I just finished an NIH study section and noted that more than half of the applications discussed did not adequately address sex as a biological variable (SABV). This is a relatively new (for some grant types) component of your grant, and while it may seem relatively minor, it is actually an important part of your grant (and your science!).

SABV is a scored component for peer review of Fellowship (F), Career Development (K), and Research (R) grants. This means that not getting the section right is an automatic weakness and will result in a lower score. Beyond the requirements for your grant proposal, numerous studies have shown that analyzing males and females separately in your study could uncover important biological differences.

I’m here to tell you that SABV is easy to “get right” in your application.

In your application, the NIH requires:

  • Explanation of how relevant biological variables, such as sex, are factored into research designs and analyses.
    • Read: mention SABV explicitly in your Research Plan. It can be in the Approach, Study Design, Data Management, or Statistical Analyses sections, but it has to be stated explicitly.
  • Animal Studies: Include a description of how you will use both male and female animals in the Vertebrate Animals section.
  • Human Participants: Include descriptions of recruitment of both men and women across the lifespan.

At Study Section, the reviewers are instructed to answer the following question: Has the applicant presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? There is actually a separate section on the Critique Template for SABV and reviewers are instructed to factor this section into their score.

How can you get this right in your application?

It is not enough to study both male and female animals or humans. In fact, this is the most common “error” I see on applications in my study section. Rather, each sex needs to be analyzed independently for sex-specific differences. Make sure you state this in your Research Plan. Ask your mentor and your institution for examples of grant text that is relevant to your specific type of research.

SABV is an easy thing to “get right” on your application and may uncover something unexpected in your research – maybe even a new direction for another grant proposal!

More on the rationale of the policy is described on the NIH Office of Research on Women’s Health page.

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Jordon says:

Any recommendation for how to address this when gender identity is the primary focus (namely transgender/nonbinary folks) rather than biological sex? 

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