On October 9, 2015, NIH released the final policy language associated with the inclusion of sex as a variable in scientific research together with additional guidance on improving the reproducibility of research findings (NOT-OD-16-011). The Women’s Health Research Institute has been a strong advocate for sex-inclusion and reporting and we are delighted that sex will now be part of scientific research in the same way time, temperature, dose and age are currently regarded. The primary literature documenting the need and value of these new policies is provided, as are a few FAQs that help guide the rationale behind this change. The new policy is effective for all grants submitted on/after Jan 25, 2016 and directions have been provided to CSR regarding study section review of these elements. We know that a change in policy requires added thought in the development of compliant applications and below we provide a guide and examples to enable your success.
The NIH provides resources for both applicants and grant reviewers to become more familiar with the sex-inclusion policy and the rationale behind sex-inclusive research:
- Consideration of Sex as a Biological Variable in NIH-funded Research
- Rigor and Reproducibility in NIH Applications
- Reviewer Guidance to Evaluate Sex as a Biological Variable
- Online Course: The Basic Science and the Biological Basis for Sex- and Gender- Related Differences
Please let us know if you have additional questions or suggestions for enabling fundamental and translational science at Northwestern University to succeed (firstname.lastname@example.org).