On Research Podcast – Updated Research Misconduct Final Rule

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1. Podcast Introduction (00:00:25) Justin Osborne introduces the podcast and guest Dr. John Baumann, highlighting his expertise in research compliance.
2. Dr. John Baumann’s Background (00:02:01) John shares his experience in research administration and compliance, detailing his career journey.
3. Context for the Updated Rule (00:04:09) Overview of the reasons behind the update to the research misconduct regulations, emphasizing the long gap since the last revision.
4. Effective Date of New Rule (00:06:43) The new final rule on research misconduct is set to go into effect on January 25, 2025.
5. Purpose of the Office of Research Integrity (00:08:56) Explanation of ORI’s mission to protect federal research funds and ensure integrity in research.
6. Structure of the Updated Policy (00:09:31) Clarification that the fundamental structure of the research misconduct process remains unchanged despite updates.
7. Impetus for the Update (00:10:31) Discussion on the dissatisfaction with the old rules and the need for clarity in research misconduct policies.
8. Impact on Research Integrity Officers (00:12:07) Identification of key personnel who need to be aware of the updates for compliance.
9. New Reporting Requirements (00:13:03) Details on the expanded information required in inquiry and investigation reports under the new regulations.
10. Significant Changes in Documentation (00:18:01) Increased documentation requirements for institutions regarding research misconduct cases.
11. Clarification on Plagiarism (00:18:30) Updated definitions of plagiarism and reiteration that self-plagiarism is not considered misconduct.
12. Confidentiality Guidelines (00:19:12) New clarifications on who needs to know about research misconduct cases within institutions.
13. Intentionality in Misconduct (00:19:46) Efforts to define terms related to intentionality in research misconduct, highlighting the challenges in interpretation.
14. Emphasis on Process Over Content (00:20:57) Highlighting the significance of following established processes rather than solely focusing on content in research integrity.
15. Flexibility in Research Integrity Programs (00:21:22) Explanation of the flexibility allowed in research integrity processes, accommodating different institutional structures.
16. Changes in Evidence Gathering (00:22:19) New guidelines on using equivalent evidence when original research records are unavailable.
17. Documentation Burden in Investigations (00:23:11) Clarification on the extensive documentation required at the conclusion of federally funded investigations.
18. Resource Allocation for Compliance Offices (00:25:30) Discussion on whether institutions should consider adding resources to manage increased documentation needs.
19. Challenges in Implementing Changes (00:27:10) Identifying potential challenges institutions face in adapting to the new research misconduct regulations.
20. Timelines for Investigations (00:28:17) Overview of the extended timeline for investigations and the practical challenges associated with it.
21. Advice for Institutions Pre-Implementation (00:29:50) Recommendations for institutions to start revising their policies before the new regulations take effect.
22. Creating a Step-by-Step Guide (00:30:46) Advice on developing a clear outline for managing allegations and documentation processes.
23. Importance of Ongoing Documentation (00:32:01) Emphasizing the need for continuous documentation throughout the investigation process.
24. Collaboration Among Peers (00:36:01) Encouragement to connect with peer institutions for shared solutions and best practices in research integrity.
25. Same Team: Teamwork in Crisis Situations (00:37:50) An example of teamwork within an institution during a significant compliance issue, highlighting collective efforts.
26. Final Thoughts and Appreciation (00:41:00) Dr. John Baumann expresses enjoyment in the discussion and shares positive feedback about the experience.
27. Podcast Promotion (00:41:04) Justin Osbourne encourages listeners to follow and subscribe to the podcast and explore other offerings.

John Baumann: There’s that expression, “When you begin losing an argument, start correcting the other person’s grammar.”

The parallel in the world of research misconduct is when it becomes apparent that they’re going to find you guilty, start challenging the process.

So having greater definition to the process is a very important tool for a research integrity office to have.

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 beginning, you heard a clip from John Baumann, my guest this episode. John is the epitome of a research compliance professional.

He only shares a piece of his research experience during our discussion, but John has over 25 years of experience in research administration, responsible conduct of research, and research compliance. Our discussion covered the recently updated Final Rule on Research Misconduct, which goes into effect January 1st, 2025, yes, less than a month from now.

