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Office of Research on Women’s Health (ORWH)

Studying Sex to Strengthen Science: Questions & Answers

In a Nature article published May 14, 2014, NIH Director Dr. Francis Collins and NIH Associate Director for Research on Women’s Health Dr. Janine Clayton discussed ways that NIH is addressing the influence of sex in research, and how the agency will be enacting new policies to expand the consideration of sex in biomedical research with animals and cells.

  1. What specific changes will NIH be making, starting in October 2014?
  2. What about October applications?
  3. Why is a new policy needed?
  4. What does NIH aim to achieve by introducing these changes?
  5. Will the new policy require that I use equal numbers of male and female animals/cells?
  6. Will NIH provide assistance to investigators unfamiliar with the influences of sex in research?
  7. Why are the changes being introduced in phases, instead of all at once?
  8. Is my current grant affected?
  9. I’m submitting an application for NIH funding now. What do I need to know?
  10. Will my costs increase?
  11. Is NIH going to give me more funding to do this new element?
  12. What has been funded through the administrative supplement program?

  1. What specific changes will NIH be making, starting in October 2014?
    Sex is an important biological variable in research design, and NIH is taking action on several fronts to ensure that the consideration of sex is reflected in NIH-funded research proposals. NIH is developing policies that will require applicants to address the influence of sex in the design and analysis of biomedical research with animals and cells. These activities will begin to roll out this October.

    NIH will also be making announcements about how the agency is working with the scientific community, including editors of scientific journals, to further consider the importance of sex differences in our research efforts.
  2. What about October applications?
    Current NIH policies will remain in effect for applications submitted in October 2014, but stay tuned for additional guidance on how NIH will be implementing policies for biomedical research applications involving animals and cells, reviewer guidelines (see section 5.5), and progress reports.
  3. Why is a new policy needed?
    For many years, animal studies have often focused on males, and investigators studying cell models have not considered or not reported the sex of the individual from which the cells were obtained.

    NIH believes that failure to address the influence of sex in research with animals and cells has not been intentional. For the most part, looking for differences between males and females has been a blind spot in biomedical research, leaving gaps in knowledge. This policy will be a first step toward filling those gaps.
  4. What does NIH aim to achieve by introducing these changes?
    By asking researchers to take sex into account, NIH will ensure that sex and sex differences are examined from the start in biomedical research. This will lead to a stronger foundation on which to build clinical research and trials.
  5. Will the new policy require that I use equal numbers of male and female animals/cells?
    Not necessarily. Applicants will be asked to address the influence of sex in the design and analysis of biomedical research with animals and cells. Given the state of knowledge in a particular area, this may or may not support the use of equal numbers of males and females. A variety of scientific publications outline some of the appropriate ways to design experiments taking sex into consideration:
  6. Will NIH provide assistance to investigators unfamiliar with the influences of sex in research?
    Sex is a fundamental biological variable, and thus addressing sex differences from the beginning is good scientific practice that will lead to a stronger evidence base.

    To help scientists understand and adapt to the changing policies both in the grantee community and at NIH, the agency will create training modules on experimental design. Please stay tuned for more information on this training, coming this year.
  7. Why are the changes being introduced in phases, instead of all at once?
    NIH understands that addressing the influence of sex in biomedical research with animals and cells is a change in the way many scientists conduct their research. NIH is approaching this thoughtfully and wants to implement what will best support this cultural change in science. Taking a phased approach, with careful attention to the impact of each phase will allow investigators to adjust their research and will also permit NIH time to assess the implementation of the policy.
  8. Is my current grant affected?
    No. Announcements about the phased approach of the new policy will be issued starting in October 2014.
  9. I’m submitting an application for NIH funding now. What do I need to know?
    Right now, applicants proposing work in vertebrate animals need to follow current NIH guidelines for using vertebrates in research: See “Preparing the Vertebrate Animal Section (VAS)” factsheet.
  10. Will my costs increase?
    Addressing the influences of sex in biomedical research with animals and cells does not necessarily imply an increase in costs. Rather, well-designed research either directly tests or controls for variables that might influence outcome, and sex is one such variable among many that must be controlled for valid data. As always, each applicant will need to assess the characteristics of animals and cells, analytic approaches, and other factors in determining his or her research design.

    Supporting optimal and rigorous research design is the best investment NIH can make. Moreover, by making more sex-specific data available, investigators can more readily ask and answer scientific questions in the future without additional expense.
  11. Is NIH going to give me more funding to do this new element?
    NIH seeks to fund the best science, and plans for addressing the influence of sex does not necessarily imply the need for more animals or cells. Budgets requested should be relative to the scope of the proposed research.

    In FY 2013 and FY 2014, the NIH Office of Research on Women’s Health created an administrative supplement program to enable investigators to expand their studies to account for sex. Thus, NIH has dedicated funds to address the influence of sex in research projects.
  12. What has been funded through the administrative supplement program?
    The NIH Office of Research on Women’s Health administrative supplement program began in FY 2013, and it allows NIH researchers to add a sex/gender lens to their currently funded research. Through this administrative supplement program, scientists obtained extra funds to conduct additional studies that do not stray significantly from the scope of their parent grant, but that allow exploration of sex influences not previously considered.
This page last reviewed on June 25, 2014

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