i'm valerie prenger director office of scientific review for national heart, lung and blood institute. i've been with nhlbi since 1997. before that, was a faculty member at the university of maryland, school of medicine and used to write grants and apply
to nih for funding and decided after being asked to attend a lot of peer review meetings. i'd rather work for them, rather than just come any way. i happen to be within the institute or center. we will talk about review done, both at the center for
scientific review, which the the ones are reviewed through, and also review within an institute or center, which is where i am. so why is this in the class? nih has known for many years that, clinical research projects are hard to design well, and present in a short number of
page that is nih allows for research applications the over all success rate of clinical research project system absolutely lower for the success rate than basic research projects, although it's not that far off, and it's been on the rise for the last several years,
but still, it doesn't attain the success rates for basic research projects. and nih has, over the years, sponsored many projects, looking at data analysis on this to try to get a handle on why that is we know it's notate to higher budgets for higher requested
budgets for clinical research because institutes and centers fund multi year, many million dollar clinical trials through these mechanisms so the fact that they cost lot is not a deterrent for funding or a success rate. it's not review panel assignment
because you see lower rates for clinical projects, regardless of study second assignment. it's not due to a disproportionate number of clinical application fist a review meeting, compared to bake. it's not like they're washed out of the peer review
meeting and it's not related to the number of clinical scientists that are actually peer reviewers on the panel. so we know a lot about what it's not due to. it must be other things we really can't the measure. so what it is, what we chalk it
up to you is clinical knowledge pros are just harder to -- clinical projects are just harder to design well, and present in a fine night number of pages. relationship revise and commit, thattic tas more time and they can make more money practicing
medicine so they give up in research and they move on. so the topics for today are related to those is first of all, ano view of the nih peer review process. review criteria for research project grants, which have to be addressed during the application
process. i'll give you a list of career development award mechanisms, which a lot of clinicians like to start out with, or supplement ones with. there is an nih space payment program for clinical researchers in a few fields, that i'll tell
you about, that may be of interest. we'll go over the format for research project applications. there have been some changes this year. nih has been at that addressing rigor and transparency in the applications so some of the
review criteria has add questions to them, and the instructions for the application have also been miamied. and at the final bit, i'll give you some hints for preparing a stronger application. so the national institutes of health has 26 -- 27, actually,
institutes and centers, all but one is a fundingsen thity. the center for scientific review, shown in red, is not a fundingity. fund -- funding entity. their budget actually comes from the other institutes and centers
centers' budget. the nih budget in 2013 was about $30.3 billion. everything shown in pink, the labels in pink on this piechart are rather than related dollars. so that 81% of nih's budget goes right back out the door in the form of grants and research
contracts. that shown in yellow, this other 16% is the research management support is the cost of doing business. that's the cost of buildings, paper, people, that administer the grants that are awarded and to pay for any suspect that is
needed along those lines and 11% is dedicated to intramural research here at nih. i should say, that's very stable, those percentages, though the amount may change, the percentage break down remains fairly consistent throughout the years.
i think last year, the intramural research program went up from 10 to 11. that's the first increase they had seen in about six years. nih uses a dual review system for grant applications before they're paid. the first level of review is what people usually
think of as review. that's the peer review system where reviewers actually critique the grant application. the standing committee is usually referred to as a scientific review group or srg. they review the application for scientific merit.
they rate or score the applications and recommend an appropriate budget and duration of award. so if they have comments on the budget, the s.r.o.'s try to ep coo the reviewers in broad brushstroke so they don't nickel and dime applicants to death.
but they may make some budget suggestions, budget recommendations. and they do not make any funding decision. the only thing they do is rate the scientific merit of the application that score, with the application, goes back to the institute that then takes
the application to council and the council, and independent group from the scientific review group, assesses the quality of the review, whether it was a good review or not. if you want to appeal the decision at the review, the score, there are standard
reasons, grounds for appeal that is allowed and any appeals go to the advisory couple of the i.c. and are considered there. if they think different areas need to be funded more or other areas tone down, they'll make those recommendations to institute staff.
and they will advise the institute if they want policies changed or not. the submission and word process take about nine months the on the average, there are three council room ace year. three dates core responding with those councils at the end.
so you as the can't, would come up with the research idea. you would then hand it over tote office of sponsored project at the institution. they then submit the application online electronically, too the national institutes of health. it then gets assigned to n.i.c.
