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False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct

 
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Episode 7: Eureka! Government Investigators Seek Out Research Misconduct

Host Jonathan Porter welcomes Husch Blackwell attorney Karen Courtheoux to the show to discuss the False Claims Act in the context of government-funded research programs that are often carried out under the auspices of institutions of higher education.

Their discussion kicks off with a short summary of the mechanics of government research funding and the reporting processes of the post-award monitoring phase of research. From there, the conversation turns to the various sets of rules in play across the expanse of government-funded research, including how research misconduct is defined and how compliance works in this context.

Jonathan and Karen also discuss specific recent examples of research misconduct and the lessons learned from them.

Jonathan Porter | Full Biography

Jonathan focuses on white collar criminal defense, federal investigations brought under the False Claims Act, and litigation against the government and whistleblowers, where he uses his experience as a former federal prosecutor to guide clients in sensitive and enterprise-threatening litigation. At the Department of Justice, Jonathan earned a reputation as a top white collar prosecutor and trial lawyer and was a key member of multiple international healthcare fraud takedowns and high-profile financial crime prosecution teams. He serves as a vice chair of the American Health Law Association’s Fraud and Abuse Practice Group and teaches white collar crime as an adjunct professor of law at Mercer University School of Law.

Karen Courtheoux | Full Biography

Karen is a Chicago-based attorney on Husch Blackwell’s Education team. She handles a variety of matters for public and private institutions of higher education, including faculty, student and employment matters; research misconduct and compliance; investigations; governance questions; and federal and state litigation. Specifically, Karen has advised universities, academic medical centers, and healthcare clients on the development, implementation, and enforcement of research-related policies—including IRB, confidentiality, and conflict of interest policies—and has negotiated sponsored research agreements, data use agreements and other contracts and memoranda of understanding. More broadly, she has well over a decade of experience in private practice and as a litigator at national law firms representing clients in all stages of federal and state litigation involving commercial, trade secret, employment, consumer finance and property disputes, including appeals and class actions.

Read the Transcript

This transcript has been auto generated

00;00;01;07 - 00;00;28;02

Jonathan Porter

Welcome to another episode of Husch Blackwell's False Claims Act Insights podcast. I'm your host, Jonathan Porter. I joined Husch Blackwell from DOJ for the healthcare group. That was my background with DOJ, healthcare. I came here to help our healthcare clients with several investigations. What I didn't know about the firm when I joined was that we also have one of the best higher education law practice groups in the country.

00;00;28;19 - 00;00;49;19

Jonathan Porter

I've slowly started working with our higher ed group in a few different ways, and I'm blown away with this team. Our higher ed group has more than 40 attorneys and more than 300 higher education institutions as clients. It's just a it's a top notch group, hugely respected in the university setting, for example. And this is all very public now.

00;00;49;19 - 00;01;19;04

Jonathan Porter

And so I can I can talk about it. When LSU had concerns that it had systemic issues with how it responded to allegations of sexual misconduct by its athletes, LSU turned to Husch Blackwell's higher ed group to run an internal investigation and make recommendations for improvements and to do so quickly and within just a few months Husch Blackwell had finished an exhaustive, independent review that LSU chose to make public as part of its commitment to improving its processes.

00;01;20;00 - 00;01;50;10

Jonathan Porter

That's just one example of many regarding Husch Blackwell's higher ed group and the great work that that group is doing for so many university clients. And today I want to talk about one specific higher ed area that has big implications for the False Claims Act and that is research misconduct. A ton of research is federally funded. NIH alone awards $38 billion to researchers every year.

00;01;51;00 - 00;02;23;05

Jonathan Porter

That's the GDP of the entire nation of Libya every year just to fund research. That's more than NASA's entire yearly budget. It's an amount of funding that is hard to fully appreciate. Those funds go to around 300,000 researchers at more than 2500 universities, colleges, research institutions, etc.. And with those numbers, people in the False Claims Act space have been saying for years that research could be the next big source of false claims, act investigations and cases.

