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Visibility and Oversight: What Paper Informed Consent Isn't Offering You

February 27, 2017 Sandra "SAM" Sather

Chesapeake IRB and CRF Health team up for a collaborative webinar to discuss informed consent oversight and visibility and why Top Pharma is turning to Electronic Informed Consent (eConsent) to exceed in these areas. 

Key learning objectives include:

  • Realize the features of eConsent that contribute to improved informed consent oversight 
  • Recognize the opportunities to decrease risks in subject enrollment and retention 
  • Discuss the important collaborations during consent implementation and monitoring 



Good morning or good afternoon everyone, depending on where you’re joining us from, and welcome to today’s webinar. My name is Tareq Audhali from Business Review, and I will be your host. It is our pleasure to have CRF Health and Chesapeake IRB  with us today. They’ll be presenting this webinar titled Visibility and Oversight—What Paper Informed Consent Isn’t Offering You.

Today’s guest speakers are Sam Sather, VP Clinical Pathways, Regulatory and Quality, TrialConsent, CRF Health. Also Lauri Carlile, Executive Director, Chesapeake IRB; and Jeff Wendel, President and CEO, Chesapeake IRB.

Now without any further ado, please allow me to welcome today’s first speaker, Sam. Sam, over to you.


Thank you so much. Hi everybody, and thank you for coming to this presentation. And I wanted to give a big thank you to Chesapeake IRB for joining us to present this important topic. So what we’re going to be covering today is the idea of improving how we do informed consent, and with using different types of technology and multimedia. And really, this focus for this presentation is how can we better oversee that the content and that the process has been per the requirement. E-Consent offers many other types of benefits—for example, helping the patient better comprehend the information being presented. But again, how can we decrease the risks and better improve our inspection outcomes. And we know that that’s been a challenge globally for—what—a couple decades or so now.

So first let’s actually start it off with a poll. So as I’m reading the poll you can start answering, so just click into the answer that best fits for you or your organization, depending on if you’re sitting with a group. And remember to click on submit, so we can get the information. And we’ll actually share the results in just a minute. So again, have you ever used eConsent on a study. So you can answer yes, no but planning to in 2017 or in the near future—you could think of it that way—and then, no, no set plan. So we’ll give you a few minutes to answer this question. And we do a lot of surveying of the different stakeholders that would use eConsent, and we’ve seen a large increase definitely in the last, I’d say, six months or less. And we’ll discuss some of the reasons why. One being oversight. So remember to click on Submit. And let’s see how the poll came out.

So for the audience that’s here today that answered the question, we have about 17—less than 20% that says yes, that you’ve used eConsent. So a lot of you are here with plans to use eConsent in 2017 or near future. It does take some planning, and we’ll talk about that in my section today, how do you really work on integrating eConsent into a quality system to be able to actually do this. And then Chesapeake IRB is going to do a fantastic job talking about what they’ve seen is successful and also working with the IRB. And then we have about 55% there’s no set plans. So we have more than half the audience definitely looking to see, maybe, what is this all about, is there something that I can make actually definite plans on.

So first thing is, let’s define what oversight is. So we know that investigators, sponsors, and IRBs have certain requirements or responsibilities for oversight. And when we take this general definition of oversight where it’s this watchful, responsible management supervision, and you think about this word, commonly we’re not doing the activity, we are overseeing. So in the case of clinical research, we’re in a regulated environment, and we’re working with human beings. So it’s quite complex with multiple stakeholders. So it’s not an easy task to be successful with the oversight, and it’s even more difficult to prove that you did it. And we know that within the informed consent space, it has really been a top ten regulatory finding for a long time. Where is the gap? Where are these things that we have not done well to prove that we’ve overseen or lack in the oversight?


So part of it is the clear responsibilities. And in the current paper process, it’s difficult to enforce who should be doing what. Also, the amount of added documentation outside of the consent form that’s required, because this is not just a paper with a signature, definitely the whole process of consent from the development all the way into the archiving. So how do we make sure we have adequate documentation for what we do. And then also, the idea of how do we actually have things within our quality systems at the sites, the sponsors, and the IRBs and CROs, to support oversight, and how do we integrate a technology to help do that.

