Unlocking Online Signature Legality for Polygraph Consent in European Union

How to eSign a document: online signature legality for Polygraph Consent in European Union

So hello everyone, and welcome to today's session where we are going to demonstrate obtaining a consent from a participant remotely using REDCap E-consent. So what we'll go over today: first of all, I'll introduce the presenters and what our assigned roles are. I'll give you a few disclaimers. I can't have an E-Consent session without just a few disclaimers before we get started. Again, another disclaimer in case you're just joining us, we are recording this and it will be posted so that you can view afterwards. I'll then just quickly show resources for E-Consent that go beyond this session, and and then we'll go back and forth between the prerecorded demonstrations that we've, we've put together, and also and then we'll have Q&A between each recording. And actually I think I forgot to share my sound. So I'm just going to stop sharing for just a moment and then I'll start sharing again. OK, now you should be able to hear the recordings when we get there. That will be helpful. OK, so the presenters today playing the role of research coordinator will be Caitlin Moore from the Cardiovascular Division. The potential participant will be yours truly, Christopher Sorensen from Bernard Becker Medical Library. Our principal investigator is Susan Kendall from the HRQA program. And we also have Andrea Morris from the HRQA program in the chat who can respond to questions if the others of us are our busy. So some disclaimers here. So as I mentioned in the email, we're not doing anything showing creating this E-Consent or how to get your E-Consent to prove this is a project. We're assuming this has already gone through IRB approval and we are we're ready to roll and and consent real participants. The demonstration project that we've created requires a consent conversation. OK and and what I mean by that, as some of you may have very low risk studies where you can just send out your survey to people and they can read through it on their own. This is one that requires a consent conversation. If you're unsure if your project or projects do, you can check my IRB application section 1.1 2. And some of these sections as we go through obtaining consent the coordinator may summarize more than during a real consent conversation. I think in the end we she did a pretty good job explaining each, but the goal wasn't necessarily to sit and listen to someone read a consent. We really wanted to demonstrate some of the things that are different between the E-Consent from a paper consent. This is for non FDA Part 11 studies, which goes for anything you have in our our REDCap our instance of of REDCap what we call REDCap Academia. There is another REDCap cloud that is available for FDA Part 11 studies. A reminder that we'll demonstrate emailing out the survey and then sending the fully executed consent to the participant, and we have template language for that. However, those that language needs to be approved by the IRB. So if you see something in this that you know, you you you've been told by the IRB, oh, you can't use that language in an email that you're sending that could just be project specific depending on the depending on the population you're studying or the condition that you are studying. And there's a couple of things that we just didn't include, and I'll actually mention this again when we get close to the recordings. We didn't have the research coordinator call to schedule a time for the Zoom call, and we didn't have a recording where we had them send a test, email and text. We thought those things were kind of self-explanatory. In my email that I sent yesterday, there's a PDF attachment with these links. So even though we're not showing how to set up this project, or what resources you have when you're trying to get your project approved by the IRB, we have several resources and work continuing to build upon these. A general summary of this demonstration. The demonstration project, specifically the project title is, "At Home Blood Pressure Measure Confidence Registry." So we just created a very simple, straightforward, made up project here that we could consent or we could obtain consent from a participant from. And the purpose of this study is that the participant, or excuse me, that the study team is documenting participant confidence in taking blood pressure measures at home after receiving training during clinic visits. And basically the logistics that you'll see as a PI will approach a patient at the end of a clinic visit to discuss the study. Then the research coordinator contacts the potential participant to set up a Zoom call. Again, we're just assuming you kind of know how to do that, since you'd probably do that with a paper consent anyways. And then, you know, the coordinator ensures that they have the correct email and everything. Again, we didn't do a recording of that, but then we go through the process where basically the coordinator and the participant are on a Zoom call and go through the entire consent process. The specific toppings of the recording topics of the recordings, there are six of them, about 30 minutes total. So we do have time, as I mentioned, for questions and answers, but the recording specifically are a short one where a PI approaches a participant at the end of a clinic visit. We then have the research coordinator add a record to REDCap, screen the participant, and deliver the survey, which is also pretty short. And then the consent conversation and obtaining consent from the participant. That's our longest recording. And then we have the research coordinator go in and sign the attestation and document the consent. Then we have two short ones where we confirm delivery of the fully executed consent and finish documentation of the consent. So for this first one, this is going to be really short and sweet. We'll have I'll give a break for a time and for questions afterwards, but I don't know that there'll be many for this specifically, but perhaps for the longer one. So I'm going to go ahead. Basically, this is where a PI is, is approaching the participant as the patient is finishing a clinical visit. Just know, we did do this over Zoom, so we're going to pretend that we're in a clinical visit over Zoom. OK. Actually, if once I start playing this, if someone could just confirm to me that you can hear it through the chat, that would be great. So I'm going to go ahead and start it now. So Chris, now that we've talked about your plan and that we're. Ope! And I also forgot that I cannot click out of the slide, or it will pause it. So let me start this one from scratch and here we go. So I think we're good