So, one of the things I think we're going over today is just really how to navigate through IRIS for the first time. Like a lot of software programs, it's not particularly hard, but if you're not used to it, there's plenty of ways to get confused. The first thing that we need to go to is the correct website. So if everybody has their computer, this is the website you want to go to to get to IRIS. And it's just cortex.case.edu. This is what the screen is going to look like. To get into IRIS, it's going to be your username that you would use for your email address. Same with the password. Once you get there, you're going to look at the study assistant, and there should be a tab here that says, add a new study. This is going to be where you click if you've never started this process before. The first screen you're going to see is basically, it gives you three options. Everybody in this room would be picking the first one, the IRB. Every time you go from one section to the next, there's going to be a button that's kind of going to be right up here. It's save and continue, or start the selected application. This is the very basic stuff. If you have your protocol document and your consent document, if it's applicable to your particular study, that would be something that would be useful while going through this to have open, because you can copy and paste a lot of this stuff. If not, that's fine. You'll still be able to get through this without too much of a problem. But it is helpful if the words you're using are similar in the actual IRIS online application as it is in your protocol, both for yourself when you go to review it, as well as for the reviewers that will be overviewing this. So you just put your full title in here, and then three keywords. While we're all catching up to the same thing, because I understand that the internet can be a little bit slow and laggy, I just kind of wanted to go over a few things. And one is, everything you're doing today is not final. So don't stress about it. This is the start of the review process. After we're done with this application, you actually can't even submit it to the IRB yet. You have to submit your application to the academic departments that will review it. So there's a lot of review process. There's a lot of legal language, as well as academic opinions that are going to go into this. So you want to make it look nice and neat for people to read, but don't stress about making it perfect. So as you can see on this one, I sort of put together one. It's kind of a simple thing, basically as if I were doing an IRB on this course. So here's the title. You put your title in there. Here I put Introduction to Navigating IRIS. Then you want three basic phrases or keywords for your study. Don't stress about this. And then every time you go from one section to the next, you have to hit Save and Continue. So once you do that, you're going to be going to this screen here, which is setting up the academic departments that you want to have access to your study. It should just have Case there right now. Chances are a lot of the studies that are being done right now, you'll actually submit it to the Internal Medicine Department. So go ahead and click on Add. So once you're here, you just click. I also just want to talk more about what this section is. This is granting access to your study to these departments. It's not being sent to them. When it goes to actually sending them your information, that will be done later. You'll have to do that through email. And then the academic departments, we'll talk more about this at the end, will email you a letter of approval or a letter saying we need some clarification or modifications. There's a lot of different, you know, it's like approve and send without revisions, approve with minor revisions, don't need to review it as long as these have been changed, you know, stuff like that. And then you append that to your application later. And again, we'll go through that. But this part right here is solely about who could look at the study if they wanted to. It doesn't mean that they actually can or will, okay? This is just granting permission. So assigning personnel to the study. You need a principal investigator, the PI, which will be the attending, okay? If that is you, then what you do is you go ahead and click on add user. Type in your last name. This section here is talking about who you want to have access to the study. So anybody that goes in this section, section 3, will be able to log on to IRIS and view the application individually. Now in section 3.2, it's the same thing, but instead of being the principal investigator, it's whoever the co-investigators are or the co-principal investigator. You can have two main investigators. And so what I did here for this mock IRB is I have Dr. Wayne as our co-principal investigator, and then the other two here, me and you and me, as just the co-investigators, and you just click. Again, you find them the same way you would by adding a user. And then you click their role. Section 3.3 is really just clicking who is contacted by the IRB when decisions are made. It doesn't have to actually be the principal investigator. One thing I'm going to kind of point out to you is these boxes, sometimes when you go in and out of adding users or in and out of the menu, like if I go forward and then I go backwards, they become unclicked. So sometimes I wait until the end to click these boxes, and then when I save and continue, even if you go back and it looks unclicked, it has been selected. So which board? This is basically determining human subject research. Everybody would be under that particular