00;02;23;15 - 00;02;53;16

Jonathan Porter

And so today we're exploring research misconduct under the lens of the False Claims Act. Joining me to talk about research misconduct is my colleague, Karen Courtheoux. Karen has serious higher ed bread. She's been in house serving in the Office of Legal Counsel at the University of Chicago, where she also went to law school. In private practice, she's not just an advisor to a host of higher ed clients on research misconduct, faculty issues, Title IX and the like.

00;02;53;28 - 00;03;20;14

Jonathan Porter

But she's also one of our higher ed teams. Go to litigators. And as if that weren't enough, Karen is also a lecturer at Northwestern, where she teaches higher ed law and ethics. I'm tremendously excited that she's here to talk about research misconduct. This is going to be a lot of fun. Karen, welcome to the podcast. Thanks for telling our listeners a little bit about research misconduct and how it can lead to false claims like problems.

00;03;21;06 - 00;03;48;10

Karen Courtheoux

Oh my goodness. Thank you for that kind introduction, Jonathan. I am truly honored to be here and happy to represent our amazing higher ed team because I agree it's one of the banner practices at Husch Blackwell. I'm truly honored to be here, and I get to talk about one of my favorite topics, which is research misconduct. I think it's a growing concern for all of our higher ed clients, or at least it should be so certainly worth the attention of your podcast.

00;03;48;28 - 00;04;12;05

Jonathan Porter

Thanks, Karen. So to get started, I just mentioned some stats on in our funding, but I'm hoping you can give our listeners a little more background on how exactly research is funded, how it works, who is funding research, who is receiving funding? How does research funding get decided and how does this funding thing actually work? Give us some some very basic background on this.

00;04;12;16 - 00;04;35;18

Karen Courtheoux

Sure. Many of us are familiar with the NIH, which last I checked, was the largest funder of health research in the world. I didn't know the stat about the Libyan GDP, but thank you for that. We are also familiar with, let's say, the NSF perhaps, but there are many federal agencies that fund research of some kind outside of those two significant funders.

00;04;35;18 - 00;05;00;16

Karen Courtheoux

Others that come to mind would be the Department of Energy, the Department of Agriculture, the Department of Defense. All of these are significant funders. The list goes on, and even NIH is composed of 27 different institutes and centers, and each one of those has its own funding strategy. So there are some generalizations we can make and some we really can't because each funder is sort of different.

00;05;01;03 - 00;05;23;23

Karen Courtheoux

The federal government is a very significant funder of research. But just to complete the picture, there are also state and local funding agencies and even outside of the government context, which I know takes us outside of the False Claims Act world. There are private sponsors which are often corporations and private gifts in the academic context where my work is focused.

00;05;24;03 - 00;05;48;18

Karen Courtheoux

I believe that the federal government remains the majority funder, at least of academic research. To your question about how to get funded, if you are a researcher and want to get in on the action. Most of the time you match the research that you want to do with a funding opportunity. You write your application, hopefully with support of your institution, and then generally your institution submits it on your behalf.

00;05;49;14 - 00;06;18;23

Karen Courtheoux

Each funding agency has criteria that it will apply, sometimes varying by grant, often varying by grant. And then if your application is selected for funding, you'll receive what's called a notice of award. The notice of award is a legally binding document that has a lot in it. Among other things, the terms and conditions of the award and some roles and responsible parties for everyone on your proposed research team.

00;06;19;24 - 00;06;46;25

Karen Courtheoux

Usually those terms and conditions include some kind of regular reporting back to the funding agency, as I'm sure we'll talk about, such as an annual progress report describing the progress made on the research as well as any changes you want to make. And that's called the Post Award Monitoring Phase. Looking ahead to the False Claims Act tion here, the grant application and each progress report and any other submissions required under the Grant's terms.

00;06;47;11 - 00;06;49;24

Karen Courtheoux

Present opportunities for false statements.

00;06;50;09 - 00;07;13;06

Jonathan Porter

Thanks, Kieran. That's really helpful. Yeah, I'm here for the questions and for Libya. GDP comparisons. That's all I'm good at. But seriously, Kerry, thanks for that background. So I think our listeners are probably all too familiar with the fact that the federal Government almost never gives funding without a comprehensive web of regulations that guide what can and cannot be be done.

