This is the last session of Scholar 7. In this session, we're learning how to place our application to the IRB. What are we doing? Essentially, we're doing a series. We've done a series of seven workshops. We explored the development of a scholarly project. We developed the scholarly project with each individual attendant. We have had monthly scholarly support meetings, and we've completed up to this point a full application. The seven steps that we did, the initial one was a fun item step. We brought fun items into the arena. We each took one. We looked at them, developed a hypothesis for each one of them, and moved it through in a relatively safe manner and completed a full grant with the fun items. We moved on to the second session, which we looked at the introduction and the hypothesis development and then the specific aims. We moved then to the third of the development of the preliminary data, development of the material methods next, following by the conclusion, following reviewing of the entire application, and then now review the application for IRB submission. At our last meeting, we asked everyone to put all their materials into one document, and we've done that. Yes, yes, we have. And we reworked our document to make sure it read correctly, but we've done that. Yes. So far, what we have is the one document, the introduction, the hypothesis, the specific aims, preliminary diagnosis, material methods, and then the conclusions. Ryan, take us through a little bit of the IRB application and what materials we need to do ahead of time. Okay. Well, each different institution, as you know, has slightly different policies in their IRBs, but the theme is very much the same. You guys have done the research background for your idea, and you've put together the application, and you filled it out, submitted it to your department chair for approval. Do we have that? Yes. Yes, we do. Okay, excellent. So now what we have to do is really just open up the website, in this case we use IRIS, and so we open... Ryan, I think we probably need to mention, though, that every institution may have a different software. Software, yes. And you may want to be able to find that software application component from your individual IRSs. Yeah. Okay. So go ahead and click on Study Assistant. Yes. And then go to My Studies. Okay. And there will probably be one that says Draft. Now, interestingly enough, what you're going to do now is hit the back button. Okay. Not the internet back button, but on the software itself on the right. And is this your research topic right there? Yes. Okay. So in this particular version of the software, once you click into the study, then you hit the back button. And that doesn't bring you back to where you just came, but it actually opens up where you can input all your forms. And so this is one of the things that if you didn't know that, you would have spent hours not knowing how to get this loaded. Okay. So I think you had already scanned electronically your department approval letter. Yes. So what you need to do is scroll down here to Other Study Documents and click on that. All good? Yes. Once there, you're going to add a new document. Now you would just type in the document title. So that would be... It's the title of your study. Okay. This is going to be the title of the document for your study. So this is the department chair approval letter. It all goes underneath your study documents for our current project. And this is version one. And the date would be today's date. Category. This is going to be department review committee letter. And once you do that, now we upload. Can you do it? Yes. Excellent. So now you just go to Save Document up in the mid-right corner. Yes. All right. So we successfully saved the department chair's approval letter. Very good. So that's our first step. We need to put that. Yes. Now, do you know if you need a consent form or if you've had a waiver of a consent form? This study involves residents, current and past new patients. Okay. So at this point, there aren't any other study documents that we have to add. If we did need consent forms or a protocol document, this would be where we would enter it. Do you actually have your protocol documents already uploaded or no? Is it the questionnaire you're talking about? No, this would be the Word file that you sent to your department chair explaining what it was you were doing. Oh, yes. Yes. And so although every software program has you break up your study protocol into different sections, overall, it's the document that you submit that's all together that's going to be approved by the IRB. And so they do have you break it up into the software to put it in the places that they want it. But in the end, they still want a Word document that's one continuous flow of your original protocol. Okay. So if we haven't uploaded that, let's grab that now. And you would do the same thing where you add a new document and document title, protocol. There's nothing specific, just so that somebody who's reviewing knows what it means. This would be the first time you're entering it, so it would be version 1. And again, today's date. And if you look down on the list, we have protocol as an option. And then we go ahead and upload. So now you can see you have two documents. You have now your protocol and your department chair approval letter. Did you say that you already uploaded your questionnaire? No, we haven't uploaded our questionnaire. No? Okay. So that would be your third document that we have to load. And this again would also go under the same tab. So just add a new document. So we're going to just go ahead and save. Now we should have three documents. Yep. You have your department chair's approval letter, you have your protocol, and then your