NIH All About Grants Podcast
Financial Conflicts of Interest (FCOI)
>> Kosub: Hello, and welcome to another edition of NIH's "All About Grants" podcast.� I'm your host David Kosub with the NIH's Office of Extramural Research.� And today we're going to be talking about an issue that all of our funded researchers, our recipient institutions, everyone needs to know about to ensure the integrity of our science, and that's the Financial Conflicts of Interest, and we have with us Diane Dean, she is a Senior Adviser to the OER's Office of Policy for Extramural Research Administration.� She will tell you everything you need to know about FCOI.� Thanks for being with us, Diane.
>> Dean: Thanks, David, it's great to be here with you today.
>> Kosub: Great.� So let's just jump right in and tell us what's the purpose of these Financial Conflict of Interest regulations that everyone has to deal with?
>> Dean: That's a great question.� So it's important to know that the real purpose of this regulation is to promote objectivity in research and safeguarding the public trust in research, by making sure that any investigators' Financial Conflict of Interests are identified and managed.� Some people think that the purpose is to eliminate FCOIs, that that's a bad thing ‑‑ and I'm saying FCOI, I'll be saying that throughout this meeting, Financial Conflict of Interest, of course, but it's not to eliminate them, because we want our scientists to have these kinds of relationships to enrich their science, but it's to identify them and manage them so that they don't become problematic.
>> Kosub: So you mentioned the investigators.� Does it only apply to investigators.� Who does this address?
>> Dean: Well, the regulation itself applies to institutions, and that's domestic institutions, foreign institutions, private, nonprofit institutions, all of our institutions.� It applies to them when they submit a grant application to NIH or when they're funded.� And then it also applies ‑‑ once they get a grant award, it applies to their investigators, which are not just principal investigators, but it's the principal investigator and any other individual who is responsible for the design, conduct and reporting of research. So it does not apply, however, to Phase I, SBIR and STTR applicants, but it does apply to the Phase II.
>> Kosub: Since you hit on the FCOI acronym, I guess the question is what is an FCOI?
>> Dean: It's simply a significant financial interest that could directly and significantly affect the design, conduct or reporting of NIH funded research.
>> Kosub: All right.� Diane.� So you mentioned the buzzword of significant financial interest.� Can you tell me what does that mean exactly?
>> Dean: Sure can.� So a financial interest of the investigator ‑‑ also applies, actually, to the investigator, spouse and dependent children ‑‑ is one that reasonably appears to be related to the investigator's institutional responsibilities and is in a publicly‑traded entity, a non‑publicly‑traded entity, and that includes things like remuneration, equity interest, and there's thresholds involved for reporting purposes, for disclosure purposes. Also, intellectual property rights and interests and reimbursed or sponsored travel. One thing that's very important to understand is in the regulation there is some aspects of remuneration and income that are not applicable to US, Federal, State or Local government agencies, institutions of higher education; however, if those interests are from foreign institutions of higher education, or the government of another country, they are not excluded from the definition of a significant financial interest, so it's important to know that. Some income may be excluded if it's US‑based, but foreign‑based is not excluded from disclosure.
>> Kosub: Cool.� So something definitely to think about for our investigators when they're disclosing this.� Can you tell us more about exactly what the investigators should be disclosing to their institutions?
>> Dean: So it's important to know that investigators need to comply with their institution's policy, so we require that our recipient institutions comply with the regulations, which is what we're talking about today, but they can be more stringent when they implement those requirements within their institutions, so an investigator needs to comply with what the institution has in their policy. And among those things will include completing training requirements, fully disclosing their significant financial interests and those of their spouse and dependent children, keeping their disclosures up to date, ensuring that they are accurate and complete.
>> Kosub: So if the investigators are supposed to be complying with their institution policies, then I guess the next question is what is the institution responsible for when it comes to compliance?
>> Dean: So this is really where we see a lot of the requirements is at an institutional level, and that's by design in this regulation, because the institution is responsible for identifying and managing the disclosures of their investigators, because they can then determine if there's a financial conflict of interest knowing what their investigators' interests are, and then knowing what their research portfolio from NIH looks like. So the institution is really the core or the epicenter of the compliance responsibilities of this regulation. So one of the most important things that the institution has to do is maintain an up‑to‑date, written, enforced policy on Financial Conflict of Interest that complies with the regulation, and make sure that policy is publicly available and posted on a website. Now, NIH recently announced in a guide notice ‑‑ and I'll give you the guide notice number and you can just search by that number and it will pop up, which is NOT-OD-21-002, which talks about a new requirement that was effective December 1st of 2020 for NIH funded recipients, and that is prior to award, they must submit their FCOI policy. And I must say that this has been a requirement for the recipient to have a written FCOI policy in place since 1995, and only in the revision of the regulation in 2012 was there a requirement added that it be publicly accessible on a website.� This is very important.� Adherence to the requirements of the guide notice that I gave you the number to is very important.� It gives you lots of information about exactly how to do this, and noncompliance with these requirements will cause NIH to delay issuing grant awards, and perhaps even taking other administrative actions that may affect your future funding.� So please, please be mindful of this very important requirement. Other things that the institution has to do is make sure their investigators understand their institutional policy, that they complete the required training that's on their policy and also on the federal requirements.� Deciding with your recipients whose FCOI policy is going to apply.� So will the prime entity's FCOI policy apply to any subrecipients or will subrecipients use their own FCOI policy? In any event, the subrecipients will report up to the prime any identified financial conflicts of interest, which will then be reported to NIH.
