Unifying Research S2E4 - HRPP vs IRB and Participant Christine

In the fourth episode of Unifying Research, I sit down with an executive director of an HRPP at a leading academic medical center and research institution to discuss the difference between a Human Research Protection Program and an IRB. I also talk with a research participant who, after participating in several studies, has spent her career inside the research industry working to improve things based on her own experiences.

My research expert guest is Adam McClintock, the Executive Director of HRPP at the University of Alabama at Birmingham. Adam has over two decades of experience in the research industry and shares some much needed guidance on the differences between an HRPP and an IRB. He explains the importance and encourages the industry to think about how we can start measuring effectiveness of our HRPPs.

My research participant guest is Christine Melton-Lopez. Christine is a research expert herself, but before that, she participated in multiple research studies. She shares the good, the bad, and the ugly of her experiences participating in different studies through college and beyond. Her stories help illuminate that while research isn't perfect, it's still a very hopeful and meaningful endeavor. Christine shares some wonderful questions to ask when you're considering participating in a study. 

Additional resources:

• Connect with Adam McClintock on LinkedIn
• Connect with Christine Melton-Lopez on LinkedIn
• Learn more about the UAB Research Program
• Learn more about the AEREO program
   
   
• Learn more about Univo's partners working together to bring the patient's voice to research:
• Clinical Trials For All
• Savvy Cooperative
• Inspire
• Children's Flight of Hope
• The Patient View
• AAHRPP

Transcript

SPEAKER_03 0:09

Hello and welcome to the second season of Unifying Research, a podcast about bridging the gap between the business side and patient side of the research industry. I'm your host, Justin Osborne. I have the privilege of working with an amazing group of people at Univo IRB, the fastest growing IRB in the industry. At Univo, we believe patients should have a bigger voice so clinical trials are better and more accessible for all. So we're using our network and platform to not only give patients a voice, but also share industry expertise for those of us working to improve research from the inside. Each episode will have two conversations, one with a research professional discussing their area of expertise, and the other conversation on the patient side and experience with research. My hope is that these episodes will spark further conversations, creating opportunities to bridge the gap between patients and research. Quick disclaimer before we dive in: the opinions you hear on this podcast are our own and don't reflect those of our employers, past or present. We could be talking about research, data, regulations, or even laws that affect your organization, but this is not legal advice. My research expert guest this episode is Adam McClintock. Adam is the executive director of the Human Research Protection Program at the University of Alabama at Birmingham. With over two decades of research experience, Adam previously served as the director of the UAB IRB and had leadership roles at Ohio Health Research Institute and Ohio State University. Adam's experience includes operations, IRB, ethics, and research oversight strategy. I sat down with Adam to talk about the difference between human research protection programs, or HRPPs, and IRBs. These terms are often conflated and I think misunderstood sometimes. While it may seem simple on the surface, Adam explains the distinctions between the two with a borrowed analogy that is sure to stay with you. We also discuss why the HRPP elements are so important, and he encourages the industry to start thinking about how we might measure effectiveness of an HRPP. Whether you have a well-established HRPP at your site or you're building a new program, there's plenty of wisdom and advice here from a great leader at one of the top research universities and academic medical centers in the country. So without further ado, I hope you enjoy my conversation with Adam. I am super excited to have Adam with me here on the podcast. Adam, thanks so much for joining. Yeah, absolutely. So before we get started into our topic, could you explain to people listening how you kind of got into research in the first place and what you're doing now?

SPEAKER_04 2:46

So I think like many of us, I think that's changing a little bit, um, but like many of us, it was it was sort of by accident. So I I have an undergraduate degree, a bachelor of science in psychology, which anybody with a that uh sort of degree knows there's not really a direct career path unless you're you know going into clinical psychology or academia. And so I couldn't find a a good job when I graduated. So I continued doing food service management, which I I I did uh as an undergrad to put myself through pay tuition.

SPEAKER_02 3:20

Yeah.

SPEAKER_04 3:20

And so I I got about six months into that. I had a full-time managing management uh job. And about six months in, I decided my fusion with Matt and Food Service. So uh I applied to every every job I could on campus that sounded interesting. And the uh IRB office at Ohio State was uh the first to call, interview, and make an offer. So I I started at the reception desk at the IRB office at the Ohio State University and worked my way up through there and eventually made my way to Birmingham. So when people I asked, you know, how I got into human research protection, that's uh I always say food service.

SPEAKER_03 3:58

That's great. That's great. Not a traditional round. Yeah. And and like you said, it's it's funny because you know, I I think you're right that it's changing. There, there's a lot more structure to this industry now than there was when we got in, right? Um but that that's funny that you got in through food service. So then tell me uh what's your what's your actual role now? What are you doing now?

SPEAKER_04 4:18

I am the executive director of the human research protections program at UAB. Been here about seven years. And even at over that seven years, we've evolved a lot, if you can imagine. Uh I started about a year before COVID hit. Oh that that took us through some detours and think we're we're out the other end of that. Uh yeah. And they're cruising along.

SPEAKER_03 4:38

That's awesome. That's awesome. Well, thank you. Thanks for the background and and the context here. And that's that's helpful because our topic that we're going to talk about today is uh I guess the world of IRBs versus HRPPs. And there's so many acronyms, but I'll let you kind of uh take us through those. But first, let's start there. HRP, everybody kind of knows what an IRB is. Take us through HRPP. What what are we what are we talking about there?

SPEAKER_04 5:03

So the analogy I would like to think think of uh is one that I first heard at a single IRB workshop in 2019 at Blick with Pural Auroric. I've heard her use it several times, but that was the first time. So she compared the the HRPP, the human research protection program, to an olive. Uh so it's it's the meat, it's the it's the body, it's the things that actually protect human subjects. And then the IRB uh is as the pimento, which is the center of the olive, and actually why the pimento is even there in the first place.

SPEAKER_03 5:41

Um yeah, that that makes sense. Okay, so so the the human research protection program is the sort of covering the outside shell, so to speak, with the IRB in the middle.

SPEAKER_04 5:53

Right. Yeah, absolutely. The the the IRB is sort of the executive function that that reviews the research, reviews all of the the things um around the research that are there to protect human subjects. So your your ancillary review, your biosafety approval, your your uh drug approvals, all of those things that that feed into the actual function of protecting human subjects.

SPEAKER_03 6:17

Yeah, okay, well, okay, so thank you. So that gets into it a little bit. So what I want to understand better is, and again, I know we're we're talking about institutions, sites, that kind of stuff, right? So at the at the research site level, local sort of IRB, local oversight kind of level, help us understand the difference. I think people throw out IRB. I mean, I hear IRB and HRPP kind of used synonymously and thrown out by a lot of people. So I guess if you want to go over like the IRB function to sort of narrow that scope down, and then let's move on to like the the actual HRPP stuff that's broader outside of the IRB.

SPEAKER_04 6:58

Yeah. So the what I would like to say is that the IRB, the IRB function, is really, you know, I know there's there's exemptions and there's expedited review, but to put it simply, the IRB function is what happens in the boardroom. It's it's the decisions that are made, the regulatory determinations, all of those things. The the HRPP is again all of those things ancillary to it, which you know, I think, I think traditionally until the last five to seven years when the single IRB mandates came into place, the HRPP and the IRB kind of in some ways were synonymous because as we as we know IRBs are asked to gatekeep all kinds of function. And until the single IRB mandates, the HRPP was often kind of baked into the IRB review, I think. And so when the single IRB mandates uh came into place and it removed the IRB review from uh the institution, then institutions really had to think about and articulate what what is an IRB function and what is uh an institutional function or an HRPP function, and how do we gatekeep those things? Because you can't with the IRB review part of it removed, it's it's harder to gatekeep uh certain things. So we had to kind of systematize it.

SPEAKER_03 8:20

No, that makes perfect sense. Okay, so you're saying once the single RB mandate kind of came out, and and like you said, you know, once reliance, right? That the the concept of relying on an outside IRB came into play as an institution, there's still so many other responsibilities that you have, and and not only figuring out what that is, but how to how to organize it, right? Like how do you structure that function? Because again, every every institution's different. I'm sure every site's um structure is is slightly different for this stuff. But uh help me understand like what besides I uh you mentioned the ancillary reviews and stuff, but what actually falls under say an HRPP umbrella that's not IRB?

SPEAKER_04 9:07

Things like uh radiation safety, okay, IBC approval, you know, if if you've got uh gene therapy, things like that, conflict of interest, uh grants accounting, sponsor programs, all of those things that oh yeah, that drive human subject research that aren't a core responsibility of the IRB.

SPEAKER_03 9:30

Right, right. Yeah, I didn't even yeah, sponsor programs, that's huge, right? Like if if you're an institution doing federally funded, you know, grant research stuff, those those offices are can be very large. That's a lot of work.

SPEAKER_04 9:43

Absolutely. And I mean, even you know, industry uh research, you have to they they negotiate the remuneration or protections if somebody gets injured.

SPEAKER_03 9:54

Yeah.

SPEAKER_04 9:55

Those sorts of things.

SPEAKER_03 9:57

So then how do you I guess how do you organize uh an HRP program? Thinking about like again, thinking of this as an a as a program. And I guess quick aside, do you say HRPP program or is that redundant? Do you just say HRP program?

SPEAKER_04 10:14

Uh I just say HRPP. Okay, so pro you don't need programs. I think I mean I think it's it would be like saying the the IRB committee.