00;07;13;24 - 00;07;37;02

Jonathan Porter

From my work, both here and at the Justice Department, I'm familiar with a couple of those big prohibitions. The biggest one I'm familiar with is that you can't lie or withhold material information in your grant application. You just mentioned that guarantee, but I'm sure there are many, many others. So, Karen, what are some of the most critical regulatory prohibition laws that researchers need to know about?

00;07;37;02 - 00;07;38;05

Jonathan Porter

What can't they do?

00;07;39;00 - 00;07;58;05

Karen Courtheoux

Well, I think you've hit on a really important one, particularly from the funders perspective. But you also know that when it comes to federal regulations, things are rarely simple. And it's important to remember that there are many different funding agencies with their own sets of rules. You might hear me say about three or four more times today as a reminder.

00;07;58;21 - 00;08;24;26

Karen Courtheoux

But let's use your example of NIH and pan out just a little bit. The NIH is part of HHS, which is an umbrella that also includes agencies like the CDC and others. And HHS particularly useful for today because it has an independent entity within it called the Office of Research Integrity or Eye, that undertakes research integrity activities and also has a role in enforcing a lot of the regulation.

00;08;24;26 - 00;08;54;08

Karen Courtheoux

And that I think of when I think about research misconduct, as I do all too often. So that's a long lead up to say that for an eye age and for the other HHS agencies, there are federal regulations that define research misconduct and give institutions a lot of rules to follow. With respect to the process of investigating allegations of research misconduct, so I would say that researchers need to know what's encompassed in that definition of research misconduct.

00;08;55;09 - 00;09;13;18

Karen Courtheoux

And I should add here, there's a potentially annoying complication, which is that our eyes in the process of drafting a new final rule that's likely to impact the scope of what's considered research misconduct. And that hasn't changed in, I think, over 20 years until whatever's coming ahead.

00;09;14;05 - 00;09;39;24

Jonathan Porter

Yeah. Karen, it'd be too much to ask for federal agencies to just keep the laws and the rules the same. And so that's why we have jobs, is that it never stays the same. So I guess stay tuned to the Higher Ed Group for more information on that or I final rule. So with the federal government giving out this much money, do they have staffers stationed in all of these, say, labs that they're funding?

00;09;39;24 - 00;09;53;09

Jonathan Porter

Is there an niche or I guy in a flak jacket following researchers around with notepads scribbling down notes with to ensure compliance? And if not, how do these agencies monitor compliance?

00;09;53;23 - 00;10;15;03

Karen Courtheoux

Well, you know, I'm picturing a government agent looking at a Western blot and just shaking his head. Of course, that's not how this works. And I think that would be a nightmare for for our university clients. But as you and I have discussed, the federal government requires reports and assurances is that everything's being done in compliance with the law.

00;10;15;23 - 00;10;46;23

Karen Courtheoux

The research regime that NIH is the part of relies largely on what we think of as an honor system. It's largely based on honest grant proposals and accurate annual reporting. Now, I know you had an episode earlier about the role of a whistleblower, and I commend that episode to our listeners. I really enjoyed it. But I would also note that with the rise of public websites and watchdog websites like Pub Peer and others, the speed of an allegation, at least with respect to research misconduct, can come from almost anywhere.

00;10;47;18 - 00;11;02;09

Karen Courtheoux

I don't have data on the extent to which the federal government uses those public websites, if at all, but they certainly could. And in a way, through some of those websites interested members of the public can all serve as sort of anonymous whistleblowers.

00;11;02;25 - 00;11;24;24

Jonathan Porter

Thanks, Karen. That's really helpful. It's good to know that there aren't over I guys and girls in full flak jacket, bulletproof stuff sitting in in labs. That would be ridiculous. But you mentioned this and that's the perfect segue ways whistleblowers and thanks for the plug for the whistleblower episode I liked that one to Jodi was an excellent guest on that, but that's exactly where I wanted to go with this conversation.

00;11;24;24 - 00;11;48;23

Jonathan Porter

Karen So I want to think about how whistleblowers play a role in research misconduct FCA cases this you know, think about someone from within a research team, for example, who has raised a compliance alarm before and who now wants to file and under seal keeps saying that, you know, a, the university and their researchers are committing misconduct in some way.

