On Research Podcast – The Evolution of IRBs: Navigating Ethical Considerations in Research

Julie Blasingim: But at the end of the day, if it’s not in the regulations, if it’s not in the guidance documents and you need to make a decision, it actually becomes very easy because you do what’s right for the patient. And if you always keep that as your moral compass, balancing the risk and the benefits, doing what the right thing is for the patient, that’s obviously the ethical direction that you should be moving into.

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

In addition, the views expressed in this podcast are solely those of our guests. At the top, you heard a clip from Julie Blasingim, my guest this episode. Julie is the CEO of Univo IRB. With nearly two decades of experience in the IRB industry, Julie shared her thoughts and insights on a wide range of IRB topics. We discussed how the IRB landscape has evolved over the years, how for-profit IRBs manage the ethics around the economics of their business, what ethical considerations may face IRBs in the future, and of course, the role AI plays in this side of the industry. We covered a lot of ground. So without further ado, I hope you enjoy my discussion with Julie. It’s so nice to see you. Thank you so much for joining the podcast.

Julie Blasingim: Hey, Justin, good to catch up with you as well.

Justin Osborne: So Julie, before we jump into the IRB world, can you tell us how you got started in the research industry and then what you’re doing now?

Julie Blasingim: Yeah, absolutely. So like many of us in clinical trials, I think we all have a journey that led us into the industry. We never, as a kid, we don’t ever dream about working at the IRB, or working in clinical trials when we grow up. So I always enjoy hearing how people landed into it. So for me, I was going to school to be a teacher and then also thinking about being a nurse at the time because my passion was really to help people.

And through that opportunity, I was working at a Phase One clinic down in Fort Lauderdale. We had several hundred beds and it really opened my eyes to what clinical research was, and how it was helping to fill a void for some of the represented populations. So I walked in, I took over as their regulatory specialist, and then started working directly with an IRB at that time.

I got a phone call from that IRB and said, “We’d love to help you finish through your college career, and we want you to join the IRB.” So I did that, and that was my first IRB experience. And that was in 2006. What I didn’t know is that that particular IRB, which was an independent IRB, was one of the first that started in the ’80s. For just a little bit of background, when the regulations were enacted and IRBs were started, most of the IRBs were associated with local institutions.

And then from there when there were physicians and other researchers that wanted to do research, if they weren’t affiliated with that institution, then they ended up having to try to find an IRB. And that’s how what we call independent IRBs was really birthed. So that was in the ’80s. So I mean, I got to be part of one of those IRBs, which was really exciting.

So from there, I finished out my degree and said, “All right, I’m going to go be a teacher. I’m going to teach kindergarten because that’s what I love to do.” And the owners said to me, they said, “There’s this thing called AAHRPP accreditation and we are not sure what it is, but we know you can probably figure it out.” So I took the task of taking their policies, which were 19 pages at the time, and interesting worked with HRP Consulting at the time, build out … With Jeff Cohen, to build out a fully robust human research protection program.

And that was probably what was the impetus for my career in IRBs. From there, I knew the regulations in and out. I knew the accreditation standards. I trained the board members on what it meant to do ethical reviews and compliance with criteria 111, and I just fell in love with the IRB space.

So I had the opportunity to stay at that company. It was one of the first independent IRBs that was acquired from another IRB. That was in about 2011. And so that was an interesting time. We got to figure out what it meant to merge two IRBs together, merge boards together, merge AAHRPP accreditations together, and kind of pioneer that process. And then from there, the industry really just continued to consolidate.

And I think we all have seen the different IRBs that have merged and acquired. And so I was part of several of those up until 2020 where I decided to go back into site compliance and work with some site networks, helping them really understand what it meant to do good research, and bring the regulatory piece to the site. So that’s a long-winded way of giving my background. A couple of things that I’m really proud of in the IRB space, I was a board chair for about three years. I worked in operations. I worked in quality and compliance. Obviously, several dozen FDA inspections and accreditations. I grew up in the IRB space and I like to tell people that it chose me. I don’t think I chose it.

