On Research Podcast – Quality Improvement vs. Research: What’s the Difference?

To easily navigate through our podcast, simply click on the ☰ icon on the player. This will take you straight to the chapter timestamps, allowing you to jump to specific segments and enjoy the parts you’re most interested in.

1. Tiffany Gommel’s Background (00:03:39) Tiffany shares her journey into clinical research and her experience with IRB operations.
2. Quality Improvement vs. Research (00:04:28) Discussion begins on the distinctions between quality improvement activities and research.
3. Defining Research (00:05:04) Tiffany formally defines research related to systematic investigation and generalizable knowledge.
4. Defining Quality Improvement (00:05:39) Tiffany explains quality improvement as activities focused on enhancing patient care without generalizable intent.
5. Generalizability in Quality Improvement (00:07:05) Exploration of how the generalizability factor helps differentiate quality improvement from research.
6. Intent and Generalizability Discussion (00:08:21) Discussion on the challenges of determining intent and generalizability in healthcare projects.
7. Publishing Quality Improvement Findings (00:10:29) Tiffany discusses the implications of publishing quality improvement results and its relation to research classification.
8. IRB Review and Publication (00:11:11) Tiffany explains how publication does not automatically classify a project as research requiring IRB review.
9. Nuances of Determining Quality Improvement (00:13:40) The conversation emphasizes the need for nuanced discussions on project classification between investigators and IRBs.
10. Process for Quality Improvement Projects (00:16:03) Tiffany outlines the general process for submitting quality improvement activities for IRB review.
11. Comfort Level with IRB Decisions (00:19:12) Discussion on the importance of comfort level in determining whether an activity requires IRB oversight.
12. Responsibility for Determining Project Type (00:21:56) Tiffany clarifies that determining quality improvement versus research is an institutional policy issue.
13. Quality Improvement Trust (00:23:10) Discussion on the importance of trust in quality improvement activities and the role of education in research.
14. Starting a Quality Improvement Program (00:25:08) Tiffany shares her experience starting a quality improvement program within the IRB office.
15. Post-Approval Monitoring Challenges (00:26:15) Insights on the complexities of post-approval monitoring and the potential for misunderstandings regarding IRB requirements.
16. Advice for Research and IRB (00:27:56) Tiffany emphasizes the need for education and guidelines to navigate quality improvement versus research.
17. Engaging with New Researchers (00:28:24) Recommendations for early education and support for new researchers to avoid confusion about IRB processes.
18. Diverse Educational Approaches (00:30:26) Discussion on providing multiple avenues for education to accommodate different learning preferences.
19. Same Team: Shared Experiences in Research (00:32:06) Tiffany reflects on her impactful experience helping establish an IRB in Nigeria.

Tiffany Gommel: We’re all type A, we want to tick off the box, we want to say, “Give me a checklist and tell me that it meets all of these things.” And sometimes it’s just we have to come to the conclusion after weighing all of the information that we get, and the devil is always in the details.

Justin Osborne: Welcome to On Research with CITI Program, your favorite podcast about the research world, where we dive into different aspects of the industry with top experts in our field. I’m your host, Justin Osborne, and I appreciate you joining. Before we jump in, as a reminder, this podcast is for educational purposes only. It is not designed to provide legal advice or legal guidance. You should consult with your organization’s attorneys if you have questions or concerns about the relevant laws and regulations that may be discussed in this podcast. In addition, the views expressed in this podcast are solely those of our guest.

At the top, you heard a clip from Tiffany Gommel, my guest this episode. Tiffany is the director of the Office of IRB Operations at the National Institutes of Health for the Intramural Research Program. She’s responsible for the operation and support of the NIH IRB, which reviews and approves human subject research from the 27 institutes across the NIH. Today we’re exploring the popular topic of quality improvement versus research. What’s the difference and how do you make that kind of determination? Being in the field of clinical research for over 24 years, Tiffany shares her knowledge, experience, and some helpful advice around this popular question of QI versus research. So without further ado, I hope you enjoy my discussion with Tiffany.

Tiffany, it’s great to see you. Thank you so much for joining the podcast.

