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Writing a grant proposal? Do you have a plan for how you will get it written, reviewed, and submitted on time?

A PLAN? Yes, a plan.

What can a plan do for you? A plan will:

• Eliminate your running around with your hair on fire trying to meet the submission deadline.
• Avoid creating emergencies for other people involved in getting your proposal submitted.
• Give you the whole picture of what needs to be done.
• Keep you focused and on track.
• Help you manage your available time.
• Reduce your stress.
• Organize your work so you can engage others in assisting you.
• Endear you to others (e.g. administrative and finance officers, your mentors, your colleagues, your co-investigators) who help you with your submission.

So what’s not to like? What’s that you say? Too much to do and you don’t have time to develop a plan? Don’t know how? Actually, the busier you are, the more you NEED an organized approach (read: plan).

Developing a plan requires a couple of things: 1) a desire to do it, and 2) some basic skills and techniques in project planning. You’re on your own for the desire part, but in my blog next week I will talk about project planning and introduce four basic concepts that will help you pace yourself for your grant submission. This will be followed by a weekly series of more in-depth blogs about each concept and its application to writing a proposal.

Your assignment, should you decide to accept it:

1. Decide on the funding agency, and opportunity, to which you intend to apply
2. Visit their website and get acquainted with their submission process
3. Determine deadlines for submission and decide when you plan to submit

Next Post: Planning to Plan: Gathering Materials

Since the holy trinity important things have come in threes—listen up. You can lose the good will of study section.

1.) Get the details right; misstating the methods or findings of a reference destroys your credibility.

Know every paper you cite. Others who know the science or did it will be in the room.

2.) The slate is not wiped clean by an A0 (first submission) if it’s a re-do.

If similar to a prior unfunded submission(s) every part must be solid platinum. The research must be substantively more compelling – new preliminary data, better approach, and highly responsive to prior critique or you will engender bitterness at having to review the same ideas again. Study sections have memory.

3.) Don’t ask for more time/money than you need.

Funding is a zero-sum game; money you receive won’t go to someone else. Reviewers get cranky when you turn a three-year project into five.

Don’t be the person we remember for prior gaffes. Even if only some members are put off by a concern it can hurt your grant score…and only nearly perfect scores clear the payline.

Getting the approach – the methods section of your grant –  fine-tuned is literally the heart of it all. You must land your science smoothly. Study section members know, and recent evidence confirms, your grant’s score is not an equal weighting of component scores. NIH criterion scores are for significance, innovation, approach, investigators, and environment.

No surprises here, approach has the highest weight. Reviewers care most if the scientific methods in are sound. For studies with human participants from case-cohort studies to clinical trials you must implement this flight checklist:

• Brief overview of the study design/population (repeated as necessary if this changes across aims).
• Summary/figure detailing the timing and sequence of data collection including biological specimens, interview data, exposure measures, and outcomes.
• Succinct summary of inclusion and exclusion criteria for participants (and if needed the larger study from which participants are identified).
• Flow diagram indicating how many individuals were, or are estimated to be, excluded. Provide reasons if you have an extant cohort.
• Clear estimates or exact numbers (better) of how many individuals will be available or recruited for analysis in each aim.
• Operational definitions for: 1) Main exposure/intervention; 2) Primary and secondary outcomes; and 3) Key candidate confounders
• Text introducing measures in a logical order (e.g., order that data is collected or order of relevance to aims).
• Summary of general data quality assessment (e.g., logic checks) and data cleaning steps.*
• Information about how missing or incomplete data will be handled.*
• Details of quality control approach for any measures (labs, surveys, etc.).*
• Description of analytic approach including data preparation, models to be used, and how choices will be made for any analysis of effect modification and confounding for each aim, if applicable.*
• Methods for how you will check for and handle any violations of model assumptions.
• Specific delineation between primary analyses and secondary analyses.
• Power calculations supplemented with a table or figure.
• Summary of potential challenges and solutions if they are encountered.
• Timeline for completion of the work.
• Conclusion/summary of the strength of the approach with a final pitch covering why the science is innovative.

Work the checklist. The glidepath provided by crisp and clear operational details will bring you in. A sound approach is required for a smooth landing.

* These items, in part, speak to the requirement to describe what aspects support rigor and reproducibility.

