Deadline-Push: 5 Weeks to Go

5 WEEKS TO GO

PUSH TO THE OCTOBER DEADLINE!

Meg Bouvier Medical Writing

This Week: Materials back; Revise Aims + Research Strategy, send out for comments

Now is the time to elicit feedback on the entire draft of the Research Strategy, and begin to run a “check list” of sorts on your draft. You are coming into the final month or so. You may feel like you have a lot of time left, but those weeks will go surprisingly quickly. Stay organized and focused.

1. “Shake the tree”—Obtain Biosketches, LOS, Approach text from team members
2. Revise entire 12-page Research Strategy + Aims
3. Send 12-page Research Strategy to colleagues for comment  

#1 "Shake the tree"—Obtain Biosketches, LOS, Approach text from team members

It is time to start nagging your team members for their sections of the grant application. Be polite but persistent when asking for their sections. Check materials carefully as they come in, and go right ahead and send them back for revisions if they are not adequate. 

• Biosketches

Check the Personal Statement carefully; Has it been written specifically for this project, or was it simply copied-and-pasted from another project? Are the project details in the Personal Statements consistent with what you have written in the rest of the submission, notably in the Approach section of the Research Strategy? Does the Personal Statement do a good job highlighting the person’s strengths that are specifically needed for this project, or do they highlight the person’s generic aptitudes? Are the Contributions to Science well written and carefully thought out and developed, or do they read as if they were dashed off as an afterthought?

• Letters of Support

Remember that you have written the template, so hopefully it was not a ‘heavy lift’ for the person to fill in a few editorial comments and biographical information. Has the person done so? Are the comments substantive? Do they relate directly to the PI and this project? Is the letter printed on letterhead? Is it signed and dated? If the person completely changed your template, is the letter still consistent with the details of their role on the project that you have written elsewhere in the application?

• Approach Text

Have your team members returned the text you requested from them? Likely not. It is time to start nagging. Be polite, but persistent. If they have returned text to you, do you understand what they wrote? 

TIP: If you have absolutely no idea what your team member has written, do yourself a favor and do not simply cut-and-paste their text into your draft; Instead, schedule time to speak with your biostatistician (for example) and ask them to please help you understand the rudiments of what they have written. While NIH reviewers and POs generally value the addition of a statistician as key personnel to a research team, most PIs could do with some remediation when it comes to understanding better what the biostatistician is doing. This sort of training is becoming more prominent among NIH-funded training for young scientists, and established researchers may do well to avail themselves of training in these areas – not to replace their statisticians as important team members, but to enhance rigor by ensuring that the PI better understands these areas of the project.

#2 Revise Aims + Research Strategy

Take this time to carefully edit the entire Research Strategy, especially the all-important Approach section. Remember that statistically, of the 5 scored sections, grantees score the worst on the Approach section; and unfortunately of the 5 scored sections, the Approach correlates most closely with the overall score.

Here are some questions to ask yourself as you review your writing on the Research Strategy:

Have you justified the dose of your intervention?

Provide clear evidence to support your proposed dose! NIH POs do not want you to come back and ask for more money because you chose the wrong dose during your initial funding period. Remember that “dose” could mean many things, not just amount of a drug. For example, your intervention might include 20 mins of moderate-to-vigorous activity 3 times a wk for 6 wks. Why 20 mins? Why moderate-to-vigorous activity? Why 3 times a wk, and 6 wks duration? Justify each element of the dose, supporting your decision using the literature or unpublished data, yours or others. Provide citations whenever possible. 

Is your section entitled “Potential Problems and Alternative Strategies” long enough?

The more junior you are, the longer and more detailed this section should be. We’ve all seen the dreaded reviewer phrase: “Poor consideration of alternative hypotheses dampens our enthusiasm…” Anyone who has spent time in a lab knows that projects never go quite as planned. When problems arise (they inevitably will), how will you manage risk? How do junior faculty convince reviewers the project is in the right hands, in the absence of a stellar publication record? When brainstorming content, remember those maxims we learned in grad school: Absence of evidence is not evidence of absence; Correlation does not imply causation; Just because your data appear to support your hypothesis does not necessarily mean your hypothesis is correct; etc.

Have you included clear, well-worded Impact Statements in appropriate locations?