on the sound. Thank you. For those of you who responded. So, Chris, now that we've talked about your plan and that we're going to have you taking your blood pressure at home more regularly, we're actually doing a study to learn a little bit more about people's confidence and how they feel about taking taking that blood pressure at home. Do you think you possibly be interested in doing that? You wouldn't need to come in to any extra visits. It's just some questionnaires and a few extra measurements. Yeah. Questionnaires via email? Yeah. So you wouldn't have to to come in or anything like that. Does that sound like something you might want to learn more about? Yeah, that'd be great. OK, great. I will have Caitlin, my coordinator, reach out to you and we can learn some more that way. So you can decide if you want to take part. Okay. That sounds great. OK, I will try to do better on the next slide. If I click anywhere on my screen. Yeah. So if I try to click into the chat during these recordings, it actually pauses it. So I will I will try to do better on that with the next slide. So that was very short and sweet. If you have questions, feel free to type them into the chat, but I think we'll just go right on to the next one that has a little more substance to it. So this is you know, we're assuming the coordinator then contacted the parti- potential participant and set up a time for this Zoom call. The coordinator adds a record to the project starting on the Add/Edit Records page, and an auto-numbering for this project has been disabled. I will explain that before I start the next video. And the coordinator screens the parti potential participant, and and for demonstration purposes, it just it made sense for us to have the coordinator sharing the screen for this session. We wanted to make this as much like a real consent process as possible. But we also wanted to show you this. What our coordinator is entering and and and our coordinator, Caitlin, also does a great job of explaining what she's doing as she's going through this. So it it's not exactly like a real one. There's a few nuances you wouldn't probably want to share your screen while you're logged into REDCap just because of concerns that you could, you know, your screening Participant Five and you accidentally click on Participant Three's record. You could, you could show some PHI. So even though we're sharing the screen while the while the coordinator is logged into REDCap, you'd have to really consider whether that's something that you needed to do or was necessary. And then we'll finish by the coordinator delivering the and informed consent form of the survey. And so as I mentioned here, we're already on the Add/Edit Records page. So if you are familiar with REDCap, when you're in a project, you click this Add/Edit Records where my little finger pointer is right now. And you come to this page and because we've disabled auto-numbering, there's a textbox here where we can enter a participant ID rather than just the participant getting whatever number is next and in the order. So I'm going to go ahead and start this one and then we'll save a little time for question and answer afterwards. All right. So now that my PI has alerted me that there is a patient that's interested, I'm going to go ahead and enter, you know, a new record for that participant. You can enter this as whatever your participant ID is. This is the site, the participant number so I'm going to go into the participant information and I have my, my patient here. I'm on the phone with me. So we're going to go through these questions with our patient. So Chris, I'm going to go ahead and enter your information here. Can you tell me what your date of birth is? Sure. 7/1/1982. And then are you being required to test your blood pressure between clinical visits? Yes. OK. And are you willing to complete questionnaires about your confidence in your blood pressure? Yes. OK. And then how would you like to complete the E-Consent? Do you want it sent by mail or. Sorry, do you want it sent by email, on the phone, or in-person. Email would be great. OK, great. And then next we want to choose a PIN number, so you're going to use that PIN number to access the E-Consent once it, once you get the link to open it. You shouldn't use a PIN such as one, two, three, four or 111. And it is four digits. OK, how about 0523? OK. And then would you like a copy of the signed consent form emailed to you, or would you like me to print it and mail it, or hand it to you at your next visit? Email would be great. And then your email, I have SorensonC@WUSTL.edu That's correct. All right. So when we're going to send him the consent form. So as you can see, the other two participants that we have in here are here as well. And then this is, you know, our current record that we want to send. So we're going to go ahead and compose survey invitations and select select who it's coming from. And. Then the next thing you're going to do is you're going to update this language based on what the SOP is on the end health website at WashU. So the subject is going to be informed consent form to review and sign. And then for this text, it's easiest probably to go ahead and go ahead and type it out versus copy and paste because we found that there are issues when you copy and paste it in with the formatting of the email. OK, I think that's right. OK, so once you're finished typing your your email out in this box, I'm just going to come up here, double check: this is the correct email address one final time; that I spelled everything correctly; that is going to the right place. And then I'm going to scroll down and send invitations. This is telling me that the emails been sent successfully. So now we'll check back in with our patient and just make sure that they've received the email. OK. So once again, I clicked into the chat and had a brief pause there. I promise I'll, I'll try to get that figured out before the next one. So we did have one question come through in the chat. Do PIN numbers have to be unique to each participant? So from a REDCap standpoint, you can have that PIN be the same each time. I think the what's important to consider, though, is that if that is, you know, secure enough, I you know. As a best practice, then you really would want them to be unique so that, you know, maybe you have family members that are both in the study so that they wouldn't be able to access each other's records. So it's really more secure if you use unique PINs for each participant. Yeah. And I just thought of a situation here where if you accidentally sent the wrong survey to the wrong part, you said, you know, a survey to Participant six that was supposed to go to Participant five. While the Participant six would be able