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Topic: NIH/NIDA Grant Funding Strategies and Insights

Continued interview from TIP column: Yes You Can: I-Os and Funded Research 
(Vol. 50/No. 3 January 2013; www.siop.org/tip)

Editors:
Ashley Walvoord, Ph.D.  (Verizon Wireless)
Liu-Qin Yang, Ph.D. (Portland State University)

Interviewees: Lillian Eby (UGA) and Lori Ducharme (NIDA, NIH)

Topic 1 of 4: PREPARING AN R-SERIES APPLICATION

Lori and Lillian, in the TIP article you touched on the composition of a research team for a grant proposal.  Can you talk a little about how NIH reviewers perceive the pairing of a seasoned PI with a “green” co-PI?
            Lori (NIDA/NIH) – Let me first note that the terms “green” or “new” or “junior” investigators don’t have any age implications, it simply refers to less experience with obtaining federal funding.  I strongly encourage new investigators to partner with another investigator who has a track record for doing good research, especially if you are pursuing a larger grant.  In fact, NIH has mechanisms to support this, such as multiple PI designation.  This option allows each PI to get the credit they desire for their university or department, and it provides assurance to the reviewers that the PI has the back up support to get the research done effectively.  I want to emphasize that biosketches in the application are incredibly important.  If you are coming from a field that is not traditionally part of the NIH enterprise, it is very important to have someone or several someones on your research team who show a strong health research track record.
            Lillian (UGA) – Another option is to have one PI and a team of co-investigators.  A junior member of the team can be well represented as a co-investigator. In that scenario, the PI is the communication lead, and you can assemble a team of co-investigators whose backgrounds will demonstrate that the project is feasible, that there are connections for collecting the data, and that the team is knowledgeable about the context in which they will be working (e.g., for NIDA, if you have never set foot in a drug treatment center, they need to know that you understand the environment and what you’re getting into).  Assembling a team is not something I consider difficult, you just need to be thinking strategically as you put your application together.  For example, even if you go in as an I-O with a strong publication record, you had better have a methodologist who publishes regularly in methodology journals because the reviewer panels always include a methods person (and this is a hot topic during review sessions).

Once you have a research team assembled and your research topic developed, it’s time to tackle the budget.  What was your first experience like in putting together a budget for a federal grant proposal?  Has your approach changed over time?
            Lillian (UGA) - I found a co-investigator with a lot of grant budget experience and handed the whole thing over to her. It is impossible to do yourself, particularly the first time out. I still take this approach. I have never crafted my own budget. I know it sounds weird, but it is so important and without experience, it is impossible to do well yourself. Plus there are tons of rules and regulations and I have no time (or motivation) to learn them! Having good grant support at your university is therefore essential also. There would be no time to write the science if I did the budgets too.

Topic 2 of 4: THE NIH SUBMISSION PROCESS

Lori, you have the NIH big picture perspective, can you put the NIH submission process in context for us?
            Lori (NIDA/NIH) - First, remember that NIH is made up of 27 Institutes and Centers, each of which focuses on a specific substantive area (often, a disease or health condition).  Identify the Institute that you think is best suited to your research idea, and then check their website for their current Funding Opportunity Announcements (FOA).  Find the FOA that best fits your topic.  In it, you will find the name of a scientific or program contact.  That’s usually a Program Official – generally a Ph.D. or M.D. who manages a portfolio of grants in a particular scientific area.  Call or email that person to talk about your topic.  If it sounds like a good fit, then it’s time to get started.  (I can’t emphasize enough the importance of this step.)

After that, NIH has a well-established process for submitting an application – you’ll find links to the application forms and the instructions in the body of the Funding Opportunity Announcement to which you will be responding.

If you have never submitted a grant application before, then at minimum you need to first get to know the people in your university or organization’s Sponsored Research and/or grants management office.  Every institution has different procedures for applying for NIH grants, and you need to approach them as allies and partners in this process.  There are also some technical details you need to deal with, such as getting an eRA Commons account, which only your Sponsored Research office can do for you. This can take months of lead time, so it’s essential that you are all working as a team on this.  I’d also strongly recommend finding another researcher who has successfully applied for NIH grants, and recruit them as a mentor in the application process.