So when we think of the sponsor responsibilities, and just general FDA statements—quite a broad statement of the responsibilities to oversee all aspects of the trial, one of the most impacting is definitely the informed consent, and the informed consent process. And we also know globally within the ICH GCP E6 Guideline, Revision 2, within the Sponsor Responsibility Sections, 5.0 and 5.2, there’s this responsibility to oversee the different aspects of a trial. So the sponsor should implement a quality system to manage quality throughout all stages of the trial process. And think of how much the informed consent really impacts and takes up that space of those activities. So it’s an activity that sponsors start very early at a quality system level, what are the requirements for your organization and then into the regional requirements, and then study specific, and then site specific. So it’s no easy task to get the right and correct consent for that particular participant for a study. and then within ICH E6 in R2 they did a revision, the addendum, added that sponsors should focus where it matters. So it’s kind of a relief, instead of focusing on every single aspect. And think about informed consent, what should we really focus on. And it’s human subject protection and the data integrity. So using a system that actually does a lot of this automatically, where less is manual, can really help with this oversight, so adding technology in the validated processes into this.

Now, when we also think about the other addendum that we’ve seen within ICH, related to sponsor’s responsibility, is the word “oversight,” so encouraging sponsors to add—and really the focus of oversight proportionate to the risk. Now we know that risk of not having adequate consent is really really monumental.

Then, when it comes to the investigator responsibilities related to informed consent, there’s mention with the FDA and also within ICH related to the consent of this research subject. And think again, where we need to be able to support oversight better is within the contents of the consent. And it gets quite complicated with all of the other regional requirements and human subject protection requirements that might be extra, like for example HIPAA or other privacy things. But also this process stuff, again, to prove you’ve done what you’ve actually said you have.

And then we have experts on the line to talk about electronic and actually just informed consent in general, and how it affects the responsibilities of oversight for the IRBs. So again, within different regulatory perspectives of what that might be. And you can kind of think about it as an age-old problem, is how to do this more efficiently and how to really oversee the research sites that are linked to that IRB’s review.


So you saw within the oversight funnel is the importance of whose roles and responsibilities is it to oversee consent. So we have three different stakeholder groups. But we also have three different levels of documentation that an eConsent system can really help us support. So what was actually performed? So what was the activity of the participant when they were going through the consent form. So in a paper consent form we have very little ability to reconstruct that and evaluate it. And the other thing is, in a validated electronic system, having the ability to date-time stamp things. So guaranteeing we have contemporaneousness. The inability to backdate something. And then also, the ability to make sure that things don’t get lost, that the documentation exists, and that we can have it in our Trial Master file, accessible during the trial for inspections but also for archive. So that link between the TMS and the eConsent. And a lot of TrialMaster files are becoming electronic, as we know.

Now another challenge is the retention of information. There’s a pretty famous warning letter out there, that the investigator shredded all of their documents, including informed consent, thinking they were done with the trial, and boom, lo and behold, unfortunately it didn’t meet the retention requirement. So think about in eConsent, though, the ability to show that we have the system that meets the electronic requirement is also kind of an added thing that we need to make sure. But in the retention of documentation, again it isn’t just the paper consent form, or the consent form itself, or even the activity, but it’s the trial management of it, the oversight of it piece. And with an electronic system a lot of that can be tracked and collected in a log and then retained to show the oversight.

Now it’s okay to be able to get electronically these notifications when something may be out of a required timeline for re-consent or, say that in the system we can actually identify where we have multiple patients within a certain region that are deciding not to consent, they go through the process and stop. In electronic consent we can actually capture that information. But also, when there are issues, especially if it’s a regulatory or human subject protection issue, the ability to, within these systems, document some issues management and the response to these triggers that show that there are challenges or non-compliance.

So better documentation, better retention, and better actual issues management documentation of that.

So the third thing that was in that goblet that was spilling oversight and pouring electronic consent is within the consenting process, all of the stakeholders—the sponsors, the site, and the IRB—have to have systems in place to ensure that their responsibilities can be fulfilled for informed consent. And it’s been very difficult in the paper process world. You might have the quality system in place but then it doesn’t really, again, give you the evidence. And we want to make sure we have evidence that we followed these systems that we say we’re going to, and also that they’re effective. So we really need to have the ability over time to see if we can get better at consenting. And with electronic consent we actually are the ability to get data across a study, across a site, and actually look at how patients went through the process, and we can improve how we’re doing consent for a particular study and also, just in general, as an industry.