questionnaire. Okay. And in your case, I actually think that that's all that's needed. Okay. Because the application part's already been filled out, or partially. But let's review it just to see if there's anything left that needs to be done. So from here, we hit the back button again. And now this is sort of the main screen of your actual application process, where you have all your options that you could possibly do for this study. And the first one we're going to look at here is the study application, which is in the top left corner in the protocol items. Now in your particular case, the first section here, okay, excellent. You have your title of the document in there. And then we'll just go through and click each section. So section two is the data department. And you have the internal medicine department, which would be appropriate, since you're only doing adults. Okay. Section three, we'll go to that one now. Okay. And you have Dr. Sahr as the principal investigator, excellent. And you have yourself listed as the additional investigator. Okay, scroll that down. Okay, excellent. Section four, towards selection. In this one, you're just basically choosing what type of study this falls under. Again, this is human research subjects, already clicked. And this is not old case cancer IRB forms, so that's why it's every other study. Okay. Department division, the next one. Okay. And here you're going to be choosing internal medicine, or medicine, yeah. And the routing for your questions is basically section number six. This is all no, you're not asking them to determine whether or not it's human research subject, or whether or not it qualifies for exemption. Okay. Section seven. Now, in this particular case, this is a questionnaire. But it's also a new study, so we go down and we click on new study. Because it wouldn't, a case report, as you had clicked on there, would just be if it's one person for one illness that everybody in the family has. So study information and personnel, this is a questionnaire that you're doing. So you went ahead and clicked that, excellent. The second section in eight is just asking the origin of the protocol. This is investigator initiated, you guys came up with this idea. Section 8.3, background, rationale, and significance. You cut and pasted that nicely into the application. That's also included, again, in your large protocol document, but this is where they have you chop it up. Yeah, lots of repeats. The fourth section under eight is the purpose and hypothesis. You cut and pasted there? Yes. Very good. And your reference section, you also cut and pasted. Okay, excellent, very good. The 8.6 is just asking the location that you're going to be doing the study. It's kind of a questionnaire, so it's... Right. So where we're from, this is our business. Excellent, yeah, so basically you're saying that people are all over the place, but the core center of where people are, they could be at different rotations on different months, but their home is here, and so that would be correct. Yep. And you've chosen how many residents do you think will be participating in this? 26. Okay, in the first year, and this is only going to be a one-year study? Yes. Okay, and so both the numbers for the first year as well as the entire protocol for study participants would be the same. Okay. And your personnel table, that's the section below that. And did you already fill that section out? So at this point, what we have to do is we have to do a personnel table. Even though you've already correctly identified who has access to the study documents in the previous section, when you're section three, granting key personnel access to it, that doesn't mean that they're the ones who are actually going to be getting the data and talking to the residents and stuff like that. That's what this section is for. This section is who in the study is actually going to be talking when people are gathering the information, not so much processing it, or looking at the IRB form. You can also be like a statistician and so things of that nature. So we would go ahead and click on this paperclip here. You scroll all the way to the bottom from here. In the bottom right-hand corner, it'll add a personnel table form. Okay. Now, will there be anybody else? It would just be myself, Dr. Peel, and then Dr. Jarrell is our other fellow. Great. So add new user and put both of you in different columns. In this particular study, because it's a questionnaire of the residents, you won't be getting into a consent form issue or having to look up private health information. But that's what this section is geared towards for the review board, to make sure that everybody who's participating has that criteria met. And so we're filling it out, but in the end, in this particular study, most of this information is just redundant. But if you were to have had to get health information, you would need to make sure that your city training is up-to-date. And we should, when we stepped into this at Scholar One, we talked about city training, so make sure to be up-to-date. And also they want to know if the person in the study is an employee of the hospital that the respective IRB has. So in this case, UH. And it doesn't mean that if anybody's not an employee of the hospital that they can't participate in the study. They just want to know to make sure that everything, all the boxes are checked and everybody has met the basic criteria to see and interact with patients. Now we're going to scroll all the way down to the bottom again, just to make sure that the table is there. Go ahead and click on this little box. Yep. Now scroll all the way to the top. You see where it says Save Attachments? Go ahead and click that. Now let's see if that was successful and it put your personnel table in your application. So that would do 8.6. And this time you now see that your personnel table form is appearing in that section. Okay, good. So you've already clicked No for the multi-centered study for Section 8.7, and that's correct. Your local site that's coordinating this, scroll up. It says, Will any local sites function as the coordinating? I'm sorry, you don't need to do this because you've said no to the multi-centered study. 