based on scientific mission. so whether it comes to heart, lung and blood or whether it goes to the institute of allergy and infectious diseases, departments on the scientific content and goals of the application in hand. and those mission statements can
be found on the internet so you can predict or try to direct where you're application goes. it then gets assigned to a scientific review group that reviews it for scientific merit and then goes back to the institute or center for the second round of review, which is
at council. the council recommends action that is to fund or not to fund and then it's up to institute staff to do the final paperwork to either fund it or not. and then if funds are allocated, then you get your research done. one note is that even though we
as researchers think of ourselves as the can't, because,as the applicant, the nih considers your institution, the cant, not you. so when formal -- the nih considers your institution as the applicant. when correspondence occurs, it's
usually to the institution's official signatory then you'll be copied on any correspondence. so notices of grant award go through the sponsored projects office. the scientific review officer. this is an md or a ph.d. that is the administrative head of
the review group that's going to be reviewing your application s.r.o.|1's 0 are housed either in the scientific review or the they repair the summary statements, the official respect the that lists your score, and the critiques from the individual reviewers and during
grant submission, until the review is complete, there, your primary point of contact with what your grant is doing and where it is in the process. so if you have any questions or you have any concerns, you can contact them. and when you register in the
e.r.a. commons as a principal investigator, when you submit a grant application you will be getting, if you log on to your account, the status of your application is always shown in there and the contact information for the s.r.o., as well as the program officer,
which i'll get to fixture, are in there. so you can always look up that contact information. also when you coget the summary statement, they're listed on on there as well. the second type of individual, a program officer or program
director, they're also an m.v. or -- m.d. or ph.d. they are howled in the institutes or centers. you won't find any of those in the centers for scientific review. that's because these are the primary administrators of the
grant, after it's funded. they manage a portfolio with awarded grans and r.&d. contracts and it's up to them to monare to the progress. so any of the reportings that you put in the annual progress reports you put if on a yearly basis go to them.
if dollar any concerns, changes up the to make in the budget, you any to them. from the time the brantleys review, and all the way through the life of the grant. -- from the time the grant is reviewed, and all the way through the life
of the grant. if you can find out which one manages a portfolio which is in the same area as your proposed grant. the third person that's important is the money person that's the grans original analysis contracts management
officer. they are also within the nih institutes and centers, are the one the ones that award the grants. these people are responsibility for fiscal stewardship for the portfolio. they'resome for monitoring the
financial progress. the program monitor monitors the scientific process, and the grants officer manages the financial progress of your grants and contracts. so there's a separation of money and scientific oversight. so actually, all of the fih
grant applications are now submitted electronically, through grants.gov. most of the r&d contracts are now submitted electronically, although there are some that still come in on paper for but all of the grants come in online there's an online portal
called grants.gov, which you can use to find funding opportunities, that you would like to apply to, and that's also the portal tayou use to submit your grant and apply. now, i say you submit t. it's actually, again, your institution that submits the
electrons to us. but it's grants.gov that you would need to pe reduce to find the funding tunes that will be of interest to you, and download the application from the site so that you can fill it out. there's plays like i said, called era commons.
this is dhhs's electronic system for receiving applications, and they actually transmit review and award information to you, and your institution through that device. and it's important that institutions, the research institutions know, they're
already registered within this system for a word management. but if you happen to go to an institution that's not a research-intensive constitution and maybe no one else has tried to apply for an nih grant before, you do need to, and your intent is to want to apply it to
grants while you're there, then you need to contact their sponsoring -- their sponsored projects person and give them the instructions for registering in both sam and the e.r.a. commons because it takes time to register. sometimes it takes over a month
for that process to occur. it is electronic, but it takes time. and once the institutions are successfully registered, then they instead to input all of their principle investigator information in there. and it's that principle
investigator information that you need to submit the grant. there are two routes now. it used to be, you had to submit your application through grans.gov. nih has been working with grant johnstowork -- grants.gov.isuggest that you use assist. there are, on the funding
opportunity announcements, there's the download button for grants, too use graand also one for assist. the main advantage for using the assist portal is that after you finish putting together your application and you think it's all there, you can use assist, a
subcomponent of assist to run your application through the error checker, and it will give you a list of errors or warnings within your application and then you can fix them and run it through again and be assured tathere are inn any errors. then finally, give a copy of
your gran the to your sponsored project's organization and they can upload it and submit it. that's the official submission to nih is when they basically upload it to the assist site. if you use grants.gov to apply, the problem is that you submit your grant application or your
sponsored project office, submits the grant through grants.gov, it stops at the fist error and kick kicks it back toyou. so it's one error at a time. submit, get an error, come back, fix t. and it's a step wide process that takes a long time. if you're like most people, and
you're waiting until maybe not the last minute. but the last couple of hours before the reap date, you'll never hit it. you'll never make the submission. so i would suggest you use assist, you use errors all at once so you can fix them
all and be done with it. all the applications coming into nih must be in response to an open funding opportunity announcement or f.o.a. they're listed in the nih guide to funding. you can get on a list serve for that or go to the website.