But don’t worry, John walks us through the specific changes and clarifications made to this Final Rule, from requiring to share transcripts with the accused, to increased documentation throughout the entire process. If you’re wondering what steps your institution should take to be ready for this new policy in the new year, John has some terrific, practical advice that can hopefully act as a starting point for your research integrity office.

It was a real pleasure to dive into this topic with such a knowledgeable expert, so without further ado, I hope you enjoy my conversation with John. John, thank you so much for joining the podcast. It’s great to see you again.

John Baumann: A pleasure to be here. Thanks for the invitation.

Justin Osborne: Of course, of course. So before we dive into the topic, I wanted to start with a little bit of your background.

For those listening, can you tell us how you got into this industry in the first place and then what you’re doing now?

John Baumann: Yeah, sure. I was a fellow on a T32 award at a private, not-for-profit research institute in New York City that focused on substance use, abuse, and related issues. It was entirely a social science place. And one day, the then chief operating officer said he’d like to transform the organization.

Would I like a staff position? So I thought about it, I was really, really leaning into it and towards it. But then, I spoke to a couple of people within the organization, and the last one I spoke to said, “If you take this job, you won’t spend your entire career writing grant applications.” I went from Bruce’s office to Fred’s office and said, “I do.”

Justin Osborne: Nice.

John Baumann: And that was a small place where what’s nice about being in a small place, is there’s virtually no division of labor.

So you really learn everything, so I assumed responsibility for the sponsored programs and compliance side.

Justin Osborne: Interesting, yeah.

John Baumann: And then became the deputy executive director and did more.

Justin Osborne: Nice, nice. That is very interesting, and then you just went from there?

John Baumann: I just went from there. When I got a little tired of being there, I went to the University of Missouri, Kansas City where I was initially hired in a sponsored projects’ role.

Justin Osborne: Okay.

John Baumann: And then they saw my compliance background and threw that under me, and I left UMKC as the vice provost for research.

Justin Osborne: Well, thank you, I appreciate the background. And that helps because obviously, you’re a compliance expert and we’re going to be talking about this updated Final Rule on Research Misconduct.

So to kick it off with that topic, can you give us the groundwork? Why was this updated? What’s the background and context of this being updated and being a big deal?

John Baumann: Well, a lot went into that. It clearly has not been updated since virtually, originally passed decades ago, and there began to be an increasing call for updating it.

So they started the process with the advanced Notice of Proposed Rulemaking, then the Notice of Proposed Rulemaking, which occurred earlier this year. And it generated a phenomenal, phenomenal response, and quite frankly, outcry among the community.

Justin Osborne: Interesting.

John Baumann: People were very, very unhappy with the proposed Notice of Proposed Rulemaking. And this is absolutely to the credit of ORI and the directorship of Sheila Garrity, is they really, really took into consideration the comments that they received and totally transformed it.

I don’t know if you remember back with the Common Rule revision, when they were talking about making all biospecimens identifiable information, people said, “If you’re going to do that, don’t revise it. We’d rather have the old rules then have the burden of this rule.”

And similarly, with the misconduct regulation, people were saying, “If this is our only choice, please don’t change and go back to the other one.” But what ORI did was, make to some people, to the more cynical people’s surprise, is they really, really listened to the comments.

And from what I could see and from what I heard talking to people, they really took the best of those comments and made it something that was much more palatable to the community.

Justin Osborne: Well, that’s nice to hear. It sounds like that’s the system designed to work in this way, so it’s nice to hear that it worked.

John Baumann: That’s how it’s supposed to work. It obviously doesn’t always and so forth, but it did in this case.

Justin Osborne: Okay.

John Baumann: Yeah.

Justin Osborne: So this hasn’t been updated in quite a while. I think I saw, was it 2005 when the first thing came out?

John Baumann: But there was a very similar policy from before then as well.

Justin Osborne: Oh, okay.

John Baumann: Back in the ’90s at the Research Institute, we used the ORI Model Policy to shape our institutions as well.

So it’s been around for a while, but it just really hasn’t been significantly updated.

Justin Osborne: Wow. Okay, okay. So obviously, I can imagine we can go through some of the big updates and whatnot. But just to back up high-level stuff, when does this new Final Rule go into effect?

John Baumann: It goes into effect 1 January ’25.

Justin Osborne: Okay. So in a month, a little over a month.