8.8, Are human subjects at more than minimal risk? No, because there's a questionnaire. And so because there's no more than minimal risk, we have the right to ask for expedited review of your protocol by the internal review board. Now this here is asking 8.9, if you've registered with the clinicaltrials.gov. In your case, no, because you're not using pharmaceuticals, medications, and devices. If you were, they would want you to register with it, but in this case you don't need to. So we just click No, and then we explain the reasons why at the very bottom. It says, If no, why aren't you? And you put, Yep, not using pharmacological drugs in this study. And you can also say, This is a question. Okay, section 8.10, Does the study use a clinical research unit? No. Okay, 8.11, The principal investigator submitting the study to another IRB, you are not. And does the study involve cancer research for 8.12? No. Okay. All right, that was the logging section in the entire application. Make sure you save. Make sure you get to the end site. So we're once again reviewing the expedited review function in this application. Now we've said that there's not more than minimal risk, but now we have to click why that is. So section 9.1, again, you answer subjects. Are the subjects at more than minimal risk? No. Then we scroll down to 9.2 and we click the appropriate one that says why they're not at, why they qualify for expedited review. And you have clicked on the, Yep, collect the data. Yep. From voice, digital, or for research purposes. Yes. I think I understand why you wanted to do it with the collection of the data part. And sometimes there's more than one right answer. Since they don't know what we're going to come up with in the research thing, sometimes the wording doesn't quite fit. Okay, so we have to pick our best. Okay, save and continue to the next section. Okay. Section 10 is the study population. We're working with adults. Again, if there were minors involved, the pediatric department would also have had to have sent you a letter of approval, and then we could have submitted it to the IRB. Okay. Vulnerable populations in the study. There is one, and that is that they're employees. This is their residence. And for everything that's a vulnerable population, they just want you to discuss how it is that you're going about protecting them, and so that you're not taking advantage. And so in this case, since they're employees, the concern would be coercion or that they didn't want to participate but were forced to. This is a questionnaire, and it's probably not of personal, private, or health information. And so the magnitude of the questions is one thing that protects them, but also you could say it's voluntary. And the questions that they answer, the information that's provided, will likely be confidential as far as you're not going to go publishing what each person said but rather the collection of the data. So it's voluntary, and the answers are kept confidential. Excellent. So go ahead and hit save. Section 10.3, the sources of subjects for the study. You've clicked other and past podiatry residents. Okay, so that would be other. This doesn't quite fit in something that they had already previously thought of as an option. 10.4 is the study population. And this basically says what's your inclusion criteria. And you've already placed that in from your protocol. Excellent. So then right below it, right after inclusion, is exclusion criteria. And again, you've already copied that over from your protocol. And below that, I want to know how you're just going to get a hold of the people. And so you're going to do it as you've already copied and pasted by email. There are no international sites, which is the next question here. So the answer there is no. Has the protocol been submitted for IRB approval, ethics committee in a foreign country? Again, no. You just keep clicking no. It's a little repetitive, but that's all you need to do. All right. So go ahead and save and continue. Now, you guys won't actually be requiring a consent form. And so you've already indicated that. Section 11 is asking for informed consent or assent, which would be the case if you had pediatrics involved. And the parental provision is needed with that. But 11.1 is asking where the informed consent will take place. And you've clicked other. This is from electronic email of past residents. But you won't actually be getting a consent form. So you could put in here exempt from consent. Now, section 11.2 ironically gives you the option to actually get a waiver of signed consent. It would be option three you want, which is a full waiver of consent. And in order to do that, they kind of want a few more questions. Is the study regulated by the FDA? This is not. Okay. And then 11.3 is asking you briefly to plan for obtaining informed consent. And, again, you can just say here that exempt from consent. 