Justin Osborne: That’s great. Yeah. So you’ve done a little bit of everything in the IRB space across the board. So then tell us what you’re doing now.

Julie Blasingim: Yeah, so I got the opportunity to take over a small IRB called Principle last year, and we decided to rebrand it as Univo to really bring out our mission and passion of helping to unite researchers with the voice of the patients. So I’m the current CEO and we’re doing some pretty cool stuff.

Justin Osborne: That’s awesome. So you kind of touched on this in your background. You’ve been in the IRB world for quite a while, right? Since the sort of beginning of the independent IRB movement and all that stuff. Can you kind of talk a little bit about how the IRB landscape in general has changed or evolved in the past decade or so?

Julie Blasingim: Yeah, yeah. So if we go back to the birth of an independent IRB in the ’80s. I mean, there was a lot of groups that came together to provide a good solid IRB offering to those physicians and providers that were not associated with a local IRB. So I mean, there were dozens of them that formed between the ’80s and ’90s, and in the early 2000s when accreditation started to become a requirement and people started to see the value of that.

I think that really started to raise the awareness and really separated the IRBs that were committed to conducting and overseeing ethical research, and ones that maybe were just doing it as a side business. So there was some independent IRBs that didn’t move forward with accreditation and kind of fizzled out, but the ones that were AAHRPP accredited from there really started to see the value of partnering together.

So with the IRB space, what normally happens is you end up servicing a certain type of research. So it could be either a certain therapeutic area. It could be a geographic area. So it wasn’t uncommon in the early 2000s that independent IRBs had the bulk of their business and the research that they were overseeing was geographically close to wherever their office was.

Justin Osborne: Interesting.

Julie Blasingim: So for example, the first IRB I worked at was in South Florida, and most of the investigators happened to be in the South Florida area. And if you think about it, it’s because we didn’t have the fancy technology systems that we have. And to get information to those IRBs, you had to FedEx it, or you had to drop it off, or you had to get it to them in a paper form.

So you really ended up with several regional independent IRBs. Technology obviously played a big role in shifting that. So as portals became available and you could submit things online, then it made more sense and you ended up with several larger IRBs servicing across different regional areas.

Justin Osborne: Makes sense.

Julie Blasingim: Yeah. And obviously technology plays a big role in how things evolve in general.

Justin Osborne: Yes. Well, and I also wonder to your point earlier, besides the technology piece, if these independent IRBs started out more regional based, was that also … did it have to do with the fact that the model before that was the sort of local institutional IRB, which you can’t get more local than that. They’re reviewing studies at their own sites, and so then you get independent IRBs. I mean, regionally focused independent IRBs makes sense as well, right? In that sense, in that context.

Julie Blasingim: Yeah, absolutely. Because you’re pulling from the regional investigators, and sponsors, and CROs that are doing research.

Justin Osborne: In those populations. Yeah, no, that makes sense.

Julie Blasingim: And then as more research started to be done in what we call the commercial space with larger pharma, CROs. CROs were born, they started to be more of a vendor that sponsors were using. Then there were a lot of regulatory changes to use what was now termed central IRBs. So these independent IRBs that were more regional now became more of a central IRB that could be what we also refer to now as a single IRB of record.

And so that was a big evolution in the IRB space because you had more research that was being done in a multicenter model where multiple centers are being used. Some of them, a combination of your hospitals and academic centers. And then others were more private research centers. And when you mix all that together, you could have hundreds of sites, and then you end up with potentially dozens of IRB determinations that we’re trying to manage.

And so there was really a big push to have work centralized so that it could be more efficient and consistent. And I think that’s what we see now with single IRB of record is not necessarily pushing everything to a central IRB, but trying to make sure that we have a single concise and deliberate determination, and that we’re using our IRB resources the most efficiently.

