Cedars-Sinai Medical Center in Los Angeles, and the topic for today is to distinguish what determines an outstanding proposal from one which is not fundable. And this is particularly hard in an era where many projects that should be funded are not because of the funding climate. So what this means for us is that we need to make our proposals even better, and we have to apply even more for any funding opportunities. And I think it's very important to have the goal that we do not lose the drive to be funded because I think hopefully these times of difficult funding are temporary, and we don't want to give up when the times may turn around, and we one day can be funded with a higher frequency again in the future. So a good proposal must be innovative, meaning new and exciting. And I think there's a whole section in the grant proposal on what makes it innovative, but I think it's very important that you have to convince the reader, the reviewer, that the proposal is an innovative one. It also must have broad impact, and I think whenever a proposal is written, that should be taken into account, particularly instead of a proposal that's going to focus on women of a certain age group, you try to broaden the people that the proposal will impact. It should fall in line with the mission of the institute that you're applying for, in the case of an investigator initiative proposal, or also with a specific RFA, which is a request for application. You want to read in fine print on these RFAs and determine what they want. And it should be feasible. You want to have the team together who can carry out this proposal. And you don't want to meet the criteria yourself. You want to include an expert in a certain area so that you won't get criticized for not being able to do the work, for not having that expertise that you need. It's also very important to have good luck. And I like to say that, you know, I don't like to say, but the reality is, the proposals I've had funded were not the ones that I poured my life into, where I turned my family into shambles. Those actually were not the funded proposals. The funded proposals I've had had a lot to do with me responding to an RFA and saying, hey, we're never going to get this left apply, and then getting that kind of grant. A recent grant we got funded was in an area that I haven't really had any funding in, which is interstitial cystitis. And some wonderful basic scientist at my institute said, hey, will you collaborate on this? I'm like, sure, just put me as a co-investigator. And my mentor, a senior to the basic scientist said, you really need to be a co-PI on this. I'm like, okay. And so I definitely helped put the grant together, but with not nearly the effort I've put in on some of my others. And it really comes down to being in the right place at the right time and good luck. And I think in some ways applying for grants is a gambling act, and we have to – and a good gambler doesn't give up. And I think it's important to continue to gamble, to not give up. And the one – it takes, you know, if it's one in 20 grants, that one will be there where they want to fund research that you're applying for, they like you, and they like your team, and you have the right fit of a review panel. Anyway, so, and I love this, and Becky Rogers always says this, you know, you're probably not going to get funded if you apply, but you definitely won't get funded if you don't. So I believe in the concept, apply, apply, apply. I also believe in not murdering yourself to apply. You're trying to only apply for one grant at a time, give a few months in between a grant. Let your life fall in order before you apply for another grant. Okay, now we're talking about budgets today. And they're very daunting to the new investigator, but they're not that hard. And I think it's important to start with what – I think, you know, my first grant was a grant I put together with Miller and Kim Kennedy at Loyola, and Becky was in business before, and she's got a really good background in business, so she says I'll put together the budget. So she puts together the budget, and I looked at the budget, and that was my first experience with the budget is I watched someone else do a budget. And then I realized that what she was doing was she was using common sense and then figuring out a budget. And I think it's very important to have someone help you, at least with your first grant, so you can understand. But it's very sort of – it's like very simple in that you have to be giving up a budget in the constraints of the money that the grant allows. So there's a lot of different line items on this grant. And the most important being salary plus fringe. Consultants who can help with the key components. Consultants can be a helpful strategic move when you're short on money but you want someone's expertise. If they function in a consultant role, you don't have to get – you don't have to do a full contract with their institution. They're in a different institution from you. But if they're actually going to be recruiting patients, they're usually not considered a consultant. A consultant is someone who gives you their expertise. Equipment, that's pretty simple. And we're like, oh, my gosh, we need iPads for this study, for patients to fill out. So something simple like an iPad. How many do we need? How much did it cost? You look online at Apple and that's how you figure it out. So some stuff you really can use common sense to figure out how something costs. Travel is usually limited on the RFA. And so you have to take that into account. You look at the RFA and then you budget your travel according to that. Patient care. Patient care is often covered unless you're non-industry funded studies. Usually the studies you do are part of patient care, but where you need to pay patients is their time for filling out questionnaires. And also you want to – you can strategize it. If you're running out of money, you can