Tiffany Gommel: Thanks, Justin. I appreciate you having me.

Justin Osborne: Yeah, yeah. So let’s jump in. I want to hear about your background first. So tell me how you got into the research industry in the first place.

Tiffany Gommel: Yeah, I actually fell into it. It wasn’t one of those things I went looking for. I applied for a IRB analyst position at the University of Maryland in Baltimore, and that was almost 25 years ago. And I got the job and did not know what I was doing. And I remember somebody handing me this big book of regulations and said, “Here, read this.” And yeah, back then it was paper pushing, a lot of paper pushing, but that’s how I started, as an IRB analyst at the University of Maryland in Baltimore. And I worked my way up there. I was there for about 10 years. And I also did education and training in the office and implemented my first electronic system going from paper to electronic. And then I actually did another electronic system while I was there, electronic to electronic, changing systems again, so a lot of processes and operations.

And then I decided to change and do quality improvement. And so we started a quality improvement program for the first time in the early 2000s when that started happening. And I did that for a little bit and then I decided I needed to go back to operations. So I became the director of the IRB at the University of Maryland for the last four years that I was there. Yeah, yeah, so I kind of stumbled into it and fell in love with it. And then I left and I went home to University of Rochester in upstate New York for about nine years and had kids and was around family. And then I got recruited to come to the NIH.

Justin Osborne: Okay.

Tiffany Gommel: And so here we are now today, I’m at the NIH for the last five and a half years.

Justin Osborne: Very nice. So what do you do at the NIH now?

Tiffany Gommel: So I am the IRB director. I oversee the day-to-day operations for the intramural research program, the NIH IRB. And we serve 27 institutes here at the NIH and the intramural research program. And it’s interesting, it’s a little bit different from being outside in the extramural world. In the 27 institutes and centers that we serve, it’s like 27 universities. And so they all have a unique way of doing things and do things a little bit differently. And so you have to be a little bit attuned to what each institute needs in conducting your review. So yeah.

Justin Osborne: Very interesting.

Tiffany Gommel: It is interesting. And I have a staff of about 17 and yeah, that’s what I do.

Justin Osborne: Very nice. So you’ve been in the IRB space for a long time it sounds like. And we’ll just jump into the topic because the topic we’re going to talk about is quality improvement versus research, or QI versus research. And you obviously have experience in this area, but this is a very common question that researchers ask and IRBs as well. Where is this line drawn? So to kind of jump into this, I guess it makes the most sense to start with definitions. So let’s define terms. What is research? Let’s just start basic.

Tiffany Gommel: Yeah, so I’m going to look over here at my little definition thing to make sure I get this correct, but I should be able to verbatim say this out loud. I used to do this in IRB meetings all the time. Research is a systematic investigation including research development, testing, evaluation, designed to develop or contribute to generalizable knowledge. And there’s a lot in that definition.

Justin Osborne: Yeah, there is. Before we pick that apart, let’s jump to quality improvement. So how would you define quality improvement?

Tiffany Gommel: So I was kind of thinking through this before we met and looking back at what I used to do when I did the day-to-day operations of myself, and I was reviewing research and reviewing exempt research or expedited or non-human subjects, and where did the line get drawn? So quality improvement, I would say would be activities that do not require IRB review except when they’re conducted with the intent to develop or contribute to generalizable knowledge, which includes research. So in general, I would say that quality improvement projects are focused primarily on improving patient care within a given in-patient environment, maybe a hospital or healthcare organization. And as such that the outcome of that project wouldn’t be generalizable to other patient care environments. So it would be really internal to that organization.

Justin Osborne: Okay, so the definition of quality improvement, just thinking through the overlap of research and how we’re going to draw the line or how you determine where that line’s drawn. Both are systematic, right? Both have very formal intentional approaches to whatever the project is. It sounds like it really hinges on the generalizable factor. Is that accurate?

Tiffany Gommel: Yeah, that would be my assessment of it. And I do think that each institution out there may draw the line a little bit differently, but in my mind it does come down to the generalizable piece. And that’s how I would educate investigators because it’s hard to wrap your head around, “Well, wait a minute, where did the line get drawn for this study versus this study or this project versus that activity?”