the website is actually the first part in nih speak, these are funding opportunity if you wants that are out there all the time. it's for a general type of application, specifically, the ro1 is an example of that that seems to be the gold standard at nih is to use the ro
ro1 mechanism it's not graham-specific. it does give the nih to make sure it's within the mission scope of nih. but other than telling you how to submit the application, that's all it does. so whatever idea you have on a
research project, you can use an ro1 and submit it there's really no other criteria there are also things there are science or mission specific opportunities on various topics and these show up for a specific period of they're not out there all the they're only out there for as
long as the institute deems it's necessary to reach their goal. whatever that is. here the link for the nih guides and contracts that you can use. when you find a founding opportunity if you want that you would be side in playing to, right up front is a list of
dates there are a number of 58 date that is go down, but they will tell you when it goes to the council for the secondary review, and when funding could start, if you were awarded the application. the person thing about this, when you find a funding opportunity announcement
that you are interested in, familiarize yourself with the dates in there and there will be a button within the fuming opportunity announcement to download a application. those application packages are specific to that funding opportunity announcement.
if you, at a previous time, submitted an ro1 to the investigator-initiated application and didn't get funded, but you'd like to use that idea towards a specific from a specific i.c. they'll just take your application that you put together for the ro1 and
submit it in response to that f.o.a. that won't work. you have to download a fresh application from the particular funding opportunity if you want that you're playing to, over even if you're resubmitting back to the original funding opportunity announcement, let's
say you done get funded the first time, so now, you amended it, and now, you're putting it in what we call an a1, download the application package again, freshly because nihad, has requirements from time to time. usually, about three times a year that come on.
m.b. or h.h.s. of mandatory form changes that have to occur. if you submit your grant application on an old form, sometimes they won't take it they'll just return it to you, without being reviewed so it's just a waste of time. funding opportunity if you wants
that are commonly used by applicants to apply for nih grant funding. again, no science involve. it's the type of grant for research support. this p.a. announcement number. this is what they look like: a. means it's going to be out there
for three years. so usually, the first set of letter citizen first fiscal year that it was published. so this will be out there from fiscal year 16 through 18 or 19. and had multiple receipt dates within that funding opportunity announcement.
there's the r.o.1, which doesn't have any kind much budget limitation to it. f.i.h. does have a general, what we call the 500k rule. so if you're submitting an application you are requesting in any one year, direct coaches of 5 homicide thousand or over,
you have to request permission to submit the application before you put your application in. if it's under 500,000, you tonight need prior permission. we have small research grants that have limitations. there's the exploratory, usually restricted in time and money.
so it's usually a two-year maybe three and there's restricted funds or limited funds. not restricted but limited funds there's the academic research enhancement award. the r15's, usually put in by institutions.
and then there's the small business research grants, and the small business technology transfer research grants, which had their own set of rules. and this p.a. actually comes out yearly because congress specifies to nih how much money needs to go to the small
business area. so sometimes they dictate the characteristics of that, the types of, the level of money that's committed and things like that. so usually, these pa's come out on an annual basis. aside from the ro1, which all
the institutes and centers participate in, these other types of research mechanisms, not all institutes and centers participate. there's a list right up front. this is the first thing you see when you open up the funding make sure the ic you temon apply
to, participates in that fuming here are some characteristics of you can read those. the other piece, the other types of that are in the nih guide are requests for applications are what people usually call r.f.a.'s. what an institute or center
does, is write a specific, unique funding opportunity announcement to support an area of research, that they either want to stimulator some other type of activity. like if they want to stimulate collaboration between two scientific fields that they feel
is important for their mission. they'll put out a funding address that and stimulate research, specifically in that area. the importance about these funding opportunity announcements, aside from foughtin-- asidefrom noting, thearea of
opportunity announcement is usually very specific. you have to make sure your research would fit within that research specificity that would address that area of research. there is usually a set-aside from the budget, from the i.c. to fund a certain number of
applications that come in to that funding opportunity so here, they're saying that there are funds earmarked to support those research areas, which you don't get in a program program announcement, there's no project promise of money behind it at all.
with these r.f.a.|1's 0 there's usually one receipt date and most of the time, the institutes and centers don't reissue them. it is time sensitive. there is usually special eligibility or review criteria. if there's a particular area the area wants to fund # maybe there
are special characteristics. those are the kinds of things, specified within the f.o.a. it should be clear and in the review criteria, they will ask the reviewers to address whether those aspects were covered within the application and if so, how well make sure you
respond to those criteria. and there are usual instructionses, in that fuming opportunity. these things are fairly lopping, and the larger scope of the research that's requested, usually, the longer the document.