00;11;49;09 - 00;12;07;02

Jonathan Porter

And while no one out there wants to be accused of committing fraud, I would imagine that universities in particular have strong desires to protect their reputation. So, Karen, talk about how higher ed institutions think about federal investigations and accusations of research misconduct.

00;12;07;14 - 00;12;37;00

Karen Courtheoux

Yeah, I think it's fair to say that allegation of research misconduct and federal investigations are never welcome developments at any institution to say. But with the professionalization of the research enterprise, particularly at some of the institutions with the most significant research enterprises, I think the capacity to handle this sort of thing can be pretty strong. But with that said, these sorts of issues can hit higher education institutions in a couple of important areas.

00;12;37;21 - 00;12;57;22

Karen Courtheoux

One of those areas is their mission and principles. Many institutions, maybe all of them, have ethical commitments in the area of research and hopefully are doing everything they can to maintain a culture of compliance. If any of my students are listening, they will be rolling their eyes because they hear about the culture of compliance for nine straight weeks.

00;12;57;22 - 00;13;20;03

Karen Courtheoux

For me, unfortunately. But the prospect that there may be a lapse in those ethical commitments and in the culture of compliance can be really troubling for institutions. And certainly it creates a lot of work and risk for them. And then there's the fact that these sorts of allegations and investigations can be public information and subject to public scrutiny.

00;13;20;03 - 00;13;44;02

Karen Courtheoux

I like to think that those of us who work in this area between allegations and findings, between minor and major infractions and between let's say, a bad Apple researcher and an institutional shortcoming. But the broader public may not be making those kinds of distinctions. And so I think you're absolutely right that there's an element of reputational risk on top of the legal risk.

00;13;44;13 - 00;14;17;25

Karen Courtheoux

And I'll add one more wrinkle here, because my practice focuses primarily on faculty issues, which is that I imagine there can be internal political ramifications to the way that the institution handles these issues. Sometimes the accused investigators, faculty peers may be outraged that there was misconduct. I've seen that on investigation committees, for example, but on many campuses, the faculty also can have expectations that the institution will do whatever it can to protect their privacy or their reputations.

00;14;18;11 - 00;14;32;04

Karen Courtheoux

And that's not always within the institution's control. It's not always even within the institution's interest. So there can be some tricky faculty management issues that arise here, too, and I'm not sure that anyone has a perfect handle on that.

00;14;32;21 - 00;14;56;19

Jonathan Porter

Interesting. Karen, in my mind, I'm a, you know, the false claims of guy McGovern investigations guy. I don't usually see the whole picture. So it's great to hear your insights about how these issues could create faculty issues as well, because I totally get that. I could totally see where you're coming from. I could see where that that could lead to a lot of interesting decision making from within the decision makers at a university when these issues come up.

00;14;56;19 - 00;15;10;17

Jonathan Porter

So Karen, given those priorities, given the potential for embarrassing press releases or whatever, I would assume that most universities take compliance seriously and take steps to ensure that their research teams are doing everything right. Is that a fair sum?

00;15;10;17 - 00;15;35;14

Karen Courtheoux

I think that's a fair assumption, but it's hard. There are a lot of inputs to a successful culture of compliance. None of it's particularly quick and much of it is very resource intensive. So maybe the most obvious place to find many of those inputs are to look at an institutions record and post award services. What kinds of supports and checks are built into the grant writing process?

00;15;35;14 - 00;16;08;02

Karen Courtheoux

What about for the annual reporting process? Now this is a little trickier, but I would also recommend attention to the hiring process. Institutions may want to make sure that they're doing everything they can at the hiring and onboarding stages within the bounds of what's legally permissible. Of course, to make sure that they're hiring folks who have the training and experience needed to conduct research properly and who have not engaged in research misconduct previously, or that they're making a conscious decision to hire that person anyway.

00;16;08;02 - 00;16;31;08

Karen Courtheoux

I think some of the institutions that are having the most success in this area are those that have raised the visibility of their REO, their research integrity officer, or whoever it is that is responsible for research integrity at the institution. That person and the institution's support of that person can go a long way. But I will say there are some aspects of research compliance that can just be persistent.