Justin Osborne: Sure, sure. And let’s just hang on this word generalizable for a few. So this is a concept, right? It is a difficult sort of thing to put your finger on. And like you’re saying, it may be different at different institutions how they define this or draw this line. But if I’m an investigator and I’m doing something that I feel is a quality improvement project because I don’t think that the findings necessarily could impact somebody outside of my organization, but I guess do you make that determination? Because healthcare, to a certain extent, there’s some standardization. So why couldn’t you theoretically take what you find in a quality improvement program and apply it outside of your organization? Does that make sense?

Tiffany Gommel: Yeah, I mean you could, and I think that these are the things that we say a lot and to our research community and in the research IRB space is it depends, right? And so it depends on what you’re doing. What you’re doing might be completely just specific to your institution and five years from now, it may no longer be just specific to your institution. Things change. And so all of a sudden something that started out with the intention of being just quality improvement now turned into something that could actually be applied and conducted at other healthcare organizations.

Now, during that process was a research study conducted to implement that at other institutions? No, most likely not. It was just the intention at the time was to do a quality improvement activity or project within that institution. And then people go and they present on that. And then all of a sudden it’s like, wow. It’s almost like when we go to a conference and we’re like, “Wow, they did that at their institution. Let me try that at my institution.” It works. Sometimes it does, sometimes it doesn’t. And so I think that that’s when it gets a little bit hard to know when all of a sudden something became or was quality improvement, and now it could be something that could be actually generalizable across other places.

Justin Osborne: Well, to your point, I mean, if you step back, isn’t that why you present your posters at conferences and/or you publish, right? I mean, even if it’s technically quality improvement, and that’s the line drawn there, you’re sharing this with the world. I mean, why else would you present and publish these things if you didn’t think that there was a chance that somebody might take some information from this and be able to apply it? What’s the point of getting it out there if there’s not a little bit of intent of sharing knowledge that could be useful to other people?

Tiffany Gommel: Yeah, I think me as an individual, my intention isn’t to do that. I think my intention is to share with you what I did, and I’m proud of what I did during that quality improvement activity.

Justin Osborne: Sure.

Tiffany Gommel: And the person listening to that or the audience listening to that may say, “Oh, that is something I do want to do, or that is a problem that we need to solve.” And some people in the audience might be like, “That is great,” and then move on and they may not use it.

Justin Osborne: Yeah, it’s an added bonus.

Tiffany Gommel: Yeah, yeah. Exactly.

Justin Osborne: Sure, sure. Okay. With the publishing aspect, whether or not you publish results, does that have any weight in the determination of the QI versus research?

Tiffany Gommel: I think it does and it doesn’t, right? So again, I think it depends. I mean, I think that the publication piece can muddy the waters. So I think that in my mind, I go back to the definition of research, and if you are conducting research and you are doing an activity that is systematic and it is designed to contribute to generalizable knowledge with that intention to do that and you publish it, then obviously that’s that straightforward path. That’s the easy path. And then now we go down a different path of it is systematic. It isn’t research, it is a quality improvement activity being done at my institution, doesn’t mean I still can’t publish it. I can, right? So we just talked about doing those poster presentations and all that. That doesn’t mean that I can’t publish it, because I can, because journals will take quality improvement programs and activities and publish them.

We’ve kind of over the years, in my mind, have changed in saying, “Well, if it’s going to be published, it’s automatically research.” And so to now kind of morph into, “Well, let’s talk through this, right? Let’s talk through what exactly are you doing and what am I comfortable telling you as an expert in the field and have seen a lot of different activities come through? I’m comfortable that you’re still going to publish, but it is a quality improvement activity. It doesn’t meet that definition or the intention to be human subjects research.” So I think some of it just is a lot of talking through with the investigators or talking through with study teams and saying, “Just because you’re going to publish or not going to publish doesn’t automatically tick off a box of you now need to submit something to the IRB.”

