Bolstering Trust in Science Through Rigorous Standards

Scientists have long considered the research process to be self-correcting; we trust that, even if scientists may sometimes make errors in the lab, those errors will eventually be discovered and corrected as others try to substantiate and extend original research findings. However, as stated in a commentary by NIH Director Francis Collins and NIH Deputy Director Larry Tabak, “A growing chorus of concern, from scientists and laypeople, contends that the complex system for ensuring the reproducibility of biomedical research is failing and is in need of restructuring.”
There are examples that indicate that our processes have room for improvement. For example, a 2008 study …. Continue reading

Change is Coming: Updates to NIH Application Forms and Instructions

We periodically need to update our application forms and instructions to accommodate changing policy, new business needs, and sometimes (not often enough) to reduce the amount of information we ask of you. Given our constraints, we have been working to provide systems support to make the mechanics of these transitions easier for you. This particular set of changes implements a number of policy changes impacting applications submitted in 2016, which we announced in a series of recent NIH Guide notices. We would like to give you a quick overview of what is happening. …. Continue reading

Enhancing Reproducibility in NIH-supported Research through Rigor and Transparency

Nothing could be more important to our enterprise than research rigor, assuring that the results of our work are reproducible. Our conversation with you on this topic began early last year with a commentary in Nature by Francis Collins and today’s guest blogger, Larry Tabak, on the importance of reproducibility and how NIH plans to enhance it. As described in a follow-up Rock Talk post, the topic of reproducibility is not new. Evidence has shown that too many biomedical-research publications are irreproducible. Thus this topic demanded our community’s immediate attention and we have had continued dialog with and participation by you over the course of the last 18 months to describe the issue, request information, launch pilots, and craft a way forward to enhance reproducibility. Continue reading

Listening to Our Stakeholders On Considering Sex as a Biological Variable

One year ago, NIH announced a plan to adopt a new policy requiring a deliberate approach to the consideration of sex as a biological variable (SABV) in preclinical research. (Read the article, co-authored by Janine Clayton and NIH Director Francis Collins, here.) Since that moment, we have been working diligently and collaboratively inside and outside NIH to craft meaningful policy that promotes the best science. …. Continue reading

Considering Sex as a Biological Variable in Research – Your Input is Requested

We as a scientific community have made major progress toward balancing the number of men and women who volunteer as participants in biomedical research studies; in fact, women now account for roughly half of the participants in NIH-funded clinical trials. However, we haven’t seen a similar pattern in the pre-clinical research involving animals and cells. …. Thus, as announced in May, NIH intends to develop and implement policies requiring NIH applicants to consider sex as a variable in biomedical research involving animals and cells. …. today we announced a formal request for information (RFI) to get input from the research community, and others. As described in the RFI, we want to hear your thoughts on several topics – for example, whether consideration of sex as a biological variable is an issue affecting the reproducibility of research findings …. Continue reading

More on Addressing Sex Differences in Pre-clinical Studies

You likely saw the recent Nature policy article, in which NIH Director Francis Collins and NIH Office of Research on Women’s Health Director Janine Clayton discussed ways that NIH is addressing sex differences in research. As our understanding of science evolves, so do our policies that govern research. This commentary cites several studies that highlight the need to further consider sex differences in preclinical research and describes how NIH will enact new policies to expand the consideration of sex differences in research studies using animal models and cells. The article generated quite a buzz in the community, and I wanted to take this opportunity to explain the roll out of our implementation plan. …. Continue reading