Periodically I’d like to share a few nuggets of wisdom I’ve learned in my efforts to help guide faculty through the travails of a career in biomedical research. Since I spend a lot of time in winter and spring reviewing grants, that’s where I am going to start. I’m often asked what I believe is most important in preparing a grant. In a nutshell, the answer is this: excite the reviewers. Your number one priority in preparing a grant is to convey the most innovative, novel and pioneering aspects of your work.

I begin my reviews by asking how a proposal moves the field in question forward. Now, one of more nuanced aspects of study sections is that a reviewer may or may not be vested in your specific discipline. Reviewers are chosen for their broad experience as well as their particular expertise. This means that the onus of responsibility for explaining the context of the proposal and why the contents are important rests squarely on your shoulders. You, as grant writer, must explain in simple and concrete terms how the study will advance the field and how that advancement influences an important (i.e., exciting!) question.

I’ve sat on study sections that give lackluster scores to scientifically solid proposals from investigators sitting atop an impressive funding history. What gives in these cases? Sometimes, when ideas or approaches become formulaic or too familiar, they run the risk of becoming, well, boring. Reviewers are people, and people get bored. Even well-seasoned grant writers often are befuddled by the criticism that their proposal was incremental – which is simply code for ho-hum.

From a reviewer’s perspective, the implicit, pervasive question is always “where is this work going?” A good reviewer examines the trajectory of an investigation and tries to imagine the possible ramifications in the broadest (i.e., again, exciting!) possible context. If the ramifications run deep – from a biological, clinical or translational viewpoint – then possible relationships are many. When these relationships are clear, then pathways or connections between disciplines begin to emerge. And when that happens, reviewers get excited. There is a certain energy generated by proposals that attempt to bridge different pools of data in new ways or from a novel perspective. The tricky part is for the investigator, not the reviewer, to connect the dots in the proposal and generate the excitement.

More Resources

Avoiding Barriers Between Your Work and Your Reviewer

Engage Readers Quickly with the Skim Test   

Responding to Manuscript Reviews While Avoiding Cerebral Aneurysms

Reviewers review. We will notice. These fresh mistakes straight from study section:

1.) Please agree with yourself.

If the abstract says n = 110, the aims say 100, the statistical section says 110, and the budget justification says 100, it makes me cranky.

2.) Please explain yourself.

When presenting power/sample size calculations let me know from which hat you picked your assumptions. A range of plausible effect estimates with citations or reprising your preliminary data will do nicely.

3.) Please don’t get ahead of yourself.

If your search for receptor variants may identify a drugable target, don’t tell me we need to fund your study because it will cure cancer. Convince me this is not your first rodeo and you are likely to find one or more targets suitable for testing.

Don’t skimp on accuracy and details in your proposal. Even if I am only subconsciously skeptical, it can hurt your grant score…and only nearly perfect scores clear the payline.

In 2009, NIH revamped their scoring system asking reviewers to provide numbers ranging from 1 (best) to 9 (worst) assessing applications Environment, Investigator, Innovation, Approach, and Significance.

NIH has emphasized Innovation (insert jazz hands), leaving many a weary grant writer to feel a need to invent fabulous new techniques to take DNA out of things, put it back in, and take it back out another time to reassure study sections that the gene you are studying does the thing you thought it would. And if you can do that in a nano platform with a high throughput screen, all the better.
It takes only a brief gander at NIH’s instructions to authors to reinforce the need for extra technological bedazzlement. It’s right there in big letters.

“Highlight Significance and Innovation”

It turns out that strategy may not be all it’s cracked up to be. PLoS One published a study by Eblen et al. evaluated over 70,000 applications looking at what metrics best-predicted funding success. Innovation and Significance were NOT the winners. Approach was.

Yes, that entirely unglamorous doing a project the right way, asking smart questions, and using robust design correlated far better with success than other metrics.

Several questions leap to mind including. Why didn’t NIH do this analysis earlier? It seems that they’ve been directing folks to the wrong area to emphasize. Either that or study sections are going rogue. And, here’s a vexing one, are we so precious that we all have to get 1’s, 2’s and 3’s for Investigators and Institutions? I don’t love statistics, but if everyone scores above average, doesn’t that mean we are all average or the space-time continuum is going to implode or something?

Read the paper. It’s pretty impressive and an excellent reason to slow down, think harder and make sure your study section is clear that not only is your question timely and relevant, but that you are doing it in a thoughtful and thorough manner.