So within ICH and the addendum to R2 for GCP, there is this promotion within the principles of GCP to definitely have these systems in place, but really to focus these on aspects that relate to human subject protection. And what better than in informed consent.


So definition of electronic informed consent, FDA gave us a nice definition in December of 2016, they finalized their guidance document. And we think of it again as a full replacement of paper or partial. So there are many many different approaches and ways to do this. To fulfill the development, to improve the use and to support the particular kind of patients, whether they’re remote or on site, where they have vulnerabilities that makes it so it’s less likely that they can read a lot of content. So we really have  a lot of choices and flexibility in what we put into the trial consent, or the eConsent. We also have a lot of flexibility in the way that we can deliver this to the participant, so it gives us a lot of flexibility in that aspect, multimedia. One thing that is very very important, that is mentioned within this guideline—and we know this—is the law is not changed for informed consent related specifically to what needs to be in the content and also in the process flow. There are some changes that have come with IRB review and things like that, but when it comes down to it, we really have—we’re adding technology to do things more efficiently, more effectively, that’s not changing the rules that you have to follow. So we still need to maintain that we’re meeting those basic criteria.

So this is from FDA’s guidance document, and they really say these are the things that you can use electronic consent to improve how we’re currently doing those predicate rules or those requirements. And it really is, really throughout the whole spectrum or life cycle, impacting for consent. So for example, it is a way to improve how we present information to people, so really better supporting. It is also a way for us to evaluate comprehension. Better way for us to document that the right people were available and conducted the informed consent. We also have a requirement to notify our participants, really timely, depending on the change, so they can actually decide whether they want to stay on the trial or not. And what better way to do this as when they’re at home, and not having to come and drive into a research site to actually re-sign something, or even get the information presented to them more understandably than on the paper form. And again, ability to actually have data coming from the experience that we can compare easily across studies is just really really beneficial, and hopefully also triggers the activities that are related to the protocol so they’re not done before consent, so preventing that regulatory issue of doing study procedures before consent. So yeah, so remote locations as well. So we have lots of opportunities here.

In the last couple slides I have, before I’ll hand it over to my friends from Chesapeake IRB, is how do we actually take and support oversight in consent with eConsent. And so how do we integrate this into our quality systems? So for the sponsor, related to sponsor oversight, think of how you would have to change how you are currently doing things related to collaboration when you’re designing your informed consent. So we’ll hear more from the IRB perspective of what that really means, but how does it change the day to day, that back and forth, I call it the pingpong matches, of that should be in the consent form. And how can we make that more efficient and more effective. You know, oversight is all about making sure that the participant is using the right version, that we all have reviewed and it has gone through official approving from the ethics committee, so making sure that we have the right people at the consenting process. And there’s such a flux of what is really required from study to study, region to region, country to country, so these systems and eConsent have to be very flexible to really allow multiple different kinds of parties that would be signing from the site perspective and also the participant. And then management, how can we have better information flowing to us. And through technology again mentioning that we can—how would we actually—how would that change our monitoring plans, how would that change our data management plants, etc. How can this work within our centralized monitoring, what would be these key data analytics that we can get from an electronic consent system, that would trigger that we need to act early before things get to where we don’t have adequate consent.


And the same thing, if you think about investigator oversight, this is not just a sponsor tool. And I really think of the benefits and think of the inspection findings, when sites get inspected, it’s a high high risk area when we have lack of documentation and lack of good informed consent processes. So it’s another one of those age-old problems. So if less can be done manually where we have the real interaction with the participant and the study staff at the site level, and really have that quality discussion versus the laborious going through multiple pages, etc. and how can we actually document what we’ve done without having to manually write a lot of different progress notes, etc.

And then finally, IRB oversight. Very similar thing, and I’m going to let Chesapeake talk to these for sure.

So the moral of the story is, there’s lots of opportunities with eConsent to improve subject enrolment and retention and the ability to oversee these things. So information is presented better, better assessment of the comprehension of an individual that can be built right into the system. The flow of information, so it’s not this linear page of words. Having the ability for someone to take a break and track their progress and they can ask questions and indicate questions as they go along. So better informed participants making a better decision when they commit to being in the study. And then also understanding what their compliance requirements are. And more supportive patients, more likely to stay on our trial, more committed.

