NIH All About Grants Podcast: Allowable Costs for Clinical Research Participants

David Kosub >> So imagine this scenario. You're starting your research project and you need to enroll some participants. And you're asking yourself, what kind of incentives could I provide someone to participate? Or what other kind of efforts are needed to ensure I have appropriate inclusion in that the appropriate folks are involved in the research study? Well, join us for this episode of the NIH All About Grants podcast to learn more about allowable costs for clinical research participation.

Announcer >> From the National Institutes of Health in Bethesda, Maryland. This is all about grants.

David Kosub >> All right, well, welcome to the show. My name is David Kosub, and I am with the NIH's Office of Extramural Research. And I'm glad to say that we have two of my OER colleagues here to talk about this important topic. We have Dr. Rebecca Favor She is senior inclusion specialist. And we also have Mister Priyanga Tuovinen, who is a senior grants policy analyst. And welcome you both to the show.

Rebecca Favor >> Thank you David. Glad to be here.

Priyanga Tuovinen >> Great to be here, David. Thank you.

David Kosub >> All right. Well let's just jump right in. What do we mean when we actually say an allowable cost?

Priyanga Tuovinen >> That's a good question, David. Basically, an allowable cost is a cost that can be charged to an NIH award. As you know, there are a number of types of costs involved with clinical research. And the NIH grants policy statement provides definitions and examples of these types of allowable costs. But for a cost to be allowable and charged to an NIH grant, you should consider a few key questions. First, is it allocable? Meaning does that cost provide a direct benefit to the clinical research or grant funded activity? Is it reasonable? This is just a common sense test. And is it in line with your university or organizational policies and practices? Is it consistent with them? Besides the NIH grants policy statement, the original notice of funding opportunity and the notice of award may also describe allowable cost considerations or restrictions that you should be aware of.

David Kosub >> Thank you for that. Now let's kind of bring it back out to the wider lens. Why is this topic important for inclusion Purposes.

Rebecca Favor >> That's a good question to. David. So to begin, I just want to briefly go over the inclusion policies because understanding what they are kind of help us to understand how allowable costs fit in. So our inclusion policies are in place to ensure that women members of racial and ethnic minorities and individuals across the lifespan, so from children and infants to older adults, are included in research where it is appropriate to answer the scientific question that the research is aimed toward. And so to do so, it's important to think about what is necessary to have the appropriate people on the study so that the research can fulfill its purpose. That means that 1st May need to think about what's necessary for including children, in terms of the space where the research is being done, what might be necessary to ensure that the individuals who need to be reached are able to come to the research center. So that can be thinking about things from, you know, transportation to a rentable space. And one of the things that we always want to make sure is that for participants to be in research, there shouldn't be a cost that they have to pay to be a participant. And so when we're thinking about inclusion, the ways that the allowable costs fit in is to help us ensure that that can happen, that participants can participate in research without a cost being applied to them.

David Kosub >> Yeah. Definitely agree. Someone shouldn't have to pay to participate in our clinical research activities. And you kind of hit on some of these with transportation and allowable space and things like that. But can you give more examples as to what may be an allowable cost for people to participate?

Rebecca Favor >> Sure. Um, just continuing with the example with children, if a participant will be possibly bringing their children to the place where the research is being conducted, it may be allowable for one to purchase toys and things like that for the waiting area so that children will be accommodated while their parents are participating in the research. It may also be allowable for meals to be covered if the type of research that's being happening will be, you know, for a long period of time. And people may become hungry during the time where they're at the research facility and so on. So those are some of the other costs that might be covered. I think another one that's important is publication costs, for example, just getting the word out to be able to recruit participants for your study, those may be allowable costs as well.

David Kosub >> Thank you for helping explain some of that. But on the flip side, what may not be allowed.