SPEAKER_03 10:23

Sure, okay, yeah, that makes sense. That makes it okay. So the uh HRPP, how do you decide and and maybe kind of share, you know, if you can, what UAB does, like what how did you guys sort of build your HRPP out well, you know, I arrived in 2019, so the so that's the single IRB mandates were already in place.

SPEAKER_04 10:46

So I think a lot of the thought about how that how that was structured was already done. So, you know, the the pieces, the parts and pieces that that we had to gatekeep and separate out from the IRB review, a lot of that had thought had already happened. Sure. So over the over the last uh seven years or so that I've been here, it's it's been more about not necessarily centralizing it, but having having a central formal like oversight, like a hub to make sure that we're thinking about all the different uh things that need to occur for any given study. Because every every study's gonna be different, right? I think sure. I think I counted it up at one time with there's it's if they if a single study had every ancillary review the we required, it would be something like 12 to 15 or something like that. So so so you know every study's different, and every every study is gonna have a different combination of of uh HRPP components to touch it. So it's I see having having a way to look at it from uh a high-level centralized view is important to make sure that that everybody who needs to be involved is involved up front. Um you don't you don't have something come up later where you know, oh this this should have gone through office of council, but it didn't, or you know, this uh distinct for sponsored programs would have been done. Um and you know, worst case scenario, you don't want to have something bad happen to a participant and realize that something else should have should be. Right.

SPEAKER_03 12:25

Yeah, no, that actually that's a that's a good point. So what what you're it sounds like the goal of uh of the HRPP at an institution, I mean like yours and others too that are that are you know bigger institutions that do a lot of research, like I if it's not centralized, I imagine that would be not only harder for you managing the actual getting getting the ancillary approvals or whatever, but that has to make it easier on the researcher too, right? Like they don't have to go to different, you know, um if my study involves radiation safety or you know review and you know IDS for pharmacy stuff, like if they have to chase all these things down themselves and there's not like a centralized process, I feel like that would be a lot harder on them too.

SPEAKER_04 13:10

Yeah, absolutely. And that's you know, that's what I always try to emphasize to my staff is that we we manage the IRB review, but we also we don't necessarily manage the processes of the others, but we we're sort of the the hub. And I think HRPP staff can often be sort of IRB centric in their thinking, and this is the most important thing in the world, this is what I do every day. But I try to emphasize to them that we need to be empathetic to the researchers because IRB review and approval is is one part of the vast array of of different processes that investigators have to go through in order to enroll that first participant, which is which is what they that's what they want to do anyway. So all of these other administrative things, while important, right, are not their end goal.

SPEAKER_03 14:07

And so that's a good point. Yeah, and again, like making it making it easier on the researcher to to just logistically get their study up and running. I mean, I mean, all all of the it's it's assumed that your your goal is to protect humans and to and make sure everybody follows the rules and stuff, but just logistics alone, it makes sense to have this stuff centralized. I'm also thinking like again, I'm I'm at a central IRB, of course. So when a site submits to a central IRB, the central IRB is not an HRPP, of course, right? Like we just do the IRB piece, and this the researcher at the site still has to make sure all of these other, you know, the outer olive is taken care of.

SPEAKER_04 14:50

Right, absolutely.

SPEAKER_03 14:51

And do sponsors know that like I'm just I don't know, do do the industry like partners, sponsor CROs, like do they fully understand? I just wonder how much how familiar they are with the fact that at the site level you have these other so many other up 12, 15 potential, you know, approvals that you have to get before your study can start. And just because they send it to a central IRB and get IRB approval, doesn't it's not the magic like, okay, now you can just start no matter what.

SPEAKER_04 15:22

You know what I mean? Yeah, I I that that's a great question. But you know, I do I do know that uh with with the proliferation of remote work and things like that, if there have been sort of boots on the ground, IRB, study coordinator they've they've gone to CROs and industry and things like that. So you know maybe maybe as uh more HRPP people get out into the um diverse uh spaces that maybe that may kind of hopefully yeah, cross-contamination.

SPEAKER_03 15:55

Yeah, exactly, exactly. I like that. So I'm also thinking like with this HRP, all the HRPP functions you're talking about, it's not just about centralizing the the approvals or the functions themselves and making sure that all these other things are are are checked off. All of this stuff does have to ultimately feed into the IRB review and approval, right?

SPEAKER_04 16:17

Absolutely. And that's that's where you know I think it's really from an efficiency standpoint, it's really important to uh that's another reason why it's really important to have a high-level view of all the different processes because you have to coordinate them. You know, there are some that absolutely they have to happen before something is submitted to the IRB, but a lot of them they can have happen in parallel. Okay. Some of them, for example, um, if you identify a conflict of interest in a clinical trial, that I think the review can be done in parallel, but you really need the the management plan if there is one in place before approval, for example, if is before IRB approves it. Right. Yeah, okay, okay. So if if if there's language that needs to be disclosed in the consent form to let participants know that an investigator has a complex, that's that's important. Others can happen in parallel, funding funding agreements can happen in parallel and don't necessarily need to wait for IRB review. So okay.

SPEAKER_03 17:21

Gosh, yeah, that is. That's a that's a ton of coordination. Do your researchers understand the value of, I mean, we just talked about how it would be easier for them, but do they understand what you all are doing and and how much coordination it takes and how much logistical stuff is going on?

SPEAKER_04 17:37

Yeah, I mean, I I I think so. And the you know, ultimately IR IRBs and the HRPP systems exist because of of things that happened in the past. Your your Henrietta Lacks, your your Havasupai, your Stanford Prison Experiment, where who would have thought that that would have happened for uh what would probably deem minimal risk social behavioral sciences uh study. Right. And the IRBs don't exist for the majority of it. It exists for the one in a thousand cases where where something really, really bad could happen.

SPEAKER_03 18:12

Yeah.

SPEAKER_04 18:13

But but even so, I think our researchers do understand the value add, even uh begrudgingly sometimes.

SPEAKER_03 18:20

Well, that's yeah, just the nature of course. So this is a great sort of high-level overview, understanding the different functions and purposes of of like an HRPP versus an IRB, right? They're they're they're distinct things that that exist. How do you make sure that they don't overlap? How do you make sure that they stay in their own sort of buckets? Does that make sense?

SPEAKER_04 18:44

Yeah, I think so. So the the HRPP, uh, gatekeeps, so many different things, because especially in in complex clinical trials and and with the the advent of big data where uh you know people's data uh can be manipulated combined with other data sets very easily and quickly, and AI at the frontier there. There are so many things that that go into protecting human subjects that fall outside of the IRB review. And so uh so the HRBP rightfully gatekeeps uh so many different things. Yeah and there I think perhaps is the temptation for other institutional stakeholders to say, hey, they keep the I the HRPP gate keep gatekeeps all of these things. They're a central thing. Maybe they could gatekeep uh you know my thing too, and it have nothing has zero to do with with uh with human subjects protection.

SPEAKER_02 19:45

Yeah.

SPEAKER_04 19:46

Things like billing compliance or or something like that.

SPEAKER_02 19:49

Oh, yeah.

SPEAKER_04 19:51

Is it important from an institutional risk perspective, sure, but not necessarily aiding in the protection of human subjects?

SPEAKER_03 20:00

Yeah, I okay, that's interesting. So I uh I know a local IRB that this is a while back, that they were at a certain time, they were charged with managing uh clinicaltrials.gov for the institution. And it was what I that sounds like one of those like, why is the IRB managing clinical trials.gov for the for the institution. You know what I mean? Like, and again, I think at the time it was like, well, they didn't have a formal department or bucket or somewhere to put it, so everything just sort of gets dumped on the IRB, right? Um, but is that sort of what you're talking about?

SPEAKER_04 20:36

That that's that's exactly what I'm talking about. And it's it's and that's another reason I think it's important to to keep us line of sight on what the HRPP is managing, because you you may identify something that's taking up a lot of HRPP resources that uh that doesn't doesn't belong in that bucket and then somehow should be managed differently outside of that office. And it really shouldn't shouldn't hold up the the throughput for approval. Yeah. And then there's also there's also the way we've always done it, uh processes and research by its very nature is dynamic, and and there are always new things, new risks that we talk about. So for example, institutions are giving a lot of uh oversight to AI right now, and probably appropriately so, but there may be a point in time where we no longer we're comfortable with it. We no longer need to review every project for this way or that way. And so there are HRP HRPPs may outgrow certain components and over time need to shed them as we become more comfortable with certain things.

SPEAKER_03 21:51

Well, like you said, I mean, I like that because it is because research is dynamic, as you said, like you almost have to build these programs to To match that that same level of dynamism? Is that a is that a word? Um, yeah, like but you know what I mean? Like that, that is you have to be able to be flexible because this industry is evolving so fast, especially now, right? Like you said with AI. That's crazy. I wonder about hybrid stuff. So what about like research compliance, right? Like, you know, and an organization, especially like yours, like you obviously have a corporate compliance office, huge corporate compliance office, I'm sure, over everything. And then you probably have some research compliance elements, but does some of that fit under the HRPP umbrella? Does it sit outside completely? Like, I'm sure there's some overlap.