John Baumann: Yeah, and everybody’s scurrying around.

Justin Osborne: Yeah.

John Baumann: Although, again, there’re not as many changes as initially there was anticipated to be.

Then in the meantime, ORI says they’re going to be releasing template policies, procedures, checklists, and guidances, but the time’s getting pretty close.

Justin Osborne: Those have not come out yet, okay.

John Baumann: No. And they also then say, and this is interesting and I think it officially introduces a little bit of wiggle room. Or unofficially introduces some wiggle room, I would think, is they don’t need to have… Everybody has to ultimately resubmit their policy.

But what they’re doing is obviously they don’t want to be flooded by a whole bunch of policies the last week of December. So what they did is recognizing that every institution does an annual report, they said the new policies have to be provided to ORI, by way of the institution’s annual report, through April 30th, 2026, at the very latest.

Justin Osborne: Okay. So some institutions will have, yeah.

John Baumann: Yeah. So in other words, you can actually follow the policy without, because they recognize most research misconduct policies have to go to a university’s faculty senate.

Justin Osborne: Which takes a while.

John Baumann: That’s not going to happen in a week.

Justin Osborne: Right, okay.

John Baumann: So they clearly recognized, and I say this very, very respectfully, they clearly recognized the practical processes at the level of the institution.

Justin Osborne: Yeah. No, that’s fair, that’s fair. That’s the way it should be, right?

John Baumann: Yeah.

Justin Osborne: If they’re going to pass something like this and make it go into effect in less than a year after rolling it out. So I guess just to back up, I guess, there are probably those listening to this that don’t fully understand.

This is an update to an old policy and whatnot. We can talk about the changes and updates, but walk us through a very high-level why this is in place. What is ORI doing to protect misconduct here?

John Baumann: ORI’s official responsibility is to protect the federal funds used for research, to ensure that they are used as they’re granted.

And more importantly for this particular niche, that they’re used with integrity.

Justin Osborne: Okay.

John Baumann: That you can trust the product of the research from those federal funds, and so their mission really is protecting the science funded by federal money.

Justin Osborne: Okay, okay. And that’s what this policy looks to ensure?

John Baumann: Yes, as the previous versions did as well.

Justin Osborne: Sure, sure.

John Baumann: The basic bones of the process were not changed.

Justin Osborne: Okay, okay.

John Baumann: The fundamental structure of the process was not changed, and same definition of what constitutes research misconduct. Same fundamental process, allegation, assessment, inquiry, investigation, determination, those things are unchanged.

And what ORI did in this policy, is tweak some of the processes, further identify what they want and what they mean by certain things, but they did not upset the apple cart. They did not fundamentally change the way it does business.

Justin Osborne: So then if they just tweaked some of those other pieces that you just mentioned, what was the impetus for making this update?

Is it just that it’s been so long, or was there something else?

John Baumann: I think in part, it’s been so long, there was some dissatisfaction. There were some consistent requests for clarification that ORI could provide but did not introduce in policy, which means they might have to provide them again and again and again.

So I think it’s also a recognition of the way research is done now versus several decades ago. Especially because where they never talked about multi-site research before, this one has a specific statement about the responsibility in a multi-site investigation.

Justin Osborne: Yeah, yeah. Just keeping up with the evolution of research.

John Baumann: Similarly, they recognize that more research is collaborative so they clarified a mechanism, by which, if in the course of an inquiry or investigation there are new charges against additional people.

They clarify that you don’t have to start all over again with them. They can be brought into the initial process.

Justin Osborne: Okay, okay. Very interesting.

John Baumann: So it’s cleaning up. A lot of operational cleanup and clarification, I would say.

Justin Osborne: Yeah, that makes sense. That makes sense. So thinking about the scope of this, if I’m listening to this and I’m just trying to figure out how this maybe applies.

People listening to this may be a coordinator, all the way through an investigator or compliance person. Who does this impact at an institution? Who needs to know that this has been updated in order to stay compliant?

John Baumann: I would say whoever is the research integrity officer, and whatever office they might be a part of, as well as the deciding official.

Justin Osborne: Got it.

John Baumann: Recognize that research misconduct fortunately affects a very small part of an institution, so it is really that group alone. And much of what was changed here, are obligations on it, on the research integrity office as to how you go about doing an inquiry.

