In part two of our series on rigor and transparency in research grant and career development award applications, we focus on scientific rigor, the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation, and reporting of results. …..
The NIH recently implemented updates to research grant and career development award applications aimed at enhancing reproducibility through rigor and transparency with a focus on four areas: scientific premise, rigorous experimental design, consideration of relevant biological variables, and authentication of key biological and/or chemical resources. This post is the first in a series addressing each of these four areas, starting with scientific premise. ….
As NIH moves ahead with implementing measures to enhance rigor, transparency and reproducibility in NIH-supported research, I’d like to give a brief update on these efforts, and highlight some important timeline changes for implementation in applications for institutional training grants (T), institutional career development awards (K12), and individual fellowships (F). ….
In 2014, NIH announced plans for policy changes to ensure that NIH-supported investigators consider relevant measures, including sex as a biological variable (SABV), in preclinical research. NIH solicited feedback through a request for information, and we invited the research community to participate in workshops and resource development. These activities led to new guidelines for addressing SABV as an aspect of rigor and reproducibility in NIH research project grant applications and mentored career development award applications due January 25, 2016, and beyond. As you prepare applications and think about addressing the new instructions we wanted to offer some reminders about the policy’s origin, and about the application and review information. In particular, we wanted to point out what including SABV does not mean. ….
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 ….
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. ….
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.
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. ….
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 ….
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. ….