 Go ahead and get started so I don't keep you for the whole time if I don't have to. So thanks for coming this morning. So early. I'm Deborah Harrison for any of you who don't know me. I manage the clinical research support group here, which consists of five research coordinators and an upthalamic tech and a regulatory coordinator. And we work with all of the faculty and students, residents, fellows to help you do research and to do better research. So every year as I put this presentation together, I try to think of some, you know, some slides that might be a little more interesting or some topics that might be, you know, kind of get you interested at seven in the morning. And I mean, I have to admit that conductive research, the ethical basis for research is, you know, kind of lends itself more to like having a discussion with the Bureau afterward, you know, those ethical conundrums more than the nitty gritty of how you do research. But nonetheless, I feel it's very valuable. And I'm hoping that, you know, I can get you to appreciate that as well. Mainly for a couple of reasons. I've been with the department, you know, in this kind of function for 25 years, believe it or not. And I can't believe it. And so I know firsthand that what, you know, what we do, what the coordinators do, what the regulations help do is create better quality research, which is really key. Why even do it if you're not going to do it well, right? And I do know also firsthand that it improves the experience for the patients who participate in research. Huge, makes a huge difference. So anyway, just to get started, you know, a couple definitions of what research is, even though everybody knows what research is. But the formal definition is that it's a systematic investigation designed to develop or contribute to generalizable knowledge. So there are really two points in that definition that I wanted to focus on. Of course, clinical research or human subjects research involves obtaining data from living individuals. And I highlight living because using decedents or samples from, I mean, data or samples from, decedents doesn't even qualify as human subjects research. That's just kind of basic research. And we can get into that when we get into the regs a little more. But and also want to emphasize not only is it data about living individuals, but that could just be data collection, even if you don't touch a patient that is considered human subjects research, as well as routine procedures, you know, where you're doing the typical evaluations that you do for research intent, as well as interactions, you know, drugs and delivery device treatments. So it doesn't have to be just a treatment trial to be considered applicable to the regulations. So in that first definition, when I talked about research being a systematic investigation, I wanted to focus on this just for a minute because what that implies is that it's something planned that you've given forth thought to, right? You've got a question. You've got a focused purpose. And frankly, it is time intensive. And as someone who has spent a lot of futile hours trying to collect data for a retrospective study from routine patient care charts, I can't apologize for research being time intensive because it's really difficult to get complete data, believe it or not, out of your standard patient care. You know, I think physicians are fabulous and amazing at remembering their patients, knowing their patients, you know, with a few cryptic notes in their medical record. But when you want to do research on that data, you'd be surprised, you know, what you actually find when you go in there and look. One of Dr. Olson's earlier studies on glistening, you would think with cataract patients, the number of surgeries we do here, getting 2,000 charts, you know, to include in your database would be no big deal. We were lucky to get 100 that had complete records in their standard of care records. So, you know, it really is a planned process, and it's very different from the usual way you interact with patients or collect their data, really. And the other thing is that no matter how good your patient notes are for that particular patient who's sitting in front of you, again, when you try to compile data to make some general statement about cataract lenses or, you know, whatever, it falls short, right? So, you really have to do some planned research up front that has a hypothesis and a study design appropriate to support that question, to obtain knowledge that is generalizable to all patients with C and V or whatever. So that's kind of the things that set research apart from your standard patient care. And the other thing which I think is a real challenge for investigators, and we see it all the time, when we're doing projects, some providers, physicians are good at this and others are not as good at it. It's something that I think you can cultivate, but when you're doing your standard care, as I said, you've got an individual patient in mind, and you're very familiar with the doctor-patient relationship and what all that involves. But when you're doing research and you're trying to gain generalizable knowledge, the individual treatment of that patient is not your prime focus. You're looking for results that you can apply across a broad population. And just because the individual therapeutic benefit to that patient sitting in front of you is not the prime focus, it doesn't mean that the risk to that patient is not your prime focus. That certainly gets into the study design where you're trying to obtain positive data about efficacy, for example, but safety for that patient is just as important. So when you're designing your study, when you're recruiting patients into a study, it's an equal consideration. And I will say that certain areas lend themselves more easily to research than others in this regard. A uveitis, for example, is so specialized, right? The drug regimens, the dosing, the frequency, the tapering, the adding of other treatments, really difficult to design those protocols and difficult to enroll in them. But