NIH All about Grants Podcast

Research Misconduct

August 31, 2020

[ Music Playing ]

From the National Institutes of Health in Bethesda, Maryland, this is "All About Grants".

>> Kosub: Hello, and welcome to another edition of NIH's "All About Grants".� I'm your host, David Kosub, with the NIH's Office of Extramural Research.� And today we're going to be talking about a topic that is critically important for ensuring the public's trust in the research that NIH supports, and that is addressing research misconduct when it happens.� Today we have with us Dr. Christine Ring, she is a NIH Research Integrity Officer here in the NIH's Office of Extramural Research, and she is going to be telling us everything we need to know about research misconduct.� Thank you for being with us.

>> Ring:� �>> Hi, David, thanks for having me on.

>> Kosub:� You're welcome.� So let's jump right in.� Can you briefly tell us what is research misconduct?

>> Ring:� �>> Sure.� Research misconduct is fabrication, falsification and plagiarism when conducting research, when reporting research, when reviewing research, and when applying for funds.� So fabrication is when you don't do the experiment at all and you just completely make up your data.� Falsification, you've done the experiment, but you've changed the results in some way, or you're describing the methods in some way so that the results are not accurate, don't accurately reflect what was done, and plagiarism is when you use someone else's words or data, and present them as your own.

>> Kosub: All right.� Well, thank you for that.� Can you provide any additional examples beyond what you've just described there as to what we mean by falsification, fabrication or plagiarism?

>> Ring: Sure.� So some of the things we've seen most frequently are duplications.� So someone may use a microscopy slide that represents kidney tissue in a mouse in one paper, or in one figure, and then you see the exact same image or a portion of that same image in another figure saying that it was a human kidney tissue image.

Sometimes you're going to see that those figures have been stretched, sometimes the color's been changed, so, you know, manipulations happen, but these are still duplications.� The other big group we see very often is allegations related to western blots or other gel images.� Sometimes people will copy and paste a band from one image into another.� Sometimes people will erase a band to make that control look extra controly.

[ Chuckling ]

But ‑‑ but those are things that we see frequently.

>> Kosub: So why do we only focus on fabrication or falsification or plagiarism?

I figure there's some other types of things that would be classified as research misconduct.

>> Ring:� �>> There are plenty of other things we care about, but they're not research misconduct, because research misconduct is a legally‑defined term.� It was defined by the White House Office of Science and Technology Policy as fabrication, falsification and plagiarism, and then incorporated into the public health service regulation that NIH works under.� As far as these other concerns, though, we want to know about them.� The responsible conduct of research community describes a lot of things as questionable research practices, or detrimental research practices.� Those may be things like not keeping adequate data, you know, not having notebooks, not keeping things archived properly.� Those would be questionable research practices that NIH cares about, so please let us know, but they're not research misconduct.

>> Kosub: I see.� So would you be able to also talk about research misconduct or addressing research misconduct in the wider scheme of why it's important to NIH's supported research?

>> Ring:� �>> Absolutely.� NIH's mission is to advance science to improve the health of Americans, and science that's false is not science that's advancing the health of Americans.

It's also not science that was a good investment of taxpayer money.� We don't want to be funding someone who's just making up their data.� That's a waste of funds.� And it's also a waste of funds for everyone who saw that made‑up data and spends years of their lives and a lot of money trying to reproduce results that aren't true.

>> Kosub: All right., let's transition to some process‑oriented questions.� If someone falsified data and published a paper, for example, what might NIH do in that situation?

>> Ring:� �>> Sure.� NIH is going to assess allegations that came into us to ask three questions.� The first one is: is it funded by the NIH or is it an NIH application?