category for this session. Now you may be able to exempt it later on and get it to be considered not human research depending on your individual study, but for this portion of it, you click human subject research and then every other study type. Because we are not doing animal research and it's not cancer, therefore it's other. You may feel like you have just done this when you were setting up department access, but nope, this is a different part, so you have to sort of do it again. This is again where you would put orthopedics or internal medicine or family medicine, whatever one happens to be applicable to your study. Section six, I can tell you is probably easily the most confusing section here. All the answers are no, and I'll go through and tell you why. This section is basically asking the IRB to determine the answers. If you already know the answers to the questions, then it's no. And later on, you will be able to address each individual one of those, like the first one here, are you requesting determination as to whether your project qualifies as human subject research? Okay, so it's basically saying, are you asking them to determine that? So if you're not sure, yes, you could click yes here, but for the most part, this is no. And later on, we'll walk through how you're able to determine that. And are you requesting determination as to whether your project qualifies for exemption? So again, we're going to go through that, so you're not asking them to determine that. And that's why I say it's a little funny the way it's worded, and I've seen a lot of people get confused with this particular point. Section seven, this is a new study. It has other options if you click down. If this is just a simple case report, you could click that, but technically, even that's a new study, and later on, you'll be able to explain that. Section eight, I'm afraid, is the longest section. Once we're done with this section, you are halfway done, even though there's 18 sections. So the type of study, I clicked other because we're doing an educational session. So the origin of where this came from, that's pretty much the principal investigator, unless somebody was approached by a pharmaceutical company or something of that nature to conduct the study. The background, if you have your Word document with the protocol, you literally can copy and paste from your document at this point. And so you just click on here to access the text editor, and just place it in. As you're going through this, and as you're answering each of these sections, if you think, my goodness, I think I just answered that in the section just above, or this is kind of being said more than once, you're on the right track. It absolutely has a degree of redundancy involved, so just keep putting it in. Don't worry about the fact that it might have just been said or something of that nature. Sometimes some studies uniquely will not overlap. So the purpose and hypothesis, again, you just place a sentence or two, copy and paste from your Word document, and the references, again, from your Word document. So I'm going to go to section 8.6 here. This is really just kind of looking at where the study is going to be. Part of making the protocol document first is that it makes this a lot easier in this section. You'll still need that protocol document, because in the end, that's what's going to get stamped by the IRB. This is just the application portion of it. So that document you made is still very important, and we'll be uploading it at the end. So for the local performance sites, in 8.6, you just click add a new row. If there's more than one site, you just keep adding rows. Over on the right, it's asking for projected study enrollment. That's the number of patients you think that are going to be in your study or hoping for. And it asks for how many would be in the first year, and how many will there be total. So your study might not be a full year, and it's just fine if the first year enrollment's the same number as the overall total. You just don't want the overall total to be less than your first year. Again, this is just an idea. There is nothing that pins this number down, and it can be changed later. After that, this is where you're going to put who is actually involved in the study. So who's actually going to be working in the study. So you're going to click here for attach any review forms. For me, I'm just going to click the edit and review. So for the personnel table, when you open this up, you have to scroll all the way to the bottom, the personnel table form, and just click on add a new form. Now even if they're not in UH's IRIS system, here's where you're going to be able to input their name regardless. So you just free type the name, the role that they have in the study. Are they going to be consenting anybody? If they are, then they need to have their HIPAA certification as well as their city training done. Human subjects expiration date. That is the date that your city training expires. So if you did it April 4th of this year, it would be two to three years from today. You're going to want to know if there's any conflicts of interest. So employees at UH. This one is a little tricky in the sense that when I first went through this, even if they're not being paid by UH, but they have some form of UH affiliation where they can access UH records, you can click yes I believe for this. And then you just place their department and their position in here. You do that for every single person in the study. If you don't know when their city training expires, that's okay. I would put a date sort of ridiculously far from now, maybe five or ten