>> Kosub: It sounds like a lot that they have to keep in mind, but it's quite important to do so.� On that same note, like how often does an institution need to report to NIH on these disclosures?
>> Dean: So initially, FCOIs have to be reported after you receive that notice of award, but prior to the expenditure of funds, the institution has to report any identified FCOIs to NIH, and then ongoing through the lifecycle of the award, investigators have to keep their disclosures up to date, as I said, and then within 60 days, any new identified FCOI, the report has to be made to NIH.� Negative reporting is not required.� You don't have to tell us that you don't have anything, but you do need to tell us that you do.
>> Kosub: I see.� I see.� So these are what the investigators and institutions need to do.� So what are we doing on the other side?
>> Dean: We have a lot to do on our side.� We have to provide compliance oversight of the whole process.� So not only do we look at our institutions to make sure that they're in compliance, not only with the requirements of the regulation, but with reporting, with managing their Financial Conflict of Interest and all that's involved there, but we also look internally at NIH to make sure that we're upholding our end of what is ‑‑ of reviewing the reports and taking actions on those as needed. We also provide a lot of education and outreach to our extramural community, because our philosophy is the more that you understand and that you know about what your requirements are, the better compliance would be, and that's a good thing for both of us. We also do a lot of activities, compliance activities.� We review FCOI policies to make sure they're compliant.� We do site visits.� We do a lot of technical assistance where we work with a recipient or an applicant to answer their questions about FCOI to help them with their policy to make sure it's compliant. We develop resources for our recipients that are available.� NIH's website to make sure they have the resources they need to comply with these requirements.
>> Kosub: Definitely seems like we're not leaving anyone hanging, I guess you could say.� We're going to get the information to help them out.� And you briefly touched on this in your answer to a previous question about like what happens about compliance, if someone is not complying with these policies, can you touch on that just a bit more?
>> Dean: Sure.� So generally, if there's a ‑‑ an issue of noncompliance, we contact the institution and try to determine why this is occurring and help them by providing technical assistance to get the institution back on track.� Is it a policy issue? Maybe it wasn't an issue known to the institution. Maybe it's incorrect information and training materials, whatever it is, we try to do that. For the requirements that we have well‑advertised and that have been place for quite some time, like I mentioned about submitting your FCOI policy, that requirement, if there is no policy submitted, we're not going to issue a grant award until the policy is submitted. We can delay the issuance of awards until we achieve compliance.� And also beyond that, if there are issues, we can impose other types of administrative sanctions, like specific award conditions or enforcement actions which could affect the ability of recipients to receive future NIH funding.
>> Kosub: Thank you very much for that.� I always like to take at the end of these conversations the opportunity for ‑‑ for guests to kind of see if there's anything last minute that they want to share, any closing thoughts? Any final things you want the listeners to keep in mind as it relates to FCOI?
>> Dean: Right.� So I ‑‑ actually, I do have a few take‑aways I'd like to talk about. For institutions, make sure that your FCOI policy is clear, that it complies with the regulation, that investigators can find it, that they know that they're subject to it.� Make that part easy for investigators. And if you have questions about your policy, please contact us, and we're very happy to help you with that. For investigators, read and understand that policy, your institution's policy, and ask questions early.� Make sure you comply and fulfill your responsibilities to the institution to disclose all significant financial interests. And I would recommend if you're not sure about whether to disclose or not, to err on the side of over-disclosure to your institution.� And remember that SFIs, Significant Financial Interests, whether they're foreign or domestic, if they're related to your institutional responsibilities, they must be disclosed. And I think for all of us to remember that transparency and accountability ensure that research is objective and in the best interest of the public.
>> Kosub: Hear, hear.� Well, thank you very much, Diane, I greatly appreciate you participating and telling us everything about FCOIs, for those who want more information, please do visit the NIH grants website that Diane mentioned, just search for financial conflict of interest. And you can also send questions or comments to our e-mail box at FCOIcompliance@mail.NIH.gov and someone will be happy to answer that. This has been David Kosub with NIH's "All About Grants".� Thank you very much.