make sure that the systems track when patients, if they’re allowed in how it’s designed, if they’re allowed to skip a page. And really the audit trail, the metadata, should show where they clicked, how long they spent their time. So depending on the system, how sophisticated it is, to actually show or really not allow a skip.
MODERATOR - Okay, that’s great. Thank you so much for those answers. And thank you to the audience for those questions. So that just leaves me to thank Sam, Melanie, Vincent, and John for what was a great presentation, and to CRF Health for sponsoring this session. To the attendees, you’ll receive an email shortly, telling you how you can access the on-demand version of this webinar. Or you can access this through our website, which is www.business-review-webinars.com. We look forward to sharing further presentations with you. So please do keep an eye out on our website, and follow us on Twitter @brwebinars for daily updates. And join our LinkedIn group, Business Review Webinars. Thank you once again, and I hope you all have a lovely day.
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