How you go about doing an investigation and things along that, and what ORI wants from you. I’d say one of the biggest changes in this, is that ORI is clearly identifying that they want additional information that was not necessarily spelled out in the original regulation.

Justin Osborne: Okay. Now when you say additional information, related to the?

John Baumann: So they clearly laid out and expanded what they want in an inquiry report, what they want in an investigation report, what they want in a final report.

Before, previously, the elements that would make up each of those was rather implied and not very expansive. And frequently, then ORI would ask for additional information, and if the institution wanted to say, “Well, where’s the regulatory basis for that request?”

Justin Osborne: Interesting.

John Baumann: There really wasn’t one, but ORI thought that they needed it to do their work. So this really lays out in much greater detail and much more precision what they want in each of those things.

And not only does it reiterate what they said they wanted before and further define it, they also have some new requirements.

Justin Osborne: Okay. So what are some of the new requirements?

John Baumann: Well, sure, one of the more glaring ones, which could have an impact, quite frankly, is it used to be that interviews during an investigation needed to be transcribed.

And it said you need to give it to the person who was interviewed, to confirm that what they said is what is in there.

Justin Osborne: Okay.

John Baumann: Now you also have to give it to the respondent. Now you also have to give it to the person who is accused of research misconduct.

And on the one hand, that can make some people very nervous about being interviewed.

Justin Osborne: Yeah, yeah. I can see that.

John Baumann: On the other hand, if you think about the idea of due process, of course, anybody accused of something should be able to see all the evidence against her or him.

Justin Osborne: Right. That makes sense.

John Baumann: So basically, it’s an outcome that makes perfect sense but does complicate things.

Justin Osborne: Sure, sure. Well, and it’s going to require institutions to figure out how to navigate that from a cultural, logistical process standpoint, if this hasn’t been the case before.

John Baumann: Yeah, it’ll be easy to give it to them. That’s not the issue. The issue is you, in good conscience, have to let everybody know what’s going to happen with the transcript.

And institutions currently have a very, very hard time protecting whistleblowers or witnesses from any consequences of doing the right thing. This adds another layer to that challenge.

Justin Osborne: Oh, that’s interesting. That is interesting.

John Baumann: But on the other hand, if you’re accused of research misconduct, the assumption is that you haven’t done it until you’re proved by a preponderance of evidence that you’re guilty.

So you got to give the person a chance, an opportunity to understand the information against them.

Justin Osborne: Yeah. No, I can see that, I can see that. But I guess to your point, if the previous version of this had a lot of implied information, and this new updated version has a lot more specifics laid out.

I can see where institutions are saying, “Where’s the guidance and the templates that you want us to use?” But it almost seems like they’re making it a little easier for people to follow if they have new rules.

John Baumann: This is not just a clarification. This is a literal change, because the standing policy regulation was you got to give it to the interviewee, and they were silent on whether the respondent got it.

Now, many times respondents asked for it, and institutions probably would share because it’s the right thing to do, if you will, to give people an idea. But it does open up the door to some very possibly damaging consequences.

Justin Osborne: Yeah, that’s interesting. So is there any mention in this new update about that side of things, or are they?

John Baumann: They don’t build that into the regulation.

Justin Osborne: Right, right, right. But any comments or anything?

John Baumann: That would be in the editorial. Yeah. That was recognized, but the principle of due process really was vitally important. And I don’t know, there’s that expression, “When you begin losing an argument, start correcting the other person’s grammar.”

The parallel in the world of research misconduct is when it becomes apparent that they’re going to find you guilty, start challenging the process. So having greater definition to the process is a very important tool for a research integrity office to have.

Justin Osborne: Yeah, that makes perfect sense.

John Baumann: Yeah.

Justin Osborne: Yeah, that does. That makes sense.

John Baumann: So it will help them in some ways in this case, I think.

Justin Osborne: Yeah. No, I guess that was a very specific update that you just went through.

Are there any other things top of mind for you that you might see as a big change, an actual change to the regs?

John Baumann: Much more documentation is required.

Justin Osborne: Yeah, okay.

John Baumann: You have to provide ORI with a lot more documentation than in the past, but they pretty much tell you what it is so you can prepare accordingly.