That means we have jurisdiction.�

Second, does this fall under the definition of research misconduct? If it does, we're going to move forward in the research misconduct process.� If it doesn't, again, I want to say, we may do something with that, may be something that we act on, but not as a research misconduct allegation.�

And the third thing to look at is this allegation specific and credible? If it is, we can move forward.� If it's not, we'll either go back to you to ask more questions or it may just be that we never get sufficiently specific to move forward.� When I talk about specificity, I very often need to ask people can you point to a particular figure in this paper that's falsified?

Sometimes we'll get allegations that are just ‑‑ nothing in this paper is reproducible.� That's not specific about falsification or fabrication, so it's not research misconduct, and we can't move forward.� If the answer to all the questions was yes ‑‑ so if it's NIH‑funded, the allegation is research misconduct, and it's specific and credible, we're going to refer that allegation to the HHS Office of Research Integrity.

>> Kosub: Thanks for that information.� Is there anything different that NIH might take if it was perhaps found as part of a research grant application or an award?

>> Ring:� �>>� There's steps we do take differently, although the overall process still looking at those three questions to determine whether we're going to send something to ORI, but if it's a funded application, we may need to look at protective measures that are taken during the process of the research misconduct proceeding.� If it's a grant that's currently under review, and the allegation came from the grant reviewer, because that's who it would come from, we will make sure that that reviewer is based in conflict so that these allegations do not affect review.

>> Kosub:� On the topic of plagiarism, for instance, as part of one of the three in research misconduct, can you tell us a little bit more about how NIH addresses plagiarism?

>> Ring:� �>> Sure the HHS Office of Research Integrity has their own policy of plagiarism that defines several subcategories of things that ORI will not review for federal findings of research misconduct, and those are description of methods.� So if someone is using the same description of a particular assay as another paper, ORI is not going to pursue that.� They'll consider that technically‑constrained language.�

Another category would be description of background information.� ORI does not pursue findings in those examples.� And the big one we see the most is authorship disputes.� So ORI defines authorship disputes as any time there's an allegation of plagiarism between collaborators or former collaborators.� In those instances, they recommend that funding agencies and institutions handle those allegations.�

So this will come up ‑‑ maybe a former collaborator will say, we were working on this application together, and then my former collaborator submitted the application without me.� That's not something that we are going to send to ORI because we know it's not within their working policy on plagiarism.� Instead, that will be referred to the institution for adjudication.

>> Kosub: If I wanted to make an allegation of possible misconduct, I notice something going on in my research lab, how might I actually go about doing that?

Who can make those allegations?

\>> Ring: Well, anyone can make an allegation, and we will accept allegations from anyone.� You don't need to be, you know, a senior professor.� You could be a grad student.� You could be an undergrad.� You don't need to be a US Citizen.� And you don't need to have direct knowledge of the research misconduct.� That may be helpful information if you do happen to be in the lab where something occurred and you are witnessed, but if someone just sees something in a paper that they believe is research misconduct, they're free to respond ‑‑ report that.�

As far as how to report, you have three major options.� The first is to report directly to NIH.� You can e-mail NIHResearchIntegrity@NIH.gov, and that is an inbox that I check.� If you're not sure yet whether you think something is research misconduct or not comfortable yet reporting, you're also welcome to e‑mail me at that e‑mail address, and we can have a phone call and we can talk through your concerns before you make a decision.�

Another option is to go directly to ORI, and you have two ways to contact them.� The first is askORI@HHS.gov.� You could also call their allegation line, 240-453-8800, and scientist investigators at ORI will be available to take those calls.

Regardless of who you make your allegation to, the entire inquiry and investigation stage of research misconduct proceedings occurs at the institution where the research is happening, and that whole process is overseen by someone called a Research Integrity Officer.� A Research Integrity Officer is another person you can make an allegation to.� So you can find that Research Integrity Officer ‑‑ we'll also call them RIO ‑‑ and make your allegation directly to the institution as well.

>> Kosub: So I can understand if like, for example, if someone felt a little iffy, felt a little scared or concerned about making an allegation of potential research misconduct especially if it's happening in their own lab or it's their PI or something to that effect.� Does NIH provide any protections for whistleblowers in such situations?