SPEAKER_04 22:43

Well, I think I think almost all of the components of an HRPP are part of the Venn diagram where where it's not all human sub, in most cases, it's not all human subject research. Like IBCs, most of their most of their work doesn't touch human subjects. The Office of Counsel, yeah, treatment. We have we have representatives, but most of what they do, not human subjects. Uh Office of Uh Compliance Risk Assurance, again, most of what they do is not not human subject research, but that's again why it's important to have a high-level view and and know who you can go to and develop relationship and cultivate relationships with the people in those offices. So they're there when you need them.

SPEAKER_03 23:28

Yeah, yeah. I mean, it to your point, it's like the you know, the IRB, when you when you really pare it down and you're looking at I like the olive analogy with the uh pimento inside with the IRB, like that, their mission is to protect human subjects. That's that's the the goal. The a it sounds like the the goal really of an HRPP is to protect the institution, this the employees, the staff, the organization itself almost, or or you know, slight variations of that, but it's much more broad than an IRB scope.

SPEAKER_04 24:00

Oh, yeah, absolutely. And and the stakeholder group you didn't mention, obviously human subjects. That's that's the they're there to protect them too, but that's that's through the HRPP.

SPEAKER_03 24:10

Yeah, yeah, exactly. It's it's just one of the levers that they have, right? Right of the HRPP. Yeah, I like that. I like I like think about this. So how would you how would you recommend? So there's a lot of smaller research sites out there, like UAB's huge, obviously. You guys do uh quite a bit of research there, you have a massive program, all that stuff. What about the smaller sites or s or even smaller institutions that you know they they have a a local IRB and and that's the extent, but in those sites, I I see a lot of times, you know, and you've probably seen them too, they they they tend to do this thing where they just everything is under the IRB. And and even though they might have elements of an HRPP obviously built within, it's still an IRB. Like what do you recommend that they sort of try to parse that out and and develop a even if it's small, or is it, you know, do you have to be a certain size to to distinguish between an HRPP and an IRB?

SPEAKER_04 25:07

No, I think I think it's in I think it's important for an institution of any size to be able to articulate what components are part of their HRPP. Even if it's a half FTE that manages all of this. And maybe perhaps even more importantly, in that case, where it's it's somebody who's part of their job, not their entire job, is to do this, to manage the HRPP. So that that portion of their job that's dedicated to human research protections, they know very clearly what's what goes into protecting human subjects and you know what's in their lane and what's out of their lane.

SPEAKER_03 25:57

Yeah. Yeah, I like that. I like that. Because again, I I I would have to agree. I mean, thinking through this, like there no matter how, if you do one study or a thousand studies a year, like you know, again, because the the goals of both of these things, you know, HRPP versus IRB have completely different goals, right? And different scopes, like it would seem like you should carve it out. It's just I don't see a lot of resources or uh conversations about this, right? It's it's just everything is about IRB, everything is about, you know, in our space. I don't hear a lot of like, how do we improve our HRPPs? Is that just because every institution is different, or what I don't know.

SPEAKER_04 26:39

Yeah, I I that's a great question. Uh it it may be just that we we use IRB and HRPP synonymously. It may be that every institution's a little bit different, you know, and it may be it goes down go back to the the conversation that uh Ario and other groups are having, particularly after the GAO report uh several years ago about IRB effectiveness. How do we how do we how do we measure IRB effectiveness? How do we measure HRPP effectiveness? We're I I think in a lot of respects we're all just trying to uh to keep the ship running as smoothly as we can. And and yeah, oftentimes there's not a lot of time to sit back and think, how do we how do we keep the ship moving and make it better?

SPEAKER_03 27:29

Yeah, but it's true because you're right. I mean, I and those reports, um maybe I'll I'll link to some of those. I know they've been out for a while, but just for people interested, because this is this is really interesting stuff, trying to think through uh measuring effectiveness. Like we're uh IRBs are very mission-driven, and and you're right, there's not a clear metric for success. Like if you ask an IRB, like, how are you how do you know you're successful? Well, all the metrics around IRB are turnaround times. It's right, you know, nothing about like because I don't know how you would no patients got hurt in this study, you know, like right.

SPEAKER_04 28:05

Yeah, I mean that's that's at the end of the day, yeah. We we look at turnaround time, that's what uh you know, the the classic, classic measure. Yeah, but how do you the measure of success is that nobody got nothing bad happened and outside of outside of nothing bad happened? How do you how do you show we've been effective effective?

SPEAKER_03 28:27

Well, and and to that point, it because every you know, these conversations have been had, I know, but just to sort of flesh this out a little bit, to say that if something does happen and there's an adverse event in a study, the whole reason they're doing research is to see what right like there so you can't necessarily say because an adverse event happened or that you know this many people got sick in this study or something happened, whatever. That's not an IRB uh you know problem necessarily. Like it's it's very hard to tie these things directly to IRB functions, you know what I mean? Right, right. So yeah, that is that is really hard, but that's different than HRPP. How would you so we talk about IRB effectiveness and I know was it part of the GOA report about HRPP effectiveness as well?

SPEAKER_04 29:14

I don't recall it.

SPEAKER_03 29:15

I've never thought about like how would you define a successful HRPP? Because again, if the if the goal of that is to like any other program to manage a successful program of of centralizing these functions and overseeing them and making sure things don't fall through the cracks, then then the centralized model I think is the only way that you can go with that, you know?

SPEAKER_04 29:37

Yeah, yeah. And and you know, I'd be I'd be very interested to to have the the conversations about you know collaboratively, how do we how do we view HRPP effectiveness, how do we make a better and again, we talked about every institution is just a little bit different. Something that that that I've thought about is that as we move further down the road of single IRB and as we have more standardization with organizations like Smart IRB helping to facilitate things, it would be an interesting exercise to get HRPP best practices. Like, for example, what what are the the best practices for an institution that's very large? What what are the best practices for institutions that are you know maybe smaller, have a handful of studies uh in any given time?

SPEAKER_03 30:32

Yeah, that's a great that's a great point. You know, it's almost like you we need like a smart HRPP to to go you know go along smart side smart IRB, but like the the idea of because there's no regulations around this, there's no regulations that require HRPPs. That's not like uh and IRBs are spelled out for us, right? They give us at least uh enough to structure an IRB, right? But yeah, that would be interesting to hear and and try to come up with best practices for an HRPP because I think it scales easily.

SPEAKER_04 31:03

Yeah, yeah, right.

SPEAKER_03 31:05

Like between small and big organizations. Again, best practice, I think the more standardized we can get with stuff at the site level, honestly, it it just helps research in general.

SPEAKER_04 31:17

Absolutely, absolutely, and particularly with the with the uh with the single IRBs in place. If we can know that we're reviewing on behalf of eight to ten institutions, let's say, and and they have substantially similar structure to their HRPP, we're going to be more efficient in in reviewing and improving their their site and getting them onboarded.

SPEAKER_03 31:41

Well, yeah, that you bring up a good point. So when when you're talking about in the institutional world, and I know you guys rely on each other through smart or through any other reliance agreement that you know you guys have in the institutional world, uh when you do multi-site studies and you rely on each other, again, you're you're totally dependent on like you have to understand every site's HRPP, right? Because again, all that stuff does eventually somehow, in some shape or form, funnel to the IRB for its sort of deliberation, but yeah, you would have to almost because and this is different than using a central IRB because central IRBs don't have again HRPP, so we don't we don't have like the same institutional things that we have to protect like you guys do. But if you're relying on you know somebody else or somebody else is relying on you as an institution, like you would have to make sure that you understand their HRPPs just as well as their research teams and what they're doing in the study itself, right?

SPEAKER_04 32:40

Right, right. I think I think as an institution, institutions serving in that capacity of of reviewing IRBs, we may have some insight into how HRPPs are structured in general. Yeah, so we're more easily able to interpret uh the local context that's given to us. Oh, there's the word. It's just so vastly different from institution to institution, which you know makes it challenging.

SPEAKER_03 33:09

Yeah, that would. That would make it challenging. You know, it's it's interesting. Going back to to talking about stuff being put under HRPP stuff kind of being put under IRB. I was just thinking, and I know there's other accreditations out there and other things coming out, but just thinking about AHARP, right, as like uh accreditation, you know. Oh gosh, I'm terrible about the AHARP acronym.

SPEAKER_04 33:31

Association for the accreditation of human research protection programs.

SPEAKER_03 33:34

Right, right, right. So like that entire organization really is set up to kind of make sure that you have it. But even with AHARP, and you tell me, does that give you enough structure to standardize some stuff, or is it is it sort of like uh as long as you have it in your policies and then you can operationalize it any way you want?

SPEAKER_04 33:57

Yeah, I think that's I think that's more the the the the setup that it's head site visitors uh essentially say that it as long as you can demonstrate that you have policy procedures and you meet the standard, yeah, it's there's a ton of flexibility. Yeah, yeah, that's interesting. Flexibility is good, but it also uh inherently leads to inconsistencies.

SPEAKER_03 34:27

Right, right. Well, especially when like I think as research is like you were saying, as as a single RB mandates or or it's it's moving, we're moving in the direction where we are working as a group a lot more than we are individually. And I feel like 10, 15 years ago, it was a lot more single site, you know, in the institutional space. It was sort of a rare thing uh 15 years ago to to have this, let's rely on a bunch of other IRBs and and do that kind of stuff. And now I mean, even within the site world, I'm not talking about pharma sponsor, that that's always been there, but like within the site institution world, there's so much more collaboration I see now that that these investigators at many different institutions are getting together and saying, hey, let's let's do let's get a grant and let's do a multi-site study together, and one of us will serve as a central. And you know what I mean?