They try to do something, they tried to clarify some of the definitions. So some of the terms are pretty fuzzy, and they came up with a much more detailed definition of plagiarism.

Justin Osborne: Oh, interesting.

John Baumann: But they also then also reconfirmed that self-plagiarism is not misconduct under the federal regulations and authorship disputes are not plagiarism, so that’s just a reiteration. But they came up with a broader definition of plagiarism, which I think is probably helpful.

They laid out more clearly, again, it’s not a significant change, but it helps is that the previous one basically said in terms of confidentiality, it’s on a need-to-know basis. But they didn’t really say much about who had that need to know?

Justin Osborne: Yeah, who needs to know?

John Baumann: This time they laid it out much more to include institutional review boards, journals, editors, publishers, co-authors, collaborating institutions.

As well as possibly people within the institution, who have direct deans or whatever, or who have direct responsibility.

Justin Osborne: Yeah, wow. Okay, so it’s a lot more clear.

John Baumann: Yep. They also, again, this was very, very difficult, is misconduct is not a mistake. It’s an honest difference of opinion. It needs to be intentional knowing or reckless.

Justin Osborne: Okay.

John Baumann: Pretty vague terms.

Justin Osborne: Yeah.

John Baumann: They tried to give a bit more definition to those, but there’s only so far you can go with that. Intentionality is to act with the aim of carrying out the act.

You can’t really “prove that” unless you have people saying, “I’m going to do it.” Knowingly, is to act with an awareness of the act.

Justin Osborne: Okay.

John Baumann: Again, pretty subjective.

Justin Osborne: Yeah, yeah.

John Baumann: Again, it requires a lot of interpretation, and reckless is defined as to act recklessly. Means to propose, perform, or review research or report research results with an indifference to a known risk of fabrication, falsification or plagiarism.

And that, you could pretty much, that ultimately gets determined behaviorally.

Justin Osborne: Right, right. But to your point, a lot of those definitions and terms are subjective to the point that how do you actually put a pin on that, right?

John Baumann: Yeah, yeah.

Justin Osborne: I guess that’s the job of the investigation, and that’s why there’s a specific process to follow, right?

John Baumann: Yeah, and that’s why the emphasis is on the process rather than this with the content.

And like was said many, many years ago in the IRB forum of, “If the rules told us what to do, we would not need an IRB.”

Justin Osborne: True.

John Baumann: Similarly, if the rules told us what to do, we would not need a research integrity program per se, and so they’re guides, if you will.

Justin Osborne: That makes sense.

John Baumann: They also just get a little bit more explicit. They made it clear that the research integrity process can include two individuals, if you will, the RIO and the deciding official.

Versus as you see it, virtually every university, a committee that does that. And they just made it clear that either of those two options are perfectly fine under any, that’s an institutional determination.

Justin Osborne: That’s nice.

John Baumann: So at the private, not-for-profit research institute, I was the RIO and I had all the authority to make decisions on my own, but I could have people help me if I thought I needed it.

Whereas, of course, at a university with the principle of shared governance, there’s always a faculty committee.

Justin Osborne: Right, right, right. Well, yeah, no, that’s nice that they built in that flexibility, understanding that every institution’s a little different and they need to figure out how to manage this.

John Baumann: Yeah. Another thing that they did that might have some implications down the road is within sequestration, initially, it was you had to gather all the direct evidence.

And there are times in which evidence was destroyed, or evidence wasn’t available, or it was lost. And now they make it clear that when the original research records cannot be obtained, copies of records that are, “substantially equivalent in evidentiary value.”

Justin Osborne: Oh, wow. Okay.

John Baumann: So now, all of a sudden you can almost, if you will, use, you can’t find the original source material, but you find something a little bit later down the road, and you can use that.

Justin Osborne: That’s nice. That seems like a good addition to make sure that you’re not just out of luck if you lose a source document.

John Baumann: Yeah. I guess they also made it very clear that at the end of an investigation when a determination has been made one way or the other, the record that…

And it’s federally funded. Of course, if it’s not federally funded, ORI is not involved.

Justin Osborne: Right.

John Baumann: They made it clear what they need to have, and it really goes all the way back to the beginning. They don’t just want the material upon which the deciding official made a determination. They don’t want just, if you will, the investigative report and determination.

