NIH Tells Scientists To Balance Gender In Studies

The National Institutes of Health (NIH) has called upon investigators to balance gender in preclinical studies. In a letter published in Nature, Janine A. Clayton, the director of the NIH Office of Research on Women's Health and Francis S. Collins, the director of the NIH, revealed upcoming policy changes and the rationale for making them. The NIH plans to address sex and gender inclusion by increasing program oversight, changing policy, instituting review processes, and increasing collaboration with investigators and publishers. Dr. Collins said in an interview with the New York Times, “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. What we’re trying to do here is raise consciousness.”

Challenges

Clayton and Collins said that the effort to include women is twenty years old and that, today, half of the participants in studies are women. However, they said, “There has not been a corresponding revolution in experimental design and analyses in cell and animal research — despite multiple calls to action.” According to Clayton and Collins:

• Scientific publications neglect gender considerations 
• Grant reviewers are unaware of this neglect
• Reliance on male animals and cells obscures key sex differences
• Women could be harmed by this neglect as they already have higher rates of adverse drug reactions
• Pharmaceutical companies are hurting themselves as excluding females contributes to poor reproducibility in trials

Having already urged the scientific community to include more women in clinical studies and acknowledging that women are included now, the new commentary represents the NIH’s commitment to dig deeper and uncover the root of the problem that occurs before drugs ever get to clinical trials.

NIH Steps

New policies are to be implemented in October 2014. Applicants for NIH funding, will have to report the balance of male and female cells and animals in preclinical studies, except for “rigorously defined exceptions.” To support investigators in complying with the changes, the NIH will provide detailed policy information and training modules. Another resource is the Office of Research on Women's Health (ORWH), which has funding for projects that need to balance gender in subjects, cells, or tissues. ORWH co-funds the fund the Specialized Centers of Research on Sex Differences program with the Food and Drug Administration (FDA).

The NIH plans to re-educate reviewers of grant applications, with a program delivered in phases. When complete, reviewers will be able to evaluate applications that include gender considerations. The agency intends to monitor compliance through data mining techniques and emerging technologies. Since the NIH has no control over scientific publications, it intends to work with publishers to include gender balanced studies.