The recently implemented NIH policy requiring grant applicants to consider sex as a biological variable in the design of basic and pre-clinical animal studies has prompted considerable discussion. Translating this policy into action is complex. For example, the cost associated with expanding the scope of a study to include additional cell lines or study animals is a pressing issue for many investigators.
The Office of Research on Women’s Health is responding to this concern by providing administrative supplements to support research highlighting the impact of sex/gender influences and/or sex and gender factors in basic, preclinical, clinical and behavioral studies. Supplemental applications, within the scope of the parent application, may include the following approaches:
- Adding the opposite sex: Adding animal or human subjects, tissues or cells of the sex opposite to those used in the parent grant to allow sex/gender-based comparisons.
- Increasing sample size: Adding more animal or human subjects, tissues or cells to a sample to increase the power of a study for analysis of sex/gender differences.
- Conducting new experiments or comparative analyses: Developing new experimental approaches or comparative analyses of existing samples or datasets to investigate the role of sex/gender.
Supplemental applications must address at least one objective from Goals 1-3 of the NIH Strategic Plan for Women’s Health Research:
- Increase sex differences research in basic science studies.
- Incorporate findings of sex/gender in the design and development of new technologies, medical devices, and therapeutic drugs.
- Actualize personalized prevention, diagnostics, and therapeutics for girls and women.
The objectives of Goals 2 and 3 are of higher programmatic importance and applications studying one or more of these goals will be given higher consideration. For applications that address Goal 1, of special interest are studies to understand the influence of biological sex on cells, primary cell cultures, immortalized cell lines, transformed cells, and tissue explants.
The Office of Research on Women’s Health intends to commit $3,000,000 in FY 2017 to fund 30 awards. Supplemental application budgets are limited to $65,000 in direct costs but additional indirect costs may also be requested. The award project period is limited to one year. The parent grant must have at least 18 months of active support remaining from the supplement application due date, which is February 13, 2017. Guidelines on submitting your application can be found here. Still have questions? Contact your Grants and Contracts Administrator.