to log in and take that if the PIN was the same for everybody. So, so, yes, as has been said in the chat and then and then as Susan said, that it would be best to have it unique for everyone. We found it incredibly helpful that when study teams actually are tracking this in their master list. So where you're keeping record of every participant who's consented to be in the study, their name, their contact information, their assigned ID number, then you would also maybe want to add a column for capturing their PIN number, because we have heard participants forget what their PIN is. They'll contact the study team. Then that way you can make sure that you're relaying the appropriate PIN number for them. And we do even have some study team members who will pre sign assign a PIN so that there are no duplicates. And so that's an option as well. Which keeps it nice and consistent as far as making sure that it's not duplicated. Yep. Thanks, Andrea and Susan. And one other question that came through that I'll just address here is how often they need to enter their PIN, like after they have consented. It's so how do we have it set up in the template if you've used our template is that it's used for every every survey throughout the study. There is an exception where if somebody enters a PIN and then within 30 minutes of entering that PIN, they open another survey from the same computer that that session stays open. That's just a REDCap setting that the PIN stays active for 30 minutes. So if you were consenting to what you'll see at the end when we deliver the fully executed consent, that is also PIN protected. When we were recording these, that took long enough that I had to enter the PIN again. But there could be a situation if you had a very short consent process and then you delivered the fully executed consent and the participant open that survey, you know, they're at the same computer they never got up and within 30 minutes they opened it that would, that would still open without the PIN. But that is the only exception. If you have this set for all surveys. OK, so I'm going to go ahead and set up our next video now. And in this one, the partici- potential participant receives the survey link. And now this point so first I'll be sharing just to show you the email that I received, just to show you what that looks like. And then that's not recommended. You probably don't have the participant sharing their screen when they're when they're in their email. But then I open up the survey and and then you can you know, at that point, if the participant is able, you can have them share their screen. And then that way you can kind of walk through it just as if you were sitting across the desk from them and then kind of leading them through the, through the consent form, just as you would for a paper consent. So this this one this will be the longest of the video here because we go through the entire consent form. And I will I will do my best to let my co-hosts answer all the questions in the chat so I don't pause our recording. OK, great. So it looks like I received the email from you, so I'll go ahead and click on the link. OK. OK. So now I've got the part where I believe I'm supposed to enter my PIN. Yeah. Oop. Oh. If you go ahead and click show value, it'll give you, it'll show you actually what you're typing. Oh, OK. 523. OK, I believe that's correct. Yeah. OK, great. Perfect. So this top part just talks about reviewing the consent form. You can download a copy of the blank consent form at that hyperlink and it will download a PDF of the document. OK, I'll do that just so I have it for later. But this this has the same information as as the survey. Yep. So the example. OK. So the PDF will actually show what the consent form normally looks like. OK. And then the E-Consent you know, document that you'll receive at the end, it does look slightly different, but all of the information inside of it is exactly the same. OK, so then I just click next page here to get started. OK, great. Yeah, Perfect. So at the top, it just gives you some information about the dates: when this document was approved, when it expired, and then the version information. The title of the project is At Home Blood Pressure Measure Confidence Registry. And then our principal investigator and research team contact are listed there as well, just in case you need that in the future. OK. So what is the purpose of this study? We're, you know, asking you to take your blood pressures in between visits. And then the purpose of this study is to document your confidence in taking blood pressure measurements at home after receiving the training in clinic. OK. So what's going to happen during this study? We'll, you know, document your normal attendance it at the normal clinical visits. It's not your participation isn't going to require you to come back for any additional visits. And then you will receive blood pressure training on how to take an appropriate blood pressure. You'll receive a packet that includes instructions similar to this to this figure below here. And then you'll also put questionnaires as part of your your participation in the study. So we'll send you some questionnaires you know, either via mail or or email, however you prefer. And then you'll you'll answer those questionnaires. OK, great. OK, so then just go to the next page? Uh huh. OK. So this section talks about saving your research information for future use in studies. So we do ask to save your information if that's OK with you, just to answer additional questions in the future. We may share that information with other researchers that are doing research in similar areas or unrelated areas. And those researchers may be at Washington University or at other institutions. We do try to, you know, keep everybody's information as private as possible. So we will remove any identifying information like your name, your date of birth, anything like that that can identify you. But, you know, sometimes that information can get out there to, you know, other other investigators and other institutions. If you decide to change your mind at any time, you can always let us know and we can, you know, not share your information. Yeah, I think for this study, I'm OK with you know, saving my my research by my data. So that's fine with me. Oh. Did you want to go ahead and have us share it with others or. Yeah. Oh, OK. Yeah, I click no, sorry. I'll change that. Perfect. OK, now. Just go ahead and finish your initials. OK? And then I'm OK with sharing it with other researchers too, so I'll say yes to that. So you got to enter your initials for both questions. Oh, OK. Yeah, I see now. Great. OK. So we're looking at having about 200 people participate in the study. Your involvement in the study