Justin Osborne: Yeah, no, that makes perfect sense actually. And I will pause here because I know for people listening that aren’t necessarily super involved in the IRB space, I think if we were to map out the history that you just gave, you could almost pinpoint when these different terms were used. But just to throw it out to you, independent IRB, central IRB, commercial IRB, single IRB, they all seem to reference the same thing. Is there a term that you prefer? Do these matter or just like in anything else in our space, there’s multiple ways to say the same thing?

Julie Blasingim: There are multiple ways of saying the same thing. I think in my opinion, it’s just the evolution of a company like ours and other central IRBs where it started off as independent from a hospital system. From there, it turned to a central IRB, or there is a lot of discussion about IRBs that are for profit, IRBs that are not for profit. And concerns, conflict of interest on both sides.

How do IRBs manage any either perceived or real conflict of interest that comes from either getting paid by the entities that are asking you to review the materials? Also on the other side, reviewing research for your fellow colleagues and your residents and such. So I mean, there’s always going to be conflict that has to be managed.

And I think what’s really important in all of that is having a very clear and transparent process. You probably know this, but with IRBs it really tends to be the black hole. We send information into the IRB and fingers crossed we get the approvals back. And I think that that’s really disheartening that it’s landed in that place. Because we need to show, and with greater transparency, what the process is and help people understand how we do our job and the ethical principles that we apply.

Justin Osborne: No, I think that you really hit on something that is the commonality. Because you mentioned this, but I think it’s true that there are … There’s the institutional local IRB, and then there’s the sort of independent central IRB world. And I think those two worlds still are a little bit at odds in some people’s views because of some of the ethical concerns on both sides, right?

But to your point, the black hole unfortunate label, it applies to both because you hear institutional local IRB saying that, and central commercial IRBs, and independent IRBs having the same kind of issue of trying to figure out how to make the IRB process and the IRB itself not be seen in that light. But to that point, on your side of the world with the IRB space, can you talk a little bit, the ethical, I guess, considerations around the fact that for-profit IRBs, obviously, have a business and you make profits off of a business, any business. But what are the processes or the things you have in place right now to manage those ethical concerns since the product that you’re selling or the thing in the forefront for you is an ethical committee?

It’s a ethical review of research to protect humans. That’s the sort of goal of an IRB, right? So how do you manage, the economics of that?

Julie Blasingim: Yeah, no, great questions. And through my career, I’ve had the opportunity to sit on the board, to lead the board through those discussions. And I’ve had the opportunity to be on the other side where talking to individuals, making submissions, and on the more of the business development side of it. And I think for the most part, IRBs do a really good job, or central IRBs do a really good job of making sure that those two worlds don’t cross.

And what I mean by that is there’s something that I like to refer to, which is the beauty of the board. When the board comes together with their different backgrounds of expertise, what they should be focused on is the patient and looking at the criteria for approval, the ethical principles, and are they applied or not applied? We keep the board and other central IRBs keep the board separated from business development activities.

They’re not involved with pricing, they’re not involved with any kind of bid defenses because we want them to be unbiased when they’re making their decisions. Because at the end of the day, it’s not about how much something was paid for, it’s about at the other side of that informed consent form is a person. And it’s our job to protect them.

And so that’s something that you have to take very seriously. And it requires daily looking through the lens of, is this information that I’m going to provide to the board? Is this something that could make them conflicted? And if so, then they need to recuse themselves. If there’s some kind of information that they have become privy to, that if they feel like they can’t make an ethical decision, then they need to recuse themselves from the vote. So I mean, there’s several different ways that there’s a firewall kept between board activities and business development activities. It’s just, it has to be intentional. And it has to be a commitment from your leadership. And part of your culture, honestly, is that there’s a respect for what the board does, for the decisions that they make. If they make a decision that impacts a business development initiative, then that … Too bad.

Like I said, at the end of the day, we have to protect the patients. And so that has to be part of your culture, and it has to be appreciated from the top down.