Justin Osborne: Yeah, no, I like that, and I actually appreciate that this is the way that IRBs have sort of evolved and research in general has evolved that there’s so much nuance to this and taking everything on a case by case basis and really looking at it to me seems like what we should be doing, that’s the right direction to go in. So that’s nice to hear. It’s just on the other side, people wanting to know, “Is this QI versus research?” They’re looking for an answer.

Tiffany Gommel: They are. And I think that that’s inherent in a lot of who we are in this field. The people that do this, the IRB geeks of the world and the research geeks of the world, that’s what we do. We’re all type A, we want to tick off the box, we want to say, “Give me a checklist and tell me that it meets all of these things.” And sometimes it’s just we have to come to the conclusion after weighing all of the information that we get, and the devil is always in the details. So I think that sometimes somebody will say something to me on the phone and I’ll say, “Could you write it up for me? Because I’d really like to see it in writing.” And then when I see it in writing, I’m like, “Wait a minute. They said something a little bit different in writing than they did on the phone and now I need to have another conversation with them.”

So I think sometimes it needs to be massaged, it needs to evolve, and there isn’t always a complete box to be checked when it comes to, “Yes, it automatically is research.” Some of those are easy, right? Those Phase 1 clinical trials and all that, so that’s the easy piece. Give me one of those research studies to review all day long and I’m happy. But I think the things that make it fun is talking through these projects with investigators and because those are the things that are neat and different that you just don’t see every single day. And so yeah, it’s like, “Tell me what you’re doing and let’s walk through it. And then if something changes, you need to come back to me because you now might have crossed the line, right?”

Justin Osborne: Absolutely.

Tiffany Gommel: You might have said, okay, your intention now is this. And then all along the way, my intention was to do this quality improvement program, and then all of a sudden in the middle of doing this quality improvement program, I have an idea that now becomes hypothesis generating. And it’s something that I want to now generalize it. So now I need to go back to the IRB and I need to talk through it with them because now I might need to submit something to them.

Justin Osborne: Yeah, and you said this earlier, but QI projects, I can’t remember your exact wording, but they don’t have to go through the IRB. Kind of talk through that, and maybe this is different at each organization, but what is the process for a QI project?

Tiffany Gommel: So you’re right. I think that each organization has their policy or guidance on how they would instruct their investigators to submit a quality improvement activity. For the most part, I think most institutions would say that, “If you are unsure, if you’ve looked at our policy, you’ve looked at our guidance and you’re unsure, please contact the IRB office.” In general, it doesn’t need IRB review or oversight. At our institution here, we do have a form that you can fill out for not human subjects research, and it ticks all the boxes too for the quality improvement piece of it. And then we will spit out a letter for you so you do have something saying that you discussed this with the IRB office and you have something that you can keep in case you go to publish. And the journal wants documentation that the IRB said, “You’re right, this is quality improvement. We agree with your assessment.” Or sometimes investigators will email us or they’ll call us.

And if they call us and they’re still wanting documentation for the regulatory files, go ahead and send me an email. And then, again, I get it in writing as well and then a simple email back saying, “Yes, I confirm that this does not meet the definition of human subjects research and doesn’t need IRB review. Keep this email for your files.” So I think that there’s a lot of different ways you can go about doing it. It’s whatever your comfort level is. I mean, I think some IRB offices would say that you get to know your investigators and you get to know the types of research that they do. And so after you’ve had these discussions with investigators for a long time, and I’ve been at two institutions for almost 10 years or more, and you get to the point where you’re like, “I know what you’re doing. Yes, this is the same thing that you’ve done before.” And I’m comfortable as an IRB office to say, “You don’t need to come to us unless something’s different. I’m comfortable with you making the decision that it meets quality improvement activity.”

Justin Osborne: That makes sense.

Tiffany Gommel: So I think that it can be different at each institution.

Justin Osborne: No, yeah, that makes perfect sense. And I guess to kind of think through that, for the researchers who don’t have those relationship built and the IRB offices who are maybe new, or newer, they don’t know their researchers as well, the IRB process itself is arduous. It can be.

Tiffany Gommel: Daunting.