nonetheless, you persevere and you get it. And because of these difference in focus, your relationship with a research participant who is also your patient changes a little bit. I think when you're doing research, you partner maybe a little bit more with that patient than you do when you've got their vision in your hands. You tell them what to do, you decide what to do. In a research protocol, they're participating with you in that protocol, right? Their compliance with the protocol, of course, it's always necessary for their own benefit and for their care, but it's essential for your research data as well. So things like informed consent, which I know carries over to your patient care as well, but becomes kind of a little bit bigger issue that they really understand what they're getting into when they're doing research. I'll give you a couple of examples of what is not research, and this is a regulatory definition, quality control. We've done projects here looking at the residency program. Residency programs across the country, certain parameters of what works and what doesn't work. The surgery center or the pharmacy will do QA types of projects where they actually do study their data and their processes, but that's not considered human subjects research. And case report forms, which the IRB defines as three or fewer patients. That's kind of interesting. That's great. It sounds kind of researchy. Here's something that's, you know, apart from our patient care, but nonetheless it's not considered a systematic investigation with only three patients. And I think that's why I know with Dr. Rwasco working with you all in developing research for your time here during your program, trying to get away from the presentation of case reports that, you know, clinical faculty day and residence day and focusing a little more on actual projects. This is a topic we could talk about in a whole nother session, but off-label use also is not considered research. If it's done within the practice of medicine, and you know better than I how widely drugs are used outside the product labeling for those things, which makes it difficult, for example, in UVitis to design protocols where you've got anti-inflammatories that are not approved for UVitis, but they're standard of care. And so you kind of have to walk a lot of different paths to get where you want to go with establishing a protocol in those areas. But most of the reasons, as you know, for using products off-label, you do use it for a clinical indication other than what it was actually studied for. You might use it in a different patient population. For the longest time, pediatric patients were given drugs that were never studied in pediatric patients. They were only studied in adults, and so the labeling was in adults. The dose or route of delivery right now, we're embarking on a couple projects in UVitis, which is investigating a suprachoroidal injection of triumcinolone. Triumcinolone, obviously, has been around forever. But even intravitreal injection is new, right, and was used, was done off-label for the longest time. Now there's a company who's formulated this long-standing, long-known, well-known product for a different type of injection. That would not be off-label use, but it could be if you were just trying it in your clinic. So to get to the kind of, you know, the basics that you've all seen before whenever you do any of the CITI training on clinical research or good clinical practices, why is research regulated? Oh, it's regulated for the reasons that anything is regulated. It kind of saves us from ourselves, right? People have biases, even well-intended people make mistakes, and they're conflicts of interest. I don't go over this case, which is kind of cited as the reason or the sentinel event that started the documentation of research regulations in this country. But if nothing else, you can see that the investigators had biases and prejudices about the people they were studying, and a conflict of interest that to them their research was more important than the patients they were studying. So really the regulations are designed to help us avoid those pitfalls, either intentional or intentional. And I'm sure you've all seen the Belmont report cited in any training you do on clinical research, and it really is the cornerstone of all of the research regulations. If you think of it, the ethical principles are the core values that we say we believe in when we're doing patient-centered research. The regulations are really the behaviors. If you say you believe in a respect for person, how do you show that respect to your patients by, you know, giving them informed consent by protecting their privacy? How do you show that you have their best interest at mind, even though they're participating in a larger project, by designing a study that minimizes their risks in order to, you know, maximize the benefits that you're going to get from that research? And as well in your justice, finally, that you're choosing subjects equitably, that you're taking special care if you're including vulnerable patient population, meaning people who can be, who have diminished capacity to understand what they're getting into or are easily coerced. And that's one of the ethical topics that comes up for the longest time. And if you have a disease for which there is no treatment, and all of a sudden there's this clinical trial, how motivated are patients to be in that clinical trial regardless of the risks to them? And so something that you have to guard against. And from the Belmont report, one of the first pieces of legislation that came into effect establishes institutional review boards or ethical review committees to review research. Everybody knows the IRB is a requirement, but it's actually regulated by the federal government in terms of how the IRB, who the IRB is composed of, how they conduct their meetings, how they conduct their reviews. And so they are as much regulated as they regulate us. And this common role of part of the Code of Federal Regulations that defines in great detail how IRBs