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New Policy Alert! National Institutes of Health (NIH)-funded Research Must Include Gender Balance

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By: Bethanie Morrison

Photo courtesy of clever cupcakes/photopin/cc

Not surprisingly, men and women progress through certain diseases differently and respond dissimilarly to certain medications. A variation in disease progression and response to therapeutics are due to many factors, some of which are linked to differences in genes expressed on the X and Y chromosomes1. In February, a 60 Minutes story highlighted the recent example of the drug Ambien, which is metabolized differently in women and men2. As a result of this story, a bipartisan group of 15 women senators wrote a letter to the U.S. Food and Drug Administration (FDA), urging the agency to improve the representation of women in drug trials3. In addition to enhancing the diversity of clinical drug trials, preclinical therapeutic development must also be addressed. For years, researchers avoided preclinical drug studies using female animals for fear that physiological changes that occur during reproductive cycles would confuse experimental outcomes. In an interview with the New York Times, NIH Director Dr. Francis Collins remarked that, “most scientists want to do the most powerful experiment to get the most durable, powerful answers. For most, this has not been on the radar screen as an important issue.4

The NIH Office of Research on Women’s Health (ORWH) is dedicated specifically to the promotion of women’s health and sex differences research within and beyond the NIH scientific community5. Dr. Janine Clayton, Director of the NIH ORWH, is leading the NIH policy change initiative that will require scientists to include female animals and cell lines in preclinical research design6. In an interview with Judy Woodruff on the PBS NewsHour, Dr. Clayton explained, “what’s really important now is right now we have been able to put the focus on getting this as a priority. In fact, we are supporting scientists who are doing this research, but it wasn’t enough of a priority. In some way, it was like a blind spot. Scientists weren’t thinking about it.7” The issue now becomes the implementation of the policy by the scientific community.

In a comment published in Nature, Drs. Collins and Clayton disclosed that the NIH would be implementing this new policy in October 20148. Grants submitted to the NIH after October will be required to include plans for experimental gender or sex considerations. The ORWH will work with the FDA to co-fund the Specialized Centers of Research on Sex Differences program, which facilitates proper incorporation of sex and gender variables within experimental design and analysis. Going forward, reviewers and administrators of research grants and programs also need to be cognizant of any discrepancies regarding gender or sex in proposals. Implementing this new policy will ensure that biomedical research funded by the NIH continues to uphold the rigorous standards for which it is internationally recognized and insure that the differences in gender biology are properly incorporated into future biological discoveries.

 

1. Mogil, J. S. & Chanda, M. L. Pain 117, 1–5 (2005).

2. http://www.cbsnews.com/news/sex-matters-drugs-can-affect-sexes-differently/

3. http://www.cbsnews.com/news/60-minutes-helps-pave-way-for-change-at-nih-fda/

4. http://www.nytimes.com/2014/05/15/health/nih-tells-researchers-to-end-sex-bias-in-early-studies.html?_r=1

5. http://orwh.od.nih.gov/about/mission.asp

6. http://orwh.od.nih.gov/about/staff/clayton.asp

7. http://www.pbs.org/newshour/bb/nih-orders-scientists-test-new-drugs-animals-sexes/

8. Clayton, J. & Collins, F. Nature 509, 282-283 (2014).

 

 

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Written by sciencepolicyforall

June 26, 2014 at 7:01 pm

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