Justin Osborne: I think to your point, it is a culture. I mean, in the research space in general, I think we’re a very mission-driven industry. And so I don’t think IRBs are any different. And to me, it’s very similar to any kind of healthcare or hospital system. I mean, your goal is to treat patients. It’s also a business. You’re also making money. You have to pay people to do these jobs. So that makes sense that you would have firewalls up and be very intentional about keeping those worlds separate from each other.

Julie Blasingim: Right. There’s some research that if you take expanded access single patient IND, when you think about the situation that a lot of those patients are in where they’re desperately looking for some kind of treatment to extend their life, give them better quality of life for the life that they have left. And when we think about putting … Yes, there’s time and costs associated with that. But that’s not an area where IRBs should be looking at profits, and margins, and making money. To me, that’s something that’s perhaps could be viewed as unethical. And so those types of things we look at and say, “Okay, this is not your standard situation. It doesn’t go through the standard process. At the end of the day, let’s do what’s right for the patient in this situation.”

Justin Osborne: Yeah. Yeah, I agree completely. Can you speak to … Because again, and I’ve been in IRBs for a little while myself. And one of the things that you hear a lot living in the IRB world is the disconnect between the patients and what you’re saying. But there is a disconnect between the studies that you’re reviewing, and it is such an important mission. I mean, talk through that barrier that exists between IRBs and patients themselves.

Julie Blasingim: Yeah, it’s a huge disconnect. And when I was … I was part of the problem for many years.

Justin Osborne: What do you mean?

Julie Blasingim: Well, so being in the IRB space 15 years, you become kind of indoctrined to the way that you think that things happen at sites. And when I went back to the site level and started seeing firsthand how research was being done, where the intersection was with the patients, the informed consent form process, the patient’s view of the IRB, and how to contact them. I mean, it was disheartening because I really felt like IRBs were doing a great job of looking at doing community outreach, and really helping patients.

But there’s a disconnect there. And that was part of what led me to go back into the IRB space, because I felt that our patients needed more from IRBs and for them to help them understand what it means to be a research participant. It’s really challenging, even with all the different tools that we have out there, patients are still having a really hard time finding studies.

So there was a study that went out, I think it was last year or maybe the year before from NIH, and it said that 95% of the population in the U.S. Had never been in a research study.

Justin Osborne: Wow.

Julie Blasingim: And that just struck me as the massive amounts of data that we do have on clinical trials is only from 5% of the population. So it’s like if we ever expect to get treatments to market quicker, you need more percentage of the population from all different regions and diversities, and … I mean, age groups. You’ve got to get more people to want to be in research. And to me, that’s where I see the biggest opportunity for all of us who are in this space, is to try to understand the patient’s journey more, understanding what the burdens and hurdles are, taking that information and really valuing it. It’s not just asking for it, but let’s figure out how we can design studies where it takes the burden off of them.

So one thing that I tell people as an example … I said, I’m really bad about going to the doctor because I’ve got to schedule an appointment. I’ve got to go, I’ve got to get parking. I’ve got to make sure someone has taken care of the kids. And that’s one time a year to go for a physical. If we’re talking about being in a research study where you have to go in routinely for different assessments. I mean, that’s a huge inconvenience and burden. So I can tell you though that if I got a phone call and I was able to do part of it on my mobile device, or my computer, or at a location that was near a grocery store, or somewhere that I was more convenient, I would be more inclined to be in more research studies.

So that’s where I think we need to think through. It’s like the way that we conduct research now has definitely changed post pandemic. And we’ve got to stay on that wave of pushing the industry to do it better, because when we do it better, we do it better for the patients.

Justin Osborne: I like that. And actually, I’ve never really thought about this before. But when you’re talking about this from an IRB perspective, you’re in a unique position at an IRB, especially a central IRB, where you see study designs across the board from everybody. You see all the protocols, you see all the designs. Any study that has a community outreach effort, those kind of educational components to their protocols. Whether they’re required or not, you see it all. I almost feel like IRBs are actually in a really good position to give feedback, or even encourage study design.