years, so that if you forget to go back and change it, it'll flag the IRB that that's not a real date. We've added the location and then below that in the same section is the personnel table. You click on the paper clip, scroll all the way to the bottom and on the right. Attach a new form, yep. You won't see the personnel table form when you first open up. You have to scroll all the way down. Click on that and then this should pop up. Okay, start filling it out. Just add a new user or add a new row. For finding out when somebody's city training expires, if the person doesn't know that's involved in your study, you can ask the IRB to look it up. That's why I'm saying for the purpose of just filling out this form, you can either leave it as they're not obtaining consent and then they don't need to have this city training date or you can put something that is so far in the future that it would absolutely be caught by the IRB because it's not a real date that somebody could possibly have at this point in time because it's only good for two to three years. Again, but that's what the human subjects expiration date's referring to is the city training expiration date. Hopefully there are no conflicts of interest and again, the UH employee aspect of it, likely if you're in this room, you're included. Now if for some reason you do have somebody in the study who's not part of UH or an employee of UH, you just explain it. It doesn't mean that they can't be on the study. They absolutely can. You just have to tell them why in the role and if they have to fill out some forms or they might have to submit their city training to UH or CASE's department so that they can verify that they've at least had the training, that I think is about as far as it goes. Once you're all done with the table, you just click on this paper clip at the very top that says saving the attached form. You've just basically made the form and so you're saving it. So then the next section, multi-centered study and coordinating sites, if any of the sites are actually the coordinating site, like sometimes it might not be. If you're coordinating everything and then leaving for the day to do the study somewhere else, then where you're going isn't the coordinating site. So 8.8, are the human subjects at more than minimal risk? If this is just a questionnaire or very simple osteopathic manipulative treatments, then this would be no. If there's not more than minimal risk, you can ask for expedited review. And that's where I'm saying at this point, you can determine for yourself if you can go expedited review. Is this a government trial? No, most likely not. It would be beyond the scope of this particular course, for introductory course, this would be like phase two to phase four drug trials, okay? Even phase one, they would still want you to register for, but, and then it asks you if you're having plans to register the study. Even if it's not a clinical drug trial, they wanna see if you're gonna have plans to register it. You have to click no, and then you have to give the reason why. And so, the reason could be very simply, this is not a clinical trial. It doesn't need to be in-depth. This is sort of like a check and balances. If this was going to be a drug trial, but you didn't register it, and for some reason you clicked no, you'd have to justify why. And so, again, a lot of these questions have to do with other studies that somehow could meet this particular questioning. Does this study use a clinical research unit? It does not, okay? They also want to know if the principal investigator has submitted this to another IRB or is planning to. And I think that the answer would be no for this session. And we are not working with cancer research. So, again, that's no. So, once you're done with that, you just hit save and continue, and literally that is half the application. So, are the subjects at more than minimal risk? Yes, you have just answered this question, but once again, we're answering it. The answer is no. Then, you answer why they're not at minimal risk. So, you choose the topic here that best suits it. So, everybody ready to move on to section 10? So, the study population, these would be adults. If there are minors, of course, you have to click here and then click the ages. The next section of 10 talks about vulnerable populations. So, again, just for my example, everybody here is a UH employee or a case employee, so I clicked that one for this one. But if you feel that there are no vulnerable populations to your research group, such as it's just chart review, and it's all retrospective, then you can click this too. Now, if you do have this in your protocol already, you can just copy and paste it into this area here. This is where they want you to say, we realize that there's a potential for these vulnerable populations, we've thought about this, and we have something in place to protect them. And there is, if you haven't finished this section yet, on the IRB's website, on the consent forms and tutorials, they do have standard language that they do use for certain vulnerable populations that you can use. The next section, so how source the subjects for the study. This would be the electronic medical records that you would use. You could go into saying, when you look into the medical records, it'll be a certain ICD code that you're looking for. So this area, the next section, 10.4, is your inclusion criteria. So you just click on that, and say like, what has to be, what is included, 18 and over, that's one aspect of the inclusion criteria, because they're all adults. And it really is kind of unique to whatever your study is. Exclusion