00;16;31;18 - 00;16;46;24

Karen Courtheoux

For example, if anyone listening has a silver bullet when it comes to enforcing training and oversight standards, when you have especially renowned investigators, I would love to talk to you about that. I think that's a very difficult one to manage.

00;16;46;24 - 00;17;08;20

Jonathan Porter

Thanks, Karen. Yeah, those are great insights. I would imagine thinking from the False Claims Act side, if a university is hiring someone with a track record of seeking research, probably going to be a problem for the university if that happens again. I would imagine DOJ having some strong feelings on that in some sort of, you know, reverse proffer down the road.

00;17;08;20 - 00;17;38;05

Jonathan Porter

So that's that that's interesting. So, Karen, let's talk about some examples. In recent years, the first one we did this is one that we've discussed a couple of times in the podcast already, but it's a well-known university that's settled with the Justice Department for over $100 million a few years back. The allegations there were that a particular researcher worked in a pulmonology lab and needed to measure mice response doses to inhaled substances.

00;17;38;25 - 00;18;08;26

Jonathan Porter

And the allegations were that she was simply faking these results. She coauthored 38 research papers with the allegedly fake results. She was lauded for getting experiments to work that no one else could make work. And other researchers in her lab started crying foul, saying that her results were too reliable to be true. And Karen, you know, I'm no mouse expert, but I'd imagine that it's hard to measure pulmonology responses in tiny creatures like mice.

00;18;09;17 - 00;18;30;14

Jonathan Porter

So years and years go by in this investigation, one of the other researchers files a key item, and the university eventually settles here. And this is one of those cases that probably every university in the country talked about when it got announced. But I don't know if there's an easy take away from the case. Sometimes researchers are going to fake results.

00;18;31;00 - 00;18;36;06

Jonathan Porter

So how are Karen Hauer University supposed to catch researchers who are doing things like this?

00;18;36;20 - 00;19;08;13

Karen Courtheoux

Well, it's a difficult question, and I suspect it varies depending on the characteristics of the institution. Personally, I like to focus again on the visibility of the real, the reinforcement of research, integrity, values and the institution's messaging, its policies. I like to focus on training, expectations, fans and support for researchers. And I'm interested in the possibilities of building institutional infrastructure and support for data, organization and storage practices, which is where we sometimes see these allegations come up.

00;19;09;15 - 00;19;45;01

Karen Courtheoux

But ultimately, that's all sort of preventative. If you have an investigator who's committing research misconduct, I think building up your reporting mechanisms can be helpful. I also wonder whether some of the work can be located. I hesitate to say it, but with strong department chairs and research mentors and having faculty sort of helping each other and also monitoring each other, which they may not want to do, but I'm not sure that there's a one size fits all solution when you have what I think I earlier called a bad apple researcher.

00;19;45;01 - 00;20;23;07

Jonathan Porter

Thanks, Karen. Yeah, I have a lot of sympathy for universities in a case like that where it is so hard to go back and double check. Is this researcher baking in measurements on inhaled mice responses? That's just a really hard thing to go back, in fact, check. And so it's difficult. You know, one of the things in an episode about a month ago, we did an episode called Creating a Culture of Compliance and Adam Briggs of UPS there talked about the mechanisms that you're talking about, how it's important to have a system in place so that people can can report up concerns and that there's someone who's going to not just not just figure out

00;20;23;07 - 00;20;48;03

Jonathan Porter

whether there's a problem, but also make sure that the person who is making that report knows that they've been heard. And I think that's a good way for you to not just get the answers, but prevent someone who thinks something's wrong. Turning to turn to the court system in order to gain some sort of corrective measure. So, Karen, another example takes us to the other end of the splashiest spectrum.

00;20;48;05 - 00;21;15;15

Jonathan Porter

If there were such a spectrum, so measuring mice, pulmonology responses is probably frankly, it's a boring way to commit fraud. But getting NIH to pay for your birthday scuba vacation is an exciting way to commit fraud. And that's what one New York college researcher did. Karen, tell our listeners a little bit about that case and why the university ended up settling with the Justice Department over false claims that conduct.