Priyanga� Tuovinen >> It would really depend on the specific award and the clinical research objectives involved with the NIH funded project. Alcohol beverages, for example, would never be allowable as an entertainment expense or for participant inclusion. But for example, you could imagine a NIH funded project involving, um, alcohol as an allowable study expense looking at alcohol disorder or other applications. So in thinking about what's not allowed. The original notice of funding opportunity may provide guidance on allowable costs or considerations. The notice of funding award will definitely state any restrictions, but it also goes back to the cost principles and the test for allowability. Is it applicable? Does it provide a direct benefit to the project? Is it reasonable? Does it conform to organizational practices? And are there any federal or award specific restrictions that may apply? Rebecca had some good examples of what types of costs are allowable. Is there anything you want to add about what may not be allowed?

Rebecca Favor >> No, I think you hit some of the main points. Priyanka. It's important for investigators while they're thinking about the costs. That may or may not be allowable to also remember that, you know, depending on the NOFO or the funding opportunity that they are responding to, there might be some costs that are allowable for one type of research, but not allowable for the other, as you mentioned. So I think you covered it well.

David Kosub >> Yeah. So I guess careful read of that notice of funding opportunity and just understand that as clearly as you can, you know, and as someone is putting together their application, you know, you mentioned what may be allowable, what may not be allowable. Do you have any advice on how someone can incorporate these costs into their application, into the budget of their application?

Priyanga� Tuovinen >> Absolutely. We want NIH to cover costs for individuals to participate in NIH funded clinical research. So, as we've said, consider the cost for participant inclusion as it relates to your specific study and study design. What are the enrollment targets? What is the community involvement or recruitment strategies and reflect the clinical research plan in these recruitment approaches in your proposed budget include the appropriate direct costs for recruitment and retention, and describe these costs in the justification, especially any costs that may be atypical, so that reviewers and NIH staff can understand how they relate to your proposed research. Rebecca mentioned some types of allowable costs may include travel and volunteer incentives, advertising and outreach, child care. nursery items, clinical services or patient care like blood draws based on protocol. So be thoughtful in how you're accounting for aspects of your recruitment plan in your application budget.

Rebecca Favor >> I think the other thing that I'll add is just it is very important to think about all of these things. Once you are just beginning your thoughts about how the research is going to be conducted. It's not something that can be easily added on. Once you have already planned out your research study, and then now you're thinking about how to add an allowable cost that you can think about inclusion. It really has to be something that is thought about from the beginning. As I mentioned, you know, the first steps in terms of thinking through your research, the question that you want to answer and the participant pool that you will be recruiting from, it's important to think about what might be necessary for that particular group, that particular population, who will be part of your research to be able to enable them to help with answering the research question and plan all of those things within your budget as you are thinking through it.

David Kosub >> Well, let's just say that someone's thought about all these things. They planned it out. Well, they got their budget, they got the award, they're working on the study, and now they're really getting into those real world expenses, allowable costs, you know, how could someone know if something is actually within scope or not within scope once they got that award?

Priyanga� Tuovinen >> We all know that nature research is experimental, so there are course adjustments and unforeseen activities. If a cost was included in the budget, obviously then then it's within scope. And that's why it's important when developing a grant application, as we've been talking about, consider how the proposed budget is a financial reflection of your clinical research and recruitment plan, and include those costs associated with participant recruitment and retention so that you have those available. If it's not in the budget, then generally recipients can re budget without prior approval as long as it's within scope. And the NIH grants policy statement explains that the recipients make the initial determination if a change is within scope, and advises consultation with NIH staff as needed. The basic test for me would start with applicability. Are you able to explain or justify how the cost provides a direct benefit to the specific aims and objectives of the original, peer reviewed and approved clinical research? Does it still align with the purposes described in the original notice of funding opportunity? If a PI was asking, of course I'd encourage them to talk to their sponsored programs office to help with that determination and to consult with the NIH staff named in the notice of award as needed. Some indicators that there may be a change in scope may be, you know, for example, a change in the approved involvement of human subjects or significant rebudgeting. But if it's within the scope of the original approved application and there aren't restrictions in the notice of award, you should be able to re-budget for that cost as needed.