You go all the way back, they want everything from documentation of the assessment, all the inquiry information, all transcripts. So it is a not insignificant burden, but technically, it helps an institution know what they need to keep.

Justin Osborne: Oh, that’s true.

John Baumann: And what they need to have as they navigate through the process.

Because most of them will say, “If I have an investigation and I have to submit it to ORI, here’s what I need to have. So let’s make sure we touch each of those steps.”

Justin Osborne: Right, yeah. Okay. So if I’m an institution and I’m in the compliance office and connected to research integrity, and I’m hearing this right, this is an update. There’s an update to the process. There’s a lot more documentation you’re talking about that’s needed.

Should I be concerned? Should institutions be considering adding resources to manage this in the future? Or is this, if they can do it now, they can do it under this updated Final Rule?

John Baumann: I think a couple of things. One, it really stresses the importance of having a good electronic system.

Justin Osborne: Oh, okay. Yeah.

John Baumann: Because that can maintain things in an orderly fashion.

Justin Osborne: Absolutely.

John Baumann: And to my knowledge, there are no research misconduct platforms like there are platforms for human subjects research or the like.

So what I’ve seen people use, are basically things that they’ve taken from the practice of law and basically treat files that way.

Justin Osborne: Sure, sure. Okay. So electronic systems are necessary, but outside of that?

John Baumann: I would expect every research integrity office to make a claim that they need at least one more entity. Whether that’s true or not, will obviously vary on a case-by case-basis.

But I would not be at all surprised, because now all of a sudden, if you don’t have any of this stuff and if you don’t maintain it properly, the whole case can go south.

Justin Osborne: Oh, right, right.

John Baumann: So all of a sudden, it raises the stakes for the institution, so I would expect many of them to actually decide they need another body.

The question is what type of body do they need? What type of skillset do they need? It may be more process based than content based.

Justin Osborne: Yeah. A lot of this stuff, honestly sounds like more project management operations level stuff, rather than being an expert in the content of misconduct, and those kinds of things and compliance.

John Baumann: And the thing is you can always find an expert who knows science.

Justin Osborne: Yeah, yeah.

John Baumann: Can’t always find an expert to help you with this process.

Justin Osborne: That’s true. Okay, that’s a good point. Knowing all of this stuff and talking through this big update, because again, this does feel like a pretty big overhaul to a policy that it’s been around for a while.

What do you think are some of the biggest challenges that institutions have with making this change, making this update? We’ve already talked that we’re waiting on templates and more guidance documents, but what do you think institutions are panicking about the most?

John Baumann: Crossing the T’s and dotting the I’s.

Justin Osborne: Yeah.

John Baumann: I’m going to assume that nothing here really changes the decision-making process. It’s all about fleshing out the process and significantly about documenting the process.

And this is all part of, when I started in research misconduct, it was much more casual. I wouldn’t say collegial, but not legalistic like it is now.

Justin Osborne: I see.

John Baumann: And it truly is increasingly resembling the typical adversarial trial.

Justin Osborne: Oh, interesting.

John Baumann: And you understand the stakes are high.

Justin Osborne: Absolutely. Oh, yeah. This is a make or break thing, right?

John Baumann: There are people who have lost their careers over this.

Justin Osborne: Right.

John Baumann: There are many others who have been able to come back from it but not easily.

Justin Osborne: Yeah. No, it is a big deal and it’s a big… To your point, the fact, the idea that this is out there to protect the integrity of the science that we’re doing in research, that’s a pretty big deal, especially these days.

John Baumann: One of the things that I will, and I’ll say it respectfully is cute, is that they said the previous regulation said the investigation had to occur within 120 days.

They now expanded it to 180 days, but I’d say 80 significant misconduct process lasts much more than 80 days, but you have to have some standard. And they make allowances for extensions, but you have to justify it, which is not that hard.

Justin Osborne: Sure, sure.

John Baumann: If nothing else, scheduling for Pete’s sake oftentimes is.

Justin Osborne: Oh my goodness. Yeah. Especially when you’re talking about some of these doctors that they’re very hard to get a hold of at some of these institutions.

John Baumann: And the challenge is not necessarily with the respondent. If you have an inquiry committee or an investigation committee, having that readily available.

Justin Osborne: Yeah, any committee.

