On Campus Podcast – How HRP Consulting Group Supports Universities in Research Compliance

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1. Justin’s Professional Journey (00:01:17) Justin shares his 17-year career in clinical research, detailing his roles in both IRB and consulting environments.
2. HRP’s Role in Bridging Gaps (00:03:12) Discussion on how HRP Consulting Group connects universities with regulatory bodies and the importance of this relationship.
3. HRP’s Commitment to Excellence (00:06:03) Justin explains HRP’s vision of conducting ethical research and establishing trust within the research community.
4. Regulatory Challenges for Universities (00:07:53) Justin discusses significant regulatory challenges faced by universities, including adapting to new regulations and AI use.
5. Customized Consulting Services (00:10:46) Justin emphasizes HRP’s tailored approach to consulting, meeting universities’ unique needs in research compliance.
6. Networking and Resources for Universities (00:11:43) Advice on leveraging networking and resources available to universities for navigating regulatory environments.
7. On Research – Cross Promotion (00:13:43) Justin shares insights about hosting the “On Research” podcast and the joy of engaging with diverse guests.
8. Future Goals for the On Research Podcast (00:17:59) Discussion on Justin’s aspirations to evolve the podcast format and reach a wider audience in the research community.

Ed Butch: Welcome to On Campus with CITI Program, the podcast where we explore the complexities of the campus experience with higher education experts and researchers. I’m your host, Ed Butch, and I’m thrilled to have you with us today. Before we get started, I want to quickly note that this podcast is for educational purposes only and is not designed to provide legal advice or guidance. In addition, the views expressed in this podcast are solely those of our guests.

Today’s guest is Justin Osborne. Justin is the associate vice president at the HRP Consulting Group. Welcome to the podcast.

Justin Osborne: Hello. Thank you.

Ed Butch: Of course. And today our discussion centers around Justin’s experience in the IRB world, how a company like HRP works with universities, and what I’m honestly most excited about, chatting about podcasting. Also, I feel that it is important to point out as a quick note to our listeners that HRP and CITI Program are both divisions of BRANY, the Biomedical Research Alliance of New York.

All right, so with that being said, let’s start our conversation. So first, can you share a little bit about your professional journey and how it led to your current role at the HRP Consulting Group?

Justin Osborne: Absolutely. Yeah, thanks Ed, and thank you again for having me. So my professional journey, I’ve been in the clinical research space for 17 years now, and I started out on the IRB side of things. I worked for a short bit at a commercial IRB, then I went quickly over to the university setting and I worked for a local IRB at University of Cincinnati for a while. Sort of cut my teeth there on this sort of IRB world, worked my way up there, kind of understood, learned the industry a little bit. Then I went back actually to the commercial IRB side for a while, and I ended up falling into business development and worked there for a little while, selling IRB services, consulting services. After that, I actually shifted again back to an academic medical center to take on operations roles and research. So I ran the clinical research department there back at the University of Cincinnati at the academic medical center. And then I ran that through COVID and got to experience the whole COVID peak through clinical research and running all the trials. It was very chaotic for all of those in the research industry that worked through that. It was obviously a challenging time, but got through that. And then shortly after that, I was brought over to a community hospital to run their clinical trials program.

My career has been a lot of building programs. A lot of building teams, building programs, growing teams, and I’ve enjoyed it. I like the fact that I have sort of jumped back from the university side to the corporate side back to the nonprofit hospital side. And then two years ago I landed here at HRP Consulting Group and joined this team to help provide consulting services to a lot of universities, institutions, and other corporate entities that perform research. So there’s a lot there, but yeah, I’ve been jumping around.

Ed Butch: There is a lot. I mean, honestly, a very interesting career path that you took. And I must say, of course, go Ohio.

Justin Osborne: Yes.

Ed Butch: Since you’re in southwest Ohio, I’m in northeast Ohio.

Justin Osborne: Absolutely.

Ed Butch: We got to wrap our state, right?

Justin Osborne: That’s right. That’s right.

Ed Butch: Well, I love that. And so we have a lot of administrative listeners and things like that out there, so thinking about HRP and its focus on being a bridge between clients and regulatory bodies, what does that really look like for a university? And could you really elaborate a little on the importance of this in the regulatory environment that we have?

Justin Osborne: Good question. That’s exactly what HRP does. As a consulting company, we provide experts from our team to clients like universities. Most of our clients are institutions and universities, but we provide services to help bridge the gap between the research team that’s there on the ground working and all the regulatory updates and the changes and the gaps that might be there. We’re very focused on helping people conduct research the right way, because that’s what matters to us. So because of that, I think it’s important that people understand that there are resources out there that can help you accomplish those goals. And so there are a lot of consulting options out there, and I think what it comes down to, just based on my experience and my career path like that we just talked about… This is a very relationship driven industry in research, and I feel like consulting is the prime example of that. You build a relationship with somebody, you get to know your client, and you help them out the best way that you can.