so read it carefully. there's also, at the very end, it's the most important piece. there's also a hot link to it, part way down in the top of the application there are point of contacts for things. there's the scientific point of contact, if you have a question
about the kind of science or whether your science would be eligible, considered eligible for the funding opportunity if you have any questions at all. call that contact. there's also an e-mail address you can e-mail them.
and people are very responsive to the questions. there's a review k-g. if you have a question about your application, and you veteran the gone on to ecomments to see who your particular s.r.o. is, you can always call that contact from the funding
and they are specific to that there's also the budgetary contact. so there will be grants management official that's also legalsed on there, as a point of please use those if you have any questions at all. the standard format or
application tanih uses is called the sf4-24 research and related those are the packets you're going to download. the way you fill it out, usually, it'll just ask for pdf. you can type up your application in any word process, anything you want to use and convert it
to a pdf and it's these separate files that are uploaded that that are then put together to make the application. and this link at the bottom is very helpful. nih has just redone their internet, and actually, it's quite nice.
it's a lot easier to use than it used to be. and they have a section called "how to apply" and there's an application guide. you can go right to the area that you have questions on. as with all things, too try to be simpler, you think would be
simpler to apply electronically, than it would be with paper but the instructionses for how to apply electronically, actually, quadrupled the length of instructionses than a paper application. so there's lots more to read, when playing, unform -- when playing.
there's also another thing i'll appointment out about the receipt date. the receipt date, it will say, it might say april 5, 2016, 5:00p.m. so you have to have your application completely uploaded by 5:00 p.m. on april 5, if that's the receipt date.
now, what's 5:00 p.m. 5:00 p.m. eastern time, central time, halfway across the word. it's your local time, wherever you are. so if you are in california, we're not writing it on eastern standard time. it's 5:00 p.m. in california.
as i said, you as the principal investigator would prepare the application, and then you hammed it over to your authorized official that actually submits the application electronically to nih. i already told you about the error correction and that kind
of thing. an application will go through with warnings. it won't with an error and there's nothing nih can do if the application was caught up in grants.gov, which is not nih, with errors. if it's with warnings and it
comes across to us, then even if it doesn't look good or there was a warning, we'll still get the application we do offer multiple the multiple principle investigator options. if you're doing team science or paired science, and both of you would like to get credit being
the principal investigator of the application, you can come in as multiple investigators. so nih at least, looks at it, as an equivalent, eqivalencey between the p.i.'s if you use the moltedel pioption then you to need to submit which one will be the contact pe.
nih will only correspond with a single individual to make it simple. a and then you have to submit a leadership plan. and there's an explanation of what all is required for the leadership plan, but basically, it's who's going to be
responsible for which piece of the administration of the grant, and what happens if something happens to one of you how is it going to be transitioned. the multi p.i. option is not available for all mechanisms it's not available for k or mentored awards.
and it's not applicable to fellowship applications because those types of grant mechanisms are given to an individual so it doesn't make sense to have multi p.i.'s when you give it to an individual. the whole thing is to develop that individual as a research
scientist. and you can have mulley p.i.'s from different institutions. so what happens in the study section meeting? so the s.r.o. scientific review officer is the designated federal official for the review meeting.
they aresome for recruiting the reviewers, identifying what expertise is needed to adequately review the application. they provide the orientation and make sure that there are no conflicts of interest that are present in the meeting when your
application is discussed. and there are also responsible for explaining confidentiality of the process. , to the reviewers and they are there to make sure that the reviewers give your application a fair and unbias review of the science, within your
the study section, there are two types. there's a standing study section, thats one that is usually made out to 15 to 25 members. each of which have agreed to a 4-year term. they meet three times a year to
review grants and they are more senior investigator for broad related fields. the scientific review has the most standing study sections of all the i.c.'s across nih and they list on their website, all of the standing committees, the science that's covered or reviewed,
within those committees, and also, acorn the roster of those study sections so that you can see who's on there, and what types of science are reviewed. so tawe maintain continuity from review term to review term on these because if you put your application in, it gets reviewed
reviewed, if you amend it, and you put it back in, it would be nice if you had some of the same reviewers, reviewing it. so they could see that you responded to their comments and that they're not coming out with yet, more reasons and more changes to your application.