So, can’t stress enough, and this is where this collaboration for this webinar came in, is we so much really know that it’s so critical as soon as possible to have very very important collaboration established related to integrating eConsent, electronic informed consent. As early as possible, sponsors and ethics committees, and then sponsors and the vendor that has the eConsent system, and of course the ethics committee and the vendor, and then obviously the sponsor and the research sites. And you can’t forget the research sites and the vendor as well, for eConsent.

Well, that’s my portion of the presentation. And I’m going to let Chesapeake—Lauri and Jeff—take over the rest of the participation, and I’ll hear you again towards the end.


Great. Thank you, Sam, and thank you everyone for joining us today. Jeff and I are now going to talk about electronic consent from an IRB review perspective, but really from a human subject protection perspective, and what we as an IRB feel, how eConsent can contribute to better protections for individuals that are wanting to sign up or potentially sign up to participate in research.

So first we wanted to take another poll. And I think this is certainly a good poll to follow on to the first poll that we had, where 56% of you didn't not have any plans to use eConsent yet. But we wanted to find out a little bit more of what are the barriers, or what’s the greatest barrier, that you see from using eConsent. So if you’ve not used eConsent before, what do you perceive to be the greatest barrier? Is it cost, time, patient acceptance or participant acceptance, or a fear that IRBs won’t adopt eConsent. So we’ll take a minute, and please don’t forget to hit the submit button when you are finished.

But one thing I wanted to touch on as well, and another reason that we had picked this particular question, is because I think about a year ago, we really had an uptick in electronic informed consent, both from a submission perspective, as well as just questions that were coming in from sponsors and CROs. And I would say over the past three months, we’ve not received as many inquiries about eConsent, so we don’t know if it’s just because people are more comfortable with it at this point, if there are plans to implement eConsent. So this is a curiosity question, as well, from an IRB perspective.


All right. So we have 61.3% that say one of the greatest barriers is from a cost perspective. Another 33% from time. Participant acceptance is about 23%. And then IRB approval of eConsent 43.5%. So I would say from an IRB perspective, at least here in the United States, I think there is a lot of acceptance of eConsent, especially when you work closely with your IRB up front. And we’ll talk a little bit more about that in just a few minutes. But we’ve also heard that there’s certainly a cost issue or barrier per se to implementing eConsent. And one thing that we have found is, working with some of the bigger vendors out there that you have probably heard of, is they’re trying to help cut costs by doing things like having stock video, stock audio that can be used, the ability for companies to go in and actually create their own eConsent versus having the vendor do it for you. So I do know that that is currently—at least with the vendors we’ve been working with—that is currently being worked on. And hopefully we’ll start to see a bigger uptick again with eConsent or the implementation of eConsent across the different sponsors and CROs.

So next we’re going to talk just a little bit about what consent is and what is it not. Often people mistakenly view the term informed consent to mean simply obtaining a handwritten signature, you know, from a participant or their representative on a written consent form. However, as most of you know, this is only a small part of what we consider to be a process. So this process includes providing the participant with adequate information so they can make an informed decision on whether or not to participate in the research, allowing them adequate time to read the consent form and to ask questions. So in addition, the process continues certainly well after the subject’s initial consent. Obviously we have updates to consent, there may be new risks that have been identified as the studies have progressed, new procedures that may have to be implemented, maybe new procedures that would require them to dedicate more time to study visits. But anyway, this process really is an ongoing decision for participants, and they need to decide not only in the beginning but thereafter if they want to continue their participation in light of, again, these potential new risks that are identified or in light of more time constraints. So again, not just a signature on a document. It is an initial and an ongoing process.

So let’s take a quick look at traditional paper-based informed consent. So we all know there’s problems with paper-based informed consent, as I’m sure there are going to be issues with electronic informed consent, nothing’s perfect. Informed consent has evolved really to be a document that includes a lot of really confusing information for participants, a lot of legal jargon that is of little value to someone that’s trying to make an informed decision as to whether or not they want to participate in the research. We often see the language in 11th, 12th, or even college level. It’s not written in what we would call lay terms. And continue, these consent forms really do continue to be longer and longer in length. I mean we’re seeing some consent forms that are over 25 pages long, and you know, certainly I think we’ve seen a lot of oncology studies that are very complicated, where all of this information is being put into a document, and it’s really quite overwhelming, I mean, even from an IRB review perspective it’s a lot for us to look at, so I can’t imagine what it must be for participants. Version control can also get messy. Sometimes you have a sponsor, they want their version on it. The IRB wants their version on it, and then you have subsequent site-specific versions. So version control and monitoring that, I’m sure can be quite challenging. In addition, more and more people, I think, are moving away from paper altogether, just people as individuals. I mean we’re reading books, magazines, newspapers on Kindles, on PCs, tablets and phones. So we may have folks that aren’t necessarily interested in sitting down and reading a document, they would prefer to be able to sit down on their iPad, and again, flip through a consent document versus again looking at a 25-page paper document.