            Lillian, as you have become more familiar with the funding game, have you realized any process efficiencies in the federal grant mechanisms (e.g., to eliminate wasted time or avoid bureaucratic rabbit holes)? 
            Lillian (UGA) - I hire excellent grant coordinators and have the luxury of running my grants through an institute at UGA that provides outstanding support for all phases of the process (e.g., budgeting, submitting, accounting).  If you have any resources like that, then outsource that work and spend your time working on the science. If you are in the applied world, or at a teaching university without access to that type of resource, you may want to ensure that you are partnering with a team of folks that do have access to some support. I recommend reaching out to these resources around 4 months ahead of when you expect to submit, and talk to them frequently.   Pulling together all the pieces of a large research grant application can sound scary, but it’s not.  Plan it out – you can ask your department head for a teaching load reduction if you agree to submit for example.  You get one resubmission on a major federal grant application so you want it to be as perfect as possible the first time.  The first time I put together my major grant submission, I spent a semester just on the science.  Lastly, talk to people in your department who have grants!  It doesn’t matter if they are in neuroscience or gerontology – regardless of topic, it will help you understand the process and resources at your institution.  Talk to successfully funded colleagues for tips about the process.
            Lori (NIDA/NIH) -  I will add to Lillian’s answer that your program official can be helpful in thinking through your scientific question, but they can’t help with the mechanics of the submission process through Grants.gov – you need to rely on your Sponsored Projects (or similar) office for that, and the Grants.gov helpdesk. There is nothing more frustrating than developing a great application and failing because you missed the deadline.  Every institution will have their own procedures that have to kick in before you can submit to NIH.  They may require you to be finished a week before the NIH deadline, or it could be a month, so go find out what your requirements are!

Is there anything that a submitter can do to facilitate a smooth submission (e.g, avoid error messages in the submission process or missing documents in the submission package)?
            Lori (NIDA/NIH) - Download the instructions, read them, and follow them.  I know this sounds simple, but I can’t tell you how often someone stumbles at the finish line because they failed to follow instructions.  Also:  submit early (You’ll see the due dates posted in the Funding Opportunity Announcement).  The system allows you to submit your application up to 30 days before the deadline.  Do not wait until 5:00pm on the due date to hit the “Upload” button. Having been a grantee myself for a number of years, I can’t imagine starting to pull everything together less than 3 months before the due date.  Six is better.  And don’t underestimate how much time this will consume.  The grants.gov system includes a number of error checks for things like page limits and required elements, and will generate warnings if anything appears out of compliance.  Allow time for the system to generate an error message, and for you to respond to it.  Some universities impose an earlier deadline on their applicants to build-in a time cushion for fixing errors.  Based on my personal experience, I would advise allowing yourself a 2-business-day cushion.  However, keep in mind that your institution may have additional cushion requirements (e.g., 2 weeks or 30 days prior to deadline).

Topic 3 of 4: THE REVIEW PROCESS

In the TIP article we touched briefly on NIH reviewers.  Let’s talk more about the NIH review of grant proposals, starting with the basics and moving into the behind the scenes scoop!

How long is the NIDA/NIH review cycle?
            Lori (NIDA/NIH)  - The application workflow at NIH goes in 3 cycles, and the key months are in February, June, and October.  If you submit your application for a February deadline, it will be reviewed in June; submit to a June deadline, it will be reviewed in October; etc.  There are exceptions, of course, but that’s a handy rule of thumb.

How does one check for the status of a grant proposal that is under review?
Lori (NIDA/NIH) - You can monitor the application’s progress electronically, although to an applicant it may appear that there are long stretches of time in which “nothing happens.”  You just have to trust that the process is working – it is.  All applications are submitted to us via Grants.gov – that interface will let you see that your application was received on time.  In addition, all Principal Investigators (the individual leading the application) must be registered in eRA Commons – this is NIH’s grants management system.  In your “Commons account” you will be able to see status updates on your application – including the Institute, program official, and review committee to which it was assigned, the date the review committee will meet, and the Scientific Review Officer (an NIH staff person) who is running the review meeting.

Can you provide some insight on the review process decisions and outcomes?
            Lori (NIDA/NIH) - There are two outcomes of the review process –  your application gets a priority score, and it gets a set of written reviews.  All applications are reviewed by a peer review committee, but only the top (best) half of them are discussed aloud in a formal review meeting.  So, half of all applications will receive a “score”  of “not discussed.”  This means it fell in the bottom half of all applications seen by that committee.  Your program official has no way of telling you where you fell within the bottom half (e.g., were you just below the line or dead last), and this isn’t something you should spend energy trying to figure out.  Rather, focus on addressing the written critiques in your revision.