so we costrive for continuity. the way we do that is that every year, 1/4 of the committee rotates off so that three quarter it is of it is still the same. there are ad hoc reviewers, that are brought in to cover special areas of expertise, too review
during those times they tonight have a standing to cover. there are usually 60 to a hundred applications. they are usually uncomplicated applications like an ro1. an ro1. you usually have three to 4 specific aims and it's a
straightforward list of specific experiments or trials. the s.r.o. will assign at least three reviewers per application. if it's a complicated application, maybe team science application, that's very complicated. they may assign more reviewers
to where they feel that the areas of expertise are covered and adequately addressed. the reviewers will get the applications at least a month, if not more, before the review meeting so they have plenty of time to read the applications, consider them and write their
critiques. and they then, might prior to the meeting, their preliminary critiques and scores. they will review each of the review criteria and usually, these meetings last 1-2 days. they will put a list of applications, that are a bottom
third of those list of applications and basically, put that for a vote for the committee they have received a far enough score that it's not worth discussing the application and scoring it you still get a summary statement, you still get the critiques and can respond
on t but you won't get anomer cal score. instead of a third, they're using 50%. so the bottom 50% don't get discussed. if they are going to be discussed, if anyone is found to be in conflict with the
application, they're asked to leave the room. they don't get a copy of the they don't review it. they don't discuss it. they're out of the room for the assigned reviewers will give their preliminary scorers to the group.
each of reviewers, you'll start with a primary reviewer. they'll give the they'll list the strengths, and weaknesses, too support their preliminary score that they voiced. they'll about to the secondary reviewer and third. and it'll be opened up for
discussion. the entire group, the 30 or so people that are there, will discuss the application when they're finished having all their questions answered and discussing the strengths and weaknesses can they're asked to voice their time score
recommendation, and the full panel votes their scores. each individual e, it's not a consensus scoring they move tote discussion of humajor subjects to make sure they were protected adequately and if there are any questions or concerns there and also, the general minority and
children proportions are and any animal welfare issues. the panel members then vote and then after that, after they score the application, the budget is discussed. so basically, the s.r.o. says are there any court reporterscourt -- are there any concerns about the budget.
the importance of this is the application has already been scored. the scores are locked in whether it's expensive or not, or cheap or not, ask not influence the score at all. these are budget recommendations made, in relation to what's proposed in
the application. so it's just fyifor the institute or center that's going to be funding it. specialty can also add to that is but there are always at least 5. the first one is significance. basically, these are the
questions that the reviewers are asked to address in their critique and asked whether the application addressed these enough and specifically. so does it address an important problem or critical barrier to progress in the field? what is in italics, is new this
year this is to address the rigor and transparency issues that nih has been addressing. this question, is there strong scientific premise for the project. so within the application, you need to address what's been done previous to your work and
critically evaluate what that is. you only get 12 pages for the application, so obviously, you don't want to take five pages doing that, but you can do it in a page. the proposed investigators, well-suited to the project, if
they are early stage or new investigators, they are asked specifically to address whether that individual has appropriate experience and training. so you now, it's not previously funded grants. it's whether you have the appropriate experience, based on
your biosketch submission, and the training. if you're an established investigator, they'll ask whether they have, what the record of accomplishment is, in addition to the training. if there's multiple p.i.'s, then like i said, they'll also
evaluate the appropriateness of the leadership plan. just about all these questions are applicable to any type obviously, some more than others. so if there are some if some of the investigative more clinically oriented, that would
inn be responsive to a basic science, the reviewers aren't to see if every question is answered for the most appropriate one for what the is approach. this one is your research strategy, the new piece is in italics here.
so in addition to your research strategy and your strategic plan egos and bench marks you'd like to put in your proposed research, now have you to address whether the investigators -- am biological variables, such as sex in vertebrae animals and human
subjects. so it's no longer okay anymore, in nih grants application to i say, you're only going to use miles in a mouse string or something like that because hormones would impact your study. you're really going to have to justify why you're only looking
at it in one sex. so really, both sexes need to be addressed somehow within your study design. unless, of course, it's a disease that only occurs in say, a gonad of one sex versus another and it's just not feasible or applicable in the
other. and the last one is environment. this is your institutional environment, support and equipment as well as your own local environment in your research area. the scoring system that nih uses uses, changed a number of years
ago. it's a 1-9. it's like a golf score. the lower the score, the better it is for you. one means exceptional. 9 is poor. each of the assigned reviewers will give each of these five review criteria, a preliminary
score before they come to the meeting what's scored at the meet -- meeting is the overall impact scores. these are the possible scores that are voted. they voted interinjuries from 1-9 and the other designations that are on their score sheet is
an abstention if they choose not to vote. if they're out of the room, they just mark it c.f. because they were in conflict so they didn't hear it the study section can choose to defer an application for review at a later meeting. so if, for instance, they have
your grant application, but there's a burning question that they need answered that juan in the application, they can choose to defer it, until they at the time that answer and then they'll increase it at the next study session. it's a delay on average, for
four months of the for the applicant. that's usually not an option. up with they do have that option. indeed means not discussioned so if you're in the lower half of the application pool of that study section.