SPEAKER_04 35:22

Absolutely. When I I think I think it's as you said, it's led to a lot more collaboration. I I think historically, when we'd see uh authorization agreements, it would oftentimes be minimal risk. And and explain authorization agreement, sorry, for for people not yeah, so IRB authorization agreements, anything that's uh federal, federally funded. If you rely, if an institution relies on an IRB outside of the institution, there has to be an agreement in place that spells out who's responsible for what, what the reviewing IRB is responsible for in their institution, and then what the relying site is responsible for. But essentially outlines the HRPP functions versus the IRB functions.

SPEAKER_02 36:07

Yeah.

SPEAKER_04 36:08

And and many institutions use that process for things that even are not federally funded. And so, you know, historically, we would we engage in IRB authorization agreements with another institution, it would be something that's fairly low-risk, social and behavioral in nature, things like that. Um, but uh with the with the single IRB mandates, it's really forced our hands into to clinical trials, high-risk things. And it's it's really there's a lot more collaboration, I think, at from the investigator level, but also at the administrative at the IRB HRPP level.

SPEAKER_03 36:47

It's okay.

SPEAKER_04 36:49

It's really expanding your network, I think, is very valuable from a from a practical everyday standpoint. You know, if something happens at a different site and I know I know the people at that site, it's really easy to pick up the phone or send a text and say, hey, we need to talk and get things resolved more efficiently, as opposed to, hey, I don't, I don't, I, I don't know this person there, have to look them up and hope their website's up to date.

SPEAKER_03 37:14

Yes, yes.

SPEAKER_04 37:15

It's it's much more efficient. Yeah, like just have somebody on speed dial to be able to pick up the phone and get things resolved through a conversation and not email back and forth.

SPEAKER_03 37:27

Yeah, yeah. No, I love that actually. And I've always loved that about the the sort of institutional culture, right? Like it it is very much a sharing, let's share knowledge, let's share experience, let's share resources, whatever, yeah, right, to make it work. So that that's but that's good advice actually for anytime you can expand your network.

SPEAKER_04 37:47

That's yeah. Uh I had somebody in the office of counsel somewhere along my career. I was talking about I got consent language or something from another institution that said, Hey, uh, you know, I'd like I'd like to use this. Do you see any issues with that? And the response was something along the lines of you should probably get a formal agreement in place and signed by so and so. And I'm like, why would I do that? You're right, it's just it's a very sharing culture across the across the industry.

SPEAKER_03 38:21

Yeah, which is I think it's the only way, you know, like you're talking about being more collaborative, all this stuff. Like that's the only way to make this work. I mean, if people were not willing to share in that way and collaborate in that way, I just it would just stall research, I feel like, you know what I mean? Yeah. So I did want to ask you, we kind of talked earlier about like, you know, as you said, like it doesn't matter the size of your institution or your site, it, you know, you really should distinguish between HRPP and IRB functions for the organization. What is what advice do you have for for institutions or sites out there that maybe they have a you know, they might call it an HRPP at their program, but it's not maybe it's not centralized in the way that you're describing. How do you go about building this at a at a site level? What are the sort of I guess advice or steps that you have?

SPEAKER_04 39:13

I mean, I I think it goes back in some ways to collaboration of you know, phone a friend.

SPEAKER_03 39:19

Yeah.

SPEAKER_04 39:19

I've had on the time that I've been been the UAB, I've had smaller institutions call me or email me and say, hey, we're you know, in Alabama and say, hey, we're ramping up our research. What are what are what things should I know about IRBs and human research protections? And that's I can tell them things, but tell them what they need to consider, but uh and and help them, given given the different difference in in scale and scope, oftentimes it's it's it's more generality. But I guess bottom line is don't don't be afraid to reach out to people, even even as it feels like a cold call. Yeah, as we as we just talked about, we're we're very sharing and giving uh community.

SPEAKER_03 40:03

So so everybody call Adam if you if you no, no, but I really I I I appreciate that because I think again, there are so many there are so many people in our industry, I feel like, you know, since COVID, well, a a lot of people left the industry, obviously, and then uh there's a lot of newer people in the industry, and I just don't know if they get that message a lot that that it is such a sharing community, right? And and even people at your in your role willing to to talk to whoever has questions and like help out. But I just yeah, I like that I like that culture.

SPEAKER_04 40:37

And that's you know, none of us got here by ourselves, and and you know, none of us are are perfect, and we all have an opportunity to learn from each other.

SPEAKER_03 40:49

I like that mindset, because that's true in any any job, honestly, in any industry. Like, you know, it's the the amount of support and people that help you along the way to get you where you're at is is obviously a long list and and for everybody, but but I think it's different than uh like acknowledging that like you're doing and saying like okay, now it's sort of like a pay it forward, return the favor kind of thing. That's that's just a again, that's a cultural thing that I think exists at the sites and institutions and not necessarily in every aspect of our industry. So yeah, I like that.

SPEAKER_04 41:24

Well, and that's that's the thing. Like I remember going to conferences and expecting people to to have all the answers. And I'd walk away, you know, early on in my career, and I'd walk away feeling disappointed that that that I didn't I walked away with more questions than answers. And at a certain point, I became one of the people going out and speaking at these conferences and and kind of realized that that the role isn't necessarily giving everybody all the answers, but helping people recognize what we need to think about as an industry. And if you want to call that a thought leader, fine. I it to me, it's more just I've been doing this long enough that that I I probably know I probably have more questions now than I I ever did when I started. So yeah.

SPEAKER_03 42:14

No, that's awesome though. I I really like that because I think that the again, this is how we grow as an industry, right? If we get to the point, I feel like in any role in research where we're like, no, this like we figured this out, we can move on. Like, that's just not a good place to be. Because again, you mentioned this earlier, the how dynamic research is. The way that things evolve and change in this industry, it's and I think that's what attracts people to this industry, to be honest. The the the questioning and the the constant innovation and the constant having to sort of be flexible, like you said, and and shift and and be and having thought leaders like you, I I like I I will go with thought leader for you. I having thought leaders like you in the industry, it's I think really important for people to be able to step outside of their own little bubbles and understand, like, okay, I have maybe I haven't thought about all these kinds of questions yet. And and that's a good that's a good framing of this situation that I'm thinking about now, right?

SPEAKER_04 43:10

Absolutely. And that's that's the the pace of change is it's fun and exciting, but it's also a little bit daunting.

SPEAKER_03 43:16

Uh yes, hard to keep up with.

SPEAKER_04 43:18

But but again, that's that will make the fun.

SPEAKER_03 43:21

Yeah, yeah, I love that. I love that. So, Adam, this has been great advice, and I really appreciate you kind of going over this this overview, talking about the difference again between HRPPs and and IRBs. And but I guess we haven't really taught it's been you know implied in the conversation, but uh help us understand why are we doing like why is this important in the first place? Why are you even talking about this? Why do we need to separate this out?

SPEAKER_04 43:47

Well, it's circling back to the the pimento and olive analogy. It's really easy to see the pimento, right? It's really easy to see the IRB and understand conceptually what the IRB do. IRBs typically they're reviewing what somebody's telling us on paper, right? And the HRPP, while also I assume largely processes that are are being reviewed on paper, those are the body to go out there and and implement the processes that actually touch real people. And without coordinating all of those different processes and really thinking through what processes need to be there, looking if they're effective, we can't ensure that as institutions we are protecting human subjects. And that becomes even more important in our current environment where we have central IRB, we have single IRB mandates, where we're where the IRBs the members of those IRBs may never have even been in the state where the research is happening. So in in some respects, IRB review is important, but it's almost more important that the HRPP is functioning the way it needs to.

SPEAKER_03 45:34

I like that. I like that. I I like this analogy. I didn't know we'd talk about olives so much, but I really kind of like this this analogy plays so well because I I do that makes perfect sense to me. That the like you said, HRPPs uh help feed the information and helps the IRB be able to do its job in the first place, like you said. And it's almost like if you don't, if you're a site or institution and you don't have a defined, a well-defined HRPP, then all you're serving is a pimento, and that's not an olive, right? Like you need like the olives what protects human subjects at the end of the day without the outer uh olive shell on this analogy, right? Like which makes it the HRPP. If that's not fully functioning, all you're fleshed out, you all you have is the the pimento piece, and that's not sufficient, like you just said, to protect human subjects in the studies that are going on.

SPEAKER_04 46:26

Also doesn't go well with martinis.

SPEAKER_03 46:29

Yes, that is perfect. That is the best way to end that analogy. I think we rode that as far as we possibly could. But I I again I I think it helps, you know, all of this stuff is especially with HRPPs. IRBs are so easy to talk about because, like you said, it's so defined that you know uh HRPPs are a little more nebulous because A, it's different, like we talked about, and B, you can't even necessarily it's like a laundry list, like you said. Like it, you know, all the ancillary reviews, you can kind of bucket it out, but it I think it is harder for people if you're not in that world and you don't, you know, have one fully fleshed out, it's kind of hard to think through it's very abstract, right? That this is a lot of like conceptual what if. Well, it depends on your type of research, it depends on how big you are, it depends on this and that, depends on the funding you get. Like all there's so much, so many dependencies with HRPP that it's just harder to talk about.

SPEAKER_04 47:22

It it may depend on state laws, it may you know right, right, yeah.