criteria, somebody for osteopathic manipulative treatment, if they have some sort of skin disorder, that might be, depending on what it is you're thinking of, the techniques, but that could be one exclusion criteria. Recruitment, you're just basically describing how you're gonna get ahold of the patients, or how you're gonna obtain the charts. It could be as simple as the patients that come to your office. It could be as complicated as having to go through the EMR, and then calling them. It's just what's unique to your study. I don't think anybody here will be part of an international site, so you just click no here. So because it's not a part of an international site, you're not gonna be submitting to an international IRB. Even though that seems very self-explanatory, you still have to type in this box, it's not an international study. If you try to save and continue, it will error. Section 11, where this is all about the consent forms. In some of your studies that are purely chart reviews, you won't be obtaining consent, almost certainly because the patients might not be present or coming back to your office on a regular basis for you to be able to obtain the consent. And in that case, you'd have to ask for a waiver. But for right now, where will the informed consent be taking place at the local site? How will the informed consent be obtained? There are four options here. And you can see that there are waiver of the signed consent form options, all the way down to full waiver of consent. The next part is just kind of describing to them how you plan on getting that consent done. Literally walking them through, I'm going to, if this were an office, you would say like, you know, we'd approach the patient in the office, in a private room, and inform them of the study and see if they would like to be a part of it. Or over the phone. Or if this is gonna be a full waiver, then you would just put that here. The next part is assent, which is specific to pediatric patients. And you will not have to worry about that since nobody in this particular session is working with the pediatric patients. But if in the future that you are, you just click on the age ranges, and I wanna point out that they have them broken down in a certain way. Seven or less, seven to 13, and 14 to 17. And each of those age ranges has a specific way that you can assent the patient. The ages 14 to 17 can sign the same form and consent form that the guardian signs. The seven to 13 age range has to have a very basic form that's different. It tries to use words that they would understand to answer their questions. And then less than seven years of age, they don't have to assent, it goes to the guardian. So everybody in here is going to be accessing some particular degree of HIPAA documents. And you're gonna copy and paste basically how you're going to protect their rights there. Study procedures. Um, questionnaires, electronic medical records, if you're doing techniques, manipulations, might be under the other one again. If anybody's doing like blood draw or specimens, that's also where you put this in here. The next section is, depending on what your study is, if you have any special procedures that are being done, how the people are trained for that. And that's where this is basically asking for. In the case of osteopathic manipulative treatment, that might actually constitute specialized training. Genetic testing. I don't believe anybody here is doing that. So this section will be very quick. 14 is your study design. This again is directly out of your protocol document. And you just copy and paste everything, the risks. Again, you copy and paste from your protocol document the risks. Risks for anybody in the study is one that everyone will share is that their private information could be breach of confidentiality exactly. And then benefits. If you were getting information and there was a treatment available from the questionnaire that you could educate them about, that would be a potential benefit. Otherwise, contributing to global knowledge, a subject in the community, that's a benefit. Even doesn't have to be a direct benefit to the patient. Alternative to participation. There is no alternative is a very fine answer. Withdrawal. For a lot of these studies, there might not actually be an ability to withdraw. Once they answer the questions on the phone, they can't really withdraw at that point. And so, basically it's okay if there is not a withdrawal point. So plans for the subjects at the end of the protocol. This is more for if your study is going over a longer period of time, but if it's just a finite chart review, there really doesn't have to be a plan for the subject at the end of the protocol. So the data and safety monitoring. This is basically asking how you're going to make sure that everything is kept confidential and who is going to be doing that. So those would be the people involved in the study. And if there's a paper questionnaire, it can be kept under lock and key. You know, in a certain location where only certain people have access to it. And there does not need to be a formal data and safety committee. Again, for the session that we're at right now. So how will your files be maintained? It can be all electronic, it can be hard copy, it can be both. They don't particularly like hard copy, especially because the chance of breaching is greater. If the patients are all University Hospitals patients that you're getting the information from, they will likely want you to use what they call UH Red Cap. And you can register for that. And that's all electronic. It's free to use, you just have to apply for the username and the