instead of anomer cal score on your summary statement, you'll get an n.d. n.p. means not present. or they can vote n.r. that means the study section has voted, that this application should not be recommended for further consideration. the institute
should not fund it under any circumstance. is, that's being uselessd to judge your grant. and an institute or center isn't allowed to charge the rules, once the applications are in, but before they're reviewed. so what's in the funding tune
announcement is what's going to happen. any human subject issues thatthat that aren't addresses or aren't ethical are allowed to impact the overall score. any plans for inclusion for women, minority and children in the research, vertebrate animal
protects if there are special i think thises that the institute or center is looking for, and they're missing that's allowed to impact the score. if you have a previous review, how you respond to previous comments is considered in the score.
usually, applications due better than new because they had the benefit of going through, and being critiqued. so usually, the scorers do better. you've had a grant for four years, and now, you're putting in a renewal application,
requesting confidential years or know continuing your research if an area those, instead of addressing changes to previous critiques, you have a page to basically discuss the project you had made in the previous grant during your current funding period.
also, if there are any biohazard issues. that should be addressed. the considereds don't affect the overall impact score. it's basically there as an f.y.i. to the program staff to make sure they address t maybe in an a negotiation period
before the award is made. to make sure all these things are adequately addressed but they're not going to affect the overall score of your application. so if there's any questions to the budget -- if there's any questions to the budget, they might talk to you
about the budget, prior to making an award and. you to adjust certain things. any resource sharing plans that maybe weren't in the remember grant application or maybe it was inn up to what the quality wasn't up to where theism c. would like to see it.
they might ask you to submit another resource sharing plan. if it's a foreign institution, nih requires that the reviewer specifically address the question of whether that grant or at least the piece that's being performed at a foreign institution, is available within
the united states. if it isn't. they need to comment on that specifically. and these grants, not the one with foreign components, but the ones that actually have institutions from foreign countries, playing to nih each
of these grants have to be brought up individually to couple and they have to listen to those reasons, why the foreign institution was needed to cover that area of science and then individually make a decision on whether it should be funded or not. so the applicant
needs to make a case for using a foreign institution. we fund foreign institutions all the there are many things you can study in foreign countries that you can't study here maybe pause the disease but the case needs to be made within the research plan, within the application,
why you're using that foreign institution. are you dealing with harmful alenenes, and how you're going to contain them. whether it's allowable under nih guidelines to use them the new piece for rigor and strands parentsy, there's another
section. so have you to, if you're using a cell line, you have to have something built into your research, too, it could be as easy, something as simple as a positive or negative control sewing that your cell line really does lack the gene you
think it looks. they can score it, defer it, not discuss your application or say we don't want to see it again. impact priority score. when i think thises are reviewed reviewed, the score, the actual impact number in parentheses next to it is what is called a
percentile. so the percentile is nih's way of trying to standardize the scores across various study sections. there might be 85 to 90 standing study sections if any one funding period that are reviewing applications.
obviously, one group of 15-25 people aren't going to have the same exact standardizing range for their scoring tan another one would. so to try to come up with a consistent way of measuring scientific merit across study sections so that one particular area of science
is not hurt by a scoring practice in one study section, nih uses a percentile. so basically, the top-10% of grants might get funded by a specific institute. so one study section might be a 15 in a score, whereas another 10% level, and another study
section might be a 17. if they were harder scorers by and large. but what the actual institutes use is the percentile mark. this goes through how they calculate percentiles, if that's of interest to you. the summary statement, like i
said, is the actual report that you will receive from the proceedings from the review group. prepared by the s.r.o. there are pieces of the summary statement that were written primary before the review. that is the raw critiques of the
reviewers that will be given. it just says reviewer 1, reviewer 2, 3. but those will be raw critiques. there's a summary of overalls discussion, repaired by the sroand this is a couple paragraphs, third to a half a page.