Ed Butch: Yeah. I mean we all need that little bit of the piece of expertise. I know having worked at universities for so many years, and having worked with multiple consultants, having that specific experience in what you’re looking for is extremely important, so you’re offering a great service.

Justin Osborne: Absolutely. Yeah. Thank you. And again, I’ll say this about university, universities have a very different culture than say the corporate world, right?

Ed Butch: That they do.

Justin Osborne: Yeah, right? And we could go through the pros and cons and differences. I think one of my favorite pros about the university life though is the culture of sharing, and the culture that if you’re a university and you’re struggling with any process, any operation, you can generally find a colleague at another university and they’ll be willing to share at least how they’re doing it, right?

Ed Butch: Definitely.

Justin Osborne: And so you ask around, you build a network, you find people who can help you out, and then as you kind of grow at a certain point there will be a time where you may have friends, but there’s maybe new regulations, there’s brand new stuff, and how do I interpret that? Well, we’re all trying to figure this out together, and that’s where consultants really come in to help bridge that gap.

Ed Butch: Definitely. Fantastic, thanks. So your vision statement for HRP, which I found out you actually had a heavy hand in creating, mentions a commitment to setting new standards of excellence. So can you really provide some examples of how HRP has pushed the envelope in working to fulfill that mission and vision?

Justin Osborne: Oh, absolutely. I mean I think, again, this kind of goes back to a vision statement. Like why we exist in what we’re trying to accomplish in this industry? Because again, there’s a lot of consultants. And for us, I think for the team at HRP we are focused on, again, helping people conduct research the right way. And we really do believe that conducting research in general is important, I think that’s something that everybody can agree with how important research is to conduct.

Ed Butch: Yes.

Justin Osborne: I think it’s equally important to conduct it in an ethical and compliant manner. And so it’s not just about getting to the end results and get the data out, get the revenue up, get the budgets, all that stuff. It’s all part of it, but I think the ethical compliant pieces of research and conducting those properly is essential. At the end of the day, I want to know that the research conducted, and the outcomes of those research, were conducted in a way that people can trust and people can rely on.

Ed Butch: Right.

Justin Osborne: So that’s why we do what we do. That’s really where we try to set ourselves apart is building that core relationship with our clients to help them do what I just said.

Ed Butch: Yeah. Yeah, for sure. I mean that’s why they need to do those CITI trainings, right?

Justin Osborne: Absolutely, absolutely. Yes.

Ed Butch: So obviously you mentioned new regulations, things are happening all the time, especially I feel like in the past 5, 10 years or so with some of those changes. So what are some of the most significant regulatory challenges you see the universities that you work with facing today? And as a consultant for HRP, how do you help them address those challenges?

Justin Osborne: Yeah, good question. I mean there’s a lot. I think there’s been, obviously years ago the common rule came out and there are still people that are trying to come on board with that. Maybe they didn’t conduct research that applied back then, but now they’re trying to go in that direction and so they’re having to deal with all the common rule updates. And that was a lot, that was the biggest regulatory overhaul in the research space that we’ve seen in 30 years.

Beyond that, I think there are the hot topics like in any industry. AI of course is impacting every industry, but I think from a research perspective and what we’re seeing at the university side when it comes to conducting research, the IRBs and the researcher side, they’re trying to figure out how to use AI ethically and effectively. And so for example, from an IRB standpoint, what kind of questions should you be asking the research team that relates to AI? Like how was this used? Was this used to develop your protocol? If so, what kind of AI was used? Where does it come from? These are a lot of things that of course the practical research operations that happen are way ahead of the regulations, and even guidance. So the regulations are always going to lag behind the actual processes that happen in day-to-day life. So it’s really a matter of understanding and implementing best practices that ensure that you are actually staying within the guidelines that are out there the best you can.

I think a couple other topics that come to mind is research security. There’s been a lot of updates recently with research security regulations. And for a university to set up programs around research security is a newer thing, and I think universities are trying to figure that out. And again, that’s where building a network and growing your network helps, comes in handy with those kinds of new requirements. I also think universities are struggling sometimes with regulations that aren’t even U.S. based, like outside regulations, GDPR. I’ve talked to a colleague a couple of weeks ago about the EU regulations on document retention that is relatively new, and whether that impacts your site here in the U.S. It’s easier in those situations to just say, “Hey, that’s EU regulations. It doesn’t apply to us”. But they actually can apply to your site, and so you really need to dig into this stuff and understand what the implications are of those things.