review research. So I think you all know that you need to apply to the IRB for review of any research project that you're going to be doing, including retrospective research. And just to give you an idea of what the IRB is looking for in general when you're submitting those applications, as I mentioned before, that the risks to subjects is minimized compared to the value of the anticipated benefits of your research. I think for the longest time, investigators resented IRBs questioning their study design. They felt, I'm not harming these patients. These are our routine care. How can they question how many patients I've got enrolled? Well, if your research doesn't have the power to prove your question, why submit, you know, why subject patients to anything, even if it's just their standard care? And so you really, it's kind of the minimum necessary. The days of the kitchen sink protocols, let's throw in everything. The IRB looks at anything, a blood draw, sure it's minimal risk, but still it's not no risk to a patient, right? Dylating, not no risk. Florescene angiogram, again, it's an accepted risk to us in clinical practice, but when you look at a research protocol, you want to see that you're actually, there's a purpose for doing every procedure that you put in there. So if you have other things that are often called secondary outcomes, you know, not your primary, that's great, but just justify them. You know, tell them why you're looking at it as an exploratory, valuable, you want to see if it has an influence or is it just kind of a nice to know or really can you leave it out, you know? And then again, it comes back to the Belmont principle of beneficence. They're also looking for that you're selecting your subjects equitably. Informal consent is a huge, huge part of an IRB application. It's as much a part as the rest of the questions that you go through when you're filling out that application. And if you all were here at the Grand Rounds, where I can't remember the gentleman's name, who was the ethics guy from the American Academy, you talked about informed consent. I mean, I was sitting there thinking, well, that's exactly could be part of a research presentation as well, right? It's been a little kind of soft sold in clinical practice, but it's becoming obviously more important. But the federal regulations and the IRB, you know, we'll get to this, have a very specific list of things that you need to cover in an informed consent document for research. And then also, you need to be monitoring your data as you go along, making sure you're collecting complete data, you know, that you're doing what you told your patients you would do at the onset. And again, that speaks for the integrity and the kind of quality that your research will show. Also, protecting the privacy of subjects, we'll talk just for a second on HIPAA, which added a new dimension to research not too long ago. But in this day and age where, you know, genetic research is so important, I mean, privacy is a huge ethical consideration. It can't just be assumed that patients don't think about that because they certainly do, as you know. And as I mentioned, vulnerable populations, if you're looking at pediatric groups, patients with terminal diseases, prisoners, of course, you'd think, oh, that would be a great captive audience, no. Highly obviously subjected to coercion possibly. So as I mentioned, HIPAA, over 10 years old now, added another dimension to doing research because so much of what we do involves looking back through patient medical records to begin with, either as a complete project or even to identify people who would be appropriate to be in a prospective project. And I think physicians and institutions have always felt like that's our data. And what HIPAA tells us is no, that's the patient's data, right? I mean, yes, you are safeguarding it for them and you're creating that information, but nonetheless, we have to take certain precautions when we're dealing with patient information, as you know. At the University of Utah, the IRB was designated as the Privacy Board. That's not the case everywhere. But here, I mean, it makes it kind of nice for research because they have incorporated HIPAA questions as part of the IRB application and it's a one-stop kind of a review. You don't have to go to separate offices, one to do your IRB review and a separate office to do your HIPAA reprise review. So that's all included here. You all, I'm sure, are familiar with all the identifiers that make health information protected, health information under the HIPAA regulations. It's less common now, but occasionally, and actually I see this from dealing with people in industry, often they think, well, we don't have patient names on here, so it's de-identified. But if you're collecting the dates of their procedures or any of these other things, it could still be considered identifiable information. And it certainly doesn't mean that you can't do research with identified information. Actually, most of the research that we do is done with identifiable information. It just means that you either need to, in addition to obtaining consent from your participants, obtain their authorization as part of that consent process or request a waiver of authorization, which is very common in the research we do if we say, you know, we need to look at all of our cataract patients to determine who might be the appropriate population for this protocol. It would be impossible to call all of those patients and get their consent or authorization to do that. So for valid reasons, the IRB, the Privacy Board, will waive that authorization, right? But nonetheless, in the consent form, there is verbiage that talks about the use of their private information in the authorization section. You can get around, of course, HIPAA by using de-identified dataset, or you can use what's considered a limited dataset, which might contain one or two of those 18 identifiers, but not a fully identified dataset. Really, the only thing that that impacts you in doing research is if you are doing collaborative