that is actually what happened, the primary points that we're discussed, at the review meeting and that paragraph, that summary of discussion is what supports the score so you may see a disparity sometimes between what a single reviewer said, and what was discussed in the -- in the
the difference is, the actual critiques listed under each reviewer, were actually written prior to coming to the meeting so that was them in a vacuum, looking at the grant but when they came, then they discussed it with their colleagues, around the table,
and may have come up with a different result. if they're not discussed, you wait a moment have the summary critiques but not the discussion. used by program staff to make funding decisions, also to flag any weaknesses or voids that they need to take
care of, before funding an award. you might see notes in there from an s.r.o. saying hey, your application was a little longer, you know, you put this in the wrong place. there might be also administrative notes to the
program officer this piece was missing from the application, you're going to have to get it before you fund it. in all of these things, your score, percentile, and summary statement, you get directly from your era commons act. you can discuss the prospect
fortunate award or need to revise the application with the program officer. they try very hard to listens into the meeting so that they might have some additional insight as to what was discussed at the meeting, if you have questions from the summary that
comes out. so what determines which applications are awarded? depends on how much money the institute has. not every center is given the same budget. they have got a lot of to pay for in different areas so it
depends how important that area of research is to that area or center an rfa they set money aside for t that's stated in the you can see how much they set aside. if at an't put out a f.o.a. but have a good amount of money. most program officer will be
able to give you an idea of what the pay line was. whether they pay 8%. 10%. 12% of their grants that come in. most institutes have a liberal pay line for new and early stage investigators so take advantage
of that. there are programmatic contributions for awarding there also might be geographic considerations, that the institute is trying to do. we are a government agency. congress does make inquiries, so we try to spread out grants
across the country, not put all our eggs in one basket. so it doesn't all end up on the east coast or west coast. we try to fund grants in between as well. there may be reasons why they would. different geographic sites represented.
so particularly, if you're in an area of the country that doesn't see much research, you could use that to your advantage when playing for grants. the availability of funds, like i said, about 81-82% of the an institute or center's budget goes back out in the form of
research grants. but knowledge abouts are given out in one-year increams to us from congress. obviously, we have got grant awards in what we call the out years. two, three, four, and 5. so we have got to pay those
first. the ones that we pay the year before or two years before. we have got to pay those first and what's left is what we can spend in new grants coming in. so it depends on how many grants the institute already has funded. in previous years.
your program officer is the best point of contact to get some idea if you want to. there is a shortened next cycle option for r.o.1's. not all grant types but r.o.1's near new and early-stage investigators for resubmission, ro1 application, it allows about
a month to revise and resubmit for the very next meeting, study section meeting if you come in and you're established investigator and come in on a normal schedule. usually, that ends up, and you submit when you can you usually end up skipping a cycle.
>> it won't be a waste of time f the problems you got back on the summary statement are easily addressable. if they're not easily addressable, then it's worth your time to take more time to fix those, take the time that you need to address those
problems if it's apeasily addressable problem. and you can make the changes and put it back in again, then go for it. and it's up to you to decide if the weak weaknesses in the summary statement are a quick fix or not.
youals a scientist will know. and there's a website on here that defines what new and early stage investigators are. and this is just a frustration of how it saves you time. so one of the standard receipt dates for new applications is june 5 of 2016.
that ends up going to a january council. so that would be january of 2017. you would filed out whether it was payable or not. the standard meetings for the june receipt date, the study section meetings are occurring
between september and november of the same year. with the new and early stage investigator addition, they'll actually release your summary statement by november 10. your promise summary statement pie november 10. so the srowill coyours first,
out that have 60-100 grants and then you are free to submit on the you were the rim, receipt date for new and early stage investigators of december 10. and that will go to june so you've anyone from january to june. that's the very next for someone that's not an early
stage investigator, they one get their summary statement until probably late december, early january. and it'll go to january council and the receipt for them is actually here in march. so they have missed this whole period of so they were inn able to make
the june council. you don't want to shoot yourself in the foot after making the amendments. like i said, contact the program officer and ask them. they would be able to give you some good council on that. it's just important ton that nih
has tried to make sure that the sections in the application that we ask you to address are in alignment with the review criteria, so that it's easy for you to line up, what little you're writing in the application, with how you're going to be evaluated.
so that you can increase the appointment that is the reviewers are anything to be told to consequence straight o. you want to bright your application as critically as you can. be concise as you can. because the page limits are
important. if you have a 12 page limits if other research strategy, and you come in with a 14 pages don't repeat the same information in different sections. you might briefly want to, you know, repeat one little thing, if it's important.
but try not to waste space repeating things. you want to emphasize rational, strategies before you move to the next. and most of the time, the r.o.1 type format, is used for many of the other multi project applications, like program
project grants, which are ro1's, with the same number of cores that might serve all of the ro1 type projects. real quick. the introduction to the resubmission. if you gotten critiques back, and you're addressing them. have you a page to explain what
it is you changed in the grant. you shouldn't go point by point, unless you only had a few things because in one page, if you have 20 things to address, you're not going to be able to explain all 20 in one page. so you can address multiple ones in the same paragraph or
something like that. one page for the research trait ego, you get 12 pages for an ro1 type application. that's probably 80% of the types of applications you're going to see are going to be 12 pages. for the really short ones, it's six pages, and really
complicated ones, there's a 30 page version. but that's not very often. there's a new biosketch format. you have to write a personal statement that states your experience and qualifications for the role, and this is application-specific.