00;21;16;02 - 00;21;40;23

Karen Courtheoux

Sure. Well, here we have a prominent HIV AIDS researcher, someone described as a rainmaker for his institution, who directed a sort of pioneering center for AIDS research. But even as he was bringing in millions of dollars in NIH funding for his research and for the support of dozens of employees who supported his project, he did a couple of things with respect to his funding that were out of bounds.

00;21;41;15 - 00;22;13;18

Karen Courtheoux

Primarily, he used NIH grant money to fund certain overseas trips, as you alluded to. And he said that those trips were for research when they were actually in exotic destinations and intended for recreation, including his scuba diving hobby, which maybe makes it more interesting. But his institution ended up bearing significant liability for another piece of this that was out of bounds because they improperly used grant money to pay him significant bonuses to retain him, and they failed to disclose that usage.

00;22;13;18 - 00;22;45;06

Karen Courtheoux

So it was kind of a twofer. They used the money to pay these bonuses and they also didn't disclose that those are to separate violations in many ways. Now, the fraud came to light as a result of this researcher's ongoing inappropriate behavioral conduct, not his research misconduct. As it happens, after years of that kind of conduct, the institution was prompted to conduct an internal investigation and that investigation into his behavior turned up the misuse of funds.

00;22;45;28 - 00;23;06;29

Karen Courtheoux

But at that point, the institution still didn't report the fraud. And eight instead there would be a whistleblower who came along and alerted the authorities. So I look at a case like this and see some missed opportunities, but at the same time I can see how easy it would be at a structurally complex institution for this kind of misconduct to go unaddressed.

00;23;07;19 - 00;23;38;10

Karen Courtheoux

I think if there are any takeaways, the main ones for institutions are the ones we talk about all the time. In other contexts, no one researcher or faculty member or staff member should be considered untouchable because the value of their grants or because they seem particularly important or get a lot of attention. Institutional policies have to be followed consistently such that complaints of misconduct are taken seriously and investigation is warranted.

00;23;38;10 - 00;24;04;17

Karen Courtheoux

That investigation is done promptly and maybe just thinking about the exercise of checks if a research expense seems too good to be true, if it seems convenient or grand, then there should be a culture that makes it both possible and encouraged for someone to examine it more carefully. I'm not saying that's what went on in this case. I frankly don't know exactly what was happening behind the curtain.

00;24;04;17 - 00;24;25;20

Karen Courtheoux

But but that issue of checks and both of those suggestions related to consistently applying processes and policies and allowing for and encouraging checks on the process could go a long way in the situation to preventing this kind of exposure.

00;24;26;06 - 00;24;43;04

Jonathan Porter

Thanks, Karen. Yeah, I agree with you there. There were probably some missed opportunities. This is a good a good example for learning for a lot of people because I think some rudimentary checks could have caught this. I think that's a fair a fair conclusion to draw here. So, Karen, totally agree with you. There's some to be learned from from this case.

00;24;43;22 - 00;25;04;28

Jonathan Porter

One of the interesting things about that case, that scuba case is, is something I think about from time to time. And that's the and this is a total diversion from the normal podcast. But, you know, I'm the host, so I get to do a little bit of fun stuff. Karen And to me the fun thing is thinking about what should be civil in the False Claims Act and what should be criminal.

00;25;05;08 - 00;25;25;08

Jonathan Porter

That researcher using NIH funds for scuba trips, there's no chance he thought that that was okay. So it's interesting to me that he didn't get criminally charged. He settled under the False Claims Act. But that office that office of DOJ never opened up a criminal investigation. I've seen a lot of people charged for a lot less egregious white collar crimes in that.

00;25;25;08 - 00;25;46;08

Jonathan Porter

So just a side note, I think it's interesting that that researcher settled with the government for money wasn't made to plead guilty to any sort of criminal repercussion. So interesting note that I just bring up because again, my podcast. So Karen, one final example before we go and this one just happened in May. So this is right out of the out of the headlines.

00;25;46;20 - 00;26;09;01

Jonathan Porter

One of the nation's top health systems settled with the Justice Department over allegations that it failed to ensure that its investigators weren't also getting funding support from foreign governments. The settlement is also notable in that it dinged the clinic for allowing its employees to share passwords. I thought that was interesting, but I doubt that piece was really driving the settlement talks.