So yeah, I mean those are a couple examples. I think your second part of the question about how HRP helps address them, I guess I would just broadly answer it and say all the services that we provide are customized to our clients.

Ed Butch: Yeah.

Justin Osborne: So we really do meet people where they’re at. We don’t have sort of one solution, we’re not a one size fits all kind of consulting company. Our approach really is focused on learning the organization, getting to know the university that we’re working with, and helping them figure out a solution that makes sense for them. I always tell people, there’s obviously not one way to do research, there’s not one answer to have a compliant research program. And if there were, somebody would’ve figured it out by now and then everybody would’ve figured it out by now. You know what I mean?

Ed Butch: Right. Yeah, for sure.

Justin Osborne: So I think the customized aspect of our services is really what we focus on, just again, meeting clients where they are.

Ed Butch: Yeah, definitely. And I really like, you’ve mentioned it a few times now with that networking aspect, and I think that is fairly unique the amount that it happens across universities with professionals and researchers and everything like that. And obviously I think that’s a part of this question too in terms of there’s a lot of universities that are trying to navigate some of these regulatory environments that don’t necessarily have extensive resources and things like that. So what is some advice that you might give them in order to help navigate those environments?

Justin Osborne: Yeah. I think staying plugged in. I think, to your point, having the networking is vital. And I think as just a professional in the research space, in this space at least at a university, there are so many resources out there. There’s memberships, organizations that you can join, there’s associations you can join in whatever your specific role in research is. There’s also forums everywhere online. You can join IRB forums, you can join coordinator forums and learn what other people are doing. LinkedIn is one of the best professional resources out there, obviously, especially in the research world. Research is a fairly niche industry, especially at the university level. It’s generally a smaller department at a university, and there’s not many of us. So it’s easier to build a network if you’re out there and you get yourself out there and understand that you’re not the only one in your university struggling with whatever the issue is that you’re dealing with.

I would say outside of that, of just doing the networking stuff and having resources that are free, because of course, universities don’t have budgets often to do these kinds of things. I do think it is important when you get to a level of trying to make overhauls on programs and grow a research program… Or we have a lot of universities that come to us because they want to start receiving federally funded grants for research, and they’ve never done that before. So how do we grow an infrastructure? Those kind of changes, that’s typically something that you should go out and seek some consulting expertise for, just because there’s so much at stake and you want to make sure that you do those kind of things correctly. Yeah, so I guess that’s the advice I would give.

Ed Butch: Perfect. Perfect. Thank you. Honestly, this has been some, I think, great information for our university and research administrators that are listening. But as I mentioned at the beginning, what I’m probably most excited to chat with you about is changing gears here a little bit and talking about podcasting.

Justin Osborne: Yes.

Ed Butch: For our listeners that might not know, you are also a host of a CITI Program podcast, so can you tell our listeners a little bit about it?

Justin Osborne: Yeah. Yeah, sure. So it’s one of the other CITI podcasts, it’s called On Research, and I talk to experts in the research industry about varying research topics. I try to be pretty broad in the subject matters that I cover. But yeah, it’s just I guess a general educational podcast with interesting people to talk about research.

Ed Butch: Yeah, definitely. I find it interesting, because I’m not sure that my listeners even know this, but when I took over season two of On Campus, it was actually this is my first time hosting. And now I’m actually getting into some other hosting duties as kind of some side projects as well. So is this your first time hosting a podcast as well?

Justin Osborne: It is, it is. Ed, I think our journeys are very similar here. I was same way. I was asked to take over season two of On Research, just started this year. And it’s funny because doing this, sitting on this side is very different.

Ed Butch: Yeah, sure.

Justin Osborne: It’s a very different experience. But again, I love it, man. It’s so much fun to do the hosting stuff, and the whole process of finding the guests, picking a topic, going through all the conversation. It’s just a lot of fun.

Ed Butch: Yeah. Yeah, agreed. Agree completely. Is there anything that you would say in the… What are we in? Month eight now or so of it?

Justin Osborne: Yeah.

Ed Butch: That you would say is your favorite part that you’ve experienced so far?

Justin Osborne: I think my favorite part… Well, after I got over the initial nerves, right?

Ed Butch: Oh yeah.

Justin Osborne: You record the first one. And I was so, “I don’t want to hear my voice. I can’t even listen to it”. You know what I mean? After you get over that kind of stuff, because you do get over it, then I really think my favorite part is talking to people. Because the goal of this is a conversation. It’s to make the other person feel comfortable enough to make this a real conversation type setting. And I think trying to achieve that in the episodes when you’re having these conversations with people that you might not even know, and you get to the point where you just feel like there’s a natural flow, they’re just talking to you.