John Baumann: I mean that are knowledgeable. There’s things that are done to help that process.

Justin Osborne: Right, okay. So do you think institutions are, because again, we’ve talked about we’re waiting on templates and guidance documents. Are institutions better served to just wait until whenever those come out?

And then whenever they come out, build your new policy, incorporate those in your move forward? Or should people start really revising stuff now and those are a bonus?

John Baumann: I would definitely say the latter because this goes into effect, if you get an allegation on January 2nd, it’s subject to this process.

And I don’t think that all those tools are going to be available by January 2nd.

Justin Osborne: Right.

John Baumann: Now, admittedly, some of it is layered. You don’t really, necessarily care about the tools for an investigation, when you’re only now just assessing the allegation, so you do have time.

Justin Osborne: Yeah, okay.

John Baumann: Nonetheless, there’s going to be cases that are going to have to be dealt with prior to all this stuff coming out.

Justin Osborne: Yeah, yeah. So what advice do you give institutions if they’re, maybe, I guess it doesn’t matter what size they are.

If they don’t have all their ducks in a row, and they do have an allegation come up early January, and this is all new to them, what kind of advice do you have for them?

John Baumann: I would suggest at the very beginning, get a big sheet of paper, put it on your wall, and then start with allegation received and identify what you need to do.

What you have to have available to provide, and just really just make a cheat sheet, because it’s not necessarily intuitive what you need to document.

Justin Osborne: Oh, interesting. Okay.

John Baumann: The extent of the documentation, the nuances of the documentation are not. Maybe a lawyer is used to that type of thing, but very few of us in the social sciences are.

Justin Osborne: Yeah. No, that’s a good point, that’s a good point.

John Baumann: So just break it down into what do I do here? What do I do next? What do I do next? What do I do next? And just have a very detailed outline to tell you what to do.

Justin Osborne: Yeah, that’s good. That’s great advice.

John Baumann: And that’s just make it easy.

Justin Osborne: Right, right. Well, yeah, because again, to your point, you don’t want to mess up this process at the front end, because it’s all cumulative. It’s all going to build off each other.

John Baumann: Now there are mechanisms within the process. If you start off a case with one responded and three allegations, it’s not at all uncommon for those three to become seven allegations. As you conduct the assessment, as you sequester material and conduct the inquiry, new information comes to light, so things could be dropped or added in the process.

And this goes back to many decades ago, I had a case of research misconduct, and it was really open and shut and the person admitted it at the end of the day. It was a graduate student who was supposed to come in over the weekend and forgot to come in, and then just doctored the lab book and the people discovered it right away, and so it was easy.

But I talked to ORI about it because it was federally funded, and the immediate thing that I heard from them was, “And how do you know this is the first time she did this?” Which meant it’s not enough to just take an allegation necessarily at face value, without thinking, “Did this happen on other occasions?”

Have had several cases of allegations of plagiarism over one manuscript, that all of a sudden led back all the way to the person’s doctoral dissertation, that there’s plagiarism there too that was documented, documentable. So these things, this is a really living activity.

This is where it has much more flexibility than a criminal trial where you can’t, it’s not as easy to just add charges, if you will, and so it changes all the time. It changes at each stage, and now the need to document those changes or nonchanges is just greater.

Justin Osborne: Well, and it seems like that is the idea behind the additional documentation from what you’re saying. You need more strict processes in place to allow you to document for those situations where things come up after the fact.

And as you dig down further, you discover more, right? Otherwise, if you’re just left to your own, who knows if you’d find that stuff.

John Baumann: Right. And in some ways, although it’s not necessarily the first thought one has, when you realize how much more you have to process and document.

Is ORI is in some ways helping the institutions to become not bulletproof, but to have some reasonable argument when the process begins to be challenged.

Justin Osborne: Yeah. No, that’s a good point. That’s a good point, yeah.

John Baumann: Although the outcome is much more day-to-day work.

Justin Osborne: Of course, yes, that’s the result of it. I’m sure in the wake of this change, people are not thanking them, but I understand.

John Baumann: I will tell you, and I’ve been at several meetings in which they did thank them for the quality of the Final Rule.

Justin Osborne: Well, to your point, they listened, that’s pretty nice. I think people should be appreciative of the fact that these organizations are actually taking their comments and considering them and actually acting on them, and not just saying, “Thanks, but we know better.”