spread it out over – if a grant has, let's say, five years, you can spread the patient care cost accordingly. And patients can get their money at the end of the – you know, when all their data is collected. So there's ways to space out the cost for patient incentives. Alterations and renovations. Those I don't have too much experience with, but that's another line item if it's relevant for your grant. And then consortium and directs and indirects. You know, usually that's – it's important to get help from your grants office with regard to the exact cost. And actually there should be people at your institution, at least at my institution, where they help me calculate. There's a woman in my grants office who plugs in a template with all the indirects. And so you shouldn't have to calculate that yourself. There's somebody in your grants office who could easily be able to do that for you. And indirects vary by institution. So how about salary and fringe? I think the most important point for a budget is to make sure that you have put enough – so if you're a PI on a grant, you should never have let him – even like an R03, my colleague and I applied for an R03 where we were actually – it was a multiple PI mechanism. So he's 10% one year, I'm 5%, and then the second year, I'm 10%, he's 5%. You have to have – definitely an R03, you need to have at least 10% effort, usually higher. Because if they think you're only putting 5% effort into a grant, it's not going to be feasible for you to do it. So you really have to make sure that your effort is enough. Salary cost sharing is – this is if you want to get the money for this grant and you realize you cannot – let's say it's an R03, which is $50,000 a year for two years. That's not a lot of money. So you can have – you talk to your chairman and say, will you cost share my salary for this? Meaning they'll cover your salary to do the effort for the grant. So that involves you having to get a letter in your department approval to – for cost sharing, which means you'll do the – your department will fund your effort, or basically your salary, and give you the time for the grant, to do the effort that you lay out on the grant. And so that can be helpful also if, like, your colleague is applying for a big center grant and you want to participate, they don't have money for you, that's a way to do that. Now, the other thing which is important is you really need to justify why someone's on there. And I put people on grants because I thought it was a good idea, either to help, like, establish a rapport with that person, but when it came down to it, they really weren't adding that much onto the grant. And it's no one in office, by the way. But so you really need – what do we need the person for? You have to really make sure you need them before you put them on, because any person is going to be – you put on as a salaried investigator, meaning they get salary from your grant. That takes a big chunk of money from you. And so you really want to make sure that everyone is there for a reason that will sort of make the grant better. So other staff are not, you know, people that you need. They are key personnel, but they could be considered your research assistant and you want a bunch of money for that. I have to be very careful. A lot of my research assistant money is going to come from grants, so you want to make sure you give them enough effort because you need to cover them. And, again, fringe benefits are part of the – look at directs when they refer to – when RFA really usually looks at directs. So indirects often are not included in the money that the NIH or other funding agency will give you. So that's a good thing that you don't have to worry so much. Briefly, but there's someone who are hired to give you professional advice or services that receive compensation, but usually these are – you borrow their expertise. They're not doing, like, heavy-hitting recruiting. And if they're going to be recruiting patients, they really should be considered a key personnel. But I think where this is helpful, and it's a little bit of a trick, but when you have a consultant, you don't have to go through establishing a subcontract. So consultants without a subcontract – I shouldn't be saying this, but they're in here to put in sort of last minute if you didn't get them in on time, and you need that to be in there. And I actually have gotten away with having someone as a consultant who really – probably, but we got them in late on the board, and we actually did get funded for that grant at the whole right place at the right time thing. So I think it's important that if a consultant – if they fit the role of consultant, it saves you money as being the primary institution to receive the money in that you can avoid that whole subcontract. So equipment is a tangible property that you – this is – you know, it's not like disposable equipment. You want it to be able to use it. And then you get a price quote, and you can even have a letter from the company that says, here's how much this aerodynamics machine is going to be. And you usually purchase the equipment at the beginning of the grant so it can be used for the rest of the grant. Supplies need to be itemized. And when you think of supplies, you also have to think of, for example, for the aerodynamics machine, you have to include the cost of any disposable, which can be $60 a person. So you have to not only think of the initial equipment, but all the supplies that will be needed. And in the case of animals, you have to be very, very clear on the species, the number to be used, the cost, the cost of maintenance of food and changing and all the things that need to be done with the animals. And I clearly am not an animal research expert, so we're going to move to the next slide. Travel, again, you have to look at the RFA and see what the limit is. There usually is a limit. I know with NIH, I think it's, what, $1,500 or at least