will last indefinitely, or as long as you are attending this clinic, and we may contact you at each time after your clinical visits. The rest of the study, so for the blood pressure cuff, you may experience discomfort in your upper arm while measuring your blood pressure. The cuff does deflate quickly, but if it doesn't, you know, please remove it and then contact the research team member at the top with the questionnaires you may experience, you know, some discomfort in answering some of the questions, but you don't have to answer them if you don't want. And there's always the risk of breach of confidentiality. But again, we do everything we can to keep your information safe. And private. We'll kind of go over that a little bit more here and in a few more sections. So what are the benefits of the study? And unfortunately, you won't benefit from being in the study. However, we do hope that, you know, other people might benefit from this study in the future as we, you know, potentially improve the confidence of patients required to to take home blood pressures. It's not going to cost you anything to be in the study. Unfortunately, you won't be paid to be in the study. And we aren't receiving any kind of funding for the study. We're being paid right there by the university to complete the study. OK, great. So this section talks, you know, a little bit more about keeping our information confidential. So the section at the top gives you information on the people who may have access to your records throughout the study. So those people include government representatives like the Office for Human Research Protections, the U.S. Food and Drug Administration, people who use the registry, the hospital or university representatives to complete hospital or university responsibilities, and Washington University's Institutional Review Board, and the Human Research Protection Office. The Institutional Review Board has reviewed this study and approved this study. So a little bit more information about the data. So it's going to be directly entered into a secure electronic database and that database is maintained in a password protected database using secure network practices. All people who have access to the database will have a username and password, and their access will be restricted to the role that they play in the study. The data that's shared with other investigators may contain identifiers and all web based information is sent in an encrypted manner, and all data is stored on a private firewall protected network. Any report that we write, it's not going to include any information that can directly identify you. However, we do have to provide that information that we collected on the study to, you know, the people who publish these these reports and articles because they like to just double check that, you know, all the information is correct that's in the in the article or manuscript. You're. The information that's shared with them, however, cannot be directly identified to you. Have you heard of HIPAA before? I think so. I think I've heard it. Perfect so HIPAA is the Health Insurance Portability and Accountability Act. So this act, you know, protects patients information and the use of your protected health information from disclosure to other people. We do follow state and federal laws to make sure that your information is, you know, kept safe and and confidential as possible. However, once your information is shared with someone else, the research team, it may no longer be protected by HIPAA. But again, we do everything we can to keep your information safe and private. Any information that's provided doesn't include your name, your date, of birth or or anything that can identify you on it. OK, great. That that all sounds good. OK, if you decide not to sign this form, it's not going to care to affect the care treatment given to you by the doctors. They're still going to take great care of you regardless if you participate in the study. Your insurance payment or enrollment in any health plans won't be affected by participating in the study, and you also won't lose any benefits to which you are entitled. However, if you do sign this form, you are authorizing the use of your personal health information for this research, and that authorization does not expire. However, you can withdraw your participation at any time for any reason. OK, that all sounds good. Perfect. Go to the next page. OK. So this section talks about sending you information via email or text. You don't have to sign up for this. It's completely optional. But if we were to email you or send you text messages, they would be reminder for reminders about scheduled clinical visits, sending links to follow up surveys and then follow ups to a question or any adverse events you may experience. OK. Just so that you know, email and text they aren't, you know, very secure methods of communication. For the email, we will send you your emails in a secure fashion that will require you to, you know, have a username and password to to access that email communication or text message. Unfortunately, we can't send it in in a more, you know, secure manner. It would just come through as a normal text message. So if your family or friends, anybody has access to your home computer or your cell phone, you know, they may they may get access to to any confidential information. But this will just be related to this particular study, not to my clinical visits or anything, anything like that. Correct. OK, yeah. Then I think I'm OK. I think having the communications that way so. OK. So being in the study is voluntary. Again, you can withdraw your participation at any time for any reason. You can do so by letting us know, just contacting one of your study team members, either the PI or myself, and just let us know that you're not interested in participating anymore. Or you can go to this hyperlink in the second paragraph, and you can download a letter template, fill it out and send it in to us. OK. If we receive any new information about the study that might affect your willingness to continue participating in the study, we'll definitely let you know that that way, you know, if you decide you don't want to continue on, you know, you have that option at any time. OK? Can someone else end my participation in the study? Under certain circumstances, the investigator may decide to end your participation in this research study earlier than planned. And this might happen for no reason, because you failed to follow instructions, or because the study is canceled. Do you have any questions on any of this? No, I don't believe so. OK, so if you have any questions, you know, once we get off the phone, feel free to give me a call at any time. My contact information