Remember that there are 5 scored review criteria, but Impact is the scoring criteria that overarches all of them:

“Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).”

Impact speaks to the project’s effect on the IC’s mission, and the mission of NIH:

“NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.”

An impact statement should appear in various lengths, in multiple locations in the grant applications: 

1. Significance (longest version ~ one paragraph)
2. Specific Aims (several sentences or short paragraph)
3. Project Summary/Abstract (1-2 sentences)
4. Project Narrative (1 sentence)

Impact Statement from Specific Aims of an R21 funded in 2016:

“By gaining a better understanding of the complexity of the molecular mechanisms of resistance and spread among CPO, we can help guide therapy and appropriate prevention strategies to halt the spread of these important and deadly pathogens within the clinical setting.”

When describing recruitment for your clinical trial, do you address competition for patients from other open trials at your site(s)? 

It isn’t enough to tell reviewers that REDCap indicates you have plenty of potential patients. You need to discuss how other open trials might affect recruitment. NIH is sensitive to money wasted on trials that are set up and then fail to recruit. The more open trials at your medical center, the more carefully you need to describe how recruitment for your trial will be prioritized over others –and it is not enough to say “NIH-funded trials have priority”, because reviewers cannot ascertain how many other NIH trials might be competing for the same patients.

#3 Send Aims + Research Strategy out for comments

You should have a fairly solid draft of the Research Strategy by now, or at least one that will not cause you too much embarrassment, that you can send to your colleagues for comment. Time is getting tight, so think carefully about from whom you would like feedback. If you send it to too many people, you may wind up with a lot of conflicting feedback; Send it to too few people and you may wind up with an email or two from busy colleagues who state simply: “Looks good!” with no one giving substantive feedback. Choose carefully. Ask the person to be honest about their bandwidth to provide feedback. You want substantive feedback from carefully chosen colleagues – that means some who have subject matter expertise and one or two colleagues outside your scientific area, and all with the bandwidth and inclination to provide meaningful feedback.

TIP: Tell your colleagues you need the draft back before the date you need it.
Despite their best intentions, you are not a top priority for your busy, harried colleagues, alas.

TIP: Choose a person or two a bit outside your field to provide feedback.
Why? Because a scientist a step to the left of your field often is the best person to help ascertain if you have written effective Significance and Innovation sections. Remember that many people on your study section – indeed, perhaps even your assigned tertiary reviewer (also known as “Reviewer 3”, or “the Reader”—multiple names for the same person on an R01 application, for maximal confusion) will be a bit outside your field. Therefore a scientist a bit outside your field can be an ideal reviewer of your near-final submission. It’s actually one of the values of working with a professional grantwriter as well.

TIP: You can improve your grantwriting skills by offering to edit other people’s submissions.
Volunteer to edit other people’s submissions as often as you possibly can. One of the best ways to improve your grantwriting is to review other people’s submissions. Another suggestion is to sign up for the Center for Scientific Review’s Early Career Reviewer Program, if you are eligible. It is a wonderful way for junior faculty to experience being an NIH reviewer for a single grant cycle. The people I know who have participated tell me they have learned a great deal from the experience. I understand there is a wait list these days, so sign up as soon as possible. 

TIP: Choose your readers carefully, and check the study section roster! 
You need feedback from your co-Is and team members, but you also likely want input from a few people not on your team, a few trusted colleagues who will provide some outside input. But be careful that these trusted colleagues will in no way put anyone on your study section in conflict by reviewing the grant. You would not want to have an otherwise friendly advocate on study section have to recuse themselves simply because you asked a colleague to weigh in on your submission. It pays to check that roster!

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Margaret Bouvier received her Ph.D. In 1995 in Biomedical Sciences from the Mount Sinai School of Medicine. After an NINDS post-doctoral fellowship, she worked as a staff writer for current NIH Director Dr. Francis Collins in the Office of Press, Policy, and Communications for the Human Genome Project and NHGRI. She has owned Meg Bouvier Medical Writing, LLC since 2007. She currently supports 2 of the top 3-ranked hospitals; 3 of the top 6 cancer hospitals; and 3 of the top 5-ranked medical schools for research in the country. She has helped clients land over $280 million in direct federal funding. Meg Bouvier Medical Writing, LLC is a woman-owned, small business.