NIH Open Mike: Meet the New HHS Office of Research Integrity Director

 

Dr. Michael Lauer: Hello. I'm Mike Lauer. I'm the NIH Deputy Director for Extramural Research. And it gives me enormous pleasure today to welcome Sheila Garrity. Sheila Garrity, as many of you may know, was recently named as the new Director of the Office of Research Integrity. We've had a longstanding history of working with the Office of Research Integrity, otherwise known as ORI, and we're absolutely thrilled that Sheila has been appointed to this important position. So let me start by saying Sheila, welcome to our NIH podcast. And also, congratulations on being named to this position. Maybe we can start by having you tell us a little bit about yourself and why you're interested in research integrity.

 

Sheila Garrity: Thanks, Mike. And thank you for the warm welcome. I feel so supported by you. My time with Mike goes way back from when I was the other side of the curtain. And when you get a call from Mike Lauer it sometimes makes you nervous, but when you're actually on the call he's not a bad guy no matter what you hear about him. My interest in research integrity goes back a long way from my time at Johns Hopkins when I entered this field in the early 2000s. At that time, Hopkins was the largest recipient of NIH funds. So, it made sense for me to go down to Rockville and meet my colleagues at ORI because I knew I was going to have a lot of interactions with them. So, I drove down and met with John Dahlberg, Chris Pascal, Alan Price, John Krieger; that original crew and developed a partnership with them. And so, for many years worked with ORI on various education initiatives, educating the community in the responsible cognitive research. And moved eventually from Hopkins, after 25 years, to George Washington and continued that work with ORI. Before I left Hopkins, I started the Association of Research Integrity in partnership with the Office of Research Integrity and that is now going strong. We have an annual meeting. We, I'm not a we anymore. They have an annual meeting. Research integrity; we can't just put it in a little box, we have to incorporate it in our daily lives. I'm a cancer survivor. I've benefited from research that way. I used to be the managing editor of the Biomedical Journal. So, I'm kind of coming full circle to now come on the government side and I'm very happy that I did.

 

Dr. Michael Lauer: Right. Thank you. Well, okay. You just alluded to coming onto the government's side, you've been on the academic side for quite a while. Of course, you've been on the government side now for a relatively short period of time, but what are you seeing so far? How are your perspectives evolving as you're moving from, you know, one end of this to the other?

 

Sheila Garrity: Well, I can tell you that government onboarding is no joke and people tell you about that, talk about government bureaucracy. It is serious. I've been here for three months and have completed all kinds of training. I'm learning this new language that we speak on the government side. And we just submitted our budget book today. And I'm understanding why this has to be this way; why we function, why we work to protect the taxpayer dollars. So, it's really not that different. I think we have the same goals. We have a different oversight role on this side of the curtain, but the theme of research integrity and the responsible conduct of research is the same.

 

Dr. Michael Lauer: Yeah. Okay. So, we are two parts of the government side. We're both within the Department of Health and Human Services. And maybe the next thing you could talk about a little bit is your sense of your top priorities for ORI, and then your sense of how how ORI and NIH can best work together.

 

Sheila Garrity: Great. And I'm going to ask you a question after I do that.

 

Dr. Michael Lauer: That's fine.

 

Sheila Garrity: So my vision for ORI. ORI is not broken, you know, contrary to these press releases that came out after my appointment was announced; you know, how she's going to change all of these things at ORI. ORI has continued to do good work since it started in 1992. There have been some hiccups with various leadership changes and there hasn't been a permanent director for a while. There's a core group of people doing really important work. And my goal is to make sure that they have their resources both in terms of staff, in terms of software programs, equipment, to do their jobs and to support them in that. I don't think we measure our success in numbers of findings, of research misconduct findings. I think we have to do a better job closing our cases. So I want to help work with the team; how do we do that? I went to my first RIO Bootcamp as an ORI representative at State College in Happy Valley or Penn State, State College. First time in Happy Valley and that was so great to be back among the community. We need more RIO Bootcamps. We need to help our community. And we have always had a great relationship with NIH, our partners, and OER. We meet regularly, our investigators talk to each other, share resources. And I hope that we continue to do that. My question for you Mike is; people on the outside, on the other side of the curtain, think ORI is NIH and they will just say, "Yeah, what are you guys doing at NIH?" So, why do they think that? And maybe because you've been here longer than I have, and you can tell me how long you've been here; how do we help them understand that distinction?