So I guess to wrap up, is there anything else that you think people should be aware of, should know about? I know you’ve gone through some of the specific updates, some of the hurdles of implementing this and whatnot. Any last-minute things or advice that you think people should know?

John Baumann: I would say what I found very useful, is going through federal regulations are not easy, clear reads.

Justin Osborne: Fair.

John Baumann: So I would say the first thing that I would do or have done is look at that thing, and really just transpose it into a process in my own language.

Justin Osborne: Okay.

John Baumann: But then there is a fabulous community of your peers out there that to always touch base with.

And I would recommend clearly not just talking to your general counsel’s office, your DO, and various people within your organization, but talk to research integrity professionals at your peer institutions.

Justin Osborne: That’s great advice.

John Baumann: And it’s important to do so at your… It’s great for a small institution to listen to a big one. It’s great for a big one to listen to a small one, and you can definitely learn things from them from that interaction.

But from a realistic perspective of actual planning and implementation, talk to your peer institutions because they’re more likely to have a solution that works for both. Rather than the same solution won’t work for a major research organization and a research integrity office of one.

Justin Osborne: Yeah. No, that makes sense. That makes sense.

John Baumann: And there are many, many, many research integrity offices of one or less.

Justin Osborne: Yeah, yeah. Well, that’s going to be, I guess, it’s a heavy lift for everybody, but that is great advice.

Oh, this is fantastic, John. I really appreciate you walking through this update. This is great.

John Baumann: Now I know it better than I did yesterday.

Justin Osborne: That’s good. Me too.

John Baumann: Because I had to study for this conversation.

Justin Osborne: Well, I appreciate that. Everybody else does too.

John Baumann: Yep.

Justin Osborne: Well, welcome back. I’m still with John here, and we’re going into our Same Team Segment here. So John, it’s easy to get bogged down in our day-to-day job responsibilities.

But I believe most of us do stay in this research industry because we actually care about the impact 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?

John Baumann: I’d say the easiest example I could give is with something that went terribly wrong, and which had a situation in which a researcher thought an amendment had been approved, but it had never been actually approved. That two years later, she did another amendment that changed that nonexisting amendment, and it’s at that point that the committee and the office noticed it.

It was clearly a major case of noncompliance that had gone on for a couple of years on a federally funded grant. And the PI, the compliance office, the grants’ office, the academic, the vice president for research, the general counsel’s office, all had to collectively deal with this. And this is one of those situations, in part because of the phenomenal good graces and integrity of the PI, there was no bluffing, there was no hiding.

And it also involved significant payback to the NIH because it was two years of expenses on a substudy that could not be repeated by her resources. And too much time had gone by and stuff, so this was a time in which the team came together. They’re all within the same institution, plus the NIH because they were fabulous in this process.

Both the NIH and the Office of Lab Animal Welfare were all very, very… Especially because the person wasn’t trying to deceive or hide, we worked together to take a very, very unfortunate situation, and make it something that did not impact the institution, did not impact her career, did not impact the academic unit except for some money.

So that was a time in which everybody worked together for the common good of correcting the noncompliance and ensuring the welfare, in this case of animals, because it was animal research.

Justin Osborne: Okay. I love that example. Well, and to your point, we’re in research. The idea of research is you test until you find something out. You’re going to fail more than you succeed anyway.

So having an example like this, like you said, that wasn’t necessarily the best, but this is what we do in this industry. So you work together and you figure out the best way forward.

John Baumann: Yeah. And it was a case study of how to productively deal with major noncompliance.

Justin Osborne: Wow. Yeah, that’s fantastic.

John Baumann: I wish I could easily think of something good, but most of this stuff comes up when there’s problems.

Justin Osborne: Absolutely. And to your point, that situation, a situation like that, could be a lot worse if everybody didn’t work together.

No, that’s good. I appreciate that, sharing that. Well, John, again, this has been awesome. I really appreciate your time here, and this is a lot of fun to learn from you.

John Baumann: Thank you. I enjoyed it as well. I actually enjoyed it more than I expected to.

Justin Osborne: Good to hear, good to hear. Well, take care, John. We’ll talk soon.

John Baumann: Take care. See ya.

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