Comments due soon: sex as a biological variable in animal, tissue, cell research
Author: Sherry Ward, AltTox
The response date for the Request for Information “Consideration of Sex As a Biological Variable in Biomedical Research” (NOT-OD-14-128) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-128.html) has been extended from October 13, 2014, to October 24, 2014 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-012.html).
“This Request for Information seeks input from the research community and other interested stakeholders on the following topics regarding the consideration of sex as a biological variable in biomedical research. Public comment is sought for but not limited to the following:
• Whether consideration of sex as a biological variable is an issue affecting the reproducibility, rigor, and/or generalizability of research findings.
• Areas of science (e.g., cancer, neuroscience) or phases of research (e.g., basic, translational) conducted with animals that have the greatest opportunity or need for considering sex as a biological variable.
• Areas of science or phases of research conducted with cells and/or tissues that have the greatest opportunity or need for considering sex as a biological variable.
• Main impediments (e.g. scientific, technical, and other) to considering sex as a biological variable in research.
• Ways in which NIH can facilitate the consideration of sex as a biological variable in NIH-supported research.
• Any additional comments you would like to offer to NIH about the development of policies for considering sex as a biological variable in research involving animals, tissues, or cells.”
Expanding all animal research studies to both sexes without first establishing when it is necessary and useful to do so will needlessly increase animal use and the cost of research. The NIH and FDA could at least start out by compiling a database of existing research studies where sex differences have been shown to be relevant, and studies where sex differences had no impact on the results. This database could then be expanded by NIH as new data are developed, so that the types of studies with and without sex as a biological variable can be determined before duplication of all animal studies is required in NIH funded research.
This is not an area of research where I have any expertise, so I am posting this to remind those with greater expertise to submit their comments to the NIH by October 24.