research with other institutions, there are guidelines about sharing information that differ between sharing fully identified information, a limited dataset, or a completely de-identified dataset. And there are legal documents that get involved at that point when you're transferring samples or sharing data between institutions. And otherwise, you know, you probably don't give too much thought to that except as far as your IRB application is concerned and how you preserve confidentiality of your records. And there's actually research, which is considered exempt from IRB oversight. The catch-22 here is that you still have to apply to the IRB for them to determine that it's exempt from their oversight. So, you know, retrospective chart reviews automatically fall into that category, but nonetheless, you have to explain your project to the IRB first. Educational and behavioral social sciences often fall under those kind of exemptions, or past specimens, for example. You don't have to do the usual continuing reviews with the IRB after you get that exempt determination. However, if you change your project significantly in terms of the risk-benefit ratio, the patients that you're looking at, or the procedures you're adding, usually if you're adding procedures, if you're taking away procedures, that's, you know, really not of significant interest. But so you might still have to submit amendments to the IRB to have them look at that project again, even if it's exempt. So they'll, at least, our IRB will send you kind of an annual email, you know, asking anything that you need to, you know, keep in mind that you've got this exempt protocol out there. Is there anything we need to know? And then I won't even get into the whole, you know, the purview of the FDA on products. But unfortunately, you know, it does come up, the IRB is the final arbiter of whether or not you can do a research project. But of course, the IRB, being regulated by the federal government, you know, is held to the standards that the FDA and the Department of Health and Human Services sets in code. And so if the IRB questions something, you're looking at using a drug off-label, and you don't want to just do it off-label in your patient population, you want to actually study it. The IRB will question whether or not you actually need an IND, an Investigational New Drug Exemption from the FDA, and we'll make you come up with it, either with an IND or a letter from the FDA stating that, no, it's not necessary. So depending on what you're doing recently, the refractive fellows wanted to look at. It wasn't topo-guided or one of the newer Lasik platforms, which I'm blanking on at the moment. And believe it or not, the labeling for that procedure was done with PRK, not with Lasik. But of course, the people are using it for Lasik. They wanted to study it and we said, oh gosh, that's a new indication, you know, for that, even though it's a software platform with that approved laser, the IRB is probably going to question whether or not you need an Investigational Device Exemption to do that. So it does come up even in your own, you know, investigator-initiated research. Here at the University, if you don't already know this, the IRB reports to the Associate Vice President for Research Integrity, who in turn reports to the VP for research. We have traditionally, forever, been required to use our local IRB. But in, I think it's December of this year, going into effect, new regulations by the NIH Department of Health and Human Services requiring a central IRB for collaborative projects that are funded by NIH, which we do several of. So this is going to be essentially, this will be new for us, that our IRB and other IRBs will defer their review to one designated IRB for a given project. Excuse me. Likewise, if you are doing a project and you want to add collaborators from other institutions, our IRB could be considered, you know, act as the central, the single IRB for those other institutions if they're willing to do that. So it's kind of new ground. We haven't used that model before. We're just getting into that with a couple of the projects that we've got coming up. So it'll be interesting. Hopefully, the intent is to save time in getting research up and going, getting it off the ground. The IRB, our IRB applications are done in this online system called AERICA. If you haven't been there, I think most of you probably have. It's a smart system, asks you questions that, depending on your answers, will direct you to other appropriate sections. But the IRB website itself, which is separate from AERICA, is really a great site. And I don't expect you to really read this, but they've got all kind of guidance and template forms and links to the FDA, Health and Human Services, whatever, Department of Defense, specifically aimed at the investigators, even for research participants, references for, if you want to share with patients who you want to enroll in your studies. So really, if you have any questions, you can certainly come and ask the folks who work with me, but don't hesitate to go to the IRB website, which is, again, separate from AERICA. You don't have to start an application to start looking through what you're going to need to do an application. It's really well done. So we've talked about a little bit of the history of the regs briefly, why they're in place, your role as investigators, the role of the IRB in overseeing research, touched just basically on the informed consent process. And I say process because obviously talking to your patient, that discussion of informed consent is more than just giving them a form to sign. But having said that, when you're doing research, there are a lot of elements that should be, must be covered in that informed consent document if it's being reviewed by an IRB and you expect it to be approved by that IRB. And it's really pretty basic, explaining to the patients the background, the purpose why you're doing the research, what you hope to show by this research, what procedures they're going to undergo when they're in this protocol. You also