SABV in NIH Grant Review

We’re several rounds of grant submission/review past the NIH’s demand that applications consider Sex As a Biological Variable (SABV). I have reviewed grants from the first round of this obligation until just recently and have observed a few things coming into focus. There’s still a lot of wiggle and uncertainty but I am seeing a few things emerge in my domains of grants that include vertebrate animals (mostly rodent models).

1) It is unwise to ignore SABV.

2) Inclusion of both sexes has to be done judiciously. If you put a sex comparison in the Aim or too prominently as a point of hypothesis testing you are going to get the full blast of sex-comparisons review. Which you want to avoid because you will get killed on the usual- power, estrus effects that “must” be there, various caveats about why male and female rats aren’t the same – behaviorally, pharmacokinetically, etc etc – regardless of what your preliminary data show.

3) The key is to include both sexes and say you will look at the data to see if there appears to be any difference. Then say the full examination will be a future direction or slightly modify the subsequent experiments.

4) Nobody seems to be fully embracing the SABV concept coming from the formal pronouncements about how you use sample sizes that are half males and half females into perpetuity if you don’t see a difference. I am not surprised. This is the hardest thing for me to accept personally and I know for certain sure manuscript reviewers won’t go for it either.

Then there comes the biggest categorical split in approach that I have noticed so far.

5a) Some people appear to use a few targeted female-including (yes, the vast majority still propose males as default and females as the SABV-satisfying extra) experiments to check main findings.

5b) The other take is just to basically double everything up and say “we’ll run full groups of males and females”. This is where it gets entertaining.

I have been talking about the fact that the R01 doesn’t pay for itself for some time now.
A full modular, $250K per year NIH grant doesn’t actually pay for itself.

the $250K full modular grant does not pay for itself. In the sense that there is a certain expectation of productivity, progress, etc on the part of study sections and Program that requires more contribution than can be afforded (especially when you put it in terms of 40 hr work weeks) within the budget.

The R01 still doesn’t pay for itself and reviewers are getting worse

I have reviewed multiple proposals recently that cannot be done. Literally. They cannot be accomplished for the price of the budget proposed. Nobody blinks an eye about this. They might talk about “feasibility” in the sense of scientific outcomes or preliminary data or, occasionally, some perceived deficit of the investigators/environment. But I have not heard a reviewer say “nice but there is no way this can be accomplished for $250K direct”.

Well, “we’re going to duplicate everything in females” as a response to the SABV initiative just administered the equivalent of HGH to this trend. There is approximately zero real world dealing with this in the majority of grants that slap in the females and from what I have seen no comment whatever from reviewers on feasibility. We are just entirely ignoring this.

What I am really looking forward to is the review of grants in about 3 years time. At that point we are going to start seeing competing continuation applications where the original promised to address SABV. In a more general sense, any app from a PI who has been funded in the post-SABV-requirement interval will also face a simple question.

Has the PI addressed SABV in his or her work? Have they taken it seriously, conducted the studies (prelim data?) and hopefully published some things (yes, even negative sex-comparisons)?

If not, we should, as reviewers, drop the hammer. No more vague hand wavy stuff like I am seeing in proposals now. The PI had better show some evidence of having tried.

What I predict, however, is more excuse making and more bad faith claims to look at females in the next funding interval.

Please prove me wrong, scientists in my fields of study.

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Additional Reading:
NIH’s OER blog Open Mike on the SABV policies.
NIH Reviewer Guidance [PDF]