SPEAKER_03 47:26

But I think this is important. I I again I really appreciate you coming on here and and talking through this. Thank you for spelling this out.

SPEAKER_04 47:34

Absolutely. Thanks for uh thanks for having me.

SPEAKER_03 47:37

Yeah, we'll talk soon.

SPEAKER_04 47:39

All right, so good.

SPEAKER_03 47:42

I hope you enjoyed that conversation with Adam. He leads with what I call humble expertise, and it's encouraging to me that someone like that is in charge of such a large research operation. Speaking of encouraging, my research participant guest this episode is Christine Melton Lopez. Christine is actually a research expert herself, currently serving as the director of the HRPP at the University of Arizona. But before she got into the research industry, Christine was a research participant in multiple studies through college and beyond. She shares the good, the bad, and the ugly of her experiences, and that wide range of experience has shaped her career and given her an empathetic lens that she still uses to this day to improve research. Christine is also very honest about her views on things like true autonomy as a participant, compensation for participants in research, and what kinds of questions you should be asking if you're considering being in a study. Her stories are not only helpful but also entertaining, and I'm sure time has allowed her to laugh at some of her past experiences, but her hopeful message about research is what really stands out at the end of the day. So without further ado, please enjoy my conversation with Christine. I am very excited to have Christine with me here on the podcast. Christine, thanks for hopping on.

SPEAKER_01 48:57

Yes, happy to be here. Thanks for having me.

SPEAKER_03 48:59

Of course. So we're gonna talk about your experience being in research studies, but before can we get into that, can you kind of explain to the people listening just a little about yourself, a little background?

SPEAKER_01 49:11

Yes. So my name is Christine, and I am currently a director at a human research protection program. So what I do for a living is really oversee all human research activities at the University of Arizona. And I would say my experience to research really started back during my undergraduate career. I was interested in going to med school. So I always knew that I wanted to get some research experience. And so I joined as an undergraduate researcher, a research study. It was called the Women's Health Initiative Study. It was funded by the NIH. It's a pretty popular study. And I what I would do all day would be call participants. And these were ladies that were followed for like 10, 15 years, and I would collect their yearly medical histories, any relevant updates. I would do reconsenting if there was ever any change in research scope. And I would also collect medical records from their doctors. And so I would sit in this tiny room and take out all of the identifiable information by scratching it out with a marker.

SPEAKER_03 50:28

Um so I original de-identifying method, yeah.

SPEAKER_01 50:34

I don't even know if I really understood uh what de-identifying meant, um, but I knew that I had to get out the names, the dates, all that good stuff. But um, yeah, so that was my first introduction to research. And I and I always thought it was super interesting. The medical thing, medical school thing didn't work out for me. And kind of at the same time where I was making the decision to step away from that, I landed this job at an IRB. And really, it's where I kind of found uh my place and my footing and my passions. And so I stuck around with that and and the rest is history. That's awesome.

SPEAKER_03 51:13

That's awesome. Well, I that's and thank you for sharing. So I think that's gonna help us sort of as you kind of go through your experience being on the other side, being the on the participant side of research. Uh, I'm sure you can kind of tie in how your actual career and and experiences have kind of helped shape that. But I am curious, like, so you you medical school path, you were always interested and and sort of already knew about research and what it was a little bit about what it was kind of thing. What made you actually get into participating? What where how did that start?

SPEAKER_01 51:44

Well, that so I knew research was a buzz re word, right? Okay. To get into medical school, right? Everyone said you have to have research experience. You have to have research experience.

SPEAKER_00 51:54

Yeah.

SPEAKER_01 51:54

I really didn't know what that meant. I'm first generation college student, and I I was I was very out of my element. I had to figure out everything kind of on my own. I didn't have any mentors, and I kind of just I literally would Google doctors' names at the institution and just email them and say, Do you have anything I can work on? Do you have any experience you can give me?

SPEAKER_02 52:17

Yeah.

SPEAKER_01 52:18

But prior to that, when I first started my undergraduate career, you know, fresh out of high school, one of the first classes they make you sign up for is like intro to psychology.

SPEAKER_02 52:29

Okay.

SPEAKER_01 52:29

And at the college that I went to, there was a requirement to either be a research participant or write a paper. And, you know, no 18-year-old wants to write papers. So we're going to just sign up for the research studies.

SPEAKER_03 52:46

Okay.

SPEAKER_01 52:47

So um, and keep in mind, I'm 18 at the time.

SPEAKER_03 52:51

Yeah.

SPEAKER_01 52:52

Just started college, no idea what really the ins and outs and nuts and bolts of research. Sure. So I signed up for I signed up for for two research studies. And the first research study that I signed up for, it was fairly easy. Uh so, you know, you go to the lab and they give you a spiel, right? That's the consenting process. But I don't think I realized that I was being consented into a research study. It kind of felt like they were just reading off instructions to me. So, really, the point of the study, according to them, when they were explaining it to me, is that they were going to hand me a $10 bill and I was to go into a private room and I was to make a decision of how much money I would keep for myself and how much money I would save for the next college student who would come into the project right after me and do the same thing. And they didn't really explain why they were doing that. So they give me the $10 bill and I go into this private room and I'm having this moral dilemma, right? Like, do I keep the full $10? Do I take half? And it's funny because my boyfriend drove me to the research site, and he's now my husband. Okay, so all I was thinking is that if I keep six of the ten dollars, me and him could share a plate at Panda Express.

SPEAKER_03 54:19

That's amazing.

SPEAKER_01 54:20

So I know, right? Like eight no Christmas.

SPEAKER_03 54:23

But I mean, that's a that's a perfect thought process. You know what I mean?

SPEAKER_01 54:27

That was my thought. I was like, yeah, I'm still leaving them four dollars. They could still go get like a dollar menu burger from like, you know, McDonald's, but you know, me and my boyfriend were gonna share a panda express plate, which was like gold back then.

SPEAKER_02 54:41

Yeah.

SPEAKER_01 54:42

So I step out of the room, and the researchers say, How much money did you keep for yourself? And how much are you gonna leave for the next college student? And I said, I'm keeping six, I'm giving four. And then they disclose to me that, oh, we deceived you. You're going to get to keep the entire $10. We wanted to know kind of the decision-making process and whether or not and how you would make the decision to split that $10 bill with a stranger, like somebody else coming after you. Um, so it was a deceptive study. So I kind of felt a little silly because they ripped apart my decisions and they didn't fully tell me that that was the point of the study, but they couldn't, right? Like right now, as a director of an IRB, I realized that if they would have told me at the very get-go that this was all a sham, sure, they would have never been able to answer the research question.

SPEAKER_02 55:34

Sure.

SPEAKER_01 55:34

So that was kind of a more positive experience for me. Now, the second research study I signed up for, I don't love. And I share, I still share this story to this day when I do education topics on IRB.

SPEAKER_02 55:49

Really?

SPEAKER_01 55:50

This study, again, we had to present to a lab. And so I get there, and again, I'm still 18 at the time. I'm I'm still pretty young. And they again go over the consenting process. I still don't think I realized that that's what was happening. I thought it was more so instructions. And they basically said, You're gonna sit in this chair, you're gonna see some things on the computer, you're gonna have some music playing in your ears. And so I went through the motions. Uh, but as they started showing me the pictures, they were very graphic. Like we're talking. Oh, and they had like heart rate monitors on me and they had um electrodes on my head. So they're clearly looking at like internal responses of this, right? And the pictures were graphic, so they were like images of people harmed there, and there was also kind of just images of people like you know, without clothing on, just like things that you don't necessarily want to see, right? But I could deal with it, right? But what really bothered me about the the situation is in my ear, yeah, they were playing like at full blast, just the most obnoxious noises you can ever imagine. So it was just like an overload of sensory, and I I remember in the moment saying, Oh my gosh, like I don't want to do this. Like I wish I could quit. But the thought in my head was, well, if I quit, I'm not gonna get the credit for my class, and you know, I'm gonna do bad in my first semester of college. So I really felt like I had no autonomy in that moment or no power. So I sat through it, I did the whole study, and of course it was another deception study, psychology, right? That's kind of their bread and butter. And I don't remember what they told me the purpose was of that study. I just remember that they did not make it clear that I could have withdrawn from that study and still got my classroom credit. I just didn't, yeah, it was it was pretty bad.

SPEAKER_03 57:48

That's that's really bad. So is that I mean, again, this is why obviously in a in a setting like a university like that, students should be considered a vulnerable population, right? Especially actually who is putting on these studies? Are these aren't other student projects? Are they? Are they faculty? Like who's the actual who was the PI of these studies?

SPEAKER_01 58:06

So, I mean, at the time I had no idea.

SPEAKER_03 58:09

Sure.

SPEAKER_01 58:09

But sitting in the position I'm in now, they're like postdocs, they're faculty. And the reason why it's justifiable is that there's an alternative to participating in research. So you don't have to take part. You can always just write the paper or do something else to get that extra credit.

SPEAKER_03 58:28

It would still be coercive as a design, even with an alternative, if they told you that if you withdraw from the study, you don't get the class credit, right?

SPEAKER_01 58:37

Yeah, but I don't think they told me that. I think I made that up in my head because they didn't make it clear, right? Like I would have now looking back, I would have expected a more like just forthcoming. Like you you can stop. Like this, this research may be a lot. If you just feel like it's overwhelming, you can stop and you'll still get your credit. Yeah, none of that was explained in a way that it clicked at the time.

