Authentication of Key Biological and/or Chemical Resources in NIH Grant Applications

The fourth and final segment in our series on rigor and transparency in research grant and career development award applications focuses on authentication of key biological and/or chemical resources. Research performed with unreliable or misidentified resources can negate years of hard work and eliminate any chance for a study to be reproduced or expanded upon. For this reason, it is imperative that researchers regularly authenticate key resources used in their research. …. Continue reading

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Consideration of Relevant Biological Variables in NIH Grant Applications

In part three of our series on rigor and transparency in research grant and career development award applications, we focus on consideration of relevant biological variables. Updated instructions for the Approach section of the Research Strategy ask the applicant to: …. Continue reading

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Scientific Rigor in NIH Grant Applications

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. ….. Continue reading

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Scientific Premise in NIH Grant Applications

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. …. Continue reading

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Updates on Addressing Rigor in Your NIH Applications

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). …. Continue reading

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What Does It Mean to Consider Sex as a Relevant Biological Variable in Your NIH Grant Application?

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. …. Continue reading

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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

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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

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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

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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

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