You don’t hear a lot of people bringing IRBs to the table when they’re talking about study design stuff. Because, and again, I understand it, IRBs are the … That’s the ethical review. You have your lane, and I’m not trying to say IRB should step out of that lane as a function, but from a resource perspective, you guys see a lot of designs. I feel like you would have some interesting input into that.

Julie Blasingim: So we see a lot in, when you think about this ecosystem of sponsor CROs, site networks, IROs, local institutions, the institution research teams themselves. At the center of all of those different parties that are part of research is the patient. It’s like we could have the best of all of those different types of companies, but if we don’t have a patient, then we don’t do the trial.

And IRBs are uniquely positioned where we protect the patient. We are sitting … We’re their insulation to all of those different stakeholders, and it’s … I really, really believe that if IRBs are really in tune with what the patient needs are, their voice concerns, complaints, helping them understand what it means to be a research participant, helping them figure out how they find studies that would be a good fit for them. If we do that better, than everybody else has the benefit of working … Designing better studies, better patient retention, all the things that we all are kind of working on in our silos. So I feel like IRBs can really help, or central IRBs especially can really help pull that together.

Justin Osborne: So thinking about the future. I mean, the landscape’s changed. You kind of talked through how we’ve gotten to where we’re at now. And I really like that this does feel like things are changing in the research industry pretty quickly these days. Technology is a big factor in that. But can you kind of walk us through, in your opinion, in your mind, with regulations changing, technology, all that stuff, how are IRBs going to need to adapt or evolve in the coming years?

Julie Blasingim: Yeah, so great point there. I think of IRBs as we need the next generation, the next iteration of IRBs. Very similar to when we went from regional IRBs to central IRBs and we went from paper records to portal systems. We need a big impetus to help us think about the way that an IRB intersects and works with all the different research parties out there. Because the issues that we have now with clinical trials are very different than what they were 10 years ago.

We’ve got technology, telehealth. The requirements are different in every state almost. You’ve got different populations who are good with telehealth and ones who aren’t. There’s obviously different types of data privacy concerns that go along with that. You have lots of digital health technologies with wearables, with real world data that can be used. And so there’s just a tremendous amount of data that’s out there. And it creates wonderful opportunities where we don’t have to repeat studies, because we can get to this information. But it also creates different types of ethical concerns. And that’s not even talking or getting into AI.

Justin Osborne: Yes. If you could, let’s go through some of these. What are some of these ethical concerns specifically that you think IRBs are going to either are starting to face now or will start facing in the future that they should be prepared for?

Julie Blasingim: Yeah, the FDA actually put out a guidance document last year on doing decentralized trials and digital health technologies. And they did a good job of outlining different considerations for the types of studies where we should be thinking about using these types of tools. And that’s the first thing, is making sure that it’s the right type of study, the right type of population to use these types of digital technologies.

But if we can do that, then we get better retention. You expand on that 5% population that we’re pulling from. So there’s definitely some things that we have to work out, but it takes some time, it takes some collaboration. And not just between the IRB and the researcher. This is where we need to understand from the patients, are you more inclined to participate in the study if it’s telehealth? What kind of challenges do you have with that? We are assuming that everybody has a smartphone, or a laptop that they could do the visit from. Are we thinking about maybe those who don’t have that type of equipment and how would they get into a study? Could they go to a library? Could they go to a health center to use their equipment for this telehealth? Because you don’t want to exclude populations because they don’t have access to this information or these types of tools.

Justin Osborne: Yeah, yeah.

Julie Blasingim: And then the biggest one that goes along with all of these technologies is data and privacy. There’s unfortunately a lot of data breaches out there, and information is being taken daily. And so we’ve got to make sure that we’ve got all the right policies and procedures and security controls in place to prevent anybody from getting access to our information.

