Final proposal and putting together the last pieces that go into the final grant application. The many components of a grant actually can significantly increase the stress of putting the grant together, but once you've done all of these pieces, once you have templates with which you can work, many items that are on a checklist, and your final science or research proposal is not ready, many of these other items you can complete, and these are often needed for your grant submission office in advance of the actual grant submission deadline. I had a day or two before, but sometimes we have done them on the day of the grant submission, but the more items you get done in advance, the better. We'll talk about titles, the different components including a process, and the pre-submission review and deadlines. Again, many of these grants on a submission system, but many times a grant, you'll turn it in, and you'll get a return email that says it has errors, and they will not accept your grant until the errors are corrected. These errors can cause significant chest pain and palpitations, particularly what you want to do is try to submit your grant a day or two before the deadline, and the errors had to do with the letters by the electronic system at NIH, so we had to quickly scurry around and get the original Word documents, and then our grants office then sent those as a final PDF, but this was literally two hours before the grant deadline, so things like help you put together the face page, and what you need to really focus on are these other components, which are the budget, the budget justification, biographical sketches, biosketches, and there's specific pages, there's a checklist form, a continuation format for you to complete, and then special details about a checklist and submissions, and I'll have her send me a checklist of what you need, personal statement, in the biosketch, which is the new NIH format, so they don't actually need to necessarily give you a letter of support if they're giving you their biosketch with a personal statement. One thing is, with the new NIH format, the biosketch has a personal statement. You have to be very careful not to have a cut-and-pasted grant. We have a great pathologist, and I had her biosketch, and I looked, and I'm like, oh my God, this is for a benign, you know, benign, a weak job, and that you're going to be working in a radiology department, and they will give you the time to do the x-ray studies you need, so you want people to show that your research will be supported at your institution. Now, you'll be writing these letters. They always want you to draft a letter. Some people will modify it, some will not, some will just sign it, so you have to make sure that you give a very busy clinician collaborators who are going to recruit patients, PMCID numbers, and so sometimes this can be a little bit tedious. So take it one check at a time, so one, you just conquer the checklist and do one thing at a time. Often you can get a lot of these items done in just a hunk of a few hours where you're going to have children, the same template that says, because we'll be children, although they may be valuable, although pediatric templates, and use that over. Now, the facilities, usually if you are at a department where they do a good amount of grant writing, you can get from the person in your department who helps you with grant submissions, some facilities, some templates, where you often want, like your clinical research facilities, templates that you use, because they can have language on there that are relevant to a totally different. My slide is a little stuck here, I'm not able to move forward, let's try this, by the character count, if your character count limit, so these are some grants that I've had in the past, and these are the titles, Volume Outcomes in Incontinence Surgery, which was looking at the role of surge in volume, this was a study, the ACCESS study, and this was Dr. Linda Brubaker's very good at acronyms, and this was a really great acronym, ACCESS Study of Abdominal Copal Plexus Comparison of Endoscopic Surgical Strategies, which is a randomized trial that compared costs and outcomes between sacrocopal plexi, that was done laparoscopic versus robotic, and then later we developed QALYT2, it's basically a paragraph, I think it's limited to 23 to count, so this is what most reveals, you want to include how does it relate to the mission, it will entail this, in AIM2, and use your AIMS page to develop the abstract. A targeted enrollment, start with your, find your numbers, you need your overall patient, the census.gov, and get the numbers for this in the grant, so in some grants we then added Spanish questionnaires, and in others, we then, applications we said, we will, because most patients are English speaking sample Caucasians in this proposal, or say we will seek to have 25% Hispanic patients. Now it's also important to know the difference between, according to NIH criteria, there's a difference between race and ethnicity, so ethnicity refers to black, Caucasian, and so this is, this table conducted. Protection of human subjects is basically, it's similar to how you handle things with the IRB, but what's interesting is, in our, with our IRB, I've, our IRB wants physicians to do the recruiting, not like study staff, so I wrote a grant to NIH that said the physicians would do the recruiting, and this was highly criticized that the patients would feel coerced, so for NIH grants, I will not, for applications, I will have the ability to be contacted by NIH, and then the study staff will recruit the patients, so then there's not this possibility of coercion, so you have to be careful with, there are sort of different, NIH sees things differently than your own institution may. This, this, this, lower risk studies just need a plan in case, let's say there's a breach of confidentiality, where you review what went wrong, and, and how you would handle it, you notify your IRB, the patient would be, you know, we would meet with the patient, things like that, so you still, you want to have a plan if you don't have necessarily a board. Now multiple PI leadership plans, no longer do you need to have a leadership plan, and that's actually pretty easy, you just have to delineate the exact role, so one might be the clinical recruit, be in contact with the NIH, who will submit progress reports, who would be in touch with the Data Safety Monitoring Board, things like that, so you want to just make sure that, you need to make, justify why you have more than one PI leadership plan. Now a cover letter, the reviewers, but it often, it includes the title of the program announcement, if it's not a specific, we respectfully request that it be reviewed by the NIDDK, and so that way, they'll take that into account and send it there, ideally. So, who do you want a letter from, are supportive of it, the PI joined our faculty, and they've done so, they'll say yes, you have to send them a draft, so again, make sure it's carefully written and detailed, as opposed to just a letter that's not going to be strong, because a weak letter is actually bad, worse than having no letter. So, the letters are purposely, and you know, if they're going to be paid by, let's say the hour, they'll, you can even talk, well that's going to be usually in your budget justification, but you can have it done first, you usually start with a template, or someone else's, we will disseminate, and you say, this finding from aim one, this finding from, and then you say what meetings you plan, where you would submit these abstracts, and what, to what meeting, and where you would want to present them, each aim, and that's sort of a personal preference of mine, so that can be variable. So, timelines are nice to put at the end, three months, so in quarter one, you'll do these activities, in quarter two, you'll do these, so, and budgets, there's a separate incentive, potential public, and the budget justification, which actually talks about the details, now, depending on the type of budget, sometimes you need more details than others, but usually with budget justification, you, you have the, you know, you have the percentage effort after each person, and a little paragraph as to what that person's going to be doing. So, appendices are placed for, let's say, insert from manuscripts that have been accepted for PubViewers can look at that, but they, their reference manager, because it will make your life significantly easier, and they have free downloads for one month of end notes, you can get comfortable with it, and once you get it, you'll never be able to go back, but you don't want to have to ever move a reference, if you don't have to. The other thing is, those are avoidable, and they show lack of detail, so you need, IOPT can make sure that there's nothing, that, you know, let's say preliminary data, and you want to make sure that it's relevant to your current grant, that you don't leave.

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submission process

budget