The work of two Northwestern researchers was influential in a recent policy change by the National Institutes of Health, which will require that researchers include their plans for balancing male and female cells and animals in preclinical studies with few exceptions.

The new policy will be put into practice beginning in October, and researchers seeking grants from NIH will be able to bypass the new requirements with only “rigorously defined exceptions.” Teresa Woodruff and Dr. Melina Kibbe worked with the NIH to institute the change, which Francis Collins, NIH director, announced on May 14.

“While it’s a step in the right direction, still more needs to be done,” said Kibbe, a professor of surgery and vice chair of research in the Feinberg School of Medicine. “Simply requiring researchers to ‘describe their plans’ is not quite there.”

Woodruff, vice chair for research in the Department of Obstetrics and Gynecology, began advocating for gender inclusion in preclinical studies in 2008 and 2009. She said she realized that many studies excluded examples with female components, normally only using male subjects.

“I realized that there are so many discoveries that could be made by including both sexes,” Woodruff said. “I thought this was an area that needed to be advocated for.”

These ideas culminated in a paper by Woodruff and two colleagues, published in 2010 in Nature, an interdisciplinary science journal. The paper, “Sex bias in trials and treatment must end,” called for journals, funding agencies and researchers to give women and men equal attention in both studies and in the clinic. “60 Minutes” picked up the story in February and filmed Kibbe and Woodruff over a two-day period. The pair said the show’s national platform was very helpful in increasing awareness about the issue.

The two researchers began working together when Kibbe told Woodruff about a breakthrough she had made in her research. When Woodruff asked if there were any differences in how male and female rats responded to a drug, Kibbe said she had only used male rats in the study. Woodruff convinced her to study the drug in both genders, and she found the effects of the drug in male and females produced different results. A grant from the Women’s Health Research Institute at NU allowed Kibbe to complete the study.

“During my research, I was surprised to see there was a difference, a pretty significant one,” Kibbe said. “That research was really what opened my eyes up to this issue.”

Kibbe said she examined five of the top surgery journals to learn what percentage of published papers studied males and females. She said of the papers she studied, about a third didn’t state the sex of the subjects being studied, and for those that did, about 80 percent of them studied males only. Currently, Kibbe is advocating for journals to be required to publish a subject’s sex in studies.

“My part in this is to get all journals, not just surgical journals, to change their policies,” she said. “There’s the NIH, the FDA, the industry and the journals, and all four of these entities could be working to create a more sex-balanced research environment.”

Kibbe has completed her study testing a particular drug in both male and female rats and submitted the manuscript, which will come out in the next couple of weeks. Woodruff said she hopes the NIH’s policy change will get more people talking about the importance of studying both genders.

“Studying both males and females is not just duplicating results,” Woodruff said. “We can actually discover things that are fundamental about biology. As our discoveries go forward from bench to bedside, we have an opportunity to help health overall.”

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