for some of the grants I've applied for. You have to have a reasonable cost for staff. Often instead of travel, you can have conference calls. If you run out of budget, you can include conference calls. And also the cost of those calls can be incorporated into a grant. But, again, you know, locals usually don't need that much detail on travel on a grant, like the number of miles and things like that. But you usually just say travel, and it's a line item with a certain amount. Sanitation care costs, again, these are additional costs that are not with sanitation normal care. So many studies we do are in the context of normal care. You can randomize trials, and they can randomize their site. If both types of procedures are within the standard of care, then there's no charge for those procedures. It's the extra tests you do on a patient that are study purposes only that need to have a line item with charges. But, again, in the case of focus groups, questionnaires, those, you can put paper, a list of paper supplies for the grant, and actually the additional money that you would give the patient as an incentive for questionnaires. Now, one other consideration. So I'm going to go back here to patient care costs. Let's say you're doing an invasive procedure, that you're doing an extra urgenomics procedure on someone that isn't necessarily in the context of their care. Those patients need to have reimbursement for that, and particularly control patients. If a control patient is going to go through an invasive test, let's say urgenomics testing, they should be compensated, let's say, $100 to do that test. They need compensation for doing a particular invasive test if they don't actually need it. And then anything else would be considered other, including patient travel, publication costs, rentals and leases, maintenance of equipment, things like that. Although that can also go into the equipment line. Now, this is where it gets tricky. So it can get tricky. And where I've learned is that the best way to handle it, if you have a subcontract and you're going to be the PI in your institution is the main recipient institution, and you want to co-investigate it from somewhere else, you have to balance two things. One is giving them enough money where they can actually do the study, and two, not giving them too much. Because you need to have what you need as the primary institution. So now, again, it's a little tricky with indirects, but it helps cross-collaboration and interdisciplinary work, but that can vary depending on the specific grant mechanisms. So you have to be careful. Now, patients are going to need to provide money for the patients, and for their research staff who will be recruiting patients. Usually what I learned, probably the hard way, is that if you are the PI and you're forming a subcontract, you have to have in your mind what you want to give, and then you tell them, I have $50,000 to give to you to recruit all these patients. Tell me how you want to divvy it up. And you work it out that way. You give them a number and let the subcontract person figure it out. Sometimes you can say, hey, how much do you think you will need? But you've got to be careful. I would usually start with a number and say, can you do this work for $50,000? And they may say no. They may say, okay, how about $75,000? That's all I have. And most people who are interested in collaboration will do what they can to help you, even if it's not that much money. So that's an important learning lesson, and you've got to keep control of the money if you're the PI. A letter of institutional agreement has been signed by the institutional official. It's required for each subcontract. What's important about that is you've got to get subcontracts well in advance of your grant deadline, almost a month. It can vary. But they will often, many places will say we can't, many institutions will not help you if you don't give them at least two to three weeks. So you want to get these going at least a month before your grant deadline. And so this is sort of what I alluded to as important to the grant and how badly you want that investigator working with you. And then, again, work backwards and determine how much you can afford for that subcontract conjugation. Tell them a number and see what they can offer. And, again, these need to be set up weeks in advance of the grant deadline. So indirect is you are contractual with your submitted grant. You are still, you're usually held to what was the grant that was funded. Now, so this is, in some places, in our case, it's we're held to what the indirect rate was when the grant was submitted. So if it were to increase, it's not going to hurt the investigator. But that can, again, vary by institution. So indirects do exclude. So final thoughts on the budget. Prepare your budget early. This is actually one of the most stressful pieces of a grant is getting that budget in because you have to particularly get that into the subcontracts. And there's a lot of costs that need to be considered. And you often forget that and think, oh, I forgot this. You want to have time to forget this and remember this. That's because you think it's more likely to get funded. If you ask for less, what you do is you, I think it's reasonable, apply for a smaller grant mechanism like an R03, let's say, but then make sure you have the money to do the work. Again, if you don't do yourself enough effort, don't think you don't know what you're doing. You're underestimating how much work it's going to be. Again, work with your institution early to prepare a good budget. And re-read the program announcements before you prepare your budget. And then understand the mission, such as, for example, NIDPK, and that will also help you in determining what budget you think you might need. And I think that's it.

outstanding proposal

fundable

mission alignment

feasibility

budgeting for grants

collaboration with institutions