Justin Osborne: No, that’s huge. And again, to your point, that’s becoming more and more of a problem with everybody across the board with data breaches and whatnot. I’m wondering, from an IRB standpoint, I’m thinking about the traditional IRB roster. And that includes medical professionals in whatever area that’s being studied. Do IRBs or should IRBs start having more of the IT security people on their boards to review studies, those kinds of things, right?

Because we’ve got the expertise on the board for all the medical stuff, all the drug stuff, all the activities going on there. But there is another side that’s evolving with this technology and the data and privacy stuff that I don’t know of an IRB that has an IT security person necessarily sitting on their board. But it seems like that might be a reasonable evolution given the concerns and the risks.

Julie Blasingim: Yeah, no, I absolutely agree. Because there’s two criteria for approval that are required around this topic. And the first one is around the data and the confidentiality of that data. And because technology is so sophisticated and complex now, you can’t expect your typical IRB members, your scientists, your non-scientists to understand the provisions for controlling how some of this PHI and study data is coded.

There’s a lot that you can do with de-identifying research markers and data elements. There’s things like blockchain, which is a new way of stripping out some of the identifiers. But you need somebody to help you understand, have the researchers done everything that they can to help protect the data itself. And then the second element of criteria for approval that goes along with this is the privacy of the patients. And we think about that as traditionally, it’s when a patient comes in and they’re doing the informed consent, do they have a private room where they can answer questions?

Will the exams be done in a private place? Well, that’s kind of old school thinking of that there’s going to be a site, there’s going to be a patient that goes to the site. When we shake that up and have a patient who’s doing an online survey, or is doing telehealth, or they’re going to a drug store to do their visit, privacy looks a lot different. And the privacy concerns look a lot different. So I think you absolutely have to have the right expertise on your board to make sure that you understand what the risks are to the patient and understand if the controls that they have in place are actually adequate or not.

Justin Osborne: So these are all great points, Julie, about the future and all this technology changing. What are your thoughts on how AI is going to impact IRBs moving forward? IRBs are already starting to talk about and starting to manage questions around it, whether or not AI is being used in a study in any way, and how and all that stuff. But how do you see that playing out?

Julie Blasingim: Well, I certainly think that there’s a place for AI in how we do our reviews. Because first off, AI has been around for a long time, but it wasn’t until open AI came about in 2022 that we’ve gotten the expansion of its use and capabilities. So what we know about AI now and open AI, generative AI is that it’s really good at writing things for us. There are activities that IRBs do that require a lot of writing. Take the informed consent form as an example. There are lots of companies now that are testing out ways that you can take a protocol and then have the informed consent form be developed through AI.

My view is that that’s a good first draft. It’s always easier to start with a first draft than a white sheet of paper. So that’s where I see it being very helpful in helping to accelerate some of the documents that need to be put together.

It’s never going to replace, in my view and in my lifetime, I don’t ever see it replacing the ethical review of the IRB itself. It could probably give you maybe percentages of if this is something that has all the criteria for approval, or maybe based off of other submissions, what your likelihood of having this study approved.

So it might be able to do some of that type of assistance. But I think functionally right now how the industry should be looking at this is can we use it to help us write information as that first draft? Are there other administrative ways that we can … Can we cut down on some of the administrative task? But with anything, these things have to be tested and validated. And part of what’s so challenging from the IRB side is that everybody wants to use AI, especially for interacting with patients. Because you can have a very smart conversation between AI and the patient.

That is obviously very challenging for an IRB perspective because you don’t have control over the information that’s being shared with the patient. And so, these are things that we have to work through with AI experts in helping us understand where’s the information coming from, which different large language models are being used for pulling this information together? What’s the accuracy rate? What kind of controls are on there? And to your prior point about expertise on the board, you have to have somebody who understands this.

Justin Osborne: Yeah, no, that makes sense. And actually, you just brought up a good point about validation. I think of this as with any technology. You have certain validated tools in certain areas of research that an IRB would approve a certain tool. You don’t necessarily have to be an expert in knowing how that tool was developed. But if it’s been validated, there is a process and a system behind that tool that for that industry, that sector, it is an approved, quote, “tool,” to be used for this type of questionnaire or whatever the tool is.