And finally, when changes to the consent are required, it can be slow to disseminate, especially if you’re working with IRBs that are still on a portal or some type of paper-based system. So we have to get these changes made to sometimes 300 sites across one study. And IRBs that are using these paper-based systems, that’s going to take a lot of time. So you potentially could have compliance issues if you have a site that’s using an outdated version just because they have really yet to receive their update documents.

So electronic informed consent and replacing traditional informed consent, what’s the same and what’s different? So from an IRB perspective, what is it that we really want to see? We know that there’s certain things, elements of consent, as we call them, that have to be included in consent, and that’s regardless, if it’s a paper document, if it’s electronic informed consent, or a hybrid of the two. So we know there’s certain information that has to be disclosed to participants. Again, we want to see that process. That process should facilitate a subject’s or potential subject’s comprehension. We know that there’s going to have to be some type of signature that’s required from either the subject or their legally authorized representative, of course unless there’s waivers of consent, but we’re not going to dive into that today. And the language has to be understandable to the individuals. So these are the same things that, regardless of the type of format you’re using, that from an IRB review perspective, from a regulatory perspective, need to be the same.

Now what’s different? And Sam touched on some of these a little while ago, but what’s different is the interface. It’s more interactive, you have text, you have graphics, audiovisual, it may include podcasts, animation. I think this is still yet to be seen, but we do think that electronic informed consent may help individuals comprehend the information a little bit more. Also, depending on your vendor I think that you’re working with, more timely amendments to implementation, and therefore subject notification. They can get these things implemented and disseminated quickly, literally by the push of a button. Hopefully there can be greater sponsor and CRO oversight, again, this is something that I’m sure is going to continue to evolve. Again, not everything is going to be perfect, I’m sure that monitoring informed consent is something that we’re not used to yet, and so I’m sure there’s going to be other processes that need to be put in place that we’re, again, not quite used to yet or that will evolve as we start to see more and more electronic informed consent. And then again, we go back to that subject  population preference, I always look at, you know, when we’re working with sponsors. And depending on the population, certainly paediatric populations, teenagers as an example, I just can’t imagine them at this point wanting to sit down and, again, read through a ten-page document or even a five-page consent form, when they could sit down and look at it on their phone or an iPad.

So what we see as far as Chesapeake, as some of the most significant benefits of electronic informed consent, include again the potential for better subject comprehension. For example, having that interactive interface, such as the audio, visual effects, the hyperlinks that are typically included within electronic informed consent, may help facilitate not only the subject’s understanding of the information presented, but also their ability to retain the information. Again, I think the jury may still be out on this, but we do know that there are a number of studies underway that are looking at this. They’re comparing the paper informed consent to electronic informed consent. And also looking at electronic informed consent compared to electronic tiered informed consent. And if you’re not familiar with tiered consent, that’s where you—traditionally in these paper documents you have all of the visits that a subject has to go to, all the different tables. Well in tiered consent, subjects are going to be able to dive down into those types of things, as they want to, but the elements of consent, and those important things that subjects really need to know in order to make an informed decision, are going to be out there in front, again where it’s more value to them, versus looking at each and every visit that they may have to go through, they’ll be able to tier down to that additional information. So we’re really excited to see some of the results and some of the data that are going to come out of some of these studies that are going on. And they’re also working with FDA as well.


Secondly, there’s greater transparency of the overall process with electronic informed consent. With some of these vendors’ systems, you can track how long an individual is on any given page, you can tell if they’ve actually skipped a page or skipped something that you feel may be of value, or what pages they may have questions on. A lot of these systems that we’ve seen include a way for subjects to highlight text that they may not understand, and therefore the individuals that are performing the consent process can come back and look at those highlighted sections and go over them and go over the subjects’ questions with them. In addition, many of the systems that we’ve seen have a way to “test” the subjects’ understanding of the information, whether it be at the end of the consent process or anytime throughout the consent process, it may be on a page by page basis. Version control is also tightly tracked and managed by most of the vendors’ platforms, and there’s a much quicker way to “shut down” past versions of the consent and disseminate new updated consents to participating sites. From an IRB perspective, there is also the ability to—again I’ll use this term “shut down” for lack of a better word—but it’s a way that we can shut down an individual site or not allow them access to informed consent forms quickly, if there are any non-compliance issues or unanticipated problems. So by limiting their access or removing their access, we have a better way to address the issues that may be going on at that particular site, and gives us the ability to work with sponsors hopefully to get that site back up and in compliance.