SPEAKER_03 59:01

Oh, of course. Well, and and why would it? I mean, I think again, thinking back, I appreciate that you recognize that the average person, even uh takeaway 18, take away college, like the average person doesn't know that research studies need to be designed in a certain way and have to be set up a certain way, and should be, you know, consent processes should happen a certain way, right? They're their experience is their experience. So yeah, that that's a pretty negative experience, I would say, into a study.

SPEAKER_01 59:29

Yeah, it really makes you think of the participant perspective all these years later. I really drill into my investigators. Research is a part of your every day-to-day life. Yes, this could be someone's very first research experience, and they're starting from fresh. And so that consenting process becomes kind of the most important piece of the puzzle, is making sure it is a one-to-one conversation. You're leaving time for questions, you're even letting the person take home the consent form to go maybe talk about the study with their friends and family before making a decision. It can't be, and I think what it felt like for me at the time was just a factory, right? Like you get a group of students, you sit them down, you read, you read this paper verbatim, and you just move them through the process. That that to me wasn't an effective consenting process. But I do have a story of undergraduate research that I took part in that was well, that was also it was a positive experience.

SPEAKER_03 1:00:30

Before you jump to that, so it sounds like you you did your first study in as an undergrad, and it was a good experience. You got to keep the $10, even though the deception thing you said was weird. Uh, but then the second study you did was was sounds terrible.

SPEAKER_01 1:00:43

It was terrible.

SPEAKER_03 1:00:44

And what went was it just because you were sort of still interested in this medical field and stuff that like why did you after that bad experience, I'm curious why you ever participated again. You know what I mean?

SPEAKER_01 1:00:55

Yeah, honestly, it it's gonna sound bad, but I was a broke college student and these studies paid money, right?

SPEAKER_03 1:01:04

Hey, uh there's yep, absolutely. That is a it's a that's a fair motivator, I think. That especially college students, yes, you you shouldn't underestimate how much that motivates people.

SPEAKER_01 1:01:16

And I know there's strong feelings in my field about you know subject compensation and how it's coercive and like undue influence, but honestly, people's time is valuable, people's data is valuable, and you should compensate your participants. It is something that motivates people to take part in research, and and in my opinion, my humble opinion, there's nothing wrong with that.

SPEAKER_03 1:01:38

Agreed. I could agree on that.

SPEAKER_01 1:01:40

No one, I mean, you're not gonna show up to your job if you know that they're not going to pay you, right? So what it's this for me, yeah, maybe it's gonna be for an abomin, but for me, it is a motivation. And as long as you're not, as long as you're not like paying subjects like what a hundred dollars for 10 minutes of their time. I could I think we should all agree that that's coercive and that's that's not gonna give you like yes, the people you want to attract to your study. There's nothing wrong with paying someone the going rate in your city to participate in research.

SPEAKER_03 1:02:17

I I agree. I feel like this as a quick aside here on compensation stuff, to your point, you go to a job, you get paid, and it's an exchange, right? Like at your work, you're exchanging your knowledge, your time, your expertise, uh your thoughts, whatever it is. And then in exchange, you get paid for that job. In research, it's very similar. You're getting you're you're giving your data, your thoughts, your opinions, whatever it is. And in exchange, why wouldn't you get compensated? Right, right. I mean, there's nothing else that you really besides I think a lot of times we compare the research industry to like the volunteer industry. Like, I'm gonna volunteer, you know, with my church this weekend to help whatever project they're doing. That that's a volunteer, obviously, right? But that's different than I think how research should be seen. Like, I like the the comparison more to almost work.

SPEAKER_01 1:03:08

Yes, yes, I agree. Research participants, they give up so much, they give up their time, energy, efforts.

SPEAKER_03 1:03:16

Well, and the other side is benefiting. Like, you know what I mean? Like, it is different than like there, you know. I I think when I think of true volunteer work, like like a Matthew 25 ministry kind of thing, right? Like they have a global mission that you're helping to contribute to. I don't think research is the same because those are not usually nonprofits, churches, whatever it is, organizations like that that take volunteers. You know, they're not patenting drugs and medications to sell and make a ton of money on. You know what I mean? It's just a different, different lens, I think.

SPEAKER_01 1:03:50

I I agree. And you know, the researcher benefits ultimately, right? They get their data, they get their papers, they get their presentations, maybe they get some payouts from companies, and a lot of the times research our research participants can be forgotten about. So I think it's just a simple way that we can thank someone for the time, energy, and efforts. And for me, as a as a broke college student, yes, knowing I'd get the $25 gift card to Starbucks was enough to get me to sign up for a research study.

SPEAKER_03 1:04:23

That's perfect. Okay, so then you got into another study. Let's hear the positive then.

SPEAKER_01 1:04:28

So this study I really like, and I still think about it to this day. It lives in my head, rent-free. Um this was also my freshman year. I get an email. I still remember the woman's name. It was Joyce. And she was studying first generation college students, and she would email and she basically she's like, you know, got your name from the list of first generation college students at your institution. I want to follow you guys for four years and beyond and just see how you go through the college systems, your successes, your failures, your future, yada yada. I'm gonna reach out to you once a year and do a survey. And as long as you do this survey, each time you do it, you're going to get like a $25 gift card. Look, I can still tell you the consent to this day. Yeah, that's a great thing that's so memorable.

SPEAKER_02 1:05:18

Yeah.

SPEAKER_01 1:05:19

So I signed up, and sure enough, every year on the dot, she would send me that survey and I would fill it out and I'd give her updates on my life, like, you know, how I'm doing in college, all that good stuff. And she would give the gift card. And it was nice too, because on my birthday, she would send like an email saying, Oh, happy birthday. Thank you for contributing to this research study. Here's what we found so far. And she would kind of give an exchange of data back, which is really nice as a participant.

SPEAKER_03 1:05:47

For sure.

SPEAKER_01 1:05:48

And then as I got through college and I graduated for a couple of years post graduation, she would still send those surveys. And she would there was some tweaks to the research design over the years. So she would also say. Consent addendums, which basically means like a reconsent.

SPEAKER_00 1:06:04

Okay.

SPEAKER_01 1:06:04

Um, and I always re-signed up for the study because I was so vested at that point. So it was seven years of data collection, seven years touch basis, seven years of her sending out birthday cards.

SPEAKER_02 1:06:16

Wow.

SPEAKER_01 1:06:17

Seven years of her also giving information back. And when the study finally concluded after seven years, she gave us, gave all her participants links to the publication and just an overall snapshot of what she found out about first generation college students and their successes and their failures. And I think she even collected data on like, you know, at the end of seven years, this was how much people were making in their jobs. And it kind of helped me look at how I matched against my peers. And so it was just a nice experience because she exchanged data back to me. And I just felt as a participant, I also felt like, okay, what I'm doing, the data I'm providing is really important because I'm seeing the fruits of her labor in my labor when she shares back all of that really interesting data set. So I I enjoyed that research study.

SPEAKER_03 1:07:12

I I I really like that example because it's like you said, it's it sounds like you felt almost like part of the team, right? Like that this is a collaboration and it really should. And I, you know, obviously it depends on the study design and the type of research you're doing, of course. But for something like that, I think it makes perfect sense to sort of and and she went above and beyond, right? Like she didn't have to do these things, all this, the check-ins and the you know, the birthday stuff, obviously. Like that's that is really above and beyond for a researcher. But what a great sort of example of treating your research participants as part of the research team. Like she couldn't do it without you, you couldn't get the data without her, like the the collective data. Like, yeah, that's why you're there, right? That that's really cool.

SPEAKER_01 1:07:58

It it was great. And it, you know, it just helps me like those types of examples help me to be better at my job because when I'm talking to researchers, I can say, hey, here's a good method to use. Like, you know, don't underestimate the checking in with your participants, the sending of the birthday cards, the just taking an extra moment to just check in with them on a human level. It's okay. And also, this is going to be big within the next few years. The returning of research results to participants, I think that is the most amazing thing we can do for our participants. It's actually something the NIH is about to mandate.

SPEAKER_02 1:08:38

Yeah.

SPEAKER_01 1:08:38

And it's it's just it builds trust, right? There is still so much mistrust with our day-to-day society in, you know, can we trust researchers? Can we trust the research process?

SPEAKER_02 1:08:51

Yeah.

SPEAKER_01 1:08:51

That's one way to build the trust, is to say, hey, you took part in the study. Here's all the good things that we found out from your data, from your contributions. I think it goes a long way with participants.

SPEAKER_03 1:09:02

I agree. I think, you know, and it's this is a uh a logical next step. Now, I mean, maybe we could have started and should have started with this with sharing with participants, but you know, I remember years ago, the argument was it wasn't just it wasn't about sharing the the research results with participants, it was just sharing the results in general and the fact that a lot of uh folks doing research would maybe not share negative results, right? Like that that remember like when that whole thing, I don't know, 10 plus years ago, and and then these you know, sort of regulations and and you know laws came out about you have to share good and bad. We have to know what's not working just as much as what is working. This sounds like a a logical step. Like, you know what, maybe we should also be sharing everything with the participants who again are giving up their time, their valuable data. And I think if you're going to the reason you participate in a study, even if it's just for money, like you didn't, you're obviously interested, right? Like, you know, and I certainly everybody's gonna be interested in like I'm I'm contributing to this, I kind of want to know what is happening.