want to tell them what their options are, what's available to them outside of the research project, not just focus on the research project. When we're doing trials of due drugs for CMV, for example, and it's gotten very difficult to recruit for those studies, obviously you have to tell patients, if we give you the sentence, you'll come in for three monthly injections and then we'll see you and if you don't need more as opposed to a new protocol, which typically the IRB requires monthly visits, monthly injections, they might be sham injections, so you've got to give the patient the full picture, not only of what you're doing as part of the research, but what they could have outside of the research project. And then, of course, you talk about the fact that it's voluntary, your relationship with them as their medical provider is not influenced by the fact whether or not they decide to participate, how you'll safeguard their confidentiality, if we're giving them any compensation, are you paying for any of their imaging procedures, for example, if they're in the research project, whereas, you know, if outside the research project they would be billed as standard of care, or you can do research and still bill for procedures that are standard, legitimately are standard of care, but patients need to know that. I think that's often a common misconception and kind of relates back directly to how well you do your informed consent process, that patients, we've had patients think, you know, like the rest of their eye care is going to be covered because they're participating in this study, and that's very rarely the case. So just kind of the most interesting part, I think, of the presentation, you know, the research is what it's about, right? That's the interesting part. The regs, the processes that you have to go through, I feel really strongly that it helps you develop quality research, but yet it's the research itself that's the really interesting part in why we do this, and I don't mean to imply that Leonardo da Vinci or Gregor Mandel did research at the University of Utah, but when I look back at the last 25 years, it almost seems that way to me. In 1992, which is when I was hired, we had essentially three research, clinical research projects ongoing. Dr. Olson always being at the forefront, and at the time of Mano Schwartz actually were looking at supplements. They were some of the first people who looked at supplements and how they affected antioxidants, how they affected your vision. Could they slow the progression of AMD or cataracts? I mean, it was kind of actually a large study, and in only the way that Dr. Olson can do, he got a lot of private funding from someone to help support that research, which unfortunately didn't prove its intended result. However, it did launch really a whole area of investigation which continues to this day. Dr. DeGree was involved in an NIH-sponsored trial of a surgical treatment for IONDT, which unfortunately proved that the surgical treatment made things worse than observation did, but how would you know? And Dr. Crandall always doing an IOP lowering meds for glaucoma. So that was it, believe it or not. Today, we have 83 IRB approved projects ongoing. About half of those are your projects, the projects that you're working on with faculty members, other projects that the faculty themselves have initiated, as opposed to the remainder which might be sponsored, meaning paid for, and probably written by either a private foundation, an NIH collaborative group, or industry pharmaceutical and device companies who are collecting data for hopefully FDA approval of new products. And so when I look back on this, I think how did we get from three projects to 83 projects? And some of it was, I think, happenstance as the department grew, obviously you bring in more faculty and they're going to want to do some research, they have some questions they want to answer. Paul Bernstein, he started right after I did, was really the big focus and still is the driving force behind clinical research. He's really gifted as a clinical researcher, can do that balance between clinical care and research in an amazing way. But really not too long after, what was it, five, six years after he got here, we were well positioned to be on that first wave of AMD trials. So the industry research was out there, it was advancing at that time. We did the first PDT trials, we were in the pivotal FDA trials for Lucentus and then ILEA. So we were well positioned to be on that first wave in retina, really the growth of retina research, which meant that our patients, of course, received those treatments sooner than the general population did. As we continued to grow with faculty, Dr. Olson was one of the first people on campus who saw the benefit of having someone like me in my group here to support investigators, to help them with all those time-consuming processes of IRB applications and the regulations. And I have to say the faculty, you hear about stories that faculty don't want to give up the control over their research projects. In the department, it was just, please help us do this. I mean, there was no hesitation whatsoever to the point where we, now, of course, we have context with biostatisticians, but really help in the development of those protocols and not just in the implementation of the protocols, which is nice. And then, you know, more recently, obviously with Dr. Ruwasco, we've come to spending more time with the residents and the fellows in helping you get a little more training and interest in doing your own research when you're finished with your program. Just a little bit of a history. I think one of the more interesting things in terms of longevity, which started before I was here either, before Dr. Hoffman was even here, were the early cryotherapy treatments for ROP. The Dr. Hoffman's predecessors were involved in the NIH collaborative study, the first one. Then when Dr. Hoffman was here at a later date, after they had established treatment guidelines for cryotherapy, then they started questioning, well, would