In virtually any type of research, small changes in data can sometimes lead to major changes in results. Josephine Allen, Ph.D., associate professor and Genzyme Professor of Materials Science and Engineering (MSE) at the University of Florida, and her team understand that the sex of the cells she uses in her experiments is more than just a secondary data point – it could literally alter the outcome of the analyses and skew the study findings, overall.
“Sex-based differences have been a long-standing interest of mine and are the primary reason I work in the area of cardiovascular disease – particularly its disproportionally negative effects on African American women and women, in general,” said Dr. Allen. “My interest is fueled by the overwhelming evidence that male and female biology is different, and these biological differences translate to disparities in health, disease and also treatments.”
Dr. Allen and her team comprised of MSE Ph.D. candidate and NIH Predoctoral Fellow Bryan James and J. Crayton Pruitt Family Department of Biomedical Engineering undergrad Paxton Guerrin observed that biomedical and biomaterials researchers and the journals publishing their papers rarely mentioned the sex of the cells involved in the studies. They knew how that data could potentially affect research results, and so they conducted their own analysis* by surveying the literature of several top biomedical journals and found that cell sex was reported in only a small fraction (roughly 3%) of papers.
That information and several other notable results prompted their own paper highlighting the findings entitled “Let’s Talk About Sex – Biological Sex is Underreported in Biomaterials Studies.”
“In the essay, we highlight what we view as the three primary sources behind this lapse: the researcher for not simply reporting the cell sex, the cell vendors for not making sex information readily available and the journal editors who do not require cell sex be included in the papers they publish,” Bryan James said. “We make the argument that even if the study is not focused on studying sex-based differences, it is still important to report the sex of the cells to provide context for the work being published. There is overwhelming evidence that male and female biology is different, and these biological differences translate to disparities in health and disease.”
They then submitted the essay to a journal designated in the study itself as one with underreported cell sex data.
“There was obviously some apprehension about spotlighting these publications, but we purposefully chose high impact and highly respected journals in the field, and we wrote our essay to present it as an opportunity to reverse this trend,” said Dr. Allen. “I thought about all of the new insight that could be gained, how studies could be more easily replicated and how, as a field, we have an opportunity to shift research from being inadvertently biased towards male biology – simply because of the greater likelihood of obtaining male cells from a commercial vendor, to becoming more representative of the population as a whole. I viewed it as a chance to make a real difference.”
When she received word that the manuscript had not only been accepted for publication but had also initiated an internal discussion about implementing a policy on reporting the sex of cell lines in the publishing company’s research journals, Dr. Allen was understandably both elated and proud.
“I see this as a small victory and am so happy that they will at least revisit their policies on cell sex reporting,” said Dr. Allen. “For our part, we are going to start including cell sex in our own work – even more than we have before. I am, of course, hopeful that all journals will eventually adopt new policies to include cell sex, but I wouldn’t expect anything to change overnight. It’s a significant shift but not impossible.”
“In our essay and in our lab, we use the term precision medicine, which speaks to the eventual, perhaps ultimate, goal of individualized healthcare,” added Dr. Allen. “I firmly believe that if we are ever to approach true individualized healthcare, the differences between male and female biology must be accounted for in biomedical and biomaterials research from the moment researchers acquire cells for a study to the time their findings are published.”
* This research was supported in part by the National Heart, Lung, And Blood Institute of the National Institutes of Health under Award Number F31HL147445 to Bryan D. James. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.”