SPEAKER_01 1:10:09

Yeah. Um and we don't have to return individual results, right? But at least returning the overall picture of the study, if you can, if it's reasonable too. I think we as investigators or researchers have an obligation to really think about just whatever we find, sharing that with the communities that we drew the data from.

SPEAKER_03 1:10:31

Yeah, which and I I understand the hesitation of in in certain clinical trials, if you're if you're testing something that's not valid, you know, validated or you know, safe and effective yet, and that's why you're doing the research, obviously. Then if you maybe if you return certain data that you've collected or information or whatever, then or results, then you don't want necessarily somebody to take that the wrong way or take it as like clinical stuff. Like I understand that there are some things we have to work through, but to your point, the general idea of when it makes sense and and especially the collective stuff, right? Like it's not just your, like you said, in your study, the seven-year study that you participated in. I I it sounds like one of the most interesting things that you got from it wasn't necessarily your track, you're living your life, you know your track. It's how did you how did the other people do, right? Like how are you tracking with everything that was collected?

SPEAKER_01 1:11:26

Yes, that that to me was the most interesting because uh like I said, I was first year college student or first generation college student. I I was figuring it out as I was going. So seeing the data from my cohort, everyone, my peers, it was very interesting to see. Am I am I on the right track here? Am I comparing with my with my peers? I thought that was very memorable, and that was a really good segue to research.

SPEAKER_03 1:11:51

That's awesome. Well, I almost wonder if you could do a side study with that because I wonder if you getting back annually those type of results was in some way motivating. Like you said, what if you got results back that you're like, wow, I'm way behind in life? Like, you know what I mean? Like, I'm not I that must be my data because that's where I'm at. And so like I see where everybody else is, and maybe I need to, you know what I mean? I just wonder if that had an impact.

SPEAKER_01 1:12:14

It it was motivating. I will say that it was motivating, it really was. And we have a few, I know it's a little off topic, but we have a few researchers at our institution that that do such an amazing job with the return of research results. Yeah, and I'll just say, outsider looking in on these research studies, my investigators that take the time to get to know their participants to have that human touch, yeah. They have no issues with meeting their recruitment goals. They have people wanting to take part because they build such of a foundation of trust in the research that they do. So I I know it might take a little more time, a little bit more effort, but I think in the long run it pays off.

SPEAKER_03 1:12:57

Well, yeah, I mean, uh again, time and effort, that's the whole thing. That's the like if you're gonna do research, it all of this takes time and effort. And to your point, if the the biggest problems that we have in research are always getting enough people to participate and retaining those people once they're in it. And both of those problems are fixed with what you're describing, right?

SPEAKER_00 1:13:15

Yeah, exactly.

SPEAKER_03 1:13:16

Yeah, that's really cool. Okay, so let's keep going down your your research participant quest after that awesome study experience that you had. Have you participated in anything since then? Any other studies?

SPEAKER_01 1:13:29

I think that was the end of my research participation as an undergrad. So when I moved to the role of working for an IRB, I would say the first 10 10 years or so working at IRB, no one really wanted to, no one recruited me for research.

SPEAKER_00 1:13:48

Okay.

SPEAKER_01 1:13:48

Well, when I moved into the role of the director, I feel like once a month I'm getting some sort of a recruitment to take part in more qualitative studies. Like, you know, how does how does your IRB deal with this? Or what are your thoughts and feelings about this topic? And it's more for my peers in the field, right? I sit in the Ario group. I don't know if you've heard of Ario.

SPEAKER_03 1:14:09

Areo? No, what is Areo?

SPEAKER_01 1:14:12

It's I I can't remember what it stands for. It's like advancing ethics. It it's a long name, basically.

SPEAKER_02 1:14:21

Okay.

SPEAKER_01 1:14:21

But essentially the point of this group is to is to collect data from IRBs to improve efficiencies of how IRBs operate. Because as you know, running an IRB is it one size fits all.

SPEAKER_03 1:14:38

Sure.

SPEAKER_01 1:14:39

So what one IRB may say is fine to do, and another IRB may say no, you can't do it at all.

SPEAKER_03 1:14:46

Yeah. So this you say it's called Aereo.

SPEAKER_01 1:14:48

Areo.

SPEAKER_03 1:14:49

Areo is this for like institution-based IRBs?

SPEAKER_01 1:14:54

Anyone, anyone interested in human subjects protections that have some sort of a job that relates can join the group.

SPEAKER_03 1:15:01

Gotcha.

SPEAKER_01 1:15:01

But the point of the group is for its members to come up with studies that that take a look at IRB efficiencies. And so now that I'm plugged into that group, we get like once a month, maybe an email like, hey, you know, how do you conduct your expedited review or how do you conduct your exempt review? Jump on an hour interview with us or a focus group.

SPEAKER_03 1:15:22

Um now are these considered, sorry, are these studies considered or they do they go through an IRB to to like be approved, or is this more like quality improvement line?

SPEAKER_01 1:15:35

I think they go through IRBs.

SPEAKER_03 1:15:38

Okay. Okay.

SPEAKER_01 1:15:39

Because it's generalizable, right? It's generalizable, and sometimes the questions do dwell into the human participants themselves. Um, if a study's only collecting data on the institution, just factual data, like how many studies do you oversee? What's your turnaround? That's not human research, right? Because you're not collecting any data on or about a human, you're collecting data on about an institution. But most I would assume most of these projects have some sort of an IRB approval.

SPEAKER_00 1:16:07

Okay.

SPEAKER_01 1:16:08

But now when I take part in research, I'm a little bit more sootier because I know what I'm doing. Uh so yeah, I always ask for, well, where's your informed consent? And I'm like, you know, I I verify IRB approval and I make sure whatever I'm getting into checks all the boxes for me that are now important. So nowadays, what I find important when I'm looking at that informed consent document is I'm looking at confidentiality of my my data that I supply. And you know, are you if if I tell you all this information about my institution, are you reporting it in a way that ties back my institution to the data set? Because I might not necessarily want that. Yeah, sometimes even just saying, maybe never even sharing my name, but saying, you know, the IRB director at the University of Arizona reported this. Well, that identifies me right away because I'm the only IRB director at the university, right? So those are kind of things that have now shifted, you know, back when I was 18, the compensation was the motivator.

SPEAKER_02 1:17:15

Sure.

SPEAKER_01 1:17:16

But now it's like, okay, am I helping my field, right? IRB operations. Yep. And is my data going to be protected? I think what Aereo does is so important because it does look for efficiencies. And as someone who runs an IRB, I'm interested in those exact same things. So if I can contribute my data and get something out of that, even better.

SPEAKER_03 1:17:34

That's awesome. And and I I like that you have, I mean, I wouldn't call it snooty. I think that you just understand what what good research means, right? And and what valuable research should look like. I I like the idea too of, and I'm sure maybe there's group, I'm sure there's groups out there that do this, that give this stuff to participants, but like the idea of having like, as a participant going into research, here are some questions, general questions you should think about, right? Like everything you just said, like you people listening to this that have never been in a study or or maybe you've been in one or being asked to be in one, like ask those kinds of questions. Let me see the consent. Explain to me how the data is going to be reported out, explain to me how things are gonna be protected, like the important stuff, my my information, you know. That's like it would just be nice to have a checklist for people, right? And to your point, building this trust, yeah. I think people should be, I don't know, should feel more comfortable about asking these kinds of questions, right? Like these are all fair game.

SPEAKER_01 1:18:34

Yes, exactly. Yeah, because I have had participant complaints over the years that said, you know, they want me to take part in their study, but they're not willing to share the informed consent. And that's an immediate red flag. And I'm like, wait, wait, what were they asking you to take part in? Like, yeah, if there's no informed consent, there's probably no IRB. So it those are important questions to ask.

SPEAKER_03 1:18:57

Yeah, no, I like that. I like that. That is interesting, and I and I like also, I mean, again, this is you know, you've been on the research participant side, which I love, and and that has obviously informed a lot of what you do now in your career and all that stuff, and uh they complement each other, but I I think it's important that people understand or hear from the research participant side that this group that you mentioned, the Aerial group, like I love that our industry is constantly trying to get better at this stuff. Like, there's not nobody in our field is like, no, we figured this out and we're good to go. You know what I mean? And I think it's important for people to hear on the participant side that this constant improvement, constant evolution stuff is always going on from people inside the industry like you.

SPEAKER_01 1:19:44

Oh, all the time. And my perception changes all the time too, because I sit on a I also sit on a community advisory board, and sometimes like I sometimes go into those meetings with a certain perception, yeah, or a certain understanding of how something works, and then a participant will say something that I'm like, whoa, like, you know, I've been doing this job for 14 years and I had no idea that's how the community still felt about XYZ topic. I think that's the fun thing too about research is it's always evolving. Yeah, and I think that's what's kept me around so long in the IRB field, is that every day is different, and I can never learn my job a hundred percent. It's just not possible. Yeah, but it keeps me engaged, which I which I really like. So we're always trying to approve in the IRB field, things change constantly. When I first started 14 years ago, yeah, like we were talking about earlier, subject compensation was a little taboo, right? Yeah, we shouldn't list compensation as a benefit, but now I feel like the tides are changing and it's like, no, it's it's it's not a bad thing to pay our participants. It's it's yeah, completely okay thing to do. Yeah, so we're always evolving and changing in research regulations and human protections.