 

Dr. Michael Lauer: Okay. I've been at NIH for 15 years. And maybe one way of thinking about this is, shortly before I came to NIH, so I had already been hired and selected. And I came down here, I was in Cleveland. So, I came down to Washington for, I guess you could call it, the beginning of orientation, beginning of onboarding. And I'm sitting with the chief of staff of the institute I was going to be part of. I was part of the National Heart, Lung, and Blood Institute. She uses the term IC. She says, "Well, you know, there are various ICs who go this way. There are ICs that go that way." And I had no clue what that meant. I said, "What's an IC?" So then she explained to me that an IC is an institute or center. So then I started to understand; oh, so that means that NHLBI is like one of the institutes and centers of NIH. So even though I had been involved with grants, I had been on study sections, I had submitted grant applications, I didn't get that. I didn't know that until that point in time. Another thing I didn't know, for example, is that not all peer review at NIH happens through the Center of Scientific Review. About a quarter of peer review at NIH occurs through the individual ICs, institutes and centers, I just thought it was all one thing. I just didn't appreciate that. So I think part of this is, you know, I guess you could call it inside baseball. If you're outside baseball some of these distinctions are not clear and so that's probably part of the reason why this is. Now, even having said that we know, from some of the questions that we get, that there are people who do not realize that the executive branch of government and the legislative branch of government are not the same.

 

Sheila Garrity: Yes.

 

Dr. Michael Lauer: And also that the federal government and the state governments are not the same. That's part of why our system is in many respects both very effective and yet at the same time very frustrating. You know, it's the fact that, you know, what we learned in school about checks and balances. The fact that we are, you know, separate units this, you know, assures that we're not going to get into a situation of, you know, abusive power and so forth. At the same time, it can also cause a great deal of confusion and I totally get that.

 

Sheila Garrity: And it makes me feel better that you didn't understand government speak when you started.

 

Dr. Michael Lauer: I had no clue.

 

Sheila Garrity: People tell me 18 months that I'll be speaking like a native. So I will watch for that. But another thing I think that distinguishes our offices, we in our investigations are talking about FFP; fabrication, falsification, plagiarism where PHS funds are involved. Patricia Valdez in your office has a different role or a different universe that seems to be growing because it's complex. So tell our community that difference.

 

Dr. Michael Lauer: Yeah. So we back in the old days, the old days being seven or eight years ago, we were typically seeing about 100 new allegations a year; maybe a little bit less. And the vast majority of them were FFP: fabrication, falsification, and plagiarism. Now, what has happened over the last few years is that NIH's leadership has taken interest in other forms of professional misconduct and perhaps the two that have gained or garnered the most amount of public attention are harassment, starting with sexual harassment. And now that has brought now to all other kinds of harassment and hostile work environment that has become a large part of our portfolio. It has even come to the point where we have new congressional authorities that we did not have even a few years ago. And then another big area has been foreign interference, although that is less of an issue now than it was a few years ago. Another big problem that we're working on is peer review. And peer review is an enormous undertaking. We review 80,000 applications a year. Vast majority of the time everything goes just fine, everybody does exactly what they're supposed to do and more importantly doesn't do what they're not supposed to do. But unfortunately, we have had some rather serious instances of peer review violations. And then there are a variety of other issues that we deal with, some of them actually go so far as outright grant fraud. So we had a very recent case that became public of somebody who was using NIH grant funds to pay for vacations in the Caribbean. That led to a Department of Justice settlement. So we get involved in those kinds of cases as well. We have grown. We've gone from about 80 to 90 allegations a year, a little less than 100, we're now averaging about 500 new allegations a year. We have a number of more staff. And by the way, it's not just that we're getting these other kinds of cases. We're now getting about 150 allegations of fabrication, falsification, and plagiarism every year. And I think part of this is because we have reminded institutions that they have an obligation to inform us when they are investigating possible classic research misconduct. They have to tell us about that not because a finding has been made. It may be a while before a finding has been made. But in our role as research stewards, we need to know what's going on and we may need to make some adjustments accordingly so that we can ensure that taxpayer money is being appropriately spent.

 

Sheila Garrity: And that brings up a good point. I think people look at the ORI and say all we do is look at research misconduct cases from sun up to sundown. We also have reporting requirements. Every year institutions, research institutes that receive public health funding have to submit an assurance to indicate if they have any new cases of misconduct, is their policy up to date. And if it's not, as good stewards of federal funding, we can put a red bar on some institutions ability to accept PHS funds which gets people to conform right away. We have worked to review policies. We have almost 6,000 assurances. And people need to understand it's not just research institutes and universities in this country, we fund people all over the world. And so we've been looking at policies, 300 last year, 300 this year, to make sure that they're in good shape and reaching out to help those that are not in good shape come up into compliance.

 

Dr. Michael Lauer: Yeah. And I know another area that ORI has been quite interested in that we've had some fascinating discussions with is technology; both sides, how we can use technology to do a better job of overseeing research integrity, and also the potential threats to research integrity from some of the new technologies.

 

Sheila Garrity: So I know you just talked about it in your most recent open mic about artificial intelligence and grant review and that there is no place for the use of AI, of ChatGPT. And we talk about that a lot on our side. You know, how is it creeping in? What is the authorship implications? A group of staff and I attended a publishing conference in DC earlier this year and learned from publishers that they have been retracting hundreds of papers at a time that are AI produced and they're just garbage science.