Figure from PLoS One How Criterion Scores Predict the Overall Impact Score and Funding Outcomes for National Institutes of Health Peer-Reviewed Applications Matthew K. Eblen, Robin M. Wagner, Deepshikha RoyChowdhury, Katherine C. Patel, Katrina Pearson

Ever since the holy trinity important things have come in threes—listen up. Every study section I have been in for years includes the complaint that certain grant authors:

1.) Cheat the font sizes in their tables and figures.

Don’t make me adjust my bifocals. It makes me cranky.

2.) Have inconsistent, sloppy, incorrect, or incomplete references.

If you can’t create a clean bibliography or biosketch, why should I trust you to create precision data?

3.) Use color schemes that don’t convert to black and white.

Yes, I’m a dinosaur; I’m going to read your grant on paper.

Don’t skimp on any aspect of formatting your proposal. Even if I am only subconsciously peeved it can hurt your grant score…and only nearly perfect scores clear the payline.

Today the Newman Society held a panel discussion with three independent investigators who recently received their first large non-NIH grants.  Their tips for diversifying your research portfolio are:

Finding Opportunities and Repurposing Ideas
Dr. Natasha Halasa
CDC Funding

1. Look for announcements and RFAs at all of these websites:
   • gov
   • CDC
   • AHRQ
   • PCORI
   • Foundations
   • Societies
   • Drug companies (investigator-initiated grants)

2. When at meetings, go to the drug company booths and ask about grants.
3. Network within Vanderbilt; lots of people here have non-NIH funding.
4. Apply to different agencies with the same idea—you’re running a business and don’t want to always have the same customer.
5. Keep a running list of ideas and specific aims to pitch.
6. Every little grant will lead to something bigger.
7. Negotiating startup funds allows you to do a pilot project without having to get a grant.
8. Spend your startup money!
9. Take advantage of having protected time on a K award: Show you can get little jobs like pilot funding, small awards, and small papers done before going for the big grant.

Put Your Best Foot Forward
Dr. Aron Parekh
American Cancer Society Funding

1. Submit your best writing and science, as you would to NIH. (Success rates for private sources of funding can be similar or have even lower success rates than NIH such as the American Cancer Society since they are receiving so many more applications now.)
2. But make sure your science is in the sweet spot for the foundation and is compatible with what they’ve funded before.
3. Don’t let the hunt for foundation funding drag you away from your primary intent.
4. The ACS Research Scholar grant provides four years of funding at $165k/year with 20% indirects.
5. It’s structured like an R01 with 1 page of specific aims and 12 pages for research strategy.
6. They allow detailed methods in an appendix, which frees up space in the main body.
7. You must complete a section for why your idea is suited to ACS and cancer.
8. There are two deadlines per year.
9. You have to be within six years of your first appointment as an independent researcher.
10. This award can be held at the same time as an R01-type award.

Demystifying the VA
Dr. Christianne Roumie
VA Funding

1. There are 4 main funding sections and study sections within each of them. As with all funding agencies know the right place to send your application.
2. A Merit or Investigator Initiated Research (IIR) award is an R01 equivalent
3. You can’t be the PI on more than one Merit concurrently unless there are two different parent grants.
4. Your research strategy is 14 pages.
5. The committee looks to see that you have VA experience and a commitment to improving veteran health .
6. Work with people who understand the VA budget:
   • Clinicians cannot request salary support because your salary as a clinician is covered through medical center funds—ask for eighths.
   • For a Merit, it’s better to have 1-2 eighths when you apply, and you can ask for up to three to be the PI on a grant.
   • PhDs and MDs should contact Drs. Robert Dittus, Don Rubin and Brian Christman to get in the eighths pipeline; or contact the service chief of your specialty at the VA.
   • For a VA K, you have to submit a letter from VA HR saying you’re eligible to be hired along with your application.
7. VA funded research must be performed within the VA facility. If your work or lab is off site (i.e., Vanderbilt) get the off-site waiver early as part of your application.
8. Certain study sections for a Merit (Epidemiology and Clinical Trials) and all Career Development awards require a LOI. This deadline is typically 3 months before the grant deadline.
9. There are only two funding cycles per year: Fall and spring for clinical and basic science, winter and summer for health services.
10. READ THE DIRECTIONS FOR THE VA–SF424!