11.4 wants to know about the assent plans. We don't have any kits, so we just skip that section without even checking anything. Now, I do believe in this particular study you won't be collecting health information or protected health information. So say no to that. And then we go ahead and save and continue to the next section. Now, this is where you're requesting in section 12 for a waiver or alteration of the informed consent. And so you are asking for an alteration. You don't want a different, like a small change to the consent, like over the phone or through email or an emergency situation where you can get it afterwards. You want this just, you cannot get informed consent. So we say waiver of informed consent, the first option. And, again, section 12.2 is asking about FDA regulations. You can go ahead and click none because you're not using foods, drugs, biologics, or devices. All right. Go ahead and save and continue. And so, again, the waiver of informed consent. Correct. Okay. Scroll down to 13.2, which is asking, in your case, the research study subject of the FDA regulations. You're not using any of those devices, so you go ahead and click no. Section 13.3 is asking, is the research subject to approve of state, local government officials and designate the study of public benefit? This is no. In section 12.4, explain how the research involves no more than minimal risk. Again, this is a questionnaire. A lot of things you'll see are a bit redundant, but in some studies, there may be different answers depending on the section. And they don't always anticipate just one person studying. So for some studies, you answer the same thing the same way. You don't have to come up with a different answer each time. Now, 12.5 wants to know why the waiver or alteration of consent will not adversely affect the rights and welfare of the participants. The questionnaire does not have any protected health information questions in it. It doesn't single out one single ethnicity or culture. And it's voluntary, and the people filling out the survey, their identities are kept private. So section 12.6 now wants to know why you couldn't get the waiver for. So in this case, since you're corresponding them with email, it would be possible. But the question is, it goes back to the previous question, is it required or needed in this case? Or I guess a better way to say that would be a waiver for it could be obtained, however, not required in this study. And let's flash forward to a scenario. You submit this to the IRB, and they say, I understand, but we still want an informed consent. And you say, okay. And you type up a very simple one, and you submit it. And you just email that out with the questionnaire, and they submit both of them back to you. 12.7, will the participants be provided additional pertinent information after participation? So basically, in being involved in the research study, is there anything else that they would need to know? This comes into play especially if there's some type of lab test that they're getting, some type of therapeutics, or something that could potentially alter their health care or change their minds about the treatments that they're getting. We don't have this in this particular case, so no. Section 14, we'd just like to know about the type of the study procedures. This is a questionnaire. 14.3 is a no for you. It's genetic testing. Okay, so no. Go ahead and keep scrolling down. You keep answering no, absolutely, correct, because the rest of Section 13 is very much asking about genetics, as well as radiation and radioactive substances that the person can be exposed to. And you won't be working in an intensive care unit, which is the very last question in Section 13, which does this protocol require approval by the intensive care area. Okay, so now Section 15 is asking about drugs and devices. We've already pretty much said no, but again, there's certain standard templates regardless of the question. Sometimes it alters the application a little bit, but a lot of it still remains. So no for this section. Not applicable for Section C. Section 15.2, device utilization. You don't even have to touch that graph area. So go ahead and save and continue to the next section. 16, study procedures. At this point, it really is copy and paste from your protocol, which you have already done, but 16 is talking about the study design and study procedures. And 16.1 is the risks. 16.3 is the benefits. The fourth section is alternatives to participation. And you have those all copied and pasted, excellent. And Section 16.5 is withdrawal from study participation. And once they submit it to you, they won't be able to withdraw, good. And the last section here is just what's the plan for the end for this participant. So Section 17, the data and safety monitoring. They really just want to make sure that whoever is in whatever information is involved in this study is going to be looked at to make sure it's followed and it's not just on a desk somewhere or being, you know, collecting dust or, you know. And so who's ever involved in the study, how you'll be making sure that that's kept safe. You said you're going to use the DEDCAPS program, okay, which is excellent. This is UH's program that's offered free of charge to anybody doing research. And even those outside our institution can actually get access to it if they're involved in the study and have approval. And you can generate forms, spreadsheets, and data tables that can be used, and they can even be exported into Excel after the study is completed. So the last part there, is there a formal data and safety monitoring committee? No, there is not. Okay, so save and continue. So Section 18, data sample confidentiality. So all these things are kept electronic files, good. Next part, how long will the research data be stored? The minimum is three years. So I see you have one year. Anytime we do research, especially, it's three years that we keep the information on file. So somebody after you've graduated, which will be your attending event, you know, Dr. Saar will be safeguarding the information to be shredded in two years. Okay? All right, so subject privacy. Again, we clicked