 

Dr. Michael Lauer: Wow.

 

Sheila Garrity: So that's the scary side of AI. But there are maybe some good uses, could help us in our forensic analysis. And when you and I started in this field; if I had a research misconduct allegation, I would take a card, go into a lab, grab all the lab notebooks, copy them, get them back, maybe there were some experimental equipment. That's not the case anymore. Research data are so complex and we need to stay on top of how we can analyze it. We have to find new ways to embrace technology to help us.

 

Dr. Michael Lauer: Yeah. Well, these are certainly very always interesting times, but perhaps even more interesting times in our world of research integrity. You know, we see this as going beyond the class as we just discussed. It's beyond just research integrity. It's professionalism, professional conduct. I think another important aspect that we've been thinking about has been institutional culture. Since you've been in a number of institutions and you've also worked in interinstitutional groups that's probably another critical part of the messaging that we're not just dealing with a few bad apples here and there who are misbehaving, but we're also trying to shape a culture of integrity.

 

Sheila Garrity: And we have a responsibility, institutions, those of us that do what we do, to train the next generation of researchers. The research community, people know how to do the right thing. You look at fabrication, falsification, plagiarism, you're basically telling people: don't lie, don't cheat, don't steal. And we've been telling our kids that since they were in kindergarten.

 

Dr. Michael Lauer: Yes.

 

Sheila Garrity: And you encounter or I encounter on the institutional side some vice chancellors, vice presidents, vice deans of research that say, "This is not ORI, you know. Let somebody else take care of that. Give them some online training." For others that get it that say this is a conversation that needs to happen all the time at journal club. When you're a PI, you can't say, "Well, this falsification or fabrication, my postdoc Mike Lauer did it not me." Well, you were responsible as PI to review Michael Lauer's primary data. So that doesn't work anymore. There's a world conference on research integrity, the next one will be in Athens next June, and our European colleagues they get it. I attended virtually the planning committee meeting in this June and learned that they want more conversations in their institution not less. They're coming up with new ways to train and continue to have conversations. That's a really important part of what we do. I know Patricia Valdez brings groups together throughout HHS and we also work to bring groups together throughout academia. And so I think we will continue to play a supporting role there. ORI has grants to help people develop programs in the responsible conduct of research and we have RIO Bootcamps. And we will continue to explore methods to build a good research integrity foundation.

 

Dr. Michael Lauer: Well, that's fantastic. Sheila, is there anything else that you would like to bring up before we close?

 

Sheila Garrity: I don't think so, Mike. But you asked me what you think the future is and now you are more ingrained. You did say the foreign interference has kind of calmed down. What do you think is next on our horizon?

 

Dr. Michael Lauer: Well, I think a couple of things: One is that the harassment work is if anything building up, part of that may be that with the pandemic being over more and more people are coming back to the physical workspace and everyone's stressed out and you put those two things together and that may create some additional stresses there. I think a second problem: our system remains hypercompetitive, it's as hypercompetitive as ever; it's going to continue to be hypercompetitive. And unfortunately what that does is it generates some bad behaviors and it also generates a temptation to cut corners. The new technologies as you mentioned, you know, potentially introduce a number of threats. Part of this is that we never really know exactly what's coming and so, you know, we try as much as possible to be in touch with the community and in touch with general trends. I guess the final thing I'll say is, I do see more and more that institutions here in the United States are taking this more seriously exactly as you say, from a culture viewpoint. So it's not just training. It's not just a matter of dealing with individual cases. It's also a matter of imbuing a culture of integrity, of honesty, of transparency. Creating systems that make it easy for people to deal with difficult situations and get help when they need it. And I'm hopeful that by doing all that, you know, we will be able to keep this system, you know, in good shape. And I guess the last thing I would say, we're under a lot of scrutiny, a lot of scrutiny. I mean, there's a lot of mistrust of science in general. And so that's all the more reason why, you know, we need to work together to, you know, make sure that our constituents understand that we are as on top of this as we possibly can be. And we want to make sure that every last dollar of taxpayer money that's being used to support research is being used appropriately.

 

Sheila Garrity: And I have to say one thing, Mike. You and I were both at a conference at Duke, in the fall, of senior research leaders and there we talked about; yes, we've got some bad actors and we have measures in place to detect to prevent if rehab is needed or if we need to debar them from science, but we also have some really good researchers doing wonderful things supported by PHS funding. And you engaged in a conversation with the institutional leaders that attended that conference. And we all agreed that we have to find ways to highlight those people to help restore public trust in science using that as well.

 

Dr. Michael Lauer: Exactly. Great. Well, Sheila, it's been wonderful talking with you today. And congratulations again. You've made it through your first three months.

 

Sheila Garrity: Yes.

 

Dr. Michael Lauer: And we look forward to working with you closely in the years ahead.

 

Sheila Garrity: Thank you, Mike.

 

Dr. Michael Lauer: Great. Thank you.