In the AI world, there’s not a validated process in place right now. All this stuff just keeps popping up. So from your perspective of reviewing a study, to your point, without having that expertise, you don’t know if one tool that’s being used, quote … And everything just falls under the AI bucket at this point, right? So you don’t know if it’s good or not because there is no validation, or credentialing, or anything like that involved.

Julie Blasingim: Yeah, no, that’s a great point. And I think about when you went from a paper protocol, and you were looking for something in that protocol, it would take you a lot of time to go to the table of contents, and then you would go and you tried to find what you’re looking for. And then when protocols became searchable PDFs, and you could control find, and you can get to that information a lot quicker.

And so, I think the next evolution is with AI, if you want to interact with the protocol in some way, you ask a question and then it’ll basically give you that control find. But you always have to be able to go back to the source of where that information came from. I think we would be really challenged and in a bad spot if we ever just said, “Okay, tell me AI what you think about this,” and never actually highlight or point to the actual section of the protocol, or the document where you’re pulling that information from. I think you’re always going to have to go back to that source of truth, whether it be the protocol, or consent form, or whatever the core document is. It’s a great search feature.

Justin Osborne: That makes sense. And that’s a great point. I think that this actually … That kind of makes me think about another general question about the IRB makeup and what you guys do. So talking about all this technology and AI and everything else, all these things are way ahead of the regulations. Obviously, you can’t write regulations for what hasn’t happened yet. Makes sense. They’re always going to be behind. So as an IRB, your source of truth as you just said, is the regulations.

You’re reviewing based on the regulations, but that’s just an ethical framework. So how, when you’re addressing some of these evolving issues and looking to the future, how do you create a base, if that makes sense, for an IRB or any kind of ethical committee like this to review something to protect humans when you don’t have a full framework to work within? And I know this is a broad question, but I think that this is a pretty general thing that IRBs just sort of have to deal with no matter who you are.

Julie Blasingim: Yeah. So when you think about the regulations, it takes a while for CFRs to get modified and updated. So I always start there, what do the regulations say? What do the CFRs say? From there, if I can’t find exactly what I’m looking for, then we go to FDA guidance documents. If you’re not aware, they publish the guidances that they plan to post for the year.

And so you can see the types of topics that they’re thinking about. And sometimes it takes several years to get those from draft to finalize. But at least even with a draft, you can understand directionally where the FDA is thinking about what’s the right thing to do in these situations. I mean, it is always advantageous to have different pieces of your organization really tied into continuous education and what I call regulatory intelligence. Looking at where are things changing in the regulatory landscape, where do we need to think about things differently?

And then coming together and having a position of here’s our position on this particular situation. But at the end of the day, if it’s not in the regulations, if it’s not in the guidance documents, and you need to make a decision, it actually becomes very easy. Because you do what’s right for the patient. And if you always keep that as your moral compass … Because there are things … We all know the regulations are gray, but if you, balancing the risk and the benefits and at the end of the day doing what the right thing is for the patient, then I think that’s obviously the ethical direction that you should be moving into.

Justin Osborne: Yeah, no, I like that. I mean, yeah, we’ll throw out the Belmont. At some point these things have sort of been addressed from an ethical standpoint, broadly speaking, but that’s good. So Julie, talking about the IRB board and the evolution of things, to kind of bring it back to the patient side, one of the directives of an IRB is, you just mentioned, the risk benefit balance.

And there is a certain, I guess, threshold or ceiling. If a study is considered, quote, “Too risky,” an IRB could say, “No, we don’t think this should happen.” Or, “We don’t think patients should be involved in this study because we deem that it’s not appropriate, or not … It’s too risky.”

And earlier we’ve already talked about how there is sort of a disconnect between IRBs and patients anyway. So what is your take on that, on the fact that IRBs are responsible for potentially saying, “No, this study can’t move forward because it’s too risky,” but on the other hand, they’re not as connected to the patients as we’d like them to be. Does that make sense?