If your application did receive a score, it will be a number between 10 (a perfect score) and 90 (the worst possible score).  The lower (closer to 10) your score, the greater likelihood you have of funding, but nothing is assured, and the vast majority of applications are resubmitted for a second review.  Because many factors go into funding an application, your program official often cannot tell you, based on score alone, whether or when your application will be funded.  But they can advise you on whether it’s strategically wise to go ahead and prepare a revision.

A few weeks after your application is reviewed, you will receive a written summary of the reviewer critiques.  Conceptually, this is not unlike written reviews of a manuscript submitted to a journal.  Once this “Summary Statement” has been released (you can access it in your eRA Commons account), you should contact your program official to review the critiques and decide on your next steps.

It’s important to remember that although you will communicate most with your program official, and while they may express great enthusiasm for your application, the ultimate funding decision is out of their hands.  Funding depends on a combination of your score, programmatic priorities of the institute, the total volume of applications received, and the available budget.  This means these decisions are rarely straightforward.  Your program official will do his or her best to help you read the tea leaves, but they can’t make promises, and sometimes they honestly just don’t know what your chances are.  (It works the opposite way too – sometimes an application we thought was dead in the water suddenly gets funded because all the planets aligned.)

All proposals receive feedback from reviewers; how do you make decisions about adjusting your proposal?
            Lillian (UGA) – I can tell you from the reviewer’s perspective, when we receive a second submission of a proposal, we judge it based on its merit as it currently stands.  We don’t take into account the previous score (often the second submission doesn’t go to the same reviewer).  However, we do take note on whether the previous review comments were addressed in the second submission.  As an applicant, you should look at the reviewer’s comments and determine if you can address the concerns without a doubt.  If you can’t, you should consider changing the focus so that the population or setting or specific topic is different and potentially submit it as a new submission (but it has to be fundamentally different to do this; different aims etc.).  If you can’t address every single reviewer comment, then it is not likely that you will be successful in receiving funding.  Sometimes it helps to gather preliminary data to respond to a reviewer (e.g., do some focus groups and report back “yes, patients will fill out a survey for $25, and I have added a co-investigator who does this methodology; she has an 80% response rate track record and here are the publications to show that she has done it”).  Finally, if you look at the reviewer’s comments and they aren’t that bad but your score was low, it may be a matter of significance; perhaps your project isn’t enough to move the field forward.  If that is the case, I would stop and not pursue the project further, at least not with that agency.
            Lori (NIDA/NIH) – I would simply reiterate one of Lillian’s points – you want to be sure to respond to every comment from the reviewers.  As you respond, be careful not to argue any points in a non-productive manner.  A healthy approach to consider if you find yourself disagreeing with a comment is to take a step back and think “perhaps I didn’t explain this clearly, maybe it’s me”.  Reviewers are receptive to you explaining yourself.
            Lillian (UGA) – Great point Lori – also, in your original application you can always try to anticipate criticisms and provide the explanation up front (e.g., “I had two options for my design, I realize the method selected has limitations, but this benefit outweighs that drawback”, or “there are 3 ways to operationalize turnover, I chose this one, it’s not perfect, but here’s why it is the most appropriate”). Be knowledgeable about what your design limitations are and explain why it’s the right choice over alternatives.  In my experience reviewers for these grants are very reasonable, these people are influencing the direction of science; they are reviewing grants because they care about the field, not because they have a chip on their shoulder. 

What is the maximum # of revisions allowed?
Lori (NIDA/NIH) - You get a total of 2 attempts at a grant application on the same topic – your initial application, and one revision.  If your revised application is not funded, it’s back to the drawing board.  NIH has pretty stringent rules designed to discourage investigators from tweaking and recycling the same idea multiple times.  Talk with your program official about your options.

Topic 4 of 4: MANAGING A FUNDED PROJECT

If your proposal is awarded funding how soon would the funding be transferred to the PI's organization?
            Lori (NIDA/NIH) - NIH grants are awarded to the PI’s institution, not to the PI. That detail is often missed, but becomes very significant in a circumstance where a PI changes organizations in the middle of a grant.  And to further clarify, the funds are not transferred to the institution’s account – they are essentially (and I’m oversimplifying here) granted a line of credit in the amount specified in their Notice of Grant Award, which is based on the budget submitted in the application. That “line of credit” is established one year at a time, and at the end of each year the PI must demonstrate adequate progress in order to have the next year’s funding approved.