`\>> Ring: Absolutely.� The first protection that we can provide is the offer for you to remain anonymous.� If you request to be anonymous, I'm not going to share your name with anyone.� I'm not going to put your name into our database of allegations.� I'm going to delete it from any e‑mail you send me.� We don't share it with anyone.� So that's the first way we can make sure you're protected.�

The HHS Office of Research Integrity is also going to offer that level of protection.� If you go to a Research Integrity Officer at an institution, it's sometimes against their policies, so that may not be offered to you.

As far as other protections, the regulation that guides all of these research misconduct proceedings for NIH‑funded research is 42 CFR Part 93, which you will be able to find at the ORI website.� That ensures protection from retaliation for both the complainant, so the whistleblower, as well as any witness in the entire proceeding.�

If you are concerned that retaliation has occurred, you can go again to that RIO, Research Integrity Officer, at the institution.� You can go to me, again, at NIHResearchIntegrity@NIH.gov, or you can go to ORI.� These issues are typically handled by ORI because they have experience and they have the authority under that regulation to look into retaliation.

>> Kosub: Thanks for that information.� You've mentioned ORI, the HHS's Office of Research Integrity quite a bit throughout.� And I just kind of want to give another opportunity to further discuss their role and how we work with them, and if you can talk on that, that would be great.

\>> Ring: Sure.� We work very closely with ORI on allegations, so they are the ones who have the authority to go to the institution about research misconduct allegations.� They're also going to be overseeing those investigations to make sure that the institutions are compliant with the regulations throughout the process.

These investigations can take a really, really long time.� If you look at the regulation, it will say you have a certain number of days for each step, but it also says you have to be thorough and you can ask ORI for extensions, so sometimes these take years, and having a good relationship with ORI helps the NIH protect the funds because ORI will tell us if there are big problems throughout the process.�

If they see that interviews are coming in and you're finding out that there are no lab notebooks in the entire lab, they will ‑‑ ORI will inform NIH.� If there's bullying or harassment occurring, ORI will inform NIH so we can take steps to protect people, so that's relationship's been very, very positive.

>> Kosub: What kind of information might NIH release as it relates to an allegation? I suspect people might want to know something is going on.� What kind of information would they see?

>> Ring: Sure.� So research misconduct proceedings are private.� And unfortunately, for the public, we can't release anything.� We can't acknowledge that a proceeding is occurring.� We can't tell you what's going on with your own complaint.� This is to protect everyone involved.� We don't know ‑‑ all the proceedings are proceeding. �We don't know whether someone has done anything that falls into the definition of research misconduct yet.� So people are protected throughout the process.�

The only time we will say, yes, there was a problem, is if ORI makes a finding of research misconduct.� That is public information.� It's published on the federal register and it's published in the NIH guide at that time.

>> Kosub: And before we go, I always like to give the opportunity for our guests to give any final thoughts on the particular issue.� So would you like to leave our audience with anything else related to research misconduct?

\>> Ring: Absolutely.� As I said earlier, we're not just concerned with research misconduct.� We're certainly concerned with research misconduct, but please, if you have any concerns, feel free to bring those up.� It may not fit under that definition of research misconduct, but there may be actions that NIH needs to take related to some of the questionable or detrimental research practices that we see out there, so please let us know.

>> Kosub: All right, thank you very much, Christine.� Great opportunity to hear more about research misconduct and how we address it here at NIH.� To reiterate a couple of points that she's made, if you would like to contact her, provide any information, and allegation, please feel free and e-mail NIHResearchIntegrity@NIH.gov.� You can check out the NIH grants website on research misconduct.� A lot of great information there.� As well as at the Department of Health and Human Services Office of Research Integrity website.� Check out their information too. This has been David Kosub with NIH's "All About Grants".� Thank you very much.