so this is not something that you can use from application to application if you're changing research areas or you're changing experiments proposed. or a, say particular rfa. you want to write the permanent statement for each particular application you're putting in.
obviously, for an application, you can use -- for an amended application, you can use the same one. then it asks you to briefly describe up to five of your most signature contributions. so while you can scribe up to 5, if you're a graduate student or
post dock, you're encouraged to consider, highlighting maybe two or three that are the most significant and really concentrate on those. you have to describe the resources. it's here, i'm not going to go through that. there are other application
components that you don't, you're going to have to worry about that they are inn the hard. believe, the human subjects there are bulletin points to address. there's no page limits on that but don't stick things that are
science related research strategy related into the human subjects section. that won't go. your applying will be returned as i think they call it stuffing the application because you use the 12 pages to describe the research strategy, and you put
four more pages on the human there's budget components and forms. nih actually has improved the budget pages and forms now. they look a lot better than they did before. so it's actually easier to fill out. when you fill in the
direct cost. it's usually the office that takes care of the indirect costs and that kind of thing. most funding opportunity announcements have a dollar restriction if these rfas. they usually, read that very carefully, it's in a table.
please pay attention to pay attention to whether they're talking about direct costs or total costs. some people word it as total costs. have you to back out the cost of doing business, the f&a reattains each institution will
put on there so you know how much money you can spend. other rfas are listed in direct cost, whichen moose you actually had that much money to spend. no page limit to address the animal welfare. the appendix. keep an eye on this.
right now, you can put things if should you need to use it. there are rules and limitations for what you can use the appendix for. that's all in the application instruction the grant application itself, everything inside it, is required reading for them.
so if there are five additional pieces of documents that you were asked to submit as part of the application package, they will have to read all of that material. if you stick something that you feel is important in the append, i guess.
that's 200 pages long, they're not required to read it. they may referendum to it, if they choose, but it's not required reading. the appendix is not required part of the official grant. nih is now looking whether we need to look at the appendix at
so keep an eye on that, and follow the strucks i gave you this url to what's called the kiosk to help you on which kind of career development award you might be interested in or might be best for you. these are what they are, although each of the institutes,
use some of these designations a little bit differently. so make sure when you pick up a announcement, let's say for a k.o.2, the independent science award, that one, the institute or center that you want to apply to, because your science is funded by them, or your science
fits within their mission, make sure that they participate in that particular type of k. there's a newer one here, it's been around for a while. but there's a transition award, the k99 interior. the path -- k99000. there's strict eligibility
criteria for this type of grant. for young scientists. this is a good mechanism to use because it starts out in more of a momentorred type of award for twoer yees, and then transitions if you're ready, after year one, if not, after year 2, into an rr00 award, which is equivalent
of an ro1. so full time, unmennorred research. so this is a great grant mechanism for new investigators. the format of career development awards are different. you have permitter. so have you to get the
candidates background and the momentor and how the mentoring is going to happen. it's all if the funding opportunity upon announcement instructionses so please, read those carefully, the review criteria are morphed a little bit for individual career
development awards, obviously, innovation isn't something that you would necessarily apply to an individual so the candidate is a scored review criteria. there are still five. just like there are in the research gran the awards. but now, you have candidate,
career development plan, the research plan is the actual proposed research being done. the mentor and the environment. the questions are spelled out within the funding opportunity there's the nih loan repayment program, a special opportunity for clinical researchers.
i list the website down here. so you can see if you'd be interested in playing and qualify for it. there are five programs. 4 are designed to attract health professionals into the research there's a clinical, pediatric, health disparities and
contraception and fertility. four different programs. the fifth one is a program for researchers from disadvantaged backgrounds and all the eligibility criteria and qualifications are spelled out at that website. this actually looks a little bit
different. and if you're funded, will repay up to educational debt up to [indiscernible] and the money doesn't come to you, it actually goes directly to thent entity that holds the loan for your student loans and you can replay there are limits to how much you
owe, before you can apply. you can't the get it down to $20 or something and apply again. there are goes programs and my institute, as well as two others, fund a lot of these you have to understand the psychology, the review process. first of all, the reviewers are
people, just like you and i. tear researchers, just like you and i they're over committed, overworked and tired, as most of us are. they're inherently, skeptical and critical, and consider them informed strangers, so they are scientist. they are familiar
with upon with the types of science that you're proposing. they're not necessarily familiar with you. how you are as a scientist. important to indicate through your application. a happy reviewer is likely to be more positive.
if you're happy, you tend to look at things more positively, than if you're unhappy. so anything that makes their job easier. they are volunteers to be reviewers. we're not paying them. we're basically, reimbursing
them for time while they're here.
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