Although researchers have made major progress in achieving a balance between male and female subjects in human studies—women now account for roughly half of the participants in NIH-funded clinical trials—a similar pattern has not been seen in pre-clinical research involving animals and cells. To inform the development of policies that address this issue, NIH has issued a request for information (RFI) on the consideration of sex as a biological variable in biomedical research.
As NIH Deputy Director for Extramural Research Sally Rockey wrote in a recent blog post announcing the RFI, “Sex is a critical variable when trying to understand the biological and behavioral systems that fundamentally shape human health.” Appropriate representation of animals and cells is also relevant to NIGMS and NIH efforts to enhance scientific rigor and data reproducibility in research.
And in her own blog post about the RFI, NIH Associate Director for Research on Women’s Health Janine Clayton said that while many scientists have already expressed support for the policy change, she has also heard from many sources that it needs “to be carefully implemented, as a true benefit to science—and not become a trivial, bureaucratic box to check.” She noted that comments in response to the RFI will guide NIH in creating “meaningful change in a deliberate and thoughtful way.”
Since NIGMS supports a significant amount of basic biomedical science that utilizes animal models and cells, we encourage our grantees to submit their input on this topic by the October 13 deadline.
UPDATE: The deadline for submitting input has been extended to October 24.
In February, we asked for input on training activities relevant to enhancing data reproducibility, which has become a very serious issue for both basic and clinical research. The responses revealed that there is substantial variation in the training occurring at institutions. One reason is that “best practices” training in skills that influence data reproducibility appears to be largely passed down from generation to generation of scientists working in the laboratory.
To increase the likelihood that researchers generate reproducible, unbiased and properly validated results, NIGMS and nine additional NIH components have issued a funding opportunity announcement to develop, pilot and disseminate training modules to enhance data reproducibility. Appropriate areas for the modules include experimental design, laboratory practices, analysis and reporting of results, and/or the influence of cultural factors such as confirmation bias in hypothesis testing or the scientific rewards system. The modules should be creative, engaging, readily accessible online at no cost and easily incorporated into research training programs for the intended audience, which includes graduate students, postdoctoral fellows and beginning faculty.
The application deadline is November 20, 2014, with letters of intent due by October 20, 2014. Applicants may request up to $150,000 in total costs to cover the entire award period. For more details, read the FAQs.
Data reproducibility is getting a lot of attention in the scientific community, and NIH is among those seeking to address the issue . At NIGMS, one area we’re focusing on is the needs and opportunities for training in areas relevant to improving data reproducibility in biomedical research. We just issued a request for information to gather input on activities that already exist or are planned as well as on crucial needs that an NIGMS program should address.
I strongly encourage you and your colleagues to submit comments by the February 28 deadline (no longer available). The information will assist us in shaping a program of small grants to support the design and development of exportable training modules tailored for graduate students, postdoctoral students and beginning investigators.
UPDATE: NIGMS and additional NIH components have issued the Training Modules to Enhance Data Reproducibility (R25) funding opportunity announcement. The application deadline is November 20.