is located right here on this form or at the top of the form. You will get a copy of this. So, you know, you'll have this information to refer back to and you can always contact me and ask me any questions you might have. If you have questions, concerns or complaints about your rights as a research participant, you can contact our Human Research Protection Office, and their contact information is listed here as well. Or if you need general information about being a research participant, you can go to their website and look up information there as well. OK. So so can you give me a little synopsis about what this study is about? Yeah, so it sounds like I will be taking my blood pressure at home in between clinic visits, and you want to know how confident I am in taking that blood pressure as I have to do it at home? Yeah, exactly. And we'll do that just by sending you the the questionnaires to fill out, you know, various time points throughout this study. Great. OK. So if you want to click next page right? So if you're agreeable to participating, go ahead and check that box. OK, and then next you're going to put your signature. So if you want to click that hyperlink. Yep. Oh, well, can I, is it, can I start over? Yeah. So if you just want to click the reset button. Oh yeah. OK, it'll. Just allow you to start over. Now. Just put your participant name in there. OK, so OK. And then this is automatically going to, you know, date and time the consent form. OK. So go ahead and click next. All right. So now what's going to come up is a copy of the consent form with all of your responses on it. So I'm going to have you go ahead and go through and just and just review it and make sure that you've answered all the questions in the way that you feel comfortable answering them and that we've signed and dated and it's all showing up here. Now, this will only show your signature and your responses at this time. Once you're finished with all of this, then I'll go in, I'll sign the consent form, and then I'll send you a copy of that consent form with both of our signatures on it. OK, look, like all the questions were answered. So here we go. OK, great. OK, signature. So if everything was OK, go ahead and certify that the information's correct and then go ahead and click submit. Perfect. And so now I will go in and complete my part, my portion. OK, OK. Before we move on to the next section, that was a pretty long and important section. So are there any questions that if you feel free to type those into the chat or you can unmute yourself at this time? If you have any questions about what we just went over. We tried to include some of the hiccups you might see during that consent process. They try to click through without answering a question or they don't have their initials as well as if they change their answer so I hope that those were helpful for you all as well. Thanks, Susan. All right. We'll go ahead and go to the next one. That was that was by far the longest. So these these next few will be a little shorter. This one, we're going to have the coordinator sign the attestation portion of the consent. The coordinator then completes the consent documentation instrument and then and again, Caitlin will be screen sharing during this and describing some things. And again, this is not something you would want to share. You know, you wouldn't want to do share screen sharing when you're when you're going through these sections with the participant. But for our purposes today, we are. And one other point that I'll make on this. So in order to do this demonstration, Caitlin's going to go through and do the entire consent documentation, or I guess I should say she'll do most of it all but the last few questions and you'll see why at the end. But this is something that if you were on the phone or excuse me on the phone or on a zoom call with a participant, you could be filling out that consent documentation at the same time that they were going through the survey. So you could have that open on your end. There's nothing, nothing will it won't bother REDCap, if the participant is completing their survey and you're entering filling in some of the questions on the consent documentation instrument simultaneously, as long as you can do those two things at the same time and explain everything properly to the participant. And it may also be best practice to do it that way just because then you're documenting at the same time that you're going through the consent process with the patient. But again, we did it separately just so that you could see what was happening as we were screen sharing. So just, you know, something to point out. Thanks, Caitlin. And so we'll go ahead and switch to this next screen here. OK, so now that Chris has completed his section of the consent form, I'm going to go in and complete my section. So I'm going to go to the Record Status dashboard and I'm going to scroll down to the informed consent form first. So here's this participant ID. I'm going to select the Informed Consent Form instrument. And if you scroll through, you'll see all of his responses have already saved here. So now I need to enter my information. I can't click on anything yet, so you can't enter it directly here. What we have to do is we have to go in and edit the responses of the survey. So I'm going to click Edit Response and scroll down. And as you can see, it still can't edit any of his responses. Obviously not that anybody would want to, but just as kind of a safeguard so that, you know, these can't inadvertently be be edited. So now when I scroll down, we'll see his his signature and name and everything is still populated here. I'm going to go ahead and click that I agree as I am to the statement, as I'm the person that obtained consent. I'm going to add my signature. I'm going to go ahead and type my name, and then I'm going to enter the date and time. As of now, you'll always want to make sure that you go in and fill this out right after the participant. Because, you know, we are date and we are dating and timing when we're completing this section. So next we want to make sure that we follow these instructions. Otherwise, the participant won't get a copy of the consent form with our signature on it. So first I'm going to select Save and Stay obviously this button says Save and Exit form. We don't want to click that. We actually want to click this down arrow, and then it's going to give us several more options. So click Save and Stay. And now it's going to have a stay on the form, but it saved all of my responses. And so then the next thing I'm going to do is I'm going to save and mark the survey complete. So again, I don't want to click the Save and Exit form, and I don't want to click this again because it says Save