patients benefit from earlier treatment than what the standard of care is? There was another NIH collaborative trial for that that we were a part of. Recently, we've been looking at and has shown, introducing the red cam, the fundus photos, into the NICU, into the ROP exams, to not only document your exams, but the chair of this trial at CHOP, his impetus, he does a lot of humanitarian work. He goes to third-world countries where there aren't pediatric ophthalmologists to look at these babies. And so really, his interest was in developing a telemedicine approach for diagnosing ROP. And even in this country, as fewer pediatric ophthalmologists are getting into ROP, don't have the expertise, maybe, that Dr. Hoffman does and other pediatrics here, to utilize telemedicine to help their patients. Right now, we're looking at a project, looking at growth parameters, which have shown to be predictive of infants at most risk for ROP, another NIH collaborative trial. And we're also finally starting to do a Vastin and Lucentus treatment trials for ROP. For the longest time, you know, the risk of those trials is tremendous. Dose is extremely important when you've got developing infants. You don't want to mess with their normal development. And so Dr. Hartnett elected to really not get into that too much until we had controlled clinical trials to give us data of what the appropriate process is for that, which we've got ongoing right now. And, you know, with all of clinical research, as I said, the research is the interesting part. We've really made a difference, as you can see with ROP, inpatient care. It has advanced patient care. It has improved patient care. Right, the enubitis mentioned, you know, quickly that the start of Vigidine PDT and then the anti-VegFs really launched that field. Geographic atrophy is still a holy grail out there. We get different trials that we're looking at. Treatments for geographic atrophy, obviously nothing is yet FDA approved for that. And then the orphan retinal diseases right now are a big interest because those single gene mutations are the ones that are most amenable to gene therapy, right? So that's going to kind of be the next way. That's what we're seeing. We've got a couple Corridorimia natural history studies going on right now with companies who are developing gene therapy products for them. And so that's kind of exciting. Mac-Tel, if you know Mac-Tel, Mac-Luric-Langentasia type 2, at some point I think Dr. Bernstein will probably be doing another grand rounds on that because he's doing some really cool imaging right now of those patients, which the exact cause of that disease is unknown. The symptoms, of course, I mean the signs are known, but might help lead to that causation and with the help of the Utah population database, here in Utah, there's always been this feeling that it's a genetic disorder, but we're actually the first center in the world who's developing these large pedigrees of families with multiple affected family members, which is really cool. And so we're working on the genetics of that. The uveitis I mentioned are always a challenge. There are NIH collaborative trials going on around the treatment of uveitis, comparing treatments for uveitis, and Dr. Battali's been a real leader in that group. And recently we did a completed a trial for Adalibamab, which was just recently FDA approved for uveitis. Again, one of those things that was probably used off-label, but then Abbott saw the usefulness of actually applying to the FDA for approval for a new indication, and it turns out it worked really well. And then, of course, you know, the interior segment has been a long-standing research endeavor and interest at the department here. Most people have probably never heard of the CLEC study in 1995, which was looking at how to best care for vision, how to best manage the vision of care to common patients, how to best fit contact lenses. It's the first NIH grant awarded to optometrists, and under Harold Wolfson, we were able to participate in that. And then more recently, even though corneal cross-linking has been used around the world, it hasn't been FDA approved in the U.S., and we completed one of the trials, you know, pivotal FDA approval trials for that recently. And, you know, kind of a clinical research coordinator's joy is we had patients calling us every day, you know, hands full of patients, can I be in your study? I mean, recruitment was not even a question. But of course you know that with Dr. Olson, Dr. Mamelas, Dr. Crandall, the field of cataract surgery is a totally different place than it was before they started doing their practice and doing their research. Anything from topical anesthetic, as opposed to retro ball bar for cataract surgery, to the anti-inflammatory agents that used irrigating solutions now to the IOLs themselves. Dr. Olson apparently coined the phrase dysphotopsia. He made up that word himself, but now it's kind of a standard part of the jargon. You know, that's thanks to our research here. So basically that's the overview. I know I skipped a lot of the details, but hopefully if you have any particular, any specific questions, you won't have to take to come to our group, which I've kind of shown up there with our coordinators, technicians, and regulatory coordinator. Dr. Bernstein does actually have an official position as the medical director for clinical research. And then Dr. Mawasko, of course, is in our position functioning in the education program for bringing more research involvement into our residency and partnership program. So that's our group. I think, as I said, I think, you know, we feel like even though research administration sounds kind of, you know, of a boring topic, my group is very dedicated, very dedicated to the research and as well as the patients. Love to do this kind of work. Love to work with you all. So please don't hesitate to come and let us help you hold your patients. Any questions about anything? Great. Well, thanks for being here so early. I guess you don't have a choice, but I appreciate it nonetheless. Thank you.