Justin Osborne: Yes, it is. And so as a researcher, if I have a project that I’m like, “You know what, maybe I could… Because I could still publish, I could still get the information out. I can still do the project, but man, if I can make the IRB, convince them that my intent is not to generalize this information, then that’s a lot less work that I have to do.” Is that a concern? Is that something that happens, or is it just there’s bad players everywhere, but yeah, what’s your experience with that kind of mindset?

Tiffany Gommel: Yeah, I think that that is a concern. I think that we do need to be careful, and I do think that we have to continue to educate our research community on what requires IRB review and that you should always ask the IRB office. I’m also of the mindset that we can’t police everything. And so we have to do our best to just continue to educate. And people get stuck in situations where all of a sudden they’ve crossed the line, and a publishing company will say to them, “Where’s your IRB review?” And they’ll come back to us, and unfortunately, they might not be able to use that data, or they might have to go back and do a secondary research study in order to be able to publish on that.

And so I think if you’re new or you’re feeling uncomfortable, I think having a conservative approach is okay until you can be a little bit more comfortable. When we were starting the office here at the NIH, we were getting to know 27 institutes. So we did take a little bit of more of a conservative approach to begin with and wanted to see everything. And so obviously, almost six years later, that’s not the case anymore, where we can have a form online where people can fill it out and then come to us. But I think that everybody has to have their own comfort level.

Justin Osborne: Yeah, I think that’s fair. I think that’s fair, right? And I understand why institutions, especially large institutions with very large research programs, would maybe create a policy around even if it’s not human subjects research or quality improvement, that somebody on the IRB side has to at least take a look at it, right? At least to know what activities are going on. Because as you said earlier, sometimes these projects can start out as QI and then evolve into research over time. And so if you never knew what was going on in the first place, that might be harder to sort of know about.

Tiffany Gommel: Yeah, of course. Yeah.

Justin Osborne: So to that point about the determination itself, you get to the point where you’re comfortable with your researchers, you know them, and you have that sort of relationship at your past organizations. And I don’t know if this is a… I guess from a regulatory standpoint or maybe it’s a policy issue, who is responsible for making the formal determination that something is QI versus research?

Tiffany Gommel: I think it’s institutional or policy issue to the letter of the law. It’s not the IRB’s right?

Justin Osborne: Yeah.

Tiffany Gommel: When I educate investigators on IRB 101 I say, “What needs to come through us?” And so if you think about the flow chart, right? Is it research? Yes. Does it involve a human subject? Yes. And these are regulatory definitions that I can point to. And so I think that helps all of us in the research world to have those defined definitions. And then if it’s yes, if it’s yes to both of those, then you need to submit something to us. And so I do think that it’s hard to give people that, I guess, flexibility to say, “I’m comfortable with what I’m doing as Investigator A that I’m doing quality improvement, and I don’t meet the definition of research, and I’m not…” I mean, obviously if you’re doing quality improvement, most likely you’re interacting with a human, but you don’t meet that definition of research.

And so it’s an uncomfortable feeling, but sometimes we just have to get a little bit comfortable with it and start to trust. And again, trust that we are delivering the information the best that we can to the research community on what our office is here to do and what our office is, the oversight that we’re here and that we’re here to help. I think when you start a quality improvement program like I did, and when you start to talk about doing quality improvement activities, whether it’s I’m conducting a quality improvement activity or I’m overseeing post-approval monitoring of something that you might consider quality improvement at your organization to ensure things are going the right way, there’s this trust but verify thing that you have to get comfortable with.

And so we can’t always know what all investigators are doing. It’s impossible. So we just have to hopefully do our best at educating and then go out there and do… That’s why there are programs at institutions to go out and monitor. And if you find something, you work with the investigator and you educate them, and then hopefully next time they get it right. And they might not. We don’t always get it right. I mean, we look back at ourselves and we’re like, “Why did we make that determination? That should have been expedited category 2B, not 2A,” I don’t know. So I think we can always Monday morning quarterback, but I do think that we do have to do our best to just inform people of what it is that they’re doing versus what it is the IRB does. And I do think that you go down a slippery slope to say the IRB has to review quality improvement stuff. I mean, I think we’re here to help guide, but I’m not sure we have to.

Justin Osborne: No, I like that.