Julie Blasingim: Yeah, no, it absolutely does. And I saw a little of this when I was back on the site network side. What really hit me was that patients are in control of their own decisions. And I think a lot of times we try to look at the scenario, we look at the risks, we look at the benefits. And we say, “This isn’t good enough. This is too risky. You can’t do it.” But at the end of the day, it’s really up to the patient to decide if they want to assume those risks or not.

It’s up to them if they want to share their data. It’s up to them if they want to participate in the study. And I think that we’ve perhaps overprotected them in some way, or us, patients in some way. That we took out their decision-making rights and empowering them to be the ones to decide if they want to assume that risk or not.

There’s always risk in studies. There’s unanticipated risks that we can’t even think about. Our job is to make sure that the risks that are foreseeable are outlined and clear in the consent form. And as long as that patient has the mental capacity to give informed consent. As long as they’re doing so in a way that they haven’t been coerced or unduly influenced, then that’s up to them. And I think we need to think about that when we’re designing studies, when we’re editing informed consent forms and such. It’s like, let’s not take the power of the individual away. We need to make sure that they are involved.

Justin Osborne: Yeah. No, I like that. I mean, I think you’re right. I think that risk as a concept is a relative concept, and it’s study specific. So somebody in an oncology trial versus a healthy patient, you have different levels. And even multiple participants in the same exact trial will have a different threshold of whether or not they feel like it’s too risky. So yeah, I like the idea of giving the patient the actual option of participating or not. And then the rest of the science part of that, of the study design is making sure that you’re systematically collecting data so that you have an outcome, and you can actually show whether or not something works. That’s the point, right?

Julie Blasingim: That’s exactly right. Exactly right.

Justin Osborne: Well, this is great, Julie. It’s been awesome talking to you. I really appreciate your time, and thanks for joining.

Julie Blasingim: Yeah, Justin, thanks for having me on the show, and look forward to catching up with everyone.

Justin Osborne: Thank you. Welcome back. I’m still sitting here with Julie, and we are going to jump into our segment called Same Team. So again, this is where we talk to everybody about a personal story. So Julie, it is easy to get bogged down in our day-to-day job responsibilities, as you know. But I do actually believe that most of us stay in this research industry because we actually care about the impact that we’re making, and we want to make a difference. So can you share an experience or an example from your career that has connected you with this idea that we’re all on the same team in research?

Julie Blasingim: Yeah, it’s a great topic. And I’m glad that you’re collecting this information because at the end of the day, we all want the same things. We all want to develop treatments, extend quality of life and work together. And there was a time at one of the IRBs that I was working with where we had a study that required a immense amount of coordination. We had to pull together a board meeting in a matter of 24 hours because there was a child patient that was in a life’s threatening situation.

And they weren’t able to get informed consent. It didn’t qualify for a waiver of informed consent. And we literally had to have 24-hour staff on call. The pharmaceutical company was on call to fly out to where the child was. And the first time that we had that situation actually be executed, we got the phone call that there was a child in this life-threatening situation. Everything was enacted, the board was put together, the information was sent to them. And we were able to get it approved for the child to receive this investigational product.

And when you step back and you look at that situation, it wasn’t a theoretical group or cohort of patients. This was a person, this was somebody’s child in a hospital. And that situation always stuck with me because when we all work together, we can do pretty amazing things. And so that really keeps me tethered and humbled to be in the role that I am.

Justin Osborne: Thank you for sharing. That’s a great story. I mean, I think that’s exactly why we’re all in this, right? We all sort of hope to be in that story that we are making a difference, and that’s … Why else do this job? You know what I mean?

Julie Blasingim: Yeah.

Justin Osborne: Well, thank you again, Julie. I really appreciate you taking the time to share so much with us, and we’ll talk soon.

Julie Blasingim: All right. Thanks, Justin.

Justin Osborne: Thanks.

Julie Blasingim: Take care.

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