and Stay. So I'm going to click this down arrow and click Save and Mark survey as Completed. Now we're going to go in here and it's going to show us that this survey has been uploaded to this instrument. So when I open that up, this has been saved and our participant should receive an email here shortly with a copy of this completed consent form. So next I'm going to go into Documentation of Consent. So I'm going to put in the consent approval which was 2/21/2022 with an expiration date of 2/21/2023 on it. And then my participants name. Oops. And then how is the participate, participant approached? And we did this over video conference. Informed consent was reviewed in its entirety with the participant and following major, major points were reinforced. The purpose requirements, duration risks and benefits were reviewed with the participant. All immediate questions, concerns were answered. The participant understands participation is voluntary and then they can withdraw at any time. And did they have questions? Yes. So next, I'm going to fill in a summary of the consent conversation. OK. Now that we have summarized, you know, our documentation of consent and how the participant was approached, that the, you know, issues that came up during the consent about, you know, them inadvertently marking. No. And then verbally told me yes. And then I followed up with them. And then them asking questions about any information via text and email. Did the participant consent to participate in the study? Yes. And then I'm going to, you know, attest to this documentation of consent. So I agree. And enter my name. Sign. So this is the end date and time of the verbal consent conversation. So that'll be here in a few moments. And then a copy of the consent form was provided to the participant via email. But I'm going to double check with my participant first just to make sure that they receive this email and that the appropriate consent form has been uploaded and that they have access to that. After that, then I'll go in complete this, this question and then put my end date and time of the verbal consent conversation. So I'm going to go ahead and save and exit this form. When I do, because there is a required field, you know, I'm going to ignore and leave. Then I can go in to my participant again and, you know, verify or do anything else I need to. If they didn't get the consent form for whatever reason. OK, so one thing to one thing just to point out a couple of things to point out before I address a question that came in the. You may have noticed there's a couple of times when we were either typing or signing our names. We we did a little video editing there. So that's the signature. If you weren't sure why we went from one letter to full names, just to point that out. And then I also wanted to point out that a couple of the features that Caitlin mentioned, such as after hitting Edit Responses, that she was unable to edit the responses that I had completed on the survey. That is a feature built into our WashU E-Consent template. There's a few there's a couple of extra things in those fields that make it so those fields can only be filled out as a survey. They can not be filled out by someone logged in to REDCap filling it in as a data entry form. And then those instructions at the bottom with the Save and Mark as Complete, those were also part of the template. Those will not if you just activate the the built in E-Consent feature in REDCap those things do not happen. You have to either build those yourself or use the WashU E-Consent template that is described in those resources from the slide earlier or the PDF that I sent in the email yesterday. And I will send that email out again to all. I'll send that PDF again out to all who registered. So we had a question about the Save and Mark Survey as Complete versus just change form status to the to the complete. So the Save and Mark Survey as Complete is not something you always need to do on all on all data entry forms that you're working on when you're logged into REDCap. You can just do the Save and Stay or Save and Exit. The Save and Mark as Complete that is specific to this form on this WashU template because is it because it, it actually triggers REDCap to upload a new version of the completed consent into that fully executed consent instrument that will be delivered to the participant. So if you don't do the Save and Mark Survey as Complete, you will only send them the the the the consent with their signature, not with the study team signature. So basically when you do Save and Mark Survey as Complete, it just sets off an extra, an extra feature in the background that makes sure the person gets the fully executed consent rather than rather than just with the participant signature. And we only have one more, or I guess, two more short videos so I can correct. Yes. We just have a few quick questions that I think would be good for everyone to hear. I've got a couple sent to me personally. OK. So with paper versions, if a participant changed their mind, you know, originally agreed to future use, then later changed their mind and didn't want to agree to. In paper world, you do a note file and attach it with the note file to that consent document so that you could notate that there their option had change. But with REDCap, what are the best practices for documenting this? And from a documentation standpoint, if it happened after they submitted their signature like as in after the first part when Chris submitted his signature and then Caitlin was going in and then came back to the conversation and said, "You know what, never mind, I changed my mind. I don't want to contribute to future use." Technically in the system, how could they fix that Chris? So quick question before I answer that. They have to complete a whole new consent form or just set a note to file. That's how we would do it in the paper world. OK, so that's a good question and I'm glad you asked. So that from a REDCap perspective, there's probably several ways you can do this. And Andrea and Susan, feel free to, you know, tell me which one is better. So you could create just an extra note to file instrument and have that with a record. And then you would only have that when it was necessary, when you had to enter a note to file but that's something all you know, that's not something that I have. So I will tell you. So I, I kind of figured this would be kind of an ever evolving question because there's a lot of different situations, right? But let's say that you are going to generate via REDCap through the data that's entered into the form. So what's entered into the form by those participants and be able to select and run a run a query that says what participant said yes to future future