Tiffany Gommel: So that’s just my thought.

Justin Osborne: I like that. I like that thought. Well, and I do want to ask you more about the quality improvement program. You said you started one in the past, so was the quality improvement program that you started, was it Maryland?

Tiffany Gommel: Yeah, yeah.

Justin Osborne: Was that a department that sort of fell under the Human Research Protection program itself, or was that more on the hospital operations side? What was the-

Tiffany Gommel: It was in the IRB office, the HRPP program. It wasn’t within the hospital, so it was something brand new that we started. We hired auditors and we went out and we did post-approval monitoring to conduct for studies that were already ongoing to ensure that investigators were following their protocol. And this was early 2000s. And so now I know a lot of HRPP programs have that, but it is set up at each institution a little bit differently. Sometimes it’s within the HRPP office or IRB office, for lack of a better word, it’s not really IRB office. And sometimes it’s external to the IRB office and it’s outside of it at an institutional level. But you never know what you find.

So when you’re doing that, you could come across an activity that all of a sudden you’re like, “Wait a minute, did you come to the IRB for this?” Or in those conversations, people start talking, right? And they start telling you things and you’re like, “Wait a minute, that sounds like something that you should have come to the IRB for. What were you…” “No, no, that was just a program evaluation. That was just something we were doing internally.” And so I think that these things are really tough to… And I think each institution, and they’re tough to say that there’s a one size fits all, and each institution does things differently. Here at the NIH and the Intramural Research Program, we’re really heavy on Phase 1 research, but that doesn’t mean that all institutions are the same. And so some institutions might do a lot more social and behavioral research or just social and behavioral research. And so I think that’s where you’re going to find a lot of quality improvement activities happening.

Justin Osborne: Yeah, that’s a lot of gray area as it is. And so then you add on the social behavioral, which is gray in and of itself.

Tiffany Gommel: Yeah.

Justin Osborne: So I guess, do you have advice for either side, researcher side, the IRB side, on this topic, QI versus research? What is the best approach? We talked about there’s some nuance to it and every institution’s different, but in terms of either having resources or intentionality, what would you recommend for people who are like, “I’m really struggling with this at our institution”?

Tiffany Gommel: Education is huge. I think doing just an education component for your research community on quality improvement on, at your institution, what are some case studies that you’ve seen? What are some things that have come up that… And have some engagement with the attendees of the education session on whether or not they maybe thought it was quality improvement or research. I think getting out there to fellows and to students when they’re brand new and that they’re going to have to do projects that are going to need to come to the IRB, I think that if you can talk with the program officers or you can talk to whatever the equivalent is at your institution that are maybe mentoring these fellows or students or graduates, go do education when they’re brand new, have some conversations with them on, “I know that they’re going to be needing to do certain activities to graduate or to finish their degree, and so let me be one of the first people that they talk to as part of the program,” so that they can start off on the right foot instead of maybe going down the wrong path and then having a really bad taste in their mouth that like, “Gosh, this is such a bad process and terrible and nobody ever told me.”

So kind of get in early so that you can help teach them. Because I think that’s where a lot of it happens, where they’re unsure of what they should be doing. I think that having a guideline written out specifically with these definitions or what your institution feels comfortable with is important as well. So yeah, I mean even maybe a page on your website that is specific to just quality improvement so that people are like, “Are you unsure of what you’re doing?” And you could kind of have a flow diagram or whatever.

Justin Osborne: No, that’s great advice. I think the education piece is really an answer to a lot of these issues in research is let’s just educate people and bring them on board. Because resources are always tight in these programs anyway. And so the first thing to always go seems to be education and training. So that’s good advice.

Tiffany Gommel: Yeah, and there’s different ways you can do it. I think that you should have different avenues for people to access the education as well. So we all know that our world is just becoming more and more electronic, and so maybe go out in person. Because I do think that, especially around areas like this, having those conversations is important. Letting them say, “This is what I want to do. Does it cross the line?” So that they can actually talk to somebody about it. But also maybe video recording it so that you can have it on your website so people can always go back to it and listen to it. So just having different avenues of that education so that when it’s 10:00 at night and they’re like, “Gosh, I remember that Tiffany came and she did a talk about this, but I can’t really remember some of the nuances. Let me kind of review it.”