Finally, electronic processes may also promote timely entry of electronic informed consent data into the study databases and allow for more timely collection of the subjects’ informed consent from remote locations. And all of this, of course, leads to—or hopefully leads to—reduced regulatory risk at the sponsor, site, and IRB level.

And with that, I am going to turn it over to Jeff Wendel, Chesapeake’s President and CEO, to talk a little bit more about things that we see from an IRB perspective and some of those challenges.


Great. Thanks, Lauri. Sam and Lauri have kind of teed up things nicely, as have the polls that we’ve done. And what we’ve seen in our experience working with sponsors, CROs, sites, and the eConsent suppliers is what I would typically describe as the barriers or typical change in management issues associated with implementing a new technology in something that’s highly regulated and also has a high personal touch to it.

If you take a look at the challenges there, you can parse them really into three areas, which again were nicely based on the polls. The cost or return on investment. The second thing, I’ll say, is participating in adoption—will the people that are participating in the studies, will they be comfortable with it. And lastly, the regulatory/IRB components—is this something that will meet all the requirements. And if you look at those, and just put it into those three types of buckets, 61% of the people in the poll said cost. Another 33% said time, which is also a function of cost, as a perceived barrier. As Lauri has mentioned, a lot of this, there’s been a lot of advances from if you worked with an eConsent approach maybe even 2-3 years ago, completely different now in terms of people looking at different processes. We’ll touch on that a little bit better. As well as investments in reusable content. Also just the type of things that you use, video being obviously the most expensive, moving to things like animation graphics if you go there, allow people to comprehend in the same manner but actually reduce the time and the cost. The second thing is team adoption and participation. And I think, as Lauri said, the average person is far more facile using electronic technology, especially in a paediatric space. Also, we’ve seen things that are very complex from a medical perspective, again, from an informed consent perspective, what is actually going to happen to me. A lot of times a graphic or a short animation is able to cover things that the jargon and language would be an impediment in the past. And lastly, certainly as Sam touched on, the 2016 FDA guidance has been very helpful in sort of saying okay this is okay and actually an approved thing to do. As Lauri has mentioned, their embracing of a tiered consent approach is also something that’s very helpful. And we’ll touch a little bit, at least from a tech-enabled IRB’s perspective like Chesapeake IRB, why in fact the IRB piece is really a no-brainer, if you will.


To look at—and again, Lauri touched on this very nicely—the issues with paper-based scenarios. But if you look at the two, both their complexity in technical terms, where paper breaks down is that if you don’t understand something, people are usually very reluctant to raise their hand and say I don’t understand the 17 items on this piece of paper, as well as just the size and complexity of it. So if you look at IRBs that are embracing the ICF, it allows you to more actively engaged these patients in the consent process. It actually enables you to, in a sense, customize each person’s participation to what might be called an adult learning model, how adults assimilate things as opposed to children or paediatric subjects. But again, you can tailor the presentation to the target audience. Again, written word gets augmented, it can be a lot shorter as augmented by graphics or multimedia audio if that’s the case, so that again, in a very short snippet, oftentimes reusable, can be something that helps folks understand what’s going on.

Again, the ability to use the technology to get the psychometric information on the participants. What is their dwell time on a particular item. If they spend a long time on a particular page, does that imply it’s hard to understand, great interest, or whatever. And you can also see that the pages that were just kind of flipped through without opening. And so you have an understanding of really what kind of consent you have with that.

And so we also find that one of the things is, we spend a lot of effort getting patients to participate in the studies, and then a lot of them don’t finish. And oftentimes it’s because IRBs get this from the questions that we get. Hey, I decided to drop out and I’m not getting the payments anymore. Well gee, okay. Well I didn’t realize I had to go all the way—I thought I was guaranteed this revenue stream, if you will, regardless of my participation. So a better understanding of, you know, really what the requirements are.