use and you would run that query by their most current consent form. Mm hmm. That's where I would say if that's at that, that's an option that you want to utilize in REDCap, then I would have them reach consent as a best practice so that you don't have to mine through attachments or notes to file to find out whether or not yes or no. Did these participants say yes to future use? That's why I think it would be beneficial to resend then the consent form. Now, would you have to go through the whole consent form with them? Again, not necessarily, especially if it was in a short period of time, unless there were changes to that consent form in which you would have to obviously review those changes to have them sign it. Also, making an attachment section within a REDCap form to attach a note to file would be an OK way to do it as long as it's documented what the participant wanted. When did they request that change and wasn't? What did you do after that? Do you have a way in the system to mark them as not being involved in future use? I think there's like Chris said, there's probably a lot of different ways to do it. Yeah, and so one other thing, just in all, Andrea and Susan now ask if this is OK, there is the I'll just switch screens here quickly. So while you're doing that, Chris, this is why, you know, so documenting the informed consent conversation is part of ICH-GCP. It's also something that has been incredibly helpful in all of our FDA audits and helping to avoid us getting cited, cited because what it does is it documents who's all involved in the conversation, what questions have occurred and things like that. So documenting that informed consent conversation is really considered the ultimate best practice. It is not quote unquote required. However, if you have an FDA regulated study or anything that falls within that purview, it is highly, highly suggested. It's a great way to make sure that you are capturing components of the conversation that you can't do on the actual informed consent document itself. What questions were asked? Were there concerns? Were there multiple people involved in the consent process? The PI, the study coordinator, the research nurse coordinator, things like that. So it is definitely considered best practice. But it also helps to talk about when things happen in real time. Right? So if mistakes are made, you can document that on that informed consent discussion, our documentation of informed consent. You know, it's a way to capture all of these one offs that you can't necessarily do on the form itself. And that would that's true both in the paper world and the electronic world. All right. Thanks, Andrea. And you know, one other option here, I'll mention it if this is a no, there is this comment log that even though I can't edit this, there is a comment log and you can actually make this it's called a field resolution workflow. There's something on the project setup where you can make it that where you can enter comments here directly with the field. Would that be sufficient, Andrea, to be considered a note to file to have this field comment log, which is something you can export if the person changed their mind, I guess could be here on this one. You know, I think it's it would be OK to capture if they wanted to change. So like let's say this consent was executed today and two weeks from now that they came back and said, you know what, I really don't want to do that. You know, participant decided on X-Y-Z date that they no longer want to contribute to future use. That would be an OK way to do it. Now, I'd caution you though. So like if you were to run a query to find out how many participants within your particular project allowed for future use, would you be able to pull that comment log within that query Chris? Not not easily. Not easily. Yeah, that's something. And so I think that's something that you would have to take into consideration. And in that case, it would be worth re consenting so that when you run that query on the most current consents, you're getting the most current responses as to who can allow for future use or genetic testing or audio or video recording, any of those optional items which is kind of why we're using red, right? Because it automates things and allows us to get information quicker than in the old days, flipping through the consent forms and trying to figure out what they said. Just as an aside. Like. Since we can't easily export the comments for these variables, if somebody were to choose to do, you know, a note to file instead of re consenting a patient, it would probably be better to create a note to file variable. And then you could export that note to file variable with your responses. So that way, if there was something that, you know, had somebody had changed their response, then you'd have that note along with that, you know, to go back and just double check that all of your responses are correct. But I agree it's going to take some extra time and it's not you know, it's not like you can just easily export it and then search for the people that said, yes. You don't need an extra step. I will I'll go back to my REDCap workshop and try to figure out a way to make that so that you know, you can have it in there and export it really nicely with both the answers and the in the and if they've changed them. But just as another aside, just so everyone knows these we are we do have an E-Consent working group that meets most months. And so when you ask these questions, it's great because it gives us time to consider them, work through them, and then we discuss them among the groups of you know, myself, my cohosts here and then representatives from the IRB, clinical CCS, different different groups like that. So even if we don't have these answer, you know, the best answer right off the bat from a REDCap perspective, we will continue to work forward and add these add these features. OK. Absolutely. Questions. It's bring back up our next video. So just to set this one up. So now we're confirming delivery of the fully executed consent form. So I will receive the email with the link and again screen sharing for demo purposes. But you probably don't want to have your participant actually share when they're in their email. You know, and all this, you know, the screen sharing stuff is, is doing the best that you can with your with your participants. So if they're just not able to screen share, you know, you just try to come up with the best solution you can. And then I access the survey using the PIN. And here's the note that I put earlier about the PIN where if this all happened within 30 minutes of the time that I first accessed the first survey, then I wouldn't open or when I opened, I wouldn't have to enter my PIN. There would