on this. Names will not be included. Excellent. And next part, data and sample confidentiality. Okay, instead of using names, you're going to use numbers to assign them. Okay. And security, next part, the data sample and security, the last section in 18. Again, you put going to be stored on red caps, which is correct. All right, so save and continue. This part is how they want to know how you're going to generate statistics. In your particular study, I'm not sure how a statistical evaluation afterwards, or is it just really kind of comparing and contrasting the answers. So it's very simple statistics. So you're just going to do a simple comparison of the number of podiatrists in the academic medicine versus those who are not. Excellent. Okay, so go ahead and save and continue. If there were more statistics involved in the study, and there never has to be, but they would want you to touch base with the statistician to see how many people you need to have in the study, what types of formulas you're going to use to generate which statistics and the p-values. It's not actually required to get approval from the IRB, but they do like it if it's already been looked at. So the financial information, this talks about the subject compensation for the study, and none of the subjects will be compensated for it. Good. Nobody will be paid for it, which is the next part. And it's free of charge to the participants. And although I do not believe that there will be any injuries related to this research project, there won't be any compensation nonetheless. Okay? So that's all that section. Your study funding, you don't particularly need funding for your study, but you do have to click no for each one of those that they're asking for. And your sponsor name. So in this particular case, the sponsorship name would be likely to be the program. Okay. Even though the financial support, I mean, financial support for the training is through Richmond, and there's a questionnaire and e-mail, there isn't a great deal of expenses. But there's still the sponsor of your program. Okay. Now we're just reviewing a few things. Okay? So this section here is, like I said, just a quick little review. Your title is correct. Your principal investigator is correct. Okay. And this is kind of the submission packet to the review board. Okay? So go ahead and save and continue. Do I have that option? Yeah. All right. And then, okay, you already have your protocol attached. That's the second part. That's your application. Study documents after that. Now this is asking for any study documents that you haven't already done. So let's say that this was we could have put in the chairman's approval letter from the department in now. We could have put the questionnaire in now at this time. Is okay, as well as the protocol. But we've already done that, so we can just save and continue at this point. So what have you been waiting for? Yes. Here it comes. Now you can notify the principal investigator to sign off. Okay. Go ahead and click. Ready? Oh, yes. No additional things need to be routed. No. That's all good. So what Brian was walking us through was the investigation research information system, or IRIS, small i, capital R, capital I, capital S. You completed the bulk of your work prior to this session. Of course, right, we went through the Scholar 7. You completed the bulk of it. Imagine if you didn't have that. You had it all ahead of time, and we did this. So the study is only as good. What we did is only as good as your hypothesis development and your research design. So putting most of our effort into that, you can see how anticlimactic this is. That's where we did all of our group. So this ends the Scholar 7 session with the IRB submission. Pay attention to your time schedule. When we talked about this initially, the time schedule is what meeting do we want to go to, which meeting do we want to submit to. Give us enough time between so that we can collect the data, analyze the data, and then publish and abstract and submit. So we always need to do this. In the real time, this took us four months in the real time of this whole session, meeting once a month, essentially. So this can be done effectively in a short time period. So always keep that in mind. Then make sure that when we submit this, it may bounce back. It may come back. It may need additional corrections. Keep on it. So as it comes back, it may take some time. Always contact them. If you think, well, I haven't heard, contact them, see what's going on. So, again, the whole thing that we've done so far is come up with a submission. After you get an approval, then it's data collection. It's analysis. It's collection and putting it into an abstract formation, submitting it, developing a poster, and eventually developing a manuscript. What have you learned through these sessions about scholarly work? Oh, I learned you have to be very diligent. Research is doing key background research, especially in developing your own hypothesis. Very good. Could you teach this to another, now that we've done this, can you teach this to another attending or resident? Do you think you could do that? Yes. So it's see one, do one, teach one. Yes. So it's not much different than we do in medicine. I think the important part that you just stated is that throughout these sessions, we have to be consistent. We have to have that intensity, that drive to do it, and then we have to have the courage to reach forward and continue to move. And as long as we have mentors and we have people, we can continue to do this and teach this to our other residents. Thanks for your participation.

IRB application

scholarly projects

hypothesis development

IRIS software

research diligence

academic research

project revisions

mentorship