NIH R01 Grantsmanship: Justify It or Else

by Tom Hollon

Not providing a scientific rationale to justify key decisions in your research plan is a major cause of granstmanshipwreck.

It can be a revelation to hear reviewers talk about grants. Or to read transcripts of reviewers talking about grants.

Here’s something I learned about NIH R01 grantsmanship from reading “Inside the NIH Grant Review Process Video Script,” which NIH published in 2004. I read it not long after I became a grant consultant.

The script is out of date in a couple of ways. NIH didn’t have its 9-point scoring scale for R01s back then, for instance. But that doesn’t matter.

What matters is that the reviewer’s task to balance the strengths and weaknesses of a R01 research plan is pretty much unchanged between now and then.

That’s why a lesson I learned from the script is worth your attention. (By the way, to download the video script as a PDF, see the download link at the bottom. It’s free.)

Justifying R01 research decisions

The video script transcribed reviewer discussions of three grants. One was a R01 proposal to test whether RK 42-B, a selective inhibitor of cyclo oxygenase II (Cox-2), could inhibit recurrence of colonic polyps.

As I read the reviewers’ discussion of the R01, two words popped out at me: justification and justify. See for yourself:

  • Howard: “…their justification for picking this particular drug, I think was somewhat lacking.”
  • Howard: “…they cite a number of centers and the numbers of patients that they’ve had, but they really don’t justify these numbers; they don’t really provide evidence that each of the sites can accrue patients appropriately for this trial.
  • Howard: “I felt it would’ve been strengthened by either a more raw justification based on the literature or based on their own work in terms of how this drug may in fact be influencing a colorectal cell-proliferation. And so for that reason, I gave it the score that I did.”
  • Dan: “… did they really justify their dose with any rational, did they say that?”
  • Nora: “…there wasn’t even that good of a justification of the drug itself considering that they looked at other inhibitors and they seemed to have similar effects in their animal models. So what I’m hearing is that there’s problems with no justification of the drug, the dose and even the statistical design of the study; sounds pretty serious.”
  • Andy: “In fact, it needs to be indicated clearly that subjects in the pediatric age group would be eligible for this study, or adequate justification why they should be excluded; it’s not as if this disease does not occur in that age group.”
  • Narrator: “… the group noted investigators had not met the NIH requirements for detailed documentation of protection of human subjects nor did they justify the lack of participation of children.”

To justify is grantsmanship, not to is grantsmanshipwreck

I know you know you’re supposed to provide reviewers with the scientific rationale to justify your decisions. And because you know, that’s not the lesson here.

The lesson is this: R01 grant writing is so complex that extremely smart people sometimes forget to justify their decisions. And when they forget, their grant scores will suffer the consequences.

Thanks to reading this video script, justification is one of the things I ALWAYS look for in reviewing a client’s grant prior to submission: Have we justified all the important decisions?

This is not the only lesson in the video script. It’s worth having and rereading every time you write a grant. Click below to download a free PDF copy.

Download

 

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