be a little note at the top of the page that says survey login still active. So that that's the one exception where they would wouldn't have to enter the PIN. And then I'll I'll download that consent form and confirm that both signatures are there. OK, so it looks like I received the email with the with the link to the consent form. I'll go ahead and open that OK. So I just use the same PIN that I used earlier. Yeah, OK. And if you ever access this and you want to know you know you've forgotten your PIN, just feel free to give us a call. We can always change it or, or, you know. Great OK, so then I just click this link. Yep. And that should download a copy of the consent. And go ahead and open that up and just make sure that the copy that you've received has my signature on it, that all of your responses are correct and everything's good to go. OK, so looks like those are good yeah. See, it looks like those responses are good and OK, I see your, your signature as well as as well as my signature. Great. All right. Pretty short and sweet there. Any questions? We did have a question that was a little bit ago but it kind of still pertains to what we just saw. So someone asked, is it required to have the documentation of consent and the attestation forms with your E-Consent as shown. And I think we kind of covered that. Documenting the informed consent conversation is considered best practice and making sure how you do it. There's a thousand different ways to do it. The one way that we've showed it where it's incorporated with the consent form process and documenting it, it just is for ease of researchers, the forms already built there for you, all of that kind of stuff. But there's a lot of different ways you can do it. There's no wrong or right way, just as long as you're doing it is is the good thing. And I was thinking like attestation form, like the actual consent process, not that attestation of the documentation of consent. So Chris is using the template that, you know has been created and uploaded to REDCap. There are likely some E-Consent projects out there that don't have it set up exactly like this currently is. But going forward, it would probably be best to use the template that's uploaded and follow the SOP instructions on the health website. Yeah. All right. We got one. So if someone calls to change their PIN, how do you verify their identity? I guess I would say in the same way. I mean, I assume if you're you know, back when I was actively working on projects and we'd have people call in, I guess I don't know that I had a specific way that, you know, someone would identify themselves, but I would I would assume it would be similar to if they called for any other information about the study. Andrea or Susan if you have a better answer, feel free to chime in or, or Caitlin or anybody. Nope. I think you covered it. That's good. OK, all right. Last video here. So now that we've confirmed that Chris has received the appropriate consent form, I'm going to go in and finish my documentation of consent. So I'm going to scroll to the bottom. I've already filled everything else out. So a copy of the informed consent was provided to the participant via email. And then the date that's today. And then the end time, the end date and time of the verbal consent conversation is also now. So now I'm going to go ahead and mark this form complete. I do want to go through double check my answers really quickly. Just make sure everything is correct. Expand this so we can read everything. OK? Great. Once you're happy with everything, then go ahead and mark this complete save and exit form and everything is complete. Great. And then one thing I'll just point out while we're on this screen here, if you you just for the sake of one thing we didn't do here is you can go into this fully executed consent form. It does not automatically switch over to the green complete status. But once you've confirmed that it's been delivered, you can certainly go in there and just manually open that and make it so it's complete. Actually, I could I could just demonstrate that right now. I have this actual thing open. Obviously, you wouldn't be doing this as the participant let's just pretend that this is a study team member going in and they can change to complete save and exit form. And then now you've got a little more closure there. So if you're if you use that coding to kind of know where you're at in those, you can you can do that. I will and oops, so that is actually all of the videos. That's all the sessions we had. I had some resources, other resources up here. I'll just scroll up to that. So I'll leave these up here, but feel free to feel free to submit any questions or unmute yourself to ask questions. I'll just look like we're OK. Andrea provided more of a response to to the question about confirming someone's identity. But if you would like to ask any other questions, we are here. We scheduled this for 2 hours. If you have attended some of my other sessions, you know that usually I tend to run a little long, so I scheduled a little longer than maybe needed. But we have plenty of time for questions. If if anybody has any additional ones. Real quick kind of going forward. So just so that everyone knows, my last day at Washington University is June 8th, and I know I get a lot of direct contects about best practices and things like that. So going forward, if guys do continue to have questions around documentation, best practices, all of that kind of stuff, please feel free to reach out to the program. Our programs email is hrqa@wustl.edu and you'll continue to get great service from my staff, my team. And to help you out with any questions or concerns that you have around best practices, study, documentation, all of that. And it's been a pleasure working with all of you, especially with all my co-hosts. We will miss Andrea. That is for sure. All right. Well, I will send out a link to everyone who registered once this video is ready. Probably what I'll do is do a quick draft so you can have access to this, you know, relatively quickly. But then when we get it up to its final landing place, at the at the Becker YouTube page, that may take a few weeks to go back and make sure we have all the closed captioning and if there's any edits required. But I will send out a link as soon as there's one ready for viewing and when it goes to its final spot on the Becker YouTube page. But feel free to reach out to any of us with questions except for Andrea, only reach out to her until June 8th. But all right. Thank you. Thank you all for all your kind words in the chat, too. I appreciate it. All right. I'm going to go ahead and in this for everybody, if I can figure out where you're my Zoom buttons are not working. Stop share.