David Kosub >> Well, let's say they've done they're doing all this research and they're, you know, buying things. And, you know, you have to to be good stewards of taxpayer funds. You have to report what you're actually doing with our awards. Um, kind of. How does someone report these expenses to NIH?

Priyanga� Tuovinen >> Oversight is important. Expenses, however, are not included in NIH, RPPR or progress report. Organizations are required to report on the financial status of the funded project through the Federal Financial Report or FFR. But more importantly, NIH recipients are subject to federal audit requirements that are described in NIH grants policy statement, and expenses just need to be documented appropriately for potential audit review.

Rebecca Favor >> Well, one thing that does need to be reported, of course, is inclusion enrollment for clinical research. But in terms of the expenses, as you mentioned, just going along with documenting, as you mentioned.

David Kosub >> And these are experiments, after all their studies, things happen. Things don't go as planned. Things work out fine. And there might be situations where something happens and it's unintended costs or part of it, you know, what should someone do if unintended costs actually happen?

Priyanga� Tuovinen >> But assuming there's unintended costs are still within scope, and unless there are restrictions in the notice of award, recipients are generally allowed to re-budget if there's significant rebudgeting, then that may be an indication that there may be a change in scope. If there are additional funds needed because of unforeseen or unexpected expenses, I would encourage you to reach out to the NIH program and grant staff that are named in the Notice of award to discuss if an administrative supplement would be an option for additional funding.

Rebecca Favor Yeah, I think going along with that one area where researchers sometimes run into some difficulty that may end up being an unintended cost is just in terms of recruitment. If recruitment, for example, is slower than they anticipated, and maybe they need to think about new ways to recruit participants for their study, or if something larger needs to happen, like adding another research site and so on. All of those things would be great things to discuss with their program officer, with the NIH staff that are involved in their grant, so that they can see whether or not a change in scope is what is going to happen, what's to go ahead, and for the research to be able to continue, or an administrative supplement, as you mentioned, Priyanka, or if there are other things that they can do, other ways that they'd be able to address those issues that have come up during the time of the research.

David Kosub >> Well, Priyanka, Rebecca, thank you very much for this opportunity to learn more about allowable costs for clinical research participation. Before we go, I would like to leave the opportunity for our guests to kind of say some final thoughts that you'd like to leave the audience with them, please.

Rebecca Favor >> Sure. I think one thing that is important, just to reiterate, is the fact that thinking about inclusion and the allowable costs that may help to be able to allow researchers to recruit the participants that they need things that they need to think about from the inception of the research, from the beginning of the point where you're thinking about your research question all the way through the end. And so in doing so, I also just encourage researchers to be creative while thinking about what might be best to help address potential recruitment issues or barriers, what might be best for the community and for the participants who they are trying to reach out to and wherever they have questions, just to feel free to reach out to the NIH staff and to their Office of Sponsored Programs about what may be allowable or not allowable for their research.

Priyanga� Tuovinen >> And I'll just add to that, I've enjoyed the opportunity to talk about these issues. So thank you, David and Rebecca, I'll underscore a couple key points that we've already mentioned on the application side. Include participant costs and explain them in the justification. You can look at the notice of funding opportunity for specific requirements, and for specific types of costs that may be applicable to one type of opportunity versus another. Reach out to the agency contacts listed in the notice of funding opportunity. If you have questions at the application stage on the award side, you know changes happen. Things happen. Work with your Office of Sponsored Programs on questions about allowable costs, or contact the NIH staff named on the Notice of Award for questions specific to that award. For general policy questions, please feel free to reach out to me and my colleagues at the NIH grants policy inbox.

David Kosub >> Well, Rebecca and Priyanga, thank you again for this opportunity to learn more about allowable costs for clinical research participation. And to underscore a couple of points that were made earlier, definitely review the notice of funding opportunity. There's a lot of information in there that might help answer your questions, you know, check out the resources we have available online. Reach out to your offices of sponsored research and talk to NIH staff. We're here to help, and if you have questions, feel free and send them to G[email protected]. This has been David Kosub with NIH is all about grants. Thank you.