Ed Butch: Mm-hmm.

Justin Osborne: And it’s almost like all the podcast stuff goes away and they’re just kind of having a conversation with you, and you just get to capture that.

Ed Butch: Exactly.

Justin Osborne: Air it out, and that’s a nice feeling. And of course meeting the new people, I really enjoy growing the network, right?

Ed Butch: Right, right. I would completely agree with that. That’s been, not only I would say with the podcast, but I think that’s really helped me. But just in my role at CITI Program in content and education as well, is growing that network. When I worked at my previous institution, I would say I wasn’t siloed within my role, but I was siloed within my university.

Justin Osborne: Yes.

Ed Butch: So I networked, and I knew a lot of people at the institution, but I didn’t necessarily get outside of it. And so this role as podcast host, as well as my role as assistant director, has just really helped me expand my network.

Justin Osborne: Yeah.

Ed Butch: And now I’m following all these previous guests on LinkedIn and seeing what they’re doing, all kinds of cool research and papers that they’re writing and everything.

Justin Osborne: Absolutely. It’s cool.

Ed Butch: So I think it’s really just been really cool to see that.

Justin Osborne: That’s cool. Yeah, it’s a cool experience to network in general, but then as soon as you start going outside of your organization, and like you’re doing outside of your industry even, right?

Ed Butch: Yeah.

Justin Osborne: To a certain extent. I don’t know, it’s a nice feeling. It’s like the world gets a little smaller, actually. You realize that everybody is sort of dealing with the same stuff, and that’s fun.

Ed Butch: Yep. For sure, for sure. That’s awesome.

Justin Osborne: Yeah.

Ed Butch: So to wrap up, I always like to ask my guests about looking into the future a little bit. So for you, I want to focus more on the podcasting side, and do you have any goals for your pod over the next year or so?

Justin Osborne: Oh man, over the next year? I mean I really like how the podcast is evolving and the conversations and those kinds of things. I like the creative aspect of this kind of venture in that there’s so many options and so many possibilities that you can do. Like I would like to get to the point… So right now the On Research podcast is a monthly podcast, and so I really only get one guest per month and work through that. But there’s a lot going on in the research space, and I think there’s a lot of people out there that I want others to hear. So other than just growing the pod and getting people to know that it’s out there and an option… Because again, everybody has a podcast. So it does seem like-

It does. Of course, right? Yeah. We’re a punchline at this point. But beyond that, I think there’s a lot of opportunity to maybe change up just stylistically having podcasts that are either shorter and more on point with specific updates, or maybe regulatory change comes out and you can quickly throw a podcast together with an expert to talk just on that one point. To your point, just so people that are working at a university and they’re in their own university silo, they can hear from somebody at a different university across the country, and hear that this is how they’re dealing with something, or this is how they’re interpreting something. All that stuff helps. So I think from a podcast standpoint it’s more of, “How can we leverage this platform to impact the most people, and help inform people in the best way?”

Ed Butch: Yeah, no, I think those are fantastic goals, and I would agree with them on my side of things as well.

Justin Osborne: Yeah.

Ed Butch: And like you said, it’s giving the voice to many people that oftentimes don’t have a voice and not able to get their information, whether it’s on research or whether it’s something happening on campus that they’re doing. So I those are great goals.

Justin Osborne: I like that. Well and I’ll add too, because what you’re doing here I think this is awesome, and I think that finding opportunities to crossover, right?

Ed Butch: Mm-hmm.

Justin Osborne: Because CITI obviously reaches all over, and your scope is huge. And I am, I’m in my own research bubble obviously on the podcast. But to your point, the people listening to yours on campus stuff, I mean there’s a lot of university people who may actually be involved in research somehow in their university, so there’s crossover. So yeah, I like this idea of continuing to figure out ways to do these kind of crossovers.

Ed Butch: Agreed. Agreed.

Justin Osborne: Yeah.

Ed Butch: Awesome. Well, thank you so much. I really appreciate you being a guest for me today. And really just once again, really want to thank you for sharing your experience, both with your career journey and the regulatory areas, and of course with podcasting as well. And I highly recommend to our audience, give On Research a listen so you can hear some of these great guests that Justin is bringing in.

Justin Osborne: I appreciate it, Ed. Thank you so much.

Ed Butch: Of course, of course. Take care.

I invite all of our listeners to visit citiprogram.org to learn more about our courses and webinars on research, ethics, compliance, and higher education. I look forward to bringing you more expert guests to discuss what’s happening On Campus.