Justin Osborne: Yeah. No, that’s great. That’s great. Yeah, I mean, we do have to meet the researcher where they are, right? As you said, they may be designing their study at 10:00 at night. That’s not when the IRB office is open, so…

Tiffany Gommel: Exactly.

Justin Osborne: Yeah. Well, thank you, Tiffany. This has actually been fantastic. I really appreciate you kind of going through this QI versus research, call it a debate. We’ll see. People are constantly asking about it, so it is a big topic. But I appreciate you giving your insights and sharing this with us.

Tiffany Gommel: Yeah, it was really nice doing this, and thanks for having me, Justin.

Justin Osborne: Of course. Welcome back to our segment, Same Team. I am still sitting here with Tiffany, and it’s easy to get bogged down in our day-to-day job responsibilities, but I do believe that most of us stay in this research industry because we actually care about the impact we’re making and we want to make a difference, right? So can you share an experience with us or an example from your career that connects you back with this idea that we’re all on the same team?

Tiffany Gommel: Yeah, actually, I have had the opportunity when I was at University of Maryland to work with the Institute of Human Virology and was asked to go to Nigeria in Africa and was there for almost two weeks, and we actually helped them set up their own IRB so that they could review their own IRB. And during that trip, it was one of the most profound experiences that I got to go through because, number one, I got to help them learn what an IRB does. And it was really interesting because they wanted to have the freedom to review their own research, but they didn’t know how.

And so in preparation for going over there, we got together and we had to kind of think about how would you start from scratch if you had nothing? You didn’t have an electronic system, you had nothing? We had to create all of our forms in paper and bring them over and all of our checklists in paper and bring them over, and what does an SOP look like and what does a policy look like? And then we taught them and we taught nurses, we taught study coordinators, we taught IRB professionals, IRB chairs, how to do each one of their roles in the research arena.

Justin Osborne: That’s amazing.

Tiffany Gommel: And at the end of two weeks, we did a mock IRB meeting. We had them review their protocols, and we made up protocols that we had done before, but slightly changed them. And it was an unbelievable experience. And the thanks that we got from them and the privilege for them to invite us in into another culture, and we got to see in real time, we got to go into remote areas of Nigeria and actually see how hard it is for subjects to get to even a healthcare environment just to get any healthcare, let alone research interventions, and so it was just amazing experience. And I think that solidified me into continuing in this field. It felt so impactful to help them create their own IRB. And hopefully they’re still doing it.

Justin Osborne: That’s incredible. I was going to ask, do you know if they’re still… I’m sure it’s evolved over time, but-

Tiffany Gommel: Yeah, I’m sure there are way more experienced than they were back then. This was probably 15, maybe more, years ago. And so I would say that I know that the Institute of Human Virology is still there, and so hopefully it has completely transformed.

Justin Osborne: That’s amazing.

Tiffany Gommel: But yeah, started them with nothing, and it was awesome.

Justin Osborne: Yeah, I can’t imagine how many people it took to set that up and do that. That’s a really cool experience.

Tiffany Gommel: Yeah, yeah.

Justin Osborne: That’s awesome. Well, thank you for sharing, Tiffany. That’s a fantastic example. Again, thank you so much for taking the time to do this and educating us a little bit more, and it’s always great to see you.

Tiffany Gommel: Yeah, thank you so much, Justin. This was my first podcast ever, so I’m so happy to share that with you.

Justin Osborne: Yeah, you’re a natural. You’re a natural. I appreciate it, Tiffany. Take care.

Tiffany Gommel: All right, have a good one.

Justin Osborne: Thanks. Be sure to follow, like and subscribe to On Research with CITI Program. If you enjoyed this episode, you may be interested in other podcasts in the CITI Program universe, including On Campus and On Tech Ethics. You can listen to all our podcasts on Apple Podcasts, Spotify, and other streaming services. You should also review our content offerings regularly as we continually add new courses, subscriptions, and webinars. Thanks for listening.