SPEAKER_03 1:21:04

Yeah, for sure, for sure. No, I appreciate that and that that sort of lens. I I will ask you, because of your experience and you have both sides, of course. What advice would you have for people that are interested in research? I mean, I like to set that up, I guess, a little bit better. Obviously, you know, being in the industry, like there's a lot of people, there are still a lot of people out there, I would say the majority of people don't actually understand what research is, how it works, how to find it, whatever. But there are people, obviously, out there that are actually interested. They look for studies, they're looking to get involved, and they just can't either they can't find something that they quote qualify for, or they just can't seem to find something around them. What kind of advice, uh, first of all, what kind of advice do you have for that second group? People who are like looking to want to be a participant.

SPEAKER_01 1:21:56

One, I think know that uh people like me exist. Um, I I had no idea as an undergraduate participating in research that there was a group of people that were there just for me.

SPEAKER_00 1:22:08

Yeah.

SPEAKER_01 1:22:09

The IRB truly is there for the research participants. We have your back. We are combing through every piece of documents, materials, making sure that that that research studies that are available are done at the highest level of ethics, are organized in a way that protects human participants. And if something goes wrong, we're there for you, for you to call, for you to tell your complaints to or your concerns to. And we go out and we investigate those. Yeah. Any type of complaint that comes through, I personally investigate and get to the bottom of things and make improvements based on those complaints. So I would say one, know that IRBs exist and that they're there to provide protections for participants taking place in research. Another thing to be aware of is that your informed consent matters. And so you should be given as much time as you need to look at that consent form, to ask questions, to take it home, to take your time. If something's not clear, then you ask the investigator. You ask that person that's in charge. There's always someone in charge. They're called the principal investigator. You ask all the questions you need to ask before making that decision. I would say things that I would look for as a person participating in research is, you know, what's my time commitment?

unknown 1:23:33

Yeah.

SPEAKER_01 1:23:34

How many times will I be asked to take part in the study? I'm also looking at what happens to my data after it's collected. Is it analyzed and discarded? Is it kept for future use in other research studies? Is it shared with outside investigators? Not that I'm opposed to those things because I think reusing of data is great, but you want to make sure that that reuse of the data is done in a manner that can't be linked back to you. So we call that de-identified future use of research data. So I'm looking for that. If biospecimens like blood or tissue is collected, I want to know are they uh looking at my genetic material? Are they doing whole genome sequencing? Because even if all of the data is de-identified, or all the specimens are de-identified, doing whole genome sequencing on specimens is always identifiable, especially with all the new technology that's coming around. So just looking at what happens to that data or those specimens after collection is important to me. And then also how is data being protected? So if I'm being audio recorded or video recorded, is that raw recording going to be discarded once the transcripts are made? Um, is the data going to be stored in a way that feels safe for me? So, like I said, now that I know all the things, those are kind of what I would suggest to someone new as a research participant to look out for.

SPEAKER_03 1:25:06

I love it. I love it. That's it, that's actually a really good, helpful list, right, for people listening to to kind of take with them. So then jump back to the first group of people. How do you have any recommendations or resources or anything, any advice, anything about how do we get more people to know that A, research is there, and B, like to your point, that you know, there is so much negative stuff and in history and bad stuff, obviously, with research and and and there are bad players, but like the majority I don't think are. So like what how do you what what advice do you have for that group? People who really just it's they're kind of on the fringe. They they might need to kind of learn a little bit more.

SPEAKER_01 1:25:49

Uh you know, working with investigators day in, day out, our investigators really believe in what they do. Um, and they should, right? I mean, these are professionals in the field. I I don't think I've ever come across an investigator that was intentionally trying to do something bad or something unethical.

SPEAKER_02 1:26:09

Yeah.

SPEAKER_01 1:26:09

I think at the heart of this, our researchers are trying to advance knowledge, advance science to make a better world for us all. I would say research brings a lot of hope. And some of my favorite uh research studies are the most fulfilling, I should say, are the oncology studies, right? Because you read these stories where someone's given, you know, six to nine months to live and they roll into an investigational clinical trial of some new investigational drug. And they're alive like five to ten years later, all thanks to research.

SPEAKER_03 1:26:50

Yeah.

SPEAKER_01 1:26:51

And so I would say if you're on the fence about joining a research study, just know that at the heart of all of this, there is an army of people that want to do the right thing, want to advance medical knowledge, and are taking a look at all of the things that you may potentially be asked to take part in. And all of this stuff is regulated. It's regulated by the federal government. We have a set of principles we follow. It's called the Belmont Report. The first principle of the Belmont report is respect for persons. And it means that we as researchers, we have an obligation, a moral duty to treat our participants as autonomous agents. Participants have the right to decide whether or not they want to take part in a research study. And they can change their mind at any time. So we let's say you give it a shot and you say, you know what, I'll take part in this study. Why not? If at any point in that study something's not sitting right with you, or you just change your mind, and maybe you get too busy, or maybe something happened that you're just not not feeling it anymore, yeah, you can walk. Away without any negative repercussions to you, even if let's say you're participating in a research study and the principal investigator is your doctor, you could still walk away and it will have no negative impact or effect on your medical care, both now and into the future. So I would just say that all of research is grounded in ethics, it's grounded in regulations and in rules. There's a process, there's a method to all of the madness. And so if you're feeling on the fence of, you know, you're not quite sure if your best interest is in mind. Trust me, as someone who sits on the side that regulates research, we are constantly thinking about the participant first.

SPEAKER_03 1:28:44

Very well said. Very well said. I like that. Yeah. And I think I think that that is important, again, an important message for people to hear because I just don't think any the average person understands or sees. I mean, it's not, you know, it's not the fault of anybody, obviously, but they don't have any access to see what you uh on the IRB side do or what, you know, even what the the research team themselves, you know, even if their their physician is their PI of their study, you know, they know their physician, but they don't see all the behind the scenes work that that goes on to actually run a study and start it up and everything. So yeah, I appreciate that.

SPEAKER_01 1:29:20

Yeah. There's a process for everything. I'll I'll say it right now. As someone who goes in and audits studies, yeah, like active studies, there's everything is organized, everything is accounted for, and everything has to follow that recipe book for the study that the IRB essentially approves. It's called the protocol. And whatever that investigator outlines in their approved protocol is exactly what the IRB expects. And we we hold investigators accountable. So we go out on a yearly basis and take a look at those studies. Are they being conducted in a way that they're approved to be conducted? So there are safeguards to participating in research, most definitely.

SPEAKER_03 1:30:03

I love it. I love it. Yeah. So thank you for going through all that. That I think this is just a nice, I know this is kind of high level, and we've kind of shifted from your research experience as a participant to uh, you know, educating everybody on the industry stuff. But I again, I these things should be bridged more often, I feel like, you know. And I I really do appreciate you coming on here, you know, sharing your stories and your experiences. Because again, I I just I feel I feel passionate about getting people to understand to your point how hopeful research is as a an industry, as a concept, as a as a thing we're trying to do to push things forward and improve everything.

SPEAKER_01 1:30:45

Yes, yes, it provides hope. Yeah, in certain contexts more than others, sure research provides so much hope. I've heard from so many families of how life-changing um participating in research can be. It truly is a gift and a blessing, and I'm I'm really happy that I get to play a small part in it.

SPEAKER_03 1:31:06

I love it. I love it. Well, and to your point, you know, even if you're not in that amazing story that sort of, you know, extended your life or saved whatever, even if you're in something that didn't necessarily work, the idea that we don't know what will work until we try it, right? Until we find like if something doesn't work, we need to know that so that we don't try that. You know what I mean?

SPEAKER_01 1:31:28

Yeah, I sometimes talk to investigators and they'll say, Oh, the data just it it was it didn't show what I wanted. And I remind them, even bad data is good data, right? Because it's just one thing we can check off and say, okay, we looked at that avenue. It that's not the answer. Now we can focus our efforts and attention on something else. Right. And human and and participants play a role in that. Even if the data isn't what we want the data to be, it's still advancing medical knowledge by giving us the answers to show us, okay, here's where we need to pivot and look at to next.

SPEAKER_03 1:31:58

Yeah, for sure. For sure. It's kind of like parenting, right? Like, you know, little kids, it's like you you want them, it's okay to make mistakes and learn and and grow because that's what happens, right? You you're not just born with the knowledge of this is the way to do things and this is gonna be the way to do it, you know, successfully or right or whatever correctly. Um you have to stumble and figure it out as you go, and that's what research is as a you know thing.

SPEAKER_00 1:32:24

Yes, it's a puzzle, right? It's putting all those pieces together.

SPEAKER_03 1:32:28

Yeah, yeah.

SPEAKER_00 1:32:29

Absolutely.

SPEAKER_03 1:32:30

Christina, thank you again. Thank you so much for for being on and sharing your story and stuff. And and I think this is gonna be very helpful for people listening that are on the fence or have been in research a lot. I just think this was a nice, uh, a nice message for everybody.

SPEAKER_01 1:32:44

Awesome. Well, thank you for having me today. It's been a pleasure.

SPEAKER_03 1:32:48

Thank you so much for listening. I hope you got something valuable out of these conversations. If you enjoyed the show, please be sure to follow, subscribe, or leave a review on your favorite podcast platform. For more information about our guests today, please check the show notes. I encourage everyone to check out our website at unibo group.com to learn more about how we are living into our mission of connecting more patients with research. Thanks again.