Again, up-front basis, and we’ll touch on that a little more detail on the next slide. But basically there are what I’ll call logistical type things when using consent. Things like, if you’re dealing with sometimes the smaller local IRBs who aren’t as technology enabled, they want to know all these various IT-related things. Is it Part 11 compliant, where is it hosted, all those types of things. And we encourage the folks that we work with, we bring them both together, we get all of those questions out at once and then those questions don’t have to be answered each time they come for an informed consent process again, that cuts down, if you will, the timeframe and the cost on that. So it’s basically understanding not only, is their system good, but how could they most effectively work with us.

From an actual process perspective, again, we find it works best if the sponsors think about both themselves, the IRBs if you will, and the consent vendors as being folks that are working together. Folks that have Part 11 compliant platforms that run their business, their IRB business, their site business, their sponsor business, on electronic platforms are usually more accustomed to sharing things in multimedia, just like we’re doing here today. I mean we could have sent everybody a document and you could be reading it and we could be having a phone conversation, but the ability for all of us to be looking at this slide right now actually makes for a better way to participate. So what we have found works really well is when the vendor and the sponsor and the IRB work together. That allows a very quick—allows the IRBs and the consent vendors to in a sense disseminate the best practices to the sponsors and the site—this is why this has worked, this is how this thing works out. And it also, again to the cost and time perspective, actually reduces how long it takes. Again, the more transparent systems you’re working with—mostly the eConsent vendors are obviously very transparent, again, depending which IRB you pick, the transparency of their document—you have the ability to literally look and work on things as opposed to the process of documents going back and forth to each other. And again, as we said, at the site level, again the types of things where changes can be quickly disseminated—obviously electronically—and then presented to folks if a re-consent is necessarily needed.


So lastly, just as you think about how we feel. Your poll was not very surprising to us at all, in that there’s the concerns as I’ve already addressed. And so what Chesapeake and other vendors have done is just tried to use the elements of consent, again, which are still required but are very easily accomplished in this type of environment, leverage technology that we have on both sides to up-front work with folks together. Again, I can’t encourage enough that it’s the collaboration in terms of at least reducing the review time  between an IRB, the sponsor’s representatives, to create the consent and the eConsent vendors are really just critical in being successful. We’ve been able to find a number of different ways to help folks do that. So Sam, I think with that it’s back to you.


Okay, thanks everybody. We’ve got some really interesting questions that have been put into our Q&A area, so I’ve just got some last points. And actually some things that can actually answer some of those questions just by a few statements.  And then we’ll do one more quick poll and then we’ll do some Q&A.

So what we went over is kind of setting the stage for the current paper process, some opportunities with technology, especially in the oversight piece. The other thing to think about is, when we adapted—and Jeff, you said this really great—we’re a regulated industry and every time we have adopted and then adapted to a technology, it takes a long time. We’re very cautious, sometimes our reaction is disproportionate to what is the risk, and we know we do that. We do that in many different areas, especially in adoption of technology. So think of the adaption and adoption of electronic case report forms, a couple decades it took, and I remember the FDA did a webinar related to eConsent and other technology, eSource, and said they really aren’t expecting it and don’t want it to take as long as electronic case report forms. Some of it is, we have better technology and better security in place. But you have to definitely go through workflows of how would we do this differently in paper, what would we permit at site level. So some of the questions that came in were related to what if the site is using paper and electronic consent at the same time. That’s like saying, what if the site was using an electronic diary and a paper diary at the same time. There is contingency plans when the electronic is not working, and only then it would be paper. Or is it going to be a combination where they sign on paper and then it’s done electronically. So clear expectations for sites as to the expectations of monitoring is very much that critical thing that we know is going to be somewhat of a learning curve. But we know that we can do it. We’ve done this as an industry before. So again, some of the auto findings that some of you were chatting about in the Q&A, they weren’t really questions, they were more like statements, are things that anticipate what could be the risk, what could go wrong, and they’re mostly about misunderstanding. What do I use, if I’m not comfortable, do I fall back to paper.

All right. So again, I can’t thank Jeff and Lauri enough for being here. There’s a lot, we could have talked all day about this, I imagine, a lot to touch on. So let’s actually do some Q&A.

[Q&A section starts at 49:30]



About the Author

Sandra "SAM" Sather

Sandra “SAM” Sather, MS, BSN, CCRA, CCRC, 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.

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