00;26;09;16 - 00;26;24;13

Jonathan Porter

So Karen, the clinic ended up settling with DOJ for $7.6 million. So here is a final example. Tell our listeners about that settlement and what research misconduct lessons our listeners can take from it.

00;26;25;01 - 00;26;50;18

Karen Courtheoux

Yeah, thanks, Jonathan. I actually hadn't seen that one until you brought it to my attention, but I read it with great interest and was pleased to find that the settlement agreement was available to review. So thanks for that. But I think the circle's back to the very beginning of our chat where we said that honesty and accuracy is the baseline here, the grant applications, the application updates, the research progress reports fell short of that expectation.

00;26;51;01 - 00;27;16;11

Karen Courtheoux

So again, without knowing what was happening behind the scenes of this health system, what comes to mind for me are due diligence types of questions for all the institutions we advise. Do the investigators, meaning the researchers, have the training and support to get the grant submissions right? These are complicated submissions. They're not lawyers most of the time. Even lawyers struggle with these sorts of things.

00;27;16;11 - 00;27;44;23

Karen Courtheoux

So it really takes some expertize. And do you have the right expertize in place? Do the right people in the research enterprise have sufficient training and authority to question the substance of grant submissions? Have you made that part of your culture? Is there sufficient staffing to allow for cross close scrutiny? Some research enterprises involve so many grants per year and so many dollars coming in, and they can have very, very talented and well-trained staff members.

00;27;45;15 - 00;28;29;07

Karen Courtheoux

But they may not have enough to cover all of their grant activity with the kind of attention that would be able to prevent something like this. And then lastly, like I mentioned before, are the right mechanisms in place for the institution to be able to hold the investigator accountable? I think research misconduct is a significant challenge, and I think that over time the institutions that are best able to manage the challenge will be the ones that recognize the incredible the increasing institutional investment required to maintain that culture of compliance, that resource intensive compliance measures are one of the cost inputs to the release of grant funds to the institution.

00;28;29;19 - 00;28;48;02

Karen Courtheoux

And I don't want to create a system of haves and have nots where all of the federal dollars are going to sort of the big players in the industry. But I do think that that cost calibration maybe needs to be weighted a little bit more heavily and compliance in order to avoid these really hefty penalties.

00;28;48;20 - 00;29;08;01

Jonathan Porter

Thanks, Karen. Those are excellent takeaways. I totally agree with you. I think maintaining a culture of compliance right now within research universities is critical. I think that this is only going to become a bigger and bigger deal under the False Claims Act. Like we said at the top, this is an area that is hugely funded by the government.

00;29;08;14 - 00;29;36;18

Jonathan Porter

I've got to think that whistleblowers and what's in the whistleblower bar that they're doing a an active job of making sure that would be whistleblowers are hearing about these cases. They're hearing about the Justice Department's priorities when it comes to this area. And I think it's only going to continue to drive these investigations. And so now is a good time for universities to ensure that they've got the right compliance mechanisms in place so they can avoid being the next press release from the Justice Department.

00;29;36;18 - 00;29;45;22

Jonathan Porter

So, Karen, thanks so much for coming on the podcast and telling our listeners and universities a little bit about research misconduct. I really appreciate you coming on.

00;29;46;02 - 00;30;00;24

Karen Courtheoux

Well, thanks so much for having me. It's been very fun to think about these issues, even though they're not fun for our institutions once they actually arise. But I appreciate the chance to to discuss these kinds of things, and I think you're wise to be putting them on a broader platform.

00;30;01;08 - 00;30;23;00

Jonathan Porter

Thanks, Karen. And I'm happy to be part of the excellent higher ed team that we've got here that's here to help clients if they have issues like this pop up. And I'm hopeful that our group has many more years of helping university clients with these difficult issues coming up. So thanks for listening to today's episode on research misconduct.

00;30;23;00 - 00;30;31;18

Jonathan Porter

We'll see you next time.

Professionals:

Karen L. Courtheoux

Senior Counsel