In terms of timing, a grant could be funded generally no less than 4 months after it is reviewed.  There are always exceptions, but the best-scoring applications generally get funded quickest – so, best-case scenario, an application with a terrific score in a high priority scientific area could be funded roughly 8-9 months after it was initially submitted. Because we fund grants during each of 3 annual cycles, it’s possible for us to fund your grant in a subsequent cycle if it didn’t make the initial cut.  It’s not unusual for us to fund a good-scoring application 12 to 18 months after it was originally submitted.  Your program official can provide general (but not specific) information about likelihood and timing of possible funding.

Do you have any tips or suggestions for getting the funded project started on time?
Lori (NIDA/NIH) - Be realistic in the timeline and workload you propose in your application. Don’t underestimate how long it takes to launch a project, both scientifically and administratively. Most projects require human subjects review, and you will have to provide NIH proof of your local IRB approval before we will even issue your award.  Understand how long it will take your Sponsored Research and/or budget office to set up an account for you to utilize the funding before you start trying to put expenses to your grant. Finally, have (or find) a good project manager to help get the grant off the launch pad. 

How often should a PI contact his/her funding agency (e.g., program officer)?
Lori (NIDA/NIH) - Outside of the formal progress report (see below), I generally prefer to hear from PI’s on two occasions – when there have been major successes (publications, important presentations, key findings), and when the PI anticipates potential problems.  I want to hear about successes because I have opportunities to use your findings to inform the direction of my programmatic area, and because I can promote you and your research if I know what you’re up to.  I want to hear about problems BEFORE they spiral out of control.  This is especially the case if there are human subjects or other serious ethical problems, but also in the case of anticipated budget overruns, poor follow-up rates, or staff turnover.  Most program officials don’t like surprises, and there comes a point where we can’t help you if the horse is already too far out of the barn.  We want your project to succeed – that’s why we funded it.  Help us help you.

On a related topic, how often should the PI turn in a progress report?
Lori (NIDA/NIH) - You are required to submit an annual progress report each year – generally this is due 3 months before the end of your grant year.  Your eRA Commons account will provide due dates and links for you and your institution’s authorized signing official to upload the required information.  Keep in mind that this is not just the story of your progress, but it’s an application for your next year’s funding.  Take this report seriously.  Ask your program official whether there are specific items they want you to address in the open narrative sections of this report (this varies within and across NIH Institutes).

To what extent can you alter your initial budget?
Lori (NIDA/NIH) - NIH has specific guidance for all grantee institutions about how funds can be spent and when they can be reallocated.  The short answer is that there is some room for making changes and still be within the rules.  You need to work with your local Sponsored Research and/or budget office on this.  If your budget office has specific questions, they can contact the NIH Grants Management Specialist assigned to your grant. This is someone different than your program official.  (Your PO handles scientific issues; your GMS handles grants management issues including budget.)  You’ll find that person’s name and contact information in your eRA Commons account.  It’s best to have your institution’s authorized signing official or their delegate handle all correspondence with the Grants Management Specialist – again, remember that the grant is awarded to the institution, not to the PI.

What are some tips for delivering what the funding agency needs on time?
Lori (NIDA/NIH) - For the most part, NIH grants are not designed to produce deliverables or specific products; they are designed to answer specific scientific questions.  So unless you have promised a certain deliverable in your application, we’re not sitting by the mailbox awaiting something from you.  You should be focused on the timeline you specified in your grant application, and ensuring that the research you proposed can get done within the time available.  Monitor your subject recruitment rates; you may need to shift resources to accelerate recruitment if you’re falling behind.  This is where a good project manager can be valuable. Mostly, though, we want to see productivity from any grant we fund.  In the scientific community, productivity is usually measured in publications.  When designing your study, think about staging it such that you can generate publications on different components of the project as you progress, rather than leaving all of the analysis and publication for the end.  This is especially important if you plan to come back to us with an application for a subsequent grant.

We thank Lillian and Lori for their contribution to ‘Yes You Can: I-Os and Funded Research.’  For more information about grant funding, check out other issues of this TIP column, and the SIOP grant resources page (www.siop.org/grants.aspx).