password. And you can set up your sheets and your forms through them. If it's your own private patients, you can use encrypted USB pins that are kind of expensive. They have like little punch keypads on them. How long do you plan on keeping the records after the study? The minimum is three years. Again, subject privacy. This is a section that you copy and paste from your protocol document. And again, if you don't have this wording the way you want it in the protocol document, we do have examples that we can email out to everybody after today's session. You can go back and copy and paste it in there. So data analysis plan. If your questions or your study are going to lead to some type of statistical analysis, they're going to want to know how you're going to do that, what equations you might use, how many patients, like the end number or the power. You don't have to have this done to get IRB approval, but they really do like you to have at least thought about it, started it, and they would dream that it would actually all be laid out. So will the subjects receive incentive reimbursement or compensation for participation? By and large, you can't pay the subjects for the research. So the answer is no. You can give like a small gift card and stuff like that, that is just for their time and inconvenience. That's really not considered payment to them or compensation. This almost sounds like the same thing that you just answered, and you can put the same answer there. Cost to the subjects shouldn't, for most of the studies here, cost them anything, okay? So literally saying there is no cost to the subject is just fine. Compensation for research-related injuries. I don't think anybody here will have to worry about that, but you still have to state that there is no compensation for research-related injuries, even if they're not anticipated, okay? If you have funding, you just have to specify it here where it came from, that's all. But you have to click at least no for all of it if you don't have any funding for this study. If you do have funding or a sponsor, you just have to list who they are. And they might not be listed, in the UH system, that's okay. You can free put in their names, where they're from, their address, and all of that in the options menu, like when, if you do have the source of funding. This is now going to be like the submission packet for the review board. And you don't need to include any comments. Section 1.1 and 1.2 will automatically pop up because you've already filled it in. So you just hit save and continue. Your application, that's what you just filled out, okay? It should already be showing up here. You don't have to attach it, it's already here. If for some reason you had another one, you could attach it here, but you won't have that. Where it says please disregard below, and you see all those green letters with the circles yes and no, ignore that that exists. They literally mean disregard what's below. Please disregard below. This is where you upload your consent forms if you have them, okay? That document that we've been talking about, the UH protocol, or like the protocol that you've filled out and been working on, this is where you'd now upload it. And again, it's not the application per se that's gonna get the stamp. They do approve the application, but they will physically place a stamp on the documents that you're uploading now, the consent forms as well as the protocol. And that's what you're going to finally print out to use or give to the patient or the subject. Any other study documents that you might have, you can upload here. And it's going to allow you to click what type of documents they are. If you have an Excel spreadsheet that you want or something like that, that's where this could go. Once you're done with that, you are done with this portion of it. But do not, if you are the PI, don't sign off. You could sign off after you review it, okay? But once the PI signs off on it, so once that happens, you can then save the application as a PDF or a print-friendly version of it. That is what you're going to email to the academic departments for review. The academic department's gonna review it. They're probably gonna come back with lots of little corrections. Could be very minor, could be a little bit larger. You edit it, you change the forms in IRIS, and you submit back to them all the changes to all the documents, okay? And depending on what the corrections are and stuff like that, like I said, you'll get an approval letter from them or a letter of their decision, whether it be approval, approval with minor corrections, approval, like, or not approved, like major corrections, stuff like that, okay? It's not uncommon to have like 20 corrections. It doesn't mean you didn't do it correctly, okay? This process for expedited review, two to four weeks each time you submit, okay? And then once the academic department approves of the study and you get that letter, you attach that letter to your study documents with all your most current study documents, like your protocol that's been approved of by the academic department. That then goes through the IRB for their initial review. Once they initially review, approve of it, then it goes to the chairman of the IRB for final approval and that's where you'll get the stamp. And then you can start your study. This process takes three, four months smoothly, okay? It can be faster depending on your study, especially in some cases if you can get exempt if it's not considered to be human research.

IRIS interface

IRB applications

research study submission

consent documents

review process

academic departments

approval timeline